On average, the FDA clinical trial review process for new therapeutics and medical devices can take between three and eight years. The new drug application (NDA) containing relevant data to be examined by the FDA follows the clinical trial process and can take an additional 18 months to two years.

How can companies get their products to market and eventually to consumers with such an arduous and difficult process in place? The panel will give attendees insight into the traditional as well as creative non-traditional approaches that get companies from preclinical development through review approval and into market. In addition, panelists will discuss how policy changes in the FDA are effecting their business model and fundraising strategies. The expert panelists have utilized their skills and ingenuity to navigate through development and FDA pathways.

Edison T. Liu, M.D joined The Jackson Laboratory in 2011 as president and CEO, and has been president of the international Human Genome Organization (HUGO) since 2007.  He served for 10 years as the founding executive director of the Genome Institute of Singapore and the chairman of the Health Sciences Authority (FDA equivalent) of Singapore. From 1996 – 2001, he was the scientific director of the National Cancer Institute's Division of Clinical Sciences, Dr. Liu obtained his B.S. in chemistry and psychology and his M.D. at Stanford University.

Panelists:

Pamela Bunes, Chief Executive Officer, President, and Director of EpiEP, Inc. Pamela has a track record of more than 20 years in the medical device industry from start up companies to Fortune 500 medical device industry leader, Johnson and Johnson, Inc. (NYSE:JNJ). In 2008, she co-founded and launched a start up cardiac device company, EpiEP, Inc., that licensed technology at its inception from the University of Virginia. The company proceeded with prototype development and followed with successful pre-clinical trials at the Mayo Clinic, which allowed the transition to its clinical trials. Pamela has recently been asked to serve as an “entrepreneur in residence” at the FDA. The goal is to assist the FDA in understanding the concerns and issues faced by entrepreneurial entities and solutions to make the regulatory process more transparent and easy to navigate.

Dr. Frank Sciavolino is co-founder, board member, Chief Scientific Officer and President of Thetis Pharmaceuticals LLC, an emerging pharmaceutical company that is developing a portfolio of prescription drugs for the treatment of type 2 diabetes, hypertriglyceridemia and dyslipidemia.  Dr. Sciavolino has more than 40 years experience in the pharmaceutical industry. At Pfizer, he held senior positions in discovery, development and licensing operations. Dr. Sciavolino was the enabling force beyond two of Pfizer’s most notable franchises, Zithromax and the Cox-2 Alliance with Pharmacia (then Searle). During their peak years, the combined sales of Zithromax and the Cox-2 inhibitors, Celebrex and Bextra, were contributing more than $5 billion annually to Pfizer top line revenues. Dr. Sciavolino has more than 30 issued patents and holds a Ph.D. in organic chemistry from the University of Michigan and B.S. in Pharmacy from St. John's University.

Harry Penner, Co-founder, Executive Chairman, New Haven Pharmaceuticals. Harry has 30+ years of management experience in the pharmaceutical and biotechnology sectors. He has previously co-founded seven other biotechnology companies, including Rib-X Pharmaceuticals, Marinus Pharmaceuticals, Affinimark Technologies, Prevention Pharmaceuticals, RxGen, MAKScientific, and RHEI  Pharmaceuticals. From 1993 to 2001, he was President, Chief Executive Officer and Vice Chairman of Neurogen Corporation, a publicly-traded biotechnology company, and from 1985 to 1993, he was Executive Vice President of Novo Nordisk A/S in Denmark and the US. He has also been co-chair of CURE, Chair of the CTC, and Chair of the CT Board of Governors of Higher Education.

We hope to see you there!

Best,

Liddy Karter                                         Nell Bourgoin                   
Executive Director                      Chief Programming Officer
Crossroads Venture Group          Crossroads Venture Group