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Monday, February 12
9:00am
Immuno-Oncology Milestones to Come: Pipelines Beyond CAR-T 1.0
Sadik Kassim; Tito A. Serafini, Atreca, Inc.; Charles J. Link, Jr. MD, NewLink Genetics; Didier Landais, Servier; Samuele Butera, Novartis Oncology; Asthika Goonewardene, Bloomberg Intelligence; Adelene Q. Perkins, Infinity Pharmaceuticals Inc. show more Time Monday, Feb 12 9:00AM - 10:15AM Location Salon 4 Speakers Sadik Kassim Tito A. Serafini Atreca, Inc. Charles J. Link, Jr. MD NewLink Genetics Didier Landais Servier Samuele Butera Novartis Oncology Asthika Goonewardene Bloomberg Intelligence Adelene Q. Perkins Infinity Pharmaceuticals Inc.
Landos Biopharma
Josep Bassaganya-Riera, Landos Biopharma show more Company Description/Mission Statement Landos Biopharma is an emerging biopharmaceutical company focused on developing improved treatments for autoimmune diseases, including inflammatory bowel disease (IBD), Crohn's disease and ulcerative colitis. Landos focuses its development efforts in a novel target pathway called Lanthionine Synthetase C-Like 2 (LANCL2), which has shown promise for the treatment of autoimmune diseases by engaging a unique mechanism of action that exerts potent anti-inflammatory effects. Landos’ lead product BT-11 is a first-in-class, orally active, locally-acting therapeutic for treatment of Crohn’s disease and ulcerative colitis that has shown benign safety profile in animal models and is advancing toward an Investigational New Drug (IND) filing. BT-11 intercepts IBD by decreasing the production of inflammatory mediators and increasing anti-inflammatory molecules within the gastrointestinal tract. BT-11 expect IND filing in 1H:18 with Phase 1 clinical testing expected to be completed in 2019. Time Monday, Feb 12 9:00AM - 9:15AM Location Gilbert Speakers Josep Bassaganya-Riera Landos Biopharma
TAHO Pharmaceuticals Ltd.
Catherine Lee, TAHO Pharmaceuticals Ltd. show more Company Description/Mission Statement TAHO is a specialty pharma focus on identifying, and developing new products that offer better therapeutic options to patient populations that may be under served. By utilizing company’s technology platform, it offers service niches in drug delivery. TAHO’s transdermal delivery platform allows the active ingredient to be absorbed by the skin and distributed through the bloodstream. It transform the patient care by: 1. Continuous delivery, safe, reliable, and pain-free application 2. Improved convenience, tolerability, and dosing 3. Flexible drug administration TAHO’s transmucosal delivery system, delivery the drug as a thin film, an evolution from tablets or capsules. It is a better patient care with: 1. Convenient dosing, no water needed 2. No risk of choking 3. Taste masking Time Monday, Feb 12 9:00AM - 9:15AM Location Wilder Speakers Catherine Lee TAHO Pharmaceuticals Ltd.
Viking Therapeutics, Inc.
Brian Lian, Viking Therapeutics, Inc. show more Company Description/Mission Statement Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders. The company's R&D activities leverage its expertise in metabolism to develop innovative therapeutics to improve patients' lives. Viking has exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, which are based on small molecules licensed from Ligand Pharmaceuticals. The company's clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator (SARM), in development for the treatment and prevention of lean body mass loss in patients who have undergone hip fracture surgery, and VK2809, a small molecule thyroid beta agonist in development for hypercholesterolemia and non-alcoholic fatty liver disease. Phase 2 results for VK5211 were announced in Q4 2017. Phase 2 data for VK2809 is expected in H1 2018. Time Monday, Feb 12 9:00AM - 9:15AM Location Odets Speakers Brian Lian Viking Therapeutics, Inc.
9:15am
Enterome SA
Pierre Belichard, Enterome SA show more Company Description/Mission Statement Enterome is a clinical-stage company specialized in the discovery and development of drugs with novel modes of action relating to defects of the gut Microbiome. Our pipeline is comprising a Phase 1 program, and 6 discovery small-molecule and peptide programs in IBD, Cancer,… Some of these programs are partnered with companies like BMS, J&J, or Takeda. Enterome has 40 employees, operating from its Paris, France headquarters and having a business office in Cambridge US. Time Monday, Feb 12 9:15AM - 9:30AM Location Gilbert Speakers Pierre Belichard Enterome SA
Hemispherx Biopharma, Inc.
show more Company Description/Mission Statement Hemispherx Biopharma, Inc. (NYSE MKT: HEB) is an advanced specialty pharmaceutical company. The company’s patented core technology applies a unique approach to helping patient immune systems at the cellular level that may improve treatment for a wide range of diseases. The first product using this technology, Alferon N Injection®, is already FDA approved in the U.S. for the treatment of refractory genital HPV, with sales expected to begin in their new high volume manufacturing facility once it has a successful pre-approval inspection by the FDA. The company has also received six orphan drug designations that potentially provide market exclusivity for its product candidates for treating Myalgic Encephalomyelitis (ME)/(CFS), HIV, Melanoma, Renal Cell Carcinoma, Ebola Virus Disease and (MERS). Additionally, the company's product candidate, Ampligen®, for Ovarian and Colorectal Cancers, Renal Cell Carcinoma and Melanoma Cancers are at the Phase I/II stages of clinical testing for approval. Time Monday, Feb 12 9:15AM - 9:30AM Location Wilder
Immune Pharmaceuticals Inc.
Elliot Maza, Immune Pharmaceuticals Inc. show more Company Description/Mission Statement Immune Pharmaceuticals Inc. is a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases. Immune’s lead program, bertilimumab, is a first-in-class, fully human monoclonal antibody that targets and lowers levels of eotaxin-1, a chemokine that plays a role in immune responses and attracts eosinophils to the site of inflammation. By neutralizing eotaxin-1, bertilimumab may prevent the migration of eosinophils and other cells, thus helping to relieve associated inflammatory conditions. Currently, Immune is conducting two phase 2 clinical trials to test bertilimumab in patients suffering from bullous pemphigoid and ulcerative colitis, respectively. Bertilimumab may have application in other diseases, including atopic dermatitis, immune and inflammatory hepatitis, and asthma. Immune is also developing NanoCyclo, a topical formulation of cyclosporine for atopic dermatitis and psoriasis, in late stage preclinical development. Time Monday, Feb 12 9:15AM - 9:30AM Location Ziegfeld Speakers Elliot Maza Immune Pharmaceuticals Inc.
Serina Therapeutics, Inc.
Randall Moreadith, Serina Therapeutics, Inc. show more Company Description/Mission Statement Serina Therapeutics, Inc. has developed a proprietary drug delivery polymer technology based upon the polymer poly(2-oxazoline), or POZ™. We are developing a pipeline of proprietary and partnered programs applying this platform to cancer, pain, refractory epilepsy, and movement disorders such as Parkinson’s disease and restless leg syndrome. Time Monday, Feb 12 9:15AM - 9:30AM Location Brecht Speakers Randall Moreadith Serina Therapeutics, Inc.
9:30am
OrphoMed, Inc.
Nikhilesh Singh, OrphoMed, Inc. show more Company Description/Mission Statement First-in-Class Dimer Therapeutics to Bring Relief to Patients with Gastrointestinal Disorders. Time Monday, Feb 12 9:30AM - 9:45AM Location Gilbert Speakers Nikhilesh Singh OrphoMed, Inc.
Probiodrug AG
Konrad Glund, Probiodrug AG show more Company Description/Mission Statement Headquartered in Halle (Saale), Germany, Probiodrug AG (Euronext Amsterdam: PBD) is a biopharmaceutical company focused on the development of new therapeutic products for the treatment of Alzheimer’s disease (AD). Probiodrug has identified a new therapeutic concept linked to disease initiation and progression. The development approaches are targeting a key neuro/synaptotoxic component of the pathology, pyroglutamate-Abeta (pGlu-Abeta, N3pG) as a therapeutic strategy. Its lead product, PQ912, has successfully completed a Phase 2a study. The company is also developing PBD-C06, an anti pGlu-Abeta specific monoclonal antibody. The Company has medical use and composition of matter patents related to the inhibition of QC and anti pGlu-Abeta specific monoclonal antibodies, and has, in the Company’s view, a leading position in this field of research. Founded in 1997 by Hans-Ulrich Demuth and Konrad Glund, the company successfully developed a novel therapeutic concept f Time Monday, Feb 12 9:30AM - 9:45AM Location Wilder Speakers Konrad Glund Probiodrug AG
9:45am
Anavex Life Sciences Corp.
Christopher U. Missling, Anavex Life Sciences Corp. show more Company Description/Mission Statement Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of sigma-1 receptor therapeutics that target cellular homeostasis. Anavex holds the potential to treat several severe, often devastating, genetically caused neurological disorders. Anavex’s lead drug candidate, ANAVEX®2-73, recently completed a successful Phase 2a clinical trial for Alzheimer’s disease. ANAVEX2-73 has also received Orphan Drug Designation from the FDA for Rett syndrome. The Company is working closely with Michael J. Fox Foundation and Rettsyndrome.org and has received grants from both organizations. Double-blind placebo controlled studies for ANAVEX2-73 in Rett syndrome, Parkinson's disease and Alzheimer's disease are advancing. Time Monday, Feb 12 9:45AM - 10:00AM Location Wilder Speakers Christopher U. Missling Anavex Life Sciences Corp.
Graybug Vision, Inc
Jeffrey Cleland, Graybug Vision, Inc. show more Company Description/Mission Statement To reduce the burden of treatment for patients with vision-threatening diseases through the development of injectable therapeutics that enable less frequent intervention and improve medical delivery for the physician. Time Monday, Feb 12 9:45AM - 10:00AM Location Gilbert Speakers Jeffrey Cleland Graybug Vision, Inc.
H3 Biomedicine
show more Company Description/Mission Statement H3 Biomedicine is a leading company in cancer genomics based drug discovery, delivering on the promise of precision medicine. The company was launched in 2011 with an unprecedented $200 million funding commitment from Eisai plus additional funding for clinical programs. As a clinical-stage biopharmaceutical company, we uniquely leverage our distinct insights from cancer genomics and real-life patient data to advance our projects to clinical proof of concept and beyond. H3 embraces a novel business model in which it collaborates with Eisai, a leading global pharmaceutical company to create a prolific drug discovery engine and partnership platform. Time Monday, Feb 12 9:45AM - 10:00AM Location Odets
Mikro Biyosistemler Elektronik Sanayi ve Ticaret AŞ
Haluk Külah, Mikro Biyosistemler Elektronik Sanayi ve Ticaret AŞ show more Company Description/Mission Statement Mikro Biyosistemler is a spin-off from METU, Turkey and develops tagCTC, a lab-on-a-chip platform for Circulating Tumor Cell isolation for cancer diagnosis and prognosis, with competitive edge on performance, cost, and time-to-result. The unique selling propositions are high purity viable CTC collection at the output and prompt cell count with minimal hand-on time. tagCTC will be in the market in 2020 as a Research Use Only purpose product. The company received seed investment through European Investment Fund, and seeks for Series A investment round for completing the clinical validation studies of tagCTC, as it is targeted to be used as an IVD device. Time Monday, Feb 12 9:45AM - 10:00AM Location Brecht Speakers Haluk Külah Mikro Biyosistemler Elektronik Sanayi ve Ticaret AŞ
10:00am
Axsome Therapeutics
show more Company Description/Mission Statement Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel medicines for the management of central nervous system (CNS) disorders. Time Monday, Feb 12 10:00AM - 10:15AM Location Wilder
ContraVir Pharmaceuticals
James Sapirstein, ContraVir Pharmaceuticals show more Company Description/Mission Statement ContraVir is developing a portfolio of novel compounds against hepatitis B, including TXL™, a highly potent prodrug of the antiviral tenofovir (active component of both Vemlidy® and Viread®), now in Phase 2 trials, and CRV431, a next generation cyclophilin inhibitor advancing into clinical development. Time Monday, Feb 12 10:00AM - 10:15AM Location Ziegfeld Speakers James Sapirstein ContraVir Pharmaceuticals
InteRNA Technologies B.V.
show more Company Description/Mission Statement Breakthrough miRNA therapeutics tackling cancer. Using its leading microRNA (miRNA) discovery and functional validation platform, InteRNA is developing a pipeline of proprietary preclinical miRNA drug candidates targeting key processes in cancer initiation and progression. Enabled with a 3rd generation drug delivery formulation, these miRNA compounds can mount a coordinated anti-cancer attack by engaging multiple signal transduction targets simultaneously. Lead development candidate, INT-1B3, represents a new approach to the immunotherapy of cancer. Time Monday, Feb 12 10:00AM - 10:15AM Location Odets
Ocugen, Inc.
Shankar Musunuri, Ocugen, Inc. show more Company Description/Mission Statement Ocugen, Inc. is a rapidly growing, clinical stage biopharmaceutical company dedicated to developing innovative therapies and novel biologics for rare and underserved ocular disorders. Ocugen is aggressively pursuing new treatments for ocular graft versus host disease (OCU300), dry eye disease (OCU310), retinitis pigmentosa (OCU100) and wet AMD (OCU200). The Company's lead programs OCU300 and OCU310 are being developed through the FDA’s 505(b)(2) pathway and expected to enter pivotal clinical trials in 2018. Time Monday, Feb 12 10:00AM - 10:15AM Location Gilbert Speakers Shankar Musunuri Ocugen, Inc.
OncoQuest, Inc.
Hany Awadalla, OncoQuest, Inc. show more Company Description/Mission Statement We are a clinical development stage immunotherapy company focused on oncology. Our lead asset is an anti-CA-125 antibody, oregovomab, which has recently completed a 97-patient randomized controlled trial in frontline ovarian cancer, for which there has been no change in the standard of care (chemotherapy) for the past 20 years. Our trial showed a greater than 3x PFS benefit and our interim results were presented at ASCO 2017. We are expecting to present our data to the FDA and move forward later this year with a registration trial. In addition, we are looking at the use of oregovomab in combination with other drugs in the recurrent setting of ovarian cancer. We are testing the drug with a PD-1 inhibitor, nivolumab, a PARP inhibitor, niraparib, and an immune adjuvant. In addition, we are proceeding with a phase 1/phase 2 with MSKCC in pancreatic cancer using our anti-MUC1 antibody. Largest investor is Shenzhen Hepalink, which invested $13 million for Chinese rights to our portfolio. Time Monday, Feb 12 10:00AM - 10:15AM Location Brecht Speakers Hany Awadalla OncoQuest, Inc.
10:15am
AzurRx BioPharma, Inc.
show more Company Description/Mission Statement AzurRx BioPharma is a development stage biopharmaceutical company (NASDAQ: AZRX) focused on the development of recombinant proteins for the treatment of gastrointestinal diseases and microbiome related conditions. Our therapeutic products will be administered to patients as oral non-systemic biologics. The company currently has two products in its pipeline: MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (for cystic fibrosis and chronic pancreatitis patients) and AZX1101, a recombinant enzyme for the prevention of hospital-acquired C.difficile infections. The company is headquartered in New York City, with scientific operations in Langlade, France. Time Monday, Feb 12 10:15AM - 10:30AM Location Ziegfeld
CytRx Corporation
Steven Kriegsman, CytRx Corporation show more Company Description/Mission Statement CytRx Corporation is a biopharmaceutical company specializing in research and clinical development of novel anti-cancer drug candidates that employ linker technologies to enhance the accumulation and release of drug at the tumor. Aldoxorubicin, CytRx's most advanced drug conjugate, is an improved version of the widely used chemotherapeutic agent doxorubicin and has been out-licensed to NantCell, Inc. CytRx is also rapidly expanding its pipeline of ultra-high potency oncology candidates at its laboratory facilities in Freiburg, Germany, through its LADR™ (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage CytRx's expertise in albumin biology and linker technology for the development of a new class of potential breakthrough anti-cancer therapies. Time Monday, Feb 12 10:15AM - 10:30AM Location Odets Speakers Steven Kriegsman CytRx Corporation
MangoGen Pharma
Paul Plested, MangoGen Pharma show more Company Description/Mission Statement MangoGen Pharma Inc is a start-up bio-engineering company that is a spin-out of McGill University, Montréal, Québec, Canada. MangoGen Pharma holds the sole rights to a patent that describes a mechanism to repair and accelerate wound repair using a genetically modified baculovirus* (insect virus) that is protected from serum inactivation. The protected baculovirus is either coated onto a medical device or formulated into a cream/gel. MangoGen is looking for a visionary investor who can see the potential of baculovirial-delivered gene-delivery across a multitude of medical avenues. MangoGen is looking for Series A round of US$15 million to develop lead product (gene-delivering cardiac stent) and establish a pipeline of wound healing gene-delivering creams/gels and sutures. Mangogen's is also looking for strategic partners to aid development of products using our innovative gene-delivering platform technology. Time Monday, Feb 12 10:15AM - 10:30AM Location Brecht Speakers Paul Plested MangoGen Pharma
NEWRON PHARMACEUTICALS SPA
STEFAN WEBER, NEWRON PHARMACEUTICALS SPA show more Company Description/Mission Statement Newron is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Italy. Xadago® has received marketing authorization for the treatment of Parkinson’s disease in the EU, Switzerland and the USA, and is commercialized by our Partner Zambon. US WorldMeds holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. In addition, we have a strong pipeline of promising treatments for rare disease patients at various stages of clinical development, including sarizotan for patients with Rett syndrome and ralfinamide for patients with specific rare pain indications. Newron is also developing Evenamide as the potential first addon therapy for the treatment of patients with positive positive symptoms of schizophrenia. Time Monday, Feb 12 10:15AM - 10:30AM Location Wilder Speakers STEFAN WEBER NEWRON PHARMACEUTICALS SPA
Sigilon Therapeutics Inc
Devyn Smith, Sigilon Therapeutics Inc show more Company Description/Mission Statement Sigilon Therapeutics, Inc is pioneering technologies that will harness the full power of cell therapeutics. Our proprietary Afibromer™ (afibrotic polymers which do not trigger a fibrotic response) technology allows a new category of therapeutic with extremely broad potential: encapsulated cell therapeutics that do not require immunosuppression. Sigilon Therapeutics’ cell-driven therapeutics are designed to have advantages over traditional biologic therapies, including improved outcomes over current care, restore protein levels at a constant rate, provide years of therapy without need of redosing, safe and reversible therapeutic modality, deliver proteins for previously untreatable diseases. These advantages are broadly applicable to a variety of biologics and treatment modalities and should provide significant clinical outcome benefits and free patients from therapies that are disruptive to quality of life. Time Monday, Feb 12 10:15AM - 10:30AM Location Gilbert Speakers Devyn Smith Sigilon Therapeutics Inc
10:30am
Conatus Pharmaceuticals Inc.
Steven Mento, Conatus Pharmaceuticals Inc. show more Company Description/Mission Statement Conatus is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease. In collaboration with Novartis, Conatus is developing its lead compound, emricasan, for the treatment of patients with chronic liver disease. Emricasan is a first-in-class, orally active pan-caspase inhibitor designed to reduce the activity of enzymes that mediate inflammation and apoptosis. Conatus believes that by reducing the activity of these enzymes, caspase inhibitors have the potential to interrupt the progression of a variety of diseases. In December 2016, Conatus announced an exclusive option, collaboration and license agreement with Novartis for the global development and commercialization of emricasan. In May 2017, Conatus announced that Novartis had exercised its license option. Conatus is also developing an independent pipeline based on its leadership in caspase inhibition and exploring in-licensing opportunities consistent with its expertise. Time Monday, Feb 12 10:30AM - 10:45AM Location Ziegfeld Speakers Steven Mento Conatus Pharmaceuticals Inc.
gel-e, Inc.
Larry Tiffany, gel-e show more Company Description/Mission Statement gel-e is a clinical-stage medical device company developing versatile hemostatic products for surgical, medical, and consumer applications. With an initial focus on external wounds, gel-e combines the use of safe, inert ingredients with proprietary chemistry that can be designed for use across a broad spectrum of clinical applications, including vascular closure and during surgery. Time Monday, Feb 12 10:30AM - 10:45AM Location Brecht Speakers Larry Tiffany gel-e
Jeffrey D. Marrazzo, Co-Founder and Chief Executive Officer, Spark Therapeutics
Jeffrey D. Marrazzo, Spark Therapeutics; Erin McCallister, BioCentury show more Session Description Jeff Marrazzo has led the creation and growth of Spark Therapeutics from a research center within the Children's Hospital of Philadelphia to a fully integrated gene therapy company that is challenging the inevitability of genetic disease by discovering, developing and delivering potential treatments in ways unimaginable – until now. He also serves on Spark’s board of directors. Under Jeff's leadership, Spark has successfully completed the first randomized, controlled Phase 3 trial of an investigative gene therapy for a genetic disease and established human proof-of-concept of Spark’s gene therapy platform in both the retina and the liver. The company is currently preparing the first Biologics License Application submission for a gene therapy for a genetic disease in the U.S. In the three years since founding Spark, Jeff has raised more than $500 million in capital, established a global collaboration with Pfizer, and built an organization of nearly 200 colleagues. During a career that has spanned the public and private sectors, Jeff has consistently championed the potential benefits of precision medicine and healthcare reform for patients. Prior to Spark, he helped build and sell the first genetic testing benefit management and pharmacogenomics medicines company to CVS Caremark. Previously, Jeff served as an advisor to former Pennsylvania Governor Edward G. Rendell, where he led reforms in the financing and delivery of healthcare. Jeff received a B.A. in economics and B.S.E. in systems science and engineering from the University of Pennsylvania. He also holds a dual M.B.A. / M.P.A. from The Wharton School of the University of Pennsylvania and Harvard University, a program which he founded. Time Monday, Feb 12 10:30AM - 11:25AM Location Salon 2 Speakers Jeffrey D. Marrazzo Spark Therapeutics Erin McCallister BioCentury
MaxCyte, Inc.
Douglas Doerfler, MaxCyte, Inc. show more Company Description/Mission Statement MaxCyte is an early stage drug development company with a novel and proprietary platform for next-generation chimeric antigen receptor (CAR) cell therapies. Our CAR platform, provides several unique attributes over existing autologous CAR-T products and platforms. First, MaxCyte’s CAR platform offers the potential to deliver therapy to the patient in in a fraction of the time with less complexity of other autologous CAR-T products. This is due to a more streamlined manufacturing process without the complexity of virus-based products. Second, MaxCyte’s unique CAR autologous cell therapies are differentiated from traditional CAR therapy by its use of human messenger RNA (mRNA) to engineer the immune cells that are delivered back into a patient, without the need for a viral component. Our platform provides for transient expression, as shown in preclinical studies, to control the adverse side-effects seen in first-generation, viral-based CAR therapies. Time Monday, Feb 12 10:30AM - 10:45AM Location Odets Speakers Douglas Doerfler MaxCyte, Inc.
SQZ Biotechnologies
Armon Sharei, SQZ Biotechnologies show more Company Description/Mission Statement SQZ Biotechnologies is a privately held company founded out of MIT advancing cellular therapies toward clinical testing using its proprietary CellSqueeze® technology. The cell engineering platform enables temporary membrane disruption to deliver a diversity of materials (such as proteins, peptides, carbohydrates, nucleic acids, small molecule drugs, and nanoparticles) into a wide variety of cells (immune cells, stem cells, cancer cell lines, and red blood cells) with minimal impact on function and viability. SQZ’s unique cell engineering capabilities enable development of next-generation cell therapies to transform patient lives. Lead programs are focused on antigen presenting cells (APCs) with applications in oncology, including a Roche-partnered program, enzyme replacement therapies (ERT), and tolerization with applications in autoimmune diseases, including T1D research recently invested in by the JDRF T1D fund. The Company anticipates IND filings for up to 2 of its programs in 2018. Time Monday, Feb 12 10:30AM - 10:45AM Location Gilbert Speakers Armon Sharei SQZ Biotechnologies
Tonix Pharmaceuticals Holding Corp.
Seth Lederman, Tonix Pharmaceuticals Holding Corp. show more Company Description/Mission Statement Tonix Pharmaceuticals (Tonix) is developing innovative pharmaceutical and biological products to address major public health challenges. Tonix’s lead product candidate, Tonmya, is in Phase 3 development for the treatment of PTSD at bedtime daily. TNX-601 (tianeptine oxalate) is in the pre-IND (Investigational New Drug) application stage, also for the treatment of PTSD but designed for daytime dosing. Tonix is also developing TNX-801, a potential smallpox-preventing vaccine based on a live synthetic version of horsepox virus, currently in the pre-IND application stage. Time Monday, Feb 12 10:30AM - 10:45AM Location Wilder Speakers Seth Lederman Tonix Pharmaceuticals Holding Corp.
10:45am
Alnylam Pharmaceuticals, Inc.
John Maraganore, Alnylam Pharmaceuticals, Inc. show more Company Description/Mission Statement Alnylam (Nasdaq:ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare genetic, cardio-metabolic, and hepatic infectious diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of severe and debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust discovery platform and deep pipeline of investigational medicines, including four product candidates that are in late-stage development. Looking forward, Alnylam will continue to execute on its "Alnylam 2020" strategy of building a multi-product, commercial-stage biopharmaceutical company with a sustainable pipeline of RNAi-based medicines to address the needs of patients who have limited or inadequate treatment options. Time Monday, Feb 12 10:45AM - 11:00AM Location Wilder Speakers John Maraganore Alnylam Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals, Inc.
Spiro Rombotis, Cyclacel Pharmaceuticals, Inc. show more Company Description/Mission Statement Cyclacel Pharmaceuticals, Inc. is a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. Time Monday, Feb 12 10:45AM - 11:00AM Location Odets Speakers Spiro Rombotis Cyclacel Pharmaceuticals, Inc.
NeuroActiva, Inc.
show more Company Description/Mission Statement NeuroActiva, Inc. is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of new drugs to treat Alzheimer’s disease. We have 2 drugs, which are clinical trials for the treatment of Alzheimer’s disease: 1. Traneurocin (NA-831), a novel neuroprotective and neurogenesis agent for treatment of Alzheimer's disease. NA-831 is an endogenous compound, i.e. already in existence in the brain. It has an excellent safety profile with no toxicity observed. Phase 2 will start in June 2018. 2. Vineurocin (NA-704) is a recombinant human growth hormone that modulates the aging process in humans. NA-704 exhibits neuroprotection and neurogenesis, which has been demonstrated as a strong candidate for the treatment of Alzheimer’s disease. The Phase 2 will start in September 2018. NA-704 will be administered with a new FDA approved controlled-release intravenous drug delivery system, known as the MICROS in home care settings. Time Monday, Feb 12 10:45AM - 11:00AM Location Brecht
RedHill Biopharma Ltd.
Dror Ben-Asher, RedHill Biopharma show more Company Description/Mission Statement RedHill Biopharma Ltd. (NASDAQ / Tel-Aviv Stock Exchange: RDHL) is a specialty biopharmaceutical company, primarily focused on the development and commercialization of late clinical-stage, proprietary drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill promotes three gastrointestinal products in the U.S. and its clinical stage pipeline includes treatments for gastrointestinal indications, pancreatic cancer and acute migraines. Time Monday, Feb 12 10:45AM - 11:00AM Location Ziegfeld Speakers Dror Ben-Asher RedHill Biopharma
Scientist.com
show more Company Description/Mission Statement Scientist.com is the world's leading marketplace for outsourced research. The marketplace simplifies the entire research sourcing process, saving time and money and providing access to the latest innovative tools and technologies while maintaining full compliance with an organization’s procurement policies. Scientist.com operates private enterprise marketplaces for most of the world’s major pharmaceutical companies, VWR and the US National Institutes of Health (NIH). Time Monday, Feb 12 10:45AM - 11:00AM Location Gilbert
11:00am
Gila Therapeutics, Inc.
Thomas Vasicek, Gila Therapeutics, Inc. show more Company Description/Mission Statement We are developing treatments for obesity based on topical application to the tongue of natural satiety hormones, such as PYY, that normally make us feel full after we eat. We provide PYY before you eat, to help you feel full sooner so that you’ll eat less and lose weight. PYY is made by special cells in the small intestines & secreted into the bloodstream in response to food intake. Shortly after blood levels rise, PYY appears in saliva activating receptors, signaling directly to the brain’s satiety centers, just as salt & sugar activate taste receptors. Application to the tongue in obese mice makes them eat less & lose weight, about 23% over eight weeks. In our clinical trial, we observed no safety or tollerability issues and a significant efficacy signal: a persistent feeling of fullness, twice as strong as the top drug on the market today. Time Monday, Feb 12 11:00AM - 11:15AM Location Brecht Speakers Thomas Vasicek Gila Therapeutics, Inc.
Infinity Pharmaceuticals, Inc.
Adelene Q. Perkins, Infinity Pharmaceuticals Inc. show more Company Description/Mission Statement Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is developing IPI-549, an oral immuno-oncology development candidate that selectively inhibits PI3K-gamma. A Phase 1 study in patients with advanced solid tumors is ongoing. For more information on Infinity, please refer to Infinity’s website at www.infi.com. Time Monday, Feb 12 11:00AM - 11:15AM Location Odets Speakers Adelene Q. Perkins Infinity Pharmaceuticals Inc.
Leading BioScieces
Tom Hallam, Leading BioSciences show more Company Description/Mission Statement Leading BioSciences is developing innovative medicines that improve a multitude of disorders arising from the gastrointestinal tract. Leading BioSciences is a clinical-stage biopharmaceutical company advancing a novel therapeutic that addresses the breakdown of the intestinal mucosal barrier — a process believed to drive a range of serious health conditions in need of effective treatment. The Company’s most advanced therapeutic candidate, LB1148 (a next generation Bowel Prep), is a small-molecule therapeutic in Phase 2 trial that is designed for use prior to CV, GI and abdominal surgery. Phase 2 clinical results demonstrated that LB1148 can improve GI recovery and reduce hospital length of stay following cardiovascular surgery. LB1148 achieved a statistically significant improvement in the same GI end-point that allowed for approval of Merck’s Entereg (Alvimopan), yet with minimal adverse events. Time Monday, Feb 12 11:00AM - 11:15AM Location Ziegfeld Speakers Tom Hallam Leading BioSciences
Orig3n, Inc.
Robin Smith, Orig3n, Inc. show more Company Description/Mission Statement Orig3n exists at the intersection of biology and emerging technology, advancing the future of health through regenerative medicine and genetic testing. Orig3n is pursuing allogeneic, iPSC-derived, cell therapy programs in a variety of indications in the pre-clinical setting. Leveraging our proprietary, crowdsourced, fully-consented cell bank, we have identified cell lines that are matched to the immune profiles of 90% of the US population. We are developing complimentary cell manufacturing capabilities. Orig3n also offers a large suite of direct-to-consumer genetic tests, the revenues from which are directed to supporting its cell therapy programs. The founding team are successful serial entrepreneurs with 60+ years of experience in the life sciences. The founders have 3 prior successful exits - the two most recent were VC-backed and both sold to publicly traded companies. The most recent exit provided a 24:1 return and 74% IRR to investors. Time Monday, Feb 12 11:00AM - 11:15AM Location Gilbert Speakers Robin Smith Orig3n, Inc.
PAION AG
Wolfgang Söhngen, PAION AG show more Company Description/Mission Statement PAION AG is a publicly listed specialty pharmaceutical company developing and aiming to commercialize innovative drugs to be used in out-patient and hospital-based sedation, anesthesia and critical care services. PAION’s lead compound is remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic drug candidate which is in the final stage of clinical development for use in procedural sedation in the U.S. PAION is headquartered in Aachen (Germany) with a further site in Cambridge (United Kingdom). PAION's vision is to become an acknowledged “PAIONeer” in sedation and anesthesia. Time Monday, Feb 12 11:00AM - 11:15AM Location Wilder Speakers Wolfgang Söhngen PAION AG
11:15am
Association for Women in Science (AWIS)
Heather Metcalf, Association for Women in Science show more Company Description/Mission Statement Time Monday, Feb 12 11:15AM - 11:30AM Location Ziegfeld Speakers Heather Metcalf Association for Women in Science
Can-Fite BioPharma Ltd.
show more Company Description/Mission Statement Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion dollar markets in the treatment of cancer, liver disease, inflammatory diseases, and sexual dysfunction. The Company’s lead drug candidate, Piclidenoson (CF101) is expected to enter Phase III trials in two indications, rheumatoid arthritis and psoriasis. Can-Fite’s liver drug Namodenoson (CF102) completed patient enrollment in a Phase II trial for patients with advanced liver cancer and is slated to enter Phase II for the treatment of NAFLD/NASH. Piclidenoson and Namodenoson have been out-licensed in select territories with $11.5 million received to date. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction in preclinical studies. Can-Fite’s intellectual property portfolio consists of 120 patents issued and pending. Time Monday, Feb 12 11:15AM - 11:30AM Location Wilder
ImmusanT, Inc.
Leslie Williams, ImmusanT, Inc. show more Company Description/Mission Statement ImmusanT is a privately held biotechnology company focused on protecting patients with celiac disease against the effects of gluten. By harnessing new discoveries in immunology, ImmusanT aims to improve diagnosis and medical management of celiac disease by protecting against the effects of gluten exposure while patients maintain a gluten-free diet. The company is developing Nexvax2®, a therapeutic vaccine for celiac disease, and diagnostic and monitoring tools to improve celiac disease management. ImmusanT’s targeted immunotherapy discovery platform can be applied to a variety of autoimmune diseases. Time Monday, Feb 12 11:15AM - 11:30AM Location Gilbert Speakers Leslie Williams ImmusanT, Inc.
Intensity Therapeutics, Inc.
Lewis H. Bender, Intensity Therapeutics, Inc. show more Company Description/Mission Statement Intensity Therapeutics is a clinical stage, biotechnology company whose mission is to greatly extend the lives of cancer patients. Our lead product, INT230-6, is currently in human clinical testing to treat refractory solid tumor cancers. Our new approach treats both the macro and the micro aspects of cancer. When injected directly into tumors (dose locally) our products have high tumor dispersion and cell penetration properties. These injected drug directly kills the tumor cells. The local cell death results in the creation of antigenic sites that stimulate the adaptive immune system (act globally). The immune response helps to destroy or regress the injected tumor and eliminates secondary tumors and micrometastases as well. Using our DfuseRx platform technology, we can create novel anti-cancer products for a given cancer type. Time Monday, Feb 12 11:15AM - 11:30AM Location Brecht Speakers Lewis H. Bender Intensity Therapeutics, Inc.
MabVax Therapeutics Holdings, Inc.
David Hansen, MabVax Therapeutics Holdings, Inc. show more Company Description/Mission Statement MabVax is a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer. Our focus is to continue in two major clinical development areas: (1) to advance the development of our lead program, our radioimmunotherapy product MVT-1075 which is currently enrolling patients, and (2) to enroll additional patients in our HuMab MVT-5873 antibody phase I trial in combination with gemcitabine and nab-paclitaxel in first-line therapy for pancreatic cancer. We remain on track to report interim data for both studies near the end of the year. We continue to implement strategies that will drive value for the Company and provide the additional capital resources necessary for continuing the development of our potentially transformative treatment therapies for unmet needs in cancer. Time Monday, Feb 12 11:15AM - 11:30AM Location Odets Speakers David Hansen MabVax Therapeutics Holdings, Inc.
11:30am
Abide Therapeutics
Alan Ezekowitz, Abide Therapeutics show more Company Description/Mission Statement Abide Therapeutics is a clinical-stage company committed to realizing the therapeutic value of novel serine hydrolase inhibitors by using its innovative discovery platform and translational biomarkers to transform the lives of patients with serious unmet medical needs. Abide’s initial focus is on central nervous system disorders with limited treatment options. The lead drug candidate ABX-1431, a first-in-class oral inhibitor that modulates endocannabinoid tone, recently achieved statistically significant positive Phase 1b data for Tourette Syndrome in a placebo-controlled trial. ABX-1431 is proceeding into more advanced trials and is being explored in other movement and psychiatric disorders. Additional pipeline candidates targeting the endocannabinoid system are being evaluated for other central nervous system indications. Abide’s unique platform is being further leveraged to generate first-in-class targets in multiple therapeutic areas ranging from oncology to liver diseases.  Time Monday, Feb 12 11:30AM - 11:45AM Location Gilbert Speakers Alan Ezekowitz Abide Therapeutics
Lantern Pharma Inc
show more Company Description/Mission Statement Clinical Precision Oncology Company using Proprietary Molecular Profiling and AI Engine For CDX development to Rescue and Position Acquired Late Stage Drugs. Time Monday, Feb 12 11:30AM - 11:45AM Location Brecht
NewLink Genetics
Charles J. Link, Jr. MD, NewLink Genetics show more Company Description/Mission Statement NewLink Genetics is a late-stage biopharmaceutical company focusing on discovering, developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer. NewLink Genetics' IDO pathway inhibitors are designed to harness multiple components of the immune system to combat cancer. Indoximod is being evaluated in combination with treatment regimens including anti-PD-1/PD-L1 agents, cancer vaccines, and chemotherapy across multiple indications such as melanoma, pancreatic cancer and other malignancies Time Monday, Feb 12 11:30AM - 11:45AM Location Ziegfeld Speakers Charles J. Link, Jr. MD NewLink Genetics
Progenics Pharmaceuticals, Inc.
Mark Baker, Progenics Pharmaceuticals, Inc. show more Company Description/Mission Statement Progenics develops innovative medicines and other technologies to target and treat cancer. Progenics' pipeline includes: 1) therapeutic agents designed to precisely target cancer (AZEDRA® and 1095), 2) PSMA-targeted imaging agents for prostate cancer (1404 and PyL™), and 3) imaging analysis tools. Progenics' first commercial product, RELISTOR® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with Valeant Pharmaceuticals International, Inc. Time Monday, Feb 12 11:30AM - 11:45AM Location Wilder Speakers Mark Baker Progenics Pharmaceuticals, Inc.
Sierra Oncology
Nick Glover, Sierra Oncology show more Company Description/Mission Statement Sierra Oncology is a clinical stage drug development company advancing targeted therapeutics for the treatment of patients with cancer. We are an ambitious oncology-focused company, oriented towards achieving the successful registration and commercialization of our product candidates. We have a highly experienced management team with a proven track record of success in oncology drug development and we are advancing an emerging pipeline of next generation therapies that target the DNA Damage Response (DDR) network. Time Monday, Feb 12 11:30AM - 11:45AM Location Odets Speakers Nick Glover Sierra Oncology
12:00pm
The Art of the Exit: Planning for Your Company’s Acquisition
Derek Hicks, Pfizer Inc.; Neil Warma, Opexa Therapeutics, Inc. ; Kimberly C. Petillo-Décossard, Partner, Cahill Gordon & Reindel LLP; Peter J. Collum, MTS Health Partners LP; Janelle Anderson, Versant Ventures show more Time Monday, Feb 12 12:00PM - 12:55PM Location Salon 4 Speakers Derek Hicks Pfizer Inc. Neil Warma Opexa Therapeutics, Inc. Kimberly C. Petillo-Décossard Partner, Cahill Gordon & Reindel LLP Peter J. Collum MTS Health Partners LP Janelle Anderson Versant Ventures
1:00pm
Updating Your China Growth Strategy: Opportunities in Investor and Regulatory Dynamism
Michael Keyoung, C-Bridge Capital; Kimberly Nearing, Cedrus Group; Hummer Mars, NYIC; Dan Zhang, Fountain Medical Development; Yuwen Liu; Alexandra Jung, Parthenon-EY; Joseph Damond, Biotechnology Innovation Organization show more Time Monday, Feb 12 1:00PM - 1:55PM Location Salon 4 Speakers Michael Keyoung C-Bridge Capital Kimberly Nearing Cedrus Group Hummer Mars NYIC Dan Zhang Fountain Medical Development Yuwen Liu Alexandra Jung Parthenon-EY Joseph Damond Biotechnology Innovation Organization
1:30pm
Amygdala Neurosciences, Inc.
Peter Strumph, Amygdala Neurosciences, Inc. show more Company Description/Mission Statement Mission: To Develop and Commercialize First-In-Class Pharmacotherapy for Addiction Disorders. Amygdala Neurosciences is developing ANS-6637, a novel Phase-2 ready, ALDH2 inhibitor for the treatment of opioid, alcohol and cocaine substance use disorders. Based on a published mechanism of action in the brain that prevents pathophysiologic dopamine surge and associated craving without changes to basal dopamine, ANS-6637 has the potential to prevent relapse and the acquisition of drug seeking conditioned response. In published preclinical studies, ALDH2 inhibition reduced alcohol cue- and drug-primed relapse in alcohol, cocaine, heroin, nicotine, methamphetamine and binge eating models and also demonstrated anxiolytic properties in models of stress. ANS-6637 has been studied in over 125 human subjects including the recently completed ANS-6637/alcohol interaction study. Time Monday, Feb 12 1:30PM - 1:45PM Location Gilbert Speakers Peter Strumph Amygdala Neurosciences, Inc.
BioTime
Adi Mohanty, BioTime show more Company Description/Mission Statement BioTime is a late stage clinical biotechnology company focused on developing and commercializing products addressing degenerative diseases. The Company’s current clinical programs are targeting three primary sectors: Aesthetics Ophthalmology Cell/drug delivery Its clinical programs are based on two platform technologies: pluripotent cells, which can become any type of cell in the human body, and cell/drug delivery. Time Monday, Feb 12 1:30PM - 1:45PM Location Ziegfeld Speakers Adi Mohanty BioTime
Checkpoint Therapeutics, Inc.
James Oliviero, Checkpoint Therapeutics, Inc show more Company Description/Mission Statement We are a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel, non-chemotherapy, immune-enhanced combination treatments for patients with solid tumor cancers. We aim to acquire rights to these technologies by licensing the rights or otherwise acquiring an ownership interest in the technologies, funding their research and development and eventually either out-licensing or bringing the technologies to market. Time Monday, Feb 12 1:30PM - 1:45PM Location Odets Speakers James Oliviero Checkpoint Therapeutics, Inc
Editas Medicine, Inc.
Katrine Bosley, Editas Medicine, Inc. show more Company Description/Mission Statement Editas Medicine is a leading genome editing company dedicated to treating patients with genetically-defined diseases by correcting their disease-causing genes. The Company was founded by world leaders in genome editing, and its mission is to translate the promise of genome editing science into a broad class of transformative genomic medicines to benefit the greatest number of patients. Time Monday, Feb 12 1:30PM - 1:45PM Location Wilder Speakers Katrine Bosley Editas Medicine, Inc.
Palladio Biosciences, Inc.
show more Company Description/Mission Statement Palladio Biosciences (Palladio) was formed to develop transformative medicines for Polycystic Kidney Disease (PKD), the most prevalent inherited genetic disease of the kidney and one of the largest unaddressed market opportunities in orphan diseases. Palladio's lead drug is lixivaptan, a selective, 2nd generation vasopressin V2 receptor antagonist with superior safety and efficacy properties. Vasopressin V2 receptor antagonism is clinically-validated for the treatment of PKD. Palladio acquired lixivaptan after a full NDA program had been completed by other sponsors, including Biogen, Wyeth and Cardiokine, with lixivaptan for the treatment of hyponatremia. Our clinical development plans for lixivaptan for the treatment of PKD contemplate a small, dose-defining Phase1/ 2 study to be conducted in the 1st half of 2018 followed by a pivotal registration study in the 2nd half of 2018, paving the way for a potential FDA approval of lixivaptan as early as 2021. Time Monday, Feb 12 1:30PM - 1:45PM Location Brecht
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Caladrius Biosciences, Inc.
David Mazzo , Caladrius Biosciences, Inc. show more Company Description/Mission Statement Caladrius Biosciences, Inc. is a development stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications. The Company is investigating its lead product candidate, CLBS03, an ex vivo expanded polyclonal T regulatory cell therapy for the treatment of recent-onset type 1 diabetes, in a currently enrolling Phase 2 trial. CLBS14 is Caladrius’ proprietary and patent protected formulation of CD34 cells designed specifically to enhance the potency of the CD34 cells for repair and regeneration of cardiovascular tissue. Its companion product, CLBS12, is specifically formulated for intramuscular administration for the treatment of lower extremity ischemia. Time Monday, Feb 12 1:45PM - 2:00PM Location Wilder Speakers David Mazzo Caladrius Biosciences, Inc.
Cellectar Biosciences
James Caruso, Cellectar Biosciences show more Company Description/Mission Statement Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells. Cellectar's PDC platform is based on the company's proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers & sites of metastases. Our lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 has been designated as an orphan drug and is currently being evaluated in a Phase 1 clinical study in patients with R/R multiple myeloma and a Phase 2 clinical study to assess efficacy in a range of B-cell malignancies. The company is also developing proprietary PDCs for targeted delivery of chemotherapeutic pipeline through both in-house and collaborative R&D efforts. Time Monday, Feb 12 1:45PM - 2:00PM Location Odets Speakers James Caruso Cellectar Biosciences
Genervon Biopharmaceuticals, LLC
Winston Ko, Genervon Biopharmaceuticals, LLC show more Company Description/Mission Statement Genervon Biopharmaceuticals is a late clinical stage biopharmaceutical company focusing on transformative, first-in-class treatments for neurodegenerative diseases and disorders. Recognizing the lack of curative therapies for patients suffering from CNS diseases and the multi-factorial processes involved in CNS pathways, Genervon devoted the last twenty years to research and development in pursuit of a cure. Genervon’s innovation is in treating neurodegenerative diseases and disorders by targeting the common underlying pathophysiology and multiple disease-specific pathways and genes. Genervon hypothesized and discovered a novel endogenous embryonic stage regulator, motoneuronotrophic factor (MNTF), that controls the development and correction of the nervous system. Genervon developed GM6, a 6 amino acid peptide and active analog of MNTF, which has advanced into Phase 2 clinical development and is planning late stage clinical trials for ALS, PD, AD, and MS. Time Monday, Feb 12 1:45PM - 2:00PM Location Gilbert Speakers Winston Ko Genervon Biopharmaceuticals, LLC
Oramed pharmaceuticals
Nadav Kidron , Oramed Pharmaceuticals show more Company Description/Mission Statement Oramed Pharmaceuticals has developed a proprietary platform technology for the oral delivery of injectable medications. Its flagship product, oral insulin, successfully completed Phase IIb trials under the FDA. In December 2015 Oramed signed a $50mm licensing deal with Chinese company HTIT for rights to oral insulin in Greater China. Oramed has a strong management team, backed by an international scientific advisory board. Time Monday, Feb 12 1:45PM - 2:00PM Location Ziegfeld Speakers Nadav Kidron Oramed Pharmaceuticals
2:00pm
22nd Century Group, Inc.
show more Company Description/Mission Statement 22nd Century is a plant biotechnology company with an important mission: To Reduce the Harm Caused by Smoking. Our proprietary genetic engineering technology and plant breeding expertise allow us to regulate the level of nicotine (and other nicotinic alkaloids) in the tobacco plant. As a result of our unique technology, we are able to grow tobacco with up to 97% less nicotine than conventional tobacco – as well as plants with relatively high nicotine levels. The applications for this technology are extraordinary; in independent clinical studies, our very low nicotine (VLN) tobacco has demonstrated remarkable efficacy as a smoking cessation aid. On the other hand, for smokers who do not wish to quit, our high nicotine tobacco enables us to produce a cigarette with what we believe is the world’s lowest tar-to-nicotine ratio. We have an extensive intellectual property portfolio of issued patents and patent applications relating to the tobacco and cannabis plants. Time Monday, Feb 12 2:00PM - 2:15PM Location Ziegfeld
Brainstorm Cell Therapeutics Inc
Chaim Lebovits, Brainstorm Cell Therapeutics Inc show more Company Description/Mission Statement BrainStorm Cell Therapeutics (NASDAQ:BCLI) is a biotechnology company developing innovative, autologous stem cell therapies for highly debilitating neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig’s disease), Multiple Sclerosis (MS) and Parkinson’s Disease (PD). Time Monday, Feb 12 2:00PM - 2:15PM Location Wilder Speakers Chaim Lebovits Brainstorm Cell Therapeutics Inc
Immunicum AB
Carlos de Sousa, Immunicum AB show more Company Description/Mission Statement Immunicum is establishing a unique immuno-oncology approach through the development of allogeneic, off-the-shelf cell-based therapies. Our goal is to improve survival outcomes and quality of life by priming the patient's own immune system to fight cancer. The company's lead product ilixadencel, consisting of pro-inflammatory allogeneic dendritic cells, has the potential to become a backbone component of modern cancer combination treatments in a variety of solid tumor indications. Time Monday, Feb 12 2:00PM - 2:15PM Location Odets Speakers Carlos de Sousa Immunicum AB
Lan Huang, PhD, Co-Founder, Charmain and Chief Executive Officer, BeyondSpring Pharmaceuticals
Lan Huang, PhD, BeyondSpring Pharmaceuticals; Joseph Pantginis, H. C. Wainwright and Co., LLC show more Session Description Dr. Lan Huang is Co-founder, Chairman and CEO of BeyondSpring. Dr. Huang has more than a decade of entrepreneurial experience in the Chinese and U.S. biotechnology industry and invented and holds patents for a number of biotech products for oncology and dermatology indications. In 2009, she was the recipient of China’s “Thousand Talent Innovator Award.” Prior to founding BeyondSpring, Dr. Huang co-founded Wuxi MTLH Biotechnology Co. Ltd., whose self-designed cancer peptide drug’s China rights were acquired in 2010 by Shanghai Pharmaceutical Group, one of the top three pharmaceutical companies in China. She also co-founded Paramax International, a clinical CRO company in China, which was sold to RPS (a global CRO), then to Warburg Pincus in 2011. In addition, Dr. Huang worked with Forward Ventures, where she led partnering initiatives between Forward’s portfolio companies and Chinese pharmaceutical companies. Dr. Huang was trained at Memorial Sloan Kettering Cancer Center, where her breakthrough research in solving the first E2-E3 ubiquitin ligase structure involving P53 degradation was published in Science. The immense importance of this field is illustrated by the 2004 award of the Nobel Prize in chemistry to the founders of ubiquitin-mediated protein degradation. She received her Ph.D. in chemistry in four-and-a-half years from the University of California at Berkeley, where she won the graduating Ph.D. woman award from Soroptimist International. Her translational research in cancer signaling pathways involving Ras was published in two Nature papers. Time Monday, Feb 12 2:00PM - 2:55PM Location Salon 2 Speakers Lan Huang, PhD BeyondSpring Pharmaceuticals Joseph Pantginis H. C. Wainwright and Co., LLC
Novoclem Therapeutics
Mark Schoenfisch, Novoclem Therapeutics, Inc. show more Company Description/Mission Statement Novoclem Therapeutics, Inc., a subsidiary of KNOW Bio, LLC, is an innovative, preclinical-stage pharmaceutical company focused on helping people who suffer from severe respiratory diseases to breath better and live life more fully. It is initially focused on developing a nitric oxide based treatment for people living with cystic fibrosis and infected with Pseudomonas aeruginosa. The company anticipates submitting an Investigational New Drug application and initiating First in Human clinical trials in 2018. Time Monday, Feb 12 2:00PM - 2:15PM Location Brecht Speakers Mark Schoenfisch Novoclem Therapeutics, Inc.
2:15pm
Akebia Therapeutics, Inc.
John Butler, Akebia Therapeutics, Inc. show more Company Description/Mission Statement About Akebia Therapeutics Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on delivering innovative therapies to patients with kidney disease through hypoxia-inducible factor biology. Akebia’s lead product candidate, vadadustat, is an oral, investigational therapy in development for the treatment of anemia related to chronic kidney disease in both non-dialysis and dialysis patients. Time Monday, Feb 12 2:15PM - 2:30PM Location Ziegfeld Speakers John Butler Akebia Therapeutics, Inc.
BioLife Solutions, Inc.
Mike Rice, BioLife Solutions, Inc. show more Company Description/Mission Statement We are the leading manufacturer and supplier of clinical grade biopreservation media products used in CAR T-cell and other cellular therapies targeting blood cancers, solid tumors and the leading causes of death. Over 2,000 customers; 250 customer clinical applications use our products. Our proprietary CryoStor and HypoThermosol biopreservation media products extend shelf life and improve post preservation yield of source material and manufactured cell products, enabling worldwide distribution. Time Monday, Feb 12 2:15PM - 2:30PM Location Wilder Speakers Mike Rice BioLife Solutions, Inc.
NeuroRx, Inc.
Jonathan Javitt, NeuroRx show more Company Description/Mission Statement NeuroRx has a patented, dual-targeted CNS drug platform addressing suicidal depression and PTSD. This platform targets the brain's NMDA and 5-HT2A receptors in order to reduce depressive and suicidal ideation while blocking psychotogenic side effects and akathisia. The Company's first drug, NRX-101, a fixed-dose combination of D-cycloserine and lurasidone has been awarded Breakthrough Therapy Designation by the FDA and has entered phase 3 trials under a Special Protocol Agreement. Phase 2 studies identified a 50% reduction in depression and a 75% reduction in suicidal ideation. Data readout is expected by year end 2018 with potential for NDA filing in 2019. NeuroRx's IP portfolio covers the combination of numerous NMDA antagonists and 5-HT2A antagonists. These combinations are designed to target suicidal bipolar depression, PTSD, and major depressive disorder. Biomarker studies demonstrate that NeuroRx antidepressant activity is associated with elevation of Glx in the brain. Time Monday, Feb 12 2:15PM - 2:30PM Location Gilbert Speakers Jonathan Javitt NeuroRx
RXi Pharmaceuticals Corporation
Geert Cauwenbergh, RXi Pharmaceuticals Corporation show more Company Description/Mission Statement RXi Pharmaceuticals Corporation (NASDAQ: RXII) is a clinical-stage company developing innovative therapeutics that address significant unmet medical needs. Building on the pioneering discovery of RNAi, scientists at RXi have harnessed the naturally occurring RNAi process which can be used to "silence" or down-regulate the expression of a specific gene that may be overexpressed in a disease condition. RXi developed a robust RNAi therapeutic platform, including self-delivering RNA (sd-rxRNA®) compounds, that have the ability to highly selectively block the expression of any target in the genome, thus providing applicability to many therapeutic areas. Time Monday, Feb 12 2:15PM - 2:30PM Location Odets Speakers Geert Cauwenbergh RXi Pharmaceuticals Corporation
2:30pm
Cesca Therapeutics, Inc.
Joe Balagot, Cesca Therapeutics show more Company Description/Mission Statement Cesca Therapeutics develops and markets cellular processing and storage systems that separate target cells from host liquid and are therefore critical to emerging immunotherapies such as CAR-T. Time Monday, Feb 12 2:30PM - 2:45PM Location Wilder Speakers Joe Balagot Cesca Therapeutics
Spyryx Biosciences, Inc.
John Taylor, Spyryx Biosciences show more Company Description/Mission Statement Spyryx Biosciences is a clinical-stage biopharmaceutical company developing innovative therapeutics to address severe pulmonary diseases. Spyryx’s lead clinical candidate, SPX-101, is a novel treatment for cystic fibrosis currently completing a multinational Phase 2 study. The product has demonstrated a robust ability to restore mucociliary clearance in animal models of the disease and has the potential to improve lung function in people living with cystic fibrosis independent of their genotype. The Spyryx leadership team and scientific staff have extensive experience in the development of respiratory medicines and work closely with a broad group of clinical and scientific experts in the pulmonary field. Spyryx is funded by a first tier syndicate of life science investors, including Canaan Partners, 5AM Ventures and Hatteras Venture Partners. Time Monday, Feb 12 2:30PM - 2:45PM Location Gilbert Speakers John Taylor Spyryx Biosciences
TapImmune Inc
Peter Hoang, TapImmune Inc show more Company Description/Mission Statement TapImmune, Inc. is a leader in the TapImmune Inc. is a leader in the development of novel immunotherapies for cancer, with multiple Phase 2 and Phase 1b/2 clinical studies currently ongoing for the treatment of ovarian and breast cancer. The company's peptide- or nucleic acid-based immunotherapeutic products comprise multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patient's killer T cells and helper T cells, and to restore or further augment antigen presentation by using proprietary nucleic acid-based expression systems. This unique approach can produce off-the-shelf T-cell vaccine candidates that elicit a broad-based T-cell response and can be given without respect to HLA type. The company's technologies may be used as stand-alone medications or in combination with other treatment modalities. Time Monday, Feb 12 2:30PM - 2:45PM Location Odets Speakers Peter Hoang TapImmune Inc
2:45pm
Bio-Path Holdings, Inc.
Peter Nielson, Bio-Path Holdings show more Company Description/Mission Statement Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous transfusion. Bio-Path’s lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers and in preclinical studies for solid tumors. This is followed by BP1002, targeting the Bcl2 protein, which the company anticipates entering into clinical studies where it will be evaluated in lymphoma and solid tumors. Time Monday, Feb 12 2:45PM - 3:00PM Location Odets Speakers Peter Nielson Bio-Path Holdings
Catalyst Biosciences
Nassim Usman, Catalyst Biosciences show more Company Description/Mission Statement Catalyst is focused on developing novel medicines to address serious medical conditions for patients who need new or better treatment options. We used a scientific approach focused on protease-based therapeutic candidates to build a clinical-stage biopharmaceutical company whose current mission is to develop valuable therapies for patients with hemophilia. Time Monday, Feb 12 2:45PM - 3:00PM Location Ziegfeld Speakers Nassim Usman Catalyst Biosciences
Humanigen, Inc.
Cameron Durrant, Humanigen show more Company Description/Mission Statement Humanigen, Inc. is a biopharmaceutical company pursuing cutting-edge science to develop its proprietary monoclonal antibodies for immunotherapy and oncology treatments. Derived from the company’s Humaneered® platform, lenzilumab and ifabotuzumab are lead compounds in the portfolio of monoclonal antibodies with first-in-class mechanisms. Lenzilumab, which targets granulocyte-macrophage colony-stimulating factor (GM-CSF), is in development as a potential medicine to make chimeric antigen receptor T-cell (CAR-T) therapy safer and more effective, as well as a potential treatment for rare hematologic cancers such as chronic myelomonocytic leukemia (CMML) and juvenile myelomonocytic leukemia (JMML). Ifabotuzumab, which targets Ephrin type-A receptor 3 (EphA3), is being explored as a potential treatment for glioblastoma multiforme (GBM) and other deadly cancers. Time Monday, Feb 12 2:45PM - 3:00PM Location Wilder Speakers Cameron Durrant Humanigen
Rain Therapeutics Inc.
Avanish Vellanki, Rain Therapeutics Inc. show more Company Description/Mission Statement A San Francisco Bay Area biotechnology company focused on small molecule therapeutics for patients with cancer. Rain seeks to pursue therapies with predictive biomarkers for improved efficacy and safety for oncology patients with an unmet medical need. The lead program is a Phase 2 small molecule therapy being developed for patients with EGFR / ErbB Exon 20 insertion mutations in non-small cell lung cancer (NSCLC), and other EGFR / ERbB-driven cancers. Time Monday, Feb 12 2:45PM - 3:00PM Location Brecht Speakers Avanish Vellanki Rain Therapeutics Inc.
Regenerative Medical Services Pvt Ltd
SATYEN SANGHAVI, Regenerative Medical Services Pvt Ltd show more Company Description/Mission Statement RMS Regrow is a leading regenerative medicine company based at Mumbai, India. RMS Regrow has developed an autologous cell therapy platform and successfully commercialized (FIRST in India) two of its patented products, CARTIGROW® (chondrocyte cell) and OSSGROW®(osteoblast cell) approved by Indian FDA (DCGI, Min of Health). RMS REGROW is expanding its product portfolio into Urology (Uregrow®) and other rare diseases. Also, utilizing it's 24000+ HLA coded cord blood CD34+ units, RMS REGROW is looking to provide an unique treatment option to patients with HIV. Vision: Improving human healthcare by innovating and delivering regenerative medicine based healthcare solutions Mission: To become the world's largest stem cell based tissue and organ development factory Time Monday, Feb 12 2:45PM - 3:00PM Location Gilbert Speakers SATYEN SANGHAVI Regenerative Medical Services Pvt Ltd
3:00pm
Funding Cures: Prioritizing Policy Barriers to Amortization of Therapeutic Spending
Michael Weiss, Cahill Gordon & Reindel LLP; Ted Haack, Haack & Associates; Dennis J. Purcell, Aisling Capital; Brady Huggett, Nature Biotechnology; Michael J. Werner, Alliance for Regenerative Medicine show more Time Monday, Feb 12 3:00PM - 3:55PM Location Salon 4 Speakers Michael Weiss Cahill Gordon & Reindel LLP Ted Haack Haack & Associates Dennis J. Purcell Aisling Capital Brady Huggett Nature Biotechnology Michael J. Werner Alliance for Regenerative Medicine
Savara, Inc.
Robert Neville, Savara, Inc. show more Company Description/Mission Statement Savara, Inc. is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel therapies for the treatment of orphan lung diseases. The company has a robust pipeline comprised of three late-development-stage assets. Lead product candidate Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF), is in Phase 3 development for pulmonary alveolar proteinosis (PAP) and has recently been expanded into orphan lung infection non-tuberculosis mycobacteria (NTM). AeroVanc is an inhaled vancomycin currently being investigated in a Phase 3 clinical trial for treatment of MRSA infection in Cystic Fibrosis. And Aironite, an inhaled sodium nitrite, is in Phase 2 development for HFpEF. Savara’s management team has significant experience in developing orphan drug and pulmonary medicine and advancing them to approvals and commercialization. Savara successfully closed offerings with gross proceeds of approximately $100 millio Time Monday, Feb 12 3:00PM - 3:15PM Location Odets Speakers Robert Neville Savara, Inc.
TraceLink
Shabbir Dahod, TraceLink show more Company Description/Mission Statement TraceLink is the World’s Largest Track and Trace Network for connecting the Life Sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace. Leading businesses trust the TraceLink Life Sciences Cloud to deliver complete global connectivity, visibility and traceability of pharmaceuticals from ingredient to patient. A single point and click connection to the Life Sciences Cloud creates a supply chain control tower that delivers the information, insight and collaboration needed to improve performance and reduce risk across global supply, manufacturing and distribution operations. The TraceLink Life Sciences Cloud is used by businesses across the globe to meet strategic goals in ensuring global compliance, fighting drug counterfeiting, improving on-time and in-full delivery, protecting product quality and reducing operational cost. Time Monday, Feb 12 3:00PM - 3:15PM Location Gilbert Speakers Shabbir Dahod TraceLink
Vericel Corporation
Gerard Michel, Vericel Corporation show more Company Description/Mission Statement Vericel is passionately committed to meeting significant patient and healthcare provider needs by providing potentially life-enhancing cell therapies to patients with serious medical conditions. Time Monday, Feb 12 3:00PM - 3:15PM Location Wilder Speakers Gerard Michel Vericel Corporation
Vidac Pharma
Oren Becker, Vidac Pharma show more Company Description/Mission Statement Vidac is a privately-held clinical-stage oncology and dermatology biopharmaceutical company developing first-in-class drugs. Its unique immuno-metabolic platform technology targets hexokinase 2 (HK2), a metabolic master regulator of proliferation, affecting both cancer and immune cells. Vidac’s drugs modulate HK2 mitochondria binding to (i) trigger tumor apoptosis, (ii) reduce metabolite immunosuppression in tumor microenvironment, and (iii) stimulate anti-tumor immune response (activating NLRP3 inflammasome in macrophages). HK2 is over-expressed in a broad range of tumors, especially with tumor-suppression mutations. Lead drug, VDA-1102 (ointment), completed Phase 2 POC trial in Actinic Keratosis, an early form of cutaneous SCC, demonstrating safety, tolerability and efficacy. Phase 2b data in 2H 2018. Vidac is also developing systemic (oral) treatments for solid tumors and hematological malignancies, as monotherapies and in combinations, with Phase I/II trials expected in 2019. Time Monday, Feb 12 3:00PM - 3:15PM Location Brecht Speakers Oren Becker Vidac Pharma
3:15pm
Armis Biopharma, Inc.
Michael Handley , Armis Biopharma show more Company Description/Mission Statement Armis is a late clinical-stage biopharmaceutical company with a growing pipeline of targeted anti-infective therapeutics designed to address the serious & rapidly growing phenomenon of antibiotic resistance and healthcare-associated infections. The Company’s lead product candidate, Ximycin™, is a first-of-its-kind combination localized antimicrobial therapy derived from a gram-positive agent, vancomycin, & a gram-negative agent, gentamicin, two potent well-established & accepted agents, using a breakthrough delivery method allowing extended polymicrobial coverage at the site of the wound. Ximycin is initially being developed for use as a prophylaxis therapy for the mitigation or prevention of multi-drug resistant surgical site infections (“SSIs”), including multi-drug resistant gram-negative and/or gram-positive infections. Armis is also focused on developing & commercializing a first-of-its-kind chemical platform directed to peracid technology and acquiring other synergistic products Time Monday, Feb 12 3:15PM - 3:30PM Location Wilder Speakers Michael Handley Armis Biopharma
Bioasis Technologies Inc.
Mark Day, Bioasis Technologies Inc. show more Company Description/Mission Statement ioasis Technologies, Inc. is a biopharmaceutical company focused on the delivery of therapeutics across the blood-brain barrier (BBB) and into the central nervous system for the treatment of neurological diseases and disorders. The delivery of therapeutics across the BBB represents the single greatest challenge in treating neurological disorders. The in-house development programs at Bioasis are designed to develop effective treatments for patients suffering with neurological diseases. The goal of these programs is to produce symptomatic and disease-modifying treatments for brain-related diseases and disorders. Time Monday, Feb 12 3:15PM - 3:30PM Location Odets Speakers Mark Day Bioasis Technologies Inc.
Immuneering Corporation
Ben Zeskind, Immuneering Corporation show more Company Description/Mission Statement Immuneering's drug discovery platform rapidly identifies new medicines using AI and high-throughput data, and is particularly well-suited to discover multi-targeted drugs. Time Monday, Feb 12 3:15PM - 3:30PM Location Gilbert Speakers Ben Zeskind Immuneering Corporation
NanOlogy LLC
Gere diZerega, NanOlogy LLC show more Company Description/Mission Statement NanOlogy has transformed systemic chemotherapy into local delivery of a patented submicron particle chemotherapeutic platform directly to the disease site to improve the treatment of cancer & related illnesses. Six phase 2 clinical trials are underway in ovarian, prostate, & pancreatic cancers, pancreatic cysts, cutaneous metastases, & actinic keratosis. A preclinical study has shown efficacy in lung cancer after PK studies showed 14+ day retention of drug in lung tissue following nebulized inhalation. Our products contain submicron particle paclitaxel or docetaxel, which are designed to be delivered locally in high concentration by intratumoral, intracystic, intraperitoneal, or topical administration, where the particles are entrapped & release drug for more than 4 weeks. Gradual clearance minimizes adverse systemic effects. We will be seeking a partner to fund activities required for NDA submission & FDA approval over next 12 months as more data are generated from our trials. Time Monday, Feb 12 3:15PM - 3:30PM Location Brecht Speakers Gere diZerega NanOlogy LLC
Summit Therapeutics plc
Glyn Edwards, Summit Therapeutics show more Company Description/Mission Statement Summit is a biopharmaceutical company focused on the discovery, development and commercialisation of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease, Duchenne muscular dystrophy, and the infectious disease, Clostridium difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc). Time Monday, Feb 12 3:15PM - 3:30PM Location Ziegfeld Speakers Glyn Edwards Summit Therapeutics
3:30pm
Catalyst Pharmaceuticals, Inc.
Steven Miller, Catalyst Pharmaceuticals, Inc. show more Company Description/Mission Statement Catalyst Pharmaceuticals is dedicated to advancing therapies targeting rare neuromuscular and neurological diseases, including Lambert-Eaton Myasthenic Syndrome (LEMS), Congenital Myasthenic Syndromes (CMS), MuSK-Myasthenia Gravis, Spinal Muscular Atrophy, and Infantile Spasms. Catalyst is an integrated pharmaceutical company with the ability to develop and market new products. Time Monday, Feb 12 3:30PM - 3:45PM Location Ziegfeld Speakers Steven Miller Catalyst Pharmaceuticals, Inc.
Denovo Biopharma LLC
Wen Luo, Denovo Biopharma llc show more Company Description/Mission Statement Denovo Biopharma is a privately held biotech company providing a novel biomarker solution to personalize drug development. The core technology of the company is its industry's first platform and algorithm to perform de novo genomic biomarker discovery retrospectively using archived clinical samples By identifying biomarkers correlated to patients' responsiveness to drug candidates retrospectively, our technology enables biotech and pharmaceutical companies to design new clinical trials in targeted patient population to achieve higher efficacy and/or less adverse effects. Time Monday, Feb 12 3:30PM - 3:45PM Location Brecht Speakers Wen Luo Denovo Biopharma llc
Innovate Biopharmaceuticals, Inc.
Christopher Prior, Innovate Biopharmaceuticals, Inc. show more Company Description/Mission Statement Innovate, is a publicly traded (Nasdaq: INNT) clinical stage biotechnology company focused on developing novel medicines for autoimmune and inflammatory diseases with unmet needs. Our pipeline includes drug candidates for celiac disease, NASH, Crohn's, and ulcerative colitis. Innovate is led by a strong management team with extensive drug development experience and a history of bringing novel therapeutics to market. All global rights to the products, which are backed by more than 150 patents worldwide, are owned by the company. Time Monday, Feb 12 3:30PM - 3:45PM Location Wilder Speakers Christopher Prior Innovate Biopharmaceuticals, Inc.
Neurotrope
Daniel Alkon, Neurotrope show more Company Description/Mission Statement Neurotrope BioScience, (NASDAQ:NTRP), formed in 2012, is at the forefront of the biotech industry and is focused on developing new therapies with Bryostatin 1 for the treatment of neurodegenerative diseases and developmental disorders. Our experience, capabilities, and passion for innovative and novel drug therapies have enabled us to build a development pipeline that includes various treatment approaches with Bryostatin 1 for serious and difficult-to-treat diseases such as Alzheimer’s dementia and the Orphan diseases, Fragile X Syndrome (FXS) and Niemann-Pick Type C (NPC). Time Monday, Feb 12 3:30PM - 3:45PM Location Odets Speakers Daniel Alkon Neurotrope
3:45pm
Brillance
Izabela Kozdras, Brillance show more Company Description/Mission Statement Brillance is a central European boutique CRO, with HQ in Krakow-Poland, delivering tailored solutions/services for phase II-IV drugs and medical devices clinical trials. During 14 years of our activity we have focused to become experts on regional markets of Poland, Czech Republic and Slovakia. We have built there numerous business relations with sites/investigators and explored deeply local regulations. From our long-lasting relationships with Sponsors (over 200 trials completed) we have learnt that smooth and quick study registration, quality of data and effective, high recruitment are key factors of success for each clinical trial. Therefore we use the skills and experience of our meticulously selected and trained staff to ensure them for each of our Clients. If You are searching for an effective CRO, that will ensure to Your study successful and quick enrollment joint with impeccable data, which will give You undivided attention and personal touch, choose Brillance. Time Monday, Feb 12 3:45PM - 4:00PM Location Gilbert Speakers Izabela Kozdras Brillance
ORYZON GENOMICS SA
show more Company Description/Mission Statement Oryzon (ORY) is a clinical stage biopharmaceutical company listed in Spain and a European leader in the development of epigenetics therapies. A Epigenetic Platform focused on developing innovative drugs to help patients suffering from diseases with strong unmet medical need such as cancer and neurodegenerative diseases. Oryzon’s pipeline includes inhibitors against Histone demethylases and other epigenetic targets. Our forerunner program ORY-2001, a human brain-penetrant, oral, dual LSD1-MAOB inhibitor, is under development in CNS indications. It has successfully finalized a Safety Phase I trial and it is currently being developed in Phase II trials in relapse-remitting and progressive forms of MS. A CTA has been submitted for a Phase II in Mild to moderate AD patients. Its oncology program ORY-1001is a selective LSD1 inhibitor. It has finalised a Phase I/IIA in acute leukaemia and a exploratory dose-finding Phase I clinical trial in SCLC. Phase II trials are in preparation. Time Monday, Feb 12 3:45PM - 4:00PM Location Odets
Saghmos Therapeutics, Inc.
Anna Kazanchyan, Saghmos Therapeutics show more Company Description/Mission Statement Saghmos Therapeutics' mission is to prevent and treat kidney injury, and thereby improve cardio-renal outcomes for patients undergoing cardiac procedures. Time Monday, Feb 12 3:45PM - 4:00PM Location Wilder Speakers Anna Kazanchyan Saghmos Therapeutics
4:00pm
Advances in Dermatology: Recent Approvals and Later-Stage Trials
Michael Sierra, LEO Science & Tech Hub; Luis Peña, Dermira, Inc.; Umer Raffat, Evercore ISI; Michael Derby, Castle Creek Pharmaceuticals, LLC show more Time Monday, Feb 12 4:00PM - 4:55PM Location Salon 4 Speakers Michael Sierra LEO Science & Tech Hub Luis Peña Dermira, Inc. Umer Raffat Evercore ISI Michael Derby Castle Creek Pharmaceuticals, LLC
Muscular Dystrophy Association (MDA)
Lynn Vos, Muscular Dystropy Association (MDA) show more Company Description/Mission Statement Time Monday, Feb 12 4:00PM - 4:15PM Location Ziegfeld Speakers Lynn Vos Muscular Dystropy Association (MDA)
Recombinetics. Inc.
Tammy Lee Stanoch, Recombinetics show more Company Description/Mission Statement Recombinetics (RCI) is a recognized leader in the development and deployment of gene-editing technologies to advance human health and the welfare and productivity of food animals. Through gene editing, RCI can have a transformative impact on humanity from improving health outcomes to feeding growing populations. RCI's Research and Development Technology Platform for use on swine, cattle, sheep, goats, poultry, aquaculture and other species, offers a competitive advantage for the Company. This common platform is the foundation for applications developed in three business lines: Surrogen: Advancing human therapeutics through customized biomedical pig models for preclinical research; Regenevida: Addressing the shortage of human cells, tissues, and organs through regenerative medicine; and Acceligen: Improving animal health and productivity through accelerated precision breeding. Time Monday, Feb 12 4:00PM - 4:15PM Location Gilbert Speakers Tammy Lee Stanoch Recombinetics
5:00pm
Market Outlook—How Durable is the IPO Resurgence and M&A Slowdown?
Stefan D. Loren, Oppenheimer & Co.; James Cappuccio, H.C. Wainwright and Co., LLC; Chris Garabedian, Xontogeny; Michael Meyers, Tivorsan Pharmaceuticals, Inc.; Matthew Roden, Bristol-Myers Squibb; Sapna Srivastava, Abide Therapeutics ; Stephen B. Thau, Morrison & Foerster LLP show more Time Monday, Feb 12 5:00PM - 5:55PM Location Salon 4 Speakers Stefan D. Loren Oppenheimer & Co. James Cappuccio H.C. Wainwright and Co., LLC Chris Garabedian Xontogeny Michael Meyers Tivorsan Pharmaceuticals, Inc. Matthew Roden Bristol-Myers Squibb Sapna Srivastava Abide Therapeutics Stephen B. Thau Morrison & Foerster LLP
Tuesday, February 13
9:00am
Eleven Biotherapeutics, Inc.
Steve Hurly, Eleven Biotherapeutics show more Company Description/Mission Statement Eleven Biotherapeutics, Inc. is a late clinical-stage company advancing a broad pipeline of novel anti-cancer agents based on our Targeted Protein Therapeutics (TPTs) platform. Our TPTs genetically combine targeting antibody fragments with cytoxic protein payloads to create a single fusion protein through Eleven's proprietary one-step manufacturing process. We have designed TPTs with the potential to offer: Multiple advantages in treating cancer over traditional antibody drug conjugates. Effective tumor targeting with cancer cell-killing properties unique to protein payloads versus small molecules, using our rational approach to therapeutics design for TPTs. The dual action of the TPT protein cytotoxic to both kill directly and promote a local inflammatory anti-tumor immune response, suggesting that TPTs will combine well with immune oncology drugs. Enhanced linker stability and more efficient and cost effective manufacturing process, based on TPT’s fusion protein construction. Time Tuesday, Feb 13 9:00AM - 9:15AM Location Odets Speakers Steve Hurly Eleven Biotherapeutics
Heat Biologics
Jeffrey Wolf, Heat Biologics show more Company Description/Mission Statement Heat Biologics a biopharmaceutical company that develops immunotherapies to activate a patient’s immune system against cancer through T-cell activation. Time Tuesday, Feb 13 9:00AM - 9:15AM Location Wilder Speakers Jeffrey Wolf Heat Biologics
Humanetics Corporation
show more Company Description/Mission Statement Humanetics is a clinical-stage drug development company with over $50 million in funding from private equity investment, non-dilutive federal grants, and proceeds from the sale of a business unit. Humanetics' leading drug candidate is a proprietary radiation modulator called BIO 300. This shelf-stable, self-administered oral suspension protects healthy tissues from damage caused by exposure to ionizing radiation, while at the same time sensitizes solid cancer tumors to radiation-induced killing. The Company is developing BIO 300 for use as a cancer therapy to increase tumor response without serious side effects commonly associated with current radiation therapies. Development partners include the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the Henry Ford Health System, and the U.S. Department of Defense. BIO 300 is protected by an expansive patent portfolio and pending Orphan Drug status. Time Tuesday, Feb 13 9:00AM - 9:15AM Location Gilbert
Interpace Diagnostics
show more Company Description/Mission Statement We are a fully integrated "commercial" company that provides molecular and diagnostic tests and pathology services to evaluate the risk of cancer by leveraging the latest technology in personalized medicine for better informed clinical decisions and improved patient management. Time Tuesday, Feb 13 9:00AM - 9:15AM Location Ziegfeld
Neuroscience of Addiction: Levers to Attack the Opioid Abuse Crisis
Roger Crystal, Opiant; Robert Radie, Egalet Corporation; Lucy Lu, Avenue Therapeutics; Corey McCann, Pear Therapeutics, Inc.; Peter Strumph, Amygdala Neurosciences, Inc.; Brandon Folkes, Cantor Fitzgerald; Michael D. Detke, Embera NeuroTherapeutics, Inc.; David Thomas, Biotechnology Innovation Organization (BIO) show more Time Tuesday, Feb 13 9:00AM - 9:55AM Location Salon 4 Speakers Roger Crystal Opiant Robert Radie Egalet Corporation Lucy Lu Avenue Therapeutics Corey McCann Pear Therapeutics, Inc. Peter Strumph Amygdala Neurosciences, Inc. Brandon Folkes Cantor Fitzgerald Michael D. Detke Embera NeuroTherapeutics, Inc. David Thomas Biotechnology Innovation Organization (BIO)
9:15am
Actinium Pharmaceuticals, Inc.
Sandesh Seth, Actinium Pharmaceuticals, Inc. show more Company Description/Mission Statement Actinium Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for safer myeloablation and conditioning of the bone marrow prior to a bone marrow transplant and for the targeting and killing of cancer cells. We are currently conducting clinical trials for our four programs, Iomab-B, Actimab-A Actimab-M and Actimab-MDS, as well as performing research on other potential drug candidates utilizing our proprietary actinium-225 technology platform. Time Tuesday, Feb 13 9:15AM - 9:30AM Location Odets Speakers Sandesh Seth Actinium Pharmaceuticals, Inc.
Avidity Biosciences LLC
show more Company Description/Mission Statement Avidity Biosciences is a privately-held company creating breakthrough medicines for the treatment of genetically defined diseases. Avidity has developed an innovative, proprietary platform technology that leverages antibody-oligonucleotide conjugates to deliver therapeutic candidates to muscle, immune cells and other tissues. The company is advancing internal programs focused on the treatment of rare neuromuscular diseases and pursuing applications in oncology and immunology through collaborations with partners. Avidity’s founders and management team have highly successful track records as executives and serial entrepreneurs. The company has raised $30 million from Takeda Ventures, F-Prime, EcoR1 and other leading life science investors. Time Tuesday, Feb 13 9:15AM - 9:30AM Location Gilbert
Immunovaccine Inc
show more Company Description/Mission Statement ImmunoVaccine is a clinical-stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and infectious diseases. ImmunoVaccine develops T cell activating cancer immunotherapies and infectious disease vaccines based on DepoVax, the company's patented delivery platform that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. ImmunoVaccine has advanced two T cell activation therapies for cancer through phase 1 human clinical trials and is currently conducting a phase 1b study with Incyte Corp. assessing lead cancer therapy, DPX-Survivac, as a combination therapy in ovarian cancer. The company is also exploring additional applications of DepoVax, including DPX-RSV, an innovative vaccine candidate for respiratory syncytial virus (RSV), which has completed a phase 1 clinical trial. Time Tuesday, Feb 13 9:15AM - 9:30AM Location Wilder
OncoCyte Corporation
William Annett, OncoCyte Corporation show more Company Description/Mission Statement OncoCyte is focused on the development and commercialization of novel, non-invasive blood and urine (“liquid biopsy”) diagnostic tests for the early detection of cancer to improve health outcomes through earlier diagnoses, to reduce the cost of care through the avoidance of more costly diagnostic procedures, including invasive biopsy and cystoscopic procedures, and to improve the quality of life for cancer patients. OncoCyte’s pipeline products are intended to be confirmatory diagnostics for detecting lung, breast and bladder cancer. OncoCyte’s diagnostic tests are being developed using proprietary sets of genetic and protein markers that differentially express in specific types of cancer. Time Tuesday, Feb 13 9:15AM - 9:30AM Location Ziegfeld Speakers William Annett OncoCyte Corporation
9:30am
BioLineRx Ltd.
Philip Serlin, BioLineRx show more Company Description/Mission Statement BioLineRx is a clinical-stage biopharmaceutical company focused on oncology and immunology. The Company in-licenses novel compounds, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization. Time Tuesday, Feb 13 9:30AM - 9:45AM Location Odets Speakers Philip Serlin BioLineRx
Curetis N.V.
Achim Plum, Curetis N.V. show more Company Description/Mission Statement Curetis N.V. is a publicly listed company group, which develops, manufactures and commercializes innovative solution for molecular microbiology. Curetis is based on the Unyvero molecular diagnostics solution business and the AMR data intelligence business GEAR. Solution offers reliable, fast and cost-effective products for diagnosing severe infectious diseases. Unyvero enables rapid multi-parameter pathogen and antibiotic resistance marker detection in only 4 to 5 hours, a process that today can take up to a few days or even weeks with other techniques. Through its subsidiary Ares Genetics, Curetis leverages the AMR database GEAR, the most comprehensive and ever growing collection of pathogen genomes and antibiotic resistance profiles. Ares Genetics offers a comprehensive BioIT, NGS service & antibiotic resistance testing infrastructure and network as well as tailored solutions for next-generation infectious disease diagnostics & therapeutics. Time Tuesday, Feb 13 9:30AM - 9:45AM Location Ziegfeld Speakers Achim Plum Curetis N.V.
CytoDyn, Inc.
Nader Pourhassan, CytoDyn, Inc. show more Company Description/Mission Statement CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of HIV infection. The Company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has completed Phase 2 clinical trials with demonstrated antiviral activity in humans and is currently in Phase 3 development. PRO 140 blocks the HIV co-receptor CCR5 on T cells, which prevents viral entry. Clinical trial results thus far indicate that PRO 140 does not negatively affect the normal immune functions that are mediated by CCR5. Results from seven Phase 1 and Phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. A recent Phase 2b clinical trial demonstrated that PRO 140 can prevent viral escape in patients during several months of interruption from conventional drug therapy. Time Tuesday, Feb 13 9:30AM - 9:45AM Location Wilder Speakers Nader Pourhassan CytoDyn, Inc.
TAXIS Pharmacetical's Inc.
show more Company Description/Mission Statement • Antibiotic drug discovery. Current lead (TXA709) - a novel, oral and IV anti-MRSA drug candidate - is in preclinical toxicology testing and will be in human trials beginning 1Q, 2017. Given very clean toxicity profile, very confident that we will complete Phase 1 Time Tuesday, Feb 13 9:30AM - 9:45AM Location Gilbert
9:45am
CEL-SCI Corporation
Geert Kersten, CEL-SCI Corporation show more Company Description/Mission Statement CEL-SCI is a Phase 3 cancer immunotherapy company. When it comes to cancer immunotherapy, CEL-SCI believes it is most logical to boost the patient’s immune system while it is still intact in order to have the greatest possible impact on survival. Therefore, CEL-SCI treats patients who are newly diagnosed with head and neck cancer with Multikine BEFORE they have received surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are used only after conventional therapies have been tried and/or failed. Head and neck cancer represents about 6% of all cancers. Multikine has received Orphan Drug designation from the FDA for the treatment of head and neck cancer patients with advanced squamous cell carcinoma. The Company’s LEAPS technology is being developed as a therapeutic vaccine for rheumatoid arthritis and is supported by grants from the NIH. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. Time Tuesday, Feb 13 9:45AM - 10:00AM Location Odets Speakers Geert Kersten CEL-SCI Corporation
Chembio Diagnostics, Inc.
John Sperzel, Chembio Diagnostics show more Company Description/Mission Statement Chembio Diagnostics, Inc. develops, manufactures, licenses and markets rapid diagnostic tests in the growing $8.0 billion point-of-care (POC) testing market. The Company markets its products directly and through third-party distributors under the brand names DPP®, STAT-PAK®, STAT-VIEW® and SURE CHECK®. In addition to its branded and proprietary HIV and fever disease assays, which it sells in the U.S. and/or internationally, the Company has several ongoing collaborations for the development of diagnostic assays for Malaria, Dengue Fever, Zika, Ebola and other febrile illness, brain injury and a specific form of cancer. Chembio has developed and patented the DPP® technology platform, which offers significant advantages over traditional POC lateral-flow technologies and provides the Company with a significant pipeline of business opportunities in the area of sexually-transmitted disease, tropical and fever disease, and technology collaborations. Time Tuesday, Feb 13 9:45AM - 10:00AM Location Ziegfeld Speakers John Sperzel Chembio Diagnostics
Gradalis, Inc.
David Shanahan, Gradalis, Inc. show more Company Description/Mission Statement Gradalis Inc. is a late-stage biopharmaceutical (Immuno-Oncology) company fo-cused on the development and commercialization of Vigil®. We believe our ap-proach to harness an individual’s already existing immune system against their cancer has great promise. The Gradalis platform, Vigil, is a fully personalized cancer immunotherapy that can be applied to virtually any cancer from which a surgical sample can be gathered. Vigil utilizes the patient’s own cancer cells to create a fully personalized cancer immunotherapy. The goal of our platform is to activate the patient’s T-cells against their own unique tumor cells. Time Tuesday, Feb 13 9:45AM - 10:00AM Location Wilder Speakers David Shanahan Gradalis, Inc.
Lakewood-Amedex, Inc.
Steve Parkinson, Lakewood Amedex, Inc. show more Company Description/Mission Statement Lakewood-Amedex is a clinical stage pharmaceutical company developing a broad portfolio of anti-infective products, including first-in-class antimicrobial compounds. The Company's products and technology are covered by an extensive patent portfolio consisting of 74 granted and/or issued patents and 13 pending patent applications covering many major pharmaceutical markets. The Company's lead therapeutic candidate is a novel synthetic broad spectrum antimicrobial proven to be effective in killing a wide range of Gram-positive, Gram-negative and antibiotic-resistant bacteria and has recently completed a Phase 1/2a clinical trial in patients with infected diabetic foot ulcers (DFU). Time Tuesday, Feb 13 9:45AM - 10:00AM Location Gilbert Speakers Steve Parkinson Lakewood Amedex, Inc.
10:00am
Berlin Cures
Johannes Mueller, Berlin Cures show more Company Description/Mission Statement Berlin Cures is rapidly emerging as the only company with an effective and practical treatment for removing autoantibodies that cause disease in about 80 percent of heart failure patients with DCM. As we complete a Phase 1b study and prepare to launch a Phase 2 study early in 2018 on a DNA aptamer-based compound known as BC007, we have already demonstrated that our approach has unique benefits for heart failure treatment. Our technology platform is also the foundation for developing drugs that hold promise for treating other diseases associated with autoantibodies, such as pulmonary hypertension, glaucoma, and preeclampsia. Time Tuesday, Feb 13 10:00AM - 10:15AM Location Gilbert Speakers Johannes Mueller Berlin Cures
Deborah Dunsire, MD, President and Chief Executive Officer, XTuit Pharmaceuticals
Deborah Dunsire, MD, XTuit Pharmaceuticals; Yasmeen Rahimi, ROTH Capital Partners show more Session Description Deborah brings over 25 years of experience in developing and commercializing novel therapeutics across three continents. She is the former President and CEO at FORUM Pharmaceuticals, which focused on therapies for Alzheimer’s disease, other dementias and schizophrenia. She served as CEO and President of Millennium Pharmaceuticals from 2005 to 2013, bringing novel therapies through development and commercialization in the areas of cancer and inflammatory disorders. Under her leadership at Millennium, Velcade® for multiple myeloma transformed outcomes for patients and became a multi-billion dollar product, with Johnson & Johnson as the commercial partner outside of the US. In 2008, Takeda Pharmaceuticals of Japan acquired Millennium for $8.8 billion and following the acquisition, Deborah became the first woman to be appointed to the board of Takeda Pharmaceuticals in the company’s 236-year history. Prior to Millennium, Deborah spent 17 years at Novartis in South Africa, Switzerland and the US. For 11 years, she led the Novartis Oncology business in North America, developing and launching a number of transformational cancer therapies notably Gleevec®, the first targeted cancer therapy, as well as Femara®, Zometa®, Sandostatin® and Exjade®. During her tenure at Novartis, the North American oncology business grew from $50 million to more than $2.2 billion. Deborah is a member of the board of trustees for the Massachusetts General Physicians Organization, Northeastern University, and Boston’s Museum of Science. She serves on the Department of Chemistry Visiting Committee at MIT and on the MGH Research Advisory Council. She has served for many years as a board member of the Biotechnology Innovation Organization. Deborah was born in Zimbabwe and completed her medical training at the University of the Witwatersrand in Johannesburg, South Africa. Time Tuesday, Feb 13 10:00AM - 10:55AM Location Salon 2 Speakers Deborah Dunsire, MD XTuit Pharmaceuticals Yasmeen Rahimi ROTH Capital Partners
Espero BioPharma, Inc.
Quang Pham, Espero BioPharma, Inc. show more Company Description/Mission Statement Espero is a platform biopharmaceutical company focusing on the late-stage development and commercialization of drugs to treat cardiovascular diseases, the leading cause of death worldwide. Time Tuesday, Feb 13 10:00AM - 10:15AM Location Wilder Speakers Quang Pham Espero BioPharma, Inc.
Invitae Corporation
Sean George, Invitae show more Company Description/Mission Statement Invitae is one of the fastest growing genetic information companies, whose mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. Specializing in genetic diagnostics in clinical areas across all stages of life, Invitae is aggregating the world’s genetic tests into a single service with better quality, faster turnaround time, and lower prices. Time Tuesday, Feb 13 10:00AM - 10:15AM Location Ziegfeld Speakers Sean George Invitae
Race Oncology Ltd
Peter Molloy, Race Oncology Ltd show more Company Description/Mission Statement Race Oncology is a specialty pharmaceutical company focused on rediscovering or repurposing overlooked drugs that can deliver early commercial milestones. Race Oncology’s first asset is Bisantrene, a small-molecule chemotherapy drug intended for use in Acute Myeloid Leukemia. Time Tuesday, Feb 13 10:00AM - 10:15AM Location Odets Speakers Peter Molloy Race Oncology Ltd
10:15am
Boston Pharmaceuticals
Constantine Chinoporos, Boston Pharmaceuticals show more Company Description/Mission Statement BOSTON PHARMACEUTICALS represents a new pharmaceutical company model, providing a bridge to value realization for early-stage clinical development programs. By offering strategic partnership options to biotech and pharmaceutical companies, our goal is to enable differentiated, under-resourced therapeutics to be developed and made available to patients with unmet medical needs. Time Tuesday, Feb 13 10:15AM - 10:30AM Location Gilbert Speakers Constantine Chinoporos Boston Pharmaceuticals
Cerecor Inc
show more Company Description/Mission Statement Cerecor is a Baltimore-based biopharmaceutical company with the near-term goal of becoming a self-sustained, integrated pharmaceutical company that is focused on pediatric healthcare. Time Tuesday, Feb 13 10:15AM - 10:30AM Location Odets
Galectin Therapeutics, Inc.
Peter Traber, Galectin Therapeutics, Inc. show more Company Description/Mission Statement Galectin Therapeutics, Inc. is the leading developer of therapeutics that target galectin proteins to treat non-alcoholic steatohepatitis (NASH) cirrhosis and cancer. Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver and skin diseases and cancer. Galectin's lead drug (GR-MD-02) is a carbohydrate-based drug that inhibits the galectin-3 protein that is directly involved in multiple inflammatory, fibrotic, and malignant diseases. The lead development program is in non-alcoholic steatohepatitis (NASH) with cirrhosis, the most advanced form of NASH related fibrosis. This is the most common liver disease and one of the largest drug development opportunities available today. Additional development programs are for treatment of severe atopic dermatitis, moderate-to-severe plaque psoriasis, and in combination immunotherapy for advanced melanoma and other malignancies. Time Tuesday, Feb 13 10:15AM - 10:30AM Location Ziegfeld Speakers Peter Traber Galectin Therapeutics, Inc.
Morphic Therapeutic Inc.
Alex Lugovskoy, Morphic Therapeutic Inc. show more Company Description/Mission Statement We are working to develop the first orally administered integrin therapeutics for patients with immunological, fibrotic, neoplastic, and cardiometabolic diseases. Time Tuesday, Feb 13 10:15AM - 10:30AM Location Wilder Speakers Alex Lugovskoy Morphic Therapeutic Inc.
10:30am
Adocia
Gerard Soula, Adocia show more Company Description/Mission Statement Adocia is a clinical stage biopharmaceutical company developing treatments for diabetes and other metabolic conditions in a more physiologic and affordable way. Time Tuesday, Feb 13 10:30AM - 10:45AM Location Odets Speakers Gerard Soula Adocia
Citius Pharmaceuticals, Inc.
show more Company Description/Mission Statement Citius Pharmaceuticals (NASDAQ: CTXR) is a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for large and growing markets. Citius products offer new and expanded indications for previously approved pharmaceutical products as a means to achieve leading market position or market exclusivity. By using previously approved drugs with substantial safety and efficacy data, Citius seeks to reduce the risks associated with pharmaceutical product development. Citius is currently advancing two proprietary product candidates, our Mino-Lok™ product and a Hydrocortisone-Lidocaine formulation. Citius believes the markets for its products are large and underserved by the current standard of care. Time Tuesday, Feb 13 10:30AM - 10:45AM Location Ziegfeld
Immunic AG
Daniel Vitt, Immunic AG show more Company Description/Mission Statement Immunic is the specialist for selective oral drugs in immunology. As a clinical stage company, Immunic delivers clinical proof-of-concept for best-in-class therapies of Th1 and Th17 mediated chronic inflammatory diseases. The company's two development programs include orally available, small molecule inhibitors of DHODH (IMU-838 program) and inverse agonists of RORγt (IMU-366 program) relevant to diseases such as ulcerative colitis, Crohn's disease and psoriasis. The final aim is to develop these oral drug candidates to clinical proof of concept. The company was founded in 2016 with headquarters in Planegg-Martinsried near Munich, Germany, and is privately held and supported by several renowned sector investors. Time Tuesday, Feb 13 10:30AM - 10:45AM Location Wilder Speakers Daniel Vitt Immunic AG
WuXi NextCODE
Hannes Smarason, WuXi NextCODE show more Company Description/Mission Statement WuXi NextCODE is a private company pioneer in big data genomics and precision medicine. The Company’s platform manages the largest sequence data sets in the world and is now driving to extend that leadership and make its data architecture a true global standard. All of this data can be more effectively used by researchers, clinicians and individuals - in a way they control - to advance health and medicine. The Company has raised $240 million in Series B rounds this year led by high profile global investors with plans to use the funding to build up the Company’s platform, help it better use artificial intelligence in its services, and build out its commercial team. Time Tuesday, Feb 13 10:30AM - 10:45AM Location Gilbert Speakers Hannes Smarason WuXi NextCODE
10:45am
CASI Pharmaceuticals, Inc.
Ken K. Ren, CASI Pharmaceuticals, Inc. show more Company Description/Mission Statement CASI is a biopharmaceutical company focused on the acquisition, development, and commercialization of quality pharmaceuticals and innovative therapeutics addressing CANCER and other unmet medical needs for the global market, with a focus on greater China and the U.S. We are a NASDAQ-listed company, headquartered in Rockville, Maryland with a wholly owned subsidiary and R&D operations in Beijing, China. Time Tuesday, Feb 13 10:45AM - 11:00AM Location Odets Speakers Ken K. Ren CASI Pharmaceuticals, Inc.
Corium International, Inc.
Peter Staple , Corium International, Inc. show more Company Description/Mission Statement Corium International, Inc. is a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty pharmaceutical products that leverage the company's broad experience with advanced transdermal and transmucosal delivery systems. Corium has multiple proprietary programs in preclinical and clinical development, focusing primarily on the treatment of neurological disorders, with lead programs in Alzheimer's disease. The company has two proprietary transdermal platforms: Corplex™ for small molecules and MicroCor®, a biodegradable microstructure technology for small molecules and biologics, including vaccines, peptides and proteins. In addition to its proprietary Alzheimer's program, the company's late-stage pipeline includes a contraceptive patch co-developed with Agile Therapeutics and additional transdermal products that are being developed with other partners. Time Tuesday, Feb 13 10:45AM - 11:00AM Location Wilder Speakers Peter Staple Corium International, Inc.
Femeda Ltd
Andrew Tasker, Femeda Ltd show more Company Description/Mission Statement Femeda is a UK-based company focused on developing a range of groundbreaking devices for female urinary incontinence Time Tuesday, Feb 13 10:45AM - 11:00AM Location Gilbert Speakers Andrew Tasker Femeda Ltd
Palatin Technologies, Inc.
Carl Spana, PalatinTechnologies, Inc. show more Company Description/Mission Statement Palatin Technologies, Inc. (NYSE MKT: PTN) is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. Our programs are based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems. Time Tuesday, Feb 13 10:45AM - 11:00AM Location Ziegfeld Speakers Carl Spana PalatinTechnologies, Inc.
11:00am
Aralez Pharmaceuticals
Adrian Adams, Aralez Pharmaceuticals show more Company Description/Mission Statement About Aralez Pharmaceuticals Inc. Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ) (TSX: ARZ) is a global specialty pharmaceutical company focused on delivering meaningful products to improve patients' lives while creating shareholder value by acquiring, developing and commercializing products primarily in cardiovascular and other specialty areas. Aralez's Global Headquarters is in Ontario, Canada, the U.S. Headquarters is in Princeton, New Jersey and the Irish Headquarters is in Dublin, Ireland. More information about Aralez can be found at www.aralez.com. Time Tuesday, Feb 13 11:00AM - 11:15AM Location Ziegfeld Speakers Adrian Adams Aralez Pharmaceuticals
BriaCell Therapeutics Corp.
William Williams, BriaCell Therapeutics Corp. show more Company Description/Mission Statement The Future of Cancer Immunotherapy Time Tuesday, Feb 13 11:00AM - 11:15AM Location Odets Speakers William Williams BriaCell Therapeutics Corp.
Embera NeuroTherapeutics, Inc.
Bob Linke, Embera NeuroTherapeutics, Inc. show more Company Description/Mission Statement Embera is a clinical stage biopharma company focused on smoking cessation, cocaine use disorder (CUD) and other significant stress mediated diseases, with a very limited range of effective drug therapies or no approved pharmaceutical treatments. Embera is developing a novel, patented drug combination (EMB-001) targeting the stress response system and specific brain functions that drive craving and relapse related to these addictions. A pilot clinical study in cocaine-dependent human subjects has been completed, showing the potential for EMB-001 to be effective in this disorder. Embera also completed an animal study in nicotine addiction in which EMB-001 was shown to be significantly more effective than Chantix®, Pfizer’s $998M smoking cessation product. Embera has completed its Phase 1 clinical development program and is advancing its CUD and smoking cessation products into Phase 2 clinical development. The EMB-001 CUD Phase 2 development program is supported by an $11.1M NIH grant. Time Tuesday, Feb 13 11:00AM - 11:15AM Location Wilder Speakers Bob Linke Embera NeuroTherapeutics, Inc.
Opsona Therapeutics Limited
show more Company Description/Mission Statement Opsona Therapeutics is a Dublin, Ireland based company that is focused on oncology. The Company is in the midst of an open-label phase 1/2 multiple dose trial of its lead program, OPN-305, for the treatment of myelodysplastic syndrome (MDS) patients who have failed standard of care (SOC). Time Tuesday, Feb 13 11:00AM - 11:15AM Location Gilbert
Policy Outlook—Implications of the Tax Code Changes of the Trump Administration
Cameron Arterton, Biotechnology Innovation Organization (BIO); Andrew J. Silverman, Bloomberg Intelligence; Brendan P. Cox, Ernst & Young LLP; Robert Masella, Shearman & Sterling show more Time Tuesday, Feb 13 11:00AM - 11:55AM Location Salon 4 Speakers Cameron Arterton Biotechnology Innovation Organization (BIO) Andrew J. Silverman Bloomberg Intelligence Brendan P. Cox Ernst & Young LLP Robert Masella Shearman & Sterling
11:15am
Cardiol Therapeutics Inc
David Elsley, Cardiol Therapeutics Inc show more Company Description/Mission Statement Cardiol Therapeutics is a nanotherapeutics company focused on the research and commercial development of proprietary drug formulations to advance the treatment of heart failure. Over five million adults in the U.S. suffer from heart failure, and it remains a leading cause of death and hospitalization with associated healthcare costs exceeding $30 billion annually. Approximately half of all heart failure patients have heart failure with preserved ejection fraction (HFpEF), for which there have been no new therapies developed in over 20 years. Cardiol’s lead product candidate, CTX01, is a proprietary nanoformulation of pharmaceutical cannabidiol being developed for the treatment of HFpEF. Cardiol is also developing CTX02, a proprietary nanoformulation of methotrexate for the treatment of heart failure. Time Tuesday, Feb 13 11:15AM - 11:30AM Location Ziegfeld Speakers David Elsley Cardiol Therapeutics Inc
CHF Solutions, Inc.
John Erb, CHF Solutions, Inc. show more Company Description/Mission Statement CHF Solutions is an early stage company focused on commercializing the Aquadex FlexFlow system. Our objective is to improve the quality of life for patients with heart failure and related conditions, such as fluid overload. At CHF Solutions, we are committed to the relentless pursuit of identifying and developing innovative solutions to address unmet clinical needs with the goal of benefiting patients, medical practitioners, and the broader healthcare community. Time Tuesday, Feb 13 11:15AM - 11:30AM Location Wilder Speakers John Erb CHF Solutions, Inc.
Precision NanoSystems
James Taylor, Precision NanoSystems show more Company Description/Mission Statement Precision NanoSystems Inc. (“PNI”) is a platform company in the global nanomedicine market, providing tools for drug development. PNI’s NanoAssemblr platform allow drug developers to rapidly develop novel nanomedicine drug candidates for pre-clinical testing and to seamless scale these drug candidates for clinical testing and eventually to commercial use. PNI provides its technology to leading pharmaceutical and biotechnology companies, and leading academic institutions in over 20 countries worldwide. Over 60 biopharmaceutical companies are using PNI’s technology to help develop their nanomedicine candidates, including 11 of the top 15 pharma. In 2017 PNI increased its user base by over 60% and revenues by over 120%. Time Tuesday, Feb 13 11:15AM - 11:30AM Location Gilbert Speakers James Taylor Precision NanoSystems
11:30am
Moberg Pharma AB (publ)
Peter Wolpert, Moberg Pharma AB (publ) show more Company Description/Mission Statement Moberg Pharma is a rapidly growing profitable Consumer Health and Pharma Company with sales exceeding $ 50million in 2017 and EBITDA of ca 15%. Moberg Pharma is the market leader in nail fungus OTC in the U.S., Canada, Scandinavia and several other countries and is developing a pipeline with two phase 3 assets with a combined annual sales potential of $300-600m We create value for patients, prescribers and shareholder by offering products that are based on proven molecules, have better efficacy and fewer side effects, or are just easier to use. We are constantly looking for the best product opportunities, and are happy to combine our own know-how with concepts and products from external partners and innovators. Moberg Pharma has its origins in the treatment of skin conditions, an area that is still in our focus today. Time Tuesday, Feb 13 11:30AM - 11:45AM Location Wilder Speakers Peter Wolpert Moberg Pharma AB (publ)
Pear Therapeutics, Inc.
Corey McCann, Pear Therapeutics, Inc. show more Company Description/Mission Statement Pear Therapeutics is the leader in FDA-cleared prescription digital therapeutics. The company integrates clinically-validated software applications with previously approved pharmaceuticals and treatment paradigms to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear’s lead product, reSET®, is an FDA-cleared, 12-week interval prescription therapy for substance use disorder (SUD) to be used as an adjunct to standard, outpatient treatment. Pear’s product development pipeline includes reSET-O™ for opioid use disorder (OUD) and additional prescription digital therapeutics in schizophrenia (Thrive™), combat post-traumatic stress disorder (reCALL™), general anxiety disorder (reVIVE™), pain, major depressive disorder, and insomnia. Time Tuesday, Feb 13 11:30AM - 11:45AM Location Gilbert Speakers Corey McCann Pear Therapeutics, Inc.
Resverlogix Corp.
show more Company Description/Mission Statement Resverlogix is bringing safe, affordable, first-in-class epigenetic therapeutics to people with heart disease, diabetes, chronic kidney disease and other life-threatening illnesses. Our lead drug candidate, apabetalone, is currently in a Phase 3 clinical trial, BETonMACE, which will be fully enrolled in the first half of 2018. Time Tuesday, Feb 13 11:30AM - 11:45AM Location Ziegfeld
12:00pm
Rachel Sherman, MD, MPH, Principal Deputy Commissioner, U.S. Food and Drug Administration (FDA)
Rachel Sherman, MD, MPH, U.S. Food and Drug Administration; James C. Greenwood, Biotechnology Innovation Organization (BIO) show more Session Description Dr. Rachel Sherman is Principal Deputy Commissioner of the U.S. Food and Drug Administration (FDA). She oversees all FDA medical programs and initiatives that are agency cross cutting and clinical, scientific, regulatory, or operational. She also provides advice and counsel to the FDA Commissioner on medical product regulation and oversees on his behalf other high-priority agency initiatives and programs. Key focus areas include modernization of combination product review, orphan product development, the Oncology Center of Excellence, promoting the use of innovative trial designs, and standards for evidence development. Dr. Sherman has served FDA since 1989 in a variety of capacities, beginning as a primary reviewer in FDA's Center for Drug Evaluation and Research (CDER) during the height of the AIDS crisis. In 2005, Dr. Sherman moved to FDA's Office of the Commissioner, where she served until 2009 as Associate Commissioner for Clinical Programs and directed the agency's Critical Path Initiative. From 2009 to 2014, as CDER's Associate Center Director for Medical Policy and Director of CDER's Office of Medical Policy, Dr. Sherman led a large, multidisciplinary staff charged with developing and implementing high-priority policies and programs, including the Sentinel Initiative, FDA's program for regulating biosimilars, and the agency's expedited drug development and breakthrough therapy designation programs. She organized multi-stakeholder public private partnerships, oversaw development of regulations and guidance for industry, and played a key role in enhancing clinical trial quality and good clinical practice. Her achievements contributed directly to more effective prescription drug promotion and to the modernization of professional drug labeling, generic drug labeling, and medication information for patients. In 2014, after 25 years of dedicated service to FDA and public health, Dr. Sherman retired. In 2015, she was asked to return to lead the Office of Medical Products and Tobacco, focusing on cross-center initiatives that foster efficient medical product development and facilitate patient access to new therapeutic products, work she will continue in her role as FDA Principal Deputy Commissioner. Dr. Sherman is an internist with a subspecialty in infectious diseases. She received her MPH from Johns Hopkins University, her MD from Mount Sinai School of Medicine, and her BA in mathematics from Washington University in St. Louis. She has served over the years as attending physician, Division of Infectious Diseases, at the Veterans Affairs Medical Center; clinical assistant professor of medicine (infectious diseases) at Georgetown University; and volunteer physician with Montgomery Mobile Health. Currently, Dr. Sherman is an adjunct assistant professor in the Division of Clinical Pharmacology in the Department of Medicine at Duke University. Time Tuesday, Feb 13 12:00PM - 12:55PM Location Salon 2 Speakers Rachel Sherman, MD, MPH U.S. Food and Drug Administration James C. Greenwood Biotechnology Innovation Organization (BIO)
1:00pm
Instilling Innovation Ambitions in your Leadership Culture
Karen Anderson, Alnylam Pharmaceuticals; Wanda Bryant Hope, Johnson & Johnson; Sabrina Johnson, Daré Bioscience, Inc.; James Sapirstein, ContraVir Pharmaceuticals show more Time Tuesday, Feb 13 1:00PM - 1:55PM Location Salon 4 Speakers Karen Anderson Alnylam Pharmaceuticals Wanda Bryant Hope Johnson & Johnson Sabrina Johnson Daré Bioscience, Inc. James Sapirstein ContraVir Pharmaceuticals
1:30pm
Bellerophon Therapeutics
Fabian Tenenbaum, Bellerophon Therapeutics show more Company Description/Mission Statement We are focused on developing innovative products combining novel drugs and devices in the treatment of cardiopulmonary diseases. Our mission is to develop well-studied molecules deployed through innovative delivery systems to treat diseases with significant unmet clinical need. Time Tuesday, Feb 13 1:30PM - 1:45PM Location Wilder Speakers Fabian Tenenbaum Bellerophon Therapeutics
Cue Biopharma
Daniel Passeri, Cue Biopharma show more Company Description/Mission Statement Cue Biopharma is an innovative immunotherapy company dedicated to developing a novel, proprietary class of biologics engineered to selectively modulate the human immune system to treat a broad range of cancers and autoimmune disorders. CUE Biologics are designed to engage directly with and modulate the activity of disease-associated T cells in the patient’s body, potentially offering significant therapeutic advantages while minimizing or eliminating unwanted side effects. Time Tuesday, Feb 13 1:30PM - 1:45PM Location Odets Speakers Daniel Passeri Cue Biopharma
Fibrocell Science, Inc.
John Maslowski, Fibrocell Science show more Company Description/Mission Statement Fibrocell is an autologous cell and gene therapy company translating personalized biologics into medical breakthroughs for diseases affecting the skin and connective tissue. Fibrocell’s most advanced product candidate, FCX-007, is the subject of a Phase 1/2 clinical trial for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Fibrocell is in pre-clinical development of FCX-013, its product candidate for the treatment of moderate to severe localized scleroderma. Fibrocell’s gene therapy portfolio is being developed in collaboration with Intrexon Corporation, a leader in synthetic biology. Time Tuesday, Feb 13 1:30PM - 1:45PM Location Ziegfeld Speakers John Maslowski Fibrocell Science
Gritstone Oncology, Inc.
Andrew Allen, Gritstone Oncology show more Company Description/Mission Statement Gritstone Oncology is a privately-held, next-generation personalized cancer immunotherapy company. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors and deep financial backing to tackle fundamental challenges at the intersection of cancer genomics, immunology, and immunotherapy design. The Company’s initial goal is to leverage deep learning to identify and deploy therapeutic neoantigens from individual patients’ tumors to develop novel treatments for lung and gastric cancer. In addition to neoantigen therapy development, Gritstone is leveraging its unique antigen discovery platform to define targets for shared antigen immunotherapies, which would provide an opportunity to treat even more patients. Gritstone Oncology is headquartered in the San Francisco Bay Area with key functions located in Cambridge, MA and Pleasanton, CA. Time Tuesday, Feb 13 1:30PM - 1:45PM Location Gilbert Speakers Andrew Allen Gritstone Oncology
1:45pm
CytoSorbents Corporation
Phillip Chan, CytoSorbents Corporation show more Company Description/Mission Statement CytoSorbents Corporation is a New Jersey-based, critical care immunotherapy company specializing in blood purification to control deadly inflammation in critically-ill and cardiac surgery patients. The company’s flagship product, CytoSorb®, is approved in the European Union with distribution in 43 countries around the world, as a safe and effective extracorporeal cytokine adsorber, designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis, as well as in cancer immunotherapy. These are conditions where the risk of death and cost of treatment are extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, that can lead to post-operative complications, including multiple Time Tuesday, Feb 13 1:45PM - 2:00PM Location Wilder Speakers Phillip Chan CytoSorbents Corporation
Exicure Inc.
David A. Giljohann, Exicure Inc. show more Company Description/Mission Statement Exicure is a clinical stage biotechnology company develeoping novel immunomodulatory and gene silencing drugs against validated targets. Our 3-dimensional , spherical nucleic acid (SNA) architecture unlocks the poential of n ucleic acid therapeutics in multiple organs. Our lead programs addressing diseases from inflammatory disorders to oncology are in Phase I trials. Time Tuesday, Feb 13 1:45PM - 2:00PM Location Ziegfeld Speakers David A. Giljohann Exicure Inc.
Leap Therapeutics Inc.
Doug Onsi, Leap Therapeutics Inc. show more Company Description/Mission Statement Leap Therapeutics (Nasdaq:LPTX) is developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein, a Wnt pathway modulator. DKN-01 is in clinical trials in patients with esophagogastric cancer and biliary tract cancer, with an emerging focus on patients with defined mutations of the Wnt pathway and in combinations with immune checkpoint inhibitors. Leap’s second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response that is in two advanced solid tumor studies. Time Tuesday, Feb 13 1:45PM - 2:00PM Location Odets Speakers Doug Onsi Leap Therapeutics Inc.
2:00pm
Aravive Biologics
Stephen Eck, Aravive Biologics show more Company Description/Mission Statement Aravive Biologics, Inc., is an innovative pharmaceutical company dedicated to translating fundamental biological insights into new therapies to address major unmet medical needs in cancer and fibrotic conditions. Our primary therapeutic focus is the GAS6-AXL pathway, which plays a critical role in multiple types of biologic processes. Our unique cancer therapies have the potential to offer more effective results either as a monotherapy or in combination with other cancer therapies, augmenting the anti-tumor activity of radiotherapy, chemotherapy, immuno-oncology agents and therapeutics. AVB-S6 (formerly, Aravive-SB), our lead product candidate, is a genetically engineered biologic with applicability to a variety of cancers including ovarian, pancreatic, and breast cancers and acute myelogenous leukemia, as well as several non-malignant fibrotic conditions. Our ongoing clinical studies employ a proprietary diagnostic that accelerates drug development and informs patient selection. Time Tuesday, Feb 13 2:00PM - 2:15PM Location Gilbert Speakers Stephen Eck Aravive Biologics
Daré Bioscience, Inc.
show more Company Description/Mission Statement Daré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women’s reproductive health. We are driven by a mission to identify, develop and bring to market a diverse portfolio of novel therapies that expand treatment options, improve outcomes and facilitate convenience for women. We are initially focused on the areas of contraception, vaginal health and fertility. Our first product candidate, Ovaprene™, is a monthly non-hormonal contraceptive ring that is currently in clinical studies. We founded Daré because we felt product development in women’s reproductive health is fragmented – the two ends of the development spectrum are being adequately addressed but the stages of clinical development between innovation / early clinical development and late stage development / commercialization are underserved, creating a potential opportunity for Daré to fill the gap by taking products from innovation through development. Time Tuesday, Feb 13 2:00PM - 2:15PM Location Ziegfeld
Dyadic International, Inc.
Mark Emalfarb, Dyadic International, Inc. show more Company Description/Mission Statement Strong Financial Position ~ $51 Million / Cash and Investment Grade Securities with no debt. $5 Million share buyback program initiated Dyadic International, Inc. is a global biotechnology company which is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the fungus Myceliophthora thermophila, nicknamed C1. The C1 microorganism, which enables the development and large scale manufacture of low cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines, monoclonal antibodies, biosimilars and/or biobetters, and other therapeutic proteins. Time Tuesday, Feb 13 2:00PM - 2:15PM Location Wilder Speakers Mark Emalfarb Dyadic International, Inc.
Erytech Pharma
Gil Beyen, Erytech Pharma show more Company Description/Mission Statement Placing the patient at the heart of our priorities, demonstrating ethics and respect towards each person, Erytech is focused on becoming a global leader in rare cancer and orphan diseases space. Since our inception, our mission has been to make a sustained investment in R&D in order to meet the challenges of public health and to offer innovative therapies to target markets with high unmet medical needs, particularly in the field of cancer. Our company has been classified as a Pharmaceutical Facility and develops its activities in close collaboration with health professionals, particularly physicians and pharmacists. Time Tuesday, Feb 13 2:00PM - 2:15PM Location Odets Speakers Gil Beyen Erytech Pharma
Vivek Ramaswamy, Founder and Chief Executive Officer, Roivant Sciences
Vivek Ramaswamy, Roivant Sciences; Robyn Karnauskas, Citi show more Session Description Vivek Ramaswamy is founder and Chief Executive Officer of Roivant Sciences. The Roivant family of companies includes multiple wholly-owned or majority-owned biopharmaceutical subsidiaries, each focused on a different disease area. Roivant has 16 drugs in its collective pipeline and has raised over $2.5 billion in capital to date to fund clinical programs and pursue adjacent business opportunities in healthcare. Prior to founding Roivant, Mr. Ramaswamy was an investor in the biotechnology sector. He currently serves as Chairman of the Board of Directors of Arbutus Biopharma Corporation and he is a member of the Board of Directors of Axovant Sciences, Myovant Sciences, and Roivant Sciences. He received an A.B. summa cum laude in biology from Harvard College and a J.D. from Yale Law School. Time Tuesday, Feb 13 2:00PM - 2:55PM Location Salon 2 Speakers Vivek Ramaswamy Roivant Sciences Robyn Karnauskas Citi
2:15pm
Eyegate Pharmaceuticals, Inc.
show more Company Description/Mission Statement EyeGate is a clinical-stage specialty pharmaceutical company developing and commercializing products for treating diseases and disorders of the eye. The Company has two proprietary platform technologies. Our most advanced platform is based on cross-linked thiolated carboxymethyl hyaluronic acid (“CMHA-S”), a modified form of the natural polymer hyaluronic acid (“HA”), which is a gel that possesses unique physical and chemical properties such as hydrating and healing when applied to the ocular surface. The ability of CMHA-S to adhere longer to and protect the ocular surface, as well as resist degradation, makes it well-suited for treating various ocular surface injuries. Our lead CMHA-S product, EyeGate Ocular Bandage Gel (“OBG”) is being evaluated in a pilot study for corneal re-epithelialization following photorefractive keratectomy (“PRK”) surgery. EyeGate OBG is classified as a Class 2 medical device, and we plan to pursue U.S. regulatory clearance via the FDA’s De Novo 510(k) path Time Tuesday, Feb 13 2:15PM - 2:30PM Location Ziegfeld
Forty Seven Inc.
show more Company Description/Mission Statement In 2015, a team of leading cancer biology and immunology researchers at Stanford University partnered with experts in drug development, production and distribution, along with leading venture capital firms to found Forty Seven Inc. Our goal is to leverage its scientific founders’ professional experience and develop novel therapies that activate the immune system to help patients defeat their cancer. Over the past decade, our scientists have discovered that the first macrophage checkpoint —the CD47-SIRPɑ pathway—is an important mechanism for cancer immune evasion. Based on this pioneering discovery, Forty Seven Inc. became the first to develop and test a novel antibody against CD47 in clinical trials. We are committed to using our expertise to bring our CD47 antibody (and other novel therapies) to the clinic so that patients and their families will be able to access treatments that will aim to be instrumental in helping them beat their cancer. Time Tuesday, Feb 13 2:15PM - 2:30PM Location Gilbert
Inovio Pharmaceuticals
J. Joseph Kim, Inovio Pharmaceuticals show more Company Description/Mission Statement Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Genentech, The Wistar Institute, University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, DARPA, GeneOne Life Science, Plumbline Life Sciences, ApolloBio Corporation, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com. Time Tuesday, Feb 13 2:15PM - 2:30PM Location Odets Speakers J. Joseph Kim Inovio Pharmaceuticals
Sanuwave Health, Inc.
show more Company Description/Mission Statement SANUWAVE Health, Inc. is an emerging leader in the development and commercialization of a high- energy, focused, shock wave technology that is used in devices for the repair and regeneration of bones, muscles, tendons and skin, and for the separation of solids and fluid in non-medical systems. Within healthcare, SANUWAVE’s proprietary, patented Pulsed Acoustic Cellular Expression (PACE) technology emits high-energy, acoustic shock waves that restore the body’s normal healing processes. This activates biologic signaling which leads to tissue repair and regeneration and blood vessel growth – revascularization and microcirculatory enhancement. SANUWAVE has three devices that employ the PACE technology. The lead device for the global wound care market, dermaPACE®, is approved for use outside the United States (CE Marked) for advanced wound care indications and is currently being studied in a U.S-based supplemental pivotal clinical trial for diabetic foot ulcers. Time Tuesday, Feb 13 2:15PM - 2:30PM Location Wilder
2:30pm
Lexi Pharma Inc.
Ali Ardakani, Lexi Pharma Inc. show more Company Description/Mission Statement Lexi is a clinical stage company developing compounds addressing unmet needs in oncology & oncology supportive care. Our lead compound, LX-001, has cleared US FDA IND, targets both bone (preventing bone resorption) and tumors (killing the tumor cells). Preclinical studies show LX-001 binds bone and selectivity inhibits osteoclast differentiation and bone resorption. It has a fast track development to market of about 4 years. Time Tuesday, Feb 13 2:30PM - 2:45PM Location Gilbert Speakers Ali Ardakani Lexi Pharma Inc.
pSivida Corp
Nancy Lurker, pSivida show more Company Description/Mission Statement Focused on preventing blindness through the development of innovative sustained-release drug products and technologies. Time Tuesday, Feb 13 2:30PM - 2:45PM Location Ziegfeld Speakers Nancy Lurker pSivida
SELLAS Life Sciences Group, Inc.
Angelos Stergiou, SELLAS Life Sciences Group, Inc. show more Company Description/Mission Statement SELLAS Life Sciences Group, Inc. is a late-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications. The Company’s lead product candidate, galinpepimut-S, is a cancer immunotherapeutic agent licensed from Memorial Sloan Kettering Cancer Center that targets a broad spectrum of hematologic cancers and solid tumor indications. Galinpepimut-S is poised to enter pivotal Phase 3 clinical trials, pending funding availability, in patients with AML and Mesothelioma. Time Tuesday, Feb 13 2:30PM - 2:45PM Location Odets Speakers Angelos Stergiou SELLAS Life Sciences Group, Inc.
2:45pm
Diffusion Pharmaceuticals Inc.
David Kalergis, Diffusion Pharmaceuticlas Inc. show more Company Description/Mission Statement Diffusion is a Phase III clinical-stage biotechnology company focused on extending the life expectancy of cancer patients by improving the effectiveness of current standard of care therapies including radiation and chemotherapy. Our lead product candidate, TSC, works by re-oxygenating hypoxic tissue. We are currently enrolling patients in our Phase III trial in Glioblastoma Multiforme (GBM). Time Tuesday, Feb 13 2:45PM - 3:00PM Location Odets Speakers David Kalergis Diffusion Pharmaceuticlas Inc.
Immunomic Therapeutics, Inc.
Bill Hearl, Immunomic Therapeutics, Inc. show more Company Description/Mission Statement Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical stage biotechnology company pioneering the study of the LAMP-based nucleic acid immunotherapy platforms. These investigational technologies have the potential to alter how we use immunotherapy for cancer, allergies and animal health. On the heels of two landmark deals in 2015, including an exclusive worldwide license with Astellas Pharma Inc. to explore the use of LAMP-Vax™ for use in the prevention and treatment of allergic diseases which resulted in over $315M in licensing revenue that year, the company has now focused on the application of LAMP technology in oncology. The mission of Immunomic Therapeutics is to pioneer vaccines that transform lives. Time Tuesday, Feb 13 2:45PM - 3:00PM Location Gilbert Speakers Bill Hearl Immunomic Therapeutics, Inc.
3:00pm
Chronic Disease Innovation: PCSK9 Treatments’ Early Lessons for Other Therapies
Steven Mento, Conatus Pharmaceuticals Inc.; Jim Tobin, Johnson & Johnson Innovation; Susan Peschin, Alliance for Aging Research show more Time Tuesday, Feb 13 3:00PM - 3:55PM Location Salon 4 Speakers Steven Mento Conatus Pharmaceuticals Inc. Jim Tobin Johnson & Johnson Innovation Susan Peschin Alliance for Aging Research
Flex Pharma
William McVicar, Flex Pharma show more Company Description/Mission Statement Flex Pharma, Inc. is a clinical-stage biotechnology company that is developing innovative and proprietary treatments in Phase 2 randomized, controlled trials for cramps and spasticity associated with the severe neurological diseases of ALS, MS and peripheral neuropathies such as Charcot-Marie-Tooth (CMT). The Company’s lead candidate, FLX-787, is being developed under Fast Track designation for the treatment of severe muscle cramps associated with ALS. Flex Pharma was founded by National Academy of Science members Rod MacKinnon, M.D. (2003 Nobel Laureate), and Bruce Bean, Ph.D., recognized leaders in the fields of ion channels and neurobiology, along with Christoph Westphal, M.D., Ph.D. Time Tuesday, Feb 13 3:00PM - 3:15PM Location Ziegfeld Speakers William McVicar Flex Pharma
Tarveda Therapeutics, Inc.
Drew Fromkin, Tarveda Therapeutics show more Company Description/Mission Statement Tarveda Therapeutics is a clinical stage biopharmaceutical company that takes a novel approach to cancer treatment by creating proprietary Pentarins™, which are potent and selective, miniaturized conjugates uniquely designed to drive efficacy through deep and rapid penetration into solid tumors resulting in sustained payload accumulation and cancer cell death. Through our Pentarin platform, we are developing therapeutics to address the limitations of current cancer therapies in solid tumors. Time Tuesday, Feb 13 3:00PM - 3:15PM Location Gilbert Speakers Drew Fromkin Tarveda Therapeutics
3:15pm
Nemus Bioscience, Inc.
Brian Murphy, Nemus Bioscience show more Company Description/Mission Statement Life-science biotech focused on developing cannabinoid-based therapies for diseases of unmet medical need like glaucoma, acute/chronic pain, inflammatory conditions, and anti-infectives. Our therapies are chemically and biosynthetically produced and are bio-engineered for enhanced bioavailability and predictive pharmacokinetics. Time Tuesday, Feb 13 3:15PM - 3:30PM Location Ziegfeld Speakers Brian Murphy Nemus Bioscience
4:00pm
Vicki Sato, PhD, Chairman, Denali Therapeutics; Chairman, Vir Biotechnology
Vicki Sato, PhD, Denali Therapeutics; Kate Merton, Johnson & Johnson Innovation show more Session Description Vicki L. Sato, Ph.D., serves as chairman of the board of directors at Vir. Dr. Sato is also a professor of management practice at Harvard Business School, and an affiliate member of the Department of Molecular and Cell Biology, Harvard University. She has taught in HBS Executive Education programs and is a business advisor to enterprises in the biotechnology and pharmaceutical industries. Dr. Sato retired in 2005 from Vertex Pharmaceuticals, where she served as president since 2000, with responsibility for research and development, business and corporate development, commercial operations, legal, and finance. Prior to becoming president, she was chief scientific officer, senior vice president of research and development, and chair of the Scientific Advisory Board. Under her leadership, Vertex created a diversified pipeline of drugs. Before joining Vertex, Dr. Sato was vice president of research at Biogen, Inc., where she led research programs in the areas of inflammation, thrombosis, and HIV disease, and she participated in the executive management of the company. Several molecules from those programs have now reached the marketplace. She also served as a member of the Biogen Scientific Board. Currently, Dr. Sato is a member of the board of directors of publicly held companies Bristol Myers Squibb Company, PerkinElmer Corporation, Borg Warner Corporation, and Syros Pharmaceuticals. She also serves as chair of the board of directors for Denali. Previously, Dr. Sato has served as an overseer of the Isabella Stewart Gardner Museum. She received her A.B. from Radcliffe College, and her A.M. and Ph.D. degrees from Harvard University. Following postdoctoral work at both the University of California Berkeley and Stanford Medical Center, Dr. Sato was appointed to the faculty of Harvard University, where she was an assistant and associate professor of biology. Time Tuesday, Feb 13 4:00PM - 4:55PM Location Salon 2 Speakers Vicki Sato, PhD Denali Therapeutics Kate Merton Johnson & Johnson Innovation
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Development Phase of Primary Product