Our Team

John Pinney

Founder and CEO

Bringing coherence to complexity by integrating proven principles in science, policy, and management

Joe Gitchell

President

Providing strategic counsel that spans policy, regulatory, marketing, and communications challenges

Lucy Owen

Senior Vice President

Guiding clients through the complex and dynamic Rx-to-OTC switch regulatory process

Judy Ashworth, MD

Vice President, Rx Strategic Services and Chief Medical Officer

Guiding the clinical development of CNS-active drugs in a challenging and rapidly evolving regulatory environment

Jack Henningfield, PhD

Vice President, Research, Health Policy, and Abuse Liability

Leading development and regulatory strategy for new treatments for neurological and psychiatric disorders with high unmet needs

Saul Shiffman, PhD

Senior Scientific Advisor, Behavioral Science, Study Design, and Analysis

Directing support for Rx-to-OTC switch, with emphasis on behavioral data and communication

Bernie Simone

Vice President, Client Strategy and Rx-to-OTC Switch

Steering OTC switch projects through regulatory and commercial challenges to success

George Quesnelle

Senior Strategic Advisor, OTC Commercialization and Optimization

Marshalling onset-to-completion resources for Rx-to-OTC switch success

Sidney Schnoll, MD, PhD

Vice President, Pharmaceutical Risk Management

Evaluating the benefit-risk balance of CNS-active drugs in postmarketing studies and REMS

August Buchhalter, PhD, MA

Director, Abuse Potential Assessment

Offering expertise in evaluating CNS-active drugs and abuse potential assessments

Marion Coe, PhD

Director, Clinical Development and Postmarketing Surveillance

Helping plan optimal pathways for the clinical development and postmarketing surveillance of unique and challenging classes of drugs

Robyn Gougelet

Director, Health Policy and Regulatory Strategy

Driving public health, science, communications, and policy alignment to support market transformation away from combustible tobacco to reduced-risk sources of nicotine

Ryan Lanier, PhD

Director, Clinical Development and Abuse Liability

Utilizing extensive clinical and nonclinical research experience to strategically guide the development of new CNS-active drugs

Mark Sembower, MS

Director, Data Management and Statistical Analysis

Uncovering the ideal analyses to support client regulatory and commercial goals

Christine Sweeney, PhD, MPH

Director, Issues Management

Establishing the data driven benefit-risk case to support regulatory approval of consumer healthcare products

Daniel Wang

Director, Cannabinoids and New Dietary Ingredients

Helping clients advance their ideas and bring meaningful innovative products to consumers

Lisa Zapawa, MD, MPH

Director, Medical Science

Providing scientific and strategic support for Rx-to-OTC switch efforts

Michelle Ertischek, MPH

Director, Planning and Operations

Sustaining the links between clients and our dedicated project teams

Steve Choi

Director of Finance

Heading up our financial and administration functions for optimal business operations

Arielle Selya, PhD

Scientist

Pursuing innovative research to hone our understanding of public health challenges and solutions

Sooyong Kim, MD, MPH

Scientist

Carrying client projects forward with research and advanced statistical methodologies

Sarah Scholl, MPH

Senior Associate

Assuring close coordination and effective, efficient management of research efforts in support of regulatory applications

Gina Bittner

Senior Associate

Ensuring excellence in scientific publications and presentations

Rachel Beck, PhD

Scientist

Enhancing understanding of the abuse potential of CNS-active drugs, from CMC and nonclinical assessments to postmarketing

Michael Hannon, MA

Data Analyst

Analyzing, managing, and visualizing data that optimize client product strategy

Steve Pype

Senior Data Manager

Providing data and analytical support for client projects and regulatory submissions

Erin Nealer

Associate

Advancing the cause of science-driven public policy through research and analysis

Floe Foxon

Data Analyst

Supporting client service teams with data analyses and powerful simulation modeling to advance client goals

Caitlyn Grubb

Junior Associate

Bringing research experience to drug discovery and development

Gabrielle Blythe

Meeting Coordinator and Executive Assistant

Assuring excellence and consistent quality in day-to-day interactions and landmark events