JBNF-Biomed is proud to invite you to presentation:
“AVOIDING THE PITFALLS OF DRUG DEVELOPMENT
– BEGIN WITH THE END IN MIND”
Richard Williams, PhD, JD, Executive Strategist, Global Regulatory Affairs, Covance
Eric Lang, MD, VP, Early Phase Development Solutions, Covance
July 13 17:30 * Jerusalem, Israel
Pharmaceutical development is both expensive and risky. Less than 1% of the compounds that originate in the labs ever make it to market. Even fewer of these compounds become commercially successful. This panel will focus on the importance of the Target Product Profile (TPP) in pharmaceutical development. The presentations will utilize examples of products that have been developed to facilitate learning about what does and does not work in development. FDA accelerated approval and breakthrough designations will also be discussed.
<a href=”http://www.jce.ac.il/entrepreneurship-center/a-to-be/”>AtoBe – Azrieli College of Engineering Startup Accelerator
Space is limited. So we urge you to register as soon as possible to this event – Wednesday, July 13th in Jerusalem at 5.30pm. Note that only people that RSVP will be able to enter the Azrieli College of Engineering.
This is a very special opportunity to hear senior executives from the global pharma industry.
Entrance donation is 20 NIS.
Moderator, Yaron Suissa, PhD, JBNF-Biomed
Greetings: Debbie Shalev, PhD, Head, Dept Pharmaceutical Eng,
Irene Guz, Covance Inc.
Shai Melcer, PhD, Bio-Jerusalem
Chung-Chu Chen, CEO, Somnics Company
& Hd BioMed Mission, Taiwan Israel Entreprenership Association
Avoiding the Pitfalls of Drug Development
• A Pharma Start-Up’s Perspective
Tamar Tennenbaum – CEO & founder, BioTen Pharma Ltd
• A Pharma VC Fund’s Perspective
David Sidransky MD
– co-Founder & Gen.Partner, Israel Biotech Fund
• Panel on
AVOIDING THE PITFALLS OF DRUG DEVELOPMENT-BEGIN WITH THE END IN MIND
Richard Williams, PhD, JD, Executive Strategist,
Global Regulatory Affairs, Covance
Eric Lang, MD, VP, Early Phase Development Solutions, Covance
About Covance Inc
Covance, the drug development business of Laboratory Corporation of America Holdings (LabCorp), is the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real® by providing high-quality nonclinical, clinical and commercialization services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development. Because of our broad experience and specialized expertise, we’re in a unique position to supply insights that go above and beyond testing — We have helped pharmaceutical and biotech companies develop each of the top 50 prescription drugs in the marketplace today.
We also offer laboratory testing services to the chemical, agrochemical and food industries and are a market leader in toxicology services, central laboratory services, discovery services, and a top global provider of Phase III clinical trial management services.
Covance in Israel
Covance established its legal entity and clinical operations office in Israel in November 2008. To date, we have been working on 35 studies involving more than 300 sites. We have hired 1 Country head, 3 Managers 3 Assoc ClinOps Managers, 60 CRAs, 15 CRAsst, 15 GSS, 4 CPA and 1 Facility Coordinator, for a total of just over 100 employees. Additional regional members include: 3 Project Managers, 6 CTLs.
<a>Israel Covance Contact</a>
Covance CAPS. Ltd., Clinical Development Services
9 Hamenofim St. Ackerstein Towers, Bldg A, 8th Floor, POB 2148 Herzlyia 46120
Office: 09 971 5696 Mobile: 0<a>54-7925533</a> Fax: 0<a>9-9715981</a>
Our Invited Speakers:
Richard Williams, PhD, JD, Executive Strategist, Global Regulatory Affairs, Covance Inc
Dr. Williams is the Senior Director of Global Regulatory Strategy where he is responsible for advising clients on global, regional or local regulatory strategy associated with preclinical or clinical study design, regulatory agency interactions, as well as for complete drug development programs. He works with, and advises, internal cross-functional product development teams as well as external clients.
In addition to leading and managing successful programs in multiple therapeutic areas, he has also interacted directly with regulatory agencies in the United States, Europe, Japan, and India.
Eric Lang, MD, Vice President, Clinical Development Leaders, Early Phase Development Solutions, Covance Inc
Dr. Eric Lang is Vice President and Global Head of Clinical Development Leaders within Early Phase Development Solutions at Covance, a group that helps clients transition their drug development programs from Non clinical development through the different phases of clinical development, with particular emphasis on phase I and Phase II proof of concept trials. Dr. Lang joined Covance in 2012 and is a Board Certified Anesthesiologist and Pain Management Specialist by training. He did practice medicine for a number of years but the majority of his career has been in the pharmaceutical industry with over 18 years of development and industry experience in large and small pharma. Dr. Lang has extensive experience in designing development programs from early translational stages through phase III including the successful filing of several INDs and NDAs.
Previously, Dr Lang worked for Grunenthal, Novartis, J&J and many others, filling key positions in clinical development and other related fields. Dr. Lang received his Bachelor of Medicine degree and MD from the Ben Gurion University of the Negev in Israel and completed several fellowships at Emory University in Atlanta, GA. Dr. Lang has been published in over 25 peer reviewed articles, chapters and scientific abstracts.
Our Guest Speakers:
Tamar Tennenbaum, CEO & Founder of BioTen Pharma Ltd
CEO & Founder of BioTen Pharma Ltd and Vice President, Strategic Affairs, JBNF-Biomed. She was the founder and CEO of HealOr and TenCure. Dr. Tennenbaum holds her degrees from the Hebrew University and has over 50 scientific publications and 40 granted patents. She is an established BioMed entrepreneur specializing in discovery and development of innovative pharmaceuticals.
Prof David Sidransky MD, Co-Founder and General Partner of Israel Biotech Fund
Co-Founder and General Partner of Israel Biotech Fund. Dr. Sidransky is a renowned oncologist, research scientist and Professor of Oncology and Cellular & Molecular Medicine at John Hopkins University and Hospital. Dr. Sidransky was Vice Chairman of ImClone Systems until its acquisition by Eli Lilly for $6.5B in 2008. He founded several biotechnology companies, including Oncormed Pharmaceuticals, (NASDAQ: OMED), a genetic testing company that was sold to Gene Logic in 1998, and Response Genetics (NASDAQ: RGDX), a developer of markers for cancer therapy.