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DIA/FDA Complex Generic Drug-Device Combination Products Conference

This event is now offered in a new entirely virtual format.


Speakers

  • 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.

  • Karen  Feibus, DrMed, MD

    Karen Feibus, DrMed, MD

    • Lead Medical Officer, CSSS, Office of Generic Drugs, CDER
    • FDA, United States

    I practiced obstetrics and gynecology for 9 years before joining FDA as a medical officer (MO). I worked in the Office of Nonprescription Products for 3 years and then served as Lead MO of OND's Maternal Health Team for 5 years. I joined the Veterans Administration as the Office of Women's Health Services' Deputy Director of Reproductive Health. I returned to FDA in October 2014 as a clinical reviewer in the Office of Generic Drugs and joined the Clinical Safety Surveillance Staff in 2017.

  • Shahreen Farah Hussain-Malik, MD, MPH

    Shahreen Farah Hussain-Malik, MD, MPH

    • Medical Officer
    • FDA, United States

    Medical officer in the Division of Clinical Review for 5 years within Office of Generic Drugs.

  • Tu-Van  Lambert, MS, RAC

    Tu-Van Lambert, MS, RAC

    • Project Manager, OGD, IO
    • FDA, United States

  • Rosario  LoBrutto, PhD

    Rosario LoBrutto, PhD

    • Head of Scientific Affairs
    • Sandoz, United States

    Rosario has 25 years of experience in driving R&D, commercial, and operational excellence in development, scale-up and launch preparation of generic/branded products at Merck, Novartis, TEVA and Sandoz. This includes development of APIs/drug products containing small molecules, synthetic polypeptides and proteins and drug-device combination products. Currently at Sandoz he is Head of Scientific Affairs responsible for external partnership product development and oversees due diligence evaluating CMC/bio-analytical aspects of new product opportunities amenable to co-development, in-licensing or acquisition. Moreover, he advances pipeline strategy and leads team for identification, evaluation and prioritization of internal/external assets.

  • Mishale  Mistry, PharmD, MPH

    Mishale Mistry, PharmD, MPH

    • Associate Director, DMEPA, CDER
    • FDA, United States

  • Sarah  Mollo, PhD, RAC

    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.

  • James  Wabby, MHS

    James Wabby, MHS

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

    James Wabby is the Executive Director of Regulatory Affairs (Emerging Technologies and Combination Products) at AbbVie in Irvine, California. He has over 20 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.

  • Howard  Chazin, MD, MBA

    Howard Chazin, MD, MBA

    • Director, Clinical Safety Surveillance Staff, Office of Generic Drugs, CDER
    • FDA, United States

    Dr. Chazin joined FDA in 2002 and has held several mid-level and senior leadership positions related to clinical safety of new drugs, generic drugs and biologic drug products. Since 2016, he has been the Director of the Clinical Safety Surveillance Staff in the Center for Drug Evaluation and Research's Office of Generic Drugs. He leads a multidisciplinary team of physicians, pharmacists and data analysts tasked with identifying and assessing emerging complex safety issues related to potentially inferior generic drug products. As Director, he also provides oversight on assessment of critical aspects related to challenging, controversial and sensitive generic drug safety issues.

  • William  Chong, MD

    William Chong, MD

    • Associate Director for Clinical Affairs, Office of Generic Drugs, CDER
    • FDA, United States

    Dr. William Chong is an Internist and Endocrinologist who has worked at FDA since 2012. He is currently the Associate Director for Clinical Affairs in the Office of Generic Drugs and lends support to the generic drugs program across an array of activities in order to provide safe, effective, and high quality generic drugs.

  • 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.

  • Andrew  Fine, PharmD

    Andrew Fine, PharmD

    • Clinical Team Leader, Office of Generic Drugs
    • FDA, United States

    Commander Fine is a clinical team leader in the Office of Generic Drug ‘s Division of Clinical Review, where he’s served since 2014. As team leader, Commander Fine leads a team of physicians and provides clinical and regulatory oversight for ANDA and pre-ANDA activities. He earned his PharmD from the University of Illinois and completed a pharmacy practice residency at Northwestern University. Andrew is board certified in pharmacotherapy and earned a certificate in pharmacoepidemiology from the University of Pennsylvania. Prior to joining OGD, CDR Fine spent 4.5 years as a safety reviewer in CDER’s Office of Surveillance and Epidemiology, Division of Pharmacovigilance where he led safety efforts for Multiple Sclerosis drug products.

  • Susan  Levine, JD

    Susan Levine, JD

    • Deputy Director, Division of Policy Development, OGD, CDER
    • FDA, United States

    Ms. Levine currently serves as the Deputy Director of the Division of Policy Development in the Office of Generic Drug Policy where she leads development and implementation of policies for the generic drug program. Prior to this role, she was a Regulatory Counsel in the Office of Generic Drug Policy’s Division of Legal and Regulatory Support where she resolved application-specific regulatory issues. She began her FDA career as a Review Chemist in the Office of Generic Drugs where she reviewed abbreviated new drug applications with a variety of dosage forms including topicals, injectables, ophthalmics, otics, and immediate release tablets.

  • Patricia  Love, MD, MBA

    Patricia Love, MD, MBA

    • Deputy Director, Office of Combination Products, OCPP, OC
    • FDA, United States

    As Deputy Director of the Office of Combination Products since 2003 Dr. Love leads the development of combination product initiatives for premarket review and post market regulation. Previously from 1993-2003, Dr. Love served as Director, Division of Medical Imaging and Radiopharmaceutical Products. She joined FDA in 1988 and has a range of FDA review and leadership experience in therapeutic, diagnostic, and combination product areas. Dr. Love is an internist with rheumatology, and allergy-immunology academic and clinical practice experience.

  • 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.

  • Bhagwant  Rege, PhD

    Bhagwant Rege, PhD

    • Director, Division of Immediate and Modified Release Products III, OLDP,OPQ, CDE
    • FDA, United States

    Dr. Bhagwant Rege is the Division Director for the Division of Immediate and Modified Release Products III in CDER/OPQ/OLDP at the FDA. Prior to joining FDA in 2010, he worked at Merck & Co. for about 9 years in oral biopharmaceutics and formulation development groups. His division at FDA is responsible for collaborative evaluation and assessment of Abbreviated New Drug Applications (ANDAs) for immediate and modified release oral drug products, transdermal and topical systems, intravaginal and intrauterine systems, subcutaneous implants, and inhalation (MDI/DPI) drug products and making risk-informed recommendations on their approvability.

  • 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.

  • 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.

  • Rumi  Young, MS

    Rumi Young, MS

    • Acting Team Lead, Combination Products
    • FDA, United States

    Rumi Young is currently the Acting Injection Team leader at FDA’s Division of Drug Delivery, General Hospital and Human Factors. Rumi’s team is responsible for the evaluation of drug delivery injection devices and combination products such as syringes, auto-injectors, pen injectors and on-body injectors. Rumi joined FDA in 2018 after 8 years of combination product development in the pharmaceutical industry. Rumi received both her Masters of Engineering in Material Science and Bachelors of Arts in Chemistry from Cornell University.

  • Roisin  Wallace

    Roisin Wallace

    • Vice President, Head of Global Device Development
    • Mylan, Ireland

    Róisín Wallace is Head of Global Device Development at Mylan. She graduated with a BSc. in Analytical Science (Chemistry) from DCU, Ireland & subsequently joined Pfizer in the UK. holding roles in Analytical R&D, a leading role establishing a new Pharmaceutical Sciences org. in India & Pfizer’s Devices Centre of Emphasis. Róisín joined Mylan’s Global Respiratory Group in the UK in 2011 to lead its Device Development Group and she moved home to Dublin, Ireland in 2012 to establish & lead a new R&D Pilot Plant. In 2016 Róisín took on a new role as Head of Global Device Development, leading a group responsible for design, development & commercialisation of device technology solutions to enable delivery of Mylan’s generic & branded products.

  • Karthik  Balasubramanian, PhD, MS

    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.

  • 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.

  • Yan  Wang, PhD

    Yan Wang, PhD

    • Acting Team Lead, Division of Therapeutic Performance, ORS, OGD, CDER
    • FDA, United States

    Dr. Yan Wang obtained her Ph.D. in Pharmaceutical Sciences from the University of Connecticut. She joined the FDA in 2014 and is currently the acting team lead for complex drug substances & formulations team in the Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, FDA. She is primarily involved in developing product specific guidances, addressing controlled correspondences and pre-ANDA meeting requests, managing research projects , and providing technical support for ANDA reviews in the areas of complex formulations including long acting injectable and implantable drugs, ophthalmic and otic drugs, as well as drugs containing nanotechnology.

  • Robert  Berendt, PhD

    Robert Berendt, PhD

    • Branch Chief, Division of Immediate & Modified Release Products III, OLDP, OPQ,
    • FDA, United States

    Dr. Robert Berendt is a branch chief in the Office of Lifecycle Drug Products (OLDP) within the Office of Pharmaceutical Quality, where he oversees quality assessment of modified-release drug products, including transdermal and topical delivery systems, vaginal systems (rings), and intrauterine systems. Previously, he supported regulatory review and policy activities as a pharmaceutical scientist in the FDA laboratories. He earned his doctorate in pharmaceutical chemistry from the University of Kansas, specializing in characterization of pharmaceutically relevant systems using solid-state NMR spectroscopy. He is a member of the CDER Transdermal Working Group and the CDER Excipient Working Group.

  • Changning  Guo, PhD

    Changning Guo, PhD

    • Research Chemist, Division of Complex Drug Analysis, OPQ, OTR, CDER
    • FDA, United States

    Dr. Guo is a research chemist at FDA/CDER/OPQ/OTR. He has been with FDA for 16 years and currently work in the Division of Complex Drug Analysis (DCDA) at Saint Louis, MO. His research at FDA focus on inhalation drug characterization, particle sizing, X-ray powder diffraction (XRPD), and spectroscopy. He has been a PI/co-PI on multiple FDA research projects, serving as a member in several FDA working groups, guidance teams, subject-matter expert panels, and grants review committees.

  • Sam G. Raney, PhD, MS

    Sam G. Raney, PhD, MS

    • Lead for Topical and Transdermal Drug Products, Office of Generic Drugs, CDER
    • FDA, United States

    Dr. Sam Raney is a thought leader in topical and transdermal drug products, with over 25 years of experience as an academic researcher, an adjunct professor, and a principal or sub investigator on over 400 studies. He has authored numerous research manuscripts, review articles, book chapters and patents related to pharmaceutical product development, lectured globally, and held senior management roles in industry. He is the Lead for Topical and Transdermal Drug Products in the FDA Office of Generic Drugs, and is an expert panel member in the U.S. Pharmacopeia. Dr. Raney holds a B.A. in Molecular Biophysics & Biochemistry from Yale University, and a Ph.D. in Biochemistry & Molecular Biology from the University of British Columbia in Canada.

  • Robin M. Weinick, PhD

    Robin M. Weinick, PhD

    • SVP/Managing Director Americas and Global Program Officer
    • DIA, 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.

  • 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.

  • Mark  DeStefano

    Mark DeStefano

    • Director: Combination Products and Device R&D
    • Teva Pharmaceuticals, United States

    Mr. Mark DeStefano is Director, Combination Products and Devices Research and Development for Teva Pharmaceuticals focusing on advanced technology identification and development for Teva pipeline products. He is an experienced Device Development Professional with a demonstrated 30+yr history of product innovation, design, development, and launch in many areas of the medical device industry. Mr. DeStefano holds a Bachelor of Science in Mechanical Engineering from Drexel University.

  • Megan  Kelchen, PhD

    Megan Kelchen, PhD

    • Reviewer (Chemist), OGD, ORS, CDER
    • FDA, United States

    Megan Kelchen, Ph.D., is a chemist in the Division of Therapeutic Performance. Her specialization is drug products for topical, transdermal, and mucosal drug delivery. Dr. Kelchen is responsible for the development of product-specific guidances for generic drug development, reviewing and responding to controlled correspondences, citizens petitions, and Pre-ANDA meeting requests. Dr. Kelchen is also engaged in regulatory science research initiatives related to complex generics under the GDUFA regulatory science research program. Prior to joining FDA, Dr. Kelchen received her B.A. degree from Wartburg College in Biology and her Ph.D. in Clinical Pharmaceutical Sciences from the University of Iowa.

  • Bryan  Newman, PhD

    Bryan Newman, PhD

    • Pharmacologist, Office of Generic Drugs, CDER
    • FDA, United States

    Bryan Newman, Ph.D., is a pharmacologist and acting team lead for inhalation and nasal drug products in the Division of Therapeutic Performance (DTP), Office of Research and Standards (ORS), under the Office of Generic Drugs (OGD). Dr. Newman’s work focuses on developing product-specific guidances, and addressing controlled correspondences, citizen petitions, consults, and Pre-ANDA meeting requests. He also serves as a project officer and contracting officer’s representative for regulatory science research initiatives related to inhalation and nasal drug products. Dr. Newman received his B.S. degree from Louisiana State University in Biochemistry and his M.S. and Ph.D. degrees from the University of Michigan in Pharmaceutical Science.

  • 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.

  • Yubing  Tang, PhD

    Yubing Tang, PhD

    • Chemist, CDER
    • FDA, United States

    Yubing Tang, Ph.D. is a Branch Chief in FDA's Office of Pharmaceutical Manufacturing Assessment, CDER/OPQ. Yubing joined the FDA as a CMC reviewer in 2006. During her tenure in the FDA, she has reviewed numerous NDAs, INDs, ANDAs and supplemental applications covering various dosage forms. Since 2015 after joining Office of Pharmaceutical Manufacturing Assessment, her focus has moved to assess manufacturing processes and facilities of pharmaceutical manufacturing. Prior to joining the FDA, Yubing has worked for 10 plus years in pharmaceutical industry in the areas of Research and Development, Technical Operations, and Quality Operations. Yubing holds a doctoral degree in Chemistry.

  • Royce  Brockett, MBA

    Royce Brockett, MBA

    • Director of Product Management, Prefilled Systems and Delivery
    • West Pharmaceuticals, United States

    Royce Brockett has 17 years of experience working in the pharmaceutical industry with a focus in sales and marketing. He is currently the Director of Prefilled Systems & Delivery at West Pharmaceutical Services, Inc. His responsibilities include supporting business development efforts, defining new products, and executing marketing strategies including product launches. Royce has published articles related to sterilization techniques for elastomer components, particle reduction strategies, and cartridge technology. Royce holds a BS in biochemistry from Lehigh University and an MBA in Health Sector Management from Boston University.

  • Farnoosh  Fazlollahi, PhD

    Farnoosh Fazlollahi, PhD

    • Product Quality Assessor, FDA-CDER-OPQ-OLDP
    • FDA, United States

    Dr. Farnoosh Fazlollahi is currently Product Quality Assessor in Division of Liquid Based Products in Office of Lifecycle Drug Products in Office of Pharmaceutical Quality. As Product Quality Assessor, she is responsible for the scientific and regulatory evaluation of drug product quality aspects, pertaining to generic drug products (ANDAs and Pre-ANDAs). Prior to joining the FDA in 2014, Dr. Fazlollahi worked as a Formulation Development Scientist at Avrio Biopharmaceutical and as a Pharmaceutical Development Postdoctoral Fellow at Allergan Pharmaceuticals. She authored several peer-reviewed papers and a book chapter. Dr. Fazlollahi graduated from the University of Southern California with Ph.D. in Chemical Engineering.

  • Monica  Garcia, PhD

    Monica Garcia, PhD

    • Acting Assistant Director, Division of Reproductive, Gynecology, and Urology
    • FDA, United States

    Monica Garcia is a Biomedical Engineer in the Obstetrical and Reproductive Health Devices Team (THT3B1) in CDRH/OPEQ/OHT3/DHT3B. She has been acting as the Assistant Director in THT3B1 since September, 2019. 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. Monica has expertise in adhesion barriers, transvaginal mesh, combination products, and other obstetrical and reproductive health products. Monica has participated in working groups/activities associated with combination products, assisted reproduction technology, and fetal monitoring.

  • Jung  Lee, MPH, RPh

    Jung Lee, MPH, RPh

    • Safety Officer, Clinical Safety Surveillance Staff, OGD, CDER
    • FDA, United States

    Jung Lee has a BS in Pharmacy from University of Maryland, Baltimore and an MPH degree from Johns Hopkins. She joined FDA in 2014 as a reviewer for the Safety Team at the Division of Clinical Review in the Office of Generic Drugs (OGD). Since 2015, she has worked as a Safety Officer conducting surveillance of generic drugs in the Data Team at the Clinical Safety Surveillance Staff in the OGD.

  • Saleh  Rifaat

    Saleh Rifaat

    • Senior Director, R&D
    • Teva Pharmaceuticals, United States

    Saleh Rifaat is a Senior Director, R&D at Teva Pharmaceuticals where he currently leads formulation and process engineering groups. After initially working for 5 years in the medical device industry, Saleh has been working in the pharmaceutical industry for over 25 years. He has been involved in the development and approval of multiple pharmaceutical products.

  • John Barlow Weiner, JD

    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 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).

  • Meenal  Chavan, PhD

    Meenal Chavan, PhD

    • Chemist, OLDP, OPQ, CDER
    • FDA, United States

    Meenal Chavan, Ph.D. is drug product reviewer in DIMRP-III, within OLDP/OPQ/CDER/FDA. She reviews ANDAs, Pre-ANDAs and DMFs including ANDA submissions of complex dosage forms such as Transdermal drug delivery systems, Modified & Immediate release solid oral formulations, Implants & Intra-Vaginal ring. She is a member of Transdermal working group and development of New Inspection Protocol Program (NIPP). Dr. Chavan joined FDA in 2016. Prior to that, she worked as a Sr. Manager R&D at Sun Pharma, NJ. She has 20 years of complex product R&D experience. She works on Developmental Technical Committee of PQRI to promote advancements in drug product development. She received her Ph.D. in Pharmaceutical Sciences from University of Mumbai, India.

  • Jennifer  Hammer, MD

    Jennifer Hammer, MD

    • Physician
    • FDA, United States

  • Brendan C Muldoon, PhD

    Brendan C Muldoon, PhD

    • Senior Director, Generics R&D
    • Teva Pharmaceuticals, Ireland

    I am Queens University Belfast chemistry graduate. I also hold a PhD in Drug Delivery from Queens School of Pharmacy. I have been working in the pharmaceutical industry for 20 years with all my experience in R&D. My career started in formulation development and I have held roles with increasing responsibility. I have worked on a number of mergers and acquisitions which has provided exposure to multiple companies Quality Management Systems and development strategies. Currently I’m a senior director of R&D and managing director for TEVA NI Limited.

  • Millie B. Shah, PharmD

    Millie B. Shah, PharmD

    • Human Factors Team Leader, DMEPA, OSE, CDER
    • FDA, United States

    Millie Shah joined the Division of Medication Error Prevention and Analysis (DMEPA) as a Safety Evaluator in in 2014. In her current role as Human Factors Team Leader, Millie is responsible for evaluation of human factors-related submissions for combination products. Prior to joining DMEPA, Millie completed the FDA/ISMP Safe Medication Management Fellowship, where she gained valuable experience focused on medication error prevention and safe medication use. Millie received her Doctor of Pharmacy degree from Drake University in Des Moines, IA. She completed her PGY-1 Pharmacy Practice Residency at Edward Hines, Jr. VA Hospital.

  • Michael  Kimball, MS

    Michael Kimball, MS

    • Vice President, Generics R&D
    • Teva Pharmaceuticals, United States

    Michael Kimball is Vice President of R&D for Teva Pharmaceutical Industries. He has over 25 years of experience in pharmaceutical product formulation, development and manufacturing, involving various dosage forms. He is the inventor on several patents related to transdermal drug delivery and is the author of a book chapter on the scale-up of topical products. Michael has been an invited speaker at GPhA, PQRI, ISPE, and other industry conferences. Michael holds a Bachelor of Science degree in Mechanical Engineering from the University of Utah and a Master of Science degree in Mechanical Engineering from the University of California, Berkeley, where he attended as a Fellow of Tau Beta Pi, the national Engineering Honor Society.

  • Kimberly  Peters, MS

    Kimberly Peters, MS

    • Biomedical Engineer/Senior Policy Advisor
    • FDA/CDER/OPQ/OPPQ, United States

    Kimberly Peters is a Biomedical Engineer and Senior Policy Advisor for combination product issues in the Office of Policy for Pharmaceutical Quality (OPPQ), which is part of the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER). Prior to joining CDER in 2016, Kimberly spent 25 years in the Office of Device Evaluation (ODE) in FDA's Center for Devices and Radiological Health (CDRH), serving as an expert biomedical engineer and lead scientific reviewer mainly in the Interventional Cardiology Devices Branch in the Division of Cardiovascular Devices. Kimberly received her MS degree from Johns Hopkins University and her BS degree from Catholic University, both in Biomedical Engineering.

  • Jianxin (Jason)  Yang, PhD

    Jianxin (Jason) Yang, PhD

    • Chemist/Quality Assessor, Office of Life Cycle Drug Products, OPQ, CDER
    • FDA, United States

  • Karyn L. Berry, MD, MPH

    Karyn L. Berry, MD, MPH

    • Medical Officer, Division of Clinical Review, Office of Bioequivalence, OGD
    • FDA, United States

  • Kuljit  Bhatia, PhD

    Kuljit Bhatia, PhD

    • Head of Global Dermatologics R&D and Scientific Affairs
    • Mylan, United States

    Dr. Kuljit Bhatia is currently Head of Global Dermatologics R&D and Scientific Affairs at Mylan. He has been part of pharmaceutical industry R&D for 23 years and with 10 of those years in senior management capacity. Dr. Bhatia’s areas of expertise include semi-solid/liquid, transdermal, nasal, aerosol, oral solid and SVP drug development. Throughout his career, he has been part of > 40 ANDA/NDA applications to FDA. He has contributed towards dozen book chapters/papers in peer-reviewed journals. Dr. Bhatia completed his doctorate in Pharmaceutical Science from North Dakota State University and was Visiting Research Investigator at University of Michigan with Dr. Gordon Flynn.

  • Diane  Burgess, PhD

    Diane Burgess, PhD

    • Board of Trustees Distinguished Professor of Pharmaceutics
    • University of Connecticut Department of Pharmaceutical Sciences , United States

    Pfizer Distinguished Chair in Pharmaceutical Technology. B.Sc. Pharmacy, Univ. of Strathclyde (1979), Ph.D. Pharmaceutics, Univ. of London (1984). Fellow of AAPS, CRS, APSTJ, & AIMBE. 2010 CRS President; 2002 AAPS President. Editor of International Journal of Pharmaceutics (2009 – 2018). Editorial board member of 13 international journals. Recipient of: 2018 AAPS Wurster Award in Pharmaceutics; 2014 AAPS Research Achievement Award; 2014 AAPS Outstanding Educator Award; 2014 CRS Distinguished Service Award; 2013 AAPS IPEC Ralph Shangraw Award; 2010 CRSI Fellowship, 2011 APSTJ Nagai International Woman Scientist Award. Over 220 refereed publications, over 635 research presentations, over 305 invited presentations (24 keynote & plenary).

  • 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. Dr. Hochhaus’ research is interested in evaluating inhalation drugs through in vitro and pharmacokinetic/dynamic approaches, both in animal models, healthy subjects and patients. He evaluated drug, formulation and device factors important for pulmonary targeting and is interested in designing strategies for developing inhalation drugs with high pulmonary

  • Samir R. Patel, JD

    Samir R. Patel, JD

    • Associate General Counsel, Global IP
    • Mylan, United States

    Samir Patel leads the Global IP team at Mylan. Samir has more than 23 years of IP experience beginning in law firms in New York and then as an in-house counsel at bioMerieux, Medtronic and now Mylan. Samir joined Mylan in August 2013 and he and his team are responsible for counseling cross-functional partners at Mylan on IP risk for Mylan's products as well as developing IP procurement strategies for Mylan's innovative products.

  • 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.

  • Elizabeth  Bielski, PhD

    Elizabeth Bielski, PhD

    • Pharmacologist, DTP, ORS, OGD
    • FDA, United States

    Elizabeth Bielski, PhD currently serves as Chemist working at Division of Therapeutic Performance (DTP), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center of Drug Evaluation and Research (CDER) at the FDA starting in January 2020. Her areas of expertise involve generic drug development for orally inhaled, nasal, and drug-device combination products. Specifically, she has focused on issues including formulation, device, formulation-device interactions, user interface, and other bioequivalence issues affecting substitutability of a generic product in reference to the brand-name product.

  • 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’.

  • Bruce  Frank, PhD

    Bruce Frank, PhD

    • Vice President, Operations and Client Services
    • Lubrizol, United States

    After earning a PhD in Organic Chemistry from the University of Maryland, I spent the first 10 years of my career in nucleic acid chemistry and human therapeutics with both large companies (Dupont Merck) and small biotechs (Hybridon, Valigen/Kimeragen). After 5 years in Agricultural Crop Protection with FMC running Discovery Chemistry to support development of safer and more effective fungicides and insecticides, I returned to the pharma industry as part of Particle Sciences, Inc. (now part of Lubrizol, Inc.) to focus on the development and manufacturing of pharmaceutical formulations for our broad base of clients.

  • Irene Z. Chan, PharmD

    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.

  • Priyanka  Ghosh, PhD, MS

    Priyanka Ghosh, PhD, MS

    • Pharmacologist, Division of Therapeutic Performance, Office of Generic Drugs, CD
    • FDA, United States

    Dr. Priyanka Ghosh is a pharmacologist within the Office of Generic Drugs, US FDA. Her specialization is drug products in the topical and transdermal drug delivery area. In her current role, Dr. Ghosh is responsible for the development of regulatory standards for complex generic dosage forms. Prior to joining the FDA, Dr. Ghosh completed her B.Tech in Biotechnology from West Bengal University of Technology (India) and a Ph.D. in Pharmaceutics and Drug design from the University of Kentucky. Dr. Ghosh is also the author on numerous research manuscripts and review articles in the topical and transdermal area.

  • Kaushalkumar  Dave, PhD, MPharm

    Kaushalkumar Dave, PhD, MPharm

    • Biopharmaceutics Reviewer, Office of New Drug Products
    • FDA, United States

    Kaushal is currently a Biopharmaceutics Reviewer at the Office of New Drug Products within the Office of Pharmaceutical Quality at the FDA. He received his Ph.D. in Pharmaceutical Sciences from the South Dakota State University, USA, and Master of Pharmacy from the Rajeev Gandhi University of Health Sciences, India. He has worked on dermal product development and drug delivery research for more than a decade. His research work has led to several publications, research presentations, awards, and a patent with licensing of the technology to a company. Besides spending time with his wife, daughter and friends, Kaushal enjoys running, biking, and skate-boarding.