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22nd Century 22nd Century Group, Inc., a plant biotechnology company, provides technology that allows for the level of nicotine and other nicotinic alkaloids in tobacco plants to be decreased or increased through genetic engineering and plant breeding. It develops smoking cessation products and modified risk tobacco products for smokers who are unable or unwilling to quit smoking and who may be interested in cigarettes, which reduce exposure to nicotine or to certain tobacco smoke toxins and/or pose a lower health risk than conventional cigarettes. The company’s products include RED SUN and MAGIC regular and menthol cigarettes; and SPECTRUM government research cigarettes. It is also developing X-22, a prescription smoking cessation aid, which is a tobacco-based botanical medical product for use as a smoking cessation therapy; and modified risk cigarettes, such as BRAND A, which has approximately 95% less nicotine than conventional tobacco cigarettes, as well as BRAND B cigarettes that contain low amount of tar per milligram of nicotine. The company was founded in 1998 and is headquartered in Clarence, New York. 25 minutes Company Presentation
2X Oncology, Inc 2X Oncology Inc. is a clinical stage precision therapeutics company that develops medicines for the unmet needs of women with cancer. Our primary focus is hard-to-treat metastatic breast, ovarian and endometrial cancers as well as primary and secondary brain cancers. Our pipeline consists of three novel drugs that have shown efficacy in cancer patients in phase 1/2 trials. A validated and unique proprietary RNA biomarker technology is used to select and treat highly likely responsive patients. This technology will serve as a companion diagnostic (cDx) to the pipeline products as they move from clinical development to market. The benefit of our drug plus cDx approach is that we de-risk and accelerate the clinical development of our pipeline as well as improve patient response rates and clinical outcome. 13 Minutes Company Presentation marie foegh
4SC AG 4SC is a biotech company dedicated to the research and development of small-molecule drugs focused on epigenetic mechanisms of action for the treatment of cancers with high unmet medical needs. These drugs are intended to provide innovative treatment options for cancer patients that are more tolerable and efficacious than existing therapies, provide a better quality of life and offer increased life expectancy. The Company's pipeline comprises promising products that are in various stages of clinical development. 4SC's aim is to generate future growth and enhance its enterprise value by entering into partnerships with pharmaceutical and biotech companies. Founded in 1997, 4SC had 47 employees as of 30 September 2016. 4SC has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005. 25 minutes Company Presentation Jason Loveridge
AcelRx Pharmaceuticals AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. The Company's late-stage pipeline includes ARX-04 (sufentanil sublingual tablet, 30 mcg), designed for the treatment of moderate-to-severe acute pain in medically supervised settings; and Zalviso® (sufentanil sublingual tablet system), designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting. Zalviso delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. Zalviso is approved in the EU as well as Norway, Iceland, and Liechtenstein and is investigational and in late-stage development in the U.S. Grunenthal Group holds the rights for Zalviso in Europe and Australia, while AcelRx retains all other world-wide rights. 25 minutes Company Presentation Timothy Morris
Actinium Pharmaceuticals, Inc Actinium Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative targeted therapies for patients with cancers lacking effective treatment options. Actinium's proprietary platform utilizes monoclonal antibodies to deliver radioisotopes directly to cells of interest in order to kill those cells safely and effectively. The Company's lead product candidate Iomab-B is designed to be used, upon approval, in preparing patients for a hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. A bone marrow transplant is often the only potential cure for patients with blood-borne cancers but the current standard preparation for a transplant requires chemotherapy and/or total body irradiation that result in significant toxicities. Actinium believes Iomab-B will enable a faster and less toxic preparation of patients seeking a bone marrow transplant, leading to increased transplant success and survival rates. The Company is currently conducting a single pivotal 150-patient, multicenter Phase 3 clinical study of Iomab-B in patients with relapsed or refractory acute myeloid leukemia (AML) age 55 and older. The Company's second product candidate, Actimab-A, is currently in a multicenter open-label, 53-patient Phase 2 trial for patients newly diagnosed with AML age 60 and over. Actimab-A is being developed to induce remissions in elderly patients with AML who lack effective treatment options and often cannot tolerate the toxicities of standard frontline therapies. Actinium is also utilizing its alpha-particle immunotherapy (APIT) technology platform to generate new drug candidates based on antibodies linked to the element Actinium-225 that are directed at various cancers that are blood-borne or form solid tumors. Actinium Pharmaceuticals is based in New York, NY. 25 minutes Company Presentation Sandesh Seth
AETERNA ZENTARIS Aeterna Zentaris is a specialty biopharmaceutical company focused on developing and commercializing therapies which enhance and improve the lives of patients worldwide. The Company has two Phase 3 product candidates in development: Zoptrex™, a first-in-class targeted therapy, which if approved will be the first FDA-approved treatment for advanced, recurrent endometrial cancer, and Macrilen™, potentially the first FDA-approved drug to be used in conjunction with the evaluation of growth hormone deficiency in adults. In addition, the Company currently co-promotes two products: Saizen® [somatropin (rDNA origin) for injection], a recombinant human growth hormone supplement, on behalf of EMD Serono; and, APIFINY®, the first non-PSA blood test for use in evaluating and managing the risk of prostate cancer, on behalf of Armune Bioscience. In addition to the clinical development programs and current commercial activities, Aeterna Zentaris actively seeks opportunities to in-license and acquire products for US commercialization. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. 25 minutes Company Presentation David Dodd
Agile Therapeutics, Inc Agile Therapeutics is a women’s health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products. Our product candidates are designed to provide women with contraceptive options that offer greater convenience and facilitate compliance. Our lead product candidate, Twirla®, also known as AG200-15, is a once-weekly prescription contraceptive patch currently in Phase 3 clinical development. Twirla is based on our proprietary transdermal patch technology, called Skinfusion®, which is designed to provide advantages over currently available patches and is intended to optimize patch adherence and patient acceptability. 25 minutes Company Presentation Al Altomari
Akebia Therapeutics, Inc. 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 therapy in development for the treatment of anemia related to chronic kidney disease in both non-dialysis and dialysis patients. Akebia's global Phase 3 program for vadadustat, which includes the PRO2TECT studies for non-dialysis patients with anemia secondary to chronic kidney disease and the INNO2VATE studies for dialysis-dependent patients, is currently ongoing. 25 minutes Company Presentation John Butler
Albireo Pharma Inc Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators. Albireo’s clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo's lead product is A4250 is a first-in-class product candidate in development for progressive familial intrahepatic cholestasis (PFIC) and potentially other orphan pediatric cholestatic liver diseases. Albireo is a spin-out from Astra-Zeneca in Sweden and has recently become a public company. 25 minutes Company Presentation Ron Cooper
Alcobra Alcobra is merging pharmaceutical company (NASDAQ: ADHD) primarily focused on the development and commercialization of our proprietary drug, METADOXINE EXTENDED RELEASE (MDX), to treat cognitive disorders including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome (FXS). MDX is not a stimulant; it works through a different mechanism of action than other ADHD treatments. Alcobra has completed multiple Phase II studies of MDX in adults and adolescents with ADHD and FXS and a Phase III study of MDX in adults with ADHD. The company is currently conducting a second, pivotal Phase III trial of MDX in adult ADHD. 25 minutes Company Presentation
Altimmune, Inc. Altimmune is a clinical stage immunotherapeutic company focused on the development of products to stimulate robust and durable immune responses for the prevention and treatment of disease. The Company has two proprietary platform technologies, RespirVec and Densigen, each of which has been shown to activate the immune system in distinctly different ways than traditional vaccines. Using these technologies, Altimmune has developed three novel clinical stage product candidates that potentially represent an entirely new approach to harnessing the immune system. The Company’s most advanced product candidate, NasoVAX, is a Phase 2-ready intranasally-delivered recombinant influenza vaccine offering broad and rapid protection with potential for significant advantages over traditional flu vaccines. The second most advanced product candidate, HepTcell, is being tested as an immunotherapy for patients chronically infected with hepatitis B and has the potential to provide a functional cure. With the support of the U.S. Biomedical Advanced Research and Development Authority, or BARDA, the Company is developing a third product candidate, NasoShield, a first-in-class anthrax vaccine designed to provide rapid, stable protection after one intranasal administration. The Company intends to leverage the RespirVec and Densigen platforms to develop additional product candidates for a variety of indications. 25 minutes Company Presentation Bill Enright
American Gene Technologies International Inc. American Gene Technologies International Inc. (“AGT”), www.amerincangene.com, is an emerging gene technology company with a broad, robust lentiviral delivery platform evolved over ten years of advanced development at its Rockville, Maryland laboratories. Recently, AGT began to advance therapeutics based on this platform and has conducted a successful FDA pre-IND meeting to initiate a Phase 1 human trial evaluating the safety of an autologous cell product for an HIV functional cure. AGT expects to file the IND and initiate human clinical trials for HIV in 2017. In parallel, AGT is actively developing therapies for phenylketonuria (“PKU”) and hepatocellular carcinoma (“HCC”), both of which are in animal studies to obtain proof of concept in preparation for pre-IND applications. AGT has developed extensive IP protection surrounding lentiviral platform innovations that accelerate the development of a wide variety of drug candidates, provide significant opportunities for out-licensing, and offer exciting clinical opportunities in large and orphan indications, complex diseases, and monogenic disorders. Examples of core elements of AGT’s intellectual property portfolio include: 1) Modifications to lentiviruses to render them “transient” – allowing high expression followed by complete degradation of the virus that preserves the low-immune and low-inflammation advantages of lentiviral vectors while greatly improving safety by preventing permanent integration. 2) An “immune-stimulating vector” that, through genetic modification of tumor cells, up-regulates tumor immunogenicity, stimulating the body’s natural immune system to eliminate tumor cells without modifications to the host immune system – thus providing greater long-term safety over other immunoregulatory approaches (such as CAR-T). 13 Minutes Company Presentation
AmpliPhi Biosciences Corp AmpliPhi Biosciences Corporation (NYSEMKT:APHB) is a clinical-stage biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. AmpliPhi's product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi has completed two Phase 1 clinical trials to evaluate the proprietary drug candidate, AB-SA01. The first trial was in Australia and designed to evaluate AB-SA01 in chronic rhinosinusitis (CRS) patients suffering from Staphylococcus aureus infections. The second Phase 1 trial, located in the U.S., was designed to evaluate the safety of AB-SA01 in the intact skin of healthy volunteers. AmpliPhi has reported final data for both trials and expects to move into the first Phase 2 phage therapy trial in 2017. AmpliPhi is also developing phage cocktails targeting Pseudomonas aeruginosa (P. aeruginosa) in cystic fibrosis patients and Clostridium difficile (C. difficile) in patients with C. diff infections. Both of these programs are in collaboration with a number of leading academic organizations. AmpliPhi maintains its wholly-owned R&D facility in Sydney and cGMP manufacturing facility in Ljubljana, Slovenia. 25 minutes Company Presentation Scott Salka
Angionetics Inc. Angionetics is a biotechnology company focused on the clinical and commercial development of angiogenic, gene- based bio-therapeutics for the treatment of the almost 1.8 million patients in the U.S. who have late-stage coronary artery disease and refractory angina as well as other medical conditions due to myocardial ischemia. Angionetics' Generx [Ad5FGF-4] angiogenic gene therapy has advanced to late-stage Phase 3 clinical study in the U.S. in men and women with refractory angina. The Generx regulatory dossier on file with the FDA represents one of the most extensive and advanced DNA-based clinical data platforms ever compiled, positioning Angionetics as the world’s leader in the field of angiogenic gene therapy. 13 Minutes Company Presentation Christopher Reinhard
Apexian Pharmaceuticals Apexian Pharmaceuticals is a clinical-stage biotechnology company focused on developing novel compounds to treat cancer, targeting the multiple functions of the APE1 protein.  The lead drug candidate, APX3330, initially targets late stage cancer refractory to existing treatments and is expected to begin clinical studies in 2016. To learn more about Apexian Pharmaceuticals, please visit the Company's website at www.ApexianPharma.com 13 Minutes Company Presentation Steve Carchedi
Applying Microbiome Research to Therapeutics New discoveries are finding links that extend significantly beyond the gut microbiome and intestinal disorders into a range of bodily systems including the immune and nervous systems.  Major biopharma companies have engaged in significant deals that envision treatments to commercialize from this research and leading companies are pushing forward on clinical trials.  This session will outline the microbiome influenced therapies most likely to create major effects for patients. 1 Hour Panel Mark Bodmer, PhD
Nikola Trbovic, PhD
Nick Conley
PIERRE BELICHARD
Jeff Riley
Aoife Brennan, MD
C. Simone Fishburn, PhD - Moderator
Apricus Biosciences, Inc. Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus’ commercial product, Vitaros®, for the treatment of erectile dysfunction, is approved in Canada and certain countries in Europe, Latin America and the Middle East and is being commercialized in several countries in Europe. In September 2015, Apricus in-licensed the U.S. development and commercialization rights for Vitaros from Allergan. Apricus’ marketing partners for Vitaros include Recordati Ireland Ltd. (Recordati), Ferring International Center S.A. (Ferring Pharmaceuticals), Laboratoires Majorelle, Bracco S.p.A., Mylan NV and Elis Pharmaceuticals Ltd. Apricus currently has one active product candidate, RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud’s phenomenon. 25 minutes Company Presentation
AptamiR Therapeutics, Inc. AptamiR's MISSION is to cure human obesity by activating thermogenesis without altering brain and cardiovascular functions or quality of life. Our STRATEGY is: ♦ To target peripheral fat-storing white adipocytes to transform them into fat-burning adipocytes (“Browning Effect”) ♦ To focus on miRNAs which modulate many target genes and pathways MARKET CHALLENGES ♦ Human obesity is a costly pandemic affecting 1/3 of the world population ♦ Current medical treatments of obesity have poor benefit-to-risk profiles, fail to reach long-term therapeutic goals and do not meet patients’ expectations ACHIEVEMENTS ♦ Since inception in 2012, AptamiR has developed a modular R&D platform leading to the selection of its first drug candidate (APT-110) for the treatment of obesity and diabetes, which is expected to reach clinical testing by the end of 2016 ♦ Breakthrough results were achieved in mouse model of Diet-Induced Obesity: o Body weight and fat mass reduction (12% after 12 weeks of treatment) despite steady consumption of 60% fat diet o Energy expenditure increase o Glucose tolerance and insulin sensitivity normalization o Serum cholesterol, pro-inflammatory leptin, and liver mass reduction ♦ AptamiR filed several patent applications in various geographic regions: o First US patent 9,034,839 B2 (May 2015): “MicroRNA modulators of thermogenesis” o US Patent 2015-0216892-A1 (August 2015): “Cell-specific delivery of miRNA modulators for the treatment of obesity and related disorders” o US Patent 62/329,537 (April 2016): Inhibition of mir-22 miRNA by APT-110  ♦ The FDA positively reviewed AptamiR’s first pre-IND application in January 2015. A full IND application will be filed in December 2016 FINANCING AptamiR completed 3 rounds of Angels Financing and Series A Financing, raising a total of $5.7M AptamiR now aims to raise $10M in order to: ♦ To reach Phase 2 clinical development of our 1st drug candidate and start clinical development for 2nd drug candidate ♦ Further develop our unique delivery platform targeting adipose tissues TEAM ♦ Marc Thibonnier, MD, MSc, founded AptamiR after a successful career in Academia and Pharmaceutical Companies ♦ Board Members and Scientific Advisors include: Philippe Camus: Chairman of AptamiR and Alcatel-Lucent/Nokia, Jean-Pierre Lehner, MD: Retired Chief Medical Officer of Sanofi, John Amatruda, MD: Former SVP and Head of Diabetes and Obesity at Merck Research Laboratories, Bernard Poussot: Retired Chairman, CEO & President of Wyeth 13 Minutes Company Presentation Marc THIBONNIER
Aradigm Corporation Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of rare severe respiratory diseases in patients with unmet medical needs. Its leading product candidate Pulmaquin  completed recently two Phase 3 clinical trials for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with P aeruginosa. Aradigm intends initially to seek approval of Pulmaquin in US and EU for this condition. Aradigm’s inhaled ciprofloxacin formulations are also product candidates for treatment of patients with cystic fibrosis and non-tuberculous mycobacteria, and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and inhaled anthrax. More information about Aradigm can be found at www.aradigm.com. 25 minutes Company Presentation Igor Gonda
Arch Therapeutics, Inc. The Mission of Arch Therapeutics is to develop products that will improve the lives of patients and enhance the quality of care offered by healthcare personnel. We intend to offer compelling options to healthcare institutions facing limited resources. Arch Therapeutics strives to be a leader in the field of stasis and barrier applications. This includes, but is not limited to, hemostasis and sealant products. We intend to develop products with dramatically improved profiles and characteristics over products on the market or in development. Arch Therapeutics is focused on capital efficiency. Our operational plans are geared toward achieving value-creating milestones in a manner that optimizes quality, probability of success, and cost effectiveness. 25 minutes Company Presentation Terrence Norchi
Arcturus Therapeutics Since the days of Watson, Crick, and Franklin, DNA has hogged the limelight, overshadowing RNA. Recently, however, RNA has claimed center stage as a multi-talented player, dialing gene expression up or down and even altering the genome through gene editing. With precision and power, RNA medicines have the potential to treat and even cure rare genetic diseases, as well as fight viral infections, cancer, and heart disease. Yet RNA is more vulnerable than DNA to rapid destruction by exonucleases. And in order to exert any effect, an RNA medicine must cross the cell membrane, making a robust delivery system critical. Arcturus Therapeutics has developed unique RNA chemistry and an LNP that overcome these obstacles. These proprietary technologies, UNA and LUNAR, have been shown to deliver single- or double-stranded RNAs to diverse cell types and tissues. With this flexible platform, Arcturus is addressing unmet needs in rare diseases, including cystic fibrosis (CF), metabolic disorders, and hepatitis B. UNA is a novel nucleoside chemistry that lacks ribose but can be incorporated into RNA. UNA is divergent enough from natural RNA that it is unrecognized by either nucleases or immune receptors. The result is a longer, yet transient, residence time for UNA-containing RNAs compared to native RNAs. LUNAR is an LNP delivery system that incorporates cationic, biodegradable lipids, shortening residence times and reducing the potential for long-term toxicity compared to other lipid particles. LUNAR is also nonimmunogenic, and therefore can be used in repeat dosing and dose-escalation studies that are not feasible with viral delivery systems. LUNAR effectively targets clinically important cells and tissues, including liver hepatocytes and stellate cells, cardiomyocytes, lung cells, and B and T cells. We have made a strong showing since its founding three years ago, inking major deals with Ultragenyx, Janssen and Takeda. Ultragenyx paid $10 million up front to license our technologies to develop mRNA drugs for rare and ultra-rare diseases. Janssen, in addition to licensing UNA and LUNAR, is collaborating with us to develop RNA-based drugs for the treatment of HBV. We also entered into a collaboration with Takeda to develop RNA-based drugs for the treatment of NASH. Four additional in-house programs to develop UNA-based RNA treatments for rare genetic disorders are also under way, targeting TTR, CF, OTC deficiency, and an unnamed GI target. 13 Minutes Company Presentation Joseph Payne
Argos Therapeutics, Inc Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos' most advanced product candidate, rocapuldencel-T, is being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). In addition, rocapuldencel-T is being studied in Phase 2 investigator-initiated clinical trials as neoadjuvant therapy for renal cell carcinoma (RCC) and for the treatment of non-small cell lung cancer (NSCLC). Argos is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated Phase 2 clinical trial aimed at HIV eradication in adult patients. 25 minutes Company Presentation Jeff Abbey
Atlantic Healthcare plc Atlantic Healthcare plc is an emerging trans-Atlantic pharmaceutical group addressing the clinical needs of patients under specialist care, with an existing focus on gastrointestinal (GI) disease. The Group intends to market its products directly in Europe and the U.S., and partner in other markets including Canada and Japan. Atlantic Healthcare has its corporate office near Cambridge, UK and a commercial office in Raleigh, North Carolina, U.S.. The Group's lead product, alicaforsen, is progressing through Phase 3 clinical development in pouchitis, a form of inflammatory bowel disease (IBD), and has potential applications in multiple IBD indications. The Group's vision is to establish an industry-leading hospital and specialist-care focussed business that positively transforms patients’ lives. 13 Minutes Company Presentation Toby Wilson Waterworth
Aveo Oncology AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The company is focused on developing and commercializing its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for Renal Cell Carcinoma and other cancers. AVEO is leveraging multiple partnerships to develop and commercialize tivozanib in non-oncologic indications worldwide and oncology indications outside of North America, as well as to progress its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome). 25 minutes Company Presentation Michael Needle
Axsome Therapeutics, Inc. Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited existing treatment options. Axsome’s product candidate portfolio includes two late-stage candidates, AXS-02 and AXS-05. AXS-02 is currently in Phase 3 trials in complex regional pain syndrome (CRPS) and knee osteoarthritis (OA) associated with bone marrow lesions (BMLs) with an additional Phase 3 trial planned in chronic low back pain (CLBP) associated with Modic changes (MCs). AXS-05 is currently in a Phase 3 trial in treatment resistant depression (TRD), and a Phase 2/3 trial in agitation in patients with Alzheimer’s disease (AD) is planned. AXS-02 and AXS-05 are investigational product candidates not approved by the FDA. 25 minutes Company Presentation Herriot Tabuteau, MD
Baebies, Inc. At Baebies our sole focus is to advance newborn screening and other pediatric testing worldwide. Baebies is guided by the vision that “everyone deserves a healthy start”. Baebies is developing innovative, easy to use and connected products to make life better for millions of babies. By bringing new technologies and new tests to the healthcare community, Baebies is providing hope to parents and the chance at a better life to newborns. 13 Minutes Company Presentation Richard West
Bellerophon Therapeutics 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. 25 minutes Company Presentation Fabian Tenenbaum
Biocept, Inc. Our mission is to improve outcomes for cancer patients by advancing oncology diagnostics. We utilize patented and innovative technologies to deliver clinically relevant oncology diagnostics to physicians by providing advanced prognostic and predictive assessments for guiding the course of treating patients. Additionally, we offer services to other laboratory testing providers, academic institutions, research organizations, biopharmaceutical companies, and clinical trial support. 25 minutes Company Presentation Michael Nall
BioLineRx Ltd. BioLineRx is a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates. The Company in-licenses novel compounds, primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization. BioLineRx’s leading therapeutic candidates are: BL-8040, a cancer therapy platform, which has successfully completed a Phase 2a study for relapsed/refractory AML, is in the midst of a Phase 2b study as an AML consolidation treatment, and has recently initiated a Phase 2 study in stem cell mobilization for allogeneic transplantation; and BL-7010 for celiac disease and gluten sensitivity, which has successfully completed a Phase 1/2 study. In addition, BioLineRx has a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates; a collaboration agreement with MSD (known as Merck in the US and Canada) to run a Phase 2a study in pancreatic cancer using the combination of BL-8040 and Merck’s KEYTRUDA®; and has recently signed a collaboration agreement with Genentech, a member of the Roche Group, to investigate the combination of BL-8040 and Genentech’s Atezolizumab in several Phase 1b studies for multiple solid tumor indications and AML 25 minutes Company Presentation Philip Serlin
BioNTech AG BioNTech AG is a clinical stage immunotherapy leader with bench-to-market capabilities, developing truly personalized, well-tolerated and potent treatments for cancer and other diseases. Established by clinicians and scientists the Group is pioneering disruptive technologies ranging from individualized mRNA based medicines through innovative Chimeric Antigen Receptors /T-cell Receptor-based products and novel bispecific antibody immunomodulators. BioNTech’s clinical programs are supported by an in-house molecular diagnostics unit whose products include MammaTyper® a molecular in-vitro diagnostic kit, marketed under CE and IVD marking in Europe and certain other countries. 13 Minutes Company Presentation Sean Marett
Bio-Path Holdings, Inc. Bio-Path is a biotechnology company focused on developing therapeutic products utilizing DNAbilize™, its proprietary liposomal delivery and antisense technology, to systemically distribute nucleic acid drugs throughout the human body with a simple intravenous transfusion. Bio-Path’s lead product candidate, BP1001 (Liposomal Grb2 antisense), is in a Phase 2 study for blood cancers and in preclinical studies for solid tumors. Bio-Path’s second drug candidate, also a liposomal antisense drug, is being readied for the clinic where it will be evaluated in lymphoma and solid tumors. 25 minutes Company Presentation Peter Nielsen
BioTime, Inc. BioTime, Inc. is a clinical-stage biotechnology company focused on developing and commercializing products addressing degenerative diseases. The foundation of BioTime’s core therapeutic technology platform is pluripotent cells. Pluripotent cells are capable of becoming any of the cell types in the human body. Pluripotent cells have potential application in many areas of medicine with large unmet patient needs, including various age-related degenerative diseases and degenerative conditions for which there presently are no cures. Unlike pharmaceuticals that require a molecular target, therapeutic strategies based on the use of pluripotent cells are generally aimed at regenerating or replacing affected cells and tissues, and therefore may have broader applicability than pharmaceutical products. 25 minutes Company Presentation Russell Skibsted
Brainstorm cell Therapeutics 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 and Motor Neuron Disease) Multiple Sclerosis Parkinson’s Disease Huntington’s Disease Our platform technology, NurOwn®, uses proprietary culture conditions to induce mesenchymal stem cells (MSCs) to secrete high levels of neurotrophic factors (NTFs) known to promote the survival of neurons. Our research efforts have shown that these MSC-NTF cells might be an effective tool for battling neurodegenerative diseases. 25 minutes Company Presentation
Caladrius Biosciences, Inc. Caladrius Biosciences, Inc. is advancing a proprietary platform technology for immunomodulation by pioneering the use of T regulatory cells as an innovative therapy for recent onset type 1 diabetes. The product candidate, CLBS03, is the subject of an ongoing Phase 2 clinical trial (The Sanford Project: T-Rex Study) in collaboration with Sanford Research, and has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration and Advanced Therapeutic Medicinal Product classification by the European Medicines Agency. The Company’s PCT subsidiary is a leading development and manufacturing partner to the cell therapy industry. PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co., Ltd. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. 25 minutes Company Presentation David Mazzo
Calithera Biosciences Calithera is discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer. 25 minutes Company Presentation Susan Molineaux
Capnia, Inc. We develop novel products based on our proprietary technologies for precision metering of gas flow. Our first commercial product, the CoSense® ETCO Monitor, measures end-tidal carbon dioxide (ETCO) in exhaled breath. The CoSense Monitor aids in the detection hemolysis, which is the breakdown of red blood cells. When present in babies with jaundice, hemolysis is a dangerous condition that can lead to long-term developmental disabilities. The CoSense Monitor also aids in the detection of smoke inhalation and carbon monoxide poisoning. We have recently commenced commercial sales of the CoSense devices and sampling sets. The CoSense Monitor is the first 510(k) cleared and CE mark approved device based on our Sensalyze™ Technology Platform. Our Sensalyze Technology Platform combines hardware, sensors, and software to provide a novel platform for non-invasive breath-based detection of various analytes. Our current development pipeline includes proposed devices for asthma in children, assessment of blood carbon dioxide, or CO2, concentration in neonates, and malabsorption in infants. Our therapeutic technology is based upon the observation that non-inhaled CO2 delivered at a low-flow rate into the nasal cavity alleviates the symptoms related to allergies as well as trigeminally mediated pain conditions such as trigeminal neuralgia, cluster headache and migraine. We are currently developing the technology for these indications. 25 minutes Company Presentation Anish Bhatnagar
Capricor Therapeutics, Inc. Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class biological therapies for the treatment of cardiac and other serious medical conditions. Capricor's lead candidate, CAP-1002, is a cardiac cell therapy that is currently being evaluated for the treatment of heart disease associated with Duchenne muscular dystrophy and myocardial infarction (heart attack). Capricor is advancing its proprietary exosome product candidate, CAP-2003, for the treatment of ophthalmic disorders and is exploring other therapeutic areas. Capricor's portfolio also features Cenderitide, a dual natriuretic peptide receptor agonist, which may have application for the outpatient treatment of advanced heart failure and other potential indications. 25 minutes Company Presentation Leland Gershell
CAR-T, TILs, and Bispecifics: Immuno-Oncology Challenges and Opportunities The maturation of new cancer treatment technologies has produced a mix of highly positive patient outcomes and some serious clinical holds, while investments for manufacturing and commercialization continue to accelerate.  This session will dive into the assumptions underlying the most aggressive approaches and the ways of reducing the risks of failure along the way to delivering immuno-oncology’s promise to patients broadly. 1 Hour Panel Jerome Zeldis, MD, PhD
Anton Xavier
Jeff Wolf
Michael King - Moderator
Catalyst Biosciences 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 25 minutes Company Presentation
Cellectar Biosciences, Inc. 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. Cellectar's PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company's lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 is currently being evaluated under an orphan drug designated Phase I clinical study in patients with relapsed or refractory multiple myeloma. In addition, the company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. The company is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1603-PTX), a pre-clinical stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For more information please visit www.cellectar.com. 25 minutes Company Presentation James Caruso
Cellular Biomedicine Group Cellular Biomedicine Group is a clinical-stage biomedicine firm developing effective immunotherapies for cancer and stem cell therapies for degenerative diseases. CBMG's technology includes two platforms: i) Immuno-oncology, including Chimeric Antigen Receptor T cell (CAR-T) and ii) Human adipose-derived mesenchymal progenitor ("haMPC") cells for joint and autoimmune diseases. 25 minutes Company Presentation Tony Liu
Centrexion Therapeutics Centrexion Therapeutics is focused on advancing the treatment of chronic moderate to severe pain with one of the largest exclusively pain-focused pipelines of non-addictive therapies in active development. Centrexion Therapeutics recognizes the needs of the one hundred million people living with chronic pain in the United States, and aims to develop new, safer and more effective therapies that overcome the limitations and challenges associated with current pain treatments. Founded by world-renowned leaders in drug development and well-funded by key investors, Centrexion Therapeutics is building a pain treatment powerhouse to address the substantial and growing global chronic pain epidemic. 13 Minutes Company Presentation
Chembio Diagnostics, Inc. Chembio Diagnostics, Inc. (NASDAQ: CEMI) develops, manufactures, licenses and markets rapid diagnostic assays in the growing $8.0 billion point-of-care (POC) testing market. In addition to its branded and proprietary HIV assays, which it sells in the U.S. and internationally, the Company has several ongoing collaborations for the development of diagnostic assays for Malaria, Dengue Fever, Zika, Ebola and other febrile illness, flu immunostatus, brain injury and a specific form of cancer. Dual Path Platform (DPP®) is Chembio’s patented POC technology, which offers significant advantages over lateral-flow technologies including enhanced sensitivity and the ability to conduct multiple tests from a single sample (multiplexing). DPP® continues to provide Chembio with a growing pipeline of business opportunities for the development and manufacture of new products. 25 minutes Company Presentation John Sperzel
Citius Pharmaceuticals, Inc. Citius Pharmaceuticals (OTCQB: 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. 25 minutes Company Presentation
CohBar, Inc. CohBar is an innovative biotechnology company focused on the research and development of mitochondria based therapeutics (MBTs), an emerging class of drugs for the treatment of age-related diseases. MBTs originate from the Company founders’ discovery of a novel group of peptides encoded within the mitochondrial genome, which regulate metabolism and cell death and whose biological activity declines with age. CohBar’s goal is to mine the mitochondrial genome for biologically active peptides and develop them into therapeutics that potentially address a broad range of age-related diseases, including obesity, fatty liver disease, Type-2 diabetes, cancer, cardiovascular and neurodegenerative diseases. To date, CohBar’s scientists and founders discovered over 50 biologically active mitochondrial-derived peptides. 25 minutes Company Presentation Simon Allen
Conatus Pharmaceuticals Inc. We are a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease. Our lead compound, emricasan, is a first-in-class, orally active pan-caspase protease inhibitor designed to reduce the activity of human caspases, which are enzymes that mediate inflammation and apoptosis. We believe that by reducing the activity of these enzymes, emricasan has the potential to interrupt the progression of liver disease and potentially provide treatment options in multiple areas of liver disease. 25 minutes Company Presentation Steven Mento
ConcentRx, Inc. ConcentRx is an IND-ready company with a patented cancer immunotherapy developed at Stanford University. We begin our process with a patient’s or a donor’s white cells. Outside of the body, we select and expand from the T-cell population a class of cells called NKT-like cells. There is no complex engineering of the immune cells required. Once activated, these cells (now called Cytokine Induced Killer (CIK) cells) have enhanced ability to home to and target tumor cells. Prior to infusion into the patient, the CIK cells are allowed to take up a tumor lysis agent for selective killing of the tumor cells. This process further activates the immune system for long-term immune killing of the cancer initiating cells. Our technology is active against both solid and non-solid tumors. The multiple mechanisms of action mean that many types of tumors cells are more effectively killed. In preclinical animal models of disease, our therapy is highly effective against chemotherapy resistant cells of multiple tumor types, and it also reduces the recurrence of disease. Since 2006, we have had ongoing development of this cell/virus combination therapy that, in preclinical models, can eradicate cancer and cancer stem cells. Each part of this combined therapy has already been used in patient clinical trials. Our novel, cell-based therapeutic approach extends beyond immune cell function. We propose to offer a combined cell-based/oncolytic viral biotherapy that will transform patient care by reducing large tumor burdens, eradicating cancer stem cells, and providing lasting immunity against the cancer treated, all with a reduced side effect profile. Our first indications are solid tumors beginning with ovarian cancer, hepatocellular carcinoma and breast cancer. Our management team and advisors at Stanford, UCSF, and U. of Pittsburgh are experts in the field of cell based therapy, and have a commitment to bring the ConcentRx biotherapy to their patients. Our executive team has experience in both private and publicly-traded life science companies, and has a demonstrated track record bringing advanced biomedical technologies from bench to market. 13 Minutes Company Presentation Pamela R. Contag, PhD
ContraVir Pharmaceuticals, Inc. ContraVir is a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies with three candidates in the pipeline. Two of its antiviral candidates for treating hepatitis B include Phase 2a clinical candidate CMX157, a novel, highly potent analog of the successful antiviral drug tenofovir that has demonstrated the potential for low, once a day dosing compared to Viread® and decreased systemic exposure, thereby potentially reducing renal and bone side effects; and CRV431, a next generation cyclophilin inhibitor with a unique structure that increases its potency and selective index against hepatitis B virus. ContraVir’s third candidate and lead clinical drug, FV-100, is an orally available nucleoside analogue prodrug that is being developed for the treatment of herpes zoster, or shingles, which is currently in Phase 3 clinical development. In addition to direct antiviral activity, FV-100 has demonstrated the potential to reduce the incidence of debilitating shingles-associated pain known as post-herpetic neuralgia (PHN) in a Phase 2 clinical study. 25 minutes Company Presentation James Sapirstein
Corium International, Inc. 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. Corium has developed and is the sole commercial manufacturer of seven prescription drug and consumer products with partners Mayne Pharma, Endo Pharmaceuticals and Procter & Gamble. 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. The company's late-stage pipeline includes a contraceptive patch co-developed with Agile Therapeutics that has recently completed all subject visits for its Phase 3 trial, and additional transdermal products that are being developed with other partners. 25 minutes Company Presentation Peter Staple
Crafting New Approaches to Value-Based Therapy Payment Models: Starting with Gene Therapies Both innovator companies and payers of medicines have expressed a willingness to look beyond the “fee per pill” model to attributing value to the effects on patients’ health instead.  The challenge of reimbursing for curative therapies versus lifelong treatments of chronic conditions presents a special challenge, but one that may shine a light on value-based approaches generally.  This session will explore with the innovators making progress on gene therapies how they are envisioning the reimbursement model in ways that all stakeholders might appreciate, including doctors’, patients’, and payers’ perspectives. 1 Hour Panel Roger Longman
Sandy Macrae, MB, ChB, PhD
John Glasspool
Ted Haack - Moderator

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