Director SRA Americas
Paisley Cameron is a regulatory professional who started her career with JTI as a Y2K consultant transitioning to Scientific & Regulatory Affairs with the introduction of the Tobacco Control Act in Canada. Since that time Paisley has expanded her area of responsibility and currently holds the position of Director, Scientific & Regulatory Affairs for JTI in the Americas region.
Paisley attended Wilfrid Laurier University in Waterloo Ontario, holds a Project Management Professional designation and is a certified Regulatory Affairs Professional.
Paisley has a great deal of hands-on experience in dealing with FDA since the Centre for Tobacco Products was granted oversight over tobacco in 2009. Since that time Paisley has been involved with ongoing compliance matters including compiling pre-market applications and has successfully obtained SE Orders from CTP, understanding the complexities and meeting the ever-moving goal posts set by CTP.
Paisley currently resides in Aurora and works out the JTI Canadian office located in Mississauga, Ontario.
President & COO
EAS Consulting Group
Dean Cirotta is the President and Chief Operating Officer for EAS Consulting Group where he is responsible for the day to day management of the technical aspects of the company with responsibility for client relations and personnel management.
Mr. Cirotta has 29 years of experience in the pharmaceutical and dietary supplement industries, including executive management roles with responsibility for regulatory affairs, compliance, quality assurance, laboratory operations and overall corporate management. In addition, Mr. Cirotta regularly speaks on GMP compliance and initiatives and is a lead trainer for EAS. He often performs audits of manufacturers and works with clients in responding to FDA 483 observations and warning letters.
He also assists the Tobacco Industry in complying with the Deeming Rule requirements and ensuring compliance with the Family Smoking Prevention and Tobacco Control Act.
Mr. Cirotta has a Bachelor of Science degree in chemistry from the University of North Carolina at Greensboro and a Master's degree in business administration from the University of North Carolina at Chapel Hill.
Latham & Watkins
Ben Haas practices in Latham & Watkins' Washington, D.C. office, where he is a corporate partner in the Healthcare and Life Sciences Practice Group. Mr. Haas focuses his practice on regulatory, transactional and legislative matters involving the medical device, pharmaceutical, biotechnology, tobacco, food, cosmetic and dietary supplement industries. Mr. Haas has counseled clients on a wide variety of regulatory matters involving the US Food and Drug Administration (FDA), including, among others: Pre-market product development and clinical and pre-clinical testing, FDA submissions, Product promotion and labeling, Compliance with good manufacturing practice requirements, and Agency inspections and recalls.
Mr. Haas has authored and co-authored articles on FDA regulatory matters, including articles in the Food and Drug Law Institute's Update Magazine and the Pharmaceutical Law & Industry Report, and has been a featured speaker and lecturer on FDA regulatory and policy matters at industry-sponsored events.
Chris Howard is Vice President, General Counsel and Chief Compliance Officer for E-Alternative Solutions, LLC, a marketer and distributor of vapor products and sister company to Swisher International, based in Jacksonville, Florida. Mr. Howard is responsible for overseeing EAS’s legal activities and policies, as well as compliance, regulatory affairs and brand protection. Mr. Howard provides industry leadership among vapor manufacturers and distributors in light of both a rapidly evolving regulatory landscape of the vaping industry and the developing science globally with respect to the vapor category. Mr. Howard also currently serves on the Vapor Technology Association Board of Directors.
Mr. Howard is a frequent speaker on marketing issues and other trends related to the vapor industry. He has a B.B.A. in Business Management and Marketing from James Madison University and a J.D. from The T.C. Williams School of Law at University of Richmond.
Senior Vice President
Top Tobacco LP
Carl is Senior Vice President for DRL Enterprises, an affiliate of the Republic Group of companies. Mr. Ioos’ responsibilities for DRL have included management of corporate development, mergers and acquisitions and regulatory affairs. Most recently, his responsibilities have expanded to managing FDA compliance and regulatory affairs for the group’s tobacco and tobacco accessories businesses.
Mr. Ioos has worked in the tobacco industry since 1991 and has presented on a wide range of business and governmental affairs topics at a number of industry and regulatory conferences. He earned a Bachelor of Science degree from the University at Albany and an MBA from PACE University.
Michael Best & Friedrich LLP
Seth Mailhot leads the FDA Regulatory practice and is a partner in the firm’s Transactional Practice Group.
Mr. Mailhot has worked on FDA-related matters for over 20 years, starting in various technical and enforcement positions at the U.S. Food and Drug Administration. Since entering private practice, Mr. Mailhot has counseled clients on all aspects of regulation by FDA, as well as related matters regulated by USDA, EPA and Department of Health and Human Services, including the National Organic Program, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH).
Advice spans issues impacting regulated product manufacturers, investors, distributors, retailers, and users (such as device user facilities with an obligation to report adverse events to FDA).
Director of Regulatory Services
Evan Richardson brings 12 years of experience in regulatory affairs and operations to Synchrogenix. His experience includes stints with pharmaceutical, biotechnology, and medical device companies, where he’s specialized in project management, system implementation, eCTD submissions, and organizational training. Prior to joining Synchrogenix, Mr. Richardson fulfilled a number of responsibilities within the regulatory departments of Bioventus and Cato Research, both located in North Carolina’s Research Triangle Park area. His career achievements include a major role in the approval of 3 distinct marketing applications, hundreds of regulatory submissions (ANDA, IND, NDA, BLA, and DMF) and a company-wide launch and implementation of a new document management system. Mr. Richardson currently oversees all of Synchrogenix’s regulatory publishing activities for tobacco applications, which includes the successful submission of 3 MRTPAs and ongoing activities for multiple PMTAs and TPMFs for a wide range of tobacco clients.
High Point Clinical Trials Center
Dr. Rusch is an executive level business development professional and drug development scientist specializing in early clinical development services as President at High Point Clinical Trials Center. Her specialized background allows her to provide a consultative service tailored to the needs of biotechnology and pharma clients.
Dr. Rusch earned her Ph.D. in Laboratory Medicine and Bioanalytical Chemistry from the Cleveland Clinic Foundation/Cleveland State University Consortium. She has significant drug development expertise in the biotechnology industry as well as operational expertise in early clinical development contract research organizational leadership.
Dr. Rusch provided preclinical, clinical pharmacology and metabolism expertise on many pre-IND drug development teams, including Merck’s Zolinza™ program, a first-in-class histone deacetyylase inhibitor (HDAC) currently approved for the treatment of cutaneous T-cell lymphoma and under study for additional indications. Dr. Rusch’s current interest is the creation of viable strategies for clients focused in achieving Proof of Concept (POC) in Phase I/IIa by use of adaptive clinical trials involving both healthy normal subjects and patient populations.
Barry S. Schaevitz
A former Assistant Attorney General for the State of New York, Barry represents product manufacturers and industry trade associations in litigation, regulatory and legislative matters. He has defended clients in complex product liability matters involving medical, scientific, and other technical issues in courts throughout the country. His experience includes representing clients in cases involving questions of disease causation and addiction.
Barry also represents clients in matters involving federal regulation and federal agencies, including the Food and Drug Administration and the Federal Trade Commission. He similarly works with clients on a wide variety of regulatory matters before state agencies and departments.
In addition to working with clients to avoid or resolve litigation or regulatory issues, Barry also engages on federal and state legislative matters. In doing so, he meets with legislators and staff, and other public officials on matters of concern to clients.
Marc J. Scheineson
Alston & Bird
Mr. Scheineson heads Alston & Bird’s food and drug law practice. He has practiced food and drug law, health care law, and administrative law for over 30 years in national law firms and at the Food and Drug Administration (FDA). His practice focuses on determining the “regulatory course of least resistance” to market medical products, and assisting clients with legal and regulatory issues, drug and medical device applications, marketing, compliance, and enforcement matters. He also represents small businesses engaged in tobacco and e-product manufacture and sale. Mr. Scheineson provides legal, regulatory, and legislative counsel to a variety of marketers, research institutions, professional associations, and manufacturers of pharmaceutical and biological drug products, medical devices, cosmetics, dietary supplements, tobacco and traditional foods. He is a frequent speaker in industry forums. He is also experienced with the application of the Office of Inspector General (OIG) anti-kickback statute, HIPAA privacy rules, clinical trial regulation, human research protection, scientific misconduct, technology transfer and licensing, advertising and promotion law, and advises on the FDA regulatory aspects of health care transactions.
He previously served as Associate Commissioner for Legislative Affairs at the U.S. Food and Drug Administration (FDA). Mr. Scheineson is a former Co-Chairman of the American Bar Association’s Committee on Food and Drug Law; chaired the Task Force on FDA Reform and is a former Chair of the Young Lawyers Section of the Bar Association of the District of Columbia. He received his B.A. and J.D. from the University of Cincinnati and its College of Law and his L.L.M. from the Georgetown University Law Center.