Robert B. Linke
Mr. Linke has 30 years of diversified healthcare experience in pharma/biopharmaceutical, medical device, diagnostic, and healthcare informatics markets. His healthcare experience includes leadership roles developing and commercializing products at both public companies, Baxter International and Caremark International, and as an entrepreneur leading private equity-backed companies, including Periodontix, a biotech company, Rapid Micro Biosystems, a diagnostic company, and Embera raising over $60 million in private equity and non-dilutive financing to fund these companies.
Mr. Linke joined Embera in 2009 as its CEO establishing strategic direction for the development stage specialty pharma company, assembling the company’s product development team and leading development partners, and financing the EMB-001 development program,that has successfully completed a Phase 1 safety and PK study and is entering Phase 2 clinical development, through both private equity and NIH grants. Prior to joining Embera, he provided consulting services to a range of growing life science companies including Allscripts, a leading pharmaceutical e-marketing company, where led their Physicians Interactive Division and the ultimate spin out of the business as an independent company. Prior to this venture, Mr. Linke built two development stage life science companies – Rapid Micro Biosystems and Periodontix in the role of President & CEO. At Rapid Micro Biosystems he developed and executed the strategy to commercialize imaging-based rapid microbiology testing systems for pharma and biotech manufacturers that are now being sold to the industry. At Periodontix, Inc., a venture-backed biopharmaceutical company, he led the effort to develop a portfolio of antimicrobial products and sold the company after advancing the lead compound through Phase 2 studies. Mr. Linke also has an extensive business leadership background that includes senior sales, marketing and general management positions at leading healthcare companies that include Baxter International, Caremark International and Sunstar Inc. (Japan).
Michael Detke, M.D., Ph.D.
Dr. Detke leads Embera’s clinical research and development. He has 16 years of experience in CNS drug development. At Eli Lilly he was Global Medical Director for Cymbalta, a $5B/year drug for depression and pain, and later head of all CNS assets in early phase clinical development. Since then, he has served as Chief Medical Officer at multiple other companies. He has over 70 peer-reviewed scientific publications, is an adjunct Clinical Professor of Psychiatry at Indiana University School of Medicine, and is an active member of selective scientific organizations such as ACNP, SOBP, etc.
Dr. Detke is a board-certified psychiatrist with 30 years of research and clinical experience, 16 in drug development. He has experience in many aspects of CNS clinical trial design and conduct, clinical development, regulatory documents such as INDs, NDAs and Fast-Track applications, and at many meetings with global regulatory bodies such as the FDA and EMA. He also has experience on scientific advisory boards, data & safety monitoring boards, etc.
He was MedAvante Chief Medical Officer from 2009-2013. He led a team dedicated to researching and improving signal detection in CNS clinical trials, using central ratings, central audio/video review, rater training, etc. He has published and presented extensively (and twice to the FDA) on various aspects of placebo response and signal detection.
He was at Eli Lilly from 2000-2009. In his last role, he was head of all CNS assets in early phase clinical development, including all psychiatric, neurological, and pain indications. Prior to that, he was Senior Medical Director responsible for Phase 3 development for Cymbalta and Phase IV for Prozac, and a Clinical Research Physician leading Phase 2 & 3 clinical trials in depression, anxiety, etc.
Dr. Detke earned a BA and MS at Yale University, and MA, MD, and PhD degrees at the University of Pennsylvania. He trained in adult Psychiatry at Massachusetts General & McLean Hospitals at Harvard University. He has published over 70 manuscripts in peer-reviewed journals, serves as a reviewer for numerous such journals, and is an active member of selective scientific organizations such as ACNP, ASCP, ECNP, ISCTM and SOBP. He has taught and supervised medical students and residents in patient care as a volunteer (adjunct) Clinical Professor of Psychiatry at Indiana University School of Medicine since 2000.
Julie Ann Straub, Ph.D.
Dr. Straub directs Embera’s nonclinical development and chemistry, manufacturing and controls (CMC) efforts on a consulting basis. She is an experienced pharmaceutical development consultant working with a range of development stage pharmaceutical and biotech companies from concept through FDA marketing approval for a variety of products. Dr. Straub is the former Executive Director of Research for Acusphere.
Dr. Straub has over 25 years of drug development experience, which includes managing IND-enabling nonclinical programs and developing and executing CMC strategies for small pharmaceutical/biotechnology companies. Prior to establishing her consultancy, she served as Executive Director of Research for Acusphere, a specialty pharmaceutical company, including working from concept as an inventor through NDA submission for a cardiovascular imaging agent. Before holding that position she was involved in drug/biologic research and development at Alkermes, and was an NIH postdoctoral fellow at Harvard. For the past six years she has been an independent consultant advising medical product companies and academic institutions on areas of product development, CMC, nonclinical studies, regulatory affairs, project management, and specific scientific topics such as drug delivery. Dr. Straub received a B.S. and an M.S. in Chemistry from Caltech and a Ph.D. in Chemistry from MIT.
Ann Robbins, Ph.D.
Dr. Robbins has 25 years of experience providing clinical and regulatory affairs expertise to drug development programs, from preparation of initial IND submissions to regulatory support of marketed products. Trained as a neuroscientist, her therapeutic focus is on central nervous system and neuroendocrinologic drug products. For the past 6 years, she has been an independent regulatory affairs consultant, providing regulatory strategy for global interactions with and submissions to regulatory bodies, lifecycle management and regulatory compliance for marketed products, and regulatory due diligence for product in- licensing and business partnerships.
Dr. Robbins has 25 years of experience providing clinical and regulatory affairs expertise to drug development programs, from preparation of initial IND submissions to regulatory support of marketed products. Trained as a neuroscientist, her therapeutic focus is on central nervous system and neuroendocrinologic drug products. For the past 6 years, she has been an independent regulatory affairs consultant, providing regulatory strategy for global interactions with and submissions to regulatory bodies, product lifecycle management, regulatory compliance for marketed products, and regulatory due diligence for product in or out- licensing and business partnerships.
Prior to becoming a consultant, Dr. Robbins held regulatory affairs leadership positions at Procter & Gamble Pharmaceuticals and Eli Lilly, served as Vice President of Clinical Development and Regulatory Affairs at Thyreos, a startup pharmaceutical company, and provided clinical trial management and regulatory affairs expertise at Organon Pharmaceuticals, and the Population Council, Center for Biomedical Research, a non-profit drug development organization. She received her B.A in Physiological Psychology from The University of Texas, her MA and Ph.D. in Neuroscience from Florida State University.
Gary Connor, R.N.
Mr. Connor heads up Embera’s clinical operations, after serving as consulting Director of Clinical Operations at Adnexus, a Bristol-Myers Squibb R&D Company. He has more than 20 years of healthcare experience, with the past 15 years dedicated to clinical operations/project management including: study design, managing budgets and timelines, selection and management of CRO’s, managing staff, developing and implementing patient recruitment strategies, writing SOP’s, CRF Completion Guidelines and other study related documents, and assuring GCP compliance. He has worked in a vast array of indications, primarily with early and emerging companies.
Mr. Connor became a Registered Nurse in 1995 and began his career in pediatrics at Massachusetts General Hospital. He ascended quickly within the hospital’s structure to serve as the First Assistant to the Chief of Pediatric Surgery, Patricia K. Donahoe, MD. In 1999, he founded Asclepius Research Services, Inc. and later co-founded Panacea Clinical Research, a clinical research organization that specialized in the execution of early phase studies. An accomplished healthcare consultant, Mr. Connor was elected to the Maine House of Representatives in 2006 and was twice named “Legislator of the Year”. He left public service in 2010, but currently serves on the Maine Vaccine Board. During his time in the legislature, Mr. Connor served on the Maine Substance Abuse Services Commission and developed a strong interest in treatment for addiction and dependence. He is a graduate (honors) of the Lawrence Memorial Hospital School of Nursing/Regis College program.