Strategic Advisory Board

 

Atlantic Research Group, Inc. (ARG) has assembled a rare disease Strategic Advisory Board (SAB) to broaden insight and knowledge into the rare disease clinical development process. The flagship goal of the SAB is to improve connectivity and collaboration to solve the most pressing challenges posed by rare disease trials and to achieve clinical trial success. The members of the SAB combine expertise from across multiple disciplines including sponsors, patient advocacy groups, government agencies, and rare disease patients, to achieve the best care for those living daily with rare diseases. #rareforareason

 

Jean Campbell is nationally recognized as one of the leading rare disease patient advocates with an impressive record of success in fundraising and corporate relations. Jean served nearly two decades with the National Organization for Rare Disorders (NORD) in senior management positions including Vice President of Development. Under Jean’s leadership, there was significant expansion of several of NORD’s individual and organization membership programs along with the creation of NORD’s restricted research, medical meeting, organization mentor and clinical broadcast programs. Jean played a key role in the establishment of the NORD Corporate Council and was instrumental in the creation and supervision of the disease-specific Patient/KOL Regional meetings. A well-respected resource in the rare disease community, Jean formed JF Campbell Consultants LLC, in 2010. Her expertise in patient advocacy, organizational governance, corporate relations, patient assistance programs and program management is valuable to all size organizations. Her clients include non-profit health organizations, pharmaceutical and biotech industries. Jean’s goal is to increase a client’s 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 serves on MedunikCanada’s Advisory Board, is a Senior Advisor for SmithSolve Communications and is a special consultant for the Volunteer Consulting Group Governance Matters (VCGGM) and Rare Disease Management (RDM). Jean also serves on America’s Charities Health 1st Board of Directors.

Jon C. Mirsalis is Vice President of Translational Development in the Biosciences Division at SRI International in Menlo Park, CA, where he has management responsibility for all regulated medical product development activities including pharmacokinetics, toxicology, clinical manufacturing and clinical trials. Dr. Mirsalis has extensive experience in the development of drugs for a broad range of indications including infectious disease, cancer and CNS. He currently manages two large programs for the National Institute of Allergy and Infectious Diseases (NIAID) for the development of promising therapeutics for the prevention and treatment of a broad range of infectious diseases including TB, malaria, HIV, influenza, hepatitis, MRSA, anthrax and Ebola. He has previously managed similar programs for both cancer chemopreventive and therapeutic agents for the NCI and brain imaging agents for the NIMH. He has personally been involved in the development of over 50 therapeutics that have entered clinical trials and several have reached the market. Before joining SRI in 1981, Dr. Mirsalis was a postdoctoral fellow at the Chemical Industry Institute of Toxicology, where he developed the in vivo-in vitrohepatocyte DNA repair assay, which is now used as a screen for potential carcinogens by government and industry. He is the author of over 200 publications and abstracts. Dr. Mirsalis received his B.S. degree in zoology/molecular biology from Kent State University, his M.S. degree in genetics from North Carolina State University, and holds Ph.D. degrees in toxicology and genetics from North Carolina State University. Dr. Mirsalis lectures at Stanford University on biosecurity and at UC-San Francisco on drug development. He is currently a member of the Board of Directors of the California Biomedical Research Association and the Advisory Council for the Critical Path Institute’s Predictive Safety Testing Consortium (PSTC). He has previously served on the Board of Scientific Councilors for the National Toxicology Program and the FDA’s Over-the-Counter Product Review Committee. Dr. Mirsalis has been certified by the American Board of Toxicology since 1983.

Carol is an experienced rare disease biotech executive with a strong track record of building, developing and assisting orphan businesses through strategic planning, direct sales and commercial and business development transactions. Carol was most recently the Head of Business Development and Strategy for Spark Therapeutics (Gene Therapy) and spent 15 years of her career with Genzyme Corporation as a Vice President Corporate Development and led cross-functional Orphan and Rare Disease team members in identifying and targeting complex rare disease products. Carol is also an active member of the Harvard Business School Leadership Training Program.

Dr. Yaffa Rubinstein is the Rare Disease Patient Registries and Bio-repositories Special Volunteer to the National Information Center of Health Services Research & Health Care Technology at the NLM/NIH. Yaffa R. Rubinstein served as the Director for patient resources for clinical and translational research at the National Center for Advancing Translational Sciences (NCATS)/National Institutes of Health (NIH), where she established directed the NIH/NCATS GRDR Program, a Global Rare Diseases Patient Registry Data Repository. She led the development of the GRDR common data elements (CDEs) and the model informed consent for participating in rare diseases patient registries. At NIH, she continues to be an active member of the CDEs working group as well as disease-specific CDE working groups. She is also active in the European rare disease initiative, RD-Connect/IRDiRC, and a passionate supporter of rare disease patient advocacy groups and their families, providing them with assistance and information about patient registries, biospecimens and the importance of sharing data. She trained as a molecular biologist and received a Ph.D. from the University of Maryland, College Park.