FDA Hosting Workshop on April 1 to Discuss Clinical Outcome Assessments

As mentioned on our Health Industry Washington Watch blog, the FDA will host a public workshop on April 1, 2015 to provide updates on the use of clinical outcome assessments (COAs), as well as to address plans for future development and use of COAs in drug development programs. The workshop, entitled “Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges,” will also cover the inclusion of patient-centered outcome measures, COA usage standards and collaborative processes for the development and dissemination of COAs. Participants may attend in person or via webcast. If you are interested in attending, please register no later than March 27, 2015.

Reed Smith Hosts Multifaceted Conference on Post-Acute Care

As highlighted on our Health Industry Washington Watch blog, Reed Smith hosted a dynamic conference on post-acute care in Washington, D.C. in early April. Entitled "Reed Smith 2014 Washington Health Care Conference: Focus on Post-Acute Care," the conference brought together a panel of experts discussing episodic care, proposed bundling models, and alternative payment and delivery systems; a specialist in health care investment banking addressing the current climate and future outlook for post-acute investments and transactions; and a legal policy analyst providing a thorough overview of recent legislative action related to post-acute care. The conference concluded with a thought-provoking keynote speech from Dr. Norman Ornstein, Resident Scholar at the American Enterprise Institute, about the politically polarizing nature of health care policy in the United States today. To read the entire post, click here.

Reed Smith to Host April 4, 2014 Washington Health Care Conference on Post-Acute Care - Eight Days Left to Register

On April 4th, 2014, Reed Smith will host its inaugural Washington Health Care Conference at The Mayflower Renaissance Hotel in Washington, D.C. With a keynote from Dr. Norman Ornstein, this year’s conference will focus on post-acute care, bringing together leading industry professionals for a discussion on several important issues, including:

Governing in Polarized America: The Prospects for Policy in 2014 and Beyond (Keynote)

  • Dr. Norman Ornstein, Resident Scholar, American Enterprise Institute, and weekly columnist for National Journal and The Atlantic

Policy discussion on episodic care, bundling models, and alternative payment and delivery systems

  • Mike Cheek, Vice President for Medicaid and Long Term Care Policy, American Health Care Association
  • Judy Feder, Professor, Georgetown University McCourt School of Public Policy, and Urban Institute Fellow
  • Dr. Barbara Gage, Fellow, Managing Director, Engelberg Center for Health Care Reform, Brookings Institution
  • Dr. Vincent Mor, Ph.D., Florence Pirce Grant Professor of Community Health, Public Health Program, Brown University School of Medicine

Wall Street perspective: the current appetite for deals

  • Jay Barnes, Senior Vice President, Healthcare Investment Banking, Jefferies LLC

Hill briefing on Medicare legislation

  • Cate McCanless, Senior Policy Advisor, Brownstein Hyatt Farber Schreck

Limited seating is still available for this complimentary program. If you are interested in registering, please email Lindsay Korenich at lkorenich@reedsmith.com. For more information about this conference, click here.

Reed Smith Gearing Up For "Big Data Monetization" Conference

Next week, Reed Smith will host a conference on “Big Data Monetization” at the Quadrus Conference Center in Silicon Valley (8:30-11:30 a.m. PDT). Big Data is a term used to characterize the accumulation of data. Virtually every company, in every industry, is now an information and technology company. Companies run on Big Data, whether it be customer information, employee information, or competitive intelligence. Companies store, share, and use that information in increasingly complex ways, taking advantage of cloud-based solutions and revolutions in analytics, and finding ways to turn these massive databases into revenue. There is no doubt a plethora of opportunities in Big Data, however, using it comes with its own set of risks. The key with monetizing Big Data is striking the balance between risk and reward.

View a preview of the types of issues we’ll be tackling at the conference over on our Global Regulatory Enforcement Law Blog.

American Health Lawyers Association's Annual Meeting

The American Health Lawyers Association's Annual Meeting will be held June 26-29, 2011, in Boston. This year's program will deliver insights from leading practitioners, in-house counsel and government representatives on the latest developments and trends concerning transactions, reimbursement, tax, privacy and security, antitrust, fraud and abuse enforcement, and accountable care organizations, among other key topics.

Elizabeth Carder-Thompson will present a session entitled "Pharma and Device Update and Prognostication: A Regulatory/Fraud and Abuse Year-in-Review and Prediction of Things to Come." Bob Hill will participate in a session devoted to providing a historical understanding of Medicare Parts A, B, C and D and forward-looking analysis of recent reimbursement-related developments ("Parts A, B, C and D Regulatory Reimbursement Update: A Look Back and Ahead").

Food and Drug Law Institute's Upcoming US-China Food and Drug Law Conference in Beijing, China

The Food and Drug Law Institute (FDLI) has an interesting upcoming conference on June 13-14 in Beijing, China that will address current legal, regulatory and economic issues regarding food, cosmetics, dietary supplements, pharmaceuticals and medical devices in China and the United States. Speakers are top government officials and internationally renowned experts who will discuss the issues in both countries.  They include Dr. Margaret A. Hamburg (Commissioner of Food and Drugs, US Food and Drug Administration), Wu Zhen (Deputy Commissioner of China's State Food and Drug Administration), Ralph Tyler (Chief Counsel, US Food and Drug Administration), Rosemary Gallant (Principal Commercial Officer Beijing, US Embassy Beijing, Commercial Section), Ding Jianhua (Deputy Director-General, Department of International Cooperation, SFDA), Wang Lanming (Supervisor-General, Department of Medical Devices Supervision, SFDA), Lin Wei (Deputy Director-General, Bureau of Import-Export Food Safety, AQSIQ) and Jinjing Zhang (Deputy Director General, Department of Food Licensing, SFDA).  Reed Smith partner Gordon Schatz will be speaking on the panel "Innovation and Access: Key Success Factors in China."

FDA to Hold Public Meeting on ACA Biosimilars Pathway - November 2-3, 2010

Today the FDA published a notice announcing public hearings on November 2 and 3, 2010 on implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was enacted as part of the Affordable Care Act (ACA). The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be “highly similar” (biosimilar) to, or “interchangeable” with, an FDA-licensed biological product. The notice outlines many implementation issues on which the agency seeks stakeholder feedback. In particular, the FDA raises a series of questions in the following areas: scientific and technical factors related to a determination of biosimilarity or interchangeability; the type of information that may be used to support a determination of biosimilarity or interchangeability; development of a framework for optimal pharmacovigilance for biosimilar and interchangeable biological products; scope of the revised definition of a “biological product”; priorities for guidance development; scientific and technical factors related to reference product exclusivity; scientific and technical factors that may inform the agency’s interpretation of “product class” as it relates to available regulatory pathways for certain protein products during the 10-year transition period following enactment of the BPCI Act; and the establishment of a user fee program for biosimilar and interchangeable biological products (the FDA seeks information about particular companies and trade associations that would be potential participants in any negotiations regarding user fee programs for biosimilars). Attendance will be on a first come-first served basis, although the meeting also will be webcast. Individuals who wish to present at the public hearing must register by October 11. Electronic or written comments also will be accepted until December 31, 2010.