Boot Camp Agenda

The Biotechnology Innovation Organization Presents:

The Fourteenth Annual Biotechnology Entrepreneurship Boot Camp

Sunday, June 3 and Monday, June 4, 2018

Special Session, Tuesday, June 5, 2018

Boston, Massachusetts

Rooms:

Sunday and Monday: TBD
Tuesday: TBD

Click here to download a .pdf Agenda

National Co-Chair

National Co-Chair

Local Co-Chairs

Dennis Gross, M.S., Ph.D.

CEO Pennsylvania Drug Discovery Institute at The Pennsylvania Biotechnology Center

James Jordan, MBA, CHT

Distinguished Service Professor in Healthcare & Biotechnology Management
Carnegie Mellon University

To Be Determined

 

Distinguished Service Professor in Healthcare & Biotechnology Management
Carnegie Mellon University

To Be Determined

National Co-Chair Emeritus

National Co-Chair Emeritus

BIO-Coordinators

Arthur A. Boni, Ph. D.

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, Ph.D.

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

Presenter:

Need Local Company

Commentators:

Local Co-Chair

Local Co-Chair

Dennis Gross

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, J.D.

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, Ph.D., J.D.

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, M.S., Ph.D.

CEO Pennsylvania Drug Discovery Institute at The Pennsylvania Biotechnology Center

Faculty:
David T. Lin, Ph.D.

Senior Consultant
Biologics Consulting Group, Inc.

2:00 PM – 2:45 PM

SESSION 7: 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

Chief Investment Officer
Pittsburgh Life Sciences Greenhouse, Distinguished Service Professor in Healthcare & Biotechnology Management
Carnegie Mellon University

Faculty:
Professor Thanigavelan Jambulingam, Ph.D.

Thanigavelan Jambulingam Ph.D.,
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 8: 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

Chief Investment Officer
Pittsburgh Life Sciences Greenhouse
Distinguished Service Professor in Healthcare & Biotechnology Management, Carnegie Mellon University

Faculty:
Ray Miller

Partner, Pepper Hamilton LLP

4:00 PM – 4:45 PM

SESSION 9: 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: T-B-D

4:45 PM – 5:30 PM

SESSION 10: 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.

Arthur A. Boni, Ph. D.

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

Faculty

Regional Co-Chair

Presenters:
T-B-D

Could be Medrobotics

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 11: 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, Ph.D.

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 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, Ph.D.

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

May want to call this building your brand or value syndicate strategy to make it less theoretical

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 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 14: 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, M.S., Ph.D.

CEO Pennsylvania Drug Discovery Institute at The Pennsylvania Biotechnology Center

Faculty:

Regional co-chair

Regional co-chair

Benjamin Chen, Ph.D.
Managing Partner, Ignatius Transaction Partners

James Foley, Ph.D.
CEO Aqua Partners, former head of Business Development, Bristol Myers Squibb

David Smith, Pepper Hamilton

11:45 AM – 12:30 PM

Lunch

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:
Regional co-chairman

Company: T-B-D

Faculty:

Benjamin Chen, Ph.D.
Managing Partner, Ignatius Transaction Partners

James Foley, Ph.D.
CEO Aqua Partners, former head of Business Development, Bristol Myers Squibb

Evan Fatcher, Tech Transfer University of Pittsburgh or a local University

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.

James Jordan, MBA, CHT

Chief Investment Officer
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

Steve Flaim, Ph.D.

Chairman Emeritus, Tech Coast Angels
Director, Angel Capital Association

Company: T-B-D

Faculty:
Rick Soni,
CEO Cellular Logistics, Inc.

Benjamin Chen, Ph.D.
Managing Partner, Ignatius Transaction Partners

James Foley, Ph.D.
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

Moira A Gunn, Ph.D.

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, M.S., Ph.D.

CEO
Pennsylvania Drug Discovery Institute at The Pennsylvania Biotechnology Center

Faculty:

David Smith, Pepper Hamilton

6:00 PM

Networking Reception

Co-Chairs

BOOT CAMP SUPPLEMENTAL SESSION (90 MIN.)

Tuesday, June 5, 2018 – 10:45 AM to 12:15 PM
Room TBD
Session Organized and Moderated by Arthur A. Boni, Ph.D. and Stephen M. Sammut, MBA
Panelists include Jim Jordan and Dennis Gross

Title of Session
Emerging Issues and Trends in the Business of Biotechnology Entrepreneurship

Room TBD

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, Ph.D.

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

Room TBD

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 TBD

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

Discussion led by Jim Jordan

James Jordan, MBA, CHT

Chief Investment Officer
Pittsburgh Life Sciences Greenhouse
Distinguished Service Professor in Healthcare & Biotechnology Management
Carnegie Mellon University

The Fourteenth Annual Biotechnology Entrepreneurship Boot Camp

Sunday, June 3 and Monday, June 4, 2018
Special Session, Tuesday, June 5, 2018
Sunday & Monday: ?
Tuesday: Room ?
Boston, Massachusetts

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Let us know if you have any questions!