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Sheraton Silver Spring

2018 年 10 月 09 日 7:30 上午 - 2018 年 10 月 10 日 5:15 下午

8777 Georgia Ave, Silver Spring, MD 20910

Complex Drug-Device Generic Combination Products Meeting


Anna K. Abram

Anna K. Abram

Deputy Commissioner for Policy, Planning, Legislation and Analysis, OC, FDA, United States

As Deputy Commissioner for Policy, Planning, Legislation and Analysis, Anna Abram plays a critical role in overseeing the development and implementation of key policy initiatives and provides strategic policy direction to advance FDA’s mission and vision of protecting and promoting public health. Prior to being appointed to this senior leadership position at the FDA, Ms. Abram served in the Office of the Secretary at the Department of Health and Human Services (HHS).

Representative Invited

Representative Invited

United States

Session Chair  Invited

Session Chair Invited

Manager, DIA, United States

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Darby  Kozak, PhD

Darby Kozak, PhD

Lead for Complex Drug Substances and Dosage Forms, OGD, CDER, FDA, United States

Dr. Darby Kozak is Chemist and Team Lead for the Complex Drug Substances and Formulations team in the Division of Therapeutic Performance (DTP), Office of Research and Standards (ORS), Office of Generic Drugs (OGD). His specialization is in the analysis and equivalence evaluation of complex parenteral, ophthalmic, and otic drug products and formulations that incorporate nanotechnology. Prior to joining the FDA in 2015, Dr. Kozak was the Chief Scientist for Izon Science, a Research Fellow at the Australian Institute for Bioengineering and Nanotechnology, Lecturer at the University of Queensland, and Visiting Fellow at the Fred Hutchinson Cancer Research Center.

Andrew A. LeBoeuf, JD, MS

Andrew A. LeBoeuf, JD, MS

Associate Director Regulatory Policy, ONDP, OND, CDER, FDA, United States

Markham  Luke, MD, PhD

Markham Luke, MD, PhD

Director for Therapeutic Performance, Office of Generic Drugs, CDER, FDA, United States

Markham C. Luke, MD, PhD is the Director of the Division of Therapeutic Performance (DTP) in the Office of Research and Standards, Office of Generic Drugs. DTP 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 research interests in dermatopharmacology, clinical pharmacology, clinical study design and endpoints assessment (including patient-reported outcomes) for medical, surgical, and aesthetic products and serves as consultant dermatologist to various parts of FDA.

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

Sam G. Raney, PhD, MS

Sam G. Raney, PhD, MS

Associate Director for Science, ORS, Office of Generic Drugs, CDER, FDA, United States

Dr. Sam Raney is a thought leader in topical and transdermal drug products, with over 30 years of experience in skin research, producing numerous research manuscripts, review articles, book chapters and patents in pharmaceutical product development. Dr. Raney has been a researcher and adjunct professor within academia, a principal or sub investigator on over 400 pharmaceutical product studies, has held senior management roles in industry, and serves on multiple expert committees and panels for the U.S. Pharmacopeia. He is the Associate Director for Science in the FDA’s Office of Research and Standards, and serves as the Chief Scientific Advisor for topical product bioequivalence issues in FDA’s Office of Generic Drugs.

Susan  Rosencrance, PhD

Susan Rosencrance, PhD

Acting Director, Office of Generic Drugs, CDER, FDA, United States

Susan Rosencrance, Ph.D., serves as the Acting Director of the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER). From 2015 to 2022, Dr. Rosencrance served as the Director of the Office of Lifecycle Drug Products within CDER’s Office of Pharmaceutical Quality (OPQ). She joined FDA in 1991, and served in various senior roles within OGD and as the Deputy Director for Generic Drug Chemistry in CDER’s former Office of Pharmaceutical Science. Before joining FDA, Dr. Rosencrance worked in R&D at Merck & Co. She holds a Ph.D. in chemistry from American University in Washington, D.C., and completed her dissertation research at the NIH Laboratory of Biophysical Chemistry.

Kimberly A. Witzmann, MD

Kimberly A. Witzmann, MD

Acting Deputy Director, Office of Bioequivalence, Office of Generic Drugs, CDER, FDA, United States

Dr. Kimberly Witzmann is a physician and is currently the Acting Deputy Director for the Office of Bioequivalence (OB) within the Office of Generic Drugs (CDER), at FDA. She is committed to making safe and effective generic drugs available to the American public. Her focus is complex generic drug products, including combination products, and she has been a key member of teams developing guidance documents and product-specific recommendations for FDA. She has spoken nationally at multiple meetings discussing development for complex generic combination products, including orally inhaled and nasal combination drug 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.

Bing  Cai, PhD

Bing Cai, PhD

Division Director, OPQ, CDER , FDA, United States

Dr. Bing Cai is Director of the Division of Liquid-based Drug Products in CDER/OPQ/OLDP at the FDA. In his twenty-year tenure within the FDA, he has been promoted to CDER Senior Review, Team Lead, Chemistry Division Deputy Director and Division Director. He has been involved in the development of several important Agency’s initiatives, including the current ANDA Integrated Quality Assessment process. He has coordinated the implementation of the comprehensive review assessment using the Quality by Design and Risk-based Review concepts for various drug dosage forms to ensure a uniform drug quality program across generic and new drug products.

Intira  Coowanitwong

Intira Coowanitwong

Acting Quality Assessment Lead, OPQ, CDER, FDA, United States

Dr. Intira Coowanitwong is a Senior Chemist and an Application Technical Lead (ATL) in the Division of Modified Release Products (DMR), Office of Life Cycle Drug Products (OLDP), FDA. As ATL, her primary responsibility is conducting secondary assessment of a wide array of submissions related to nasal/inhalation, modified release, and injectable ANDAs. Dr. Coowanitwong completed her post-doctoral training at University of Maryland. At Chrysalis Technologies, she worked on development and characterization of novel inhalation products. She subsequently joined Next Breath LLC where she led efforts towards evaluation of nasal and inhaled drug formulations for in vitro bioequivalence and CMC evaluation.

Gary  Henniger

Gary Henniger

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

Gary is Chemical Engineer with 39 years of medical device and drug-device combination product development experience with companies such as Teva Pharmaceuticals, Becton Dickinson, Philips Respironics and Pfizer, along with other small medical device and biotechnology companies. He has implemented design control systems within FDA and ISO compliant Quality Management Systems in multiple organizations. He has been with Teva since 2013 and is currently the Sr. R&D Director responsible for device engineering operations for the R&D Combination Product and Device Development organization.

Steven  Hertz, MBA, MS

Steven Hertz, MBA, MS

Consumer Safety Officer, Office of Pharmaceutical Quality, CDER , FDA, United States

Mr. Hertz is an officer in FDA’s Center for Drug Evaluation and Research, Office of Pharmaceutical Quality. He has been with FDA since 2008 and his work is focused on pre-approval process and facility assessment. He is an office subject matter contact for issues regarding computer validation, combination products, control systems, electronic records, bio-pharmaceutical engineering, QbD, PAT, and process validation. He earned his B.S. in chemical engineering from the University of Virginia, his M.S. in biotechnology and his M.B.A. from Johns Hopkins University, and is a licensed Professional Engineer in the state of Maryland.

Anthony  Hickey

Anthony Hickey

Distinguished Fellow, RTI International, United States

Anthony J. Hickey, PhD, DSc is Distinguished RTI Fellow, at the Research Triangle Institute, Emeritus Professor of Molecular Pharmaceutics of the Eshelman School of Pharmacy, and Adjunct Professor Biomedical Engineering in the School of Medicine, at the University of North Carolina at Chapel Hill. He is a Fellow of the Royal Society of Biology, AAPS, AAAS and the Royal Society of Medicine. Among other awards he received the David J W Grant Award in Physical Pharmacy of the AAPS and the Thomas T Mercer Joint Prize for Excellence in Inhaled Medicines and Pharmaceutical Aerosols of AAAR and ISAM.

Robert A. Lionberger, PhD

Robert A. Lionberger, PhD

Director, Office of Research and Standards, Office of Generic Drugs, CDER, FDA, United States

Robert Lionberger, Ph.D. 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 PhD from Princeton University in Chemical Engineering.

Brian  McCormick

Brian McCormick

Vice President - Chief Regulatory Counsel, Teva Pharmaceuticals, United States

Brian McCormick is a Vice President and the Chief Regulatory Counsel for Teva Pharmaceuticals. Brian and his team are the primary contact on regulatory law and policy issues for Teva’s innovative, generic, and biosimilar businesses in the United States. They also manage the global clinical contracting function and represent Teva in various trade associations. Previously, Brian was an Assistant General Counsel at a major research-based biopharmaceutical company and a Partner in the FDA regulatory group of an international firm. Brian earned his law degree from Georgetown and has a master’s degree in health policy from Johns Hopkins and a bachelor’s degree in government from Franklin & Marshall College.

James Jefferis Norman, PhD

James Jefferis Norman, PhD

Senior Chemist, OPF, OPQ, CDER, FDA, United States

James Norman is a senior chemist in FDA’s Office of Process and Facilities. He joined FDA in 2015, where he primarily reviews complex combination products such as transdermal systems, intravaginal rings, and microneeedles. He completed his PhD in Chemical Engineering at Georgia Tech. Prior to joining FDA, he developed vaccine delivery technologies at MIT and the CDC.

Brock  Roughton

Brock Roughton

Acting Quality Assessment Lead, OPQ, CDER, FDA, United States

Brock Roughton is an acting Quality Assessment Lead in the Office of Lifecycle Drug Products in the Center for Drug Evaluation and Research at FDA. Brock is a member of the FDA Transdermal Working Group and is involved with quality assessment of transdermal drug products. He holds a PhD degree in bioengineering and bachelor's degree in chemical engineering.

Alan  Stevens, MS

Alan Stevens, MS

Acting Division Director, Division of Drug Delivery, General Hospital and Human , FDA, United States

Alan Stevens is acting Division Director of FDA's Division of Drug Delivery, General Hospital and Human Factors. His division is responsible for regulation of drug delivery and general hospital device premarket submissions and postmarket safety and compliance. The division also provides evaluation of human factors information. Prior to his current assignment, he was the Assistant Director for the CDRH Injection Devices Team and spent ten years as a premarket reviewer and three years as a compliance officer in CDRH. He has a masters degree in reliability engineering and undgraduate degree in mechanical engineering from the University of Maryland.

Audra L. Stinchcomb, PhD

Audra L. Stinchcomb, PhD

Professor, University of Maryland, United States

Dr. Stinchcomb is Professor of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, and founded AllTranz Inc. (now Zynerba), a transdermal cannabinoid pharmaceutical company. She is currently the Chief Scientific Officer and Co-Founder of F6 Pharma Inc., a palliative care product company. She received her Bachelor's in Pharmacy from the University of Colorado, and a PhD in Pharmaceutics from the University of Michigan. She completed a postdoctoral fellowship at UCSF. She was a Professor at the University of Kentucky from 2001-11, and joined the faculty at UMB in November 2011. She is a Fellow of the American Association of Pharmaceutical Scientists.

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).

Charles  DiLiberti, MS

Charles DiLiberti, MS

President, Montclair Bioequivalence Services, LLC, United States

Charlie DiLiberti is President of Montclair Bioequivalence Services, LLC, a consulting firm specializing in finding innovative solutions to difficult problems in formulation development, PK, biopharmaceutics, and clinical study design, particularly for difficult/complex drugs. Charlie has over 35 years’ experience in the pharmaceutical industry, including at Barr Labs and Teva Pharm. Charlie has given numerous public presentations in the US and internationally, on a wide variety of topics.

Xiaohui (Jeff)  Jiang

Xiaohui (Jeff) Jiang

Division Deputy Director, Division of Therapeutic Performance, Office of Generic, FDA, United States

Xiaohui Jiang received his Ph.D. in chemistry from the University of California, San Diego. Currently he is the Deputy Director of the Division of Therapeutic Performance in the Office of Research and Standards, under the Office of Generic Drugs. His work at the Agency is focused on the complex generic products in an effort to develop and implement novel scientific approaches in the evaluation of active ingredient sameness, pharmaceutical equivalence and bioequivalence. Prior joining FDA, Dr. Jiang worked in biopharmaceutical industry and government agencies.

Denise  Conti, PhD, MSc

Denise Conti, PhD, MSc

Senior Staff Fellow, Division of Therapeutic Performance, ORS, OGD, CDER, FDA, United States

Denise Conti, Ph.D., is a Chemical Engineer in the Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs Dr. Conti’s specialization is drug products in the nasal and oral inhalation drug delivery area. In her current role, Dr. Conti is responsible for the development of product-specific guidances for generic drug development, reviewing and responding to controlled correspondences, pre-ANDA meeting requests, citizen petitions and internal consults. Dr. Conti is also the project officer on multiple regulatory science research initiatives related to nasal and oral inhalation drug products, under the GDUFA regulatory science research program.

Kris  Andre

Kris Andre

Regulatory Affairs Advisor, Office of Generic Drug Policy, CDER, FDA, United States

Kris Andre is an Associate Director of Regulatory Affairs and works in the Office of Research and Standards within OGD. Before joining the FDA, Kris was in private industry in the biotechnology field for 17 years and worked for several small companies during that time. At the FDA, Kris is heavily involved in implementing the pre-ANDA complex generic drug program under GDUFA II. She received her Master of Science from Virginia Polytechnic Institute and State University.

Guenther  Hochhaus, PhD

Guenther Hochhaus, PhD

Professor, University of Florida, United States

Dr. Hochhaus received his Ph.D. in 1984 at the Institute of Pharmaceutical Chemistry, Westf. Wilhems University (Münster, Germany). He completed a postdoctoral fellowship at the University of California-San Francisco and subsequently joined the University of Florida’s College of Pharmacy as an Assistant Professor in 1987, where he continues to serve today as a Professor of Pharmaceutics. Dr. Hochhaus’ research is interested in evaluating inhalation drugs through in vitro and pharmacokinetic approaches. He collaborates with regulatory authorities to improve methodology for drug approval of generic inhalation drugs. Dr. Hochhaus is a Fellow of AAPS and the American College of Clinical Pharmacology (ACCP).

Jürgen B. Bulitta, PhD

Jürgen B. Bulitta, PhD

Professor, Department of Pharmacotherapy and Translational Research, UF College , University of Florida, United States

Jürgen Bulitta, PhD, is a Professor in the Department of Pharmacotherapy and Translational Research at the UF College of Pharmacy. He is the Perry E. Foote Eminent Scholar Chair and supported by the University of Florida’s preeminence program in Drug Discovery and Development. Dr. Bulitta’s translational research focuses on the pharmacokinetics and bioequivalence of inhaled corticosteroids as well as on developing novel strategies of how to combat multidrug-resistant bacterial and viral ‘superbugs’.

Jason D. Rodriguez, PhD

Jason D. Rodriguez, PhD

Division Director, CDER/OPQ/OTR/Division of Complex Drug Analysis, FDA, United States

Jason Rodriguez is a Laboratory Chief for Branch I at the FDA Division of Pharmaceutical Analysis in St. Louis, MO. He has a Ph.D. in Chemistry from the University of Illinois Urbana-Champaign. As a Laboratory Chief at DPA, he leads a team of analysts that works on pharmaceutical science and research projects including dissolution, chromatography, inhalation, transdermal and mass spectrometry. Dr. Rodriguez also has extensive experience in rapid spectroscopic screening techniques using Raman and near infrared technologies. The work of his team has spanned the areas of improving raw material (excipient) identification, counterfeit medicine detection and screening of stockpiled medical countermeasures.

Carol  Kim

Carol Kim

Acting Team Lead, Division of Clinical Review,Office of Bioequivalence,OGD, CDER, FDA, United States

Dr. Carol Kim is an acting team leader in the ANDA team in the Division of Clinical Review in the Office of Bioequivalence in OGD. Her area of expertise is in bioequivalence analysis of ANDAs and in the review of clinical endpoint bioequivalence study for applications of locally acting generic drug products for which standard pharmacokinetic studies are not appropriate for evaluating bioequivalence. She received her Pharm.D. degree at Howard University College of Pharmacy and Pharmacal Sciences in Washington DC.

Sarah  Yim, MD

Sarah Yim, MD

Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER, FDA, United States

Sarah Yim, M.D. has been the Director of the Office of Therapeutic Biologics and Biosimilars, in CDER's Office of New Drugs (OND), FDA since 2019. Prior to that, she spent 2 years as Director of the Division of Clinical Review in the Office of Generic Drugs, and 11 years in various roles in rheumatology drug review in OND. She received her undergraduate degree from Stanford University, her Doctor of Medicine degree from the Uniformed Services University of Health Sciences, and completed a postdoctoral fellowship in rheumatology at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), at the National Institutes of Health.