8:15 AM - 9:00 AM
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Registration and Breakfast
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9:00 AM - 9:10 AM
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Welcome and Opening Remarks
PRESENTER
Kyle Faget, Of Counsel, Foley & Lardner LLP
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9:10 AM - 9:20 AM
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FINANCING AND INVESTMENT LANDSCAPE YEAR IN REVIEW
PRESENTER
Jonathan Norris, Managing Director of Healthcare, Silicon Valley Bank
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9:20 AM - 10:10 AM
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FINANCING PANEL DISCUSSION
Capital Raising: The Landscape and Lessons Learned
Raising capital is a significant challenge for many precision medicine companies. Following a brief review of the state of the financing and investment landscape for precision medicine companies, this panel will discuss several topics that founders and executives frequently identify as being particularly difficult when seeking to attract new investors.
Featuring investors, entrepreneurs, and others who form part of the early-stage capital formation ecosystem, this discussion will focus on how companies can more effectively talk about their intellectual property with prospective investors and how they can use equity more effectively as part of their human capital strategy, among other topics.
PANELISTS
Taha Jangda, Partner, HealthX Ventures
Christine Meda, Chief Business Officer, IncellDx
Nick Naclerio, PhD, Founding Partner, Illumina Ventures
Frank Witney, PhD, Operating Partner, Ampersand Capital Partners
MODERATOR | Curt Creely, Partner, Foley & Lardner LLP
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10:10 AM - 10:40 AM
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TECHNOLOGY SPOTLIGHT – GENE AND CELL THERAPY
Finding the Way Forward: Can Gene and Cell Therapy Change the Paradigm?
Gene and cell therapy is making a difference for patients — current FDA-approved therapies include KYMRIAH®, Novartis’ CAR-T cell therapy for relapsed or refractory B-cell acute lymphoblastic leukemia; YESCARTA®, Kite Pharma’s CAR-T cell therapy for non-Hodgkin lymphoma; and LUXTURNA®, Spark Therapeutics’ gene therapy for inherited retinal disease.
With many more products still in development, momentum is building in the space, suggesting that gene and cell therapy will be pivotal in managing and curing diseases driven by specific genetic mutations. However, this new treatment paradigm will challenge biopharmaceutical companies to evolve their traditional business models to better serve patients, providers, and payers with their complex, novel therapeutics.
With more than 100 investigational new drug applications filed last year for gene therapy products and multiple CAR-T cell therapy programs underway, Dr. Ekta Patel of Mustang Bio will shine a light on this evolving technology area, touching on some of the challenges her company has faced in its efforts to develop next-generation therapies. She will then be joined on stage by Ron Leuty, biotech reporter for the San Francisco Business Times, for a fireside chat addressing the future of the industry as the technology and therapies advance as well as the question of whether the pharmaceutical industry can change the paradigm to confront challenges such as access, cost, and payment for these new and exciting therapies.
PRESENTER
Ekta Patel, PhD, Head of Pre-Clinical and Translational Sciences, Mustang Bio
MODERATOR | Ron Leuty, Biotech Reporter, San Francisco Business Times
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10:40 AM - 10:50 AM
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Break
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10:50 AM - 11:35 AM
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BUSINESS MODEL PANEL DISCUSSION – CONSUMER GENETIC TESTING
Consumer Genetic Testing: Are There Sustainable Business Models and at What Risks?
The marketplace indicates that direct-to-consumer genetic testing is here to stay. However, the regulatory pathways and risks differ based on the business model utilized.
During this panel, we will discuss the business challenges facing companies that offer direct-to-consumer genetic testing, including regulatory considerations, reimbursement strategies, and data privacy considerations. We will also explore case studies of companies currently operating in the space.
Ultimately, we aim to answer the question, “Is there a strategic path forward that can benefit those looking to capitalize on the commercial potential of direct-to-consumer genetic testing?”
PANELISTS
Lisa Alderson, MBA, Co-Founder and Chief Executive Officer, Genome Medical, Inc.
Kathryn Phillips, PhD, Founding Director, UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS)
Robin Smith, Founder and Chief Executive Officer, Orig3n
MODERATOR | Kyle Faget, Of Counsel, Foley & Lardner LLP
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11:35 AM - 12:20 PM
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BUSINESS MODEL PANEL DISCUSSION – HEALTH CARE PROVIDERS
Clinical Adoption: It Takes a Village!
The ultimate consumer for personalized medicine is the patients who will benefit with better care and improved outcomes. The path to clinical adoption that makes personalized medicine products available to those patients, however, can be long and hard — no matter how promising a product’s use.
Commercializing a personalized medicine product involves all of the expected hurdles of clinical adoption for any drug or companion diagnostic, plus some additional factors that are especially difficult for personalized medicine. Patient access requires the involvement of many parties, including the scientists; capital funders who believe in the product’s potential for commercial success; clinical trial participants who can help predict success for a small disease population; government regulators who assess safety and efficacy; payers who decide coverage and reimbursement; hospitals and other providers who purchase the product, but rely on formularies or other categorization that can make access easy — or hard — for particular products; and the physicians who must learn about the products and prescribe them with confidence for their patients.
This panel will address some of the hurdles confronting the clinical adoption of personalized medicine and offer tips for planning for, and clearing, those hurdles.
PANELISTS
Kathleen Barnes, PhD, Director, Colorado Center for Personalized Medicine
Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates LLC
Emily Weber, Partner, Foley & Lardner LLP
MODERATOR | Judy Waltz, Partner, Foley & Lardner LLP
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12:20 PM - 1:05 PM
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Networking Lunch
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1:05 PM - 1:50 PM
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BUSINESS MODEL PANEL DISCUSSION – BIG DATA AND ARTIFICIAL INTELLIGENCE
Unpacking the Promise Behind AI for Diagnosis, Personalization, and Data Sharing
This panel will cover the expanding role of artificial intelligence in the personalization of healthcare. Topics covered will include applications of AI in therapeutic treatment options, decision support, and outcomes analysis and prediction. Our panelists will provide perspectives on where organizations are finding the limits of allowing AI to drive decisions, and how data sharing initiatives across multiple organizations can drive value in everything from research to treatment.
PANELISTS
Cory Kidd, PhD, Founder and Chief Executive Officer, Catalia Health
Beau Norgeot, PhD, Director, Clinical AI at Anthem.ai, Anthem, Inc.
MODERATOR | Matt Gardner, Founder and Chief Executive Officer, California Technology Council
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1:50 PM - 2:35 PM
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BUSINESS MODEL PANEL DISCUSSION – COMPANION DIAGNOSTICS
The Next Generation: Evolving Business Models for Companion Diagnostics
PANELISTS
Paul Billings, MD, PhD, Chief Medical Officer and Senior Vice President, Medical Affairs, Natera
Anita Chawla, PhD, Managing Principal, Analysis Group
Nicholas Dracopoli, PhD, Chief Scientific Officer, Delfi Diagnostics
MODERATOR | Ron Mazumder, PhD, MBA, Vice President and Global Head of Oncology Biomarker Development and Companion Diagnostics, Genentech, Inc.
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2:35 PM - 2:45 PM
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Closing Remarks
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2:45 PM - 4:00 PM
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Reception
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