EMBERA NEUROTHERAPEUTICS - Key Persons
Job Titles:
- Vice President, Regulatory Affairs
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 drug treatment for central nervous system disorders and neuroendocrinologic drug products for women's reproductive health. For the past 10 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.
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 M.A. and Ph.D. in Neuroscience from Florida State University.
Job Titles:
- CEO of Tilos Therapeutics
Dr. Fox is CEO of Tilos Therapeutics. Tilos is developing novel antibody therapeutics to modulate the immune system for the treatment of cancer, fibrosis and autoimmune diseases. Dr. Fox has broad background in addiction R&D that includes VP Discovery Research of ImmuLogic Pharmaceutical Corp. where she led their cocaine vaccine development program and Recovery Pharmaceuticals, as founder, President and CSO, developing and marketing medications for the treatment of addiction including nicotine dependence products.
Job Titles:
- Chief Medical Officer
- Member of the Management Team
- Company Consultant
Dr. McCarthy is a drug development and start-up company consultant. Most recently, he was the President and CEO of Afferent Pharmaceuticals, a clinical development stage company developing treatments for pain, bladder and respiratory disorders based upon P2X3 antagonism which was ultimately purchased by Merck in 2016 transaction valued at $1.25B in cash and contingent payments. His experience includes 25 years of neuroscience drug development. At Pfizer, Inc., Dr. McCarthy served as vice president, neuroscience development. Clinicians in his organization obtained approval for Chantix® for smoking cessation. Prior to joining Pfizer, he held various roles at Abbott Laboratories, including venture head, where he managed clinical development programs for neuroscience drug candidates, including ABT-594 (an NNR antagonist for pain) and Depakote. He has previously served as an industry consultant, when Dr. McCarthy served as head of development and chief medical officer for several start-up companies including Embera, developing treatments for neurological and psychiatric disorders. Dr. McCarthy received an M.B.A. from Kellogg School of Management, an M.D. from the Johns Hopkins University School of Medicine and a B.S. in biological sciences from Stanford University. He completed his residency in neurology at the University of California, San Francisco.
Dr. Gloff has over 33 years of drug development experience, with responsibilities ranging across nonclinical pharmacology, pharmacokinetic and toxicology programs, early stage clinical studies, chemistry, manufacture and control activities, and development and execution of regulatory strategies for both drugs and biologics. As the founder and principal of Carol Gloff & Associates, for the past 20 years she has advised medical product companies and academic institutes on areas of product development, regulatory affairs, quality, compliance, and specific scientific topics such as pharmacokinetics. Earlier in her career she served as the Vice President of Regulatory Affairs for two pharmaceutical companies, ImmunoGen and Alkermes, and was previously involved in drug/biologic development at Triton Biosciences and formulation development at Pennwalt Pharmaceuticals. In addition to teaching a semester course on regulatory affairs at Boston University for 16 years (1995-2011), from 2005 to 2014 she was an elected member of the Board of Selectmen in Natick, MA, and from 2013 to 2015 she served as President of the University at Buffalo Alumni Association. She is currently a member of the Board of Directors of the American Foundation for Pharmaceutical Education. Dr. Gloff received her B.S. in Pharmacy from the University at Buffalo and her Ph.D. in Pharmaceutical Chemistry, with a concentration in pharmacokinetics, from the University of California San Francisco.
Dr. Feltner is Vice President, Pharmaceutical Development, Neuroscience, AbbVie Inc. where he leads neuroscience development for AbbVie, focusing on projects in Alzheimer‘s disease, Parkinson's disease, and multiple sclerosis. He has more than 18 years of experience in pharmaceutical drug development and translational medicine, including past positions with Solvay, Warner Lambert and Pfizer, where he was Vice President, Global Head of Translational Medicine. Prior to that he worked on Lyrica® and Chantix®. He has over 40 peer-reviewed scientific publications.
Dr. Kathleen T. Brady is a board-certified psychiatrist specializing in addiction psychiatry. As a Professor of Psychiatry at the Medical University of South Carolina, Dr. Brady is Director of the Clinical Neuroscience Division, Director of the Women‘s Research Center, Associate Director of the General Clinical Research Center (GCRC), Director of the Southern Consortium of NIDA's Clinical Trials Network, Director of MUSC's application for the Clinical and Translational Science Award and Associate Dean for Clinical Research. Her research interests are in the areas of drug and alcohol abuse/addiction and comorbid conditions such as posttraumatic stress disorder and other anxiety disorders. She has served as Principal Investigator, Co-Principal Investigator, and Mentor on numerous research projects. Dr. Brady has been very active in organizations addressing the concerns of psychiatry and addictions. She is Past President of the Association for Medical Education and Research in Substance Abuse and Past President of the American Academy of Addiction Psychiatry. She has served on the Scientific Advisory Council of the National Institute of Drug Abuse and the Committee on Community Based Treatment of the Institute of Medicine, the National Academy of Science, as well as the Board of Directors of the College of Problems of Drug Dependence.
Job Titles:
- Member of the Management Team
- Registered Nurse
- Chief Operating Officer and Vice President, Clinical Operations
Mr. Connor leads the Embera organization as its Chief Operating Officer in addition to his clinical operations responsibilities, 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.
Job Titles:
- Director of the Duke Center for Smoking Cessation Research
Jed E. Rose, Ph.D. is Director of the Duke Center for Smoking Cessation Research and Professor in the Department of Psychiatry and Behavioral Sciences at Duke University Medical Center. Additionally, he is President and CEO of Rose Research Center, based in Raleigh, NC. Dr. Rose is considered one of the leading authorities on the treatment of tobacco addiction. In the early 1980's, Dr. Rose led the initial studies of transdermal nicotine administration, which helped pave the way for the development of commercial nicotine skin patches as a smoking cessation treatment; he also conducted pioneering studies into the role of sensorimotor aspects of cigarette smoking and methods to substitute for them, including novel e-cigarette like technologies. Since then, Dr. Rose and his colleagues have continued to develop smoking cessation treatments, including novel pharmacologic approaches and extinction-based treatments to enable smokers to quit smoking more successfully. Their studies of agonist-antagonist treatment provided support for the development of varenicline as a partial agonist for smoking cessation treatment. In addition to developing more effective smoking cessation and tobacco harm reduction strategies, Dr. Rose's research program strives toward a deeper understanding of tobacco dependence. His research is currently applying brain-imaging methodologies, including positron emission tomography (PET) and functional magnetic resonance imaging (fMRI), to identify brain substrates underlying craving and addiction. Genomic and other individual predictors of quit smoking success are also being elucidated. The knowledge gained from this basic research program will be applied to the design of novel therapeutic approaches, and to the development of algorithms for personalizing treatment so that each smoker receives the treatment most likely to yield a successful outcome.
Job Titles:
- Principal for NeuroPharma Advisors
Dr. Ives is a Principal for NeuroPharma Advisors, LLC, a Boston area advisory group dedicated to assisting companies developing therapeutics for central nervous system diseases. From 2008 until 2013, Dr. Ives served as the Chief Executive Officer of Satori Pharmaceuticals, Inc., a neurodegenerative disease company focused on discovery and development of breakthrough therapies for the treatment and prevention of Alzheimer's disease. Prior to Satori, Dr. Ives held numerous senior management and scientific leadership positions at Pfizer. Dr. Ives led the CNS and pain research teams at Pfizer for over two decades and, from 2001 until 2006, served as a Senior Vice President leading the global Pharmacokinetics, Dynamics and Metabolism organization. Dr. Ives received his doctorate and master degrees from Yale University and his bachelor of arts degree from Colgate University.
Mr. Beaird manages diverse investments in real estate, private equity and other alternative assets for his family and their private foundation. Beaird Properties, one of the companies managed by his office and majority owned by the foundation, has an active mission related investment program targeted toward local minority firms. Mr. Beaird began his career in media and advertising (Dresher Advertising, JbCableAds) and has previously owned an Internet Services Provider (Softdisk).
His civic and philanthropic activity is centered on his membership on the Strategic Action Council of Northwest Louisiana (SAC), serving as its President for 2015/2016 and as a Board member of the Carolyn W. and Charles T. Beaird Family Foundation. In addition to Embera, he sits on the Board of other portfolio companies including Thornhill Securities, Inc. headquartered in Austin, TX, JWBP Broadcasting, LLC of Alexandria, LA and CyberReef Solutions, Inc. in Shreveport, LA.
Job Titles:
- Director
- Managing Director of Louisiana Funds
Mr. Lovett is a Managing Director of Louisiana Funds (LF I & II), two early stage venture capital funds based in Louisiana with offices in New Orleans and Baton Rouge. LF's focus is on forming early stage companies primarily based on research at the major Louisiana research universities Mr. Lovett has over 34 years of venture capital and operations experience in the healthcare areas of biotechnology, medical devices and equipment, diagnostics, imaging and services. Operations experience included increasingly responsible positions in marketing and general management at CR Bard, Mallinckrodt and Damon Biotech. Venture capital experience includes three venture capital funds (1988-2003) as general partner in affiliation with Harvard University managing $70,000,000 which resulted in 13 IPOs, 6 sales of private companies, 3 private companies. Mr. Lovett has a BA in economics from the University of Vermont and an MBA from California State Polytechnic University (Pomona).
Job Titles:
- Vice President, CMC and Nonclinical Development
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 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 more than 10 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.
Dr. Detke is CMO of Cortexyme developing a novel approach to treating Alzheimer's and other degenerative disorders. Mike has 20 years of experience in CNS drug development including most recently serving as Embera's CMO leading the effort to advance two EMB-001 indications into Phase 2 clinical studies. Previous roles include: Eli Lilly, 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 and CMO roles at MedAvante and Comentis.
Dr. Goeders is the scientific founder of the Company, which was based on his preclinical research. U.S. patent number 9,415,107, the technology underlying the Company, was issued in his name in 2016. He is currently Head of the Department of Pharmacology, Toxicology & Neuroscience at the Louisiana State University Health Sciences Center in Shreveport, Louisiana, where he has been a member of the faculty since 1985. Prior to that time, Dr. Goeders was a Staff Fellow of the National Institute on Drug Abuse (NIDA) at the Addiction Research Center in Baltimore, Maryland and a Postdoctoral Fellow at The Johns Hopkins University School of Medicine, Department of Neuroscience. In 1984, he received his Doctor of Philosophy from the Louisiana State University Medical Center with a major in Pharmacology. His research has been actively funded by NIH since 1983. He has published over 105 scientific papers in peer-reviewed journals and has presented the results of his research worldwide. He is a member of the American College of Neuropsychopharmacology, a former member of the Board of Directors and a current Fellow of the College on Problems of Drug Dependence, the Neuropharmacology Division of the American Society for Pharmacology and Experimental Therapeutics, the Behavioral Pharmacology Society and the Society for Neuroscience.
Rajita Sinha, PhD is a Clinical Neuroscientist and the Foundations Fund Endowed Professor in Psychiatry and Neuroscience at the Yale University School of Medicine. She is also the Chief of the Psychology Section in Psychiatry and Co-Director of Education for the Yale Center for Clinical Investigation (home of Yale's CTSA) and she is founding Director of the Yale Interdisciplinary Stress Center. Her own research has made discoveries on stress mechanisms that link to addiction and poor health outcomes, and on developing and validating novel stress reduction strategies that target these mechanisms. She has also elucidated sex differences in stress biology that affects addiction risk, relapse and recovery. Her research has been supported by a series of NIH funded research projects for over 20 years and she has published over 250 scientific peer reviewed publications in these areas. She currently serves on the NIAAA Advisory Council and also on the Expert Scientific Panel for the NIH Common Fund supported Science of Behavior Change program. She has served on many other NIH special emphasis panels, review committees and workshops, presented at numerous national and international conferences, with a focus in the areas of stress, neuroscience of addiction and treatment development.
Job Titles:
- Director
- Executive Chairman
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 Embera, Periodontix, a biotech company, Rapid Micro Biosystems, a diagnostic company, and Embera raising over $70 million in private equity and non-dilutive financing to fund these companies.
In his previous role as CEO of Embera Mr. Linke established strategic direction for the development stage specialty pharma company, assembled the company's product development team and leading development partners, and successfully secured financing of the EMB-001 development program, that has successfully completed a Phase 1 safety and PK study and has two Phase 2 clinical studies that are underway, through both private equity and NIH grants.
Job Titles:
- Director
- Managing General Partner for BVM Capital
Mr. Barrett is the managing General Partner for BVM Capital and founder of the Company. He is a co-founder of VC Experts, Inc., a New York based publishing company. Mr. Barrett also serves on the Boards of Esperance Pharmaceuticals, Calosyn Pharma, MicroBiome Therapeutics, NuPotential, VC Experts, Inc., and K-94 Discoveries. Previously, Mr. Barrett worked on Capitol Hill as a legislative aide to senior U.S. Senator, J. Bennett Johnston, where he specialized in budget and appropriations, risk assessment and regulatory reform. He has been an adviser to, or investor in, more than twenty early-stage privately held companies. Mr. Barrett holds an LLM. Degree in Taxation from the New York University School of Law, a J.D. from Louisiana State University School of Law, and a B.A. in Political Science from Southern Methodist University.
Dr. Winhusen has conducted NIDA-funded research for the past 18 years devoted to improving the treatment of substance use disorders with a particular emphasis on cocaine and tobacco use disorders. As a Professor of Psychiatry at the University of Cincinnati, Dr. Winhusen is the Director of the Addiction Sciences Division as well as the Director of the Ohio Valley Node of NIDA's Clinical Trials Network. She is one of the foremost experts in conducting multi-site addiction clinical trials, having been the national PI for five NIH-funded multi-site clinical trials. Dr. Winhusen's research has contributed to our understanding of co-occurring mental health and substance use disorders and to the neurocognitive functioning of individuals with stimulant use disorders.