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.
With over 20 years of experience in the healthcare and clinical research sector, Evelyne is a Vice President of Business Development at Velocity Clinical Research, Inc. She leads key strategic partnerships globally and drive sales in Europe. She is committed to partnering with CROs/Sponsors to deliver high-quality clinical trial data and patient care with unprecedented efficiency. She is also passionate about diversity, equity, inclusion, and belonging (DEIB), she serves as a co-chair of the DEIB Council at Worldwide Clinical Trials. In this capacity, Evelyne collaborates with other leaders and stakeholders to foster a culture of respect, empowerment, and belonging across the organization. Her mission is to contribute to the advancement of healthcare and clinical research.
Shilpa is a Principle Investigator and Site Director at Velocity Clinical Research with over 8 years of physician experience. She is passionate about diversity and inclusion of ethnic minorities within clinical trials, and hope that by leading Velocity’s new trial site in Romford we can improve trial access for this population. Shilpa is committed to achieving this goal which will allow us to have a better understanding of the chronic disease burden in this population and develop more targeted therapies in the future.
Michael’s career has been shaped by his passion for solving problems with the use of data and technology. With over 13 years at Oliver Wyman, where he served as a Partner and Head of the London office, he gained extensive consulting expertise. However, it was during his tenure at Coalition Greenwich, a data analytics specialist firm, that he witnessed firsthand the transformative power of data-driven insights enabled by cutting-edge fintech solutions and the pivotal role these technologies play in driving innovation.
Today, Michael is the CEO of Validis, a leading fintech that harnesses the power of technology to unlock financial data insights for accounting firms, financial services organizations, and small businesses. Michael firmly believes that leveraging data-driven insights through innovative technologies is crucial for delivering exceptional customer experiences and fostering more rewarding jobs.
Mark Butler, as the dedicated Managing Partner at HLB Ireland, is at the forefront of the firm’s expansion and consultancy services, ensuring a steadfast commitment to our clients and partners.
Mark Butler’s extensive experience in accountancy, as a member of both the Institute of Chartered Certified Accountants and the Institute of Certified Public Accountants in Ireland, and as a registered auditor in Ireland and the UK, instils confidence in his expertise. With over two decades of strategic business planning and advisory across diverse Irish and international market sectors, Mark is a seasoned professional. His leadership has been instrumental in assisting high-achieving entrepreneurs through comprehensive accounting and advisory services.
Additionally, he holds significant roles outside HLB, including Non-Executive Director at FutureRange, a Technology and Cyber Security Business and a Director and Council Member position at HLB International Limited.
As the Managing Partner of HLB Ireland, Mark Butler is instrumental in charting the firm’s strategic course and managing its operational activities. An early adopter of technology, Mark has a strategic focus on encouraging the team to integrate innovative solutions to drive the firm’s progression, ensuring it meets and surpasses its goals of delivering exceptional client service. His deep expertise in governance, compliance, and cross-border financial practices, combined with a robust advisory service, makes him a pivotal figure in navigating the intricacies of international advisory. Under his leadership, the firm adheres to and strategically aligns with global compliance standards while providing top-tier advisory services, maintaining a cutting-edge approach to advisory services.
Lynn leads Mercia’s Product Strategy and strategic relationships and supports firms of all sizes to nurture and develop their people. As a qualified accountant, she has spent the last 20 years in Accountancy education, both with training providers and within practice as Director of Learning at a mid-tier practice. With this experience, Lynn is uniquely placed to advise firms on modern and innovative practices for technical learning across all areas of the profession and to design engaging learning which drives performance.
An Executive-level Human Resources professional with Financial and Professional Services experience; specialising in building high-performing teams focused on commercial and strategic solutions, with expertise in working with PE-backed businesses focused on high-growth models involving transformation and integration activities.