Marlene E. Haffner
Marlene E. Haffner | Principal, Founder | Haffner Associates LLC
From a young age, Marlene E. Haffner knew she wanted to be a doctor. The daughter of two physicians, she greatly admired her parents for the work they contributed and for making a difference in people’s lives—ultimately inspiring her own career. She attained her Doctor of Medicine from the George Washington University School of Medicine and Health Sciences in 1965, followed up with fellowships in dermatology and hematology and a residency in internal medicine in New York City. She launched her career at the U.S. Public Health Service in 1971, where she remained active across numerous roles and assignments for decades up until 2007.
Amid this position, Ms. Haffner excelled as the Director of the Office of Health Affairs at the Center for Devices and Radiological Health from 1981 to 1986 and then the Director of the Office of Orphan Products Development, the treatments for rare diseases, at the Food and Drug Administration from 1987 to 2007. Under her leadership, programs were developed for rare diseases worldwide, including the European Medicine Rare Diseases Program and across Japan, the European Union, Australia, and beyond.
Having accumulated decades of expertise in the industry, Dr. Haffner founded her own company, Haffner Associates LLC, in 2009, dedicated to facilitating the development of therapies for diagnosis and providing treatment and prevention for rare diseases. As principal, founder, and president of the organization, she guides her team through work with biotechnology and pharmaceutical companies, and patients and patient advocacy groups, providing a wide array of services and regulatory agencies. In addition, she’s lent her experience and insight to students as an adjunct professor in the Department of Medicine at the Edward Hebert School of Medicine at Uniformed Services University since 2003.
As a further extension of her prominence in the field, Dr. Haffner has long been a presenter across hundreds of meetings centered on patient safety and orphan products development. She’s also authored and contributed numerous articles concerning rare diseases for professional journals. Outside of her primary endeavors, she dedicates her time and effort as a member of the board of directors for the DADA2 Foundation, DeNovaMed, and ViDa; she’s also worked on the Navajo Reservation for 10 years, seven as its program director for seven. Her extraordinary work hasn’t gone unnoticed: over the last two decades, she’s been recognized with a Special Recognition Award from the American Academy of Pharmaceutical Physicians, two Distinguished Service Medals from the U.S. Public Health Service, a Woodrow Wilson Award from Johns Hopkins University, a Vision and Policy Award from the Canadian Organization for Rare Diseases and a Lifetime Achievement award from the European Organization for Rare Disorders.
Grateful to have followed her childhood dream of making a difference in people’s lives, Dr. Haffner lookd forward to further doing so in her field. She also advises others starting in the industry to “keep their eyes open to new opportunities and accept challenges.”
Press Release
Marlene E. Haffner, MD, MPH, Presented with the Albert Nelson Marquis Lifetime Achievement Award by Marquis Who’s Who
Dr. Marlene E. Haffner has been endorsed by Marquis Who’s Who as a leader in internal medicine, hematology, public health, orphan product development, and entrepreneurship
ROCKVILLE, MD, December 15, 2023 /24-7PressRelease/ — Marquis Who’s Who, the world’s premier publisher of biographical profiles, is proud to present Marlene E. Haffner, MD, MPH, with the Albert Nelson Marquis Lifetime Achievement Award. An accomplished listee, Dr. Haffner celebrates many years’ experience in her professional network, and has been noted for achievements, leadership qualities, and the credentials and successes she has accrued in her field. As in all Marquis Who’s Who biographical volumes, individuals profiled are selected on the basis of current reference value. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all considered during the selection process.
Dr. Haffner is the principal and founder of Haffner Associates LLC, an organization dedicated to facilitating the development of therapies for diagnosis and providing treatment and prevention for rare diseases. As an experienced physician and expert in this area, she and her team have worked closely with biotechnology and pharmaceutical companies, patients, and patient advocacy groups, providing a wide array of services and regulatory agencies worldwide since 2009. Besides her fieldwork, Dr. Haffner taught as an adjunct professor in the department of medicine at the F. Edward Hébert School of Medicine, Uniformed Services University of the Health Sciences, in Bethesda, Maryland, since 2003.
Leveraging many former years of expertise, Dr. Haffner began her career with the U.S. Public Health Service in 1971 and remained with the organization until 2007, achieving the rank of Rear Admiral. She also worked for the Food and Drug Administration (FDA) from 1986 to 2007 as the Director of the Office of Orphan Products Development. Additionally, Dr. Haffner held the title of executive director of global regulatory intelligence and policy at Amgen Inc. between 2007 and 2009, was a member of regulatory consultants for Kakkis EveryLife Foundation between 2009 and 2010, and she was the vice president of medical services at File Bank Inc. from 2009 to 2010.
Throughout her distinguished tenure, Dr. Haffner has been instrumental in developing programs for rare diseases worldwide. She was notably responsible for helping create the European Medicines Rare Diseases Program and assisted with developing the Japanese and Taiwanese programs, among others. Dr. Haffner was professionally responsible for administrating the U.S. Orphan Drug Act. Additionally, she served on over a dozen professional boards, including the board of directors for Dada 2 since 2018, DeNovaMed since 2014, and IORD (The Indian Organization for Rare Diseases) since 2018.
Inspired by both her parents, who were physicians, Dr. Haffner sought to pursue a similar career path by becoming a doctor to positively impact people’s lives. She notes that every job responsibility she has ever had has been an exciting and rewarding growth opportunity, and she is grateful for it all.
Dr. Haffner studied at Case Western Reserve University until she was accepted to The George Washington School of Medicine, from which she graduated in 1965. She also earned a Master of Public Health in health policy and management from Johns Hopkins Bloomberg School of Public Health in 1991.
Affiliated with several professional organizations, Dr. Haffner is a member of the American Public Health Association and an elected fellow of the American College of Physicians and the Royal College of Physicians in London. In light of her accomplishments, she was awarded a Lifetime Achievement Award by the European Organization for Rare Disorders and a Vision and Policy Award by the Canadian Organization for Rare Diseases in 2014. She previously received a Woodrow Wilson Award from Johns Hopkins University in 2009 and a Special Recognition Award from the American Academy of Pharmaceutical Physicians in 2002.
