Monday, October 17, 2016
|12:00 PM - 1:00 PM||SPARK Registration|
|1:00 PM - 5:00 PM||BIF Registration|
|1:00 PM - 5:00 PM||Partnering Desk|
|1:00 PM - 5:30 PM||SPARK Program|
|5:30 PM - 6:30 PM||SPARK Reception|
Tuesday, October 18, 2016
|6:30 AM - 5:00 PM||Registration|
|6:30 AM - 5:30 PM||Partnering Desk|
|7:00 AM - 7:55 AM||Networking Breakfast|
|7:15 AM - 5:30 PM||Satellite Partnering Desk|
|7:30 AM - 5:30 PM||Partnering Meetings|
|7:30 AM - 5:30 PM||Partnering Hospitality Suite|
|8:00 AM - 5:25 PM||Company Presentations|
|9:00 AM - 10:15 AM||The Intersection of Inflammation and Immuno-Oncology: Risks and Opportunities|
|10:00 AM - 10:30 AM||Mid-Morning Coffee Service|
|11:00 AM - 11:55 AM||Policy Outlook—PDUFA VI: What Changes to Expect, plus Congressional Action Update|
|12:00 PM - 1:25 PM||Opening Plenary Lunch
Fireside Chat: Ryan Watts, PhD, CEO, Denali Therapeutics
|2:00 PM - 2:55 PM||Implications of Large-Cap Pharma M&A Trends on Biotechs: Rising or Falling Deal Volume?|
|3:00 PM - 3:30 PM||Mid-Afternoon Coffee Service|
|3:00 PM - 3:55 PM||View from the Board: What Do Private Company Investors and Outside Directors Want from Their CEOs?|
|4:30 PM - 5:30 PM||Translating Microbiome Research into Treatments|
|5:30 PM - 6:30 PM||Welcome Reception|
Wednesday, October 19, 2016
Therapeutic Topic Panels
The success of checkpoint inhibitors for particular cancers, such as melanoma, has inspired extensive research into combination therapies and pursuit of extra indications, including in treating inflammatory diseases. However, when immuno-oncology treatments run into trial-stopping problems, those setbacks often involve cytokine release syndrome issues caused by too much inflammation. What do we need to know about this intersection to guide research and investment prioritization in this terrain?
Moderator: Michael King, Managing Director and Senior Research Analyst, JMP Securities
- Paul Biondi, Senior Vice President, Head of Business Development, Bristol-Myers Squibb
- Pablo Cagnoni, MD, President and Chief Executive Officer, Tizona Therapeutics, Inc.
- Mitchell H. Gold, MD, Executive Chairman & Acting CEO, Alpine Immune Sciences
- Shawn Iadonato, PhD, Chief Executive Officer, Kineta, Inc.
- Alex Szidon, PhD, Executive Director, Business Development & Licensing; Head, West Coast Innovation Hub, Merck & Co., Inc.
Recent years have seen a lot of excitement in the microbiome space, with the intention of bringing new microbiome-derived drugs and therapies to the market. As more collaborations get underway and investment grows in the space, including the $121M National Microbiome Initiative commitment from the White House, we can anticipate that this space will garner more attention as biopharma develops new approaches and advances candidates further into the clinic. However, getting microbiome-inspired candidates to become commercially viable therapeutics presents a number of challenges, including uncertainties in drug development and questions about intellectual property and regulatory pathways. This panel will feature discussions about current experiences in microbiome drug development and the promising future of microbiome therapies.
Moderator: Andres Hurtado-Lorenzo, PhD, Director of Translational Research, Crohn’s and Colitis Foundation of America
- Nick Conley, PhD, Co-founder and Chief Executive Officer, EpiBiome
- Colleen Cutcliffe, PhD, Co-founder and Chief Executive Officer, Whole Biome
- Glenn Nedwin, PhD, MoT, Chief Executive Officer and President, Second Genome, Inc.
Benefiting from Innovative Clinical Trial Designs: Biomarkers, Patient-Oriented Endpoints, Batch Trials, and Digital Tools
Recent analysis from BIO and from McKinsey & Company suggest higher clinical trial success rates related to use of selection biomarkers and from trial collaborations. Traditional outcomes measures are being reconsidered, by trial sponsors and regulators, to impact drug development in ways that can help patients faster while and digital tools such as Apple’s Research Kit hold promise for cheaper, bigger trials. This panel will showcase some of the latest approaches currently being used to increase success and improve productivity in clinical development.
Moderator: Komathi Stem, ReThynk Consulting
- Sanjay Kakkar, MD, MSC, MPH, Chief Executive Officer, Armetheon
- Melissa C. Paoloni, DVM, DACVIM-O, Executive Director of Clinical Trials, QuantumLeap Healthcare Collaborative (I-SPY trials)
- Aidan Power, MB, BCh, Msc, MRCPsych, Vice President of Program and Portfolio Management, Alzheon, Inc.
- Beth Rogozinski, Chief Product Officer, Pear Therapeutics
- David Thomas, CFA, Senior Director, Industry Research and Policy Analysis, BIO
Enthusiasm for gene therapy continues to be strong as indicated by recent IPOs and the FDA granting breakthrough status for multiple candidates in this space. However, as gene therapies get closer to commercialization in the U.S., often stunning with remarkable clinical results for specific patient populations, legitimate questions arise concerning the scalability of their treatments and the valuation models to deliver economically sustainable therapeutics. This panel will discuss the current gene therapy landscape, including present market environments and investment opportunities, and how biopharma is addressing the challenges to commercialization.
Moderator: Birgitt Schuele, MD, Associate Professor and Director of Gene Discovery and Stem Cell Modeling, Parkinson’s Institute
- Louis Breton, Chief Executive Officer and Director, Calimmune, Inc.
- Scott Clarke, Senior Vice President, Product Development, BioMarin Pharmaceutical Inc.
- Sandy Macrae, MB, ChB, PhD, President and Chief Executive Officer, Sangamo Biosciences, Inc.
- Carole Nuechterlein, Head, Roche Venture Fund
The Prescription Drug User Fee Act (PDUFA) comes up for its five-year reauthorization by the U.S. Congress next year with negotiations over adjustments going on already. This act sets the terms for the major economic model for drug developer/FDA relationships. In addition, Zika-response funding and unresolved proposals for 21st Century Cures, IP reform, antibiotic resistance research, the TPP, and CMS reimbursements may take dramatic twists related to the election cycle, with implications on biopharma budget plans and company valuations. Hear from BIO experts and others close to the policy process.
- Elona Baum, Managing Director, DEFTA Partners
- John Glasspool, Executive Vice President, Head of Corporate Strategy and Customer Operations at Baxalta US, Shire
- Elizabeth Krutoholow, Senior Analyst, Bloomberg Intelligence
Business Development Topic Panels
2015 was a vibrant year for biopharma M&A, with nearly $170B in total deals closed. This year has also seen its fair share of large deals in the headlines, and activity may continue as companies try to remain competitive at scale. These mergers typically shed valuable talent that both biotechs and investors look to hire. However, recent stock market conditions suggest a rebalancing between deal premiums and IPO fundraising expectations. Learn from a panel of M&A experts whether deal fatigue exists now, and what larger trend changes they foresee for large-cap pharmas, small to mid-size biotechs, and investors.
Moderator: Matthew K. Hudes, Chief Executive Officer, bdlBiologx
- Scott Brun, MD, Vice President, Corporate Strategy Office Head, AbbVie Ventures
- Clare O'Brien, Partner, Shearman & Sterling LLP
- David Parrot, Managing Director, Head of Life Sciences Investment Banking, SunTrust Robinson Humphrey
- Matthew Roden, PhD, Vice President and Head of Strategic Corporate Development, Bristol-Myers Squibb
- Marc Schneidman, Founder, Chief Investment Officer and Managing Member, Aquilo Capital
More than half of biotech CEOs are first-time CEOs; as such, many have less experience with engagement of a Board and the growth challenges of private companies than most of their investors. Building these critical relationships and leveraging the cumulative experience of the Board can greatly increase a company's success and ability to navigate obstacles. This panel of experienced outside directors will discuss best practices for effective CEO-board relationships and give CEOs insight into the expectations from their Board.
Moderator: Michael J. O'Donnell, Partner, Morrison & Foerster
- David Donabedian, PhD, Partner, Longwood Ventures
- Elaine J. Heron, PhD, Director, BioMarin Pharmaceutical Inc.; Chair and former CEO, Amplyx Pharmaceuticals, Inc.
- Charlotte Hubbert, PhD, Partner, Gates Foundation Venture Capital
- Nina Kjellson, General Partner, Canaan Partners
- Camille Samuels, Partner, Venrock
Reversing the Crossover Flow: Venture Fund Investments in Public Companies (presented by BioCentury)
While 2015 was marked by a surge of public investors dipping into private biotechs, the flow of capital in 2016 is dramatically different. Crossover-backed IPOs are few and far between and the follow-on market is highly selective. Amid this backdrop, private investments in public equities (PIPEs) are accelerating as an option for biotechs seeking capital, with 64 such deals in Q2 2016, according to data assembled by BioCentury. A closer look at the PIPE data reveals that multiple traditional venture funds are participating, either to support existing portfolio companies or because they are finding public companies with valuations on par with early stage private biotechs. This panel will delve into venture funds that are increasingly looking to the public markets, including the types of financings they prefer and whether it will lead to a capital crunch for some types of private companies.
Moderator: Steve Edelson, Senior Editor, Finance, BioCentury Publications Inc.
- Allyson Rinderle, Vice President, Longitude Capital
- Mahendra G. Shah, PhD, Managing Director, Vivo Capital
- Kurt Von Emster, Managing Partner, Abingworth
Changes in corporate portfolio strategy or trial design complications can land promising drug candidates on the shelf—often with no plans to return to the clinic. This past year has seen an uptick of deals in which biotechs have taken "unwanted" assets from large companies to advance into development. Companies making these bets are looking for opportunities to repurpose these candidates, either through new clinical targets or to reduce toxicity or increase efficacy. Hear from biotech executives attempting to shepherd these candidates toward approval and with higher ROI than the first owners.
Moderator: Effie Toshav, Partner, Fenwick & West LLP
- James McArthur, PhD, Chief Executive Officer, Imara; Founder & Chief Scientific Officer, Cydan Development, Inc.
- Michael A. Metzger, President and Chief Operating Officer, Syndax Pharmaceuticals, Inc.
- Julia C. Owens, PhD, President & CEO, Millendo Therapeutics
- Asish K. Xavier, PhD, Vice President, Venture Investments, Johnson & Johnson Innovation–JJDC, Inc.
The 2016 U.S. presidential campaigns have generated notable discussion regarding valuation of medicines, as well as numerous healthcare policy suggestions from candidates and industry players alike. This recent attention correlates with a slowdown in stock market returns to biotech. As we near Election Day, uncertainty abounds—how will the biotech sector be affected by a new president’s healthcare agenda? Meanwhile, global licensing, M&A, and other deal activity remain robust despite a tepid IPO climate. A diverse panel of experts will discuss what we might expect in the coming year, as companies seek the capital to grow.
Moderator: Elizabeth Krutoholow, Senior Analyst, Bloomberg Intelligence
- John Chambers, Vice-Chairman and Head of Healthcare Investment Banking, ROTH Capital Partners
- Brian Hagerty, Senior Director, New York Stock Exchange (NYSE)
- Brian Leuthner, Co-Founder, President and Chief Executive Officer, Edge Therapeutics, Inc
- Wendye Robbins, MD, President and Chief Executive Officer, Blade Therapeutics
October 19, 2016
12:00 p.m. - 1:25 p.m.
Moderator: David Schechner, Managing Director and Head of Life Sciences, Baird
Rachel is a co-founder of Caribou Biosciences and has been President and CEO since its inception. She has a research background in CRISPR-Cas biology, and in 2014, she was named by Forbes Magazine to the "30 Under 30" list in Science and Healthcare. She is also a co-founder of Intellia Therapeutics where she is a member of the board of directors. Rachel is an inventor on several patents and patent applications covering multiple CRISPR-derived technologies, and she has co-authored scientific papers in high impact journals characterizing CRISPR-Cas systems. Rachel earned an A.B. in Biological Sciences from Harvard College, and received a Ph.D. in Molecular and Cell Biology from the University of California, Berkeley.
Liam Ratcliffe is a Managing Director at New Leaf Venture Partners, and concentrates on biopharmaceutical investing. Liam joined New Leaf in September 2008. Liam was previously Senior Vice President and Development Head for Pfizer Neuroscience, as well as Worldwide Head of Clinical Research and Development. Additional positions during his 12 years at Pfizer included Vice President of Exploratory Development for the Mid West region (based in Ann Arbor, MI), and Head of Experimental Medicine at Pfizer’s Sandwich, UK Laboratories.
Liam received his M.D. degree and Ph.D. degree in immunology from the University of Cape Town and his M.B.A. degree from the University of Michigan. He completed his internal medicine training and fellowship in Immunology at Groote Schuur Hospital and associated teaching hospitals in Cape Town, South Africa.
Liam serves on several academic and industry advisory boards, including the Leadership Counsel of the University of Michigan Life Sciences Institute and the Advisory Council of the Keck Graduate Institute. Liam is a director on the boards of the following companies: Aptinyx, Arvinas, Calchan Ltd., Deciphera Pharmaceuticals, Edge Therapeutics, Karus Therapeutics and Unum Therapeutics.
October 18, 2016
12:00 p.m. - 1:25 p.m.
Moderator: Andrew Fein, Managing Director and Senior Healthcare Analyst, Research Division, H.C. Wainwright & Co., LLC
Ryan Watts is one of the co-founders of Denali Therapeutics and a member of the Board of Directors. He serves as the President and Chief Executive Officer. Ryan previously served as Director of the Department of Neuroscience at Genentech, where he was employed for 11 years. During his tenure there, he led the company’s entry into neuroscience, building a department and advancing multiple programs for neurological disease from discovery to clinical testing. Ryan’s own laboratory focused on drug discovery for Alzheimer’s disease and on understanding mechanisms of neurodegeneration guided by human genetics. Ryan is also a leader in the development of improved methods for delivering therapeutic antibodies across the blood-brain barrier. He obtained his B.S. from the University of Utah and his Ph.D. in biological sciences from Stanford University.