2019 Boot Camp Agenda

The Biotechnology Innovation Organization Presents:

The Fifteenth Annual Biotechnology Entrepreneurship Boot Camp

Sunday, June 2 and Monday June 3, 2019

Pennsylvania Convention Center

1101 Arch Street, Philadelphia, PA 19107

Room:

Room 108A, Level 100

Click here to download the Agenda as a PDF.

*Agenda is subject to change.

National Co-Chair

National Co-Chair

Local Co-Chairs

Dennis Gross, MS, PhD
CEO, Pennsylvania Drug Discovery Institute at the Pennsylvania Biotechnology Center, Doylestown, PA
James F. Jordan, MBA, CHT
President & CEO, Pittsburgh Life Sciences Greenhouse 
Distinguished Service Professor of Healthcare & Biotechnology Management
Senior Director of Healthcare & Biotechnology Programs, Carnegie Mellon University
Wendy DiCicco
Board Member, Carmell Therapeutics

Kathryn Doyle, PhD, JD
Partner, Saul Ewing Arnstein & Lehr
Harold Safferstein, PhD, JD, MBA
Senior Vice President, Corporate Development, Cognition Therapeutics

National Co-Chair Emeritus

National Co-Chair Emeritus

BIO Coordinators

Arthur A. Boni, PhD
John R. Thorne Distinguished Career Professor of Entrepreneurship Emeritus, Tepper School of Business, Carnegie Mellon University
Editor in Chief, Journal of Commercial Biotechnology
Sarah Arth, CAE
Vice President, Education, Biotechnology Innovation Organization
Sarah Maki
Manger, Education, Biotechnology Innovation Organization
Jocelyn Moratzka
Coordinator, Education, Biotechnology Innovation Organization

Convention Registration opens at 1:00 PM on Saturday, June 1. Participants in the Boot Camp should obtain their Convention Badges prior to the Boot Camp.

Sunday, June 2, 2019 Program Schedule

8:00 AM – 8:30 AM

Registration & Continental Breakfast

8:30 AM – 9:00 AM

Opening Remarks, Program Overview and Sponsor Acknowledgments

National Co-Chair Emeritus
Stephen M. Sammut, MBA

9:00 AM – 9:45 AM

SESSION 1: Keynote Speaker

Jeffrey D. Marrazzo, MBA, MPA
Chief Executive Officer, Spark Therapeutics, Inc.

Introduced by:
Kathryn Doyle, PhD, JD

Partner, Saul Ewing Arnstein & Lehr

 

9:45 AM – 10:45 AM

SESSION 2: Project, Product, or Platform: Assessment and Qualification of Technologies as a Basis for a Business Startup

Forming a company around a technology is relatively easy. Staffing and capitalizing it is another story. Savvy employees, astute venture capitalists, and selective prospective strategic partners know that companies without technological “critical mass” sufficient to bring a series of products to the market are unsustainable. This session will provide tools and a contextual framework (the metaphor of a “project, product, or platform”) as to how technologies can be assessed for capitalization and partnering. The session includes a real-time review of the technology of a new company with intent of recommending commercialization and risk reduction strategies.

Moderator and Lecturer:
Arthur A. Boni, PhD

John R. Thorne Distinguished Career Professor of Entrepreneurship Emeritus, Tepper School of Business, Carnegie Mellon University
Editor in Chief, Journal of Commercial Biotechnology

Presenter:
D. Kacy Cullen, PhD

Founder, Innervace, LLC

Associate Professor of Neurosurgery & Bioengineering, University of Pennsylvania School of Medicine

Sponsor:
Kathryn Doyle, PhD, JD

Partner, Saul Ewing Arnstein & Lehr

Commentators:

Wendy DiCicco

Board Member, Carmell Therapeutics

Dennis Gross, MS, PhD

CEO, Pennsylvania Drug Discovery Institute at the Pennsylvania Biotechnology Center

Vivian Lee

Managing Director, Aqua Partners LLC

Harold Safferstein, PhD, JD, MBA

Senior Vice President, Corporate Development, Cognition Therapeutics

John S. Swartley, MBA, PhD

Associate Vice Provost for Research
Managing Director, Penn Center for Innovation

 

10:45 AM – 11:00 AM

Break-out with refreshments for case discussion followed by group recommendations 

 

Reconvene for group recommendations

11:00 AM – 11:45 AM

SESSION 3: Reimbursement & Pricing Strategies

It is never too early to assess how the market will respond to products, especially as it relates to pricing and reimbursement. Many companies do not address this issue and then run into problems (and potentially failures). This session will address the fundamentals of pharmaceutical pricing and reimbursement strategies

Moderator:
Stephen M. Sammut, MBA

Senior Fellow, Health Care Management and Lecturer, Entrepreneurship, Wharton School, University of Pennsylvania

Faculty:
Robert Wanerman, JD, MPH

Partner, Epstein Becker & Green, PC

 

11:45 AM – 12:45 PM

SESSION 4: What Every Investigator Must Know about IP in Biotechnology Startups

The goal of the session is to provide information and insight into the specific issues confronting investigators, entrepreneurs, investors, and their patent attorneys.

Additionally, the speakers will describe the prevailing treatment by the PTO and the courts of specific issues and implications.

Moderator:
Stephen M. Sammut, MBA

Senior Fellow, Health Care Management and Lecturer, Entrepreneurship, Wharton School, University of Pennsylvania

Faculty:
Kathryn Doyle, PhD, JD

Partner, Saul Ewing Arnstein & Lehr LLP

Raymond A. Miller, JD

Partner, Pepper Hamilton LLP

12:45 PM – 1:15 PM

Lunch

1:15 PM – 2:15 PM

SESSION 5: Regulatory Planning for the U.S. & Global Market – Implications for Strategy and Financing

This session provides the specific insight into planning for U.S. and global regulations and clinical trials.  What are the considerations and the challenges that sponsors might encounter?

Moderator:
Dennis Gross, MS, PhD

CEO Pennsylvania Drug Discovery Institute at The Pennsylvania Biotechnology Center

Faculty:
David T. Lin, PhD, MBA

President, TS Pharma Experts

 

2:15 PM – 3:00 PM

SESSION 6: The R&D – Marketing Interface

By expanding upon a strategic development tool based upon FDA Guidance called the target product profile (TPP), alignment of R&D, reimbursement, pricing, regulatory, label claim, IP, marketing, and sales strategies are aided.

The TPP ensures product strategy and commercialization plan details do not disconnect as resource and technical constraints avail themselves during implementation.

 

Moderator and Speaker:
James F. Jordan, MBA, CHT

President & CEO, Pittsburgh Life Sciences Greenhouse
Distinguished Service Professor in Healthcare & Biotechnology Management, Carnegie Mellon University

Faculty:
Thanigavelan Jambulingam, PhD

Professor, Pfizer Fellow, Arrupe Research Fellow, Department of Pharmaceutical and Healthcare Marketing, Haub School of Business, Saint Joseph’s University

 

 

3:00 PM – 3:15 PM

Bio-Break

3:15 PM – 4:00 PM

SESSION 7: Building an IP Pyramid impervious to competitive advancement

A patent excludes others from replicating an approach, however that may not equate to an exclusive market position. True exclusivity is creating a competitive position impervious to competitive advancement.

The goal of the Intellectual Property PyramidTM is to understand the exclusivity a patent provides matched with the desired result. What you are trying to understand is the reason the patent exists (the problem it’s solving), and then ask yourself if your patent is the only path to achieving that goal.

 

Faculty:
James F. Jordan, MBA, CHT

President & CEO, Pittsburgh Life Sciences Greenhouse
Distinguished Service Professor in Healthcare & Biotechnology Management, Carnegie Mellon University

4:00 PM – 4:45 PM

SESSION 8: Building and working with the Board

Building and working with a board is a key element for success in entrepreneurial companies. Better boards make better companies. We will cover the best practices and successful principles of a great board and sound corporate governance processes.

 

Presenter/Faculty:
James F. Jordan, MBA, CHT

President & CEO, Pittsburgh Life Sciences Greenhouse
Distinguished Service Professor in Healthcare & Biotechnology Management, Carnegie Mellon University

4:45 PM – 5:30 PM

SESSION 9: Building an Entrepreneurial Management Team

Team building in biotechnology companies is the most challenging task for entrepreneurs and the backbone of venture capitalists’ decision to invest or not to invest. The session provides exploration of the issues in forming an entrepreneurial team of a start-up or early stage company and approaches to successful team formation and management of the team.

The panelists represent the perspective of a CEO and a venture capitalist who built the management team of local company.

Lecturer and Moderator:
Arthur A. Boni, PhD

John R. Thorne Distinguished Career Professor of Entrepreneurship Emeritus, Tepper School of Business, Carnegie Mellon University
Editor in Chief, Journal of Commercial Biotechnology

Presenter:
Steve Nichtberger, MD

Co-founder, Chairman and CEO, Cabaletta Bio

Sponsor:
Kathryn Doyle, PhD, JD

Partner, Saul Ewing Arnstein & Lehr LLP

Faculty:
Wendy DiCicco

Board Member, Carmell Therapeutics

Vivian Lee

Managing Director, Aqua Partners LLC

Harold Safferstein, PhD, JD, MBA

Senior Vice President, Corporate Development, Cognition Therapeutics

David Smith, JD

Of Counsel, Pepper Hamilton LLP

 

5:30 PM – 7:00 PM

Networking Reception

Monday, June 3, 2019 Program Schedule

8:30 AM – 9:00 AM

Registration & Continental Breakfast

9:00 AM – 9:40 AM

SESSION 10: The Business Plan and Pitch in the Fund Raising Process

Experienced entrepreneurs and their investors openly recognize that within a year of operating, few companies resemble their original business plan. Business plans and the accompanying pitch, however, provide the starting point of a shared vision and evidence that the founding team can reach a consensus in the business and technology development planning process and the resources required to meet critical milestones. The session provides a framework for developing a pitch to investors/partners, and the essentials of a business plan.

 

Moderator and Lecturer:
Arthur A. Boni, PhD

John R. Thorne Distinguished Career Professor of Entrepreneurship Emeritus, Tepper School of Business, Carnegie Mellon University
Editor in Chief, Journal of Commercial Biotechnology

9:40 AM – 10:00 AM

SESSION 11: Leveraging Resources of Partners to Optimize Value Creation and Capture

The Business Model contains all elements required by a firm to create, deliver, and capture value. In developing and validating the business model elements, the firm can leverage the resources and channels of partners across the value chain and share the value created and delivered with others. Creative partnering can be used to reduce the risk profile and also reduce capital requirements for the firm as it evolves through the commercialization, testing, and go-to-market phases. In the last decade or so, this open innovation approach has been used extensively in the biopharma and medtech community to commercialize using both internal and external resources. In effect, the firm “rents” elements of the business model from others. This session is designed to introduce and rationalize “Open Innovation 101” for early-stage companies and complements the Lean Startup model to more efficiently validate product/market fit via creative partnering. 

Moderator and Lecturer:
Arthur A. Boni, PhD

John R. Thorne Distinguished Career Professor of Entrepreneurship Emeritus, Tepper School of Business, Carnegie Mellon University
Editor in Chief, Journal of Commercial Biotechnology

10:00 AM – 10:15 AM

Break-out with refreshments for Group Discussions

10:15 AM -10:45 AM

SESSION 12: Group & Presentations

Utilizing the worksheet provided, students will discuss and identify the areas where partnerships could either accelerate, de-risk, or deepen domain relationships. Utilizing group discussions, gather potential partners and introductions.

Two volunteers will take 15 minutes each to discuss their strategies.

Moderator:
Stephen M. Sammut, MBA

Senior Fellow, Health Care Management and Lecturer, Entrepreneurship, Wharton School, University of Pennsylvania

10:45 AM – 11:45 AM

SESSION 13: Building your Capitalization Strategy

A start-up requires the continuous alignment of customer, investor, and acquirer’s objectives and concerns. Investors fund the journey, and a poorly planned and ill-provisioned journey increases the probability of failure.

This discussion will center around the customer (who in this case is the investor) so students can understand their needs, timing and investment criteria.

– Non-Dilutive Funding – NIH
– Angels
– Corporate Venture Capital
– Venture Capital
– Corporate Partners

 

Moderator:
Stephen M. Sammut, MBA

Senior Fellow, Health Care Management and Lecturer, Entrepreneurship, Wharton School, University of Pennsylvania

Faculty:
Steven M. Ferguson, MBA, CLP

Deputy Director, Licensing and Entrepreneurship, National Institutes of Health

James Foley, PhD

CEO, Aqua Partners
Former head of Business Development, Bristol Myers Squibb

David Smith, JD

Of Counsel, Pepper Hamilton LLP

Wei Wu, PhD

Healthcare Investment Director, BOE Ventures

11:45 AM – 12:30 PM

Lunch

12:30 PM – 1:30 PM

SESSION 14: Pre-seed/Seed Funding Pitch

The facilitator will give a brief introduction on the phases of private equity funding.

Companies need to be aware of the expectations of investors for each phase and also learn to handle objections. For example, if a pre-seed funder is asking you for human data, they either aren’t a pre-seed funder, or they are using the objection to avoid investing or providing feedback.

In this segment, two companies will present their investor pitch and receive feedback appropriate to their investment phase.

 

Moderator:
Harold Safferstein, PhD, JD, MBA

Senior Vice President, Corporate Development, Cognition Therapeutics

Presenters:
Mahesh Narayanan

President and CEO, PepVax, Inc.

Michael Nelson, JD

Chief Executive Officer and Co-Founder, Intrommune Therapeutics

Sponsor:
Wendy DiCicco

Board Member, Carmell Therapeutics

Faculty:
Wendy DiCicco

Board Member, Carmell Therapeutics

James Foley, PhD

CEO Aqua Partners
Former head of Business Development, Bristol Myers Squibb

Wei Wu, PhD

Healthcare Investment Director, BOE Ventures

1:30 PM – 2:00 PM

SESSION 15: Defining your Exit Triggers

Running out of cash can be caused by a poorly planned and ill-provisioned journey. Startups frequently run out of cash when they mis-plan their exit. This discussion will offer you a tool to aid in your planning.

 

James F. Jordan, MBA, CHT

President & CEO, Pittsburgh Life Sciences Greenhouse
Distinguished Service Professor in Healthcare & Biotechnology Management, Carnegie Mellon University

2:00 PM – 2:45 PM

SESSION 16: Early-Stage Funding Pitch

Early-stage valuation points are frequently aligned with Phase II clinical trial inflection points from an investor perspective. Additionally, the probability of strategic investors and a milestone-based exit are available. This requires a pitch that satisfies a broader audience.

In this segment, a company will present its investor pitch and receive feedback appropriate to its investment phase.

 

Moderator:
Kathryn Doyle, PhD, JD

Partner, Saul Ewing Arnstein & Lehr LLP

Presenter:
Jessica M. Gibson, MBA

CEO and Co-founder, Ariel Precision Medicine

Sponsor:
Harold Safferstein, PhD, JD, MBA

Senior Vice President, Corporate Development, Cognition Therapeutics

Faculty:
Wendy DiCicco

Board Member, Carmell Therapeutics

James Foley, PhD

CEO, Aqua Partners
Former head of Business Development, Bristol Myers Squibb

Wei Wu, PhD

Healthcare Investment Director, BOE Ventures

2:45 PM – 3:00 PM

Break-out with refreshment for Group Discussions

3:00 PM – 3:45 PM

SESSION 17: Group & Presentations

Utilizing the feedback given during the two investor pitches, students will discuss and identify areas of improvement in their pitches. Two volunteers will take 15 minutes each to discuss their strategies.

 

Moderator:
Kathryn Doyle, PhD, JD

Partner, Saul Ewing Arnstein & Lehr LLP

 

3:45 PM – 4:30 PM

SESSION 18: Working with the Media: Thoughts for Bio-Entrepreneurs

 

Lecturer:
Moira A. Gunn, PhD

Host, NPR – BioTech Nation
Director, Business of Biotechnology Program
Professor, School of Management, University of San Francisco

 

4:30 PM – 6:00 PM

SESSION 19: Capitalization of the Venture – Mechanics

CEOs and CSOs of biotechnology companies spend as much time raising capital as managing their company.

An attorney specializing in company formation and capitalization will join the panel to provide legal models.

 

Moderator:
Dennis Gross, MS, PhD

CEO, Pennsylvania Drug Discovery Institute at the Pennsylvania Biotechnology Center

Faculty:
David Smith, JD

Of Counsel, Pepper Hamilton LLP

6:00 PM

SESSION 20: Boot Camp Wrap-Up, Acknowledgements, & Adjournment

 

National and Local Co-Chairs

 

 

The Fifteenth Annual Biotechnology Entrepreneurship Boot Camp

Sunday, June 2 and Monday June 3, 2019

Pennsylvania Convention Center

1101 Arch Street, Philadelphia, PA 19107

Room 108A, Level 100

 

Add Boot Camp to your BIO International Convention agenda here!

 

 

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