2018 Boot Camp Agenda

The Biotechnology Innovation Organization Presents:

The Fourteenth Annual Biotechnology Entrepreneurship Boot Camp

Sunday, June 3 and Monday, June 4, 2018

Boston Convention & Exhibition Center

415 Summer St., Boston, MA 02210

Room:

Room 204AB, Level 2

Click here to download the Agenda as a PDF.

*Agenda is subject to change.

Convention Registration opens at 1:00 PM on Saturday, June 2. Participants in the Boot Camp should obtain their Convention Badges prior to the Boot Camp.

Sunday, June 3, 2018 Program Schedule

8:00 AM – 8:30 AM

Registration & Continental Breakfast

8:30 AM – 9:00 AM

Opening Remarks, Program Overview of Program and Sponsor Acknowledgments

National and Local Co-Chairs:
James Jordan, MBA, CHT

9:00 AM – 9:45 AM

SESSION 1: Keynote Speaker

Ketan Patel, MD, MBA
Partner, F-Prime Capital

Introduced by:
James Jordan, MBA, CHT

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

9:45 AM – 10:45 AM

SESSION 2: Project, Product or Company: 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 product to the market are unsustainable. This session will provide tools and a contextual framework (the metaphor of a “project, product, or company”) 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, Tepper School of Business, Carnegie Mellon University

Presenter:
Mark Tepper, PhD

President & Chief Scientific Officer, Corbus Pharmaceuticals

Commentators:

Edward Ross, Jr., MBA

Amy Siegel, MA

Dennis Gross, MS, PhD

Hank Safferstein, PhD, JD, MBA

10:45 AM – 11:00 AM

Break-out with refreshment 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 – 12:30 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

12:30 PM – 1:00 PM

Lunch

1:00 PM – 2:00 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 FDA regulations in light of strategy, financial needs, and the concerns of prospective partners and investors.

A global clinical trial is frequently used to obtain early first in human data and to reduce clinical trial costs.

What are the other advantages of running trials internationally? 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

Senior Consultant, Biologics Consulting Group, Inc.

2:00 PM – 2:45 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, I.P., 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 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

2:45 PM – 3:00 PM

Bio-Break

3:00 PM – 3:45 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.

Moderator:
James Jordan, MBA, CHT

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

Faculty:
Ray A. Miller, JD

Partner, Pepper Hamilton LLP

Hank Safferstein, PhD, JD, MBA

Executive in Residence, Pittsburgh Life Sciences Greenhouse
Senior Vice President, Cognition Therapeutics

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.

Moderator:
Stephen M. Sammut, MBA

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

Presenter:
James 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.

Moderator:
Arthur A. Boni, PhD

John R. Thorne Distinguished Career Professor of Entrepreneurship, Tepper School of Business, Carnegie Mellon University

Presenters:
Samuel F. Straface, PhD

President & CEO, Medrobotics Corporation

Mark A. Peters, MBA, CPA

Chief Financial Officer & Treasurer, Medrobotics Corporation

Faculty:
Edward Ross, Jr., MBA

President & CEO, ReadyDock, Inc.
Member, MassMedical Angels and Launchpad Venture Group

Amy Siegel, MA

Co-founder and President, S2N Health

5:30 PM – 7:00 PM

Networking Reception

Monday, June 4, 2018 Program Schedule

8:30 AM – 9:00 AM

Registration & Continental Breakfast

9:00 AM – 9:40 AM

SESSION 10: The Business Plan and Pitch Book 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, Tepper School of Business, Carnegie Mellon University

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 thru 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, Tepper School of Business, Carnegie Mellon University

10:00 AM – 10:15 AM

Break-out with refreshment 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: Capitalization of your Venture

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:
Edward Ross, Jr., MBA

President & CEO, ReadyDock, Inc.
Member, MassMedical Angels and Launchpad Venture Group

Faculty:
Steven M. Ferguson, MBA

Deputy Director, Licensing and Entrepreneurship, National Institutes of Health

Benjamin Chen, PhD

Managing Partner, Ignatius Transaction Partners

James Foley, PhD

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

David Smith, JD

Pepper Hamilton LLP

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:
Edward Ross, Jr., MBA

President & CEO, ReadyDock, Inc.
Member, MassMedical Angels and Launchpad Venture Group

Presenters:
Ed Goluch, MS, PhD

Founder and President, QSM Diagnostics, Inc.

Isaac Stoner, MBA

President and COO, Octagon Therapeutics

Faculty:
Benjamin Chen, PhD

Managing Partner, Ignatius Transaction Partners

James Foley, PhD

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

Amy Siegel, MA

Co-founder and President, S2N Health

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 Jordan, MBA, CHT

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

2:00 PM – 3:00 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, two companies will present their investor pitch and receive feedback appropriate to their investment phase.

Moderator:
Amy Siegel, MA

Co-founder and President, S2N Health

Presenters:
Jeff Behrens, MS, MBA

President and CEO, Siamab Therapeutics, Inc.

Ashley Kalinauskas, MS

President and CEO, Torigen Pharmaceuticals, Inc.

Benjamin Chen, PhD

Managing Partner, Ignatius Transaction Partners

James Foley, PhD

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

Edward Ross, Jr., MBA

President & CEO, ReadyDock, Inc.
Member, MassMedical Angels and Launchpad Venture Group

3:00 PM – 3:15 PM

Break-out with refreshment for Group Discussions

3:15 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

Pepper Hamilton LLP

6:00 PM

SESSION 20: Boot Camp Wrap-Up Acknowledgements & Adjournment

National and Local Co-Chairs

The Fourteenth Annual Biotechnology Entrepreneurship 
Boot Camp

Sunday, June 3 and Monday, June 4, 2018
Room 204AB, Level 2

Boston Convention & Exhibition Center
415 Summer St., Boston, MA 02210 

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