Day’s Theme: Designing and Conducting Clinical Trials
2nd PROGRAM
- 8:00 AM | Registration/Administrative Continental Breakfast
- 8:30 AM to 9:00 AM | Session 1: Welcome and Opening Remarks:
Professor Simon Benninga, Ph.D., Max and Steffi Perlman Professor of Financial Economics, Visiting Professor of Finance, Wharton School, University of Pennsylvania, Former Dean, Faculty of Management, Tel-Aviv University, Israel
Dr. Benny Zeevi, Managing General Partner, DFJ Tamir Fishman Ventures, Board Member ILSI & IVA
Professor Stephen Sammut, Senior Fellow, Wharton Health Care Systems and Entrepreneurship and Venture Partner, Burrill & Company
Dr. Robert Goldberg, Co-Founder and Vice President of the Center for Medicine in the Public Interest (CMPI)
Acknowledgement of Sponsors
Course Infrastructure:
Introduction to Program Structure
- 9:00 AM to 10.00 AM | Session 2: Opening Keynote Address
Introduction: Ruth Alon, Partner and Managing Director Healthcare, Pitango Venture Capital, Chairperson of ILSI: The Israel Life Science Industry
Keynote Theme: “Mergers and Acquisitions: Negotiations and Implementation”
Israel Makov,Chairman of Given Imaging, Former President and CEO of Teva Pharmaceutical Industries
- 10:00 AM to 1 PM | Session 3: Demonstrating Quality and Value to Consumers: The Key to Reimbursement Success in the 21st Century, Implications for Clinical Trials Planning
This session will be led by experts, including the former director of CMS and the leader of the largest patient advocacy organization in the United States, who are in the business of demonstrating quality and value to health care consumers. They will explain why this is more important than demonstrating cost-effectiveness for the success of a product in the marketplace. They will also describe ways start ups can inexpensively conduct research to show the value of to customers. Finally, the faculty will provide participants will tools and methodologies they can use for conducting their own assessments
Moderator: Dr. Robert Goldberg, Co-Founder and Vice President of the Center for Medicine in the Public Interest (CMPI)
Doug Badger, Partner, Nickles Group
Bill Molmen, Co-Founder, Integrated Benefits Institute
Ralph Snyderman, MD, President , Proventys Inc. and Chancellor Emeritus Duke University Medical Center
Susan Horn, Ph.D. Senior Scientist, Institute for Clinical Outcomes Research
Dr. Azin Parhizgar, former Vice President and COO of Conor Medsystems, Inc.and now an executive in J&J
- 1 PM to 1.45 PM | Networking Luncheon
- 1:45 PM to 2:45 PM | Session 4: Clinical Effectiveness Case Studies
Prior to the program, participants will be asked to prepare, submit and present a real situation for group review; questions provided.
Faculty from previous sessions to serve as commentators.
- 2:45 PM to 4.15 PM | Session 5: Life Science industry Ethics, Social Responsibility and Global Health Needs
This session will focus broadly on the initiatives addressing global health needs.
The session will include a presentation of an actual project: an initiative to address and
prevent asthma in India and the accompanying challenge: “What low cost diagnostics, devices etc can be developed so that families and non physicians can reduce emergence of certain parasites implicated in asthma.” He will be accompanied by a venture capitalist managing a global life science fund focusing on India and China.
In addition the session will address changing diabetes as a global initiative – mobilizing forces at the local, regional and global level.
Moderator: Professor Stephen M.Sammut, Senior Fellow, Wharton Health Care Systems and Entrepreneurship and Venture Partner, Burrill & Company
Kanwarjit “KJ” Singh, MD, MBA Senior Program Officer Bill & Melinda Gates Foundation
Leonard Bielory, M.D., Head of Allergy and Immunology at University of Medicine and Dentistry of New Jersey
Dr. Alan Moses, Vice President and Chief Medical Officer Worldwide, NovoNordisk
Gad Berdugo, Former Director and Sector Leader for global healthcare equity investment research at Lazard in New York
- 4:15 PM to 4.45 PM | Bio – Break
- 4:45 PM to 6:30 PM | Session 6: Intellectual Property
The goal of the session is to provide information and insight into the specific issues confronting investigators, entrepreneurs, investors and their patent attorneys. The session will address the
Current hot issues in biotech and devices, recent developments in US/PCT/TRIPS policies as related to biotech and devices, claims development strategy, managing the freedom to operate process, jurisdiction strategy and partnering implications
Moderator: Dr. Benny Zeevi, Managing General Partner, DFJ Tamir Fishman Ventures, Board Member ILSI & IVA
Ivor Elrifi, Ph.D., LL.B. is Co-chair of the Intellectual Property Section and Member, Policy Committee Mintz Levin
Brent Ahrens, General Partner, Canaan Partners (TBC)
- 6:30 PM to 7:30 PM | Session 7: IP Case Studies
Case analysis on issues provided by participants, Faculty to serve as commentators.
- 7:45 PM | Opening Dinner for Faculty and Participants
At the Green Vila, Tel Aviv University
Keynote lectures: Prof’ Manuel Trajtenberg, Head of the National Economic Council
Ralph Snyderman, MD, President , Proventys Inc. and Chancellor Emeritus Duke University Medical Center
Day’s Theme: Marketing, Partnering and Intellectual property
- 8:30 AM | Continental Breakfast
- 9:00 AM to 12:30 PM | Session 8: Designing and Conducting Clinical Trials: From Proof of Concept to Marketing Success
Break at 10:30 AM
This is a how-to guide for drug, device and diagnostic companies about how to use emerging tools, techniques and tips regarding the FDA’s new approach to product development. The FDA is more than just a regulatory body, it is a agency the shapes policy based on new science. Start ups should be aware and part of this process, called the Critical Path, as much as possible. This session bring these two important trends to course participants. The current system will be contrasted with the critical path. Examples from pharmacokinetics, genetics/proteomics, medical devices etc.
The session will also take a special look at applying technology to chronic disease with diabetes as a case example.
Moderator: Dr. Robert Goldberg, Co-Founder and Vice President of the Center for Medicine in the Public Interest (CMPI)
Hugh Rosen, MD DPhil Scripps Research Professor, Principal Investigator and Director , Scripps Research Institute Molecular Screening Center.
Raymond Woosley, MD, President and CEO, Critical Path Institute
Daniel Troy, former general counsel FDA and partner Sidley Austin
Dr. Alan Moses, Vice President and Chief Medical Officer Worldwide, NovoNordisk
Dr. Azin Parhizgar, former Vice President and COO of Conor Medsystems, Inc. and now an executive in J&J
Dr. Daniel G. Schultz, Director of FDA’s Center for Devices and Radiological Health (CDRH)
- 12.30 PM to 1.30 PM | Networking Luncheon
- 1:30 PM to 2.30 PM
Session 9: Creating Global Cross Border Collaborations and Knowledge Networks in the Life Sciences: Practical Considerations for Emerging Israeli Companies
The Israeli life sciences sector is poised for long-term growth and success; however, to achieve the economic promise of the life sciences industry, entrepreneurs need to consider targeted cross border research collaborations, joint business ventures and syndicated investments “from day one”. This interactice session describes how to position your company to “think globally” and highlights the model of the Boston Haifa Life Sciences Initiative (BHLSI). In this session we will provide practical strategies to catalyze collaborations to facilitate angel and venture investments and alternative revenue streams, enhance opportunities for joint ventures and strategic alliances, and strategies to promote cross border research, clinical trials and strategic access to US markets.
Moderator and Lecture: Robin JR Blatt, Director, Boston Haifa Life Sciences Initiative (BHLSI)
Publisher, The Journal of BioLaw & Business, Adjunct Lecturer, Harvard School of Public Health
Eisenhower Fellow (India and Singapore).
Dr. Shimon Eckhouse, Founder and Chairman of the Board, Syneron Medical
Shy Levanon, CEO, Rcadia
- 2:30 PM to 3.00 PM | Bio-Break
- 3:00 PM to 4.15 PM Session 10: Partnering in a Borderless World
This session will address partnering strategy, planning, execution and management of the relationship.
Moderator: Dr. Benny Zeevi, Managing General Partner, DFJ Tamir Fishman Ventures, Board Member ILSI & IVA
Jeremy Levin, Senior Vice President of External Science, Technology and Licensing, Bristol-Myers Squibb Company
Amos Goren, Venture Partner (previously Head of European Healthcare team), Apax Partners
John A. Dellapa, Of Counsel in the Corporate practice at Mintz Levin
- 4.15 PM to 6.45 PM | Session 11: Essentials of Marketing in Biotechnology and Medical Devices
This session will focus on Market analysis, Clinical state of the art and product positioning: assessment of different applications for the same product (choosing the right application from commercial point of view), Determination of subgroup of patients most appropriate for the product, Competitive analysis, Pricing and reimbursement strategy, Importance of opinion leaders, patients groups, patients organization and Selling strategy
Moderator: Professor Stephen M.Sammut, Senior Fellow, Wharton Health Care Systems and Entrepreneurship and Venture Partner, Burrill & Company
Dr. Azin Parhizgar, former Vice President and COO of Conor Medsystems, Inc.and now an executive in J&J
David Frank, Head of BD, Ortho Diagnostics, J&J
Brent Ahrens, General Partner, Canaan Partners
An Israeli CEOs (TBD)
- 6:45 PM to 7.45 PM Session 12: Marketing Workshop- Moderator: Amos Goren, Venture Partner (previously Head of European Healthcare team), Apax Partners
Case analysis on issues provided by participants Biotech/device breakout. Faculty to serve as commentators.
- 7.45 PM | COURSE ADJOURNS
