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Bethesda North Marriott Hotel and Conference Center

Oct 29, 2019 7:15 AM - Oct 30, 2019 4:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Combination Products Conference

Where regulators and industry share insights on leveraging regulatory and technological change to advance combination products.


Sudip  Parikh, PhD

Sudip Parikh, PhD

Senior Vice President and Managing Director, DIA Americas, DIA, United States

Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

Kirsten H. Paulson, MS, RAC

Kirsten H. Paulson, MS, RAC

, Pfizer, Inc., United States

Kirsten Paulson, RAC, is the Senior Director, Global CMC-Medical Devices at Pfizer Inc., with the lead for Combination Products, diagnostics and software medical devices. She was previously the Senior Officer, Medical Device Initiative of The Pew Charitable Trusts and Head of the PPD Medical Device and Diagnostics group. She began her career as an FDA medical device reviewer. Kirsten has a BS from Boston University and an MS in Bioengineering from Penn State.

James  Wabby, MHS

James Wabby, MHS

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States

James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Nutritional, Cosmetic, Branded Pharmaceutical, Generic, Biologic, Medical Device and Combination Product areas. James received his undergraduate and graduate degrees from Duquesne University and received his Health Care Compliance Certificate from Seton Hall University Law School. He is a member of various regulatory and quality work groups including RAPS, OCRA and the ASQ Orange Empire Section.

John  Weiner, JD

John Weiner, JD

Associate Director for Policy, Office of Combination Products, OCPP, OC, FDA, United States

John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration's Office of Combination Products, which is tasked with ensuring the sound and consistent regulation of combination products and also with the classification and assignment for regulation of medical products (drugs, devices, biological products, and combination products).

Ryan  McGowan

Ryan McGowan

Associate Director, Combination Products, AstraZeneca, United States

Ryan McGowan is the Director of Digital Devices and Combination Products in Regulatory Affairs at AstraZeneca. He has responsibility for developing regulatory strategies for the approval of combination products and digital health products including software as a medical device. Prior to joining AstraZeneca, Ryan 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.

Bill  Zeruld

Bill Zeruld

Business Development - Digital Strategy, Otsuka America Pharmaceuticals, Inc., United States

Senior executive with track record of delivering strategies and corporate development initiatives that grow and transform healthcare companies. 20+ years in: digital health, life sciences, medical devices, payers, and providers. Wharton MBA with dual concentration in Health Care Management and Finance.

Lori-Ann  Archer

Lori-Ann Archer

Medical Device and Combination Products QMS Expert, Independant Consultant, United States

Mrs. Archer Woodard delivers expertise in the creation, implementation and management of Quality Management Systems for Medical Devices, SaMD, and Combination products. She has more than 20 years of experience that includes building cGMP and ISO quality management systems from the ground up in these areas. Mrs. Archer Woodard has lead Global assessments of Quality Management Systems with expertise in creation of global corporate policies and led projects on combination product harmonization of drug and medical device development, medical device design control, and design history file remediation. Mrs. Archer Woodard has ASQ Certifications in Biomedical Auditing, Quality Engineering and Software Quality Engineering.

Daniel  Becker

Daniel Becker

Associate Director, Global Device R&D Operations, Teva Pharmaceuticals, United States

Daniel Becker is an Associate Director in Global Device R&D Operations at Teva Pharmaceuticals. In this role, he has been working to integrate Drug/Device teams to drive successful development of Generic and Specialty Drug/Device combination products. After graduating from the State University of New York College at Buffalo, Daniel joined the FDA as a chemist working on multiple dosage forms and ultimately specializing in respiratory combination products. Following the FDA, he spent over 10 years as a project manager before taking responsibility for leading an integrated project management group consisting of device and pharmaceutical professionals to develop and successfully deliver complex combination products.

Kristina  Lauritsen, PhD

Kristina Lauritsen, PhD

Combination Products Regulatory Policy Advisor, OEP, CDER, FDA, United States

Kristina Lauritsen, PhD serves as a Combination Product Policy Advisor within the Center for Drug Evaluation and Research (CDER) at the FDA. In this role, she is responsible for engaging in development of CDER's policies related to combination product review and regulation, including activities such as guidance development, facilitating coordination with the FDA's Office of Combination Products, CBER and CDRH, and representing CDER in cross-center combination product working groups. Prior to joining CDER in 2014, she spent four years in the Center for Devices and Radiological Health, followed by seven years in the Office of Combination Products. She holds a B.S. in Biology from Shippensburg University.

Iris K. Marklein, PhD

Iris K. Marklein, PhD

Biomedical Engineer, FDA, United States

Iris Marklein, Ph.D. is a Biomedical Engineer in the Cell Therapies Branch of the Division of Cellular and Gene Therapies (DCGT), Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). In this role, Dr. Marklein reviews cell therapies, medical devices, and combination products in the tissue engineering and regenerative medicine fields. Previously, Dr. Marklein served as the Device and Combination Products Team Lead in the Cell Therapies Branch and as a Biomedical Engineer in the Center for Devices and Radiological Health (CDRH).

Darin Seth Oppenheimer, DrSc

Darin Seth Oppenheimer, DrSc

Executive Director, Device & Digital Health Solutions, Merck & Co., Inc., United States

Dr. Darin Oppenheimer is an Executive Director of the Drug Device Center of Excellence focusing on Medical Devices and Combination products at Merck. After spending 15 years working in Regulatory Affairs and Development for various organizations within the Medical Device and Pharmaceutical industry, Darin knows how to strategically maneuver the regulated industry to develop and bring products to market.

Bakul  Patel, MBA, MS

Bakul Patel, MBA, MS

Senior Director, Global Digital Health Strategy and Regulatory, Google Health, United States

BAKUL PATEL was the Director for Digital Health Center of Excellence, at the Food and Drug Administration (FDA). Mr. Patel is responsible for providing leadership, development, implementing, execution, management and setting strategic direction and regulatory policy and coordinate scientific efforts for digital health, software and emerging technologies. Mr. Patel, in 2013, created the term “software as a medical device”(SaMD) and under his leadership the International Medical Device Regulators Forum (IMDRF) established the globally harmonized definition of SaMD. Mr. Patel subsequently led global regulators at IMDRF to create and author the globally harmonized regulatory framework for SaMD.

Anil  Sachdeva, MPharm, RAC

Anil Sachdeva, MPharm, RAC

Senior Director, Regulatory Affairs, Gx Steriles , Teva Pharmaceutical Industries Ltd., United States

Anil Sachdeva is Senior Director, Regulatory Affairs, Gx Steriles at Teva. He has more than 25 years of pharmaceutical industry experience. Prior to joining Teva, he has held various global and US positions in R&D and Regulatory Affairs at Ranbaxy, Jubilant, Agila, and Mylan. Anil is currently responsible for complex products, including drug-device combination sterile products. His regulatory experience includes filings and strategy for ANDAs and 505(b)2 / NDAs, which spans mainly in sterile products in the US.

Ibim B. Tariah, PhD

Ibim B. Tariah, PhD

Vice President, EU MDR & IVDR Services, Regulatory & Quality Solutions (R&Q), United States

Dr. Tariah has over 30 years experience in the medical device industry, including 21 years at BSI. In his role of VP of EU MDR and IVDR Consulting Services at R&Q, he provides leadership, strategic advisement and implementation expertise to R&Q's consulting team and clients. Prior to R&Q in his role of Technical Director of Medical Devices for BSI Americas, Dr. Tariah was part of the BSI Americas leadership team responsible for transitioning from MDD to MDR certification. He created and led customized MDD and MDR workshops for clients and industry, and spoke on behalf of the notified body at global conferences and events.

Karthik  Balasubramanian, PhD, MS

Karthik Balasubramanian, PhD, MS

VIce President, CMC & Technical Operations, Verrica Pharmaceuticals, United States

Dr. Karthik Balasubramanian, Ph.D is Vice President for CMC and Technical Operations at Verrica Pharmaceuticals. He has over 15 years of experience in all phases of medical device and combination product development, from R&D to Technical Operations. Prior to joining Verrica, he has worked in numerous combination product and device areas in roles of increasing responsibility, from syringes to large scale diagnostic systems, as well as in sterile injectables, topicals, transdermals, and respiratory products. He has a bachelors in Biomedical Engineering from Columbia University, and a Ph.D in Mechanical Engineering from Drexel University.

Lisa  Bercu, JD

Lisa Bercu, JD

Regulatory Counsel, Office of Generic Drug Policy, FDA, United States

Lisa Bercu is a regulatory counsel in the Office of Generic Drug Policy, Office of Generic Drugs (OGD) where she focuses on policy development for combination products. Before joining OGD in October 2016, Ms. Bercu worked at a medical society providing strategic advice on issues including pain medicine, drugs, and devices. She holds a JD degree from Georgetown University Law Center and a BA from the University of Michigan.

James P. Bertram, PhD, MS, RAC

James P. Bertram, PhD, MS, RAC

Director, Office of Combination Products, OC, FDA, United States

James Bertram is currently an Assistant Director with the Regulation, Policy, and Guidance Staff in CDRH/OPEQ. In this capacity, James and his team collaborate across the Agency on cross-cutting policies, many of which apply to the review and regulation of combination products.

Melissa  Burns, MS

Melissa Burns, MS

Senior Program Manager, Office of Combination Products, OCPP, OC, FDA, United States

CAPT Melissa Burns is a Senior Program Manager in FDA’s Office of Combination Products (OCP). In this role, she is responsible for coordinating activities related to combination product review and regulation including development and review of guidance documents, regulations, and procedures and policies. Prior to joining OCP, Melissa worked for several years in FDA CDRH. Melissa worked for several years in the private sector including positions with a medical device manufacturer, a hospital, a healthcare architecture firm, and a consulting firm. Melissa received a Bachelor of Science degree in Mechanical Engineering from Virginia Tech and a Master of Science degree in Biomedical Engineering from The University of Connecticut.

Michael  Drues, PhD

Michael Drues, PhD

Founder and President, Vascular Sciences, United States

Michael Drues, Ph.D., is President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies. He received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies. He also works for the FDA, Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services and other regulatory and governmental agencies around the world. Dr. Drues is an internationally recognized expert, featured keynote speaker and an Adjunct Professor at several universities & medical schools.

Thinh X. Nguyen

Thinh X. Nguyen

Director, Office of Combination Products, OCPP, FDA, United States

Mr. Nguyen is the Director of the Office of Combination Products (OCP) since January 2008. OCP is primarily responsible for making jurisdictional determinations, ensuring timely premarket reviews, ensuring consistent and appropriate post-market regulations, and developing policy, guidance documents, and regulations. Mr. Nguyen joined the agency in 1993 as a scientific reviewer in the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH). From 2000 - 2007, Mr. Nguyen was the Chief of the Pre-Market Approval Program in CDRH where he was primarily responsible for ensuring the uniform and consistent application of the PMA regulations and policies across CDRH and CBER.

Matthew  Raymond, PhD

Matthew Raymond, PhD

Director, Science and Regulatory Policy, Astellas, United States

Dr. Raymond currently serves as Director, Science and Regulatory Policy at Astellas. Prior to joining Astellas, Dr. Raymond served as a Director, Science and Regulatory Advocacy at PhRMA. In this role he focused on regulatory policy and advocacy issues including combination products, digital health, drug development tools, preclinical development, and model-informed drug development. Prior to PhRMA, he held a Health Program Specialist position with the National Institute of Neurological Disorders and Stroke at NIH where he coordinated efforts for the White House BRAIN Initiative, including developing the BRAIN Initiative Public-Private Partnership Program that brought together stakeholders from academia, industry, NIH, and FDA.

Khaudeja  Bano, DrMed, MD, MS

Khaudeja Bano, DrMed, MD, MS

Vice President, Combination Product Quality, Amgen, United States

Dr. Bano is the Vice President of Combination product Quality at Amgen. She is a Physician, with a Masters in Clinical Research (UCSD), Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional. She is an Abbott President’s award winner, avid Toastmaster and a certified coach. Khaudeja has more than 25 years professional experience, including patient care. She has held several global safety positions at Guidant, Abbott (multiple divisions like Vascular, Diagnostics, and Established Pharma), and AbbVie Inc. She currently serves as the working group chair of the Combination Product Coalition's Post-marketing Safety Reporting team.

Sheryl L. Lard Whiteford, PhD

Sheryl L. Lard Whiteford, PhD

Associate Director for Quality Assurance, OCD, CBER, FDA, United States

Sheryl Lard-Whiteford, MS, PhD, is the Associate Director for Quality Assurance in the Center for Biologics Evaluation and Research (CBER). With 32 years of experience at FDA, Dr. Lard serves as the center's Chief Product Jurisdiction Officer, working closely with the Office of Combination Products and center counterparts to help ensure consistency and predictability in product jurisdiction decisions, generate guidance on product classification practices and address cross-center review issues. She also works within CBER on matters related to CBER product classification, assignment and regulatory path considerations as well as serving as the center’s Ombudsman, and supervisor for its quality management group.

Lisa  Parks, RPh

Lisa Parks, RPh

Senior Vice President, Regulatory and Scientific Affairs, CHPA, United States

Lisa holds an R.Ph. in Pharmacy from the Massachusetts College of Pharmacy in Boston, MA. Lisa is Principal of Daedal Regulatory Strategies, LLC, a consultancy specializing in navigating complex regulatory and scientific issues involving interactions with the FDA. In her previous role as the Vice President of Sciences and Regulatory Affairs at the Association for Accessible Medicines (AAM), she assists with the development of scientific affairs initiatives and member communications and training opportunities. She is involved with facilitating discussions and efforts with FDA, law makers and other industry stakeholders on numerous topics that impact the generic and biosimilar industry.

Suzette  Roan, JD, MS

Suzette Roan, JD, MS

Senior Director, GRA Device Combination Products, Sanofi, United States

Suzette Roan joined Sanofi as Sr Director, Device Reg Affairs in Sept. 2017 and is responsible for combination product and diagnostic device regulatory strategies for products in the portfolio. Prior to Sanofi, Suzette worked at Biogen for 3 years leading the combination product regulatory team. Previous to her time at Biogen, Suzette was with Pfizer for 19 years, with roles in Analytical Development, Outsourcing and Reg CMC. She has experience with pulmonary inhaler, prefilled syringe, autoinjector and on body delivery systems. Suzette holds a BS in Chem from Univ of CT, a MS in Mgmt from Albertus Magnus College and a JD from Univ of CT School of Law. She active member in ISO/TC 84 and is chair of the CPC Submissions working grou

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