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2019 Program

Reshaping Tumor Microenvironments via Immunotherapies
Monday, February 11, 9:00-9:55 am

Current CAR-T therapies have shown significant benefits attacking hematological malignancies, and currently approved checkpoint inhibitors are highly but selectively effective in their impact on solid tumors.  This session will examine the next wave of innovation in immunotherapies for leveraging knowledge of how tumor microenvironments develop to create treatments able to demonstrate more durable effects on shrinking tumors across wider ranges of patients.

Advances in Neuromuscular Disease Treatments
Monday, February 11, 11:00-11:55 am

After a long era without progress, recent years have seen regulatory approvals of treatments for Duchenne muscular dystrophy (DMD) and spinal muscular atrophy (SMA), among other neuromuscular disorders.  In particular, SMA is the most common genetic disorder leading to infant death in the world, and now has a first therapy that can slow disease progression, giving patients and families more time together. This session will examine the exciting pipeline of additional neuromuscular disease therapies, and what the underlying science is teaching across disease indications, amid a complicated reimbursement context where the shortage of effective treatments bears significant healthcare costs over time.

Navigating Payers’ Expectations for Value-Based Agreements
Monday, February 11, 1:30-2:25 pm

As biomedical innovation has developed advanced therapeutic modalities and prospective cures for ailments that previously had no comparable courses of treatment, the challenge of crafting sustainable reimbursement models has inspired a variety of value-based agreements.  Departure from traditional dosage-based models makes it difficult for therapy developers, payers, patients, and investors to plan for a new therapy’s rollout and breadth of patient access.  This session will explore the early lessons from current value-based agreements to explain the payers’ expectations for future models of reimbursing treatments based on outcomes versus delivery.

Attacking Biological Mechanisms of Aging to Extend Healthspan
Monday, February 11, 3:30-4:25 pm

A growing number of biopharma companies have responded to the emerging medical consensus that many of the individual ailments experienced by older people have underlying, connective biological causes.  These companies are developing drugs in areas such as neurodegeneration, macular degeneration, arthritis, and similar highly prevalent diseases by pursuing novel mechanisms versus existing treatments.  This session will discuss the frontier of science in extending the years of healthy aging and in which indications patients might first see progressive new therapies in clinical trials.

Are Record Levels of IPOs Disrupting M&A Deals?
Monday, February 11, 4:30-5:45 pm

In 2018, biotechs are on track for the second-best year for public issuances ever. The attractive IPO market has however resulted in fewer M&A deals than prior years, with high pre-money IPO valuations for later-stage companies making it less enticing for them to accept early-exit offers. This has led to an M&A shift to focus on early-stage companies. The session will examine the current deals and market trends while highlighting the path forward amid a market with greatly increased volatility and reimbursement policy uncertainty.   

New Treatments for Diabetes and Obesity: Innovations for Chronic Diseases
Tuesday, February 12, 9:00-9:55 am

BIO research on venture funding trends shows a long-term slowdown in overall investment in chronic diseases, despite their large patient populations, but with recent signs of hope in investor support for new treatments for diabetes and obesity.  This session will detail those drug pipelines, which research approaches are convincing skeptical investors, as well as the sources of investor resistance, plus opportunities for streamlining high-cost clinical trials in these disease areas through application of digital technologies.

Policy Outlook—How Could the Trump Administration’s Drug Reimbursement Proposals Affect Medical Innovation?
Tuesday, February 12, 11:00-11:55 am

The U.S. Department of Health and Human Services has proposed piloting an “International Pricing Index” (IPI) payment model to reduce reimbursement levels for the Centers for Medicare & Medicaid Services (CMS), as well as proposing other reforms to long-standing policies regarding commercialized medicines.  In a year with a record number of new medicines being approved to reach patients in the United States, such reforms introduce significant uncertainty for many investors’ valuation models.  This session will feature drug developers, investors, and policy experts to explain the resource allocation implications if these reforms proceed and risks of shrinking the pipelines of new medicines for years to come unless alternative approaches can be introduced.

Regulatory Changes to Cross-Border Investments: CFIUS and Biotech Deals
Tuesday, February 12, 1:00-1:55 pm

New national security regulations under the Foreign Investment Risk Review Modernization Act (FIRRMA) are changing the landscape for cross-border investments in biotechnology.  In November 2018, new rules for a “pilot program” apply to foreign investors into U.S. companies who now need to file with the Committee on Foreign Investment in the United States (CFIUS) to approve covered transactions before entering licensing deals or other equity investments. This session will update market participants on the evolving national security review process and its impact on the biotechnology industry, as well as consider how additional rules may impact future business development and investment opportunities.

Removing Commercialization Barriers for New Antimicrobial Drugs
Tuesday, February 12, 2:00-2:55 pm

After years of sparse development of new antimicrobials, R&D incentive initiatives such as CARB-X have helped grow late-stage pipelines and new approvals.  Unfortunately, difficult commercialization experiences of leaders in this space threaten to derail the momentum of the sector.  In response, the FDA has proposed the health care system consider a subscription model for the purchase of antibiotics by hospitals in an effort to increase the reliability of a return on investment in new antibiotics and avoid high-volume prescribing practices that would accelerate antimicrobial resistance. This session will include policy, antimicrobial developer, and payer perspectives on this issue to discuss the opportunities and challenges of business model changes and what it will take to avoid a crisis described by the World Health Organization as a “post-antibiotic era where common infections and minor injuries can once again kill.”

Market Outlook—Distinguishing a Correction from a Downturn
Tuesday, February 12, 4:00-4:55 pm

After a multi-year expansion of company formation and in biopharma valuations, 2018 is seeing extreme swings in market volatility.  Investors’ eagerness to support new modalities are enabling faster progression to IPO, but with much less mature clinical development progress than traditionally demonstrated. However, this trend of funding ambitious research without proven results has not gone unnoticed by industry observers who point out that these newly public companies with no approved drugs or near-term forecasts for revenue are trading well below their IPO prices.  As interest rate worries, international trade disputes, and regulatory reimbursement uncertainty have increased, biopharma stock indexes have seen significant corrections.  This session will assemble market experts to diagnose what separates a temporary correction from a long-term downturn and what forces continue to energize the sector as a wave of innovative therapies start reaching patients.


2018 Program

Did you miss the 2018 event? Gain access to recorded video of 16 educational sessions, including panel discussions and fireside chats by clicking here.

2018 Fireside Chats

Deborah Dunsire, MD, President and Chief Executive Officer, XTuit Pharmaceuticals

Deborah Dunsire

Tuesday, February 13, 10:00-10:55 am

Deborah brings over 25 years of experience in developing and commercializing novel therapeutics across three continents. She is the former President and CEO at FORUM Pharmaceuticals, which focused on therapies for Alzheimer’s disease, other dementias and schizophrenia. She served as CEO and President of Millennium Pharmaceuticals from 2005 to 2013, bringing novel therapies through development and commercialization in the areas of cancer and inflammatory disorders. Under her leadership at Millennium, Velcade® for multiple myeloma transformed outcomes for patients and became a multi-billion dollar product, with Johnson & Johnson as the commercial partner outside of the US. In 2008, Takeda Pharmaceuticals of Japan acquired Millennium for $8.8 billion and. following the acquisition, Deborah became the first woman to be appointed to the board of Takeda Pharmaceuticals in the company’s 236-year history. Prior to Millennium, Deborah spent 17 years at Novartis in South Africa, Switzerland and the US. For 11 years, she led the Novartis Oncology business in North America, developing and launching a number of transformational cancer therapies notably Gleevec®, the first targeted cancer therapy, as well as Femara®, Zometa®, Sandostatin® and Exjade®. During her tenure at Novartis, the North American oncology business grew from $50 million to more than $2.2 billion.

Deborah is a member of the board of trustees for the Massachusetts General Physicians Organization, Northeastern University, and Boston’s Museum of Science. She serves on the Department of Chemistry Visiting Committee at MIT and on the MGH Research Advisory Council. She has served for many years as a board member of the Biotechnology Innovation Organization.

Deborah was born in Zimbabwe and completed her medical training at the University of the Witwatersrand in Johannesburg, South Africa.

Moderator: Yasmeen Rahimi, PhD, Director, Research Analyst, ROTH Capital Partners

Yasmeen Rahimi, Ph.D. is a Director, Research Analyst focused on biotechnology with particular interest in therapeutic areas encompassing nonalcoholic fatty liver disease (NASH), metabolic and rare diseases. Dr. Rahimi joined ROTH Capital directly from H.C. Wainwright & Co., where she worked as an equity research associate and before that, she was a research associate at Guggenheim Securities. Dr. Rahimi also worked as a research scientist at Shire Pharmaceuticals where she developed biomarker strategies for a number of clinical programs.

Dr. Rahimi has extensive expertise in NASH and liver metabolism with 16 publications in highly prestigious journals. She trained at Yale University in the laboratory of Dr. Gerald Shulman, a world-renowned endocrinologist who pioneered the understanding of lipid-induced insulin resistance contributing to the pathogenesis of NASH. In addition, she completed her Ph.D. training in the laboratory of Dr. Robert A. Harris, a distinguished biochemist at Indiana University and a former trainee of Sir Hans Krebs, the “father of biochemistry”.  Over the last several years, she utilized her understanding in NASH and metabolic diseases with bridging it to equity research through publications of in-depth industry notes, expert discussion series, and an investor conference.

Dr. Rahimi earned her Ph.D. in Biochemistry with highest distinction from Indiana University School of Medicine. In addition, she has M.S. in Bioanalytical Chemistry from Purdue University, and a joint B.A. in German and Chemistry from Butler University.

Lan Huang, PhD, Co-Founder, Chairman and Chief Executive Officer, BeyondSpring Pharmaceuticals

Lan Huang

Monday, February 12, 2:00-2:55 pm

Dr. Lan Huang is Co-founder, Chairman and CEO of BeyondSpring. Dr. Huang has more than a decade of entrepreneurial experience in the Chinese and U.S. biotechnology industry and invented and holds patents for a number of biotech products for oncology and dermatology indications. In 2009, she was the recipient of China’s “Thousand Talent Innovator Award.”

Prior to founding BeyondSpring, Dr. Huang co-founded Wuxi MTLH Biotechnology Co. Ltd., whose self-designed cancer peptide drug’s China rights were acquired in 2010 by Shanghai Pharmaceutical Group, one of the top three pharmaceutical companies in China. She also co-founded Paramax International, a clinical CRO company in China, which was sold to RPS (a global CRO), then to Warburg Pincus in 2011. In addition, Dr. Huang worked with Forward Ventures, where she led partnering initiatives between Forward’s portfolio companies and Chinese pharmaceutical companies.

Dr. Huang was trained at Memorial Sloan Kettering Cancer Center, where her breakthrough research in solving the first E2-E3 ubiquitin ligase structure involving P53 degradation was published in Science. The immense importance of this field is illustrated by the 2004 award of the Nobel Prize in chemistry to the founders of ubiquitin-mediated protein degradation. She received her Ph.D. in chemistry in four-and-a-half years from the University of California at Berkeley, where she won the graduating Ph.D. woman award from Soroptimist International. Her translational research in cancer signaling pathways involving Ras was published in two Nature papers.

Moderator: Joseph Pantginis, PhD, Managing Director, Senior Healthcare Analyst, H. C. Wainwright and Co.

Joseph PantginisDr. Joseph Pantginis, Ph.D., is a Managing Director at H.C. Wainwright, focused on healthcare research.  Dr. Pantginis has over 16 years of experience in healthcare equity research. Prior to joining HCW, Dr. Pantginis was most recently Senior Research Analyst and Head of Biotechnology Research at ROTH Capital Partners. Prior positions included senior positions at Merriman, Canaccord Adams, Commerce Capital Markets, JBHanauer and Ladenburg. Prior to his equity research career, Dr. Pantginis worked at Regeneron Pharmaceuticals, where he founded the Retroviral Core Facility. Dr. Pantginis earned a Ph.D. and M.S. in molecular genetics from the Albert Einstein College of Medicine as well as an M.B.A. from Pace University.

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

Jeffrey D. Marrazzo

Monday, February 12, 10:30-11:25 am

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.

Erin McCallisterModerator: Erin McCallister, Senior Editor, BioCentury

Erin McCallister serves as senior editor for BioCentury where she is responsible for covering emerging issues in market access and reimbursement as well as innovative product development strategies, including novel clinical trial designs, patient-centered drug development and new methods for making R&D more efficient. Prior to joining BioCentury in 2008, Erin served as a program officer for the Great Lakes Protection Fund and a biologist at Dow AgroSciences. She holds an M. Sc. in environmental science and policy from the University of Chicago and a B.S. in biology from Purdue University.

Vivek Ramaswamy, Founder and Chief Executive Officer, Roivant Sciences

Vivek Ramaswamy

Tuesday, February 13, 2:00-2:55 pm

Vivek Ramaswamy is founder and Chief Executive Officer of Roivant Sciences. The Roivant family of companies includes multiple wholly-owned or majority-owned biopharmaceutical subsidiaries, each focused on a different disease area. Roivant has 16 drugs in its collective pipeline and has raised over $2.5 billion in capital to date to fund clinical programs and pursue adjacent business opportunities in healthcare.

Prior to founding Roivant, Mr. Ramaswamy was an investor in the biotechnology sector. He currently serves as Chairman of the Board of Directors of Arbutus Biopharma Corporation and he is a member of the Board of Directors of Axovant Sciences, Myovant Sciences, and Roivant Sciences. He received an A.B. summa cum laude in biology from Harvard College and a J.D. from Yale Law School.

Moderator: Robyn Karnauskas, Analyst, Citi

robyn-karnauskasRobyn Karnauskas joined Citi in October 2015 as a Director and Senior Analyst covering the Large Cap Biotechnology sector. Prior to joining Citi, Robyn covered the same sector at Deutsche Bank and has worked on the sell-side in the Biotechnology Sector since 2004. Robyn was ranked runner up in the Large and Smid-cap Biotechnology categories in the 2015 Institutional Investor Survey. Prior to Deutsche Bank, Robyn worked for Morgan Stanley and Bear Stearns. She holds a Ph.D.in Cancer Biology from the University of Chicago and is a graduate of Massachusetts Institute of Technology.

Vicki Sato, PhD, Chairman, Denali Therapeutics; Chairman, Vir Biotechnology

Vicki Sato

Tuesday, February 13, 4:00-4:55 pm

Vicki L. Sato, Ph.D., serves as chairman of the board of directors at Vir.   Dr. Sato retired recently as Professor of Management Practice at Harvard Business School, where she taught from 2006-2017. During this time she also had an appointment as Professor of the Practice in the Department of Molecular and Cell Biology, Harvard University.  In addition to her academic work, she is a business advisor to enterprises in the biotechnology and pharmaceutical industries.

Dr. Sato retired in 2005 from Vertex Pharmaceuticals, where she served as president since 2000, with responsibility for research and development, business and corporate development, commercial operations, legal, and finance. Prior to becoming president, she was chief scientific officer, senior vice president of research and development, and chair of the Scientific Advisory Board. Under her leadership, Vertex created a diversified pipeline of drugs. Before joining Vertex, Dr. Sato was vice president of research at Biogen, Inc., where she led research programs in the areas of inflammation, thrombosis, and HIV disease, and she participated in the executive management of the company. Several molecules from those programs have now reached the marketplace. She also served as a member of the Biogen Scientific Board.

Currently, Dr. Sato is a member of the board of directors of publicly held companies Bristol Myers Squibb Company, Borg Warner Corporation, and Syros Pharmaceuticals. She also serves as chair of the board of directors for Denali. Previously, Dr. Sato has served as an overseer of the Isabella Stewart Gardner Museum. She received her A.B. from Radcliffe College, and her A.M. and Ph.D. degrees from Harvard University. Following postdoctoral work at both the University of California Berkeley and Stanford Medical Center, Dr. Sato was appointed to the faculty of Harvard University, where she was an assistant and associate professor of biology.

Moderator: Kate Merton, PhD, Head of JLABS @ NYC, Johnson & Johnson Innovation

Kate Merton is Head of Johnson & Johnson Innovation, JLABS @ NYC. Kate has over 15 years of experience working across the Healthcare industry starting in R&D before moving onto roles in in Marketing, Business Development, External Alliances, Medical Affairs, Health Outcomes and most recently Disruptive Innovation. During her career Kate has been part of teams that have discovered new drugs, worked to develop and gain approval for blockbuster diabetes products and is passionate about being part of the future of healthcare where science intersects with the rapid advancements in health care technology. Kate received her undergraduate degree in Pharmacology & Toxicology from King’s College London, holds a PhD in Pharmacology & Toxicology from University of California, Irvine Medical School and received her MBA from the Fuqua School of Business at Duke University.

Rachel Sherman, MD, MPH, Principal Deputy Commissioner, U.S. Food and Drug Administration (FDA)

Rachel Sherman

Tuesday, February 13, 12:00-12:55 pm

Dr. Rachel Sherman is Principal Deputy Commissioner of the U.S. Food and Drug Administration (FDA). She oversees all FDA medical programs and initiatives that are agency cross cutting and clinical, scientific, regulatory, or operational. She also provides advice and counsel to the FDA Commissioner on medical product regulation and oversees on his behalf other high-priority agency initiatives and programs. Key focus areas include modernization of combination product review, orphan product development, the Oncology Center of Excellence, promoting the use of innovative trial designs, and standards for evidence development.

Dr. Sherman has served FDA since 1989 in a variety of capacities, beginning as a primary reviewer in FDA's Center for Drug Evaluation and Research (CDER) during the height of the AIDS crisis. In 2005, Dr. Sherman moved to FDA's Office of the Commissioner, where she served until 2009 as Associate Commissioner for Clinical Programs and directed the agency's Critical Path Initiative.

From 2009 to 2014, as CDER's Associate Center Director for Medical Policy and Director of CDER's Office of Medical Policy, Dr. Sherman led a large, multidisciplinary staff charged with developing and implementing high-priority policies and programs, including the Sentinel Initiative, FDA's program for regulating biosimilars, and the agency's expedited drug development and breakthrough therapy designation programs. She organized multi-stakeholder public private partnerships, oversaw development of regulations and guidance for industry, and played a key role in enhancing clinical trial quality and good clinical practice. Her achievements contributed directly to more effective prescription drug promotion and to the modernization of professional drug labeling, generic drug labeling, and medication information for patients.

In 2014, after 25 years of dedicated service to FDA and public health, Dr. Sherman retired. In 2015, she was asked to return to lead the Office of Medical Products and Tobacco, focusing on cross-center initiatives that foster efficient medical product development and facilitate patient access to new therapeutic products, work she will continue in her role as FDA Principal Deputy Commissioner.

Dr. Sherman is an internist with a subspecialty in infectious diseases. She received her MPH from Johns Hopkins University, her MD from Mount Sinai School of Medicine, and her BA in mathematics from Washington University in St. Louis. She has served over the years as attending physician, Division of Infectious Diseases, at the Veterans Affairs Medical Center; clinical assistant professor of medicine (infectious diseases) at Georgetown University; and volunteer physician with Montgomery Mobile Health. Currently, Dr. Sherman is an adjunct assistant professor in the Division of Clinical Pharmacology in the Department of Medicine at Duke University.

Moderator: James C. Greenwood, President and Chief Executive Officer, Biotechnology Innovation Organization (BIO)

James C. Greenwood is President and CEO of the Biotechnology Innovation Organization (BIO) in Washington, D.C. BIO represents 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 countries worldwide. BIO members are involved in the research and development of innovative healthcare, agricultural, and industrial & environmental biotechnology products.

2018 Schedule of Events

Monday, February 12

9:00am - 4:15pm 

Company Presentations

9:00am - 10:15am

Therapeutic Panel
Immuno-Oncology Milestones to Come: Pipelines Beyond CAR-T 1.0

10:30am - 11:25am

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

12:00pm - 12:55pm

Business Session
The Art of the Exit: Planning for Your Company’s Acquisition

1:00pm - 1:55pm

Business Session
Updating Your China Growth Strategy: Opportunities in Investor and Regulatory Dynamism

2:00pm - 2:55pm

Fireside Chat
Lan Huang, PhD, Co-Founder, Chairman and Chief Executive Officer, BeyondSpring Pharmaceuticals

3:00pm - 3:55pm

Business Session
Funding Cures: Prioritizing Policy Barriers to Amortization of Therapeutic Spending

4:00pm - 4:55pm

Therapeutic Panel 
Advances in Dermatology: Recent Approvals and Later-Stage Trials 

5:00pm - 5:55pm

Business Session
Market Outlook—How Durable is the IPO Resurgence and M&A Slowdown?

6:00pm - 7:00pm

Welcome Reception

7:00pm - 9:00pm 

Scientific American Custom Media Cocktail Salon

Registration Required

 

Tuesday, February 13

9:00am - 3:45pm

Company Presentations

9:00am - 9:55am

Therapeutic Panel
Neuroscience of Addiction: Levers to Attack the Opioid Abuse Crisis

10:00am - 10:55am

Fireside Chat
Deborah Dunsire, MD, President and Chief Executive Officer, XTuit Pharmaceuticals

11:00am - 11:55am

Business Session
Policy Outlook—Implications of the Tax Code Changes of the Trump Administration

12:00pm - 12:55pm

Fireside Chat
Rachel Sherman, MD, MPH, Principal Deputy Commissioner, U.S. Food and Drug Administration (FDA)

1:00pm - 1:55pm

Business Session
Instilling Innovation Ambitions in your Leadership Culture

2:00pm - 2:55pm

Fireside Chat
Vivek Ramaswamy, Founder and Chief Executive Officer, Roivant Sciences

3:00pm - 3:55pm

Therapeutic Panel
Chronic Disease Innovation: PCSK9 Treatments’ Early Lessons for Other Therapies

4:00pm - 4:55pm

Fireside Chat
Vicki Sato, PhD, Chairman, Denali Therapeutics; Chairman, Vir Biotechnology

5:00pm - 6:00pm

Closing Reception

2018 Panel Session Topics

Immuno-Oncology Milestones to Come: Pipelines Beyond CAR-T 1.0
Monday, February 12, 9:00-10:15 am

As the recently approved, initial CAR-T therapies have shown they can produce dramatic improvements for some closely defined patient populations, the next phase of attention shifts to stretching those immuno-oncology (I-O) findings into additional targets, platforms, and indications. These new approaches include allogenic CAR-T products, T-cell regulators, oncolytic viruses, natural killer (NK) cells, and other I-O technologies. This session will discuss the dynamic opportunities in this space to fight cancer even more effectively.

Moderator: Asthika Goonewardene, Senior Biotechnology Analyst, Bloomberg Intelligence

Panelists:

  • Samuele Butera, Global Cell & Gene Therapies Business Leader, Novartis Oncology
  • Sadik Kassim, PhD, Vice President, Head of Process and Analytical Development, Mustang Bio
  • Didier Landais, Global Head of Licensing, Servier
  • Charles Link, Jr., MD, Co-Founder, Chairman, CEO, Chief Scientific Officer, NewLink Genetics
  • Adelene Q. Perkins, Chair and Chief Executive Officer, Infinity Pharmaceuticals, Inc.
  • Tito A. Serafini, PhD, President, Chief Executive Officer, and Co-Founder, Atreca, Inc.

The Art of the Exit: Planning for Your Company’s Acquisition
Monday, February 12, 12:00-12:55 pm

There are times when a company for reasons such as clinical trial expense, achieving scale in a global sales force, or needing manufacturing capacity, recognizes that shareholder returns are best served by being acquired by a strategic buyer. Leadership teams that manage their process well can maximize the eventual benefits for their shareholders, employees, and patients of this transformation through careful partner identification, negotiations management, and integration planning. This session will feature experienced perspectives on the do’s and don’ts for CEOs considering options for proactive selling of their companies, rather than just reacting to external purchase offers.

Moderator: Kimberly C. Petillo-Décossard, Partner, Cahill Gordon & Reindel LLP

Panelists: 

  • Janelle Anderson, PhD, Entrepreneur-in-Residence, Versant Ventures
  • Peter J. Collum, Partner, MTS Health Partners
  • Derek Hicks, Senior Director, Worldwide Business Development, Pfizer Inc.
  • Neil Warma, Director, Orpheris; former President & Chief Executive Officer, Opexa Therapeutics, Inc. 

Updating Your China Growth Strategy: Opportunities in Investor and Regulatory Dynamism
Monday, February 12, 1:00-1:55 pm

The policy shifts announced by the CFDA and Chinese investment authorities within the past two years have unlocked significant new opportunities for biopharma companies to access the patient population in China and obtain capital from new sources. Already the world’s second largest market for biopharmaceuticals, the increasing pace of drug reviews and harmonization of clinical trials expectations means companies should revisit their market launch prioritizations. This session will share advice from successful leaders in this market for partnering with Chinese biopharmas and investors.

Moderator: Joseph Damond, Executive Vice President, International Affairs, Biotechnology Innovation Organization (BIO)

Panelists:
  • Alex Jung, Managing Director, Parthenon-EY, Ernst & Young LLP
  • Michael Keyoung, MD, PhD, Managing Director and Head of North America, C-Bridge Capital 
  • Yuwen Liu, Founding Partner, BOHE Angel Fund; former Chairwoman & CEO, Suzhou Industrial Park Biotech Development Co. Ltd. (BioBAY)
  • Hummer Mars, Executive Director, China Group, Global Investment Banking Division, NYIC
  • Kimberly Nearing, Managing Director, Head of Life Sciences, Cedrus Group
  • Dan Zhang, MD, Chairman, Fountain Medical Development

Funding Cures: Prioritizing Policy Barriers to Amortization of Therapeutic Spending
Monday, February 12, 3:00-3:55 pm

The tradition of health systems paying for biopharma treatments by the dose gets strained when confronted by the latest therapeutic technologies that may offer multi-year benefits or lifetime relief from disease per a single administration of a highly customized therapy.  Finding analogous methods of matching payment schedules to long-duration benefits, while covering up-front costs, shows how unprepared organizations are for the era of delivering access to gene therapies and other potential cures. This session will consider market-based options and identify relevant policy barriers to experimenting with amortization models and other techniques for funding non-traditional treatments that could greatly improve or extend patients’ lives.

Moderator: Brady Huggett, Business Editor, Nature Biotechnology

Panelists: 

  • Ted Haack, Vice President, LatticePoint Consulting
  • Dennis J. Purcell, Founder and Senior Advisor, Aisling Capital
  • Michael B. Weiss, Partner, Cahill Gordon & Reindel LLP
  • Michael J. Werner, Partner, Holland & Knight LLP, Co-Founder & Senior Policy Counsel, Alliance for Regenerative Medicine

Advances in Dermatology: Recent Approvals and Later-Stage Trials
Monday, February 12, 4:00-4:55 pm

2017 produced seven FDA approvals for new dermatology medicines, the most since 2014.  Additionally, several treatments in late-stage clinical development suggest opportunities for new help for patients suffering from some chronic and acute skin ailments.  This session will examine some of the exciting clinical results illuminating biological understanding of dermatological diseases and the emerging opportunities for investors in this space.

Moderator: Umer Raffat, Senior Managing Director, Evercore ISI

Panelists:

  • Michael Derby, Founder and Chief Executive Officer, Castle Creek Pharmaceuticals, LLC
  • Luis Peña, Founder & Chief Development Officer, Dermira, Inc. 
  • Michael Sierra, PhD, Vice President, LEO Science & Tech Hub

Market Outlook—How Durable is the IPO Resurgence and M&A Slowdown?
Monday, February 12, 5:00-5:55 pm

With more than 30 biotech IPOs in 2017 but M&A deal activity running at lower than average levels, the tension for CEOs is delivering a confident story of how to achieve profitable growth for investors while drug launches receive more scrutiny than ever.  As large biopharmas prune their portfolios and consider their repatriation options, the expectations run high for an uptick in M&A in 2018.  This session will include experienced deal makers and investors sharing their perspectives on where they see the promise of intensifying activity within the industry this year.

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

Panelists:

  • James Cappuccio, Managing Director, H.C. Wainwright and Co., LLC
  • Chris Garabedian, Chairman and CEO, Xontogeny
  • Stefan D. Loren, PhD, Managing Director, Healthcare Investment Banking, Oppenheimer & Co.
  • Michael Meyers, Head of Investment Banking, T. R. Winston & Company; Interim Chief Executive Officer, Tivorsan Pharmaceuticals, Inc.
  • Matthew Roden, PhD, Head of Strategic Corporate Development and Global BD Assessment, Bristol-Myers Squibb
  • Sapna Srivastava, PhD, Chief Financial Officer and Chief Strategy Officer, Abide Therapeutics 

Neuroscience of Addiction: Levers to Attack the Opioid Abuse Crisis
Tuesday, February 13, 9:00-9:55 am

With official recognition of the magnitude of the opioid abuse crisis, government institutions and investors are showing increased willingness to support novel approaches to attacking this health challenge.  This session will explore the most promising avenues in the neuroscience of addiction and alternatives to opioid-based pain management, as well as identify the most pressing bottlenecks in our understanding of the brain’s addiction to painkillers.

Moderator: Michael Detke, MD, PhD, Chief Medical Officer, Embera NeuroTherapeutics, Inc.

Panelists:

  • Roger Crystal, MD, Chief Executive Officer, Opiant
  • Brandon Folkes, Director, Specialty Pharmaceuticals Analyst, Cantor Fitzgerald
  • Lucy Lu, MD, President and CEO, Avenue Therapeutics
  • Corey McCann, MD, PhD, Founder and Chief Executive Officer, Pear Therapeutics
  • Robert Radie, President and Chief Executive Officer, Egalet Corporation
  • Peter Strumph, President and Chief Executive Officer, Amygdala Neurosciences Inc.

Policy Outlook—Implications of the Tax Code Changes of the Trump Administration
Tuesday, February 13, 11:00-11:55 am

As the U.S. tax code experiences its greatest changes in decades, the financial assumptions underlying investors’ valuations will shift significantly, creating some new advantages and disadvantages within the biopharma community.  This session will explain in depth the implications for pre-market and for commercial biopharma companies of changes to R&D credits, orphan drug credits, repatriation conditions, and other key dimensions of the tax rules for 2018, plus where policy adjustments might be worth recommending.

Moderator: Cameron Arterton, Vice President, Tax Policy, Emerging Companies, Biotechnology Innovation Organization (BIO)

Panelists:

  • Brendan P. Cox, Partner, Ernst & Young LLP
  • Robert Masella, Partner, Shearman & Sterling
  • Andrew J. Silverman, Government Analyst—Tax, Bloomberg Intelligence

Instilling Innovation Ambitions in your Leadership Culture
Tuesday, February 13, 1:00-1:55 pm

As the scientific challenges of developing new and superior treatments increase in difficulty, corporate management’s ability to maximize the capacity of their teams to innovate becomes ever more urgent.  Recent research in cognitive science and comparative stock investment results suggest clear performance advantages that more highly diversified teams and boards can deliver.  Traditional recruitment processes for corporate executive teams often fail to reflect the employee bases they lead or patient populations they serve.  This session will focus on practical approaches and successful examples to diversify leadership recruitment efforts, create inclusive cultures for development/retention, and better align organizations with the full measure of talented people available.

Moderator: James Sapirstein, RPh, Chief Executive Officer, ContraVir

Panelists: 

  • Karen Anderson, Senior Vice President, Chief Human Resources Officer, Alnylam Pharmaceuticals
  • Wanda Bryant Hope, Chief Diversity & Inclusion Officer, Johnson & Johnson
  • Sabrina Martucci Johnson, President and Chief Executive Officer, Daré Bioscience, Inc.

Chronic Disease Innovation: Issues and Opportunities in Addressing Unmet Need for Small and Large Companies
Tuesday, February 13, 3:00-3:55 pm

While a majority of venture funding goes into development of oncology and rare disease treatments, the broader population with chronic diseases can also look forward to innovations from established biopharmas as well as smaller companies with promising new approaches to compete with existing care options.  The slower-than-projected growth of the PCSK9 segment, despite clear clinical advantages, suggests that commercialization within the chronic disease space presents particular recent challenges that companies should be prepared to overcome once their medicines receive approvals and roll-out begins.  This session will highlight some exciting late-stage pipelines and review the structural challenges of convincing providers, payers, and patients of the value of a new medicine for treating a chronic disease.

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

Panelists:

  • Steven J. Mento, PhD, President and Chief Executive Officer, Conatus Pharmaceuticals
  • Jim Tobin, PhD, Vice President, Scientific Innovation, Cardiovascular & Metabolic, Johnson & Johnson Innovation