BIOTECHNOLOGY  ENTREPRENEURSHIP

BOOT CAMP 2017

Created by Academia; Supported by Industry 

Founded in 2005 by Carnegie Mellon University & Wharton School Faculty

 

The Biotechnology Innovation Organization Presents:

 

The Thirteenth Annual Biotechnology Entrepreneurship Boot Camp

Sunday, June 18 and Monday, June 19, 2017

Special Session, Tuesday, June 20, 2017

San Diego, California

Rooms:

Sunday and Monday:  1B
Tuesday: 5B

Click here to download a .pdf Agenda

Convention Registration opens at 1:00 PM on Saturday, June 17. Participants in the Boot Camp should obtain their Convention Badges prior to the Boot Camp.

Sunday, June 18, 2017 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:
James Jordan, MBA, CHT
President & CEO, Pittsburgh Life Sciences Greenhouse
Distinguished Service Professor in Healthcare & Biotechnology Management
Carnegie Mellon University

9:00 AM – 9:45 AM

SESSION 1: Keynote Speaker

Magda Marquet, PhD
Chairman and Co-Founder
Ajinomoto Althea, Inc.

 

 

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

Presenter:  

Michael J. Kamdar
President, Chief Executive Officer
& Board Member, Molecular Assemblies

Commentators:

Larry G. Stambaugh
Steve Flaim PhD, FACC, FAHA
Dennis Gross, MS, PhD
James Jordan, MBA, CHT

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
Partner, Epstein, Becker & Green, PC

11:45 AM – 12:30 PM

SESSION 4: Regulatory Planning for the Global Market – Implications for Strategy and Financing

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:

Jim Ackland – International
Managing Director, Global
BioSolutions

12:30 PM – 1:00 PM

Lunch

1:00 PM – 1:45 PM

SESSION 5: Regulatory Planning for the U.S. 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.

Moderator:

Dennis Gross, MS, PhD
CEO Pennsylvania Drug Discovery Institute at The Pennsylvania Biotechnology Center

Faculty:

David T. Lin, PhD – Domestic
Senior Consultant
Biologics Consulting Group, Inc.

1:45 PM – 2:00 PM

SESSION 6: 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 such as the doctrine of equivalents, gene sequencing, process patents, international issues, etc.

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

2:00 PM – 2:45 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 Pyramid (TM) 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 is 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 Miller, JD
Partner, Pepper Hamilton LLP

2:45 PM – 3:00 PM

Bio-Break

3:00 PM – 4:00 PM

SESSION 8: The R&D-Marketing Interface

By expanding upon a strategic development tool based on 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 that 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, St. Joseph’s University

4:00 PM – 5:00 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
Tepper School of Business, Carnegie Mellon University

Faculty:

Larry G. Stambaugh
Founding Principal, Apercu Partners
Chairman, Molecular Assemblies, Inc.
Chairman, MindXSciences, Inc.
Lifetime Director, BioCom
Chairman, ParaNetics

Presenter:

Carol Gallagher
Partner
New Enterprise Associates

5:00 PM – 5:45 PM

SESSION 10: 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

Faculty:

Stephen F. Flaim, PhD
Chairman Emeritus, Tech Coast Angels
Director, Angel Capital Association

Presenter:

Larry G. Stambaugh
Founding Principal, Apercu Partners
Chairman, Molecular Assemblies, Inc.
Chairman, MindXSciences, Inc.
Lifetime Director, BioCom
Chairman, ParaNetics

5:45 PM – 7:00 PM

Networking Reception

Monday, June 19, 2017 Program Schedule

8:30 AM – 9:00 AM

Registration & Continental Breakfast

9:00 AM – 9:40 AM

SESSION 11: The Business Plan and Pitch Book in the Fundraising 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 12: Open Innovation 101

Open innovation uses both internal and external resources to accelerate a product’s 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 for 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 13: 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, participants will gather potential partners and make introductions.

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

Moderator:

Stephen M. Sammut, MBA
Senior Fellow, Healthcare Management
Lecturer, Enrepreneurship, Wharton School
University of Pennsylvania

10:45 AM – 11:45 AM

SESSION 14: Capitalization of your Venture 

A start-up requires the continuous alignment of customer, investor and acquirer 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:

Steve Ferguson, MBA, CLP
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, Esq.
Pepper Hamilton

11:45 AM – 12:30 PM

Lunch Box in Room

12:30 PM – 1:30 PM

SESSION 15: 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:

Stephen F. Flaim, PhD
Chairman Emeritus, Tech Coast Angels
Director, Angel Capital Association

Presenter:

Jon Wilensky, MD
Chief Executive Officer
Braykion, Inc.

Faculty:

Benjamin Chen, PhD
Managing Partner, Ignatius Transaction Partners

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

Marc Malandro, PhD, CLP, RTTP
Vice Chancellor for Technology Management & Commercialization, University of Pittsburgh

1:30 PM – 2:00 PM

SESSION 16: 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.

Moderator:

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 17: 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:

Stephen F. Flaim, PhD
Chairman Emeritus, Tech Coast Angels
Director, Angel Capital Association

Presenter:

Tom Hallam, PhD
Chief Executive Officer
Leading Biosciences, Inc.

Faculty:

Rick Soni
Chief Executive Officer
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 18: 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 19: Working with the Media: Thoughts for Bio-Entrepreneurs

Moderator & Presenter:

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 20: Capitalization of the Venture

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

6:00 PM

Session 21: Boot Camp Wrap-up Acknowledgements & Adjournment 

Co-Chairs

BOOT CAMP SUPPLEMENTAL SESSION (90 MIN.)

Emerging Issues and Trends in the Business of Biotechnology Entrepreneurship

Tuesday, June 20, 2016 – 10:45 AM to 12:15 PM

Room 5B

Session Organized and Moderated by Arthur A. Boni, Ph.D. and Stephen M. Sammut, MBA

Panelists include Jim Jordan and Dennis Gross

Room 5B

Title: Emerging Biotechnology Business Models – disruption, open innovation, and building teams to transitions thru value inflection points

Discussion led by Art Boni

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

Room 5B

Title: Pricing of Biotechnology Products

Discussion led by Steve Sammut

Stephen M. Sammut, MBA

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

Room 5B

Title: Application of Principles of Lean and Agile Management to Biotechnology

Discussion led by Jim Jordan

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