DDCP 101 – Identifying, Developing, and Evaluating Generic Drug Device Combination Products (DDCP)

Dr. Somesh Chattopadhyay received his Ph.D. in Statistics from the University of Virginia. He was a faculty member at Duke University and at Florida State University before joining FDA as a mathematical statistician in the Office of Biostatistics in CDER where he has supported review of oncologic products, generic drug products, and biosimilar products. Currently, he is a team leader in the Division of Biometrics VIII that supports the Office of Generic Drugs and partially the Office of New Drugs. For the last four years, he has been leading the team of statisticians that review comparative use human factors studies and generic drug and biosimilar products.

Dr. Meenal Chavan is Senior Pharmaceutical Quality Assessor in DIMRP, Branch 7 within OLDP/OPQ/CDER/FDA. Her areas of expertise include complex drug products such as topical and transdermal drug delivery systems, IUDs, implants, and intra-vaginal ring. In her current role, Dr. Chavan performs secondary risk­ based review assessment of ANDAs, Pre-ANDAs and DMFs. She works as an Application Technical Lead for IQA team AT-13. Dr. Chavan is a contributor tonTransdermal working group in CDER. Additionally, she works on Developmental Technical Committee of PQRI to promote advancements in drug product development. Dr.ChavanjoinedFDAin2016.Prior to joining FDA, she worked as a Sr. Manager R&D (Transdermal) at Sun Pharma, NJ. Dr. Chavan has 20 plus years of complex drug product development experience. She received her Ph.D. in Pharmaceutical Sciences from University of Mumbai, India.

Dr. William Chong is the Director of OGD’s Office of Safety and Clinical Evaluation. He leads a multidisciplinary group of scientists that work to ensure that generic drug products have the same safety and efficacy profile as the reference listed drug. Dr. Chong joined FDA in 2012 in CDER’s Office of New Drugs where he primarily evaluated new drug products for patients with diabetes mellitus. He subsequently joined OGD in 2019 as the Associate Director for Clinical Affairs before becoming the Director of OSCE in 2022. He is a board-certified internist and endocrinologist and completed his Internal Medicine residency at Thomas Jefferson University Hospital in Philadelphia, PA and his Endocrinology and Metabolism fellowship at the National Institutes of Health in Bethesda, MD. Dr. Chong earned his undergraduate degree in Engineering Science at Penn State University, and his Medical Degree from Temple University School of Medicine.

Dr. Katharine Feibus is an obstetrician/gynecologist who was in clinical practice for nine years before joining the U.S. Food and Drug Administration. During nearly 20 years in civil service, Dr. Feibus has worked as a medical officer and team leader for the Office of New Drugs’ Office of Nonprescription Drug Products and Division of Pediatric and Maternal Health and for the Office of Generic Drugs’ (OGD) Division of Clinical Review, Division of Clinical Safety and Surveillance, and Division of Therapeutic Performance-I (DTP-I). Currently, Dr. Feibus leads the DTP-1 Device Evaluation Team in OGD’s Office of Research and Standards. In addition, Dr. Feibus served as the Deputy Director of Reproductive Health in the Office of Women’s Health Services at the Veterans Health Administration. Outside of work, Dr. Feibus enjoys spending time with family and friends, hiking, Nordic skiing, biking, and snuggling with her three poodles.

Commander Andrew Fine is the Senior Advisor in the Office of Generic Drug’s, Office of Safety and Clinical Evaluation, Division of Clinical Review. As part of the division management team, Commander Fine, provides clinical, regulatory, and process oversight for generic drug activities in the division. Prior to his role as Senior Advisor, Commander Fine served as a team leader in the division for 7 years where he led a team of physicians in their clinical work to support the Generic Drug Program. He earned his Pharm.D. from the University of Illinois College of Pharmacy and completed a pharmacy practice residency at Northwestern Memorial Hospital. Andrew is board certified in pharmacotherapy and earned a certificate in pharmacoepidemiology from the University of Pennsylvania. Prior to joining the Office of Generic Drugs, Commander Fine spent 4.5 years as a safety reviewer in CDER’s Office of Surveillance and Epidemiology, Division of Pharmacovigilance where he led post marketing safety efforts for Multiple Sclerosis drug products.

Jason Flint is the Associate Director for Human Factors with the Division of Medication Error Prevention and Analysis I (DMEPAl) within the Center for Drug Evaluation and Research. He is also co-chair for the Office of Medication Error Prevention and Risk Management (OMEPRM) Research Workgroup and is the FDA scientific lead for research on training decay designed to inform the Agency’s recommendations on human factors validation protocols.

Prior to joining the DMEPA team, Jason spent 13 years supporting the Air Force Medical Acquisition community by planning, conducting, and reporting on operational testing activities for the Air Force Medical Evaluation and Support Activity (AFMESA), including two years as their Director of Operations. He spent the previous six years conducting research in virology, immunology, and nanoparticle science at Cincinnati Children’s Hospital and the University of Florida. While in college, he also served in the United States Army Reserve as a combat medic and surgical technician.

Jason received his Bachelor of Science in Biology from the State University of New York College at Brockport in 1998, an MBA from the University of Florida in 2005, attended the Human Factors Short Course at the University of Michigan in 2009, and earned a project management professional certification in 2015.

Dr Monica Garcia is a Biomedical Engineer and Assistant Director of the Obstetrical and Reproductive Health Devices Team (THT-IIIBl) in the Center for Devices and Radiological Health at the FDA. She received her Bachelor’s degree in Bioengineering from Rice University in 2004 and her Ph.D. in Molecular Physiology and Biophysics from Baylor College of Medicine (BCM) in 2013. Monica joined FDA in 2015 and has been an Assistant Director since 2019.

Dr. Kathryn Hartka is a Pharmacologist in the Division of Therapeutic Performance I. Dr. Hartka’s area of work focuses on the user interface assessment of generic drug-device combination products. She is involved in the development of product-specific guidances and responding to controlled correspondences and pre-ANDA meeting requests related to drug-device combination products. In addition to her review work, she is a member of several interdisciplinary working groups, and is engaged in regulatory science research initiatives related to generic drug-device combination products. Dr. Hartka earned her B.S. in Neuroscience from the University of Pittsburgh, her Pharm.D. from Virginia Commonwealth University (VCU), and her Ph.D. in Pharmacology and Toxicology from VCU. Prior to joining the Office of Generic Drugs, she was a pharmacologist reviewer at the Center for Tobacco Products in the Office of Science.

Dr. Viral Jogani holds an M.Pharm. in Pharmaceutical Technology (Gold Medalist) from L M College of Pharmacy, Ahmedabad, India. He completed his Ph.D. in Pharmacy on “Nasal Drug Delivery for CNS Disorders” from Maharaja Sayajirao University of Baroda, Vadodara, India. He is responsible for formulation development of drug device combination products at Sun Pharmaceutical Industries Limited. He is leading formulation development of Peptide based complex drug device combination injectable products, Nasal Sprays, and Biosimilars. He has experience in developing NCE and generic products. He has hands on experience on Peptide Sameness Characterization, Immunogenicity Evaluation, and Population Bioequivalence of In vitro BE studies. He comes with 22+ years of experience in the pharmacy field including approx. 6.5 years of experience in academics and 16 years of experience in pharmaceutical industry.

Rakesh Khilwani, PhD is a Principal Device Development Engineer within the Combination Products and Device group at Teva Pharmaceuticals. He joined Teva in 2018 and in this role R&D role, Rakesh works on development of drug-device combination products that include prefilled syringes (PFS), autoinjectors, large volume injectors and transdermal patches spanning generics, biosimilar and biologics. Rakesh has a MS and PhD in Mechanical Engineering from Carnegie Mellon University where he worked on development of flexible neural probes and microneedle patches.

Dr. Kristina Lauritsen serves as the Combination Product Policy Advisor and Product Jurisdiction Officer (PJO) 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. This includes activities such as product designation, guidance development, coordination with the FDA’s Office of Combination Products, Center for Devices and Radiological Health (CDRH), Center for Biologics Evaluation and Research (CBER), and representing CDER in cross-center combination product working groups. Kristina originally joined FDA in 2003 as a device reviewer in CDRH. She later joined the Office of Combination Products and spent several years there prior to joining CDER in 2014. She holds a B.S. in Biology from Shippensburg University, and a Ph.D. in tumor biology from Georgetown University.

Dr. Mary Lee is a Senior Physician in Division of Clinical Review in the Office of Generic Drugs. Dr. Lee joined the FDA in 2016, and has been involved with reviews for ANDAs, Bio-INDs, Product Specific Guidance documents, controlled correspondences with the generic industries, and consults with clinical issues in the development of generic drugs. Prior to coming to the FDA, Dr. Lee worked as a Geriatric Medicine physician for the Mid-Atlantic Permanente Medical Group and Inova Fairfax Hospital. Dr. Lee received her Bachelor of Science degree from Massachusetts Institute of Technology, and her medical degree from Albert Einstein College of Medicine in New York. She completed her family medicine training at Abington Hospital, and geriatric medicine fellowship at George Washington School of Medicine and Health Sciences.

Dr. Yili Li received her B.S. and Ph.D. in Chemistry from Peking University, Beijing, China. She continued her career training as a Marie Curie Fellow of the European Commission in the Biochemistry Department, University of Cambridge, UK and a Post-doctoral Fogarty Visiting Fellow in the National Cancer Institute,  National Institute of Health, Bethesda, MD. Before joining FDA, Yili was a Senior Scientist in the University of Maryland Institute for Bioscience and Biotechnology Research (IBBR), Rockville, MD. She had two decades research experiences in the field of structural immunology and published two dozen of first author research papers in the world most prestigious life science journals.

Dr. Yili Li joined FDA in 2016 as a chemistry reviewer. Currently, she serves as a Senior Pharmaceutical Quality Assessor (SPQA) in the Division of Liquid-Based Products I for ANDA and pre­ ANDA applications. She has extensive experiences in the review of complex peptide drug products, parenteral products, and topical products.

Dr. Michelle Lin is a trained and board certified in pediatrics and pediatric endocrinology. She joined the FDA in 2015 as a primary reviewer in the Division of Clinical Review. In this role, she routinely conducts comparative analyses assessments as well as other clinical consults and reviews for the generic drug approval process. She has been involved in several working groups for internal process improvement and reviewer training in relation to comparative analyses assessments.

Dr. Robert Lionberger serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). Dr. Lionberger leads OGD’s implementation of the GDUFA science and research commitments including internal research activities and external research grants and collaborations to ensure the therapeutic equivalence of generic drug products. ORS also provides pre-submission advice on complex generics through pre-ANDA meetings, product specific guidance and correspondence responses.
He received his undergraduate degree from Stanford University in Chemical Engineering, and a Ph.D. from Princeton University in Chemical Engineering. After his Ph.D., he conducted post-doctoral research in Australia in the Department of Mathematics and Statistics at the University of Melbourne. Prior to joining the FDA 20 years ago, he was an Assistant Professor of Chemical Engineering at the University of Michigan.

Dr. Markham C. Luke serves as FDA Supervisory Physician (Dermatology) and Director of the Division of Therapeutic Performance 1 (DTP-I) in the Office of Research and Standards, Office of Generic Drugs at FDA. DTPl is responsible for facilitating pre-application development of generic drugs by conducting and promoting regulatory science research to establish standards to ensure therapeutic equivalence of new generic drug products. Markham has an M.D. and a Ph.D. in Pharmacology from Johns Hopkins University and completed his dermatology residency and fellowship at Washington University, St. Louis, MO and the National Institutes of Health, Bethesda, MD. He is an Associate Professor at the Uniformed Services University of the Health Sciences, Bethesda, MD with research interests in dermatopharmacology, clinical pharmacology, clinical study design and endpoints assessment (including patient-reported outcomes) for medical, surgical, and aesthetic products. Markham has been at FDA since 1998 serving various roles, including as the Lead Medical Officer for dermatology drugs, Chief Medical Officer and Deputy Director for the Office of Device Evaluation in the Center for Devices and Radiologic Health, and as Acting Director for Cosmetics in the Center for Food Safety and Applied Nutrition.

Claire McDiarmid leads the Device Risk Management and Human Factors programs for Combination Products including Complex Generics at Viatris. Claire joined the organization in 2011 and has over 25 years of experience in Drug Product Development with specific focus on drug delivery systems. Claire’s remit includes injectable, respiratory, ophthalmic, and transdermal products and her team delivered the Human Factors programs for Wixela lnhub® – the first generic Dry Powder Inhaler approved by FDA and Semglee® – first biosimilar Prefilled Insulin Pen approved by FDA. Claire holds a Batchelor degree in Chemistry and Environmental Science from the Universities of Kent, UK and Bergen, Norway and a Master’s degree in Environmental Management and Legislation from Brunel University, UK.

Dr. Jamie L. Michalek is a Senior Pharmaceutical Quality Assessor (SPQA) for the Division of Liquid Drug Products II, within the Office of Lifecycle Drug Products (OLDP), under the Office of Pharmaceutical Quality (OPQ). As a SPQA, Dr. Michalek performs secondary drug product quality assessments for Abbreviated New Drug Applications, as well as serves as the application technical lead within her aligned team. Prior to joining the FDA in 2014, Dr. Michalek earned her Ph.D. in Pharmaceutical Sciences from the University of Maryland, School of Pharmacy, under Dr. Sarah L. J. Michel. Dr. Michalek received a B.S. in Biochemistry from the University of Maryland, Baltimore County.

Dr. Ripen Misri obtained his Ph.D. in pharmaceutical sciences from the University of British Columbia (Canada) and further pursued a post-doctoral fellowship at BC Cancer Research Center. Dr. Misri’s expertise is in development of complex dosage forms such as nanoparticulate and microparticulate drug delivery systems, and peptide therapeutics. Dr. Misri joined Apotex in 2015 and is currently Director of the Co-Development R&D, leading development of complex generic drug, and drug device combination products.

P Srinivas Naidu serves as Head of Packaging and Medical Devices in SUN Pharma. He joined the organization over 8 years ago and has well over 27 years of experience in Packaging, Medical Devices, New machinery development and in developing human centric packaging for various dosage forms for global markets. His current focus area is developing Primary Packaging and Medical Devices for complex drugs of all dosage forms.
Srinivas’ work involves an end-to-end support to the Formulation, Regulatory, Business Development, Operations, and Marketing teams. In addition, he has experience previously working with Branded and OTC products. Srinivas holds degree Mechanical Engineering and Plastic Processing and Molding.

Mitul Patel is Regulatory Affairs Specialists in development, submission, and approval of applications for Drug Device and Complex Generic product.
Mitul Patel is accountable for 505(b)2 and 505(i) regulatory submission of complex and drug device combination product for Sun Pharmaceutical Industries Limited. He is actively involved in product development, regulatory submissions till approval of ANDA/NDAs filed for such products. His current experience includes development of drug-device combination products (DDCP) like pen injector, auto injector, applicator, prefilled syringes (PFS), and ready to use bag (RTU bag). He comes with total 17+ years of experience in regulatory affairs with 10+ years of experience in area of complex and drug device combination product regulatory submissions for US and Europe market. Mitul previously worked with Apotex research private limited, India and Torrent Research Center, India as a regulatory specialist for different dosage forms of generic products.

Mitul is graduated Bachelor of Pharmacy from the National College of Pharmacy, India and holding Post Graduate Degree in Pharmaceutical Quality Assurance from Ganpat University, India.

Nitesh Patel is a Senior Manager, Regulatory and Business Continuity at Sun Pharmaceutical Industries Inc. In his current role, he provides insights on strategic regulatory considerations, ensuring quality submissions for the generics and 505(b)(2) applications and evaluating the change proposals during life cycle management phase for approved products. His core areas of expertise include critical review of Original Applications, PIND/PNDA Meetings/Briefing Packages for Complex Dosage Forms/Drug-Device Combination Drug Products, Labeling and Regulatory Administrative Requirements for Different Dosage Forms. He has well over 17 years of experience in pharmaceutical regulatory affairs for US market. Nitesh is post graduated in Pharmacy from Gujarat Technological University, India.

Satyashodhan Patil is responsible for drug delivery device development for Sun Pharmaceutical Industries Limited. He is leading end to end device development from conceptualization to commercialization through development, design verification, design validation studies like stability, clinical bio-compatibility and human factors and also supporting PLM activities including complaint handling and CAPA. He is working for the development of several types of medical devices for several therapeutic uses with drug-device combination products (DDCP) like pen injectors, auto injectors, applicators, prefilled syringes (PFS), ophthalmic devices and inhalers. He is instrumental in implementing the regulatory guidance (USFDA 21 CFR, EMA EU MDR, MHRA, TGA, HC) and ISO standards for medical devices developed for global market by authoring Global Quality Standards for device development and also bringing best practices of Mechanical Design Engineering to Medical field.

He comes with 21+ years of experience in product development including 16+ years of experience in medical device development. He previously worked with Johnson and Johnson Medical as a part of R&D’s Front-End Innovation As-Pac Team for the design and development of orthopedic implants and instrumentations. He also worked with GE Healthcare in JFWTC R&D center as a Senior Design Engineer.

Satyashodhan graduated in Mechanical Engineering from SRT Marathwada University, Nanded, India and also completed certificate course in Medical Device Development from Stanford University’s Center at All India Institute of Medical Sciences, New Delhi. He also received Post Graduate diploma in International Business Operations. He has several patents to his credit.

Dr. James E. Polli is Professor of Pharmaceutical Sciences and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at University of Maryland. His research interest is oral drug absorption and formulation, involving laboratory and clinical research. He has served as advisor to 24 Ph.D. graduates. Dr. Polli is co-Director of the recently initiated Center for Research on Complex Generics, an FDA-funded collaborative agreement with the Agency. He is Director of the online M.S. in Regulatory Science program.

Dr. Anna Schwendeman is William I Higuchi Collegiate Professor of Pharmacy and Associate Professor of Pharmaceutical Sciences at the University of Michigan. Her research focus is on optimization high-density lipoprotein (HDL) nanoparticles for treatment of atherosclerosis, sepsis, and drug delivery purposes. In 2016, she co-founded a company EVOQ Therapeutics (www.evoqtherapeutics.com) focused on the use of HDL nanodiscs for delivery of personalized neoantigen cancer vaccines. Dr. Schwendeman received her B.S. from Moscow Institute of Physics and Technology and Ph.D. in Pharmaceutics from The Ohio State University. Prior to starting her academic career in 2012, Dr. Schwendeman spent 12 years in the pharmaceutical industry at Cerenis Therapeutics, Pfizer, and Esperion Therapeutics. She was involved in different products including nanoparticles, liposome, recombinant proteins, peptides, and small molecules. Her laboratory’s research in regulatory sciences is focused on analytical characterization of liposomes, polymer microspheres, peptides, and biosimilar products. She is co-director of FDA sponsored Center for Research in Complex Generics (http://www.complexgenerics.org). Dr. Schwendeman is an Associate Editor for Nanomedicine NBM and Eur. J Pharm and Biopharm.

Ed Stanley, P.Eng. is the Manager, R&D Quality Assurance, Compliance and Combination Products, for Apotex, Inc. In this role, Ed oversees the compliance of combination product development and life-cycle management for generic pharmaceutical products. Prior to working in QA compliance, Ed gained over 20 years of pharmaceutical packaging development experience which included development of nasal spray, ophthalmic and injectable packaging systems. Ed is a licensed professional Engineer with a BASc degree in Mechanical Engineering from the University of Toronto.

CAPT Alan Stevens has 20 years of experience at the FDA regulating drug delivery devices. As an assistant division director in CDRH’s Division of Drug Delivery and General Hospital Devices and Human Factors, Alan manages the Injection Devices Team and oversees the product lifecycle of injection devices, including premarket submission review and postmarket safety and compliance. Previously, Alan spent ten years as a premarket 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. Alan received his undergraduate Mechanical Engineering degree and Master’s degree in Reliability engineering from the University of Maryland.