program

“HEALTH CARE TECHNOLOGICAL INNOVATION – FROM IDEA TO COMMERCIALIZATION”
IN MEMORY OF DR. BENNY ZEEVI
THE 16TH PROGRAM

An Executive Program for Biotechnology, Medical Device and Health IT Entrepreneurs and Managers

December 10th-13th, 2023 – Sunday through Wednesday, Tel Aviv, Israel

*The following Agenda is tentative and subject to changes*

December 10th-13th, 2023 – Sunday through Wednesday, Tel Aviv, Israel

*The following Agenda is tentative and subject to changes*


 

8:30 – 9:00 AM

Registration/Administrative & Continental Breakfast

9:00 – 9:20 AM

Welcome and Opening Remarks:

Prof. Dan Amiram, Dean, Coller School of Management, TAU

Course Directors:

Introduction to Program Structure, Faculty and Participants Introduction
Mike Berman, medical device investor/entrepreneur, past President of the Cardiology business of Boston Scientific


 

9:20 – 10:10 AM

Session 1: The New “Kids” on the Block: Microbiome – Case study, what can we learn?

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


 

10:10 – 11:00 AM

Session 2: The Persuasive Pitch, Part 1: Introduction of course participants

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 FDA

Mike Berman, Medical device Investor/Entrepreneur, Past President Cardiology Business, Boston Scientific

Dafna GabbayFounder and CEO, Curical Technologies

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


 

11:00 – 11:20 AM

Coffee Break


 

11:20 – 12:40 PM

Session 3: The Persuasive Pitch, Part 2: Introduction of course participants


 

12:40 – 1:30 PM

Session 4: Project, Product or Company?: Assessment and Qualification of Technologies as a Basis for a Startup

Healthcare (Medicine) has to actively adopt Innovation in its teaching and culture, rather than letting it occur passively. Innovation is needed to overcome the many unmet needs that exist in Healthcare (Medicine) today
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 new ideas originating by life science companies ventures. One has to define what is the objective vs. what is possible in the healthcare market. Many healthcare innovations fall because they neither integrate with existing clinical practice nor are successful in creating new ones. 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.

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 FDA

Dafna GabbayFounder and CEO, Curical Technologies


 

1:30 – 2:20 PM

Networking Lunch


 

2:20 – 3:20 PM

Session 5: Market Analysis and Competitive Analysis – Essentials of Marketing in life Sciences Companies

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.

Competitive analysis – product differentiation linked to improvements in efficiency and effectiveness – can help potential customers’ better grasp the implication of economic value for their own businesses. Economic value to the customer analyses are calculated as cost savings, improvements in long-term client retention, decreased speed in client acquisition, increased average revenue/customer, and revenue associated with the opportunity/ability to establish entry barriers. Often times, making these explicit links from the market and competitive data can lead to powerful insights as to the value of the offering to the customer, and help make a transformative difference in outcome.

Mike Berman, Medical device Investor/Entrepreneur, Past President Cardiology Business, Boston Scientific

Dafna GabbayFounder and CEO, Curical Technologies


 

3:20 – 3:40 PM

Coffee Break


 

3:40 – 4:25 PM

Session 6 : Innovation Lessons from the Birth of TAVR

Stanton Rowe, Founder & CEO NTX Biomedical


 

4:25 – 6:00 PM

Session 7: What are key issues life sciences companies need to be thinking about – from the beginning!

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 FDA


 

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* Changes in curriculum may occur*

Monday, December 11th, 2023
Day’s Theme: Strategy and Execution


 

8:30 – 9:00 AM

Continental Breakfast


 

9:00 – 10:30 AM

Session 8: The Healthy Way to Build Your Community – Interactive Master Class for Fast Growth Life Sciences Companies

No one accomplishes much on his/her own; we all depend on others in some way. For many, networking means connecting on LinkedIn and distributing business cards at industry events. There’s value in growing the network of people you know, but it’s far more valuable when you build a community.

When you reach out to people in service of what you want to create or achieve, you start to create a sense of community. Reaching out with a purpose makes it easier to network, and when you thoughtfully ask people for help, it builds a stronger connection between you. You community becomes a network that shares a common aspiration or goal. Communities are so much more powerful because of this one important difference.

In this session, we will ask you to reflect on your network – are you strategic about building your community? who is in it? who is missing? what can you do to strengthen it so it can help you reach your personal and professional ambitions?

Gila Tolub, Partner, McKinsey, Tel Aviv


 

10:30 – 11:30 AM

Session 9 : The Persuasive Pitch, Part 2: Presenting Your Idea—and Yourself—With Purpose, Clarity, and Power

On 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.

Barry Katz, Founder and CEO, Barry Katz Communicating Success


 

11:30 – 11:50 AM

Coffee break


 

11:50 – 1:20 PM

Session 10: 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.

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 FDA


 

1:20 – 2:00 PM

Networking Luncheon


 

2:00 – 3:15 PM

Session 11: Incorporating Reimbursement in the Company Development Strategy

Stuart Kurlander, Healthcare and Life Sciences Partner at Latham & Watkins LLP

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


 

3:15 – 4:15 PM

Session 12: 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 strategies and execution and using intellectual capital for competitive advantage. Content includes major issues confronting companies with US and filings in other biotechnology-related jurisdictions, e.g., patent ownership, non-obviousness rulings, the scope of what can be patented. A VC will also provide an investor viewpoint.

Brian Hopkins, Special Counsel, Cooley LLP


 

4:15 – 4:35 PM

Coffee Break


 

4:35 – 5:10 PM

Session 13: Healthcare 2030 – The Future Hospital, The Coming Transformation

Eyal Zimlichman, MD, MSc (MHCM), Deputy Director General, Chief Medical Officer and Chief Innovation and Commercialization Officer at Sheba Medical Center


 

5:10 – 5:50 PM

Session 14: Elevance Health
TBD


 

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* Changes in curriculum may occur*

Tuesday, December 12th, 2023
Day’s Theme: Bringing the product to the market


 

8:30 – 9:00 AM

Continental Breakfast


 

9:00 – 10:30 AM

Session 15: Biopharmaceutical and Medical Device Licensing, Partnering and Strategic Alliances

Major practical issues in the 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, and closing the deal, with special emphasis on how to design alliances and avoid many potential problems and complications in managing this relationship.

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

Adi Gillat, PhD, Founding Partner at H-F & Co. and leads its IP, IT and Tech-Transactions Practice


 

10:30 – 11:30 AM

Session 16: Capitalization of a life science Venture –Value Inflection Points, Milestones and Capital Requirements, Alternative financing, Terms etc. (Part 1)

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.

Introduction: How you prepare yourself for fund raising

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


 

11:30 – 11:50 AM

Coffee break


 

11:50 – 12:40 PM

Session 17: Capitalization of a life science Venture –Value inflection Points, Milestones and Capital Requirements, Alternative financing, Terms etc. (Part 2)

Understand the Term Sheet

Dr. Ayal Shenhav, Head of Hi-Tech & Investment Funds Department, Gross & Co.


 

12:40 – 1:30 PM

Session 18: My Path Through Medicine, Engineering & Innovation

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


 

1:30 – 2:20 PM

Networking Luncheon


 

2:20 – 3:30 PM

Session 19: Capitalization of a life science Venture –Value inflection Points, Milestones and Capital Requirements, Alternative financing, Terms etc. (Part 3)

Panel of VCs:
Mike Berman, Medical Device Investor/Entrepreneur, past President of the Cardiology business of Boston Scientific

Todd Sone, General Partner, aMoon

Alon Maor, Partner at BRM

Ittai Harel, Managing Partner, Pitango Healthtech


 

3:30 – 4:30 PM

Session 20: Lessons learned from our experience: A life science CEOs Panel

Mike Berman, Medical Device Investor/Entrepreneur, past President of the Cardiology business of Boston Scientific

Jonathan Solomon, CEO BiomX

David Golan, PhD Co-Founder and CTO, Viz.ai

Keren Leshem, CEO, OCON

Avner Halperin, CEO, Tel Hashomer Medical Research, Infrastructure and Services (THM)

Ori Hadomi, VP Strategic Initiatives & Partnerships at Medtronic. Former CEO, Mazor Robotics


 

4:30 – 4:50 PM

Coffee Break


 

4:50 – 6:00 PM

Session 21: Resilience and adaptability of CEOs and Executives
Interactive session

Gila Tolub, Gila Tolub Ltd, Former Partner, McKinsey


 


 

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* Changes in curriculum may occur*

Wednesday, December 13th, 2023
Day’s Theme- Health Care IT / Digital Health


 

8:30 – 9:00 AM

Continental Breakfast


 

9:00 – 10:15 AM

Session 22: GPT/AI and the impact on Healthcare

Peter J. Fitzgerald, MD, PhD, FACC, Professor Emeritus, Medicine & Engineering, Director, Center for Cardiovascular Technology, Stanford University, Co-founder, Managing Partner, Triventures


 

10:15 – 11:15 AM

Session 23: Pharma Perspective on Technology & AI Innovation

Tamara Mansfeld, Global Innovation Lead, Pfizer 

Karin Noy, Head Emerging Science & Innovation in Pfizer Israel

AI technology to accelerate drug discovery
Michal Rosen-Zvi, PhD, Director for Healthcare Informatics at IBM Research 


 

11:15 – 11:30 AM

Coffee break


 

11:30 – 12:15 PM

Session 24: Healthcare IT and Health Tech

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

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 FDA

12:15 – 1:00 PM

Session 25: Establishing a US Entity

The legal focus of this session will cover the key building blocks required for an Israeli company to successfully enter the U.S. market.  It will also provide essential contract tips to help achieve these milestones.

We will explore common concerns including:

1.        Whether to register in Delaware and navigating multiple state requirements
2.        Choosing the C Corporation from the get-go
3.        Implementing a 2-factor strategy for IP sourcing
4.        Best practices for cost-effective SEC registration
5.        Avoiding punitive pitfalls in talent management

John Lieberman, Perelson Weiner LLP

Carolyn Hochstadter, E. Carolyn Hochstadter Dicker LLC 


 

1:00 – 2:00 PM

Networking Luncheon


 

2:00 – 4:00 PM

Session 26: Healthcare IT and Connected Health – Continue

Opportunities and Challenges in Healthcare Big Data and AI
Adam Dicker, MD, PhD, FASTRO, Enterprise Senior Vice President, Professor and Chair of Enterprise Radiation Oncology, Sidney Kimmel Cancer Center, Sidney Kimmel Medical College, Thomas Jefferson University

Partnership with a Startup- the Health Plan’s Perspective

Sigal Admony Ravid, Head of Strategic Partnerships at Carelon Digital Platforms, Israel


 

4:30 – 5:30 PM

Session 27: The Persuasive Pitch, Part 3: Presentations Workshop

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

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 FDA


 

5:30 – 6:00 PM

Session 28: Program Adjournment Teams gather for “Take-aways Exercise”

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


 

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* Changes in curriculum may occur*

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