Archives: Speakers

Carrie focuses her practice on intellectual property counseling, prosecution and enforcement, with an emphasis on intellectual property litigation. She has represented clients in disputes in federal trial and appellate courts, before the Trademark Trial and Appeal Board, and before the International Trade Commission. Carrie represents clients of various sizes, ranging from individuals and startups to Fortune 500 companies, which span a broad range of industries, including apparel, medical devices, pharmaceuticals, school and office supplies, agricultural equipment, and various service sector industries.

Howard has undertaken a diverse range of roles in the financial services sector spanning the disciplines of operational management, corporate relationship management, strategy and risk management.

Passionate about preventing Economic Crime his current role is to provide Oversight of Economic Crime risks with particular focus on screening and transaction monitoring.

He is an advisory board member for Cifas, the UKs largest cross-sector fraud data sharing organisation, as well as a member of the European Banking Federation Exco financial crime strategy group. He is also an active member of the Europol Financial Intelligence Public Private Partnership.

As an active LinkedIn member Howard regularly shares thoughts and insights into the world of Economic Crime Prevention and the latest developments around the globe.

Angela Ho-Chen is currently a Managing Counsel at RAI Services. Angela received her Bachelor of Arts degree from Emory University, her Master of Public Health in Cancer Epidemiology and Biostatistics and Master of Public Administration from the University of Miami, and her Juris Doctorate from American University.

Angela’s career has spanned nearly 20 years in the medical device and tobacco regulatory arenas. Angela is an attorney and practiced criminal food and drug law as outside counsel prior to transitioning into FDA’s Center for Devices and Radiological Health (CDRH) where she leveraged her Master of Public Health degree to take a role as a Consumer Safety Officer in the Office of Compliance. In her 15 months at CDRH, Angela worked on several task forces and served as an acting case expert. In January 2010, Angela took a Regulatory Counsel position at the Center for Tobacco Products (CTP). Angela was one of the founding members of the Office of Compliance and Enforcement at CTP and left CTP in February of 2017 as Division Regulatory Counsel. She then transitioned into the legal and regulatory departments at Altria Client Services and Juul Labs prior to establishing her own consulting firm, FDA Regulatory and Legal Services, PLLC.

Angela has extensive cross-functional regulatory and legal leadership and project management experience. Her legal and regulatory review portfolio specifically includes pre-market and post-market regulatory submissions strategy and execution, gap analyses, marketing and labeling reviews, inspection/audit readiness, compliance analyses and enforcement mitigation in medical devices and tobacco. Angela has assisted clients with interpreting the Food, Drug, and Cosmetic Act (FDCA), the Family Smoking Prevention and Tobacco Control Act (TCA), their implementing regulations as well as other federal agencies’ statutes.

Stanley Lewis, MD MPH is a graduate of the University of Texas McGovern Medical School and the University of Texas School of Public Health.  He completed an Internal Medicine residency and fellowship and joined the faculty as Assistant Professor of Medicine.  Dr. Lewis has dedicated his professional career to patient care, teaching, clinical research, and drug development.  His areas of interest are infectious disease, oncology, and metabolic disorders.  He has participated as an Investigator on over 30 clinical trials and authored over 50 scientific abstracts and publications.  Dr. Lewis served as Chief Medical Officer at both public and private biotechnology companies including TaiMed Biologics where he led a small team to develop the first monoclonal antibody for treatment of multi-drug resistant HIV disease.  He later Founded and serves as CEO of A28 Therapeutics where he is developing a targeted lytic peptide for treatment of cancer.

Thomas M. Chen is the co-founder and Chief Technology Officer (CTO) of Berify, a leader in

blockchain-based authentication solutions that seamlessly bridge the physical and digital worlds.

Prior to his role at Berify, Thomas founded TrinityTech in 2012, a global systems integrator (SI)

and managed service provider (MSP). TrinityTech is renowned for assisting organizations in

achieving regulatory compliance and frameworks from DO/ISO/IEC, particularly within the

military, aerospace, automotive, healthcare, and medical verticals. Under Thomas’s leadership,

TrinityTech significantly expanded its global presence and consistently achieved revenue growth

exceeding 70% year over year.

From 1996 to 2011, Thomas held various executive positions at Parasoft Corporation, a leading

company in automated software testing and application security solutions. His strategic

contributions were instrumental in growing the startup to over $60 million in annual recurring

revenue (ARR). During his tenure at Parasoft, he served as the President and Chairman of the

Board for Parasoft Asia, overseeing operations across the Asia-Pacific (APAC) region.

Additionally, he held roles such as Senior Vice President of Development Tools and Senior Vice

President of Sales and Support.

Currently, Thomas serves as the Chairman of the Board for TrinityTech. He also holds board

position at Crosscheck Networks, a leader in API testing solutions; Forum Systems, a leading

provider of API Security Gateway solutions, securing 10B+ transactions daily with 100%

success deployments spanning across United States Treasury, Blue Cross Blue Shield, Federal

Aviation Administration and more; and Visure Solutions, a leader in requirement management

and application lifecycle management (ALM) tools, ensuring compliance for 1000+ highly

regulated organizations.

Thomas holds a Bachelor of Science degree in Electrical Engineering from Loyola Marymount

University (LMU) and an MBA from the Marshall School of Business at the University of

Southern California (USC). An innovator in his field, Thomas has been awarded seven patents in

blockchain technology, natural language processing (NLP), and artificial intelligence (AI).

Ed Carmines PhD brings over a three decades of experience in regulatory and compliance solutions within the tobacco and nicotine industry. He is a proven leader with the ability to merge science and business.  He has extensive experience with the Center for Tobacco Products at the FDA. He has a proven track record with Premarket Tobacco Applications, Modified Risk Tobacco Applications, Substantial Equivalence, and Exemptions Requests. He is known for his detailed knowledge of the technical aspects of all types of e-cigarettes, oral tobacco, tobacco leaf free oral products, cigars, Heat Not Burn products and cigarettes as well as the regulatory requirements for product authorization. He is known for his ability to understand complex scientific problems and to develop business relevant solutions.

During his tenure at Altria, Ed was initially responsible for the safety of cigarettes worldwide.  He played a pivotal role in designing and executing a program to test the safety of ingredients and materials used in the manufacture of cigarettes. He was intimately involved in the development of new reduced risk products including the original Heat Not Burn product, Accord. This product was the precursor to IQOS. At the end of Ed’s career at Altria, he was responsible for innovation. His team was involved in finding and evaluating new technology and products. After retiring from Altria, Ed was employed by Reynolds. His role there was shepherding product safety review of novel and oral products. He was involved in the early development of the VUSE e-cigarette.

Ed has been a consultant to the tobacco industry for over 20 years. He single handedly designed the program, executed the studies, and wrote the PMTA and MRTP applications for VLN reduced nicotine cigarettes (over 20 million pages of documents). The PMTA was authorized in 2019 and the MRTP in 2021. This is the only cigarette ever to receive market authorization. He joined Chemular in 2019 as the Chief Scientific Officer. Ed directs all aspects of the scientific studies involved in PMTA and MRTP applications. During his tenure with Chemular, Ed has directed the work on over 1000 PMTAs on all types of ENDS, smokeless tobacco, modern oral products, and novel products.

Michael Wang was promoted to the role of Co-Chief Executive Officer (CEO) on August 7, 2023. Mr. Wang had previously served as our Chief Financial Officer since August 2020. Mr. Wang is an experienced CEO, COO and President for a number of companies. From September 2018 through August 2020, he was the President, COO and then Co-CEO of The Pharm/Sunday Goods (located in California and Arizona), a vertically integrated leader in the cannabis cultivation, processing, manufacturing, distribution, wholesale, and retail industry. Mr. Wang served as President and COO of Onestop Commerce from 2013 to 2015 and as CEO from 2015 to 2018. Onestop Commerce managed all aspects of omni-channel-commerce for over 100 of the world’s top lifestyle brands and retailers. From 2005 through 2012, he was the Chief Operating and Fulfillment Officer and an investor in Zazzle, a world leader in online customization and personalization service. He started his leadership career in 1992 at Honeywell. Mr. Wang received Bachelor of Science and Master of Science degrees in Aerospace Engineering in 1983 and 1985 respectively, from the Beijing University of Aeronautics & Astronautics. In 1987, he received a Master of Science degree in Systems Engineering from Oakland University located in Rochester, Michigan. In 1992, Mr. Wang received an MBA in Finance and General Management from the University of Chicago’s Booth School of Business.