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Biotechnology Entrepreneurship Boot Camp 2018
June 3, 2018 @ 8:00 am - June 4, 2018 @ 6:00 pm
Biotechnology Entrepreneurship Boot Camp 2018
Created By Academia Supported By Industry
Founded In 2005 By Carnegie Mellon University
& Wharton School Faculty
Investment requires more than just technology, and startups must tell a compelling story that meets the needs of their customers, their funders and acquirers. Funders must receive a return, which requires a liquidity event, sometimes an IPO, frequently the sale of the company to an acquirer. Importantly, this requires that the acquirer’s needs be built into the company from the very beginning.
It is a simultaneous equation that must be balanced, and this Boot Camp provides you the tools and considerations to improve the success of your journey. The Boot Camp was created in response to the growing need in the managerial, scientific and academic community to learn about these elements and the skills to transform technology and invention into a viable company.
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
Rooms:
Room 204AB, Level 2
Click here to download a .pdf Agenda
National Co-Chair
National Co-Chair
Local Co-Chairs
Dennis Gross, MS, PhD
CEO Pennsylvania Drug Discovery Institute at The Pennsylvania Biotechnology Center
James Jordan, MBA, CHT
President & CEO, Pittsburgh Life Sciences Greenhouse
Distinguished Service Professor in Healthcare & Biotechnology Management, Carnegie Mellon University
To Be Determined
To Be Determined
National Co-Chair Emeritus
National Co-Chair Emeritus
BIO-Coordinators
Arthur A. Boni, PhD
John R. Thorne Distinguished Career Professor of Entrepreneurship, Tepper School of Business, Carnegie Mellon University
Stephen M. Sammut, MBA
Senior Fellow, Health Care Management and Lecturer, Entrepreneurship, Wharton School, University of Pennsylvania
Sarah Arth, CAE
Vice President, Education
Biotechnology Innovation Organization
Sarah Maki
Manger, Education
Biotechnology Innovation Organization
Stephanie Haines
Coordinator, Education
Biotechnology Innovation Organization
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
To Be Determined
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:
Local Company TBD
Commentators:
Local Co-Chair
Local Co-Chair
Dennis Gross, MS, PhD
James Jordan, MBA, CHT
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
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 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
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
Faculty:
Local Co-Chair
Presenters:
Samuel F. Straface, PhD
President & CEO, Medrobotics
VC TBD
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: Open Innovation 101
Open innovation use both internal and external resources to accelerate a products path to market. Partnering with experienced providers also further de-risks the company to investors as partners have validated processes, scale, and deep domain relationships. In this session, a framework of aligning your partnership strategy to your business plan is offered. It is also important to note that this methodology is supportive of the Lean Startup discussions offered in the Supplemental Sessions.
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 work sheet provided, students will discuss and identify the areas of where partnerships could either accelerator, 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:
Dennis Gross, MS, PhD
CEO Pennsylvania Drug Discovery Institute at The Pennsylvania Biotechnology Center
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 a company will present their investor pitch and receive feedback appropriate to their investment phase.
Moderator:
Local Co-Chair
Company: T-B-D
Faculty:
Benjamin Chen, PhD
Managing Partner, Ignatius Transaction Partners
James Foley, PhD
CEO Aqua Partners, former head of Business Development, Bristol Myers Squibb
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, a company will present their investor pitch and receive feedback appropriate to their investment phase
Moderator:
Local Co-Chair
Title, Company
Company: T-B-D
Faculty:
Rick Soni, MBA
CEO, Cellular Logistics, Inc.
Benjamin Chen, PhD
Managing Partner, Ignatius Transaction Partners
James Foley, PhD
CEO Aqua Partners, former head of Business Development, Bristol Myers Squibb
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:
Stephen M. Sammut, MBA
Senior Fellow, Health Care Management and Lecturer, Entrepreneurship, Wharton School, University of Pennsylvania
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
Co-Chairs