Archives: Speakers

Sabrina has over 12 years of experience working with Medical Devices, starting with sponsored projects on various prostheses at Queen Mary, University of London. These projects – including simulation and study of the wear of coatings on replacement hip joints, the mechanical properties of a prosthetic meniscus made from artificial silk, and the de-encrustation of nickel-titanium urethral stents with shape memory – further increased Sabrina’s passion for medical device design and development. Subsequently, her industry-linked PhD in the field of urinary incontinence at University College London (UCL) exposed her to a wider range of devices and research topics. Sabrina completed two postdoctoral research posts at UCL in the same field, also sponsored by SCA Hygiene Products AB (now Essity). Since then, she spent 5 years working in Ostomy Care R&D at ConvaTec, where the majority of her time was focused on a New Product Development (NPD) project, for which she led several workstreams. Sabrina joined Recipharm in May 2022 as Principal Development Engineer, supporting NPD work for nasal and injectable drug delivery devices.

Adam has been Recipharm’s design authority on new product development for intranasal delivery for the last 3 years. Adam’s background is in consumer product development having completed a BSc in Product Design at Loughborough University. After studying, he joined Dyson, gaining experience within new product innovation and development. Adam joined Recipharm in 2018 keen to apply his design engineering knowledge within the medical device industry.

Dr. Jessica Zdinak is an Eastern Shore of Virginia native who received a B.S. in Psychology from Christopher Newport University, and a M.S. and Ph.D. in Experimental Psychology & Statistics from Oklahoma State University. Dr. Zdinak has dedicated 20 years working as a behavioral scientist in a variety of settings, including academic, federal government, public health, and industry, and now serves as Chief Research Officer of a leading U.S. based Contract Research Organization, ARAC. 

Her team services both U.S. and International clients in their product development and consumer research supporting innovation and “next generation” products, with a focused expertise on the regulatory sciences for U.S. applications including: ITPs, PMTAs, MRTPAs, SEs, 510(k), and Breakthrough Designations. 

The ARAC firm specializes in providing boutique-level personalized research services, combining their expertise in psychology, statistics, and behavior change, with a focus on the consumer, and the role of the regulator. Their triangular approach has proven successful across a variety of studies, including label development and comprehension, human factors/usability, clinical behavioral studies, specifically randomized experimental trials, TPPI, and post-market surveillance systems.

Mr. Nirajkumar Patel, founder and CEO of Bidi Vapor, LLC, attended AISSMS College of Pharmacy in Pune, India, where he received a Bachelor of Science Degree in Pharmacy in 2004. He moved to the United States in 2005. Mr. Patel also has a Master’s Degree in Chemistry from the Florida Institute of Technology and holds a Six Sigma Black Belt Certification. His goal in founding Bidi Vapor was to provide a quality alternative to combustible cigarettes for adult smokers 21 and over.

Martin Steinbauer is the Chief Engineer and co-founder of SMOOD, where he focuses on youth access prevention technologies and sustainability solutions for ENDS. SMOOD has grown into a global business built on sustainability, advanced chemistry, IoT-enabled devices, and consumer centricity. Prior to SMOOD, Martin was an investment analyst at BlackRock in New York City. Martin graduated from Harvard University with a degree in Applied Mathematics.

John O’Brien serves as Vice President and Assistant General Counsel – Regulatory for RAI Services Company, where he counsels Reynolds American Inc.’s operating companies on a wide range of regulatory-related matters.

Prior to joining Reynolds in 2018, John spent over a decade in private practice, where he counseled some of the largest consumer packaged goods companies on a wide range of FDA, USDA, and FTC regulatory matters, including enforcement actions, civil litigation, investigations, inspections, product recalls, claims substantiation, labeling, and compliance.

He earned his BM from Northwestern University and earned his MM and JD degrees from the University of Illinois at Urbana-Champaign.

Todd is the Deputy Director of Regulatory Management in the Office of Science of CTP.  Todd joined CTP in 2015 and has served in many roles within the Office of Science from a chemistry reviewer, through several leadership roles.  He has also served in the Technical Project Lead role for SE, EX, and PMTA programs.  He currently provides leadership for the SE and EX pathways and serves in the PMTA clearance review for the center.

Prior to joining FDA, Todd spent over 23 years at the United States Pharmacopeia (USP), where he served as the Vice-president of Compendial Science.

He received his BS in Chemistry from the University of Iowa and Ph.D. in Analytical Chemistry from Virginia Commonwealth University

Darren Riva is the Chief Executive Officer of Capitas Finance.

A seasoned energy sector professional, he has an enviable resume that includes the position of Head of Energy Finance at Siemens Financial Services and Northern European Group Services Director at Zumtobel Group. His specialist knowledge and skills in financial services combine with a solid understanding of the challenges facing industry and the energy services market. As a result, he has the understanding required to formulate both strategic business plans and tactical ideas to rapidly mobilise best practice solutions producing tangible, high quality results.

Darren sits on the Renewable Energy Association (REA) Finance Forum Steering Group, having previously served as the Chair