Dr. Tina Kiang is currently Acting Division Director for the Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices (DAGRID) in the Office of Device Evaluation in the Center for Devices and Radiological Health of FDA. She received her Bachelor of Engineering in Chemical Engineering in 1997 from the Cooper Union for the Advancement of Science and Art, and her PhD in Biomedical Engineering from the Johns Hopkins University School of Medicine in 2005. She began her career at FDA in 2005 as a chemistry and engineering reviewer in the Division of Ophthalmic and Ear, Nose and Throat Devices, where she became the branch chief of the Intraocular and Corneal Implants Branch in 2009. She then became the Deputy Division Director for DAGRID in January of 2015, and has been serving as the Acting Director since July of 2016.

Hemal is Associate Director, Global CMC-Regulatory Affairs, Medical Devices and Combination Products, for Janssen Research & Development, LLC, and is responsible for worldwide regulatory activities related to Janssen drug delivery devices and combination products. Hemal joined Janssen in 2015 from DePuy Synthes where he was a part of the Spine and Trauma regulatory teams responsible for device regulatory filings. Before joining DePuy Synthes’ Regulatory department, he was their Manager of Evidence Development, where he initiated and created evidence-based programs in support of medical device reimbursement challenges. Prior to joining DePuy Synthes, Hemal co-founded a spinal medical device start-up company and was a Research Assistant at the Orthopedic Biomechanics Laboratory at Harvard Medical School. Hemal holds an M.S. in Biomedical Engineering from Boston University and a B.S. in Engineering Science (Biomedical Engineering concentration) from the University of Tennessee, Knoxville.

Larry Nichols is the CEO of Steri-Tek, located in Fremont, CA.
Larry began working in the E-beam industry for Nutek Corp in 1996 as the business manager. He soon assumed the position of Operations Manager, overseeing the shipping/receiving department as well as the machine operators. Next he was promoted to VP of Business Development. In 2009, he assumed the position of CEO. In 2010, he became active on the committees ISO/AAMI 11137 and ASTM Dosimetry working group. When Nutek closed in 2016, he started Steri-Tek where he assumed the role of CEO.
Larry earned his BS degree in Business Management from Cal Poly in San Luis Obispo, CA.

Amit Khanolkar has been with Janssen, Pharmaceutical Companies of Johnson & Johnson since 2014 in the Combination Product Center of Excellence. In his current role, Amit is involved in providing leadership and oversight for New Product Development of Janssen Combination Product pipeline.

Amit has a background in Medical Device and Combination Product development, with 12 years in R&D in the Medical Device sector and 4 years in Quality Engineering in the Pharma sector of Johnson & Johnson; where he held successive roles of increasing responsibilities in development as well as commercialization of numerous medical devices and combination products. Amit has actively collaborated across operating companies/sectors of Johnson & Johnson and provided strategic leadership in evaluating product and technology concepts in drug device combinations and convergent technologies.
Prior to Johnson & Johnson, Amit worked in materials and process development of high performance polymer materials for the pharmaceutical/medical device and semiconductor applications.
Amit holds a Master of Science degree in Polymer Engineering from the University of Akron and an MBA from University of Florida. He is a certified Design Excellence Black Belt, Process Excellence Green Belt and also has a certification in Statistical Engineering.
 

Carl Dabruzzi has over 20 years of experience in the pharmaceutical and drug delivery industries. He joined West Pharmaceutical Services in 2017 in the Product Management organization. His primary responsibilities are to manage the development and commercialization of West’s portfolio of Self-Injection Systems. The portfolio includes the SmartDose® platform of wearable on-body infusors and the SelfDose™ injector. These devices are marketed through West’s Biologics, Pharmaceuticals and Generics business units.

Prior to joining West, Carl worked in the Pharmaceutical and Drug Delivery Systems divisions of 3M. He has an extensive background in respiratory and transdermal drug delivery systems that includes biological research of new chemical entities, analytical development and validation, regulatory affairs, account management, portfolio management and strategic business development. Carl holds a B.S. in chemistry from the University of Wisconsin in River Falls.

Linda Ricci began her career developing artificial intelligence solutions in the defense industry before moving to the medical device industry as a software engineer. She helped to develop several diagnostic cardiology devices and has participated in all phases of product life cycle development. Ms. Ricci moved to the FDA in 2005 and has had several roles including scientific reviewer and branch chief within the Division of Cardiovascular devices. Currently Ms. Ricci is the Associate Director for Digital Health within the Office of Device Evaluation. In this role she, leads the development and implementation of digital health policy within the Office of Device Evaluation. She has degrees in Electrical Engineering and Medical Engineering.

John is a Regulatory/Quality/Clinical professional with over 25 years of experience in research & development, quality assurance/control, clinical affairs, regulatory affairs and executive management. Experience with CDRH, CBER, and CDER managing all FDA interactions and submissions. John started his career as an analytical chemist before moving into regulatory affairs. John has an undergraduate degree in chemistry and a Master’s degree in Biomedical Engineering. John also has certification in regulatory affairs, healthcare compliance and drug development.

Nick works at Biogen in Technical Development as a member of the Medical Devices and Packaging Team. Nick focuses on human factors and usability engineering management throughout all phases of combination product development, including concept and feasibility stages. Prior to joining Biogen, Nick worked as a drug product formulator, responsible for combination product development of pre-filled syringes and biologics formulation development. Nick holds a B.A. in Biology for the University of Rochester, an M.S. in Biotechnology from Tufts University, and a D. Eng in Engineering Management and Systems Engineering from George Washington University.

MOLLY FOLLETTE STORY, PhD is Head, Global Usability Engineering and Risk Management in Sanofi’s Medical Device Development Unit. She was formerly Human Factors and Accessible Medical Technology Specialist at FDA/CDRH/ODE, where she had an appointment to the Senior Biomedical Research Service. While at FDA, she authored, with Ron Kaye, the CDRH draft (2011) and final (2016) human factors guidance documents. Dr. Story has particular expertise in universal design of products and the accessibility and usability of medical devices. Dr. Story is Co-chair of AAMI’s Human Factors Engineering Committee.

Brian Lewis is a senior consultant engineer in the Delivery, Device, and Connected Solutions organization at Eli Lilly and Company. He currently leads development of the prefilled syringe platform through design, development, and qualification of syringe systems and their application to early and late stage biomolecules. Brian has been active in the pharmaceutical industry for over 30 years, gaining experience in commercial fermentation, inhaled insulin powder filling and primary packaging technical transfer and launch, and in packaging development at Pfizer prior to joining Eli Lilly.
Brian received his B.S. and M.S. in Chemical Engineering from Rose-Hulman Institute of Technology.
 

George Cusatis is Associate Director of Merck’s Device & Digital Health team, part of Global Regulatory Affairs & clinical Safety based in Upper Gwynedd, PA. In this role, he supports the Medical Device and Combination Product (MDCP) and digital health solutions business across Merck. George provides guidance and support for more than 40 products, including auto injectors, prefilled syringes, digital health software, and contraceptives.
George has extensive experience with the Product Development Lifecycle, including product safety, regulatory submissions, quality assurance, and clinical affairs. Prior to joining Merck, he worked at Sanofi in Swiftwater, PA, as a Pharmacovigilance Scientist for postmarket and clinical vaccine and drug products, and as a Research Associate focused on clinical pharmaceutical and vaccine applications and discovery. George also has extensive experience as a research scientist, managing research and clinical teams at Johns Hopkins University and SUNY Upstate Medical University.
George received a M.S. in Regulatory Affairs / Quality Assurance from Temple University in Philadelphia, a M.S. in Bioengineering from Syracuse University in New York, and a B.S. in Biology from Wilkes University in Wilkes Barre, PA. He is a member of RAPS to which he holds the RAC certification, ASQ, and DIA professional societies and holds ISO certifications in Quality Management Systems Requirements (ISO 9001), Information Security Management (ISO 27001), Service Management Systems (ISO 20000), and Medical Devices Quality Management Systems (ISO 13485). He is also an author on 14 peer-reviewed publications.
 

MOLLY FOLLETTE STORY, PhD is Head, Global Usability Engineering and Risk Management in Sanofi’s Medical Device Development Unit. She was formerly Human Factors and Accessible Medical Technology Specialist at FDA/CDRH/ODE, where she had an appointment to the Senior Biomedical Research Service. While at FDA, she authored, with Ron Kaye, the CDRH draft (2011) and final (2016) human factors guidance documents. Dr. Story has particular expertise in universal design of products and the accessibility and usability of medical devices. Dr. Story is Co-chair of AAMI’s Human Factors Engineering Committee.