Archives: Speakers

Jamie has a rich history in marketing, with over seven years of experience within software. He continues to drive the NX story, focusing on innovative marketing tactics, compelling content creation, and creating content to suit everyone’s needs. Jamie’s mission is to continue educating the market on Siemens Digital Industries Software solutions by looking at how product design will evolve in the future.

Kento Nakamura is a global professional having worked both in the Western and Eastern healthcare landscapes. He has been in various roles, contributing significantly to drug development, market access, and pharmaceutical marketing.

At CMIC, Japan and South Korea’s first CRO, Kento wears multiple hats including helping formulate corporate strategy, creating mutually beneficial partnerships with other companies, and taking initiative to create business development opportunities.

During his tenure at KM Pharmaceutical Consulting, a boutique drug development consulting firm, Kento co-pioneered the market access perspective on drug development, resulting in key additional endpoints in an ongoing phase 2 study. He also played a crucial role in developing the global drug safety plan, ensuring compliance with reporting requirements across multiple continents.

Kento holds an MPH in Health Management from Harvard University and a BS in Biology from Tufts University. He is fluent in English and Japanese. In his free time, Kento enjoys playing tennis, watching football, visiting contemporary art museums, and traveling around the world.

Isabel is a Market Solutions Specialist at Optum UK, specialising in clinical trials and real-world evidence with a focus on EMIS Web primary care data and systems. She supports the UK’s only clinical trial recruitment solution fully embedded within the GP clinical system, enabling faster, more accurate patient recruitment while reducing the burden on sites.

Alex French serves as VRG Project Oversight utilizing her out-of-the-box mindset to develop and provide the most efficient and effective strategy. She is a highly experienced project manager and decentralized clinical trials oversight director with considerable global CRO and site experience over the last 9 years. Alex has expertise in Phase I-IV clinical trials ranging from fully decentralized trials, pediatric nutrition and imaging to adult pulmonary, critical care, infectious, and rare diseases. She brings expertise from not only her CRO background, but site, pharmaceutical, and patient perspectives as well. Building on her experience, she seeks to add decentralized aspects where applicable to fully enhance the experience for the patient, CRO, and site.

Alex ensures detailed management and compliance with ICH-GCP, SOPs, and FDA/IRB regulations within each trial. She has been an integral part in the development of VRG at Premier, which has been a pivotal addition in patient recruitment, engagement, and decentralized elements. Alex earned her B.S. in biomedical sciences and neurobiology from the University of Cincinnati.

Evan Grossman is the founder of Pixotine Products and has a background that includes organic chemistry and neurobiology. Evan also serves as an aviation contractor handling diplomatic movements, evacuations, humanitarian aid, security movements and more. “I stay busy. I like solving problems while making people happy.”  Along with his work, Evan is an avid fisherman, enjoys golf and dabbles in the dog show world. He is a former dipper from South Florida who wanted better alternatives to traditional oral tobacco products. “I did not want my kids growing up watching me chew and spit tobacco.”  Pixotine is the first nicotine-infused toothpick brand in the world, and is the only brand on the market that submitted PMTAs with the FDA.

Matt Fields is the Vice President of AgeChecker.Net, a leading provider of online age verification solutions for retail and ecommerce businesses. Based in Westlake Village, California, Fields has played a pivotal role in developing and scaling the company’s technology to help retailers comply with age-restricted sales laws while enhancing user experience and data security.

Fields has also emphasized the importance of regulatory compliance and social responsibility in ecommerce. He highlighted the company’s commitment to replacing outdated “age gate” methods with real-time verification using public records and secure ID uploads, ensuring that businesses avoid underage sales without disrupting the customer experience.

With a focus on innovation and adaptability, Fields continues to lead AgeChecker.Net in expanding its integrations across ecommerce platforms and enhancing its fraud prevention capabilities, positioning the company as a trusted partner in the rapidly evolving landscape of online age-restricted commerce.

With decades of Medical Device experience – first as a military-trained surgical assistant, then as an orthopedic total joint sales representative, an independent medical device distributor, and most recently, experience in business-to-business in the Hydrophilic coating space. Kristian Killian’s skill set, knowledge, and vast surgical experience are centered on keeping complex things simple, asking the right questions, solving problems, and moving only in the forward direction, with an unwavering commitment to his clients.

Owner & Principal Consultant, QualReg Solutions LLC
Former Director of FDA Regulatory Quality Compliance, JUUL Labs
Former FDA Director & Investigator, Office of Regulatory Affairs (ORA), U.S. FDA

Gabriel Muniz is the Owner and Principal Consultant at QualReg Solutions LLC, where he advises tobacco and ENDS manufacturers on regulatory compliance, quality systems, and FDA readiness. With over 15 years of experience spanning federal oversight and private industry leadership, Gabriel offers a uniquely integrated perspective on compliance strategy and operational excellence.

Prior to founding QualReg Solutions, Gabriel held multiple leadership roles at JUUL Labs, including Director of Regulatory Compliance and Quality Systems, where he led ISO certification efforts, managed global supplier quality, and directed eQMS implementations. He was instrumental in building the company’s audit and inspection readiness framework and regulatory submission infrastructure.

Gabriel also served as an Investigator and Director at the U.S. Food and Drug Administration (FDA), where he was the first to lead the Tobacco Operations Staff within the Office of Regulatory Affairs. There, he developed nationwide enforcement strategy, oversaw high-impact inspections, and coordinated regulatory responses tied to the Family Smoking Prevention and Tobacco Control Act.

Gabriel’s expertise spans tobacco, medical devices, biologics, and food safety. He is known for his ability to translate complex regulations into actionable strategies, helping clients achieve both legal compliance and business continuity. From quality systems and document control to supplier audits and FDA communication, Gabriel is a trusted advisor for companies navigating the evolving nicotine delivery landscape.

Julie is the Chief Commercial Office at Deallus, a market leading strategy consultancy, which was acquired by Global Data  at the beginning of the year. Julie’s career in life sciences spans 20 years with a focus on partnering with clients on strategy development on local, regional and global level . For more than decade Julie has led large global and regional competitive mindset training programmes for large pharma. Since 2017 Julie has regularly been engaged as an inspirational speaker on Competitive Mindset across brand, portfolio and corporate audiences. Her expertise includes clinical and commercial planning, brand & portfolio strategy  as well as advising organisation  on personalised healthcare approaches across various disease areas.  Julie holds a PhD in Neuroscience from Imperial College London sponsored by Pfizer.