Acer Scientific Advisory Board

Gerard T. Berry, M.D.

Dr. Berry, a practicing biochemical geneticist and pediatric endocrinologist as well as a renowned scientist, is the Harvey Levy Chair in Metabolism and Director of the Metabolism Program at the Boston Children’s Hospital, and Professor of Pediatrics at the Harvard Medical School, and Director of the Harvard Medical School Biochemical Genetics Training Program. He is a Member of the Board of Directors of the Society of Inherited Metabolic Disorders, and a Communicating Editor for the Journal of Inherited Metabolic Diseases.  His review panel and other NIH service work included serving as a Member of Gene Therapy and Inborn Errors (GTIE) Special Emphasis Panel, a Member of the Therapeutic Advances for Genetic Diseases (TAG) study section and the Chairman of the Rare Diseases Clinical Research Network Data and Safety Monitoring Board 2.  Dr. Berry has been the recipient of many NIH and non-federal grant awards.  He has published over 150 peer reviewed papers and over 40 book chapters.  Dr. Berry was the recipient of the 2004 Emmanuel Shapiro Award from the Sociery for Inherited Metabolic Disorders.  He is the site principal investigator for a NIH-funded multicenter trial to determine to evaluate treatments of urea cycle disorders and organic acidemias.  Dr. Berry’s primary basic science and clinical research efforts have focused on Galactosemia, myo-inositol metabolism in the brain, and other metabolic disorders.

Thomas Fleming, Ph.D.

Dr. Fleming is Professor in the Department of Biostatistics, Member of the Fred Hutchinson Cancer Research Center, and former Director of the Statistical Center for HIV/AIDS National Institutes of Allergy and Infectious Diseases Prevention Trial Network. He has authored or coauthored several books and more than 250 research articles in peer-reviewed journals, many regarding development of state of the art methods for the design, conduct and analysis of clinical trials, and many others reporting the results of landmark trials including the 2011 NEJM publication on prevention of HIV transmission. This research, on which he was senior author, was recognized by Science Magazine as scientific “Breakthrough of the Year”.  Dr. Fleming is the former Chair of Biostatistics at the University of Washington.  He has chaired or served on Data Monitoring Committees for more than 100 clinical trials.  In addition, Dr. Fleming is a Special Government Employee for the FDA, and for more than 25 years he has served as a regular member of FDA Advisory Committees and as an invited voting member on more than 100 occasions. Dr Fleming has received numerous awards including Outstanding Teaching Award in the School of Public Health from the University of Washington, and the FDA Commissioner’s Special Citation Award for Extraordinary Contribution to the Agency. He was the 2007 Greenberg Lecturer at University of North Carolina, the 2009 Distinguished Lecturer at the School of Public Health at the University of Washington and, in 2011, the Ross Prentice Endowed Professor of Biostatistical Collaboration. In 2012, he was elected to membership in the Institute of Medicine of the National Academies.

Marlene Haffner, M.D., M.P.H.

Dr. Haffner is founder of Haffner Associates, a firm dedicated to the field of rare and orphan diseases.  She is the former Director of the Office of Orphan Products Development at the Food and Drug Administration (FDA) and since 2009 has been the CEO of her own firm.  A graduate of the George Washington University School of Medicine, she trained in Internal Medicine, Dermatology and Hematology.  Dr. Haffner is the recipient of numerous professional governmental awards and honors as well as academic awards and received the Outstanding Government Service Award from the John Hopkins University Bloomberg School of Public Health.  A career Public Health Service Officer, Dr. Haffner rose to the rank of Rear Admiral in the US Public Health Service (USPHS).  For 20 years, Dr. Haffner directed the Office of Orphan Products Development at the FDA, becoming one of the world’s experts on the research, development, and approval of designated orphan drugs and products for people suffering from rare diseases.  On retiring from the USPHS in 2007, Dr. Haffner served as the executive director, global regulatory affairs and policy for Amgen, Inc, following which she founded her own firm.  Having worked as a physician for both the FDA, and for a pharmaceutical company, she has a uniquely broad perspective on the subject of developing therapies for rare disorders.  Currently, as a consultant, Dr. Haffner works with organizations for rare diseases to help them form constructive partnerships with researchers and pharmaceuticals to create and approve drugs for their condition. She is an adjunct Professor in the departments of Medicine and the Department of Preventive Medicine and Biometrics at the F. Edward Hébert School of Medicine, Uniformed Services University of Health Sciences (USUHS).  She is a sought after speaker throughout the world and has given almost 300 presentations during her distinguished career.

Brendan Lee, M.D., Ph.D.

Dr. Brendan Lee is Chair of Molecular and Human Genetics Baylor College of Medicine (BCM) and Robert and Janice McNair Endowed Chair and Professor of molecular and human genetics at Baylor College of Medicine and Howard Hughes Medical Institute investigator.  He was elected to membership in the National Academy of Medicine in 2013.  Dr. Lee is co-director of the Rolanette and Berdon Lawrence Bone Disease Program of Texas.  He is a practicing clinical geneticist as well as an educator and researcher.  Dr. Lee combines studies in the laboratory that focus on mammalian tissue and organ development with clinical research involving patients to try to solve some of the most difficult problems in human genetic disease.  Dr. Lee is a world renowned researcher studying people with urea cycle disorders who cannot effectively move nitrogen from their blood.  Dr. Lee was an M.D./Ph.D. at SUNY Downstate student in the late 1980s, when he cloned two genes for connective tissue diseases – Marfan syndrome and spondyloepiphyseal dysplasia. He completed his pediatric residency and genetics fellowship at BCM.  Dr. Lee is a member of the graduate programs in the Departments of Genetics, Cell and Molecular Biology, Developmental Biology and Translational Biology and Molecular Medicine at BCM. Dr. Lee serves on multiple national advisory boards and has chaired the National Institute of Dental and Craniofacial Research Board of Scientific Counselors (BSC).  He is the recipient of numerous awards, including the 2005 American Philosophical Society’s Judson Darland Prize for Achievement in Patient-Oriented Clinical Research, the 2007 Michael E. DeBakey Excellence in Research Award, the 2009 Edith and Peter O’Donnell Award of The Academy of Medicine, Engineering and Science of Texas and the 2009 E. Mead Johnson Award from the Society for Pediatric Research, BCM Alumni Association Medical School Young Alumnus Award (2012), and election to the Association of American Physicians (2010), American Society for Clinical Investigation (2008), Alpha Omega Alpha (1989) and Phi Beta Kappa (1986).  Dr. Lee is the author of more than 170 articles in peer-reviewed journals.

Stuart Swiedler, M.D., Ph.D.

Dr. Swiedler is a biotechnology consultant with more than 25 years of experience in the biotechnology field, primarily as a scientist and junior executive at Glycomed, Inc., and as a clinical scientist and senior executive at BioMarin Pharmaceutical, Inc. Over a 10-year period at BioMarin, he contributed to both the non-clinical and clinical aspects of drug development for the regulatory approvals of the orphan drugs Aldurazyme, Naglazyme and Kuvan. He continues to focus on orphan drug products for genetic diseases, working with both biotech companies and investment firms. Dr. Swiedler received his BS degree from the University at Albany, and his M.D. and Ph.D. degrees from the Johns Hopkins University. He completed residency in Anatomic Pathology at Yale University School of Medicine and Duke University School of Medicine, as well as a post-doctoral fellowship at Duke.