Médunik Canada’s Advisory Board is composed of industry experts and thought leaders who assist and advise us on topics ranging from partnership opportunities and the compliance of our regulatory submissions, to new technologies and clinical trial protocols.
As regulatory requirements have become increasingly complex, so has the role of our advisory board. Médunik Canada is proud to call upon the expertise of the following industry professionals:
JEAN F. CAMPBELL
FORMER VICE-PRESIDENT, MEMBERSHIP DEVELOPMENT AT THE NATIONAL ORGANIZATION FOR RARE DISORDERS (NORD)
Jean Campbell is nationally recognized as one of the leading rare disease patient advocate with an impressive record of success in fundraising and corporate relations. After serving nearly two decades with the National Organization for Rare Disorders (NORD) she retired as Vice-President of Membership Development after spending over ten years mentoring and consulting with many nonprofit organizations and their board of directors. Under Jean's leadership, there was significant expansion of several of NORD's membership programs along with the creation of NORD's restricted research, medical meeting, organization mentor and clinical broadcast programs. Jean also played a key role in the establishment of the NORD Corporate Council, which has grown to 50 pharmaceutical and biotechnology companies.
A well-respected and extremely connected resource in the rare disease health community, Jean has now created her own consulting company, JF CAMPBELL CONSULTANTS LLC. Her expertise in non-profit strategic planning, organizational governance, corporate relations and program management is extremely valuable to all size organizations. Her clients are the non-profit health community, pharmaceutical corporations, and biotech industries. The primary goal of her services is to increase a client's national and international visibility in the health industry as well as create productive partnerships, effective strategic planning, and optimal program development. In addition, Jean provides valuable mentorship to start-up and growing patient organizations helping to strengthen their infrastructure in order to better serve their mission, members and communities.
Jean F. Campbell is a member of the Advisory Board of Medunik USA.
ABBEY S. MEYERS
Former President of the National Organization for Rare Disorders (NORD)
Abbey S. Meyers is the founder and Past President of the National Organization for Rare Disorders (NORD), a coalition of national voluntary health agencies and a clearinghouse for information about little known illnesses. She was also Honorary President of the European Organization for Rare Disorders (EURORDIS)
In the United States Mrs. Meyers served as the consumer representative on the National Commission on Orphan Diseases (1986-89), the NIH Human Gene Therapy Subcommittee (1989-92), the NIH Recombinant DNA Advisory Committee (RAC) (1993-96), the FDA Biological Response Modifiers Committee (1995-99), and the HHS National Human Research Protections Advisory Committee.
Mrs. Meyers is the recipient of the FDA Commissioner's Special Citation for Exceptional Dedication and Achievements on Behalf of All People Afflicted with Rare Disorders (1988), and the Department of Health and Human Services Public Health Service Award for Exceptional Achievements in Orphan Drug Development (1985). Mrs. Meyers holds an Honorary Doctorate from Alfred University in New York. She is considered the primary American consumer advocate responsible for passage of the Orphan Drug Act of 1983. Mrs. Meyers was also instrumental in the development and enactment of several other health related laws including a requirement to provide notice to physicians and patients before a treatment will become unavailable or experience a shortage; the Rare Diseases Orphan Products Development Act of 2002; the Rare Diseases Act of 2002; and she participated in the planning of the European Union's Orphan Drug Regulation.
Throughout her career, Mrs. Meyers has been sitting on many committees, boards and commissions dealing with orphan diseases at the national and international levels. She is also the author of many articles and papers related to this topic and was a frequent speaker at numerous conferences.
Abbey Meyers is a member of the Advisory Board of Medunik USA.
Marlene E. Haffner, M.D., M.P.H.
Former FDA's Director of Orphan Product Development
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 Master of Public Health degree 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. She is board certified in internal medicine. It was at the Albert Einstein College of Medicine that Dr. Haffner first became interested in the underserved and in rare diseases, as she was responsible for patients in the sickle cell clinic and performing research on abnormal hemoglobin.
Following her residency, Dr.Haffner and her physician husband joined the United States Public Health Service(USPHS) in Gallup, New Mexico.From 1974 to 1981, Dr.Haffner served as the Director, Navajo Area Indian Health Service.As such, she was responsible for the broad range of public health services provided to the Native American population – preventive services, curative services, public health nursing, dental, water and sanitary services, as well as long term care.As a member of the uniformed service of the USPHS, Dr.Haffner's next assignment was with 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. Under Dr. Haffner's direction, the fledging program became the Orphan Products Program in the world and was emulated widely.With her assistance, programs were developed in Japan, the European Union, Australia and beyond.During her tenure at OOPD more than 300 products were developed to treat more than 15 million rare disease patients in the United States and many more world wide.In addition, the biotech industry credits the US Orphan Drug Act for shepherding the tremendous growth in that industry with the exclusivity provisions provided by the Act.
In December 2006, following almost 36 years of active duty, Marlene retired from the USPHS as Rear Admiral and became Executive Director, Global Regulatory Intelligence and Policy for Amgen, Inc., the largest biotechnology company in the world.She served in that role for two years prior to launching, March 2009, her own business, Haffner Associates, LLC.Haffner Associates is dedicated to furthering the treatment and prevention of rare diseases through assistance to patient supports groups and assisting the pharmaceutical industry in the development of products for those devastating diseases.
Dr.Haffner is the recipient of many awards: the Meritorious Service and Distinguished Service Awards from the USPHS, the Outstanding Service to the Public Health Award from the National Organization for Rare Disorders (NORD), The Outstanding Contributions to Pharmaceutical Medicine Award from the American Academy of Pharmaceutical Physicians, and in May 2009, the Woodrow Wilson Award for Outstanding Government Service from the Johns Hopkins University.Marlene is the author of many articles and book chapters 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.
When not involved in matters of public health and drug development, Marlene can be found in her large rose garden, cooking for friends in her wonderful kitchen, hiking and skiing with her family or pursuing any number of travel pursuits to the four corners of the earth.
Dr.Haffner is a member of the Advisory Board of Medunik USA.