Regulatory Advisory Committee
The CURETHEPROCESS campaign has created the Regulatory Advisory Committee to help provide expert guidance in the development of regulatory change at the FDA specifically for the review and approval of treatments for rare diseases. The team consists of:
Peter Saltonstall, President and CEO, National Organization for Rare Disorders
Marlene E. Haffner, MD, MPH, CEO of Haffner Associates
Frank J. Sasinowski, M.S., M.P.H., J.D., Attorney, Hyman, Phelps & McNamara, P.C.
Patti A. Engel, President & CEO Engage Health, Inc.
By adding an experienced group of professionals with knowledge of all aspects of the regulatory process, the Foundation intends to optimize its efforts with regulators and work closely with leading patient organizations. The Regulatory Committee will be focused on advising the Foundation on the nuances of regulatory process and administrative change.
Peter Saltonstall
President and CEO, National Organization for Rare Disorders
The National Organization for Rare Disorders (NORD), a 501(c)3 organization which is a unique federation of voluntary health organizations dedicated to helping people with rare "orphan" diseases and assisting the organizations that serve them. Prior to joining NORD Saltonstall held senior executive positions within a number of major academic medical centers and organizations, including Harvard's Brigham and Women's Hospital, Tufts-New England Medical Center, St. Elizabeth's Medical Center of Boston, and Harvard's Risk Management Foundation.
Devoted to improving patient safety, he was a founding member of three health service oriented businesses that developed computerized patient safety reporting systems. He also played a major role on Capitol Hill in the development of the Patient Safety Act of 2005, which has dramatically improved the reporting of events that adversely affect patients. As the leader of NORD, he brings this same commitment to improving health care and development of new therapies for the more than 6,000 rare diseases which in aggregate affect more than 25 million people in this country.
Marlene E. Haffner, MD, MPH
CEO of Haffner Associates
Marlene E. Haffner, MD, MPH is a career Public Health clinician and administrator. She received her MD degree from the George Washington University School of Medicine and a Masters in Public Health from the Johns Hopkins Bloomberg School of Public Health. She obtained further training in internal medicine, hematology, and dermatology at the Columbia University School of Medicine and the Albert Einstein School of Medicine both in New York City. Dr. Haffner is board certified in internal medicine. It was at the Albert Einstein College of Medicine that she first became interested in the underserved and in rare diseases, as she was responsible for patients in the sickle cell clinic as well as performing research to delineate abnormal hemoglobins.
Following residency, Haffner, joined the United States Public Health Service (USPHS). From 1974 – 1981 Dr. Haffner served as the Director, Navajo Area Indian Health Service. Haffner was then assigned to the Food and Drug Administration (FDA). She initially was the Director, Office of Health Affairs for the Center for Devices and Radiological Health. In 1986 she moved to the Office of Orphan Products Development (OOPD) where she directed that program for the next 20 years.
After 36 years of active duty, Haffner retired from the USPHS at the rank of Rear Admiral and became Executive Director, Global Regulatory Intelligence and Policy for Amgen, Inc., the largest biotechnology company in the world. In, 2009 Haffner, began her own organization, Haffner Associates, LLC. Haffner Associates is an organization totally devoted to assisting companies and patient organizations in the development of products to treat their disease. Haffner writes articles concerning drug development in rare diseases in peer-reviewed journals and serves as Adjunct Professor of Preventive Medicine and Biometrics as well as Clinical Professor of Medicine at the Uniformed Services University of the Health Sciences (USUHS) in Bethesda, Maryland.
Frank J. Sasinowski, M.S., M.P.H., J.D.
Attorney, Hyman, Phelps & McNamara, P.C
In 2000, Frank received NORD’s Humanitarian Award for “enhancing the lives of people with rare ‘orphan’ diseases,” and was elected to the NORD Board of Directors, where he now serves as Vice Chair. Frank joined FDA as a regulatory counsel in 1983, where he played a major role in implementing the 1984 Waxman-Hatch law and the Orphan Drug Act. His research and analysis were integral to the 1984 and 1985 Amendments to the Orphan Drug Act. He rose to Deputy Director of the Health Assessment Policy Staff in the FDA Commissioner’s Office before moving to Hyman, Phelps & McNamara, P.C., in June of 1987. At HPM Frank assists sponsors in developing new drugs and has secured FDA approvals for 45 novel therapies treating rare disorders and hundreds of orphan drug designations.
Frank is also Vice Chair of the Board of Directors of the Catholic Medical Missions Board, an international health organization which provides health products and services to those in less developed nations and is a leader in the PEPFAR program in Africa. Frank holds a M.S. in nutritional sciences and a M.P.H. from the University of California at Berkeley, a B.S. in biological sciences and genetics from Cornell University, and a J.D. from the Georgetown University Law Center. He co-authored Drug and Biologic Approvals: The Complete Guide for Small Businesses.
Patti A. Engel
President & CEO Engage Health, Inc. Engage Health, Inc., is a drug, device and biotech consulting group that specializes in unique commercialization issues. Engel has worked extensively in the areas of market development, product launch, strategic planning, infrastructure planning, market research, clinical trial recruitment, risk management, and orphan drugs, and is a national presenter on complex issues related to commercialization of therapies for rare diseases.
Prior to founding Engage Health, Inc., Engel was Vice President of Marketing and Sales at Orphan Medical, Inc., where she built the commercial functions of the business including sales, marketing, distribution, professional services and reimbursement services and helped to bring a number of complex specialty products to market. Additionally, she spent over 10 years at 3M Pharmaceuticals in various sales and marketing management roles. Engel’s personal experience includes significant policy and governmental affairs work, both on the state and federal level, and extensive work rallying patient support groups around important policy issues. She has worked extensively in strategic planning and vision definition, market valuation and market research around products for special populations, design and implementation of comprehensive risk management programs, controlled substance market planning and launch, in the reimbursement issues around treatment INDs and the approval and marketing of medications under sub-part H regulations.
Engel is an RN and holds a BS in nursing and sociology from the College of St. Catherine in St. Paul, Minnesota.