Barbara J. Mason, Ph.D. is a Professor and Director of the Laboratory of Clinical Psychopharmacology in the Committee on the Neurobiology of Addictive Disorders at The Scripps Research Institute and is an adjunct member of the faculty at The Rockefeller University, New York, NY, the University of Miami School of Medicine, Miami, Florida, and the University of California, San Diego, CA. Dr. Mason received her Ph.D. in clinical psychology and is licensed in the states of New York and Florida. Dr. Mason was a member of the faculty of Cornell University Medical College (1981-1991) where she initiated a program of clinical research funded by the National Institute on Alcohol Abuse and Alcoholism with a focus on investigating treatment of comorbid depression and alcohol dependence. Results of this work were published as a lead article in the Journal of the American Medical Association (1996, 275(10):761-767) and were the topic of a media briefing by the American Medical Association, as “landmark work of major public health significance.” Moving to the University Of Miami School Of Medicine (1991-2003), Dr. Mason developed a nationally accredited addiction psychiatry fellowship program for advanced psychiatry residents and continued her program of research on pipeline development for relapse prevention by initiating an investigation of nalmefene as a novel treatment of alcohol dependence. This work was chosen by the National Institutes of Health for presentation to the US Congress as a pivotal study of 1999 and was the topic of a press release by the National Institute on Alcohol Abuse and Alcoholism, with publication in the Archives of General Psychiatry (1999, 56:719-724). Dr. Mason served as overall principal investigator for the first US study of acamprosate as a novel treatment of alcohol dependence. This study was conducted in 21 centers across the United States. Dr. Mason developed the research protocol and behavioral therapy materials (http://www.alcoholfree.info) for this major study involving 601 outpatients with alcohol dependence. In seeking to further optimize the safety and efficacy of pipeline to treat alcohol dependence, Dr. Mason and colleagues conducted the first pharmacokinetic/pharmacodynamic interaction study of acamprosate and naltrexone to evaluate the safety of the combined use of these pipeline (Neuropsychopharmacology 2002, 27(4): 596-606).

Dr. Mason’s work in medication development to prevent relapse in alcohol dependence has been recognized with a MERIT Award from the National Institutes of Health, the Dean’s Senior Clinical Research Award from the University Of Miami School Of Medicine, and the Andrew W. Mellon Foundation Teacher-Scientist Award from Cornell University Medical College. Dr. Mason has served on the National Institute on Alcohol Abuse and Alcoholism National Advisory Council and as a member of their clinical and treatment subcommittee Initial Review Group, as an ad hoc member of the National Institutes of Health Government Performance and Results Act Review Group, as a guest expert for the Food and Drug Administration, and a consultant to the National Institute on Drug Abuse. Dr. Mason is field editor for the drugs and alcohol section of Neuropsychopharmacology and has served as a member of the editorial boards for Alcoholism: Clinical and Experimental Research, Journal of Substance Abuse, and The Ninth and Tenth Special Reports to the US Congress on Alcohol and Health from the Secretary of Health and Human Services. She is currently serving as Co-Director of The Pearson Center for Alcoholism and Addiction Research and pursuing a program of NIH-funded research at The Scripps Research Institute that includes human laboratory studies to rapidly screen potential relapse prevention pipeline and clinical trials to evaluate the safety and efficacy of novel pipeline to prevent drinking relapse in recovering individuals with alcohol dependence.

Daniel E. McLain, PhD is President of Walker Downey & Associates, Inc., a medical product safety and development consulting firm and certified Veteran-Owned Small Business (cVOSB) located in the heart of the Third Coast Scientific/Biotechnology Community (Madison, WI). He received his MS/PhD in nutritional toxicology and preventive medicine from Cornell University and has more than 30 years of broad-based experience in toxicology, drug and device development, vaccine development, statistics, and risk assessment. He has specific expertise in medical device material biocompatibility, immunotoxicology, and is the current AAMI US Chair for TC194/WG7 and convener of ISO 10993 – Biological Evaluation of Medical Devices – Part 11: Systemic Toxicity Evaluation (standard revised 2006; reaffirmed 2010). He has contributed to and has meaningful personal experience with IND, BLA, 510(k), GTAC, CTD and MEDDEV 2.7.1 CER preparation. He is fully experienced with the design, conduct, analysis, and reporting of preclinical safety and pharmacokinetic studies for drugs, devices, biologics, and combination products, and with the international regulatory submissions associated with them.

Steven is currently the president of TechReg Services, Inc. (TRSI). He has personally written well over 100 domestic/international new drug, biologic, and generic CMC submissions for numerous healthcare companies across a wide variety of dosage forms including orally administered immediate and extended release solids, semi-solids and liquids; parenterals; nasal sprays, metered dose, and dry powder inhalation products; peptides; oligonucleotides; liquid inhalation anesthetics; pulmonary surfactants; dermal and transdermal products; medical devices; and a number of other drug therapies. His role in these projects usually involved complete management of CMC development as well as preparation of the corresponding regulatory documentation, cGMP compliance audits and interaction with the regulatory agencies. Prior to founding TRSI in 1999, he held various positions in over 20 years in the pharmaceutical industry in Drug Discovery, Manufacturing Operations, Analytical Research, Quality Control, Quality Assurance, and CMC Regulatory Affairs. He has also taught with various government, trade, and academic organizations, and has presented to the FDA and non-US regulatory agencies on CMC related topics. He has been a visiting scientist at Rutgers University, where he performs select non-GMP API and impurity syntheses under contract, and from 1998 to 2012 was an adjunct professor in the graduate Pharmaceutics/Regulatory Affairs programs at Long Island University, where he taught several courses related to pharmaceutics and regulatory affairs.

President and Co-founder of Fast-Track Drugs and Biologics, Dr. Ransom has over 25 years experience in biomedical research including product inception, research, development, clinical trials, and product licensure. She has managed diverse projects including the development of therapeutic cancer vaccines, therapeutic biological products and drugs to treat carcinomas, genetically engineered T cells for the treatment of AIDS/HIV, antitoxins for the treatment of neurotoxins, biological defense vaccines, pipeline for the treatment of substance abuse, and cardiovascular disease in vitro diagnostic tests. Depending upon the development phase of these projects, she was involved with the regulatory development strategy, clinical trial design, pre-clinical development plans, and data analysis and reporting to support product licensure. Dr. Ransom has designed and written Phase 1, 2, 3, and 4 clinical protocols to assess the safety and therapeutic effect of numerous biological and chemical agents for the treatment of malignancies. Furthermore, she has analyzed data from multi-institutional clinical trials and written the Clinical Summary Reports of numerous phase 2 and 3 studies according to the ICH Guidelines for inclusion in Biologics License Applications and New Drug Applications. Her clinical trials coordination activities have included the development of a clinical data management system using an Oracle database, electronic data capturing technology, and web-based applications to collect, store, analyze and report pre-clinical and clinical data in support of therapeutic product development for government and pharmaceutical clients. She established systems specifications and implemented system installation, validation, release for production, and system oversight for multiple large multicenter clinical trials enrolling thousands of study participants.

Mark Wallace, MD, is a board-certified anesthesiologist who specializes in multi-modal pain management. As a pain management specialist, he evaluates, diagnoses and treats all forms of pain, though most of his patients are affected by chronic pain. Since 1996, Dr. Wallace has been program director of UC San Diego Health’s Center for Pain Medicine, which is dedicated to reducing and eliminating suffering, and improving function in individuals with lower-back or other spine-related pain issues, joint and muscular-skeletal pain or pain due to surgery, injury, nerve damage, psychological factors and metabolic problems such as diabetes. Under his leadership, the Center for Pain Medicine was named a Clinical Center of Excellence in Pain Management in 2010 and 2014 by the American Pain Society. The award recognizes pain care teams that “provide outstanding exemplary care.” Dr. Wallace is also chair of the Division of Pain Medicine within UC San Diego School of Medicine’s Department of Anesthesiology and has co-authored 119 peer-reviewed articles and five books on pain medicine. He is active in clinical trials of investigational drug and techniques for managing chronic pain.

Prior to joining UC San Diego Health, he was an assistant clinical professor in the Department of Anesthesiology at University of Texas, Houston. Dr. Wallace completed sub-speciality fellowship training in pain management at UC San Diego School of Medicine and residency training in anesthesiology at University of Maryland School of Medicine in Baltimore. He interned in general surgery at Washington Hospital Center in Washington, D.C. and earned his medical degree at Creighton University School of Medicine in Omaha. Dr. Wallace is board-certified in anesthesiology and pain medicine.

He received the Leonard Tow Humanism in Medicine Award in 2012 and is consistently elected as one of San Diego’s Top Doctors in San Diego Magazine’s “Physicians of Exceptional Excellence” annual survey. Dr. Wallace is currently a member of the Board of Directors of the American Pain Society and serves on scientific planning meetings for both national and international meetings, including the World Congress of Pain, World Institute of Pain, American Academy of Pain Medicine and American Society of Regional Anesthesia and Pain Medicine.