Khaudeja Bano

Vice President Combination Product Quality, Amgen

Khaudeja Bano is a physician with a master’s degree in clinical research and a Pharmaceutical Engineering Certification; she is also a Database Administrator and a certified Project Management Professional.

Including her clinical practice, Bano has more than 25 years of professional experience. She has held several global medical positions at Guidant, Abbott, AbbVie Inc., and now Amgen. Her career includes global medical/clinical and safety leadership roles in devices, diagnostics, pharmaceuticals, and combination products.

She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).

Charlotte Brandt

Senior Quality Lead, Digital Health Quality, Novo Nordisk

Charlotte Brandt is Senior SaMD Quality Lead in Digital Health Quality at Novo Nordisk A/S. In her role as Senior Specialist within the Novo Nordisk SaMD Competency Center she has been instrumental in establishing the Novo Nordisk certified SaMD QMS supporting the company’s drugs and devices. Charlotte also acts as senior advisor in Digital Health projects across Novo Nordisk worldwide. Charlotte has 28 years of experience within software quality and compliance for products and systems across different industries – 20+ of these are from the pharmaceutical industry within the GXP, Medical Device, and Data Privacy regulated space as well as non-regulated systems and products. Brandt holds a master’s degree in Mechanical Engineering from the Danish Technical University.

Sandra Boyd

Associate Director, Biogen

Sandra Boyd is a Quality accredited (CQA and RAC) business professional with diverse experience in pharmaceutical, biotechnology, medical device, Contract Research Organization (CRO), and clinical environments.  She is currently Head of the Device Development Quality department where she leads the team responsible for the quality oversight of design and development of medical devices/combination products and digital devices, and the incorporation and maintenance of these products into Biogen’s Quality Management System. Throughout her 30-plus-year career, Boyd has held positions in the R&D of antibiotics, polymers, and semiconductors; healthcare; and quality assurance for pharmaceuticals, biotechnology, and medical device/combination products. She holds a bachelor’s degree in biochemistry from the State University of New York and an MBA with a concentration in new product development from North Carolina State University.

Inta Buhr

Associate Director, Regulatory Affairs CMC, Alkermes

Inta Buhr is an Associate Director of Regulatory Affairs (RA), CMC at Alkermes. In her role she serves as the RA CMC lead for their front running biologic drug development program as well as the RA CMC subject matter expert on combination products. In her role she collaborates with colleagues across the organization to ensure compliance and establish best practices for the company’s sterile injectable combination product drugs. Buhr holds a bachelor’s degree in biomedical science and is completing her MBA focused on business analytics and information systems this fall.

Tim Chesworth

Senior Director, Regulatory Affairs – Medical Devices & Combination Products, AstraZeneca

Tim’s role is to lead the Devices & Digital Therapeutics group within AstraZeneca CMC Regulatory Affairs. The group is responsible for developing and implementing regulatory strategies and processes for both new and existing devices and digital therapeutics. This encompasses conventional pharmaceuticals, biologics and AZ’s activities in Digital Health. Tim plays a leading role in a number of industry associations including EFPIA and Combination Products Coalition.

Shannon Clark

Founder & CEO, UserWise, Inc.

Shannon Clark is founder and CEO of UserWise, a consultancy that helps medical device manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants at UserWise conduct usability testing for a variety of medical devices ranging from surgical robots to home–use injection platforms. UserWise consultants also perform safety assessments to comply with U.S. and international regulations related to Human Factors.

Before founding UserWise in 2014, Clark was a Human Factors engineer at Intuitive Surgical and Abbott Laboratories.

She graduated from UCLA with a bachelor’s degree in mechanical engineering. Clark is additionally a Certified Professional Industrial Engineer, holds two patents, and has written and published three books.

Josh Cosman

Director, Digital Health Strategy, AbbVie

Cosman is an interdisciplinary neuroscientist with 20 years of experience developing neurophysiological and behavioral markers of perception, cognition, and motor function in healthy aging and neurological disorders. For the past decade his work has focused on supporting therapeutic development in both the digital health and pharmaceutical industries; Cosman has also led development of translational biomarkers and novel functional markers using scalable research-grade tools and consumer devices in a range of therapeutic areas. He is actively involved in several precompetitive initiatives in both the digital health and translational neuroscience domains and currently serves as industry co-director for Critical Path for Parkinson’s 3DT consortium.

Fran DeGrazio

President, Strategic Parenteral Solutions LLC | Advisor to C-Suite and Senior Executives

Fran DeGrazio has 35+ years of experience in the pharmaceutical packaging and delivery industry with extensive expertise in sterile drug product systems, including vial container closure systems and prefillable systems for combination products. She is currently President & Principal Consultant at Strategic Parenteral Solutions LLC. Prior to this she held numerous technical roles at West Pharmaceutical Services, including R&D, Quality & Regulatory, Technical Customer Support, Analytical Laboratories and Scientific Affairs. Her final role prior to retiring from West was as Chief Scientific Officer. 

 DeGrazio has published numerous technical articles and book chapters. She is the recipient of the PDA Packaging Science Award for 2021, Philadelphia Business Journal 2018 Healthcare Innovators of the Greater Philadelphia Region Award and the Healthcare Businesswoman’s Association Luminary Award for West in 2017. 

Carolyn Dorgan

Director, Technical Services, Suttons Creek, Inc

Carolyn Dorgan has over 10 years’ experience in the medical device and combination product industries, including over six years at the US Food and Drug Administration (FDA) leading the Infusion Devices team. Her unique approach to product development and risk management has been instrumental in working with products for which there are no established performance or regulatory standards which includes pediatric medical devices, novel on body drug delivery systems, and rare disease combination products. Carolyn has a demonstrated ability for working through complex problems at a system level to implement practical solutions using her multi-disciplinary background which includes engineering, software, cybersecurity, human factors, and business.

Courtney Evans

Team Lead, Injection Devices, FDA-CDRH

Courtney Evans is the current Team Lead for Injection Devices in CDRH’s Division of Drug Delivery and General Hospital Devices and Human Factors. In her role she serves as a technical and regulatory SME for drug delivery combination products. As the Team Lead and combination product SME, she frequently collaborates with FDA’s CDER and CBER to regulate CDER- or CBER-led pre- and post-market actions. Prior to working at the FDA, she spent four years working as a Materials Scientist and Test Engineer for Medline Industries, Inc. Evans holds bachelor’s degrees in biomedical engineering and chemistry and is completing her master’s degree in materials science and engineering at Johns Hopkins University.

Michael Fahmy

Exec. Director at Otsuka Pharmaceutical Development & Commercialization, Otsuka Pharmaceutical Companies (U.S.)

Michael is the Executive Directory of Global Regulatory Affairs at Otsuka and oversees the global regulatory strategy team in the US and EU. He has over 20 years experience in regulatory affairs and joined Otsuka Pharmaceuticals Development & Commercialization in February 2013, serving as the lead in multiple therapeutic areas including Digital Medicine/Therapy, Cardio/Renal and medical devices. Michael lead the regulatory strategy for the development of several products and led the first FDA approved digital medicine. Michael has a Master’s from Temple University in Quality Assurance/Regulatory Affairs and a Bachelor’s in Biological Sciences from Rutgers University.

Charles Goldberg

Senior Director, Quality Assurance, Medical Devices and Combination Products, Pfizer

Charles has over 30 years of experience in medical device, pharmaceutical and combination products quality assurance. Charles has also work in manufacturing engineering as well as design engineer. Charles holds a Master’s and Bachelor’s in mechanical engineering from the University of Florida and an MBA from the University of South Carolina with a focus in International Business.

Raj Gulati

Founder, REGUNALYS

Ryan Hoshi

Director, Regulatory Policy and Intelligence, AbbVie

Ryan Hoshi is Director of Regulatory Policy & Intelligence at AbbVie and serves as the global policy lead for medical devices, combination products, personalized medicine, and digital health. Before joining AbbVie, Hoshi served as an international policy analyst at the Center for Devices and Radiological Health (CDRH) and promoted international regulatory harmonization activities through the Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee Medical Device Priority Work Area, Medical Device Single Audit Program, and International Medical Device Regulators Forum. Hoshi also worked on drug policy at the Center for Drug Evaluation and Research (CDER) and as a Lead Reviewer in CDRH on interventional cardiology devices. He earned a bachelor’s degree in Bioengineering from the University of California, Berkeley, a doctorate and master’s degrees in Biomedical Engineering from Northwestern University, and an MBA from Georgetown University. 

Shannon Hoste

President Agilis Consulting Group, Agilis

Shannon Hoste is the President of Agilis Consulting Group, an assistant professor in the Quality Science Education program at Pathway for Patient Health, and she is active on several standards and conference committees for medical devices and combination products.

Formerly, she worked as Team Lead for Human Factors in FDA’s Center for Devices and Radiological Health (CDRH) and as reviewer within the Center for Drug Evaluation and Research (CDER). At the FDA, Hoste led reviews of Human Factors data for medical device premarket submissions through 510(k); PMA and De Novo pathways; combination products through NDA, BLA, ANDA pathways; as well as data to support IND and IDE requests.

Outside of Hoste’s work for the FDA, she continues to build on her 25-plus-year career where she has worked in the medical device, IVD, and combination product industry as an R&D and Quality Engineer, Manager, and Director. Over this time, she has worked within and directed project teams in all phases of product development from front end research to post-market support; as well as architecting process improvements for design controls, risk management, requirements management, software validation, system verification/validation, and the incorporation of human factors and usability into overall product development processes.

Hoste has earned a bachelor’s degree in mechanical engineering from the University of Toledo, a master’s degree in management from Mount Vernon Nazarene University, and a master’s in cognitive systems engineering from the Ohio State University.

Jason Lipman

Senior Director, Global Regulatory Affairs, Device and Combination Products, Sanofi

Jason Lipman is Senior Director of Global Regulatory Affairs for Devices and Combination Products at Sanofi. He is responsible for worldwide regulatory activities related to drug delivery devices and combination products. Lipman has over 20 years of regulatory and product development experience within the medical device and pharmaceutical sector, including roles at Janssen, DePuy Synthes/Synthes Spine, and FDA’s CDRH General Hospital Devices Branch. He has a master’s degree in applied biomedical engineering from Johns Hopkins University and a bachelor’s degree in mechanical engineering from Tufts University. Lipman is an active member of the Combination Products Coalition. 

Mary-Beth McDonald

VP, Regulatory and Quality Management, Glooko

Mary Beth McDonald, M.B.A., is Vice-President, Regulatory and Quality Systems at Glooko, Inc., a SaMD company working in diabetes data and patient management. She has 30+ years of Quality Systems and Regulatory Affairs experience in the medical device, SaMD, digital health, wearable, diagnostic, and drug-device combination products in start-ups and large companies. Her experience includes Class I, II, III / 510k / PMA / NDA, with unique expertise in FDA/MDR expectations for software as a medical device. Ms. McDonald is a past member of AAMI’s Medical Device Software committee, where she has contributed to AAMI standards and guidance documents.

Ryan McGowan

Director of Digital Devices and Combination Products within CMC Regulatory Affairs, AstraZeneca

Ryan McGowan is a Director of Digital Devices and Combination Products within CMC Regulatory Affairs at AstraZeneca. He has responsibility for developing regulatory strategies for the approval of digital health products including software as a medical device as well as traditional parenteral and inhalation combination products. Prior to joining AstraZeneca, McGowan was a premarket reviewer and combination products team leader at FDA’s Center for Devices and Radiological Health, where he evaluated and influenced regulatory policy for drug delivery constituent parts of combination products.

John McMichael

Director of Devices & Digital Therapeutics within CMC Regulatory Affairs, AstraZeneca

John McMichael is a Director of Devices & Digital Therapeutics within CMC Regulatory Affairs at AstraZeneca. Prior to joining AstraZeneca, he acted as a Combination Products Team Lead within CDRH at the FDA. McMichael has extensive regulatory experience with all types of Combination Products throughout the entire product life cycle, including digital therapeutics. McMichael has a background in biomedical engineering; his bachelor’s degree is from the University of Virginia and his master’s is from Johns Hopkins University.

Susan Neadle

Principal Consultant & President, Combination Products Consulting, LLC

Susan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience.  She is well networked, published, and highly active in numerous industry groups with links to teaching institutions. Neadle’s leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, Johnson & Johnson’s highest honor for excellence in Research & Development, and most recently, as a Finalist in TOPRA’s 2021 Awards for Regulatory Affairs Excellence.  Neadle retired from a distinguished and impactful 26-year career at Johnson & Johnson.  She is now Principal Consultant at Combination Products Consulting Services LLC, providing international Q&C, regulatory and design excellence services, to the pharm, biotech and device industries.   Neadle serves as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International,  AAMI and PQRI.  She teaches curricula in Combination Products through UMBC and AAMI, as well as customized training upon request. 

Thinh Nguyen

Director, Office of Combination Products, FDA-OCP

Thinh Nguyen has been the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration since January 2008. OCP is primarily responsible for making jurisdictional determinations, coordinating premarket reviews, ensuring consistent and appropriate post-market regulations, and developing policy, guidance, and regulations. Prior to joining OCP, Nguyen spent seven years as the Director for the Premarket Approval Section in the Center for Devices and Radiological Health where he played a key role in the passage of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the Medical Device User Fee Amendment of 2007 (MDUFA) legislations. During this time, he established significant policies and wrote numerous guidance documents relating to the PMA programs (e.g., expedited review, user fees, PMA actions). Prior to coming to the FDA, Nguyen worked as a senior electronics engineer for the Naval Electronics Systems Engineering Center, Portsmouth, Virginia, from 1986 to 1993, where he was responsible for developing hardware/software for testing aircrafts and radar systems. Nguyen received a bachelor’s degree with honors in electrical engineering from North Carolina State in 1986.

Chelsea O’Connell

Director, Global Regulatory and R&D Policy, Amgen

Chelsea O’Connell joined Amgen in 2011 and is currently a Global Regulatory and R&D Policy Director for Combination Products, where she advances strategic regulatory policy goals by engaging with regulatory authorities, industry, professional associations, and other stakeholders across a variety of policy topics. Prior to joining Policy, she was a Regulatory Lead and developed and executed filing strategies across various therapeutic areas and also product presentations including combination products, companion diagnostics, and software. Previous to Amgen, she worked for several medical device companies in ophthalmology and cardiology. O’Connell earned both a bachelor’s and a master’s degree in biomedical engineering from California Polytechnic State University in San Luis Obispo. She is a member of the Combination Product Coalition and TC 84 working groups.

Annie Saha

Assistant Director, Digital Health Center of Excellence, FDA

Anindita (Annie) Saha is the Assistant Director for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). Ms. Saha is leading the development of partnerships, regulatory science, strategic planning, and operations for the DHCoE to empower digital health stakeholders in advancing healthcare. Additionally, Annie helped incubate and continues to support CDRH’s patient science and engagement efforts to advance the science and adoption of patient input as evidence, including patient preference information (PPI), clinical outcome assessments (COAs) including patient-reported outcomes (PROs), and patient-generated health data (PGHD). These efforts include researching the use of digital health technologies to capture the patient perspective. Previously, Annie was the Director of Partnerships to Advance Innovation and Regulatory Science (PAIRS) where she oversaw a broad program portfolio, supporting a number of strategic partnership and regulatory science programs for CDRH. This included relationships with the Medical Device Innovation Consortium and other public-private partnerships, Network of Experts, Critical Path, and technology transfer. Ms. Saha began her FDA career as a researcher in the CDRH’s Office of Science and Engineering Laboratories in the Division of Imaging and Applied Mathematics in the area of imaging display technologies. Ms. Saha has a Bachelor of Science in Bioengineering and Minor in History from the University of Pittsburgh. She was a student researcher at the McGowan Institute for Regenerative Medicine working in tissue engineering and wound healing.

Jiaying Shen

Distinguished Scientist, Medical Device and Combination Product Development, Regulatory and Quality, Merck

Jiaying Shen obtained her Ph.D in Industrial and System Engineering from University of Wisconsin – Madison and she has over 17 year experience in pharmaceutical and medical device industry. She is currently a distinguished scientist in the device development department at Merck, managing a large team that are responsible for Design Control, Risk Management, Human Factors activities and other Device Quality and Regulatory issues for drug delivery devices. She also leads several product development projects, from pre-clinical phases all the way through post market commercial support. Prior to join Merck, she worked at Medtronic Neuromodulation R&D and Honeywell automation and control laboratory.

Chin-Wei Soo, FRAPS

Global Regulatory Head – CMC/Devices and Combination Products, Genentech

Chin-Wei Soo is the Global Regulatory Head, Devices and Combination Products at Roche/Genentech. He is accountable for providing technical regulatory oversight to Roche’s entire device, combination product, and digital health portfolio, covering all large (BLA) and small molecules (NDA) throughout the product life cycle.

Soo has 21 years of regulatory and quality experience, including strong expertise in combination products and digital health. Prior to joining Genentech, he was with Medtronic and Boston Scientific where he worked on various combination products such as the IN.PACT drug-device coated balloon, TAXUS drug-device coated stent, and implantable, programmable drug infusion pumps.

Soo graduated from Iowa State University with a bachelor’s degree in industrial and manufacturing systems engineering. He also has a master’s degree in bioscience regulatory affairs from the Johns Hopkins University, and a doctorate in regulatory policy from the University of Southern California School of Pharmacy.

Alan Stevens

Assistant Division Director, Division of Drug Delivery and General Hospital Devices and Human Factors, CDRH, US Food and Drug Administration

Alan Stevens has 20 years of experience at FDA regulating drug delivery devices. As an assistant division director in CDRH’s Division of Drug Delivery and General Hospital Devices and Human Factors, he manages the Injection Devices Team and oversees the product life cycle of injection devices, including pre-market submission review and post-market safety and compliance. Previously, Stevens spent 10 years as pre-market engineering reviewer of drug delivery devices in CDRH’s Office of Device Evaluation and three years as a compliance officer in CDRH’s Office of Compliance.  He received an undergraduate mechanical engineering degree and a master’s degree in reliability engineering from the University of Maryland.

Pascal Venneugues

Principal Scientist, European Medicines Agency

Pascal Venneugues qualified as a pharmacist from the University of Paris, with a doctorate in molecular genetics. He also holds master’s degrees in medicines regulation in the European Union and in health economics. From 2001 to 2003 he worked in pharmaceutical industry. He joined the European Medicines Agency in 2003 and works as Principal Scientist in pharmaceutical quality, with focus on biologics.

Steve Vesole

Drug Delivery Systems Engineer, Associate Director, CMC Regulatory Affairs, Janssen Research & Development

Steve Vesole supports regulatory activities related to drug-device combination products including pre- and post-approval submissions at Janssen. He works with global regulatory, supply chain, and commercial partners to provide region-specific device regulatory guidance. Prior to working in regulatory affairs, Vesole supported the design and development of delivery devices for large- and small-molecule drug products as a device engineer. He holds a bachelor’s degree in polymer science and engineering and a master’s degree in biomedical engineering from Case Western Reserve University.

James Wabby

Global Head, Regulatory Affairs (CoE) – Emerging Technologies, Combination Products and Devices, AbbVie

Jambes Wabby has more than 20 years of experience in quality compliance, regulatory affairs responsibilities, and in increasing quality operations within the GxP regulated environment pertaining to Medical Device, Technology Medicinal Delivery Platforms, Complex Generics, Companion Diagnostics, Digital Medicine, and Combination Product areas. In addition, he is an Adjunct Assistant Professor at USC – School of Pharmacy – Regulatory and Quality Sciences and a recognized international speaker, chair, and keynote at various symposia. Wabby is also the Chairman of the DIA Combination Products Committee, and a moderator for various global regulatory panel discussions.

John “Barr” Weiner

Associate Director for Policy in FDA’s Office of Combination Products, FDA

John Barlow Weiner is the Associate Director for Policy in FDA’s Office of Combination Products, which is tasked with ensuring the efficient, effective, and consistent regulation of combination products and the classification and assignment of medical products. In addition to overseeing the policy program for OCP, Weiner’s responsibilities include providing guidance and direction for FDA policy initiatives and precedential regulatory actions concerning combination products and other medical products intended for combined use. His work involves engagement with components throughout FDA, with foreign counterparts, and with standard-setting bodies, as well as outreach to stakeholders and trade associations.

Weiner was previously an Associate Chief Counsel for FDA, focusing on drug regulation and related innovation and competition issues, and on cross-cutting topics such as use of nanotechnology. He has served as FDA’s liaison to the United States Trade Representative and other components of the United States government on issues relating to pharmaceutical trade and competition, participating in multiple rounds of bilateral and regional trade negotiations as a technical advisor. Before coming to FDA, Weiner was in private practice, focusing on food and drug, environmental, and related public international and trade law. He received a bachelor’s degree from Princeton University and a JD with honors from the Columbia University School of Law.

Richard Wolf

Head of Pv Operations at CSL Behring, CSL Behring

Rich Wolf is the Executive Director, Pv Operations in the GCSP group at CSL Behring.  He directs Case Management, Medical Evaluation, Manufacturing Site Pharmacovigilance Representative, Pv Business Process and Technology, and Pv Combination Products & Device Center of Excellence groups.

Rich has been with CSL for the past 7 years having spent the prior 12 years working across many areas in Global Medical Safety at Johnson and Johnson.

Prior to joining the pharmaceutical industry Rich spent 5 years at Accenture and was an Airborne Ranger qualified Infantry Officer.  He earned his undergraduate degree from the University of Richmond and MBA from Rutgers University.

CSL Behring is a global leader in the plasma protein biotherapeutics industry.  They research, develop, manufacture and market biotherapies that are used to treat serious and rare conditions. Rich is an advocate for Project Healing Waters Fly Fishing – Project Healing Waters Fly Fishing, Inc. is dedicated to the physical and emotional rehabilitation of disabled active military service personnel and disabled veterans through fly fishing and associated activities including education and outings.

Rumi Young

Director, Regulatory Policy, BD

Rumi Young, Meng, RAC is the Director of Regulatory Policy at Becton Dickinson (BD). In this role she leads a team that advances policies to speed time to market, promote innovation and ensure reasonable regulatory requirements for medical devices, diagnostics and combination products. Young joined BD from FDA where she spent four years in CDRH’s Division of Drug Delivery, General Hospital and Human Factors. As Acting Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors and smart connected devices. Prior to FDA, Young worked at Genentech and AstraZeneca for eight years in combination product development.  She has both a bachelors in chemistry and chemical biology and masters in engineering in material science from Cornell University.