Linda Dujack, retired from Johnson & Johnson (J&J), was Vice President for Product Evaluation and University Relations, where she was responsible for proactively establishing relationships with universities, small bio-tech companies, and major pharmaceutical companies in order to identify new opportunities that would merit participation by J&J.
Prior to that Linda served as Vice President of Worldwide Regulatory Affairs at J&J, resulting in many successful submissions and approvals. She was also part of the licensing/financing team responsible for evaluating new product/technology opportunities and developing R&D cost models for the financial evaluation of these opportunities. At J&J Linda also served as Executive Director for the Erythropoietin (EPO) Worldwide Development Project and Director for Medical Services and Support, a department she established for Ortho Biotech.
Prior to joining J&J, Linda was Deputy Director for the Food and Drug Administration in the Center for Biologics Evaluation and Research. She was also Vice President for Regulatory Affairs and Special Projects at Geritech, a small start-up company whose technology came from Rockefeller University. Linda was also Associate Director of Regulatory Affairs at Hoffmann La-Roche. Prior to that she was a Senior Staff Officer at the National Academy of Sciences/Institute of Medicine.
Linda earned her PhD in biology from Georgetown University with distinction and her BS degree also in biology from Ramapo College of New Jersey with honors. She taught biology and cell biology as an Assistant Professor at Hood College in Frederick, MD.
Since retiring from Becton Dickinson (BD) in Jan 2016, Charles has been acting as a strategic advisor to large and medium companies seeking to expand further into or enter the Health Care market. Charles also serves as Board member for innovative start up companies. On the investment side, Charles is a seed stage angel investor. Overall Charles expertise covers technology, business and go to market strategy and also deep knowledge of product development for medical devices, diagnostics and life science research tools.
From October 2013 to Jan 2016 Charles was Sr. Vice President / Chief Scientific Officer Greater Asia, responsible for the strategy and global performance of BD’s regional R&D operations in Asia. The strategic goal was to enhance the companies’ growth in emerging countries via market appropriate solutions. A lucrative Regional pipeline was created, a fully functional R&D operation was created in China and the existing Singapore capability was expanded to enable product development and responsibility as the Regional R&D hub. An extensive external network was established that enabled sourcing and deal making for new opportunities from start ups, Universities and other companies. In 1997 Charles was appointed BD's Vice President, Research responsible for BD Technologies. BD Technologies engages in technology development in support of downstream product development carried out by the businesses. Some of BD Technologies accomplishments include commercialized micro needle based drug delivery, nano- technology based point of care diagnostics and novel products for stem cell growth. Extensive external networking and partnering was done to tap outside innovation.
In addition, Charles has championed and introduced new Innovation practices on a global basis. Charles established in-house incubators in NC and Singapore for collaboration with and investment in start-ups. Charles led the effort to revamp and revitalize BD's Technology Leadership Development program as part of a broader initiative to provide a pipeline of talent for the company and has served as a leaderteacher of BD leadership training courses.
Charles has been with BD since 1988. From 1988 to 1997 Charles was Vice President of R&D for BD's Hypodermic and Injection Systems business. During this period, Charles initiated and led the major product development work that was done for BD’s highly successful healthcare worker needle stick prevention safety products, IV flush platform and a market appropriate catheter for China. These projects and others Charles was instrumental in championing and leading throughout his career at BD have created billions of dollars in annual revenue for BD for many years, The China catheter has been and remains BD’s largest selling product in China.
Prior to joining BD Charles led the product development efforts for Millipore Corp in Bedford, Massachusetts.
Charles served on the Board of NC BIO the local affiliate of BIO, the national Biotechnology industry organization. NC BIO advocates on behalf of its member companies mostly locally in North Carolina. Charles served and was Chairman of the Board of Ibiliti a non-profit focused on supporting and growing the Med Tech industry in N C. Charles served as Chairman of the Board of the Singapore Bio Venture Center an incubator that was a joint venture between BD and Johns Hopkins Medical. He also served as a member of the Board of Synecor. Charles has a Ph.D and MA from Princeton University an MSE degree from Johns Hopkins University and a B Ch E degree from the City College of New York. Charles has numerous publications and has given many talks.
Charles is member of numerous professional organizations and engages in outside charitable and philanthropic efforts on behalf of the Juvenile Diabetes Research Foundation and Princeton University. He served 6 years as a board member of the Eastern North Carolina chapter of the JDRF.
Charles serves on advisory committees for the Chemical and Biological Engineering Department at Princeton, the Whiting School of Engineering at Hopkins, the Chemical and BioMolecular Engineering Department also at Hopkins. He is an Annual Giving fund raiser for Princeton.
Charles received an award from the Johns Hopkins University for distinguished alumni service. Charles received several awards from the Juvenile Diabetes Research Foundation for service to that organization as well. At BD Charles has received highest level company awards for Technology Leadership, Innovation and Lifetime Achievement.
Randall Kaye, MD serves as the Global Head of Medical Affairs at SSI Strategy, a boutique consulting firm focused on Medical Affairs, Pharmacovigilance and Clinical Development. In Dr. Kaye’s role at SSI Strategy, he focuses on providing a medical and scientific perspective to transformative initiatives in Medical Affairs and Pharmacovigilance. He plays a key role in SSI’s bespoke advisory services and regulatory compliance service offerings.
Most recently, Dr. Kaye was Chief Medical Officer at Axsome Therapeutics, a biopharmaceutical company developing novel therapies for the treatment of pain and other neurological diseases. While at Axsome, Dr. Kaye developed and executed all Clinical Research functional areas that resulted in the initialization of three clinical programs (IND Filing, FPI) in less than one year. Prior to joining Axsome, Dr. Kaye was Chief Medical Officer at Avanir Pharmaceuticals (acquired by Otsuka), a CNS specialty company. While at Avanir, Dr. Kaye provided leadership and vision to the clinical, regulatory and medical affairs areas, and supported the commercialization of new products from a medical, scientific, regulatory, technical and quality perspective. Prior to Avanir, Dr. Kaye served in a variety of medical affairs leadership positions at Scios Inc. (acquired by Johnson and Johnson) a cardiovascular specialty company, InterMune Inc. (acquired by Roche), a specialty company focusing on Idiopathic Pulmonary Fibrosis and Pfizer Inc.
Dr. Kaye earned his Doctor of Medicine, Masters in Public Health and Bachelor of Science degrees at The George Washington University in Washington, D.C. Dr. Kaye trained in Pediatrics at the University of Massachusetts Medical School and was a Research Fellow in Allergy and Immunology at Harvard Medical School.
Dr. Mahmoudian’s career spans 20 years in the biotechnology, pharmaceutical, and chemical sectors. He joined Purdue Pharma in 2016 as Vice President, Head of Virtual Discovery business unit worldwide to incubate, build and commercialize an innovative R&D pipeline outside pain/ CNS. At Ferring Pharmaceuticals, he served as Vice President, Head of Innovative Medicines responsible for setting and delivering corporate strategy in immunotherapy, and external research. Prior to that, he was at Merck managing its External Research and R&D Operations in vaccines, biologics and biosimilars (Merck BioVentures) on a global basis. At Dow he was the Global Head of Biotechnology overseeing all of research and strategic alliances in five sites (US, UK, France, China, Japan) generating $600M sales. Dr. Mahmoudian was recruited to Eastman earlier in his career as the Worldwide Head of Biotechnology responsible for R&D, partnering, managing growth, and development of its BioProducts portfolio. He launched his career with GlaxoSmithKline, where he held a variety of research, technology, and management roles of increasing responsibility in drug discovery, preclinical development and BioPharm R&D.
Dr. Mahmoudian has extensive hands-on scientific and operations experience leading international teams in R&D (discovery, preclinical, phase I-III), CMC, tech transfer, GMP biomanufacturing, and licensure of six blockbusters (Abacavir®, Epivir®, Lamuvidine®, Relenza®, Trizivir®, Zygara®) with $15B sales. He drives corporate and business development strategies to identify, incubate, or syndicate early/ late phase clinical assets, build NewCo and future R&D portfolio (cell therapies, vaccines, biologics, small molecules). He leads cross-functional scientific due diligence teams to scout, evaluate, and negotiate external innovations in products, platforms, academic alliances, and startups (40 deals) across multiple therapeutic areas (immunotherapy, cancer vaccines, immuno-oncology, rare diseases, microbiome, infectious diseases).
Arikha Moses, PhD, is a seasoned executive with 15+ years of experience creating and leading medtech companies. Dr. Moses started her career at a seed-stage venture firm, where she was responsible for sourcing, building, and managing early-stage life science companies including EluSys Therapeutics and TyRx. As TyRx’s Founder and Chief Scientific Officer, she was responsible for the company’s strategy and during her tenure she was involved in all aspects of the company’s business including financing, licensing, product development, corporate partnerships with Boston Scientific and Bard, and the commercialization of multiple drug-eluting devices. TyRx was sold to Medtronic for $160MM. She has also worked with the venture capital firm the Vertical Group as an EIR, where she assisted with due diligence on investments in both private and public companies. While working with Vertical, she founded and led Galatea Surgical, a plastic surgery company, through clinical studies and commercial product sales.
Arikha received a PhD in Chemistry from Yale University and a BA with Honors in Chemistry from Brandeis University.