Expertise

John M. Pinney oversees the company’s strategic direction and advises clients on integrating science, policy, and management principles to provide coherent solutions for clients’ health policy, regulatory, and operational issues. John applies the experience and insights from his background in public health policy and involvement in numerous major prescription and OTC drug development projects to his support for consumer healthcare and pharmaceutical companies.

Experience

John has spent 50 years in the fields of disease prevention, substance abuse, health policy, and pharmaceutical consulting. He has held 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 products, employees, and services.

John began his career in 1971 in the Office of the United States 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 Health, Education and Welfare and Director of the Office on Smoking and Health.

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 consumer healthcare and 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.

In addition, John is co-founder and serves as Chairman of the Board for Harm Reduction Therapeutics, a non-profit organization working to make naloxone available as an OTC product at the lowest cost possible in order to save lives from opioid overdose.

Education

• Graduated from Yale University

Expertise

Joe G. Gitchell has extensive experience in providing strategic counsel to clients across a wide range of health policy, regulatory, and marketing and communications challenges. Joe leads efforts:

• Supporting regulatory approvals, conducting public policy analysis, and developing communications approaches
• Devising, refining and defending product claims
• Providing input on strategic market opportunities and directions

Experience

Since joining PinneyAssociates in 1993, Joe has counseled clients navigating health policy and communications challenges around the world, including in the United States, Europe, Latin America, Asia, and the Middle East. His work has included extensive collaboration with highly respected researchers, policy experts, and nonprofit organizations.

A co-author on over 40 articles, Joe has been published on topics including population health, drug-use behaviors and simulation modeling 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 Tobacco Manufacturers Association, the Global Forum on Nicotine, and the Consumer Healthcare Product Association’s Annual Executive Conference on topics including the impact of personal technologies on healthcare regulations and a strategic research agenda for e-cigarettes.

Education

• Graduated magna cum laude from Yale University

Follow Joe on Twitter @jgitchell

Expertise

Lucy Owen provides strategic advice to clients, with a focus on the issues management process in the context of Rx-to-OTC switch. She specializes in development and execution of science-based regulatory and commercial strategies, including:

• Developing the public health benefit/risk case for an Rx-to-OTC switch
• Developing product labeling through an iterative development process including qualitative and quantitative testing with consumers and advising on behavioral and other studies/data needed to support the switch
• Preparing for regulatory submissions, FDA interactions and Advisory Committee meetings

Experience

Lucy joined PinneyAssociates in 1998 and 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 for approved OTC products, prescription medications and vaccines, and non-profit public health advocacy organizations.

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

Education

• Completed graduate work in the History of Medicine at Oxford University
• Graduated with High Distinction and High Honors from the University of Michigan

Expertise

Judy B. Ashworth came to PinneyAssociates with nearly two decades of experience in pharmaceutical drug development. Since joining the company in 2018, Judy primarily supports our clients who are developing CNS-active drugs, from traditional pharmaceuticals to psychedelics and cannabinoids, across a range of neurologic and psychiatric indications with:

• Clinical development plans and trial design
• Regulatory strategies including agency interactions
• Strategic target product profile development with attention to potential market access challenges
• Strategies for assessing abuse potential of novel compounds as well as new formulations of marketed compounds

Experience

Judy began her pharmaceutical career in 2001 as a clinical pharmacologist at Grunenthal GmbH. In 2003, Judy took on the project leadership of Gruenenthal’s abuse deterrent formulations (ADFs) program and an internal working group tasked with developing expertise in abuse potential 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 worked on the development of novel 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. In parallel, she established the Center of Excellence for Abuse Liability at Gruenenthal USA, Inc, supporting the company’s commitment to help develop safer alternatives for pain management.

Upon returning to Germany, Judy was the clinical lead for tapentadol during its marketing registration process in the US and EU, then set up a partnering intelligence department to support business development, with asset search and evaluation and scientific due diligences, and later helped establish the Innovative Medicines Unit at Gruenenthal’s headquarters before opening its first external hub in the Leiden BioScience Park in the Netherlands.

Judy has published on clinical development and abuse potential assessment of CNS-active drugs.

Along with her work at PinneyAssociates, Judy also serves as the Chief Medical Officer for Harm Reduction Therapeutics, a non-profit organization working to bring a low-cost, naloxone product to the OTC market to reduce opioid overdose deaths by reducing barriers to access.

Education and Training

• Completed the Internal Medicine residency program at Santa Barbara Cottage Hospital, serving as chief resident in her final year of training
• Graduated as a Dean’s Scholar from UCLA School of Medicine, in recognition of research in geriatric medicine
• Graduated with high honors from the University of California Santa Barbara with a bachelor’s in biology

Expertise

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 has received numerous awards for his research and policy contributions to the understanding and control of addiction. In his role at PinneyAssociates, Jack:

• Counsels clients on assessment of the abuse liability of new CNS-acting drugs and formulations, and develops assessments of abuse potential (8 Factor Analyses) to support potential Controlled Substances Act scheduling recommendations
• Leads assessment of the tamper resistance of novel formulations, and development of risk management approaches
• Counsels clients on finding regulatory pathways for psychedelics, cannabinoids, and CNS-active dietary supplements such as kratom and some cannabinoids
• Liaises with the FDA on issues concerning drug scheduling and addiction/abuse liability and presents frequently to FDA Advisory Committees on behalf of product sponsors

Experience

Jack 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 led abuse potential assessments and developed drug scheduling recommendations in frequent collaboration with the FDA and DEA. He has served on numerous US Government agency committees and international committees including more than 13 years on a World Health Organization (WHO) expert committee.

At NIDA, he served as Chief of the 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) and directed the Minority Recruitment and Training Program (1990-1996). He was a frequent contributor to NIDA’s reports to Congress, Reports of the Surgeon General, and provided congressional testimonies on behalf of NIDA.

Since leaving NIDA he has served as a Special Government Employee to the FDA Center for Drug Evaluation and Research (2009-2014) and Center for Tobacco Products (2010-2013).
Jack 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 adjunct faculty member with the Program of Toxicology at the University of Maryland at Baltimore.

Throughout his career Jack 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 450 published papers on myriad topics in public health, pharmacology, and addiction. He has received numerous national and international awards recognizing his scientific and public health leadership efforts.

Education

• Postdoctoral research fellow at the University of Minnesota and at the Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit
• Postdoctoral training supported by National Council on Alcoholism Fellowship at the University of Minnesota, Department of Psychiatry
• Received his doctorate in experimental psychology with a pharmacology supporting program from the University of Minnesota’s Psychopharmacology Training Program, with a focus on addiction, CNS medications, preclinical abuse liability assessment, and drug addiction control
• Graduated summa cum laude from the University of Minnesota with a bachelor’s in psychology

Expertise

Saul Shiffman is a world-renowned researcher in the fields of behavior change, consumer use of non-prescription medications, self-management and self-control, field research methodology, statistical analysis, and addiction and dependence. At PinneyAssociates, Saul guides:

• Rx-to-OTC switch
• 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
• Shaping the scientific and policy environment for OTC products, including directing strategic efforts to build and explain the benefit/risk profile of those products.

Experience

Since 1984, Saul has been a professor at the University of Pittsburgh where he is appointed in the departments of psychology and pharmaceutical sciences, 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 400 published papers on a variety of topics related to psychopharmacology, substance abuse, dependence, coping, and both traditional and computerized methods for assessing behavior, and has presented widely in medical and scientific forums around the world.

A fellow of numerous professional societies, Saul has served as a scientific reviewer and editorial board member for several major medical and scientific journals, and on grant review standing committees. In 2007, he 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.”

Education

• Earned his doctorate in psychology from UCLA
• Graduated with a bachelor’s in psychology from Brooklyn College

Expertise

Bernie Simone has over 30 years’ experience in the OTC industry encompassing product marketing, business development and Rx-to-OTC switch. Since joining PinneyAssociates in 2018, Bernie has focused on supporting our consumer healthcare clients with:

• Rx-to-OTC switch regulatory strategy, consumer/clinical studies, commercial opportunity assessments and inter-functional project management
• Marketing and consumer research to drive business growth opportunities and mining for consumer insights
• New business development across licensing, acquisition and supply agreements involving some of the leading and more innovative brands in the United States (US)

Experience

Bernie’s experience spans over 50 therapeutic categories in OTC medicines, prescription drugs, medical devices, and dietary supplements. He has extensive practical experience across the range of activities required in Rx-to-OTC switch, including regulatory strategy, consumer study methodology and reporting, commercial opportunity assessment and project management.

He has overseen marketing and consumer research for some of the top 20 brands in the US to drive business growth and identify optimal consumer targets and key consumer insights. He also led new business development for some of the leading and more innovative brands in the US.

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 HealthCare
• Global Strategic Category Director for Bayer’s CardioAspirin franchise
• Business Development, Innovation and Rx-to-OTC Switch at Bayer and Ciba-Geigy
• Head of Rx-to-OTC Switches for Sanofi CHC North America

Bernie’s switch project leadership includes the critical task of leading multi-function teams, including regulatory, medical, clinical, safety, marketing and manufacturing functions. He led the first-in-class switch of Nasacort 24HR, and the first-in-class introduction of an OTC TENS (Transcutaneous Electrical Nerve Stimulation) medical device. He was also responsible for the licensing and the Rx-to-OTC switch of Xyzal Allergy 24HR. He led the successful licensing of the OTC switch rights for Cialis and the initial three years of the cross-functional, global Cialis switch team. He has led the licensing of several other popular OTC brands including Maalox, Rid and Rolaids.

Since joining PinneyAssociates Bernie has helped clients to strategize, prepare regulatory submissions, and interface with FDA, to conduct due diligence of licensing opportunities, develop and test high-scoring marketing concepts, and develop commercial and regulatory strategies for new products. In addition, Bernie serves as the Chief Operations Officer and the Chief Commercial Officer for Harm Reduction Therapeutics, a non-profit organization working to make naloxone available as an OTC product at the lowest cost possible in order to save lives from opioid overdose.

Education

• Earned a master’s in management from Stevens’ Institute of Technology
• Graduated with bachelor’s of science in engineering from Rutgers University – College of Engineering

Expertise

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. Now at PinneyAssociates, he:

• Counsels clients on the business planning process, including resource allocation, identifying and evaluating licensing and acquisition targets, and identifying and negotiating business partnerships
• Advises on the commercialization process for Rx-to-OTC Switch projects, including switch candidate identification, and forecasting OTC switch volume
• Helps to develop or evaluate marketing plans as well as consumer and trade promotions
• Assists with development of launch scenarios and timing.

Experience

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 United States, 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, CHPA 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 United States.

Education

• Earned a master’s of arts from Oakland University
• Graduated with a bachelor’s from Eastern Michigan University

Expertise

Sidney (Sid) H. 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 pharmaceutical risk management. In his strategic leadership role, Sid counsels clients and provides strategic input on:

• Regulatory and scientific strategy
• Development, implementation, and assessment of risk management activities, including engagement with the FDA
• Risk assessment during early product development, and development of Risk Evaluation and Mitigation Strategies (REMS)
• Postmarketing surveillance reports for submission to FDA

Experience

Sid has served on numerous committees and boards including the FDA’s Drug Abuse Advisory Committee (DAAC), National Institutes of Health (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. 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. He is currently a member of the RADARS® System Scientific Advisory Board and Industry Advisory Board.

Sid has held several academic positions. He was the Career Teacher in Addictions at the University of Pennsylvania, after 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 the College on Problems of Drug Dependence and the American Society of Addiction Medicine. He has published over 150 research papers, book chapters and educational materials.

Education

• Completed his internship, residency in neurology and doctorate in pharmacology at Jefferson Medical College (now the Sidney Kimmel Medical College)
• Earned his medical degree at the New Jersey College of Medicine and Dentistry
• Graduated from Union College

Expertise

August R. Buchhalter joined PinneyAssociates in 2004, bringing extensive research experience in assessing drugs with abuse potential. He oversees in vitro assessments of abuse-deterrent drug formulations and contributes to abuse potential assessments and drug scheduling recommendations of CNS-active drugs. In his role, August is involved in:

• In vitro assessment of CNS-active drug products such as abuse-deterrent drug formulations, including development of protocol outlines and interpretive reports for submission to FDA
• Abuse potential assessments (8 Factor Analyses) and drug scheduling recommendations of CNS-active drugs
• Assisting in the design, management, and interpretation animal abuse-related behavioral pharmacology and human abuse potential (HAP) studies

Experience

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

He has co-authored more than 20 review and research papers and three book chapters.

Education

• Completed his postdoctoral fellowship at the University of Vermont College of Medicine
• Earned his doctorate in psychology, which included training in drug dependence and behavioral pharmacology from Virginia Commonwealth University
• Trained in drug abuse research at The Johns Hopkins University School of Medicine’s Behavioral Pharmacology Research Unit. In parallel, earned his master’s in clinical psychology from Loyola College in Maryland (now Loyola University Maryland)
• Graduated from Clark University with a bachelor’s in psychology and minors in philosophy and economics

Expertise

Marion Coe is a clinical pharmacologist with experience working across the drug development pipeline with small and big pharma, academic, government, non-profit, and contract research organization partners and clients. She has expertise in clinical development and operations, development and management of postmarketing surveillance programs, and strategic analysis supporting due diligence for potential pharmaceutical in-licensing and/or acquisitions. She spent eight years working on clinical trials for various substance use disorders and specializes in clinical development for unique and challenging classes of drugs. Marion advises clients on:

• Clinical development, commercialization, and postmarketing strategy for psychedelic compounds (e.g., MDMA and psilocybin)
• Clinical development plans and trial design
• Regulatory strategy and agency interaction
• Strategic Target Product Profile development
• Postmarketing surveillance and Risk Evaluation and Mitigation Strategies (REMS)

Experience

Marion joined PinneyAssociates in 2019. Before joining, Marion worked in a clinical pharmacology unit at the National Institutes of Health utilizing innovative clinical trial design elements (e.g., intravenous ethanol self-administration in humans) to assess efficacy of medications for alcohol use disorder. She continued to support clinical trials design, start-up, and management during her doctoral work, including for a pivotal Phase 2 trial assessing a novel formulation of buprenorphine. Her dissertation, which was funded by a National Institute on Drug Abuse (NIDA) grant, utilized a driving simulator to characterize the time course and severity of benzodiazepine-and hypnotic-induced psychomotor impairment.

Working in the Office of Technology Commercialization at the University of Kentucky, Marion performed strategic analyses of patent literature, competitive analysis of existing and pipeline pharmaceutical products, and synthesis of market trends related to key stakeholder activity and profitability further client commercialization goals.
Marion’s 15 plus publications include, among others, a review of all marketed buprenorphine products, results from a survey of kratom users, and an inpatient study examining pain responses during an oxycodone maintenance procedure.
In addition, Marion also serves as Head of Clinical Operations for Harm Reduction Therapeutics, a non-profit organization working to bring a low-cost, naloxone product to the OTC market to reduce opioid overdose deaths by reducing barriers to access.

Education

• Received her doctorate in pharmacology from the University of Kentucky
• Earned her bachelor of arts in psychology from the University of Wisconsin at Madison

Expertise

Michelle D. Ertischek manages a range of internal operations at PinneyAssociates to ensure services can be delivered when clients need them. In her role, Michelle uses resourcefulness, a commitment to anticipating challenges, and problem solving to:

• Supporting project management of client projects to ensure delivery of quality timely services by the appropriate team
• Support implementation of company and client Standard Operating Procedures
• Serve as the primary contact for our alliances with a range of partner companies to support client needs for a range of preclinical, clinical and behavioral studies

Experience

Michelle has supported the pharmaceutical and consumer health industries for more than 20 years. Since joining PinneyAssociates in 2001, Michelle has advised clients on risk management plans and postmarketing surveillance for CNS-acting drugs, controlled substances and Rx-to-OTC switch. She has been responsible for overseeing multi-disciplinary teams to deliver strategic scientific and regulatory counsel to clients, conducting expert interviews and shepherding issues and scientific and policy environment assessments, and has co-authored publications on topics such as nonmedical use of drugs and risk management. Michelle has helped clients pursue their regulatory goals in the United States, Canada, Europe, Australia, Japan, and South Africa.

After more than 20 years of providing services to pharmaceutical and consumer healthcare clients, in 2020, Michelle took on the role of Director of Planning and Operations and now focuses on the management of internal operations that are critical to PinneyAssociates’ ability to provide clients with services and deliverables prepared by the best team of company experts for their needs.

Education

• Earned her master’s in public health with a focus on health policy from George Washington University
• Graduated from Wellesley College

Expertise

Since joining PinneyAssociates in 2015, Robyn Gougelet has advised clients on public health legislative and regulatory policy strategy, including for regulatory submissions to and Advisory Committee meetings at the FDA Center for Tobacco Products. In that role, Robyn:

• Maintains relationships with public health and tobacco control policy experts and scientists to advance relative risk-based nicotine policy and regulation
• Supports efforts to communicate the continuum of risk for nicotine-containing products to a wide range of stakeholders

Experience

Before joining PinneyAssociates in 2015, Robyn worked at Trust for America’s Health (TFAH), a non-profit, non-partisan organization in Washington, D.C. dedicated to saving lives by protecting the health of every community and working to make disease prevention a national priority. In that role, Robyn helped to inform Members of Congress and their staff members about state-specific prevention and public health provisions and programs created by the Affordable Care Act. As part of her work at TFAH, Robyn advocated for public health programs during the appropriations process.

Before joining TFAH, Robyn interned in the office of Senator Jeanne Shaheen.

Education

• Graduated magna cum laude from the University of Maryland with honors and was elected to Phi Beta Kappa
• Studied history and politics as a visiting student at Lady Margaret Hall at the University of Oxford

Expertise

Ryan Lanier has 20 years’ experience conducting preclinical and clinical research supporting the development of a variety of CNS-active drugs, including over a decade working in the pharmaceutical, cannabinoid, and dietary supplement industries. At PinneyAssociates, Ryan supports clients with:

• Assessment of abuse potential, including interpretation of nonclinical and clinical abuse potential studies, and assessing potential abuse-related events in clinical trials and postmarketing
• Regulatory meeting interactions (including FDA type A, B and C meetings, and Advisory Committee meetings) from preparation to direct participation
• Strategic input into clinical development plans, clinical trial design, and the assessment of market opportunities, with particular expertise in analgesic drugs
• Scientific and regulatory strategies for the development and marketing of dietary supplements and cannabinoid-based products

Experience

Ryan began his career in the pharmaceutical industry as a clinical research scientist at Javelin Pharmaceuticals, where he assisted in the development of reformulated analgesic drug products intended to treat acute pain syndromes, including novel intranasal formulations of ketamine and morphine.

He then joined Rock Creek Pharmaceuticals, Inc., where he oversaw the development of CNS-active dietary supplements and modified risk non-combustible tobacco products.
Ryan went on to lead the consulting team at Analgesic Solutions, Inc., providing strategic scientific and regulatory counsel to companies developing new analgesic therapies. He was the scientific lead for the validation and implementation of MADDERS®, a novel standardized system for prospectively identifying and assessing potentially abuse-related adverse events in clinical trials of CNS-active drugs to better estimate a drug’s true abuse potential.
Just prior to joining PinneyAssociates, Ryan worked on the early clinical development (phase 1 through 2a) of cannabinoid-based medicines and novel cannabinoid formulations for treating pain and other indications. He also led the assessment of market opportunities and created development plans for new products which could address unmet medical needs, including orphan indications. He counseled AusCann and worked as Associate Director, Pain and Abuse Liability for Spectrum Therapeutics (a Canopy Growth Corporation Company).

Ryan has authored or co-authored more than 30 papers and book chapters, and has presented his research findings at a wide variety of prestigious scientific meetings.

Education and Training

• Completed a postdoctoral research fellowship at the Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit
• Earned a doctorate in biological psychology from the University of North Carolina at Chapel Hill
• Earned dual bachelor’s degrees with distinction in biology and psychology from the University of North Carolina at Chapel Hill

Expertise

An accomplished statistician, Mark A. Sembower leads PinneyAssociates’ data management team, using a wide range of applicable analytical methods to serve clients. In his role, Mark:

• Analyzes and reports on a variety of datasets, including post-marketing and pharmacovigilance data, consumer surveys, clinical trial data, and large public datasets, including federal surveys
• Provides essential statistical support for clients’ OTC and prescription products and dietary supplements related to risk management, post-marketing surveillance, Rx-to-OTC switch, abuse potential assessments, human abuse potential (HAP) studies, clinical research, and consumer research

Experience

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.

He has conducted research into non-medical use of prescription pharmaceuticals, medication compliance, smoking cessation, ENDS usage, and drug use and psychological disorders among adolescents. Mark is an author or co-author of more than 25 published papers in peer-reviewed journals, as well as numerous posters and presentations.

Education

• Completed a master’s of science in applied statistics at Bowling Green State University
• Earned his bachelor’s in mathematics with a minor in statistics from Penn State Erie, The Behrend College

Expertise

Christine T. Sweeney brings more than two decades of experience to our Rx and OTC clients; she focuses on helping clients to strategically utilize the science found in the published literature and proprietary data sources to support regulatory and commercial goals. In this role, Christine:

• Develops public health rationales, benefit/risk assessments, and issues inventory and management plans
• Assists clients in the development of product labeling and the design of consumer (label comprehension, self-selection, actual use) and other studies
• Drafts regulatory submissions in support of our Rx-to-OTC switch and OTC product stewardship projects
• Conducts literature reviews and analysis

Experience

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.

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.

Education

• Post-doctoral fellowship in cancer prevention at the National Cancer Institute, including a master’s in public health with a concentration in epidemiology at Johns Hopkins University
• Earned her doctorate in biobehavioral health from Penn State University
• Graduate with a bachelor’s in psychology from LaSalle University

Expertise

Daniel (Dan) Wang applies his experience with opioids, stimulants, and other CNS-active compounds to lead efforts on the development of CBD and other cannabinoids and new dietary ingredients, providing clients with valuable policy and regulatory perspectives in this rapidly evolving area. In this role, Dan currently:

• Provides policy and regulatory guidance to companies seeking to market cannabinoids and new dietary ingredients
• Contributes to reports and manuscript publications on abuse potential of CNS-active products
• Assesses changes in the regulatory landscape surrounding novel therapeutics such as cannabinoids and other botanically derived health products

Experience

Before joining PinneyAssociates in 2010, Dan coordinated early phase clinical trials in oncologic drug development at the Hospital of the University of Pennsylvania.

At PinneyAssociates, for over ten years, Dan has provided scientific and regulatory support for companies developing and marketing drugs and other products with abuse potential. He has presented and co-authored a number of articles on the abuse potential of novel botanical products, including kratom, and real-world outcomes of use of these products.

Education

• Graduated with a bachelor’s in the biological basis of behavior from the University of Pennsylvania

Expertise

Lisa M. Zapawa provides strategic and science-based support on Rx-to-OTC switch programs, consumer healthcare products, prescription medications and vaccines, and non-profit public health advocacy. Lisa:

• Conducts literature reviews and analysis
• Develops reports, manuscripts, public health rationales, benefit/risk assessments, meeting requests and briefing books for sponsor meetings with FDA, as well as safety and efficacy sections for New Drug Application submissions
• Oversees integrated teams to advise clients on issues assessment and management

Experience

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, DC. She 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, allergic rhinitis, smoking cessation/tobacco control, women’s health conditions, reproductive health and family planning, pain management, cholesterol lowering, blood pressure lowering, and vaccines for childhood diseases and bioterror agents.

Education

• Received her master’s of public health in health management and policy from the University of Michigan School of Public Health
• Earned her medical degree from the University of Michigan Medical School
• Graduated with a bachelor’s of science in psychology from the University of Michigan

Expertise

In her indispensable role at PinneyAssociates, Gabrielle:

• Coordinates client meetings, conferences and corporate events
• Provides administrative support to the company’s senior leadership and PinneyAssociates’ Pittsburgh office

Experience

Gabrielle undertakes every aspect of client and corporate meeting planning with great enthusiasm, bringing almost 20 years of experience and innovative ideas to the challenges of planning both small and large events. Gabrielle joined PinneyAssociates in 1997. Prior to joining PinneyAssociates, 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.

Expertise

Steve Choi brings almost 30 years of financial and accounting experience to PinneyAssociates where he:

• Manages the day to day financial and accounting operations
• Provides Human Resources support
• Supports project managers in managing budgets
• Works with our legal counsel to manage and oversee client and vendor contract execution

Experience

Steve began his career in public accounting in 1991. He spent four years at a mid-size 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 and director of finance for several small IT services companies and a startup digital advertising company before joining PinneyAssociates in 2002.

Education

• Earned a bachelor’s in accounting from the University of Maryland
• Earned a bachelor’s in finance from the University of Maryland

Expertise

Edward (Ed) J. Cone is recognized world-wide for his expertise on the chemistry and pharmacology of drugs of abuse. At PinneyAssociates, based on his expert knowledge of pharmacokinetics and drug testing methodologies, he consults with clients on the:

• Evaluation of abuse-deterrent formulations
• Development of novel drug delivery systems

Experience

Throughout his career, Ed has emphasized the value of applying real-world experience to solving 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 many doctoral candidates.

Ed has published over 250 research and review articles and chapters on a broad array of topics concerning human drug administration. In 2020 he was cited as the most highly cited scientist worldwide in forensic toxicology and he was cited by ScienceWatch as the most highly cited author in forensic science over the period of 1981-1993. He was additionally recognized with the Scientist Professional Advisory Committee Career Scientist of the Year Award granted by the US Public Health Service Commissioned Officer’s Association (1996), was awarded the Irvine Sunshine Award in Clinical Toxicology (1995), received the Rolla Harger Award from the American Academy of Forensic Sciences for “Outstanding Contributions to Forensic Toxicology” (2000), and won the Irvine Alan Curry Award for his extensive research in Clinical Toxicology from the International Association of Forensic Toxicologists (2006).

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

Education

• Served as a postdoctoral Fellow, Department of Chemistry, University of Kentucky, Lexington, KY
• Earned his doctorate in organic chemistry from the University of Alabama
• Graduated with a bachelor’s in chemistry from Mobile College, Mobile, Alabama

Expertise

As an advisor to PinneyAssociates’ clients, Marilyn Huestis brings an extraordinary breadth and depth of expertise and experience in clinical and forensic toxicology, anti-doping, diagnostic screening and confirmation drug testing, and cannabinoid agonists and antagonists. Marilyn applies the following areas of expertise to clients’ needs:

• Clinical and forensic toxicology
• Diagnostic screening and confirmation drug testing
• Cannabinoid agonists and antagonists

Experience

In 2016, Marilyn retired as a tenured senior investigator and Chief, Chemistry and Drug Metabolism Section, Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, after 23 years of conducting controlled drug administration studies. Through her research, Marilyn 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.

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 additionally 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, and the National Safety Council’s Alcohol, Drugs and Impairment Division Executive Board.

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.

Marilyn has published 474 peer-reviewed manuscripts and book chapters and had more than 800 abstracts presented at national and international meetings.

The journal Clinical Chemistry featured Marilyn as an “Inspiring Mind”. 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, 2015, and Irving Sunshine Award for Outstanding Research in Forensic Toxicology, 1992.

Education

• Received a Doctor Honoris Causa from the Faculty of Medicine, University of Helsinki in Finland
• Received her doctorate in toxicology with honors from the University of Maryland
• Graduated with honors with a master’s in clinical chemistry from the University of New Mexico
• Graduated cum laude with a bachelor’s in biochemistry from Mount Holyoke College

Expertise

Karen L. Sees joined PinneyAssociates as an advisor in 2000. She applies her deep experience in both clinical trial design and interpretation as well as postmarketing pharmacovigilance surveillance and reporting to the development of safety summaries for submission to FDA. In this role, Karen:

• Develops integrated summaries of safety (ISS) in support of NDAs
• Advises clients on integration of legacy data into the ISS

PinneyAssociates:

Experience

With more than 30 years’ experience in substance abuse treatment, research, and pain management, with an emphasis on innovative treatment of opioid and nicotine dependence, Karen has first-hand knowledge of forensic evaluations focusing on the effects of psychoactive drugs and alcohol, and issues involving the misuse, abuse, and diversion of psychoactive drugs.
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 postmarketing 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 helped companies prepare for FDA Advisory Committee meetings, and has provided expert testimony at such meetings.

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.

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.

Education

• Completed a substance abuse fellowship at the VA Medical Center in San Francisco
• Served as an internal medicine resident at Brentwood Hospital (now Meridia Southpointe Hospital affiliate of the Cleveland Clinic Health Care System)
• Participated in a rotating internship at Richmond Heights Hospital (now Sinai Medical Center East)
• Received her doctorate in osteopathic medicine from the West Virginia School of Osteopathic Medicine
• Graduated magna cum laude from West Virginia Wesleyan College with a bachelor’s in science