December 4, 2012 Program
- John C. McKew, Ph.D. Chief; Therapeutic Development Branch, National Center for Advancing Translational Science, National Institutes of Health
The Bridging Interventional Development Gaps program (BrIDGs) makes available, at no cost, certain critical resources needed for the development of new therapeutic agents. Available services include: production, bulk supply, GMP manufacturing, formulation, development of an assay suitable for pharmacokinetic testing, and animal toxicology. Assistance also will be provided in the regulatory process, through access to independent product development planning expertise. BrIDGs is not a grant program; successful projects will gain access to the government’s contract resources, as well as the assistance of the NIH in establishing and implementing a product development plan. Click here for more information…
- Delcath (DCTH; NASDAQ CM) – Krishna Kandarpa, MD, PhD, Executive Vice President, Research and Development and Chief Medical Officer
Delcath is a development-stage, specialty pharmaceutical and medical device company focused on oncology researching breakthroughs in regional chemotherapies with the goal of improving clinical outcomes and potentially reducing drug-related adverse events.
Dr. Kandarpa has been Delcath’s Executive Vice President, Research and Development and Chief Medical Officer since October 2009. Dr. Kandarpa earned his M.D. from the University of Miami Miller School of Medicine, Miami, Fla. He completed his residency and fellowship in Interventional Radiology at the Brigham & Women’s Hospital, Harvard Medical School in Boston, Mass. Dr. Kandarpa earned his Ph.D. in Engineering Science & Mechanics from Penn State University and a BS in Aerospace & Mechanical Engineering from Washington University (in St. Louis). Prior to joining Delcath, since 2002, he was a tenured Professor and Chair of the Department of Radiology at the University of Massachusetts Medical School (UMMS) and Radiologist-in-Chief at the University of Massachusetts Memorial Medical Center.
Prior to 2002, he was at the Weill Medical College of Cornell University, where he was a Professor of Radiology and Chief of Service and Director of the Division of Cardiovascular & Interventional Radiology at The New York Presbyterian Hospital (Cornell), New York, N.Y. He was also a faculty member at the Harvard-Massachusetts Institute of Technology, Division of Health Sciences and Technology from 1987 to 1998. Prior to attending medical school, Dr. Kandarpa was a Research and Development Engineer at Duracell International Laboratory for Physical Science. Dr. Kandarpa is past-President (1997-2001) and past-Chair (2001-2002) of the Research and Education Foundation of the Society of Interventional Radiology (SIR). He completed his final term on the Board of Directors of the Academy of Radiology Research in 2007.
Dr. Kandarpa has authored over 50 original peer-reviewed scientific publications, including book chapters and invited articles, and is the author/editor of several specialized books, including the Handbook of Interventional Radiologic Procedures, and a new textbook entitled Peripheral Vascular Interventions (2008). Dr. Kandarpa is listed among Best Doctors in America and America’s Top Doctors.
- Immune Pharmaceuticals – Daniel Teper, PharmD, MBA, CEO .
IMMUNE Pharmaceuticals a privately held Israeli company, and EpiCept Corporation (“EpiCept”) (NASDAQ OMX Stockholm Exchange and OTCQX: EPCT) have entered into a definitive merger agreement on November 8th, 2012. The transaction is anticipated to close during the first quarter of 2013. The combined company, to be named Immune Pharmaceuticals, Inc. (“Immune Pharmaceuticals”), will be primarily focused on developing antibody therapeutics and other targeted drugs for the treatment of inflammatory diseases and cancer. Immune’s lead product candidate, bertilimumab, is a full human monoclonal antibody that targets eotaxin-1, a chemokine involved in eosinophilic inflammation, angiogenesis and neurogenesis. Immune is currently initiating a placebo-controlled, double-blind Phase II clinical trial with bertilimumab for the treatment of ulcerative colitis. The companies’ collective oncology portfolios comprise: Immune’s NanomAbs®, a new generation of antibody drug conjugates, and EpiCept’s vascular disruptive agents. Immune Pharmaceuticals will continue efforts to secure a partner for EpiCept’s Phase III clinical development candidate AmiKet™, for which efficacy has been demonstrated for the treatment of chemotherapy-induced neuropathic pain and post-herpetic neuralgia.
Dr. Daniel Teper is the founder and CEO of IMMUNE Pharmaceuticals.Dr Teper was previously a New York based Partner at leading Strategy Consulting firms advising Pharma and Public Biotech companies. He has also held senior executive positions in the US and Europe at Novartis, GSK and Sanofi-Aventis, and is a co-founder of Novagali (NYSE Euronext: NOVA), which was recently acquired by Japan’s Santen. Dr. Teper holds a Doctor of Pharmacy degree from Paris XI University and an MBA from INSEAD.
- Advaxis, Inc. –Thomas A. Moore, Chairman / CEO
Advaxis is a clinical-stage biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Advaxis immunotherapies are based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete antigen/adjuvant fusion protein(s) designed to redirect the powerful immune response all human beings have to the bacterium to the cancer itself.
In April 2012, Advaxis’ lead construct, ADXS-HPV, was selected as the Best Therapeutic Vaccine (approved or in development) at the 5th Annual Vaccine Industry Excellence (ViE) Awards by the vaccine industry and the journal Expert Reviews of Vaccines. The ViE awards, sponsored by Novartis Vaccines and Diagnostics, were created to recognize the accomplishments and contributions of companies and individuals in the vaccine industry over the previous 12 months. Additional information is available at the World Vaccine Congress website.
Advaxis’ lead construct, ADXS-HPV, is being evaluated in 4 ongoing clinical trials that are open to enrollment for HPV-associated diseases: CIN 2/3 (US study, Clinical Trials.gov Identifier NCT01116245), locally advanced cervical cancer (GOG/NCI US study, Clinical Trials.gov Identifier NCT01266460), recurrent/refractory cervical cancer (India), and head & neck cancer (CRUK study, Clinical Trials.gov Identifier NCT01598792). Over fifteen (15) distinct constructs are in various stages of development, developed directly by the Company and through strategic collaborations with recognized centers of excellence such as: the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, the University of British Columbia, the Karolinska Institutet, and others. For more information please visit:
Thomas Moore has been CEO of Advaxis since 2006. Previously, from June 2002 to June 2004 Mr. Moore was President and Chief Executive Officer of Biopure Corporation, a developer of oxygen therapeutics that are intravenously administered to deliver oxygen to the body’s tissues. From 1996 to November 2000 he was President and Chief Executive Officer of Nelson Communications. Previously, Mr. Moore had a 23-year career with the Procter & Gamble Company in multiple managerial positions, including President of Health Care Products where he was responsible for prescription and over-the-counter medications worldwide, and group vice president of the Procter & Gamble Company.