9th PROGRAM

“Health Care Technological Innovation– From Idea to Commercialization” The Ninth Course

An Executive Program for Biotechnology and Medical Device Entrepreneurs and Managers Offered by:
The Leon Recanati Graduate School of Business Administration, Tel Aviv University
In collaboration with
Israel Advanced Technology Industries Organization (IATI)

December 14th-17th, 2015 – Monday through Thursday, Tel Aviv, Israel

Program Directors:

Program Founder For the IATI

Dr. Benny Zeevi

Managing General Partner, Tel Aviv Venture Partners

For International Institute for Biotechnology Entrepreneurship 

Stephen M. Sammut

Senior Fellow, Health Care Management and Lecturer, Entrepreneurship,

Wharton School, University of Pennsylvania

For Canaan Partners

Brent Ahrens

General Partner

For The Center for Medicine in the Public Interest 

Robert Goldberg, Ph.D.

Vice President

 In memory of late Prof. Simon Benninga (1947-2015), Program director and founder for the Recanati School of Management, TAU

Monday, December 14th, 2015

Day’s Theme: The Creative Process and Technology Assessment


 

  • 8:30 AM | Registration/Administrative Continental Breakfast

 


 

 

  • 9:00 AM | Session 1:  Welcome and Opening Remarks:

Prof. Moshe Zviran, Dean, Faculty of Management, Tel Aviv University

 

Course Directors:

Introduction to Program Structure –

Benny Zeevi, M.D. Managing General Partner, Tel Aviv Venture Partners

 

Review of required assignments-

Stephen M. Sammut, Senior Fellow, Health Care Management and Lecturer, Entrepreneurship,

Wharton School, University of Pennsylvania

 


 

  • Session 2: How do we Bridge the Gap in Medical Innovation?

Prof’ Elazer Edelman, Institute for Medical Engineering and Science, MIT,Cambridge, USA

 


 

  • 10:10 AM | Coffee break

 


 

  • 10:30 – 12:30 AM | Session 3: The Persuasive Pitch, Part 1: Introduction of course participants

Orly Glick, Owner of a company of public speaking, interpersonal communication and cultural skills

 

Brent Ahrens, General Partner, Canaan Partners

 

David Frank, Managing Director MEDX Associates LLC – “Making YOUR Pitch Persuasive”

 

In order to give participants a chance to learn more about their colleagues in the course, and as the first part of our special focus on presentations, we are asking each participant to prepare to deliver a 3 minute presentation, using 4-5 power point slides, to introduce yourself and your company to the group.

 


 

  • 12:30 – 1:30 PM | Session 4:  Project, Product or Company?: Assessment and Qualification of Technologies as a Basis for a Startup

 The successful translation of discoveries from the lab to the market is the greatest challenge facing an entrepreneur. Many companies are formed on technologies emanating from university laboratories and spinouts from major corporations as well as life science companies themselves. Many healthcare innovations fall because they neither integrate with existing clinical practice nor are successful in creating new ones. Forming a company around a technology is relatively easy. Staffing and capitalizing it is another story. This session will provide tools and a contextual framework as to how technologies can be assessed by founders, corporations and VCs so that they can orient and characterize their business for capitalization and partnering.

Moderator: Stephen M. Sammut, Senior Fellow, Health Care Management and Lecturer, Entrepreneurship, Wharton School, University of Pennsylvania Brent Ahrens, General Partner, Canaan Partners, David Frank, Managing Director MEDX Associates LLC, Tamara Mansfeld, Director, Strategy & Portfolio Management, Pfizer

 


 

  • 1:30 – 2:30 PM | Networking Luncheon

 


 

  • 2:30 – 4:30 PM | Session 5: Lessons learned from our experience: A panel of life science CEOs and Entrepreneurs

 In this session we will have several Israeli CEOs in life sciences sharing their experience.Specifically addressing issues: Building a management team, financing, collaborations, dealing with the board, working with cross-border teams and more 

Moderator: Ruti Alon, General Partner, Pitango Venture Capital Fund Avner Halprin, CEO, Early Sense, Udi Cohen, CEO Biocontrol, Ascher Shmulewitz, M.D., President Medegenesis, Ori Hadomi, CEO Mazor Robotics

 


 

  • 4:30 – 6:00 | Session 6: Market Analysis and Competitive Analysis – 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, Importance of opinion leaders, patients groups, patients organization and  Selling strategy: To build mutually satisfying long-term relationships with key customers in order to acquire and retain their business

Moderator: Brent Ahrens, General Partner, Canaan Partners David Frank, Managing Director MEDX Associates LLC, Yael Glassman, President & COO, Nutrino

 


 

  • 6:00 PM | End Of the day…

Tuesday, December 15th, 2015

Day’s Theme: Strategy and Execution


 

  • 8:30 AM | Continental Breakfast

 


 

  • Part 1 – 9:00 AM – 10:30 AM |  Part 2 – 11:00 AM – 12:00 AM  | Session 7: Capitalization of a life science Venture –Value inflection Points, Milestones and Capital Requirements, Alternative financing, Terms etc.

Financing a life science venture is challenging. When meeting with investors and prospective strategic partners, entrepreneurs will often hear questions that ask: Where are you in the value chain?” How does your business model reflect this?” “How do you describe your milestones and how are you managing towards them?” How do your milestones tie-in with your value inflection points?”  This session will consist of a brief overview of typical value inflection points for each type of product, classical and alternative ways of financing, terms of financing rounds and more.

 

Moderator: Brent Ahrens, General Partner, Canaan Partners

 

Morris Laster M.D., Venture Partner, OurCrowd

 

Yaron Breski, Managing Director, Roberts Mitani Israel, LTD- Alternative Financing Sources.

 

Gad Berdugo, Managing Director and Head of Life Sciences and Healthcare at Tegris Advisors, Formerly Founder of Explorium Capital and Former Director and Sector Leader for global healthcare investment research at Lazard

 

Dr. Ayal Shenhav, Shenhav & Co –Term Sheet, investment agreements

 


 

  • 10:30 – 11:00 AM | Coffee break

 


 

  • 12:00 AM | Session 8: Keynote Lecture

The Chinese Market Opportunities for Life Sciences Companies

Peggy Wang, Founder and Managing Partner of LongTec China Venture, Founder and CEO of Shanghai LongTec Medical Technology Co

Or Elazer Edelman

 


 

  • 12:45 PM – 1:30 PM | Session 9: Keynote Lecture

    Stanton Rowe, Corporate Vice President, Advanced Technology and Chief Scientific Officer, Edwards Lifesciences

 


 

  • 1:30 PM – 2:30 PM | Networking Luncheon

 


 

  • 2:30 PM – 4:30 PM | Session 10: Biopharmaceutical and Medical Device Licensing, Partnering and Strategic Alliances

Format: Brief lectures, panel discussion, Q&A

 

Major practical issues in formulation of partnering goals and managing different types of strategic alliances,  preparation for positioning for partnering, identifying and qualifying prospective partners,  making the approach, negotiation, closing the deal, with special emphasis on how to design alliances and avoid many potential problems and complications in managing these relationship.

 

Moderator: Benny Zeevi, M.D. Managing General Partner, DFJ Tel Aviv Venture Partners

 

Robert (Bob) Hariri, MD, PhD, Co-Founder, President, Human Longevity Cellular Therapeutics

 

David Frank, Managing Director MEDX Associates LLC

 

Maya Racine – Netser, Adv, Partner, Co-Head of the Hi-Tech department and Head of the Technology Licensing group,  Herzog, Fox & Neeman

 

Ed Zaltsman- Defined Health

 

John Lieberman, Perelson Weiner LLP – ” Cross border planning”

 

Robert L. Grossman, Shareholder; Co-Chair, Israel Practice, Greenberg Traurig

 

Stanton Rowe- Corporate Vice President, Advanced Technology and Chief Scientific Officer, Edwards Lifesciences

 

Discussion and Q&A

 


 

  • 4:30 PM – 5:15 PM | Session 11: Round table discussions with the experts and Coffee break

 


 

  • 5:15 PM – 6:15 PM | Session 12: The Persuasive Pitch, Part 2: Presenting Your Idea—and Yourself—With Purpose, Clarity, and PowerOn the path from ‘idea to commercialization’ you will need to communicate persuasively about your product, your company, and yourself to a wide range of audiences—investors, regulators, partners, customers, and your own team. During this session we will focus on one of the most common—and, perhaps surprisingly, often one of the more difficult—types of presentations that entrepreneurs must deliver: the short introduction.Orly Glick, Owner of a company of public speaking, interpersonal communication and cultural skills

 


 

  • 6:30 PM | Opening Dinner for Faculty, Participants and life sciences executives At the Green Vila, Tel Aviv UniversityLecture: “Innovation Strategy”, Corie Chung- Bar Dea, Director of Strategy, Designit

 


Wednesday, December 16th, 2015

Day’s Theme: Bringing the product to the market


 

  • 8:30 AM | Continental Breakfast

 


 

  • 9:00 AM – 10:30 AM | Session 13: Biotechnology and Medical device Regulatory Planning, Clinical Development and the Implications for Strategy and Financing: From Proof of Concept to Marketing Success. Designing and conducting clinical trials  This session provides an abbreviated view of the overall process and specific insight into planning for FDA regulations in light of strategy, financial needs, and the concerns of prospective partners and investors. Entrepreneurs need to understand that there is an increasing need to perform clinical studies to support medical device safety and performance claims. They also need to have a basic understanding of the activities, resources and costs associated with the design and conduct of clinical studies. The failure to incorporate an effective clinical strategy into new project planning can lead to significant project and funding delays or, worse, the failure of the project. This session will provide an overview of the increasing need for device clinical study data; key activities, resource needs and costs; and planning for the successful design and conduct of medical device clinical studies for acceptance in the United States and Europe, even when these studies are conducted outside of these regulatory jurisdictions. 

 

Moderator: Stephen M. Sammut, Senior Fellow, Health Care Management and Lecturer, Entrepreneurship, Wharton School, University of Pennsylvania Susan Alpert, PhD, MD, Principal, SFA Consulting LLC, Former Senior Vice President, Chief Regulatory Officer of Medtronic, Former Director, Office of Device Evaluation, CDRH at the FDAUdi Cohen, CEO Biocontrol – The experience of a CEO in conducting multinational clinical trial

 


 

  • 10:30 AM – 11:00 AM | Session 14:Keynote Lecture

Regenerative medicine as the platform for future innovation in medicine

Robert (Bob) Hariri, MD, PhD, Co-Founder, President, Human Longevity Cellular Therapeutics


 

  • 11:00 AM – 11:30 AM | Coffee break

 


 

  • 11:30 AM – 12:30 PM | Session 15:Keynote Lecture

The Medical Device Industry in 2015: New Imperatives

David Cassak and Stephen Levin,  Managing Partners, Innovation In Medtech, LLC, Editors-in-Chief, The MedTech Strategist

 


 

  • 12:30 PM – 1:30 PM | Session 16: Intellectual Capital Management 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 formation of specific IP strategy and execution and using intellectual capital for competitive advantage. Content includes major issues confronting companies with US and filings in other jurisdictions related to biotechnology, e.g., patent ownership, non-obviousness rulings, the scope of what can be patented. A VC will also provide an investor viewpoint. Moderator: Steve M. Sammut, Senior Fellow, Health Care Management and Lecturer, Entrepreneurship, Wharton School, University of Pennsylvania Brian Hopkins, Special Councel, Cooley LLP

 


 

  • 1:30 PM – 2:30 PM | Networking Luncheon

 


 

  • 2:30 PM – 3:30 PM | Session 17: Incorporating Reimbursement in the Company Development Strategy Moderator: Bob Goldberg Ph.D.,Vice President  CMPI Mike Berman, medical device investor/entrepreneur, past President of the Cardiology business of Boston Scientific

 


 

  • 3:30 PM – 4:30 | Session 18: Case Study- IceCure
  • Yaron Breski, Managing Director, Roberts Mitani Israel, LTD

 


 

  • 4:30 PM – 5:15 PM | Round table discussions with the experts and Coffee break

 


 

  • 5:15 PM – 6:00 PM | Keynote Lecture

Medical Device and Health Care Innovation -Challenges and Opportunities

Mike Berman, medical device investor/entrepreneur, past President of the Cardiology business of Boston Scientific

 


 

  • 6:00 | End of the day….

 


Thursday, December 17th, 2015

Day’s Theme- Health Care IT\Digital Health


 

  • 8:30 AM | Continental Breakfast

 


 

  • 9:00 AM – 9:45 AM | Session 20: Mobile/Connected health…

a view from silicon valley

Peter J. Fitzgerald, MD, PhD, FACC, Director, Center for Cardiovascular Technology,Stanford University

 


 

  • 9:45 AM – 10:15 AM | Session 21: Keynote Lecture
    Maneesh Goyal, SVP Corp Dev and Head of M&A for Welltok?

 


 

  • 10:15 AM – 10:45 AM | Coffee break

 


 

  • 10:45 AM – 12:00 PM | Session 22:The Future of Digital Health
    Benny Zeevi, M.D. Managing General Partner, DFJ Tel Aviv Venture Partners

 


 

  • 12:00 PM – 1:30 PM | Session 23: Healthcare IT and Connected Health- Part 1

Quality and efficient healthcare delivery is highly depended on information and communication, anytime anywhere. Despite Healthcare Delivery Industry having much to gain from Information and Communication Technologies; it is the slowest from all industries in the adoption. HCIT investment will only be successful if the fit between IT and clinical processes will be close to matching, which will be reflected by the acceptance or rejection of end users. The emergence of new, disruptive technologies plays a crucial role in closing the capability gap and gaining more acceptances from the main users. The latest innovations are changing not only how the medical care is organized, practiced and delivered but are also redefining host of other qualities including changing patient-physician model and facilitating the emergence of new industry players within the value chain.Mobile devices and services are transforming the way people all over the globe live, work, play and now also revolutionize the way they receive medical care. Mobile devices are the most personal technology that consumers and healthcare providers own, and allow consumers to be introduced to new services quickly and intuitively and establish personal preferences. Digital health enables health and wellness to be delivered through mass personalization anywhere and anytime, in the comfort of patients’ own homes and during daily routines. Many new players are entering the mobile health industry; it is highly fragmented market worth several billions of dollars. The adoption and deployment of mHealth requires new regulatory clarity, standards and interoperability of devices and software, new viable business models, consumers and provider’s cultural changes and proven evidence –based outcome measures, clinically and economically.The potential applications of HCIT technologies and digital health, it’s role in global health, new business models, the use of social media by pharma and medical device companies as well as by healthcare providers and insurance companies and regulatory issues will be discussed. 

 

Moderator: Benny Zeevi, M.D. Managing General Partner, DFJ Tel Aviv Venture Partners Michal Geva, Co-Founder & Managing  Partner, TriVentures- “The Challenge of Investing in Digital Health” Yael Glassman, President & COO, NutrinoMichal Rosen-Zvi, Director, Health Infomatics, IBMPeter J. Fitzgerald, MD, PhD, FACC, Director, Center for Cardiovascular Technology,Stanford UniversityAnat Naschitz, Managing Director, Orbimed Israel- Telemedicine and Big Data in HC

Laurence Ainouz, CEO, Health Augmented former SVP and Chief Innovation Officer of Teva Pharmaceuticals – The Pharma perspective on digital health

 

Susan Alpert, PhD, MD, Former Senior Vice President, Chief Regulatory Officer of Medtronic, Former

Vice President of Regulatory Sciences for C.R. Bard, Inc., previously worked at FDA-

Are Digital and Mobile Health Tools Medical Devices? Who’s Opinion Counts?

 

Peggy Wang, Founder and Managing Partner of LongTec China Venture, Founder and CEO of Shanghai LongTec Medical Technology Co

 

Maneesh Goyal, SVP Corp Dev and Head of M&A for Welltok

 


 

  • 1:30 PM | Networking Luncheon

 


 

  • 2:30 PM – 4:30 PM | Session 24: Healthcare IT and Connected Health- Part 2

 


 

  •  4:30 PM – 5:30 PM | Session 25: Case study- American Well

 Yael Glassman, President & COO, Nutrino

 


 

  •  5:30 PM – 6:30 PM | Session 26:  The Persuasive Pitch, Part 3: Presentations WorkshopModerator: Steve M. Sammut, Senior Fellow, Health Care Management and Lecturer, Entrepreneurship, Wharton School, University of Pennsylvania Orly Glick, Owner of a company of public speaking, interpersonal communication and cultural skillsBenny Zeevi, M.D. Managing General Partner, DFJ Tel Aviv Venture PartnersMichal Geva, Co-Founder & Managing  Partner, TriVentures David Frank, Managing Director MEDX Associates LLC

 


 

  •  6:30 PM | Program Adjournment

Session 27: Teams gather for “Take-aways Exercise”

Each participant will receive at registration a work-sheet to record for each session one major lesson or “take-away.”

 


 

* Changes in curriculum may occur