FDA/CMS Summit for Biopharma Executives


FDA/CMS Summit For Biopharmaceutical Executives 2014
Innovation After Health Reform


The health insurance expansion under the Affordable Care Act is in full swing — a late enrollment surge helped the Obama Administration meet its goal of enrolling 7 million patients into the health care exchanges. Now the questions really begin. What does the first year of the exchanges mean for drug manufacturers? Who are those enrollees, and are there enough healthy participants to ensure the sustainability of the system? What will the White House do to secure its health care legacy in the final two years of the Obama Administration?

And most important of all: how can biopharmaceutical companies anticipate and shape the policy debates that will come now that the ACA expansion is done?

What will the rules for formulary access be? As industry wades through the ACA’s approach to prescription drug formularies, it also faces changes to Medicare Part D. While the Centers for Medicare & Medicaid Services withdrew a controversial proposal to cut back on the protected classes of covered drugs, it’s clear that CMS hasn’t finished tinkering with the prescription drug benefit.

Will FDA’s drug review process keep pace? At the same time, FDA and industry are gearing up for the next reauthorization of the Prescription Drug User Fee Act. At the center of the PDUFA VI negotiations will be the fate of FDA’s new drug review “Program,” under which FDA agreed to greater communication with sponsors in exchange for a slightly longer review period. Is the process is increasing the number of first-cycle reviews, and will FDA and industry will want to retain it?

What surprises await industry after the 2014 mid-term elections? Those PDUFA VI negotiations — and the second go-round of the Generic Drug User Fee Act and the Biosimilar User Fee Act — will kick off next year, with plenty of other hot topics on the table for discussion. Will the result be major reforms to the regulatory process for drugs and biologics, or just some minor tweaks? And with FDA getting closer to approving the first biosimilar under the abbreviated pathway, will those early products see commercial success?

Come to the tenth annual FDA/CMS Summit for Biopharma Executives to find out. Our keynote speakers and panels will take a deep dive into each of these topics, and more. You’ll leave better able to make strategic decisions on issues such as:

  • The commercial outlook for biopharma under the new health care exchanges;
  • Updates on the latest drug review statistics from the Office of New Drugs and industry’s experience under the new review “Program”;
  • The future of drug safety at FDA — both for the increasingly popular rare disease drugs as well as new treatments for large primary care markets like obesity and diabetes;
  • What’s in store for the reauthorization of PDUVA VI, and a preview of what’s to come as industry and FDA take a second look at BsUFA and GDUFA.
  • Coming changes to Medicare Part D and what CMS has in store for the prescription drug benefit;
  • What the mid-term Congressional elections will mean for the biopharma industry.

Register now and join us at the Fairmont Washington DC, December 11-12, 2014 for this can’t-miss event.
CHI Members enjoy a $400 Discount






Thursday, December 11, 2014
7:00-8:00am Registration and Continental Breakfast
8:00-8:15am Welcome & Opening RemarksMichael McCaughan
Editor, The RPM Report
Founding Member, Prevision Policy, LLC
8:15-9:00am OPENING KEYNOTE: Priorities for FDA’s Drug Center in 2015
Janet Woodcock, MD
Director, Center For Drug Evaluation & Research
Food and Drug Administration (FDA)
9:00-10:30am FDA Roundtable Hear from the heads of the Office of New Drugs, Office of Safety & Epidemiology and from industry
stakeholders on the implementation of PDUFA V, including the latest data on drug approvals and safety trends, as well as
updates on the future of the “Program,” Breakthrough Therapies, and risk management.
John Jenkins, MD
Director, Office of New Drugs
Center for Drug Evaluation and Research
Food and Drug Administration (FDA)Gerald Dal Pan, MD
Director, Office of Surveillance & Epidemiology
Food and Drug Administration (FDA) Robert Clark
VP, US Regulatory Affairs
Novo Nordisk

Francois Nader, MD
NPS Pharmaceuticals

Karen Jones
VP, Global Head of Oncology Regulatory

Kate Rawson (Moderator)
Contributing Editor
Prevision Policy

10:30-10:45 am Networking Break
10:45am – 12:00pm Drug Pricing: An Honest Conversation About Innovation The high-price and extraordinary demand for Gilead’s Sovaldi has prompted calls from insurers and other health care stakeholders for action on specialty drug pricing. What is the potential public policy response?
Panel of Industry/Payor expertsChris Garabedian
President & CEO
Sarepta Therapeutics 
David Beier
Bay City Capital 
John McHutchison, MD
Executive Vice President, Clinical Research
GileadMark McClellan, MD, PhD
Senior Fellow and Director, Health Care Innovation and Value Initiative
Brookings Institution 
12:00pm-1:15pm Lunch
1:15 pm-1:45pm Medicare Payment Data: What’s Next CMS’ release of physician-level payment data has brought unprecedented transparency to the federal government’s largest health care program. Here from the head of the group that oversees the data on the process to release it, how it is being analyzed, and what next steps may follow.
Niall Brennan
Acting Director, Office of Enterprise Management

1:45pm-2:15pm KEYNOTE ADDRESS
2:15-3:15pm Medicare Priorities: Part B & D Hear from leaders in Medicare’s Part B and Part D groups on priorities for 2015, including the evolution of coverage with evidence development and potential hot topics for coverage review.
Tamara Syrek-Jensen
Acting Director, Coverage & Analysis Group Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services (CMS
)Ramsey Baghdadi (Moderator)
Founding Member
Prevision Policy
3:15 -3:30pm Networking Break
3:30-4:30pm Drug Coverage Under The ACA Hear from an expert panel on the lessons learned from the first year of expanded insurance coverage under the Affordable Care Act, and the key changes to expect in 2015 and beyond.
Deborah Bachrach
Partner, Healthcare Industry

Manatt, Phelps & Phillips, LLPJonathan Blum
EVP, Medical Affairs

4:30-5:00pm KeynoteJim Robinson
Astellas Pharma US
5:00-5:30 pm Closing Keynote
Mass Customization: Should Healthcare Adopt This Model? 
This session raises the issue of whether we can bridge the chasm between innovation and standardization and offer utility with affordability. Given other sectors outside of healthcare achieved innovation and affordability through mass customization, does the model provide opportunities for healthcare.

  • Customization should be affordable and evidence-based
  • Utility will increase in significance for value-based healthcare

Trent T. Haywood, MD, JD, SVP
Chief Medical Officer
BlueCross BlueShield Association

5:30-7:00pm Cocktail Reception
Friday, December 12, 2014
7:45-8:15am Registration and Continental Breakfast
8:15-8:45 am Pricing and Reimbursement – The Tipping Point in the Future of HealthcareKaren Ignagni
President and CEO
America’s Health Insurance Plans
8:45-10:00am Biosimilars or Biosames: Who Cares, Who Decides and Who Pays? Over four years after the creation of the biosimilar regulatory pathway as part of the Health Care Reform, FDA has accepted its first biosimilar applications. These candidates have already been approved and marketed as biosimilars in Europe, as well as multiple other countries. How similar or the same will the US market be? What do we expect to be the impact on access and affordability of these specialty competitors at a time when the pressures on the cost of medicines are increasing and the US is going through massive changes in its heath care system more broadly. Are biosimilars an opportunity, and who will benefit the most?
FDA Update:Leah Christl
Associate Director, Biosimilars Program, Office of New Drugs
Food and Drug Administration (FDA)
Panel Discussion:Mark McCamish, MD, PhD
Global Head Biopharm.& Oncology Injectables Development
Sandoz International GmbH
Sumant Ramachandra, MD, PhD, MBA
SVP & Chief Scientific Officer

Richard F. Kingham
Covington & Burling LLP

Meredith Miller
Chief Corporate Governance Officer
UAW Retiree Medical Benefits Trust

Gillian Woollett (Moderator)
Senior Vice President

10:00-11:00am FDA and the First Amendment FDA is reviewing its policies governing communication of off-label use and scientific exchange. How will the agency and the industry find the right balance between preserving the integrity of the approval process while recognizing the evolving legal and technological framework for scientific communications?
Coleen Klasmeier
Sidley Austin LLP 
Rachel Sherman, MD, MPH, FACP
Principal, Drug and Biological Drug Products
Greenleaf Health
Former Director, CDER Office of Medical Policy
Mike Ryan
VP, Value & Access Team

AmgenCole Werble (Moderator)
Founding Member
Prevision Policy
11:00am-12:15pm The Next FDA Reform: Looking Ahead to PDUFA VI The formal FDA/industry user fee negotiation process will begin in earnest in 2015, and the House Energy & Commerce Committee has already kicked off a companion review of all aspects of the climate for innovation in the US. What should industry and other stakeholders look for in the next big FDA bill?
Ron Cohen, MD
Acorda Therapeutics 
Sascha Haverfield
Vice President for Scientific and Regulatory Affairs
Robert Metcalf, PhD
Vice President, Global Regulatory Affairs – US and Quality
Eli Lilly and Company
Margaret Anderson
Executive Director
Michael McCaughan (Moderator)
Founding Member
Prevision Policy
12:15-1:00pm CLOSING KEYNOTE