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2017 Fireside Chat Speakers:

Giovanni Caforio, MD, Chief Executive Officer, Bristol-Myers Squibb

Tuesday, February 14, 2017 
3:30 pm - 4:25 pm
Moderator: Stephen Sands,
 Vice Chairman Investment Banking and Chairman Global Healthcare Group, Lazard

Giovanni Caforio, MD, became CEO of Bristol-Myers Squibb on May 5, 2015. Prior to becoming CEO, Giovanni served as chief operating officer with responsibility for leading a fully integrated worldwide commercial organization and the companywide functions of Enterprise Services and Global Manufacturing & Supply. In June 2014, Giovanni was elected to the company’s Board of Directors. Prior to serving as chief operating officer, he served as the company’s chief commercial officer. Giovanni joined Bristol-Myers Squibb in 2000 as vice president and general manager, Italy, in the Worldwide Medicines Group. In 2001, he assumed added responsibility for Greece and Israel, and then all of South East Europete in 2003. In 2004, he was appointed senior vice president, European Marketing and Brand Commercialization. In 2007, he was named senior vice president, U.S. Oncology. In 2010, he was named senior vice president, Global Commercialization, Oncology and Immunology, before becoming president, U.S., in 2011. In 2013, he was named chief commercial officer. Prior to joining Bristol-Myers Squibb, Giovanni spent 12 years with Abbott Laboratories in a number of leadership positions. Born and educated in Italy, Giovanni received his MD from the University of Rome. In addition to Italian and English, he is fluent in Spanish, French, and Portuguese. He currently resides in New Jersey with his wife and two children.

Tony Coles, MD, Chairman and Chief Executive Officer, Yumanity Therapeutics

Tony Coles

Monday, February 13, 2017
2:30 pm - 3:25 pm
Moderator: Ian Woo
, Managing Director, Lazard

Dr. Coles is a founding investor and the chairman and chief executive officer of Yumanity Therapeutics, a Cambridge, MA-based biotechnology company focused on transforming drug discovery for neurodegenerative diseases caused by protein misfolding such as Alzheimer’s, Parkinson’s and amyotrophic lateral sclerosis (ALS).   Dr. Coles also serves as chairman and chief executive officer of TRATE Enterprises, LLC, a privately held company.
 
Previously, Dr. Coles was chairman and chief executive officer of Onyx Pharmaceuticals, Inc., which was acquired by Amgen in late 2013. Under his leadership, Onyx introduced two new innovative cancer medicines to patients and established the company's international presence outside of the U.S. Prior to joining Onyx in 2008, he was president, chief executive officer and a member of the board of directors of NPS Pharmaceuticals, Inc. Before joining NPS Pharmaceuticals in 2005, Dr. Coles was senior vice president of commercial operations at Vertex Pharmaceuticals Inc., and earlier, held a number of executive positions at Bristol-Myers Squibb Company. Additionally, from 1992 until 1996, Dr. Coles held a number of positions of increasing responsibility at Merck & Co., Inc.
 
Educated at Johns Hopkins University, he earned an M.D. from Duke University and a master’s degree in public health from Harvard University. He completed his cardiology and internal medicine training at Massachusetts General Hospital and was a research fellow at Harvard Medical School.
 
Dr. Coles currently serves as chairman of the board of CRISPR Therapeutics, a biopharmaceutical company focused on developing transformative gene-based medicines for patients with serious diseases. He also serves as a member of the board of directors of McKesson Corporation (NYSE: MCK), is vice chair of the board of trustees for Johns Hopkins University and is a member of the board of trustees for Johns Hopkins Medicine. In March 2015, Dr. Coles was named to the National Institutes of Health (NIH) working group tasked with charting the course for President Obama’s Precision Medicine Initiative, now part of the PMI Cohort Program Advisory Panel. Dr. Coles also serves as a member of the council for the Smithsonian’s National Museum of African American History and Culture in Washington, D.C.; a member of the board of trustees for The Metropolitan Museum of Art in New York City; and a member of the Council on Foreign Relations, an independent, nonpartisan membership organization, think tank and publisher.

J. Joseph Kim, PhD, President and Chief Executive Officer, Inovio Pharmaceuticals

Joseph Kim

Monday, February 13, 2017
10:00 am - 10:55 am
Moderator: Phyllis A. Arthur
, Managing Director, Infectious Diseases and Diagnostics Policy, Biotechnology Innovation Organization (BIO)

J. Joseph Kim, PhD, entrepreneur, immunologist, and health policy leader, is co-founder and chief executive officer of Inovio, a biotechnology company leading the world in developing novel immunotherapies—medicines that attack a broad array of cancers and challenging infectious diseases by training the body’s immune system to identify and fight disease. He previously developed vaccines for Merck & Co. An immunologist by training, Joseph holds an MIT undergraduate degree, a PhD in biochemical engineering from the University of Pennsylvania, and an MBA from The Wharton School. He has published more than 100 scientific papers, holds numerous patents, and sits on editorial boards and scientific review panels. In 2015, Dr. Kim was named Entrepreneur of the Year for Life Sciences by Ernst and Young in the Philadelphia region. He also serves on the board of the International Vaccine Institute and the Council of Korean Americans. The World Economic Forum selected Dr. Kim as a member of its Global Agenda Council and named him a Technology Pioneer as well as one of its Young Global Leaders. He is a frequent guest on CNBC’s Fast Money and other financial programs, where he comments on Inovio’s breakthroughs and the pharmaceutical landscape. MIT’s Technology Review magazine called him "one of the world’s top innovators." Joseph is a Fellow of the inaugural class of the Health Innovators Fellowship and a member of the Aspen Global Leadership Network where he is working with a team to develop a vision of tomorrow’s healthcare system.

Jeffrey D. Marrazzo, Co-Founder and Chief Executive Officer, Spark Therapeutics

Jeffrey Marrazzo

Tuesday, February 14, 2017
11:00 am - 11:55 am
Moderator: Erin McCallister,
Senior Editor, BioCentury Publications

Jeff Marrazzo has led the creation and growth of Spark Therapeutics from a research center within the Children’s Hospital of Philadelphia to a fully integrated gene therapy company that is challenging the inevitability of genetic disease by discovering, developing and delivering potential treatments in ways unimaginable – until now. He also serves on Spark’s board of directors. Under Jeff’s leadership, Spark has successfully completed the first randomized, controlled Phase 3 trial of an investigative gene therapy for a genetic disease and established human proof-of-concept of Spark’s gene therapy platform in both the retina and the liver. The company is currently preparing the first Biologics License Application submission for a gene therapy for a genetic disease in the U.S. In the three years since founding Spark, Jeff has raised more than $500 million in capital, established a global collaboration with Pfizer, and built an organization of nearly 200 colleagues. During a career that has spanned the public and private sectors, Jeff has consistently championed the potential benefits of precision medicine and healthcare reform for patients. Prior to Spark, he helped build and sell the first genetic testing benefit management and pharmacogenomics medicines company to CVS Caremark. Previously, Jeff served as an advisor to former Pennsylvania Governor Edward G. Rendell, where he led reforms in the financing and delivery of healthcare. Jeff received a B.A. in economics and B.S.E. in systems science and engineering from the University of Pennsylvania. He also holds a dual M.B.A. / M.P.A. from The Wharton School of the University of Pennsylvania and Harvard University, a program which he founded.

Lynn Seely, MD, Chief Executive Officer, Myovant Sciences

Lynn Seely

Monday, February 13, 2017
4:30-5:25 pm
Moderator: K.C. Stone
,
Managing Director, Head of Healthcare Investment Banking, BTIG

Dr. Seely is an endocrinologist with over 20 years of drug development experience and biopharmaceutical company leadership. At Medivation, she served as Chief Medical Officer from 2005-2015 and led the development of XTANDI® (enzalutamide) for the treatment of metastatic castration-resistant prostate cancer from IND-enabling studies through to NDA approval and post-approval clinical studies. Dr. Seely currently serves on the Board of Directors of Blueprint Medicines Corporation. She completed her residency in internal medicine at Yale-New Haven Hospital and a basic science and clinical fellowship in endocrinology and metabolism at the University of California, San Diego.


Schedule of Events

Monday, February 13, 2017

6:00 AM - 6:00 PM Registration Open 
6:30 PM - 8:00 AM Continental Breakfast 
6:30 AM – 6:00 PM BIO One-on-One Partnering™ Desk Open 
7:20 AM – 6:00 PM Satellite Partnering Desk Open
5:30 PM - 6:30 PM   One-on-One Hospitality Suite Open
  7:30 AM – 6:00 PM BIO One-on-One Partnering™ Meetings 
8:00 AM – 11:55 AM Company Presentations 
9:00 AM – 9:55 PM Therapeutic Session
Applying Microbiome Research to Therapeutics 
9:00 AM - 4:30 PM Buzz Center Open 
Hosted by Rob Wright, Chief Editor Life Science Leader
9:30 AM – 10:30 AM     Refreshments Available 
Coffee and tea service will be provided throughout the day
10:00 AM – 10:55 AM Fireside Chat: 
J. Joseph Kim, PhD, Co-Founder, President and Chief Executive Officer, Inovio Pharmaceuticals 
11:00 AM – 11:55 AM Therapeutic Session
CAR-T, TILs, and Bispecifics: Immuno-Oncology Challenges and Opportunities 
11:30 AM – 12:30 PM Boxed Lunches Available 
1:00 PM – 5:55 PM Company Presentations 
1:30 PM – 2:25 PM Therapeutic Session:
Next Generation Pain Control: Beyond Opioids 
2:00 PM – 3:00 PM     Refreshments Available 
Coffee and tea service will be provided throughout the day
2:30 PM – 3:25 PM Fireside Chat:
Tony Coles, MD, Chairman and Chief Executive Officer, Yumanity Therapeutics
3:30 PM – 4:25 PM Business Session:
IPOs and Beyond: Tapping into the Public Market’s Capital
4:30 PM – 5:25 PM Fireside Chat:
Lynn Seely, MD, President and Chief Executive Officer, Myovant Sciences 
6:00 PM – 7:00 PM BIO CEO & Investor Welcome Reception


Tuesday, February 14, 2017

6:30 AM - 4:00 PM Registration Open 
6:30 AM - 8:30 AM Continental Breakfast
6:30 AM - 5:30 PM BIO One-on-One Partnering™ Desk Open
6:50 AM – 6:00 PM Satellite Partnering Desk Open
7:00 AM – 5:00 PM One-on-One Hospitality Suite Open 
7:00 AM – 5:30 PM BIO One-on-One Partnering™ Meetings
8:00 AM – 11:55 AM Company Presentations 
9:00 AM – 9:55 AM Business Session: 
Living with Biosimilars: Strategy Formulation and Lessons from Other Markets 
9:00 AM – 3:00 PM Buzz Center Open 
Hosted by Rob Wright, Chief Editor Life Science Leader
9:30 AM - 10:30 AM     Refreshments Available 
Coffee and tea service will be provided throughout the day 
10:00 AM - 10:55 AM Business Session: 
Embedding Diversity into Board and Executive Team Recruitment
11:00 AM - 11:55 AM Fireside Chat:
Jeffrey D. Marrazzo, Co-Founder and Chief Executive Officer, Spark Therapeutics
11:30 AM - 12:30 PM Boxed Lunches Available
12:30 PM – 1:25 PM Therapeutic Session: 
Policy Outlook—ACA, CMS, PDUFA VI and the Trump Administration 
1:00 PM – 4:25 PM Company Presentations
1:30 PM – 2:25 PM Business Session: 
Crafting New Approaches to Value-Based Therapy Payment Models: Starting with Gene Therapies 
2:00 PM – 3:00 PM     Refreshments Available 
Coffee and tea service will be provided throughout the day
2:30 PM – 3:25 PM Therapeutic Session:
Designing Clinical Trials in a 21st Century Cures Paradigm 
3:30 PM – 4:25 PM Fireside Chat:
Giovanni Caforio, MD, Chief Executive Officer, Bristol-Myers Squibb 
4:30 PM – 5:25 PM Business Session:
Market Outlook—Post-Inauguration Scenarios for M&A 
5:30 PM – 6:30 PM BIO CEO & Investor Closing Reception

 


Therapeutic Topic Descriptions: 

Applying Microbiome Research to Therapeutics

New discoveries are finding links that extend significantly beyond the gut microbiome and intestinal disorders into a range of bodily systems including the immune and nervous systems.  Major biopharma companies have engaged in significant deals that envision treatments to commercialize from this research and leading companies are pushing forward on clinical trials.  This session will outline the microbiome influenced therapies most likely to create major effects for patients.

Moderator: C. Simone Fishburn, PhD, Editor, BioCentury Innovations

Speakers:

  • Pierre Belichard, PharmD, PhD, Chief Executive Officer, Enterome
  • Mark Bodmer, PhD, Chief Scientific Officer, Evelo Biosciences
  • Aoife M. Brennan, MD, Chief Medical Officer, Synlogic
  • Nick Conley, PhD, Board of Directors, Co-founder & Chief Executive Officer, EpiBiome
  • Jeffrey Riley, Chief Executive Officer, President and Director, Synthetic Biologics
  • Nikola Trbovic, PhD, Director R&D Technology Strategy, Genome Sciences & Technologies, Worldwide Research & Development, Pfizer Inc.

CAR-T, TILs, and Bispecifics: Immuno-Oncology Challenges and Opportunities

The maturation of new cancer treatment technologies has produced a mix of highly positive patient outcomes and some serious clinical holds, while investments for manufacturing and commercialization continue to accelerate.  This session will dive into the assumptions underlying the most aggressive approaches and the ways of reducing the risks of failure along the way to delivering immuno-oncology’s promise to patients broadly.

Moderator: Michael King, Managing Director and Senior Research Analyst, JMP Securities LLC

Speakers:

  • Joseph Pearlberg, MD, Vice President Clinical Development, Infinity Pharmaceuticals, Inc.
  • Anton Xavier, Senior Scientist, Pfizer Inc.
  • ​Jerome Zeldis, MD, PhD, Chief Medical Officer and President of Clinical Development, Sorrento Therapeutics
  • Jeffrey Wolf, Chief Executive Officer, Heat Biologics

Designing Clinical Trials in a 21st Century Cures Paradigm

The passage by Congress of the 21st Century Cures Act in late 2016 has opened up new opportunities and expectations for the design of clinical trials that the FDA will consider for regulatory review.  Real world evidence and the stronger inclusion of patient perspectives on endpoints are two examples of the shifts that will impact therapy development.  This session will explain the advantages and complications that drug developers and investors should be aware of as the Cures Act gets implemented.

Moderator: Wade Ackerman, Partner, Covington & Burling LLP

Speakers:

  • Jeff Allen, PhD, President & Chief Executive Officer, Friends of Cancer Research
  • Gregory W. Daniel, PhD, MPH, RPh, Deputy Director, Duke-Margolis Center for Health Policy
  • Steven Kaminsky, PhD, Chief Science Officer, Rettsyndrome.org
  • Christopher U. Missling, PhD, President and Chief Executive Officer, Anavex Life Sciences Corp.
  • Raghuram Selvaraju, PhD, Managing Director, Senior Healthcare Analyst, Rodman & Renshaw, a unit of H.C. Wainwright & Co., LLC

Next Generation Pain Control: Beyond Opioids

The scourge of rising addiction and heroin overdoses has been associated with the growth in usage of important, opioid-based, prescription pain treatments.  New approaches to pain control are looking at different biological mechanisms and methodologies for improving patients’ lives with lower risks of ill effects or addiction. This session will speak with experts developing therapeutic innovations that do not rely on opioid-based drugs and can provide doctors additional alternatives for helping patients.

Moderator: Corey Davis, PhD, Managing Director, Senior Healthcare Analyst, H.C. Wainwright & Co., LLC

Speakers:

  • Gail Cawkwell, MD, Chief Medical Officer, Purdue Pharma
  • Derek Chalmers, PhD, DSc, Chief Executive Officer, President, and Director, Cara Therapeutics
  • Russell Herndon, President and Chief Executive Officer, Hydra Biosciences
  • Jeffrey B. Kindler, Chief Executive Officer, Centrexion Therapeutics

Policy Outlook—ACA, CMS, PDUFA VI and the Trump Administration

From a healthcare policy point of view, 2017 has the potential of being the most dramatic since the initial introduction of the Affordable Care Act.  The new Trump Administration has suggested an interest in making wholesale changes in how medicines are regulated and paid for by the U.S. government.  PDUFA will expire later this year if its planned replacement is not passed in a timely fashion, greatly complicating companies’ drug development strategies and budgets.  This session will share the latest details on what policies the Trump Administration and Congress are pursuing that would support or upend the assumptions that biopharma executives and investors have built into their financial models. 

Moderator: Susan Peschin, MHS, President and Chief Executive Officer, Alliance for Aging Research

Speakers:

  • Alex M. Azar II, Chairman, Seraphim Strategies, LLC; former President, Lilly USA, LLC (2012-2017); former Deputy Secretary, U.S. Department of Health and Human Services (2005-2007)
  • Jeanne Haggerty, Senior Vice President, Federal Government Relations, Biotechnology Innovation Organization (BIO)
  • Jonathan Leff, Partner, Deerfield Management; Chairman, Deerfield Institute
  • Brian Rye, Senior Healthcare Policy Analyst, Bloomberg Intelligence

Business Topic Descriptions:

Crafting New Approaches to Value-Based Therapy Payment Models: Starting with Gene Therapies

Both innovator companies and payers of medicines have expressed a willingness to look beyond the “fee per pill” model to attributing value to the effects on patients’ health instead.  The challenge of reimbursing for curative therapies versus lifelong treatments of chronic conditions presents a special challenge, but one that may shine a light on value-based approaches generally.  This session will explore with the innovators making progress on gene therapies how they are envisioning the reimbursement model in ways that all stakeholders might appreciate, including doctors’, patients’, and payers’ perspectives.

Moderator: Ted Haack, Owner, Managing Partner, Haack & Associates

Speaker:

  • John Glasspool, (formerly Executive Vice President, Head of Corporate Strategy and Customer Operations at Baxalta US, Shire)
  • Roger Longman, Chief Executive Officer, Real Endpoints
  • Sandy Macrae, MB, ChB, PhD, President and Chief Executive Officer, Sangamo Biosciences, Inc.

Embedding Diversity into Board and Executive Team Recruitment

The biopharma industry has seen enormous growth in recent years of the number of start-ups and IPOs, with hundreds of new executive team and board member positions being filled.  However, the inclusion of underrepresented groups in these influential positions has failed to keep pace with the growth of biopharma companies and too often the decision-makers fail to reflect the employee bases they lead or patient populations they serve.  This session will focus on practical approaches and successful examples to improve the diversity of leadership recruitment efforts and better align organizations with the full measure of talented people available.

Moderator: Julie L. Gerberding, MD, MPH, Executive Vice President & Chief Patient Officer, Strategic Communications, Global Public Policy and Population Health, Merck

Speakers:

  • Faith L. Charles, Partner, Chair, Life Sciences, Thompson Hine LLP/ Chair, Women in Bio—Metro New York
  • Colleen Cuffaro, PhD, Principal, Canaan Partners
  • Linda S. Grais, MD, President and Chief Executive Officer, Ocera Therapeutics, Inc.
  • Paul J. Hastings, Chairman and Chief Executive Officer, OncoMed Pharmaceuticals 
  • Stephen M. Ritoch, Chairman of the Board and Chief Executive Officer, Blaise Group

IPOs and Beyond: Tapping into the Public Market’s Capital

As biotech IPO activity has cooled from its 2015 peak, companies are more deliberately weighing reverse mergers and other alternatives to benefiting from the capital in public markets. With post-election market uncertainty, does the IPO market for 2017 seek to rise, fall, or stay level?  What markers should CEOs watch for to gauge their timing and choices?  This session will feature experienced voices for explaining the practical techniques for getting into public markets and what investors are expecting to see in order to win their support.

Moderator: Stephen B. Thau, Partner, Morrison & Foerster LLP

Speakers:

  • James Cappuccio, Managing Director, Investment Banking, H.C. Wainwright & Co., LLC
  • Brian Hagerty, Senior Director, Head of Healthcare Capital Markets, New York Stock Exchange
  • Douglas E. Onsi, Chief Financial Officer, Leap Therapeutics, Inc.
  • Sapna Srivastava, PhD, former Chief Financial Officer and Chief Strategy Officer, Intellia Therapeutics
  • Nassim Usman, PhD, President and Chief Executive Officer, Catalyst Biosciences

Living with Biosimilars: Strategy Formulation and Lessons from Other Markets

As biosimilar medicine options begin to roll-out in the United States, the regulatory and legal uncertainties are also starting to shrink below the market adoption uncertainties.  As some innovator companies also pursue biosimilar development, and others seek to compete, there are opportunities to learn from jurisdictions that have allowed biosimilar medicines for longer periods, such as Japan and Europe regarding the reactions of doctors and payers.  This session will feature executives from innovator companies explaining how they evaluate biosimilars within their pipelines, plus those with expertise on understanding the economic effects seen when biosimilars launch within a market.

Moderator: Elizabeth Krutoholow, Senior Analyst, Bloomberg Intelligence

Speaker:

  • Jennifer Alltoft, Head of Global Biosimilars, Pfizer
  • Patrick K. Lucy, Interim Chief Executive Officer, Pfenex

Market Outlook—Post-Inauguration Scenarios for M&A

While the past year has seen a fading in the IPO market, the volume of deal flow and valuations for M&A remain high.  Many of the largest industry members have strong cash positions, and most analysts continue to expect pipeline enhancement via acquisition.  As political forecasts suggest high potential for tax reform and other changes in how international deals might be reviewed, there are multiple ways 2017 could be a great year or a terrible year for biopharma M&A.  This session will talk through the likely and extreme scenarios, as well as provide insight on what signs to watch for from Washington and Wall St. along the way.

Moderator: Asthika Goonewardene, Senior Biotech Analyst, Bloomberg Intelligence

Speakers:

  • Adam H. Golden, Partner, Head of Corporate Practice Group—New York, Hogan Lovells 
  • Ellen Lubman, Vice President, External Science & Innovation, Allergan PLC 
  • Michael A. Margolis, RPh, Head of Healthcare Investment Banking, ROTH Capital Partners
  • Dennis J. Purcell, Founder and Senior Advisor, Aisling Capital
  • Matthew Roden, PhD, Vice President and Head of Strategic Corporate Development, Bristol-Myers Squibb