Combination Products Conference
James Wabby, MHS
- Executive Director, Regulatory Affairs, Emerging Technologies and CMC - Device
- AbbVie, Inc., United States
James Wabby is the Executive Director of Regulatory Affairs (Device and Combination Products) at Allergan in Irvine, California. He has over 15 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.
Karthik Balasubramanian, PhD, MS
- Director, Combination Products and Semisolids, Generic CPD
- Teva Pharmaceuticals, United States
Dr. Karthik Balasubramanian, Ph.D is Director in the Combination Products and Semisolids Group at Teva 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 Teva, he has worked in numerous device areas in roles of increasing responsibility, from syringes to large scale diagnostic systems, as well as in sterile injectables and radioactive contrast imaging devices. He has a bachelors in Biomedical Engineering from Columbia University, and a Ph.D in Mechanical Engineering from Drexel University.
Khaudeja Bano, DrMed, MD, MS
- Executive Medical Director, Combination Product Safety Head
- Amgen, United States
Dr. Bano is an Executive Medical Director, Head of Combination Product Safety 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.
John Barlow 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 the classification and assignment for regulation of therapeutic products (drugs, devices, biological products, and combination products), and with ensuring the sound and consistent regulation of combination products.
- Associate Director, Regulatory Affairs
- Biogen, United States
Jonathan Amaya-Hodges is an Associate Director in the Regulatory Affairs CMC department at Biogen, specializing in Combination Products and Medical Devices. His previous experiences include combination product development/engineering and Quality Engineering/Quality Assurance at manufacturers of medical devices and in-vitro diagnostics. He is an American Society of Quality (ASQ) Certified Quality Engineer (CQE) and Certified Manager of Quality/Organizational Excellence (CMQ/OE). He is active in various industry groups, including the Combination Product Coalition (CPC) where he currently serves as Chair of the Cross-Labeling Working Group. Jonathan holds a BS in Chemical Engineering from Northwestern University.
Chin-Wei Soo, DrSc
- Global Regulatory Head, PTR Devices and Combination Products
- Genentech, A Member of the Roche Group, United States
Chin-Wei Soo is the Global Regulatory Head, Combination Products, Devices, and Digital Health at Roche/Genentech. He is accountable to provide 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 lifecycle. Chin has 18 years of regulatory and quality experience, including strong expertise in combination products and digital health.
Demetra Macheras, MBA
- Director, Regulatory Policy and Intelligence - Regulatory Affairs
- AbbVie, Inc., United States
Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S. and Canada regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and final regulatory policies. She also provides regulatory and strategic support to global project teams. Demetra has over 21 years of industry experience and has held positions in Regulatory Affairs, QA, Compliance, and Operations.
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.
- DIA, United States
Karl Saldanha, PhD
- Associate Regulatory Program Director
- United States, United States
Karl Saldanha is an Associate Regulatory Program Director at Genentech where he focuses on regulatory strategies associated with development and marketing approval of devices and combination products. He has 10 years of industry experience spanning roles in process engineering, manufacturing, and regulatory. He holds a B.S. in Bioengineering from UC Berkeley and a Ph.D. in Bioengineering from UC Berkeley/UC San Francisco Joint Graduate Program.
Michael Fahmy, MS
- Senior Director, Global Regulatory Affairs
- Otsuka Pharmacutical Development & Commercialization, Inc., United States
Michael is the Global Regulatory Therapeutic Area Lead at Otsuka Pharmaceuticals Development & Commercialization covering multiple Therapeutic Areas including Digital Medicine/Digital Therapy, Cardio/Renal and medical devices. He is accountable for the regulatory strategy in the development of several products in these therapeutic areas and led the first FDA approved digital medicine. Michael has 19 years of experience within the regulatory space covering the U.S., E.U., Japan, and other key geographical areas and has strong expertise with combination products and digital medicine.
Suraj Ramachandran, MS
- Director, Regulatory Affairs
- Merck & Co., Inc, United States
Suraj Ramachandran, MS, RAC, is a Director, Regulatory Affairs in the Device and Digital Health Center of Excellence at Merck. With over 10 years of experience, Suraj is currently responsible for supporting various medical devices and combination products, such as pre-filled syringes, inhalers and contraceptives. In addition, he is heavily involved in providing guidance for digital solutions and has led many development efforts regarding medical device software. Suraj is also an active participant on the TransCelerate Patient Technology Workstream and leads the Regulatory sub team within this initiative. Suraj holds both a Bachelor’s and Master’s Degree from the University of Michigan. In addition, he has earned the RAPS RAC Certification.
Kim Trautman, MS
- Executive Vice President Medical Device International Services, Medical Devices
- NSF International, United States
Experienced Medical Devices and InVitro Diagnostics Executive Vice President with 26 years of working at the U.S. FDA Center for Devices and Radiological Health (CDRH) and working with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes medical device regulatory services and recently developed a formal Education/Training business, as well as an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body in Ireland for EU IVDR/MDR Designation.
Michael Benecky, PhD
- Senior Director, Global Regulatory Affairs
- UCB, United States
Mike Benecky joined GSK in October 2011 as Senior Director, Global Regulatory Affairs in located in Research Triangle Park, North Carolina. Mike is a Subject Matter Expert in the Regulatory Aspects of Digital Medicine. Successful projects at GSK included launch of the MyAsthma mobile medical device app in the UK, execution of the PARADE Virtual Clinical Study in Rheumatoid Arthritis Patients and implementation of digital adherence technology within respiratory medicine clinical trials. In April 2020, Mike joined UCB as a Senior Director, Global Regulatory Affairs where he provides regulatory strategy for UCB Teams seeking to implement wearable sensor technology in clinical trials.
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.
Susan Holmes, MSc
- GlaxoSmithKline, United States
Sue is a Director in Global CMC Regulatory Affairs with GSK. In her role she is responsible for leading the Mature Products Respiratory CMC Regulatory team developing strategies to support manufacturing site change projects and is a Subject Matter Expert for Devices and Combination Products. Sue joined GSK in 1988 as an analyst leading the analytical development of respiratory products. She moved to regulatory affairs in 2002 continuing with GSKs respiratory products; spanning clinical trial, marketing application and post-approval variation global submissions. Sue has a BS in Chemistry & Toxicology, and an MSc in Pharmaceutical Analysis & QC. She is active on the IPAC-RS Board of Directors, CPC Steering Team and associated Working Groups.
Karen D Kazak, MS
- Principal Regulatory Scientist
- Eli Lilly and Company, United States
Stephanie Sabatino Kelly, JD, MS
- Associate Director North America Regulatory Intelligence and Policy
- CSL Behring, United States
Stephanie Kelly has over 20 years work experience in the biotech, medical device, and pharmaceutical industries as well as the legal field having worked at GlaxoSmithKline, the Pennsylvania Department of Health Legal Department, Ratner Prestia, Pfizer and Siemens Healthineers prior to joining CSL Behring in November 2018 as the North America lead for Regulatory Intelligence and Policy. Stephanie has served in Regulatory & Standards Policy roles since 2013, She has been active in the Combination Products Coalition (CPC) since joining CSL Behring and now serves as the vice-chair of the International Affairs working group. Stephanie is also active in both BIO and the Alliance for Regenerative Medicine regulatory policy working groups.
Christina Mendat Mendat, PhD
- Managing Director
- Human Factors MD, United States
As a partner and Managing Director, Christina is responsible for the operations and technical oversight of Human Factors MD. Christina is an expert at translating research findings such as user needs, requirements, product strengths, and weaknesses into compelling design directions and solutions. She brings over 15 years of experience in human factors having spent more than 5000 hours in surgical suites, medical device usability studies, and outpatient facilities. She has presented papers to the Human Factors and Ergonomics Society, the American Psychology Society, and has been providing multiple workshops and lectures on navigating the various HF Guidance documents.
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.
Robin M. Weinick, PhD
- Senior Vice President and Managing Director, Americas and Global Program Officer
- DIA Global, United States
Robin M. Weinick, PhD. brings 25 years of experience to her DIA role as Senior Vice President & Managing Director, Americas, and Global Program Officer.Robin joins DIA from RTI International, a large, nonprofit research institute dedicated to improving the human condition. She also has served as Associate Director for Health at the RAND Corporation, a premier U.S.-based think tank, and on the faculty of Harvard Medical School and Massachusetts General Hospital. She began her career in federal service with the U.S. Department of Health and Human Services. She holds a B.A. in Health and Society from the University of Rochester and a Ph.D. on Population Dynamics from Johns Hopkins University.
- Senior Director Regulatory Affairs
- AstraZeneca, United Kingdom
Tim joined AstraZeneca in 2007 to lead a team responsible for developing delivery devices for AZ’s new drug portfolio. This encompassed all dosage forms and had a significant focus on inhalation and injection devices. Tim’s current role is to lead the Medical Devices & Combination Products group within AstraZeneca Regulatory Affairs. The group is responsible for developing and implementing regulatory strategies and processes for both new and existing medical devices and combination products. This encompasses conventional pharmaceuticals, biologics and AZ’s activities in Digital Health. Tim is a leading member of a number of medical device & combination product industry groups and associations.
Michael Koenig, MS
- Group Head – Regulatory Affairs Established Products
- Bayer, United States
Mike has over 25 years of pharmaceutical industry experience, ranging from QC labs to CMC development and Regulatory Affairs. He has worked with a variety of combination products, including drug eluting intrauterine devices, prefilled syringes, and most recently received one of the first FDA approvals for a mobile app in combination with a drug and autoinjector.
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.
Keith Morel, PhD
- Vice President Regulatory Compliance | Principal Consultant
- Qserve Group US, Inc., United States
Dr. Keith Morel is VP of Regulatory Compliance at Qserve Group, one of the largest European-based medical device consulting companies. He has worked in the medical device industry since 2000. Prior to joining Qserve, he was Senior Director or Regulatory Compliance at Accuray. Keith was also a Senior Project Manager for DEKRA Certification for 9 years. During his time at DEKRA he was a quality system and regulatory lead auditor, as well as a design dossier reviewer. He performed more than 100 audits and 200 Design Dossier/Technical File reviews. Before DEKRA, Keith worked in R&D in various roles as Engineer, Manager and Director, for several technologies including IVUS catheters and super-oxidized water products.
Armin Ritzhaupt, PhD, MPH
- Scientific Administrator
- European Medicines Agency, Netherlands
Armin Ritzhaupt, is a scientific administrator at EMA providing regulatory support to development, evaluation and surveillance of medicinal products for human use. He provides regulatory support to the Innovation Task Force and leads on activities related to the implementation of the new medical device and in vitro diagnostic regulations. Armin worked in industry from 2002 to 2015 in different roles in clinical development and global regulatory affairs before joining EMA. He holds PhD in biochemistry from the University of Liverpool, and a Masters of Global Public Health from the University of Manchester. He completed a postdoctoral fellowship in virology at the Center for Biologics Evaluation and Research (CBER), FDA.
Robert Berlin, JD, MPH
- Division Director, Division of Clinical Policy, OND Policy, OND, CDER
- FDA, United States
Rob Berlin oversees a staff addressing clinical and labeling policy activities for the Office of New Drugs. He and his teams are working on a range of policy issues including evidentiary standards for approval, clinical trial design, and novel labeling initiatives. In recent months they have been heavily engaged in preparing guidance documents and other materials to support the COVID-19 response, while also directly assisting with the review of submissions regarding COVID-19. In addition to his managerial responsibilities and work on COVID-19, Rob is particularly focused on issues that cross jurisdictional lines, including issues related to the review of combination products, digital health, and diagnostics.
Susanne Fornero, PharmD, PhD
- Medicinal Expert
- BSI, Netherlands
Susanne Fornero-Quaak is a pharmacist by training with a PhD in pharmaceutical development of a plasmid DNA vaccine from the University of Utrecht. Susanne started her professional career as project pharmacist at the Dutch Cancer Institute in Amsterdam, The Netherlands. She then worked as a formulation scientist at HAL Allergy in Leiden, The Netherlands, before joining BSI in 2017 as a medicinal expert. In this function she reviews medicinal dossiers of device drug combinations, coordinates consultations with national competent authorities and EMA and assists in the preparation of notified body opinions for art 117 devices.
Shannon Hoste, MS
- Senior Director, Development Quality and Human Factors Engineering
- Enable Injections Inc., United States
At Enable Injections, Shannon leads teams of quality and human factors professionals who work in partnership with pharmaceutical companies on combination products utilizing On-Body Delivery Systems. Prior to this, Shannon was a reviewer within FDA’s Center for Drug Evaluation and Research Division of Medication Error Prevention and Analysis (CDER/DMEPA) and team Lead for Human Factors in FDA’s Center for Devices and Radiological Office of Device Evaluation (CDRH/ODE). Additionally, in past industry experience, she has worked as a device development engineer, quality/design assurance engineer and R&D manager.
Manfred Maeder, PhD
- Head of Device Development & Commercialization
- Novartis, Switzerland
Manfred Maeder PhD: Manfred Mäder is Head Device Development & Commercialization in TRD (Technical Research and Development). Prior to this, he held the position Head of Global Compliance & Audit for Devices & Combination Products overseeing all Alcon, Pharma, and Sandoz sites producing this type of products and Global QA Head of Technical Research and Development at Novartis Pharma starting in February 2011. Prior to this position he was Senior VP of Quality Management & Regulatory Affairs, at Ypsomed, a company producing Medical Devices and Combination Products starting in 2007. Previously, he was responsible for Quality Assurance Management at Sanofi-Aventis for the Frankfurt Injectables site. Before then, being based in Kansas
Sarah Mollo, PhD, RAC
- Combination Product Policy Analyst, OPEQ, CDRH
- FDA, United States
Sarah Mollo serves as a Combination Product Policy Analyst and Product Jurisdiction Officer in CDRH. Prior to joining the CDRH combination product policy team, Sarah was a lead reviewer and biocompatibility consultant for general hospital devices branch for 3 years before serving the team lead for injection products within OHT3/OPEQ/CDRH. Sarah earned her bachelor’s in Microbiology and Cell Science from the University of Florida and her doctorate in Immunology from the University of Alabama at Birmingham. Prior to joining the FDA she was a post-doc at Harvard University.
Paul Blowers, MA
- Director, Human Factors - Drug Delivery Solutions
- AbbVie Inc., United States
Paul has 28 years of experience as a human factors professional working in the healthcare industry including combination product development, pharmaceutical dosing form delivery, implantable devices and medical software. Paul joined AbbVie in 2013 leading pipeline biopharmaceutical product human factors efforts and is now the director of human factors within combination product development in R&D. Paul has a Master’s degree in human factors / applied experimental psychology. He is also a standing member of both the AAMI and IEC human factors standards boards.
Julia Frese, MBA
- Department Manager Centre of Combination Products
- TÜV SÜD , Germany
By education biomedical engineer with a Master degree in business administration. Julia gained experience in development, regulatory approval of combination devices and ATMP products. She was further involved in the development of standards for ATMP products. Currently Julia Frese is heading the division of Medical and Health Services at TÜV SÜD Japan and is responsible for the development of article 117 service within the organisation. She is further co-chair of the Team NB working group for article 117.
Irene Z. Chan, PharmD
- Deputy Director, Division of Medication Error Prevention and Analysis, OSE, CDER
- FDA, United States
CAPT Irene Z. Chan received a B.S. in Pharmacy and Doctor of Pharmacy degree from Rutgers University. CAPT Chan currently works at the Food and Drug Administration where she serves as Deputy Director in the Division of Medication Error Prevention and Analysis, responsible for leveraging her knowledge of regulations, human factors, and risk management to provide oversight of safety recommendations regarding drug nomenclature, labels, labeling, packaging, and product design.
Primer: APPs/Digital Health in Combination Products - QMS and Risk Management Opportunities and Challenges