Speakers & Moderators from 2024

Director, Technical Services

Director Regulatory Affairs, Medical Device Cell Therapy Development

Global Head of RegCMC Device and Combination Products

Kristin Benokraitis leads Global Regulatory CMC Device and Combination Products at Biogen, bringing 20+ years of biotech experience. As former leader at Gilero and Boston Scientific, she specializes in regulatory affairs, quality, and product development. She holds a Chemical Engineering degree from Virginia Tech and has been awarded 5 patents.

Director, Office of Policy, Center for Drug Evaluation and Research (CDER)

Ashley Boam is Director of the Office of Policy for Pharmaceutical Quality (OPPQ) in OPQ at CDER. She oversees the development and communication of science- and risk-based drug quality policies and standards, including application assessment and inspection. OPPQ coordinates OPQ’s international quality efforts, leads CDER’s compendial operations, participates in quality standard-setting organizations, and addresses policy issues related to drug-device combination products. Ashley holds an MSBE from the University of Alabama at Birmingham and a BSE from Tulane University, both in Biomedical Engineering.

Senior Director Regulatory Affairs – Devices & Digital Therapeutic

Tim Chesworth leads the Devices & Digital Therapeutics group within AstraZeneca Global Regulatory Affairs, developing strategies for medical devices, combination products, and digital therapeutics. He chairs EFPIA’s Medical Devices Regulatory Working Group and actively participates in industry associations including the Combination Products Coalition.

Senior Consultant

Global Head, Regulatory Affairs

Katie leads Digital Health Technology Devices and Specialty Products at AbbVie, overseeing combination products and digital health initiatives since 2021. She collaborates on clinical trials with Data Science and leads regulatory strategy for combination products, including gene therapy devices. She holds a BSE in Biomedical Engineering from Pittsburgh and MS in Healthcare Technology Management from Marquette/Medical College of Wisconsin.

Director, Regulatory Affairs

Sara Coon leads Combination Product Regulatory strategies at Halozyme, with 30+ years in medical device and pharmaceutical industries. As Regulatory Affairs Director, she’s supported various FDA approvals and implemented EU quality systems. Her expertise spans Quality Systems, Regulatory Affairs, and Technical Dossiers, focusing on developing safe, effective products for patients.

Associate Director for Information Management

Danita Dixon serves as Associate Director for Information Management at FDA’s Office of Clinical Policy and Programs, leading informatics initiatives across medical product centers. During her tenure at the Office of Combination Products, she implemented the Salesforce Intercenter Consult Request System. She holds an MS degree and focuses on strategic planning for cross-Agency collaboration.

Principal Regulatory Consultant

Biomedical Engineering Advisor, Center for Biologics Evaluation and Research (CBER)

Andrea Gray serves as Biomedical Engineer Advisor in FDA CBER’s Regulatory Operations Branch, specializing in device and combination product reviews and cross-center policy development. She holds a BS in Chemical Engineering from University of Maryland and PhD in Biomedical Engineering from Rutgers University.

Senior Regulatory Program Director

Nishchay (Nish) Gupta serves as Senior Regulatory Program Director in Genentech’s Pharma Technical Regulatory group, developing global strategies for devices and combination products. Previously at Medtronic Endovascular, he managed Class III medical implant regulations. He holds a Biomedical Engineering background and a Masters in Medical Devices and Diagnostics Engineering from USC.

Head of Portfolio Strategy and Management

Director, Division of Regulation and Guidance, Office of Policy for Pharmaceutical Quality/Office of Pharmaceutical Quality (OPPQ/OPQ)

Tina Kiang, PhD, directs FDA’s Division of Regulation and Guidance in Pharmaceutical Quality. Since joining FDA in 2005, she’s led multiple divisions including Drug Delivery and General Hospital Devices. She holds a BE in Chemical Engineering from Cooper Union and PhD in Biomedical Engineering from Johns Hopkins School of Medicine.

Health Science Policy Analyst, Center for Drug Evaluation and Research (CDER)

Beth Kunkoski currently works in the FDA’s Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP). She oversees several projects involving decentralized clinical trials, digital health technologies and electronic records and storage in clinical investigations (Part 11). She previously worked in the Center for Devices and Radiological Health (CDRH) overseeing the review of orthopedic devices. She earned a Master’s Degree in Biomedical Engineering and a Bachelor’s Degree in Chemical Engineering from the University of Michigan.

Combination Product Policy Advisor, Center for Drug Evaluation and Research (CDER)

Kristina Lauritsen, PhD, serves as Combination Product Policy Advisor and Product Jurisdiction Officer at FDA’s CDER, developing policies and coordinating cross-center initiatives. Since joining FDA in 2003, she’s worked in CDRH, Office of Combination Products, and CDER. She holds a Biology degree from Shippensburg University and PhD in Tumor Biology from Georgetown University.

Senior Director, Regulatory Policy

Director, Division of Drug Delivery, General Hospital Devices, and Human Factors, Center for Devices and Radiological Health (CDRH)

Dr. Juliane Lessard directs FDA CDRH’s Division of Drug Delivery, General Hospital Devices, and Human Factors, overseeing medical device reviews including combination products. She holds a PhD in Biochemistry from Johns Hopkins and previously spent 8 years as lead reviewer and Branch Chief for Chemistry Devices in FDA’s Office of In Vitro Diagnostics.

Director of Regulatory Affairs

Willy Liou is currently Director of Device Regulatory Affairs at Amgen overseeing global regulatory strategy and execution for combination products and human factors across all programs. Willy joined Amgen in 2013 at a time when the company was preparing for the first wave of combination product submissions. Prior to Amgen, Willy served at a Johnson and Johnson medical device company where he held positions in international regulatory affairs and quality compliance. He earned a B.S. in biochemistry from University of California, Irvine, and an M.S. in biotechnology from Johns Hopkins University.

Business Development Director – Drug Delivery

Alex Lyness, PhD, is Business Development Director – Drug Delivery at TTP. He has recently joined TTP from West Pharmaceutical Services where he gained extensive experience in the research, development and commercialisation of novel drug delivery devices and containment systems. Dr Lyness is based in Philadelphia (US) and leads business development activities for TTP in North America. He obtained his PhD while working at a drug delivery start-up in Oxford (UK) and is a Chartered Engineer with the Institution of Mechanical Engineers.

Senior Regulatory Counsel, Office of Combination Products

Annette Marthaler is a Senior Regulatory Counsel with FDA’s Office of Combination Products (OCP). She is an attorney with a master’s degree in health informatics and has over twenty years’ experience advising on FDA regulatory matters, including those involving medical devices, human subject protection, and tobacco products. Prior to joining OCP, Annette has held legal or regulatory roles at FDA’s Office of the Chief Counsel, the Center for Devices and Radiological Health, and the Center for Tobacco Products.

Executive Director, Head of GRS Medical Devices

Amanda Matthews brings 25 years of experience from Pfizer R&D (UK), where she currently heads the GRS-Medical Device group. She specializes in regulatory strategy for medical devices, drug-device combinations, and digital diagnostics. Amanda has led global regulatory activities to launch numerous treatments under EU medical device regulations and contributes to industry standards through EFPIA, Combinations Products Coalition, and ISO technical committees, including ISO 20069 and ICH Q12.

Director, Medical Devices & Combination Products

John is a Director of Devices & Digital Therapeutics within CMC Regulatory Affairs at AstraZeneca. At AstraZeneca, he has built extensive global regulatory experience for all types of combination products throughout the entire product lifecycle, including digital therapeutics. Prior to AstraZeneca, he acted as a Combination Products Team Lead within CDRH at the FDA. John has a background in Biomedical Engineering, receiving a BS from the University of Virginia and MS from Johns Hopkins University.

Assistant Director, Injection Devices Team, Center for Devices and Radiological Health (CDRH)

Shruti Mistry is the Assistant Director of the Injection Devices Team in the Office of GastroRenal, ObGyn, General Hospital and Urology Devices in FDA’s Center for Devices and Radiological Health (CDRH). She earned her B.S. and M.S. in Biomedical Engineering from the Georgia Institute of Technology and Johns Hopkins University, respectively.

Combination Products Analyst, Center for Devices and Radiological Health (CDRH)

Chemist, Center for Drug Evaluation and Research (CDER)

Dr. Neely serves as Pharmaceutical Quality Assessor at FDA’s CDER, reviewing generic drug applications across various formulations. Previously, he spent 10 years as Assistant Research Professor at Oklahoma State University, researching process design and drug delivery. He holds a BS in Biochemistry from BYU and MS/PhD in Chemical Engineering from Oklahoma State University.

Associate Director in Regulatory Strategy

Senior Director, Device Development

Renato Ravanello leads Late Stage Development in Genentech’s Device and Packaging team, designing combination products for clinical and commercial use. With 19+ years developing drug delivery devices, his expertise spans pre-filled syringes, injectors, and ocular systems. He holds an MS in Aerospace Engineering from the University of Colorado and an Aeronautical Engineering degree from Politecnico di Milano.

Associate VP, Head of GRA Devices

Executive Director, Sr GPRD

Director, Combination Products

With more than 20 years of experience within Medical Devices and Drug Delivery, I have helped multiple organizations develop and manufacture Combination Products. I have built, improved, and implemented compliant quality systems for Combination Products for both large and small organizations. My roles have spanned process engineering, quality, and device development, as both a consultant and as a leader.

Vice President, Corporate Quality

Eric Staib serves as VP of Corporate Quality at Syneos Health, with 25+ years of pharmaceutical expertise in GXP, quality systems, and software validation. A former GAMP Americas Chair, he leads the Software Automation and AI Special Interest Group. He holds degrees from James Madison, Temple, and Drexel Universities, contributes to industry publications, and helped author GAMP5’s 2nd edition.

Managing Partner

Brandi Stockton is Founder and Managing Partner of The Triality Group, providing life sciences consulting with 20+ years of GxP expertise in computer systems quality. She serves on ISPE GAMP Global Steering Committee, chairs GAMP Americas, and co-chairs the Software Automation and AI Special Interest Group. She contributes to industry publications and GAMP® Good Practice Guides.

Director, Device Quality and Regulatory

Abhishek is currently a Director in the Device Quality and Regulatory group at Merck and is based in Rahway, NJ. In his current role, he has supported multiple drug-device combination products enabling clinical studies, global registrations, and lifecycle management. He has over 8 years of experience across R&D, regulatory science and commercialization of medical devices and combination products. Abhishek holds a PhD in Materials Science and Engineering from the University of Cincinnati.

Senior Program Manager, Quality and Compliance

Policy Officer

Executive Vice President, Regulatory Affairs

Nathalie’s journey in Regulatory Affairs started more than two decades ago when she joined a medical device company, Synthes (today DePuy) developing implantable devices combined with drug. She took her device regulatory experience to Roche in Switzerland and later Genentech. She is currently overseeing the Regulatory Department of Coherus, a company involved in the development and commercialization of Biosimilars and innovative Immuno-oncology drugs.

Director, Device Design & Process Development

Combination Products Drug Delivery Devices

Vice President, Regulatory and Quality Services

A leader with 25+ years in medical device and pharmaceutical regulatory affairs and quality systems. Expertise includes translating regulations into product development strategies, managing successful submissions, and developing commercialization plans. Known for fostering cross-organizational collaboration through clear communication of regulatory requirements and risk mitigation strategies.

Director of Regulatory Policy

Associate Director, Human Factors,

Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH)

Andrew Yeatts serves as a Combination Product Policy Advisor at the FDA. He develops cross-cutting guidance and policy related to combination products. Andrew has also worked to implement legislation such as the Combination Product Provisions of 21st Century Cures. Prior to joining FDA, Andrew received his Ph.D. in bioengineering from the University of Maryland and his undergraduate degree in biomedical engineering from Bucknell University. Andrew enjoys traveling with his 6 year old daughter and four year old son and lives in Silver Spring, MD.