FDA/CMS Summit December 5-6, 2017 Renaissance Washington DC Downtown, Washington, D.C.
HEAR THE LATEST DEVELOPMENTS AND UPDATES FROM REGULATORY LEADERS ON THE FDA DRUGS PROGRAM & CMS POLICIES IMPACTING BIOPHARMA The only forum granting exclusive access to FDA/CMS leaders driving regulatory changes and providing formulary guidance for the industry
Join 250+ Regulatory decision makers in Washington D.C this December.
Register online by August 25th and
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FDA & CDER AT THIS YEAR’S FDA/CMS SUMMIT Meet with the new FDA Commissioner, Dr. Scott Gottlieb and the Director for the Center for Drug Evaluation & Research (CDER) Dr. Janet Woodcock at this year’s event.
FEATURED KEYNOTES
FDA Scott Gottlieb, MD
Commisioner of Food and Drugs, THE FOOD AND DRUG ADMINISTRATION (FDA)
Janet Woodcock, MD
Director, Center for Drug Evaluation & Research (CDER) U.S. FOOD AND DRUG ADMINISTRATION (FDA)
INNOVATION & SCIENCE Matthew Might Ph.D.
Director, Hugh Kaul Precision Medicine Institute, UNIVERSITY OF ALABAMA AT BIRMINGHAM; Strategist, THE WHITE HOUSE
Sarfaraz Niazi, Ph.D.
Adjunct Professor, Department of Biopharmaceutical Sciences, UIC COLLEGE OF PHARMACY
INTERESTED IN SPEAKING?
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Register online by August 25th and
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HEAR THE LATEST DEVELOPMENTS IN THE DRUGS PROGRAM AND FORMULARY GUIDANCE DIRECTLY FROM DECISION-MAKERS At this year’s event, hear the year in review and plans for 2018 from CDER and an update from the Office of New Drugs.We’ll also examine the state of biosimilar adoption in the US, and how they impact the cost curve across healthcare in emerging markets and abroad.
Know What’s Coming Down the Pipeline Hear directly from CDER on goals, trends, and new drug development for 2017 and beyond.
Biosimilars Implication Understand the obstacles to biosimilar adoption and their impact on the healthcare cost curve with a presentation and global case study
The Evolving Role of PROs Understand the implications of increased FDA use of Patient Reported Outcomes (PROs) in drug development with a panel of stakeholders from industry, patient advocacy and the FDA.
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TUESDAY, DECEMBER 5TH, 2017 MAIN CONFERENCE DAY 1 7:15 am Morning Coffee & Registration 8:00 am Informal Breakfast Roundtable Discussion Janet Woodcock, MD, Direcotr, Center for Drug Evaluation and Research, Food and Drug Administration 8:45 am Chairman’s Opening Remarks Nielsen Hobbs, Editor, The Pink Sheet 9:00 am Opening Keynote Address Scott Gottlieb, MD, Commisioner of Food and Drugs, The Food and Drug Administration (FDA) 9:30 am Keynote Address: The Center for Drug Evaluation and Research in 2017 and the Year Ahead Here an update from CDER on current initiatives, challenges and accomplishments of 2017 and what’s in store for the year ahead Janet Woodcock, MD - Director, Center for Drug Evaluation & Research (CDER), U.S. Food and Drug Administration (FDA) 10:00 am CDER Office of New Drug Update: Here an update on developments in OND and what is currently in the pipeline for 2018. Speaker TBD, Center for Drug Evaluation and Research (CDER) 10:30 am Networking Refreshment Break 11:00 am Update on Drug Safety and Post Market Surveillance Here an update from the director on the latest developments from the office of Surveillance and Epidemiology. Gerald Dal Pan, MD, MHS - Director, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration (FDA)
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TUESDAY, DECEMBER 5TH, 2017 MAIN CONFERENCE DAY 1 11:30 am Industry Panel Follow up on Office of New Drug Update PANEL Participate in an industry panel discussion in follow up to the morning’s keynotes and updates. What are the current trends and developments affecting the industry, and hear the perspective of stakeholders on the past year, and what’s anticipated for 2018 Moderator: Meg Tirrell, Reporter Biotech and Pharma, CNBC Kay Holcombe - Senior Vice President for Science Policy, Biotechnology Innovation Organization Karen Hauda, Senior Director, Regulatory Policy, Novo Nordisk John Maraganore, Ph.D., Chief Executive Officer, Alnylam Pharmaceuticals, Inc Peter Honig, SVP, Worldwide Safety and Regulatory, Pfizer Inc 12:30 pm Networking Lunch 1:30 pm Understanding the Emerging Role of Patient Reported Outcomes (PRO) and FDA Use in Drug Programs PANEL Patient reporting has not historically held much sway in FDA considerations, but the tide has been turning. As the FDA more seriously considers including patient-reported outcomes (PRO) as part of its approval processes, examine the potential impact on drug manufacturers as well as what this will mean for the approval process moving forward and current developments and considerations for individual diseases and treatments. Panelists Cynthia Grossman, Ph.D., Associate Director, Science of Patient Input, FasterCures, Milken Institute Christine McSherry, Executive Director, The Jett Foundation Carmen Bozic, Senior Vice President, Global Development, Biogen 2:15 pm Update: Current Political and Regulatory Proposals and Developments Impacting Pharma and Healthcare Discuss the latest DC developments, what is coming down the pipeline? Identify and examine current proposals that are circulating the Hill which would impact the Bio/Pharma and healthcare industries. Hector De La Torre - Executive Director, Transamerica Center for Health Studies 2:45 pm Networking Refreshment Break 3:15 pm The Opportunities and Challenges of Expanded Access
PANEL This session examines best practices and modern approaches to integrating well-designed large-
group access programs into the drug development process. Expert panelists will discuss the drivers of commercial feasibility, including cost recovery, regulatory considerations, and pragmatic design. Moderator: Jess Rabourn, Managing Director, Wide Trials Panelists: Richard A. Moscicki, M.D., Deputy Center Director for Science Operations, Food & Drug Administration Beth E. Roxland, J.D., M.Bioethics, Senior Consultant on Law, Ethics and Policy Associate, Division of Medical Ethics, NYU Langone Medical School
4:00 pm Keynote Fireside Chat: When Science Becomes Medicine Sit in on a discussion on the intersection of ethics, innovation and precision medicine, from patient to pill Matthew Might Ph.D., Director, Hugh Kaul Precision Medicine Institute, University of Alabama at Birmingham; Strategist, The White House Nicole Fisher, Contributor, Forbes Magazine, founder & CEO, HHR Strategies 5:00 pm Cocktail Reception
Register online by August 25th and
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WEDNESDAY, DECEMBER 6TH, 2017 MAIN CONFERENCE DAY 2 8:00 am Morning Coffee & Registration 8:45 am Chairman’s Opening Remarks Nielsen Hobbs - Editor, The Pink Sheet 9:00 am Opening Keynote Address: Partnering Opportunities with Industry to Solve Market Challenges Office of the Administrator, CMS invited 9:30 am Pricing, Value and Leverage: Addressing the Ever-Growing Cost of Drugs Through New Channels PANEL Continuing the ongoing discussion around pricing, hear industry perspectives on the driving forces behind the continual increase in drug prices, the role of value in controlling cost as well as what, if any, tools and leverage federal agencies like FDA and CMS have in addressing the issue. Panelist: Hervé Hoppenot, Chairman, President, and Chief Executive Officer, Incyte 10:15 am Networking Refreshment Break 10:45 am CMS Update: Medicaid and Prescription Drug Coverage 11:15 am Obstacles to Success for Biosimilars in the US Market This presentation will explore why biosimilars for chronic diseases, the largest category of biological therapies, are unlikely to yield cost savings and look at examples of biosimilar adoption has impacted healthcare economics in emerging countries and abroad. Also address: • Why are so few biosimilars approved in US? • What is the one key mistake biosimilar developers are making repeatedly? • Discuss the most cost-effective approach to developing new biosimilars Moderator: Nicholas Florko, Associate Editor, Inside Health Policy Aaron Hakim - Researcher, Yale School of Medicine Sarfaraz K. Niazi, Ph.D., Adjunct Professor, Department of Biopharmaceutical Sciences, UIC College of Pharmacy 12:00 pm Fast Track vs Breakthrough Therapy Designation - Small Business Perspective Hear perspective from a a small biotech company that has been granted fast track designation and breakthrough therapy designation in some of its programs on the differences, challenges, and opportunities presented by these two designations. Catherine Melfi, Chief Regulatory Officer, Omeros Corporation 12:30 am Lunch 1:45 pm Rare Tropical Diseases and Outbreaks: Addressing Pandemics, The Latest in Infrastructure Preparedness, PANEL and Accelerating Turnaround Time for Treatment and Eradication Sit in on a panel discussion on current developments in the landscape of tropical disease and pandemic threats, achievements and the current state of preparedness and infrastructure to support outbreak scenarios. Panelists: Cameron Durrant, MD, Chairman and CEO, Humanigen Denise Hinton, Acting Chief Scientist, FDA (invited) 2:30 pm The Impact and Implications of the “right to try” Movement Examine the current situation with “right to try” and state legislation around the country. What will be the impact of such legislation on state operations of Biopharma companies? Perhaps more importantly: • Discuss the implications of political movements and politicized issues on the Life Sciences industry. • How do they impact the evolution of an industry issue via increased scrutiny and informed or misinformed market reaction? Moderator: Meg Tirrell, Reporter Biotech and Pharma, CNBC Panelists: Jess Rabourn, Managing Director, Wide Trials Alison Bateman-House, Ph.D., Division of Medical Ethics, NYU Langone Health 3:15 pm Conference Concludes
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SPONSORSHIP & EXHIBITION OPPORTUNITIES We provide flexible, tailored solutions to optimize your investment. Below are some examples of how you can get involved at the event. To learn more about available sponsorship opportunities, contact Sarah Scarry: +1.646.220.6655 sarah.c.scarry@knect365.com
Lead-generation Shake hands with qualified decision makers in need of your products and services. Thought Leadership Demonstrate your expertise through case study presentations, breakout sessions, panel discussions, and themed solution briefs. Brand Awareness Ensure that your event presence and brand make a lasting impression on clients, prospects, and partners. Messaging Engage delegates before, during, or after the event through a wide range of digital and onsite messaging opportunities. Custom Opportunities Select a sponsorship/exhibition package or work with us to develop a custom package aligned to your individual marketing objectives. New in 2017: Digital Week Sustain your momentum from the face-to-face event by sponsoring a free-to-attend virtual event
Register online by August 25th and
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PRICING & REGISTRATION SAVE $400
STANDARD RATE
ONSITE FEE
$1,695
$2,095
$2,195
by August 25, 2017 General Delegates
Group Discounts • Groups of 3-5: 10% off current rates • Groups of 5-8: 15% off current rates For custom group rates, please contact Brian Schiff at brian.schiff@knect365.com or call 646-895-7444
Venue and Accommodations Renaissance Washington DC Downtown 999 9th St NW, Washington, DC 20001
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