John Pinney oversees the company’s strategic direction and serves as a member of multiple client teams. His experience and insights help integrate science, policy, and management principles to provide coherent solutions for clients’ regulatory, scientific and operational issues. John has consulted on numerous major Rx-to-OTC switch, drug development, issues management and product stewardship projects in support of consumer and prescription companies. His background in public health policy lends an important perspective to his approach to problem solving.

John has spent 45 years in the fields of disease prevention, substance abuse, health policy, and pharmaceutical consulting. His experience includes a wide range of executive positions in government, nonprofit, and academic organizations, together with over 30 years of consulting with private companies on health issues related to their employees, products and services.

John began his career in 1971 in the Office of the Secretary of Health, Education and Welfare where he was involved in policy initiatives affecting biomedical research, health services delivery and drug regulation. In 1973, he joined the National Council on Alcoholism and served as managing director of the Council’s Washington office. He returned to government in 1978 as Special Assistant to the Secretary of HEW and Director of the Office on Smoking and Health, serving as executive editor for four Surgeon General’s Reports on the health consequences of smoking. In 1983, he co-founded and served as executive director of Harvard University’s Institute for the Study of Smoking Behavior and Policy. The Institute played a seminal role in advancing tax and other tobacco control policy approaches. John’s consulting career initially focused on advising companies, many from the Fortune 500, on employee disease prevention and health promotion programs. In 1994, he founded PinneyAssociates to focus on consulting to the pharmaceutical industry, bringing a wealth of experience at the intersection of policy, science and regulation to developing and implementing solutions to complex regulatory challenges and public health problems.

Joseph (Joe) G. Gitchell has extensive experience providing strategic counsel to clients across a wide range of health policy, regulatory, and marketing and communications challenges. With a focus on client service, Joe leads efforts supporting regulatory approvals, conducting public policy analysis, developing communications approaches, devising, refining and defending claims, and providing input on strategic market opportunities and directions.

He has counseled clients navigating health policy and communications in the US, Europe, Latin America, Asia and the Middle East. This work has included extensive collaboration with highly respected researchers, policy experts, and nonprofit organizations around the world.

A co-author on over 40 articles, Joe has been published in journals including the American Journal of Preventive Medicine, Addiction, Archives of Internal Medicine, Morbidity and Mortality Weekly Report, and Tobacco Control. In addition, Joe has presented at industry and policy conferences, including the TMA, the Global Forum on Nicotine, and the CHPA Annual Executive Conference on topics including the impact of personal technologies on healthcare regulations and a strategic research agenda for e-cigarettes.

Joe joined PinneyAssociates in 1993 after graduating magna cum laude from Yale University and working on the 1992 U.S. presidential campaign.

Lucy Owen provides strategic advice to clients, with a focus on the issues management process in the context of Rx-to-OTC switch. She helps clients to develop and execute science-based regulatory and commercial strategies to address the concerns of regulators and other key stakeholders in order to facilitate regulatory approval for new products and to maximize product acceptance. Lucy manages the development of the research base to build the benefit/risk case for Rx-to-OTC switch candidates.

Lucy directed PinneyAssociates’ Issues Management Team for over 10 years before becoming Vice President of Program Operations and Rx-to-OTC Switch, and in 2018, Senior Vice President. Her responsibilities have included the management of a wide variety of projects involving support for Rx-to-OTC switch programs, as well as support of OTC products, prescription medications and vaccines, and non-profit public health advocacy organizations.

In the area of Rx-to-OTC switch, Lucy provides critical support to companies from the earliest stages of assessing the feasibility of a switch, including helping sponsors to identify and manage issues typical of all switches and unique to particular switch candidates; to develop the public health case for the switch; to develop labeling through an iterative development process including qualitative and quantitative testing with consumers; to design consumer studies (including label comprehension, self-selection and actual use trials); to develop supporting materials; and to prepare for regulatory submissions, FDA interactions and Advisory Committee meetings.

Lucy has advised clients on a wide array of treatments for public health issues including, among many others, allergy, cholesterol lowering, dermatological conditions, gastrointestinal conditions, insomnia, migraine, treatment of infectious disease, pain management, problem drinking, women’s health conditions including reproductive health and family planning, smoking cessation/tobacco control, and vaccines for childhood diseases and bioterror agents.

Lucy Owen joined PinneyAssociates in 1998 after completing her graduate work in the history of medicine at Oxford University. Before attending Oxford University, Lucy graduated from the University of Michigan with High Distinction and High Honors.

Judy Ashworth draws on nearly two decades of experience in pharmaceutical drug development to provide clients with strategic input on target product profile development, clinical development plans, regulatory pathways (US and EU) and unmet medical need analyses with attention to potential market access challenges. Given her vast experience in the development of analgesics, including abuse deterrent formulations, Judy is particularly adept in advising clients on the development of CNS-active drugs with an emphasis on strategies for assessing abuse liability of novel compounds as well as new formulations of marketed compounds.

Trained in internal medicine, Judy began her pharmaceutical career in 2001 as a clinical pharmacologist at Gruenenthal GmbH, a German pharmaceutical company primarily focused on the development of innovative pain medications. In 2003, Judy took on the project leadership of Gruenenthal’s development of abuse deterrent formulations (ADFs) and an internal working group tasked with developing Gruenenthal’s expertise in abuse liability assessment as well as monitoring the rapidly evolving regulatory landscape surrounding the development of these new products.

From 2006-2008, Judy served as a visiting lecturer in Columbia University’s Department of Substance Abuse Research where she and Professors Sandra Comer and Herbert Kleber worked to develop new clinical trial designs for assessing the relative abuse potential of ADFs. During this time, she participated in the Tufts Health Care Institute’s Program on Opioid Risk Management – a series of summits which brought together major stakeholders including FDA, DEA, academia, and industry to work on potential solutions to the rising abuse of prescription opioids.

Judy established the Center of Excellence for Abuse Liability at Gruenenthal USA, Inc, a unit which supported the company’s commitment to help develop safer alternatives for the management of pain. In addition, Judy was the clinical lead for tapentadol during its registration process in the US and EU, set up a partnering intelligence department to support business development, helped establish the Innovative Medicines Unit at Gruenenthal’s headquarters and opened its first hub, and performed the search for and evaluation of novel analgesics to help enrich the company’s internal pipeline with external innovation from academia and biotech.

Judy graduated as a Dean’s Scholar from UCLA School of Medicine in 1993 and then completed the Internal Medicine residency program at Santa Barbara Cottage Hospital in 1996, serving as chief resident in her final year of training.

Jack E. Henningfield is one of the world’s leading experts on addiction, and the behavioral, cognitive, and central nervous system (CNS) effects of drugs. He counsels clients on assessment of the abuse liability of new CNS-acting drugs and formulations, evaluation of potential application of the Controlled Substances Act to new products, assessment of the tamper resistance of novel formulations, and development of risk management approaches.

Jack frequently liaises with the Food and Drug Administration on issues concerning drug scheduling and addiction, and has presented frequently to FDA Advisory Committees. He has contributed to numerous comments to FDA on topics including prescribing of opioids for chronic pain, development and regulation of abuse-deterrent opioid formulations, and regulation of nicotine delivery systems.

Jack’s research has resulted in the writing of numerous books and monographs, and over 400 published papers on myriad topics in public health, pharmacology, and addiction. He has received numerous awards for his research and policy contributions to the understanding and control of tobacco addiction.

He joined PinneyAssociates in September 1996 after 16 years of public service at the Intramural Research Program of the National Institutes of Health’s National Institute on Drug Abuse (NIDA), where he studied the abuse liability and cognitive effects of a broad range of drugs and contributed to the development of improved methods for abuse liability assessment.

At NIDA, he served as Chief of its Human Performance Laboratory (1984-1985), Chief of the Biology of Dependence and Abuse Potential Assessment Section (1985-1996), and Chief of the Clinical Pharmacology Research Branch (1989-1996). He was a frequent contributor to NIDA’s reports to Congress, Reports of the Surgeon General, and contributed to numerous congressional testimonies on behalf of NIDA.

He has been a member of the Johns Hopkins University School of Medicine faculty since 1978 and is presently Adjunct Professor of Behavioral Biology, at the Medical School’s Department of Psychiatry and Behavioral Sciences, and an affiliated faculty with The Johns Hopkins Bloomberg School of Public Health. Jack is also a former faculty member with the Program of Toxicology at the University of Maryland at Baltimore.

A summa cum laude graduate of the University of Minnesota in 1974 with a bachelor’s in psychology, Jack received his doctorate in experimental psychology in 1977 from the University of Minnesota’s Psychopharmacology Training Program, where his focus was addiction, CNS medications, preclinical abuse liability assessment, and drug addiction control. Jack’s post-doctoral training included roles as a National Council on Alcoholism postdoctoral research fellow at the University of Minnesota from 1977-1978 and at the Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit. He was a staff fellow at the NIDA Addiction Research Center from 1980-1982.

Saul Shiffman is a world-renowned researcher in the fields of behavior change and relapse, self-management and self-control, field research methodology, statistical analysis, and addiction and dependence.

At PinneyAssociates, Saul leads efforts on Rx-to-OTC switch strategy, development and testing of consumer communication including product labels, design and analysis of clinical and consumer research (including label comprehension, self-selection, and actual use studies), behavioral surveillance and risk management, and behavior-change program development and evaluation. He also counsels clients on the scientific and policy environment for OTC products, including directing strategic efforts to build and explain the benefit/risk profile of OTC products.

Since 1991, he has been a professor in the departments of psychology and pharmaceutical science at the University of Pittsburgh, positions he retains while working with PinneyAssociates. Saul has taught in the departments of psychology and psychiatry and behavioral medicine at various universities, including the University of South Florida, the University of Washington, and the University of Pittsburgh.

Saul has authored or co-authored over 300 published papers on a variety of topics related to psychopharmacology, substance abuse, dependence, relapse, coping, and computerized assessments of behavior, and has presented widely in medical and scientific forums.

A fellow of numerous professional societies, Saul has served as a scientific reviewer and editorial board member for several medical and scientific journals, and on grant review standing committees. In 2007, Saul was awarded Good Clinical Practice Journal’s inaugural Lifetime Achievement Award in recognition of his work on real-time, real-world data collection with eDiaries. In 2013, The Society of Behavioral Medicine selected Saul for their Research to Practice Award which “recognizes an individual’s contributions and exemplary work in translating or extending behavioral medicine from research into practical application, dissemination, or implementation.”

Bernie Simone has over 30 years’ experience in the OTC industry, including product marketing, business development and Rx-to-OTC switches. His experience spans over 40 therapeutic categories in OTC medicines, prescription drugs, medical devices, dietary supplements, and skin care.

Bernie is an expert in enhancing company growth through Rx-to-OTC switch, business development, and marketing strategies. Over his career, he has held a diverse range of strategic leadership positions including:

• Marketing Director on Aleve, the Alka-Seltzer franchise and other flagship brands at Bayer CHC
• Global Strategic Category Director for Bayer’s CardioAspirin franchise
• Business Development, Innovation and Rx-to-OTC Switches at Bayer and Ciba-Geigy

More recently, as Head of Rx-to-OTC Switches for Sanofi CHC North America, Bernie was responsible for the assessment of new switch opportunities, as well as providing switch project leadership across the regulatory, medical, clinical, safety, marketing and manufacturing functions. His most recent successes include the “first-in-class” switch of Nasacort 24HR and Xyzal Allergy 24HR. Bernie was a key member of the Sanofi CHC Team that licensed the OTC switch rights for Cialis from Eli Lilly, and has led the cross-functional global development team since its inception. He has also licensed and developed the first-in-class OTC TENS (Transcutaneous Electrical Nerve Stimulation) medical device as well as the acquisition of Rolaids for Chattem, a division of Sanofi CHC.

Bernie graduated from Rutgers Engineering with a BS degree in industrial engineering. Early in his career he worked in engineering for J&J and Sterling Drug. Bernie received his Master’s Degree from Steven’s Institute of Technology in Management. He worked in marketing for Bristol-Myers and the Rx-to-OTC Switch of Habitrol for Ciba-Geigy, before his career at Bayer CHC.

George Quesnelle joined PinneyAssociates in 2009 following his retirement from GlaxoSmithKline (GSK) Consumer Healthcare after 30 years in the pharmaceutical and consumer healthcare products industries. George counsels clients on the business planning process, including resource allocation, identifying and evaluating licensing and acquisition targets, and identifying and negotiating business partnerships. In Rx-to-OTC Switch, he advises on the commercialization process for the switch, including OTC switch candidate identification, forecasting OTC switch volume, helping to develop or evaluate marketing plans as well as consumer and trade promotions, and helping to develop launch scenarios and timing.

George has nearly 30 years of Rx-to-OTC switch experience, with commercial responsibility for some of the most successful switches in the industry, including Nicorette and NicoDerm CQ. Since joining PinneyAssociates he has helped numerous companies with their Rx-to-OTC switch efforts and other business challenges.

He has held positions in sales, sales management, marketing, marketing management and general management. At various times George’s responsibilities spanned the US, Australia, New Zealand, Japan, India and South Africa. George had global commercial responsibility for Rx-to-OTC Switch and for Strategic Initiatives for GSK. From 2004 to 2008, he was President of GSK Consumer Healthcare North America, overseeing $2 billion in consumer business. While in that role, he served on the Board of Directors of the Consumer Healthcare Products Association (CHPA) and was a member of the CHPA Executive Committee.

In 2014, the Consumer Healthcare Products Association awarded him the Ivan D. Combe Lifetime Achievement Award for his contributions to the industry, especially his pioneering work in OTC switch and directly improving self-care for consumers in the US.

Previously, George worked for Merrell National Pharmaceuticals, Merrell Dow Pharmaceuticals, and Marion Merrell Dow Pharmaceuticals, where he also held various positions starting as a Territory Sales Representative and working his way up to Vice President of Marketing.

Mr. Quesnelle graduated from Eastern Michigan University in 1971 with a bachelor’s in English and a minor in speech with secondary education certification.

Sidney (Sid) Schnoll is an internationally recognized expert in addiction and pain management who applies his experience of over 30 years in academic medicine to the issues of risk management. Sid counsels clients on regulatory and scientific strategy, and development, implementation and assessment of risk management activities, including engagement with the FDA. Sid leads efforts to conduct risk assessment during early product development, develop Risk Evaluation and Mitigation Strategies (REMS), and develops post-marketing surveillance reports for submission to FDA. He is currently a member of the RADARS® System Scientific Advisory Board and Industry Advisory Board.

Sid has served on numerous committees and boards including the FDA’s Drug Abuse Advisory Committee (DAAC), NIH study sections, National Board of Medical Examiners test development committees, and the board of the College on Problems of Drug Dependence (CPDD).

Sid was a member of the team that developed the Tramadol Independent Steering Committee (ISC), which resulted in Ultram being launched as an unscheduled analgesic and monitored for abuse and diversion of tramadol. As part of the ISC, he was the principal investigator on the health care professional surveillance project. In 2001, Sid joined Purdue Pharma L.P. where he developed the RADARS® System to study the abuse and diversion of prescription opioids.

Sid attended Union College, and earned his medical degree at the New Jersey College of Medicine and Dentistry. He completed his internship, residency in neurology and doctorate. in pharmacology at Jefferson Medical College. Sid has held several academic positions. He was the Career Teacher in Addictions at the University of Pennsylvania, following which he was Medical Director at the Eagleville Hospital and Rehabilitation Center, which is noted for many innovations in the treatment of addictive diseases. In 1980, he became Associate Professor of Psychiatry and Pharmacology and Director of Chemical Dependence programs at Northwestern University Medical School. In 1986, he became Professor of Internal Medicine and Psychiatry at the Medical College of Virginia, Virginia Commonwealth University and Chairman of the Division of Substance Abuse Medicine. He also held faculty positions in the departments of Pharmacology and Toxicology and Psychology at Virginia Commonwealth University. Additionally, he held a position as a Voluntary Professor of Behavioral Science at the University of Kentucky.

Sid has received numerous awards including listings in The Best Doctors in America and is a Fellow of CPDD and the American Society of Addiction Medicine.

Sid has published over 150 research papers, book chapters and educational materials. His areas of research include both addiction and pain management with special emphasis on prescription drug abuse and perinatal addiction.

August R. Buchhalter oversees and contributes to in vitro assessments of abuse-deterrent drug formulations, including assisting in the development and preparation of protocol outlines and interpretive reports. He also contributes to abuse potential assessments (often referred to as the 8-Factor Analysis) and drug scheduling recommendations.

Prior to joining PinneyAssociates in 2004, August’s research encompassed three major areas: drug abuse, which included trials akin to human abuse potential studies; the treatment of opioid dependence, which focused on computerized behavior therapy; and nicotine and tobacco, specifically in the areas of potential reduced exposure products and placebo-induced withdrawal suppression.

August’s initial training in drug abuse research was at The Johns Hopkins University’s School of Medicine’s Behavioral Pharmacology Research Unit. Thereafter, he received his doctorate in experimental psychology, which included training in drug dependence and behavioral pharmacology, from Virginia Commonwealth University in 2002 and completed a postdoctoral fellowship at the University of Vermont College of Medicine in 2004.

He has co-authored more than 15 review and research papers and three book chapters. When not working, August enjoys down time with his wife, which involves exercising, traveling, and watching and cheering for the Iowa Hawkeyes and Pittsburgh Steelers.

Michelle Ertischek oversees multi-disciplinary teams to deliver strategic scientific and regulatory counsel to clients. With more than 20 years’ experience in the pharmaceutical and consumer health industries, through her resourcefulness and commitment to anticipating challenges and problem solving, Michelle helps ensure the delivery of timely high-quality deliverables to our clients.

Since joining PinneyAssociates in 2001, Michelle has advised clients on risk management plans and post-marketing surveillance for CNS-acting drugs, controlled substances and Rx-to-OTC switch. She has been responsible for conducting expert interviews and shepherding issues assessments of the scientific and policy environment. Michelle has helped clients pursue their regulatory goals in the US, Canada, Europe, Australia, Japan, and South Africa.

A graduate of Wellesley College, Michelle completed her masters of public health, with a focus on health policy, at George Washington University. She speaks Spanish and enjoys taking her toddler to the park at the end of the work day.

Reginald (Reggie) Fant leads our abuse potential assessment activities and serves as the primary author on the development of comprehensive reports on abuse potential, including the abuse potential assessment required as part of the NDA per the 2017 FDA guidance on Assessment of Abuse Potential of Drugs (often referred to as the 8-Factor Analysis). He advises our prescription and OTC clients on abuse liability and drug scheduling, as well as risk management programs designed to monitor and/or reduce abuse. He has also participated in meetings with the Controlled Substances Staff at FDA on behalf of Sponsors.

With a background that includes clinical research on the abuse liability of nicotine and other drugs of abuse, physiological and subjective efforts of drugs (including opioids, stimulants, sedatives, cannabis, nicotine, and alcohol), and laboratory studies of potential smoking and opioid treatment medications, Reggie brings a breadth of scientific and regulatory knowledge to meeting our clients’ needs.

Since joining the company in 1997, Reggie has written literature reviews, reports, and peer-reviewed articles on topics such as, abuse liability of prescription and over-the-counter medications, nicotine replacement, smoking cessation medications, and new product development. He also participates in the company’s development of novel drug delivery systems, enjoys a cold pint of beer (with a preference for something hoppy), and cheers boisterously for the Steelers.

After completing his doctorate in experimental psychology at the University of Southern Mississippi in 1993, Reggie completed postdoctoral fellowships in the Behavioral Pharmacology Research Unit of Johns Hopkins University School of Medicine and the Clinical Pharmacology Branch of the National Institute on Drug Abuse.

Karen Gerlach plans and implements risk management programs, and designs and executes surveillance efforts and product labeling assessments for our prescription and OTC clients. An expert in public health and health policy, Karen applies her training and practical experience in epidemiology to meet our clients challenges in postmarketing surveillance.

Karen’s research covers a wide array of topics including public health, health policy, and risk management. She has authored or co-authored multiple papers in peer-reviewed journals, presented at major national and international meetings, and served as a member of the editorial board of the American Journal of Health Promotion.

Before joining PinneyAssociates in 2007, Karen was a Senior Program Officer and Team Leader at the Robert Wood Johnson Foundation in Princeton, New Jersey and an Epidemiologist with the Centers for Disease Control and Prevention in Atlanta, Georgia. Karen earned her doctorate in microbiology and immunology at Indiana University School of Medicine and her master’s of public health in epidemiology and health policy at The Johns Hopkins University.

Along with our interdisciplinary team of scientists, health policy experts, and regulatory experts, Janine Pillitteri works with pharmaceutical and consumer health care clients in the areas of Rx-to-OTC switch, risk management, and tobacco control and harm minimization. Janine is involved in the development and oversight of pharmaceutical studies supporting Rx-to-OTC switch projects including post-marketing surveillance and consumer behavioral research such as label comprehension studies, self-selection studies, actual use trials, and human factors studies.

To help clients prepare for regulatory submissions, FDA interactions, and advisory committee meetings, her work in this area includes qualitative and quantitative research design, protocol development, the design and testing of questionnaires and consumer surveys, comprehensive Drug Facts label development and testing, as well as report writing including final study reports and briefing books for submission to FDA.

Janine also works in the areas of tobacco control and tobacco harm minimization, with a focus on research design and analysis and regulatory submissions. Given her extensive research and writing experience, she also writes scientific publications and has co-authored more than 30 published papers.

Janine joined PinneyAssociates in 1998. After receiving her doctorate in biobehavioral health from Penn State University in 1996, Janine completed a post-doctoral fellowship in human behavioral pharmacology at the University of Vermont in 1998. She has a broad research background in drug abuse, nicotine addiction and smoking cessation, the interaction of health and behavior, and health promotion and disease prevention.

Mark Sembower analyzes and reports on a variety of datasets, including postmarketing and pharmacovigilance risk management data, consumer surveys, clinical trial data, VAS studies, and large government-funded datasets, including federal surveys. He also provides statistical support for Rx-to-OTC switch projects and contributes to final study reports and manuscripts for peer review.

He has conducted research into non-medical use of prescription pharmaceuticals, medication compliance, smoking cessation, and drug use and psychological disorders among adolescents. Mark is an author or co-author of more than 20 published papers in peer-reviewed journals.

Prior to joining PinneyAssociates in 2007, Mark worked at the University of Pittsburgh Medical Center (UPMC), where he served as the senior statistician for a large longitudinal psychosocial research study. In addition to statistical analysis, he authored methods and results sections for various manuscripts, presentations, and grant proposals, developed data management procedures, and consulted with outside investigators regarding study data. Mark completed a Master of Science in Applied Statistics at Bowling Green State University (BGSU) in 2002. As a graduate research assistant at BGSU, he worked in the statistical consulting center and helped develop a new statistical computing course.

Christine Sweeney conducts literature reviews, develops public health rationales and issues inventory and management plans, and assists clients in the development of labeling and the design of consumer studies (label comprehension, self-selection, actual use), as well as the drafting of regulatory submissions in support of our Rx-to-OTC switch and OTC product stewardship projects.

Since joining PinneyAssociates in 2000, Christine has supported a range of Rx and OTC clients in therapeutic areas including, pain management, smoking cessation, weight loss, cholesterol lowering, allergic rhinitis, women’s reproductive health and men’s health.

After completing her doctorate in biobehavioral health at Penn State University in 1998, Christine began a post-doctoral fellowship in cancer prevention and control at the National Cancer Institute. As part of her post-doctoral training, Christine completed a master’s in public health, with a concentration in epidemiology, at Johns Hopkins University.

Christine has authored or co-authored several papers published in scientific journals, including CNS Drug, Tobacco Control and Pharmacology Biochemistry and Behavior. Her research experience has focused on the areas of health promotion and disease prevention, with a primary emphasis on behavioral risk factors for chronic disease.

Lisa Zapawa manages projects across a wide variety of projects involving support for pharmaceutical companies’ Rx-to-OTC switch programs, consumer health care products, prescription medications and vaccines, and non-profit public health advocacy organizations. She focuses primarily on supporting issues management processes, with responsibilities that have included conducting literature reviews and analysis, developing reports, manuscripts, and public health rationales, and overseeing integrated teams to provide strategic advice to clients on issues assessment and management.

Lisa has provided support to clients with a primary focus on health promotion and disease prevention across an array of public health issues and health conditions including, among many others, smoking cessation/tobacco control, women’s health conditions including reproductive health and family planning, pain management, cholesterol lowering, blood pressure lowering, and vaccines for childhood diseases and bioterror agents.

Lisa joined PinneyAssociates in 2003 after spending three years as a Senior Consultant for the Oncology and Cardiovascular Roundtables at The Advisory Board Company in Washington, D.C. Prior to that, she earned her Medical Degree from the University of Michigan Medical School and Master of Public Health in Health Management and Policy from the University of Michigan School of Public Health.

Gabrielle Blythe coordinates our client meetings, conferences and corporate events, managing all aspects throughout the process with enthusiasm, bringing almost 20 years’ experience and innovative ideas to the challenges of today’s meetings. In addition, she provides administrative support to the company’s senior leadership and our Pittsburgh office.

Gabrielle Blythe, joined PinneyAssociates in 1997. Prior to joining the company, Gabrielle honed her organizational and creative skills at the world-renowned Pittsburgh Symphony and Pittsburgh Cultural Trust.

Gabrielle believes in giving back to the community and has been actively involved with voluntary causes that hold special meaning for her including the Allegheny General Hospital Auxiliary where she successfully co-chaired three gala events that raised significant monies to support patient care including a state-of-the-art epilepsy monitoring unit at one of the region’s premier academic health centers.

Steve Choi brings over 25 years of financial and accounting experience to PinneyAssociates. He manages the day to day financial and accounting operations as well as provides HR support. Steve also supports project managers to help them manage client budgets and works with our legal counsel to manage and oversee client and vendor contract execution. His other responsibilities include preparing financial statements, the annual budget, and tax return work papers.

Steve began his career in 1991 in public accounting. He spent four years at a mid-size regional firm developing his knowledge of audit and tax. Using public accounting as a stepping stone, Steve moved on to hold various positions, including accounting manager at a large law firm as well as director of finance for a number of small IT services companies and a startup digital advertising company.

Ed Cone is recognized world-wide for his expertise on the chemistry and pharmacology of drugs of abuse. At PinneyAssociates, he consults on the evaluation of abuse-deterrent formulations and development of novel drug delivery systems, based on his knowledge of pharmacokinetics and drug testing methodologies.

Throughout his career, Ed has emphasized the value of applying real-world experience to solve problems in the laboratory. Doing just that, his practical model for in vitro laboratory assessment of abuse-deterrence predicted much of what appears in the 2015 FDA Guidance on Abuse-Deterrent Opioids — Evaluation and Labeling. He has presented in meetings with the FDA reviewing divisions and Advisory Committees on behalf of numerous pharmaceutical clients.

At the Addiction Research Center of the National Institute on Drug Abuse, Ed completed a series of seminal studies on the metabolism and excretion of opioid agonists and antagonists. As Chief of the Chemistry Section, he was responsible for executing a variety of clinical studies concerning the pharmacokinetics and pharmacodynamics of psychoactive drugs.

He has extensive experience in the design and execution of clinical research studies and has trained six doctoral candidates. Ed has published over 250 research and review articles and chapters on a broad array of topics concerning human drug administration.

He has been a member of the Johns Hopkins University School of Medicine faculty since 1998 and is presently Adjunct Associate Professor in the Department of Psychiatry and Behavioral Sciences.

• Cited by Science Watch as the most highly cited author in forensic science over the period of 1981-1993
• Awarded the Irvine Sunshine Award in Clinical Toxicology, “In Recognition of Pioneering Work in Clinical Toxicology” (1995), at the International Association of Therapeutic Drug Monitoring and Clinical Toxicology meeting
• Recognized as the Scientist Professional Advisory Committee Career Scientist of the Year Award by the US Public Health Service Commissioned Officer’s Association (1996), “To acknowledge an exemplary career of pioneering research on the detection of psychoactive drugs in human and for the broad implication of discoveries to improve drug abuse prevention and treatment”
• Received the Rolla Harger Award from the American Academy of Forensic Sciences for “Outstanding Contributions to Forensic Toxicology” (2000)
• Received the Irvine Alan Curry Award for his extensive research in Clinical Toxicology from the International Association of Forensic Toxicologists (2006)

Professor Dr. Dr. (h.c.) Marilyn A. Huestis brings an extraordinary breadth and depth in clinical and forensic toxicology, anti-doping, diagnostic screening and confirmation drug testing, and cannabinoid agonists and antagonists. Through her research, she focused on improving people’s lives by reducing deaths from drugged driving, finding novel medications to treat drug dependence and using drug testing as a tool for drug dependence treatment. Her research encompassed the mechanisms of action of cannabinoid agonists and antagonists, effects of in utero drug exposure, and the neurobiology and pharmacokinetics of novel psychoactive substances.

In 2016, Marilyn retired as a tenured senior investigator and Chief, Chemistry and Drug Metabolism Section, IRP, National Institute on Drug Abuse, National Institutes of Health, after 23 years of conducting controlled drug administration studies. Her research program focused on discovering mechanisms of action of cannabinoid agonists and antagonists, effects of in utero drug exposure, alternative matrices drug testing, driving under the influence of drugs, and the neurobiology and pharmacokinetics of novel psychoactive substances. She also was an Adjunct Professor at the University of Maryland School of Medicine until 2017.

Currently, she is a Senior Fellow at the Institute on Emerging Health Professions, Thomas Jefferson University, on the Smart Approaches to Marijuana (SAM) Science Advisory Board, a Senior Scientific Advisor of NMS Labs, Consultant to the US Department of Transportation, and President of Huestis & Smith Toxicology, LLC.

She has published 474 peer-reviewed manuscripts and book chapters and more than 800 abstracts were presented at national and international meetings. Professor Huestis received a bachelor’s degree in biochemistry from Mount Holyoke College (cum laude), a master’s degree in clinical chemistry from the University of New Mexico (with honors), and a doctoral degree in toxicology from the University of Maryland (with honors). Professor Huestis received a Doctor Honoris Causa from the Faculty of Medicine, University of Helsinki in Finland in 2010.

Other important awards include the 2018 National Safety Council’s Borkenstein Award for her “significant and prolific contributions to forensic toxicology”, 2017 Sir Kenneth Standard Distinguished Lecturer for the University of the West Indies, 2016 Victorian Institute of Forensic Medicine Orator, Melbourne, Australia, 2016 Marian W. Fischman Lectureship Award from the College on Problems of Drug Dependence, 2016 Saferstein Memorial Distinguished Lecturer at Northeastern University, 2015 Excellence in Scientific Research, Women Scientist Advisory NIDA Investigator Award, 2015 Norman P. Kubasik AACC Lectureship Award, 2015 Distinguished Fellow from the American Academy of Forensic Sciences (AAFS), 2010 The International Association of Forensic Toxicologists (TIAFT) Alan Curry Award, 2008 American Association for Clinical Chemistry Outstanding Contributions in a Selected Area of Research Award, 2007 International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) Irving Sunshine Award, 2005 AAFS Rolla N. Harger Award, and 1992 Irving Sunshine Award for Outstanding Research in Forensic Toxicology.

The journal Clinical Chemistry featured her as an “Inspiring Mind”. She currently serves on the Organization of Scientific Area Committee on Toxicology, World Anti-doping Agency’s Prohibited List Committee, Transportation Research Board Committee on Alcohol and Other Drugs, the National Safety Council’s Alcohol, Drugs and Impairment Division Executive Board, and on the National Commission on Forensic Sciences prior to its termination. She is past president of the Society of Forensic Toxicologists, past Chair of the Toxicology Section of the American Academy of Forensic Sciences, and past president of The International Association of Forensic Toxicologists.

Michael Hufford brings more than 20 years of experience in clinical research, drug and medical device development, and behavioral science across a wide range of therapeutic areas to our clients.  He currently is the Chief Executive Officer of LyGenesis, a biotechnology company, and co-founder and CEO of Harm Reduction Therapeutics.

Michael’s drug development experience includes serving as Cypress Bioscience’s Vice President of Corporate and Clinical Development, where he had responsibility for development of the drug and medical device portfolio for multiple CNS assets, including the FDA approval of Savella (milnacipran) for fibromyalgia. Before joining Cypress, he worked at Amylin Pharmaceuticals, leading drug development teams focused on orphan drug development for rare metabolic diseases, and combination peptide and protein therapies for obesity.

Michael has also consulted extensively with the pharmaceutical industry, including serving as Vice President of Scientific Affairs at invivodata, where he was responsible for scientific consulting on patient-reported outcome claim construction for more than 50 drug development programs. He also served as Chief Operating Officer for NeuroCog Trials, which specializes in providing clinical and neurocognitive assessment, experimental design and data analysis services for clinical trials.

An entrepreneur, Michael co-founded multiple pharmaceutical, device, and mobile health companies. He is the co-founder of NQ Oncology, a clinical stage oncology drug company. He also co-founded and served as Chief Medical Officer of e-Nicotine Technology, a device company committed to reducing the harms associated with combustible tobacco products. He was also the co-founder and Chief Executive Officer of MindApps, a company that provides mobile electronic Cognitive Behavioral Therapy applications focusing on major depressive disorder, anxiety disorders, and PTSD.

A graduate of Purdue University, Michael earned his master’s and doctoral degrees in clinical psychology from the University of Pittsburgh, where his research focused on smoking and other addictive behaviors.

Karen L. Sees, D.O., began consulting with PinneyAssociates in 2000. She has over 29 years’ experience in substance abuse treatment, research, and pain management, with a particular emphasis on innovative treatment of opioid and nicotine dependence.

Previously, Karen served as a clinical instructor in the Department of Psychiatry at the University of California in San Francisco from 1987 to 1998. From 1989 to 1996, she served as Assistant Chief and then Chief for the Substance Abuse Treatment Clinic in the Department of Psychiatry at the San Francisco Veteran Affairs Medical Center. She was Associate Director of Clinical Research & Development at the ALZA Corporation from 1996 to 1997.

Through her extensive research and development experience, Karen has served as principal investigator for nationally funded R01 grants and as Clinical Program Management/Medical Monitor on Phase I through Phase IV clinical trials. Her responsibilities have included managing Phase I-IV clinical studies and various post-marketing ventures, researching and writing clinical protocols, and the abuse liability and risk/benefit sections for INDs and NDAs. Karen has served as a consultant on new drug development including those with novel delivery systems for pharmaceutical and biotechnology companies since 1998. She has worked extensively on medications for the treatment of acute and chronic pain, opioid and nicotine addiction, ADD/ADHD, urinary urge incontinence, osteoporosis, and post-operative bowel dysfunction. Karen has also helped companies prepare for FDA Advisory Committee meetings, and has provided expert testimony at such meetings. Karen has extensive experience in post-marketing pharmacovigilance surveillance and reporting, and has been involved in forensic evaluations focusing on the effects of psychoactive drugs and alcohol, and issues involving the misuse, abuse, and diversion of psychoactive drugs.

Karen’s research has resulted in the writing of numerous book chapters, as well as articles, letters, and abstracts for prominent peer-reviewed medical journals on topics in substance abuse and pain management. She is on the editorial review board of several substance abuse journals.

Having graduated magna cum laude from West Virginia Wesleyan College in 1976 with a bachelor’s in science, Karen received her doctorate in osteopathic medicine from the West Virginia School of Osteopathic Medicine in 1983. Karen’s post-doctoral training included a rotating internship at Richmond Heights Hospital (now Sinai Medical Center East) from 1983 to 1984, an internal medicine residency at Brentwood Hospital (now Meridia Southpointe Hospital affiliate of the Cleveland Clinic Health Care System) from 1984 to 1987, and a substance abuse fellowship at the VA Medical Center in San Francisco from 1987 to 1989.

Karen is Board Certified by the American Osteopathic Board of Internal Medicine, holds a Certificate of Added Qualifications in Addiction Medicine and a Certificate of Added Qualifications in Pain Medicine, both from the American Osteopathic Board of Internal Medicine, and is certified by examination by the American Society of Addiction Medicine. She is a fellow in the American Osteopathic Academy of Addiction Medicine.