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ABOUT US

Strategic Advisory Board

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Marlene Haffner, M.D.

Dr. Haffner is an internist and hematologist who graduated from the George Washington University School of Medicine and did further training at the Columbia University School of Medicine and the Albert Einstein College of Medicine, in New York City. Marlene received her Masters of Public Health from the Johns Hopkins Bloomberg School of Public Health in Baltimore.

For more than twenty years, Dr. Haffner was the Director of the Office of Orphan Products Development at the FDA. During her tenure in that program, it became one of the leading orphan products programs in the world. In addition to assisting in the development of more than 300 products in the United States, she is credited with assisting in the development of programs in Japan, the European Union, Australia, and beyond. Her extensive speaking and writing brought the term “orphan products” to the mind of many in the pharmaceutical world. In addition to her work at FDA, Dr. Haffner was also employed for two years by Amgen, the largest biotech company in the world. Her responsibilities there were as Executive Director, Global Regulatory Intelligence and Policy.

During her tenure at the FDA, and as stated above, more than 300 products were brought to market. Those 300 products have the ability to treat more than 15 million individuals in the United States and far more beyond those borders.

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Philippe Monteyne, MD, PhD

Dr. Monteyne is a VC Partner with the newly created investment ‘FUND+’, an open-ended fund for long-term equity investment in innovative life sciences companies with a focus on Belgium. Philippe is also visiting Professor of Neurosciences at UCL, Catholic University of Louvain in Belgium.

His experience includes serving as Senior Vice President – Head of Development and CMO, GlaxoSmithKline (GSK) Rare Diseases (2010-2012), acting as Global Head of R&D, and significantly contributing to building the Orphan Drugs pipeline of GSK.

Other experience includes executive positions such as Vice President R&D France, Sanofi (2012 until end 2014), in Paris area, reporting directly to the President Global R&D. Philippe worked at setting up a new hub structure in France, across all R&D disciplines and all French sites resulting in, an organization of more than 6,000 scientists. During that period, he was also Board Member of SARD (Sanofi Aventis R&D), of the LEEM (Pharmaceutical association in France “Les Entreprises du Médicament”), of the Technological Research Institute (IRT) Bioaster in Lyon, and of the “Fondation Plan Alzheimer France”.

He has also held several positions with GSK Vaccines (1998 to 2010), up to Senior Vice President, Head of Global Vaccine Development. Dr. Monteyne was responsible for the management of all vaccine projects and products after proof of concept, as well as for regulatory affairs and for medical affairs for GSK vaccines worldwide. He was the Chairman of the Development Review Committee for GSK Vaccines. Among his achievements, was his contribution to the acceleration of the development of GSK’s cervical cancer vaccine, Cervarix.

Trained as a Medical Doctor and Neurologist, and holder of a Ph.D. in Immunology from UCL Belgium (Catholic University of Louvain), Dr. Monteyne started his career in the academic field with the public research foundation of Belgium and as Neurologist at Saint Luc Univ Hospital Brussels, and as post doctoral fellow with the Pasteur Institute in Paris.

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Grannum R. Sant, M.D., F.R.C.S., F.A.C.S.

Dr. Sant has a unique combination of extensive academic, clinical medicine and biopharmaceutical industry experiences. He is a national and international key opinion leader (KOL) in urology, cancer and men’s and women’s health, as well as an expert in rare diseases. He served as the Past President of the New England Section of the American Urological Association (AUA). He was Professor and Chair of the Urology Department at Tufts University School of Medicine before he joined industry.

He has served as Head of U.S. Oncology and Urology Medical Affairs at Sanofi US and its legacy companies (Sanofi-Synthelabo, Sanofi-Aventis) and Head of US and Global Medical Affairs for Rare Orphan Diseases at Genzyme. He spearheaded six product launches in urology, oncology and rare orphan diseases; and has led six disease state Registries (two in urology/oncology in the U.S. and four Global Registries for Lysosomal Storage Diseases). He has served on publication and scientific communication teams across multiple therapeutic areas and built Medical Scientific Liaison (MSL) and Medical Affairs teams in Urology, Oncology and Rare Orphan Diseases at Sanofi and Genzyme.

He was a Principal Investigator for many pivotal registration trials and National Institutes of Health (NIH-NIDDK) grants. He has served on multiple pharmaceutical medical advisory boards. He edited two urology textbooks (The Pathologic Principles of Urology and Interstitial Cystitis) and ten Journal Supplements and authored 180 peer-reviewed journal articles and book chapters.

He remains Professor (Adjunct) of Urology at Tufts University School of Medicine and is the President-elect of the Academy of Physicians in Clinical Research (APCR), and is on the Board of Trustees of the Academy of Physicians in Clinical Research (APCR) and the Association of Clinical Research Professionals (ACRP). He is a member of the Standards Committee of the International Society of Medical Publications Professionals (ISMPP). He serves on the editorial boards of multiple national and international scientific journals.

Dr. Sant holds a Bachelor’s degree and an M.D. degree from Trinity College, Dublin.  He also did a general surgery residency at the Albert Einstein College of Medicine of Yeshiva University and a general surgery fellowship at the Royal College of Surgeons, Edinburgh, Scotland, UK.  He then went on to do a urology residency at Tufts University School of Medicine.

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Dick H. A. Meijer

International Executive with more than 30 years of experience in commercial development and operations in the medical and (bio)pharmaceutical industry in North and Central-Eastern European countries, Benelux, Greece and Portugal. He was co-founder of the Dutch Biopharmaceutical Industry Association Biopharmind, and Chairman of the Working Group on Orphan Drugs in The Netherlands. In 2002 he relocated to the headquarters of Genzyme in Boston to assume the position of Vice President International, where he was responsible for business development in the Asia Pacific region, Sub–Saharan Africa and Canada. Prior to joining Genzyme, he held positions of increasing responsibility at Boehringer Mannheim, GD Searle and Baxter. Following Genzyme’s acquisition by Sanofi, Mr. Meijer left Genzyme after almost 20 years.

He is President and Founder of Bioneur, a boutique consultancy company specializing in rare diseases – orphan drugs. Bioneur conducts rare disease-specific market research about, but not limited to, pre-commercial pathways and timelines, provides strategic advice to market entry and hands-on operational support to emerging biopharmaceutical companies interested in expanding their commercial footprint in countries around the world. Mr. Meijer is a permanent resident of the United States and studied International General Management at the European Center for Executive Development, CEDEP in Fontainebleau, France and INSEAD in Singapore.

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