Agenda

THURSDAY, DECEMBER 6, 2018
7:30 AM - 1:00 PM	Registration
7:30 AM - 8:30 AM	Continental Breakfast
8:30 AM - 8:50 AM	WELCOME AND OPENING REMARKS PRESENTERS \| Antoinette F. Konski, Partner and Life Sciences Industry Team Co-Chair, Foley & Lardner LLP and Edward Abrahams, PhD, President, Personalized Medicine Coalition
8:55 AM - 9:25 AM	OPENING KEYNOTE Don't miss opening remarks from the co-founder and CEO of Guardant Health, a pioneer in the liquid biopsy space that is hot on the heels of an impressive $238M IPO debut – one of the largest in life sciences so far this year. Dr. Helmy Eltoukhy will talk lifecycle strategy regarding his company's potentially game-changing technology for early cancer detection, growth trajectory in a promising yet complex and increasingly competitive field, and what the future holds in terms of innovation and market interest. PRESENTER \| Helmy Eltoukhy, PhD, Co-Founder and Chief Executive Officer, Guardant Health
9:30 AM - 10:40 AM	FINANCING AND VENTURE CAPITAL PANEL Personalized Medicine Investors: Who Are They and What Are They Thinking? The personalized medicine investment landscape continues to be in flux, whether it’s in therapeutics or in diagnostics. The panel – comprised of investors, an advisor, and a head of business – will parse out the characteristics of investors and the metrics they use in separating potential winners from losers. Their discussion will include: A brief analysis of the financing and investment landscape What issues investors consider during their due diligence and risk assessment of personalized medicine investments How innovators can preempt hot spots and strengthen their chances of being funded Deal terms and due diligence for licensing and collaborative transactions Alexis Ji, PhD, MBA, Partner, Illumina Ventures Patricia Lawman, PhD, Chief Executive Officer, Morphogenesis, Inc. J. Blake Long, MD, Investor Member, Ariel Southeast Angel Partners & President, Long Health Care Consulting Jonathan Norris, Managing Director of Sales Origination, Silicon Valley Bank MODERATOR \| Curt P. Creely, Partner, Foley & Lardner LLP
10:40 AM - 11:10 AM	Networking Break
11:10 AM - 12:00 PM	BIG DATA PANEL Exploiting AI: From Discovery to Treatment We are at the cusp of realizing the true promise of personalized medicine – making clinical decisions that are specific to a patient based on his or her individual health and disease – and the advancement of artificial intelligence (AI) technologies such as machine learning are playing a pivotal role. This panel will address: The latest developments in AI and novel applications within genomics and personalized medicine How pharma, biotech, and other industry stakeholders are investing in the AI space, plus their strategies for product development and commercialization How the digital health cultural transformation is enabling AI and impacting Big Data projects What challenges lie ahead with respect to applications of AI, including within diagnostics and therapeutics Blanca Baez, MBA, Senior Vice President and Global Head, Pharma & Biotech, Molecular Health David Hardison, PhD, Vice President, Health Sciences, ConvergeHEALTH by Deloitte Girish Putcha, MD, PhD, Chief Medical Officer and Clinical Laboratory Director, Freenome Jo Varshney, DVM, PhD, Founder and Chief Executive Officer, VeriSIM Life MODERATOR \| Matt Gardner, Founder and Chief Executive Officer, California Technology Council
12:00 PM - 1:00 PM	Luncheon
1:00 PM - 2:15 PM	DISRUPTIVE INNOVATION PANEL Disruptive Technologies Creating Revolutionary Opportunities Technological breakthroughs are adopted throughout our health care system at a glacial pace, often the result of competing interests among different players. Despite this, a culture of innovation persists within the industry that continues to drive change and advancement. This panel will examine several disruptive technologies that, coupled with exceptional business plans, have resulted in innovations that are poised to transform the personalized medicine marketplace and revolutionize the standard of care. With an eye towards next-generation T-cell therapeutics, epigenomics, liquid biopsy, CRISPR, and more, the following panelists will address: Existing and potential future applications of emerging technologies within personalized medicine The process by which innovation is cultivated, for example, within an academic laboratory setting Strategies for promoting product development to its fullest while mitigating operational risk Building in protections for innovations that allow a company to withstand and in some cases monetize off of eventual competitors Other early business plan considerations Mickey Kertesz, PhD, Chief Executive Officer, Karius Caitlyn Krebs, Chief Business Officer, Bluestar Genomics, Inc. Trevor Martin, PhD, Co-Founder and Chief Executive Officer, Mammoth Biosciences Donaldson Santos, Associate Director of Licensing, Life Sciences, USC Stevens Center for Innovation James S. Scibetta, Chief Executive Officer, Maverick Therapeutics MODERATOR \| Ashley Van Zeeland, PhD, MBA, Vice President, Product Development, Business Operations and Systems Integration, Illumina
2:20 PM - 3:10 PM	FDA REGULATORY PANEL Collaborating With the FDA: What Has Worked and What Hasn't? FDA approval of personalized medicine is on the rise. In fact, over 30% of new drug approvals in 2017 were personalized medicines. This panel will discuss how businesses can further build on this momentum and continue to cultivate a productive working relationship with the FDA. Discussion topics will include: Perspectives from various companies on their current experiences and challenges of working with the FDA on product development A look at whether the review process is any easier to navigate now compared to in the past FDA’s new initiative and related guidance surrounding digital health technologies and product approvals Regulatory requirements and approvals in the U.S. versus abroad Updates regarding the regulation of laboratory developed tests, companion diagnostics, and human cells, tissues, and cellular and tissue-based products The impact of the 21st Century Cures Act, including the outlook for drug pricing and clinical trials Joseph Monforte, PhD, Precision Medicine and Genomics Advisor, Wild Type Advisors Dan Snyder, MBA, President and Chief Executive Officer, MolecularMD MODERATOR \| Nathan A. Beaver, Partner, Foley & Lardner LLP
3:10 PM - 3:40 PM	Networking Break
3:40 PM - 4:30 PM	PAYMENT AND REIMBURSEMENT PANEL Reimbursement: The Best-Laid Plans? Any successful business needs a plan as to how it will secure payment for its products or services. Developing a sustainable reimbursement strategy requires more than just a great product, however. Particularly within personalized medicine, the best-laid plans for reimbursement must be developed very early on in the product lifecycle and carefully reflect – and anticipate – critical industry considerations. This panel will explore some of those considerations, including: What payers (and investors) expect from a product developer with respect to reimbursement strategy Demonstrating clinical utility and economic value for personalized medicine innovations within today's complex coding system, plus the possibility of reform Legislation, healthcare trends, payer approaches, enforcement actions, and other potential roadblocks to success Building on success and responding to additional challenges that develop along the way Anita J. Chawla, PhD, Managing Principal, Analysis Group Mark McCoy, MBA, Vice President, Reimbursement, Guardant Health Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates LLC MODERATOR \| Judith A. Waltz, Partner, Foley & Lardner LLP
4:35 PM - 5:25 PM	CLINICAL ADOPTION PANEL The Business of Integration: Exploring the Clinical Adoption Models of Three Distinct Institutions Patients can only benefit from personalized medicine when a clinical care institution treats patients according to its principles. Developing a business model that makes personalized care possible, however, is a challenge for most clinical institutions, many of which have historically optimized their procedures, processes, and practices for one-size-fits-all medicine. To help inform clinical integration efforts, this panel will explore how three distinct institutions – an integrated delivery network, a community care center, and an academic medical center – are pioneering unique business models to integrate personalized medicine at their respective institutions. The following panelists will discuss both current successes and chief obstacles. Thomas Brown, MD, MBA, Executive Director, Swedish Cancer Institute & Co-Chairman, Providence Health & Services Personalized Medicine Program James Ford, MD, Director, Clinical Cancer Genetics Program, Stanford Health Care & Associate Professor of Medicine and Genetics, Stanford University School of Medicine Lincoln Nadauld, MD, PhD, Executive Director, Precision Medicine and Precision Genomics, Intermountain Healthcare MODERATOR \| Edward Abrahams, PhD, President, Personalized Medicine Coalition
5:30 PM - 6:00 PM	CLOSING KEYNOTE Closing out this year's program is an influential leader with more than 20 years of experience in life sciences, healthcare, and health IT who has been a driving force behind major business transformations that accelerated growth, efficiency gains, cost reductions, and competitive advantage for market leaders as well as up-and-coming innovators with next-generation ideas. Drawing from his most recent book, Mr. Harry Glorikian will offer his insights and advice for thriving in the new data-driven market. PRESENTER \| Harry Glorikian, MBA, Senior Executive, Board Director, Consultant, Investor and Author of “MoneyBall Medicine”
6:00 PM - 7:00 PM	Closing Remarks and Reception