Navigating the Transition to Low Global Warming Potential Propellants

The workshop will be held at the Universities at Shady Grove (USG).

Address: Ballroom (please follow signs), 9630 Gudelsky Drive Building II, Rockville, MD 20850

• Travel from local airports to Rockville, Md. (The Universities at Shady Grove (USG)) will require an Uber or Lyft, which is by far the best way to obtain car service.
• As there is road traffic in the region, the fastest way to the Shady Grove campus is the DCA airport, then taking the Metro subway from the airport to Shady Grove, then taking Uber or Lyft. Alternatively, fly into any WAS airport and take Uber or Lyft. If flying into BWI airport, we suggest taking Uber or Lyft to USG.
• The Metro subway serves DCA and IAD airports, which connects with the Shady Grove stop on the red line. If flying into IAD, taking the Metro will save some cost, but will probably take extra time, even if traffic is heavy.

More links and information:

• Directions and transportation options to USG
• Public transportation
• Campus map

• The Traville-Gateway Garage is the closest parking garage to the venue (parking map). Attendees may also park in the Shady Grove Garage but will need to allow more walking time to reach the event.
• Visitor Parking: Levels 2-6 of Traville Gateway Garage. PLEASE NOTE: The ground floor of Traville Gateway Garage requires a USG employee permit at all times.
• Guests are responsible for the cost of parking; parking will not be validated. Parking is $15 for all day.

Click for parking information from the USG website.

Please click on the following “all transportation options” links to find transportation from the airport via subway, bus, taxi, car, and town car.

• Reagan National Airport (DCA): 21.1 miles from Rockville, Md. (all transportation options from DCA) (train options from DCA)
• Dulles International Airport (IAD): 27.8 miles from Rockville, Md. (all transportation options from IAD) (train options from IAD)
• Baltimore/Washington International Thurgood Marshall Airport (BWI): 37.5 miles from Rockville, Md. (all transportation options from BWI) (train options from BWI)

Train tickets (Omio)

• Washington, DC to Baltimore: Approximately 35 minutes
• Penn Station Marc SB (Baltimore): Approximately 41 miles from campus

Bob’s Limo Service (Email): 301-525-2525

B&B Executive Sedan (Email): 240-533-6262

East Coast Limousine (Email): 301-527-0413 or 240-793-8196

Uber: Baltimore, BWI Airport, Washington, DC, Dulles (IAD) Airport

Guests should mention they are attending a conference at Universities of Shady Grove; most hotels offer discounts.

There are many hotels within a short driving distance to the USG campus including:

• Hilton Garden Inn Rockville-Gaithersburg (book using our reduced rate by Nov. 12, 2024)
  14975 Shady Grove Road, Rockville, MD 20850 (0.6 miles from USG)
  240-507-1800
• Homewood Suites by Hilton Rockville-Gaithersburg
  14975 Shady Grove Road, Rockville, MD 20850 (0.6 miles from USG)
  240-507-1900
• Courtyard by Marriott Rockville
  2500 Research Boulevard, Rockville, MD 20850 (0.9 miles from USG)
  301-670-6700
• Sleep Inn Rockville
  2 Research Ct., Rockville, MD 20850 (1.2 miles from USG)
  301-507-8000
• The Rockville Hotel, a Ramada by Wyndham
  3 Research Ct., Rockville, MD 20850 (1.2 miles from USG)
  301-202-1098
• Spring Hill Suites by Marriott Gaithersburg
  9715 Washingtonian Blvd, Gaithersburg, MD 20878 (1.4 miles from USG)
  301-987-0900
• Sheraton Rockville Hotel
  920 King Farm Blvd, Rockville, MD 20850 (1.4 miles from USG)
  240-912-8200
• Courtyard by Marriott Gaithersburg Washingtonian Center
  204 Boardwalk Place, Gaithersburg, MD 20878 (1.6 miles from USG)
  301-527-9000
• Comfort Inn Shady Grove-Gaithersburg-Rockville
  16216 Frederick Rd., Gaithersburg, MD 20877 (2.2 miles from USG)
  301-330-0023

Senior Physician, DPACC, OII, OND, CDER, FDA

Dr. Aishah Ali completed undergraduate and medical school at Michigan State University, her internal medicine residency training at Thomas Jefferson University Hospital in Philadelphia, and her fellowship at Johns Hopkins School of Medicine in Baltimore. She currently works in the Division of Pulmonology, Allergy, and Critical Care (DPACC), where she works on allergy, pulmonary, and critical care products. She is part of the FDA team working on inhaler propellant switch programs to lower global warming propellants.

CMC Reviewer, DPQA VII, OPQA II, OPQ, CDER, FDA

Dr. Craig Bertha received his B.A. in Chemistry from the University of Maryland, Baltimore County, in 1986 and his M.S. and Ph.D. in Organic Chemistry from the University of Maryland Graduate School at Baltimore in 1989 and 1992, respectively. He was a postdoctoral fellow in the Laboratory of Medicinal Chemistry at the National Institutes of Health under the direction of Kenner Rice, Ph.D. from 1992-1995. Craig then joined the FDA as a reviewer co-located in the Division of Pulmonary and Allergy Drug Products (DPADP) in 1995 and currently serves as a CMC reviewer in OPQ/DPQA II under Nina Ni, supporting both the Division of Pulmonology, Allergy, and Critical Care (DPACC) and the Division of Rheumatology and Transplant Medicine (DRTM). Craig currently serves on the working group revising the 2018 draft quality guidance for MDIs and DPIs, the internal Agency working group for ICH Q3E guidance for extractables/leachables, and several Agency working groups involved in regulatory aspects related to the changing of propellants for MDIs to reduce global warming.

President & Global Chief Scientific Officer, Cipla Ltd.

Mr. Pradeep Bhadauria is President and Global Chief Scientific Officer (CSO) at Cipla, Ltd. In his current role, Mr. Bhadauria leads Cipla’s Global Integrated Product Development (IPD) organization to strengthen the company’s position as an innovation-driven generic, biosimilars, and specialty pharmaceutical organization. Mr. Bhadauria is also a member of the Management Council of Cipla. He joined the organization in February 2020.

Prior to joining Cipla, he served as Chief Scientific Officer and member of the Executive Committee at Amneal Pharmaceutical Inc. Mr. Bhadauria also served as Executive Vice President of Global R&D for Apotex Inc. Before joining Apotex, he served as Vice President of Generic R&D for Allergan/Actavis. Mr. Bhadauria has also held leadership positions with increasing responsibilities with Watson Pharmaceuticals Inc., Sandoz Inc., and Cardinal Health (now Catalent). With more than two decades of experience, Mr. Bhadauria is an industry veteran with expertise in building the industry’s largest pipelines for several leading generic and specialty pharmaceutical companies. Throughout his career, his leadership has resulted in the development and filing of more than 250 products, including numerous first-to-file and first-to-market opportunities. He has deep R&D expertise across nearly all dosage forms and has extensive experience with complex generics, 505(B)2, specialty Biosimilars, and other difficult-to-formulate products.

Mr. Bhadauria holds a Master of Pharmacy (M. Pharm.) from the Birla Institute of Technology in India and a Bachelor of Pharmacy from the Shri G. S. Institute of Technology and Science (SGSITS) at Devi Ahilya University in India. He also holds several patents and has published research in various publications.

Senior Pharmacologist, DTP I, ORS, OCD, CDER, FDA

Dr. Elizabeth Bielski is a Senior Pharmacologist working in the Division of Therapeutic Performance-I (DTP-I), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center of Drug Evaluation and Research (CDER) at the FDA since October 2022. Before her role as a Senior Pharmacologist, she served as a Pharmacologist from October 2020 to October 2022 and as a Chemist from January 2020 to October 2020 within DTP-I. Her expertise includes orally inhaled and nasal drug products (OINDPs) and drug-device combination products (DDCPs). She is actively involved in developing general and product-specific guidances, addressing controlled correspondences, pre-ANDA meeting requests, citizen petitions, internal consults, and collaborating on current research projects to promote generic drug development of OINDPs and DDCPs. Prior to joining the FDA, she served as an ORISE Fellow at FDA within DTP from August 2018 to December 2019. Elizabeth completed her Ph.D. in Chemical Engineering from Wayne State University (Detroit, MI, USA) in July 2018. Her encompassing work was also conducted in the Department of Chemistry at the University of São Paulo (São Paulo, Brazil) and in the Department of Pharmaceutics at Virginia Commonwealth University (Richmond, VA, USA), related to novel drug delivery strategies for treatment of lung cancer and lung metastases. Prior to receiving her doctorate, she received her Bachelor of Science in Biomedical Physics Honors with University Honors in 2011 and her Master of Science in Biomedical Engineering in 2012 from Wayne State University.

Global Senior Director, Product Stewardship & Toxicology, Honeywell

Dr. Mark Boelens is Honeywell’s Global Senior Director of Product Stewardship and Toxicology, ensuring the safety of products and regulatory compliance with horizontal and vertical chemicals legislation in all applicable jurisdictions across the globe.

Prior to joining Honeywell in December 2013, Mark was at Keller & Heckman LLP, a specialized regulatory law firm counseling clients regarding, among other global Greenhouse gas phase-downs. Mark started his professional career back in 1995 at Shell and has been deeply involved in EU and US chemical policy and regulations since 2001. Equipped with profound science and toxicology understanding and in-depth regulatory expertise, he is well-positioned to support pharmaceutical companies transitioning to Low-Global Warming Potential (LGWP) Propellants for use in Metered Dose Inhaler (MDI) applications.

Mark obtained his Master of Science in Chemical Engineering and his Ph.D. in Organic Chemistry from the University of Ghent in Belgium.

Lead Medical Officer, DPACC, OII, OND, CDER, FDA

Dr. Stacy Chin received her medical degree at Georgetown University School of Medicine. She then completed her pediatric residency training at the Children’s National Medical Center in Washington, DC, followed by her fellowship training in Allergy and Immunology at the Duke University Medical Center. She joined the FDA in 2012 and has been a Lead Medical Officer/Clinical Team Leader in her current division since 2018. Dr. Chin’s roles and responsibilities include overseeing clinical development programs for new drugs, including inhalation products, to treat respiratory and allergic conditions.

Acting Lead Physician, DTP I, ORS, OGD, CDER, FDA

Dr. Andrew Clerman is a Lead Physician (acting) in OGD’s Division of Therapeutic Performance I (DTP I) in the Office of Research and Standards. Andrew leads the Drug-Device Combination Product Team in DTPI, overseeing both pre-ANDA interactions with the industry regarding drug-device combination product issues and the GDUFA research activities to support drug-device combination product development. Additionally, Andrew provides clinical subject matter expertise across a range of generic drug development areas. Prior to joining OGD, Andrew was a clinical reviewer in the FDA’s Office of New Drugs. He received his M.D. from George Washington University and his Ph.D. in Molecular Microbiology and Immunology from the University of Maryland, Baltimore. He completed his post-graduate clinical training at the University of Maryland Medical Center/Baltimore Veterans Affairs Medical Center and maintains clinical board certifications in Internal Medicine, Pulmonary Disease, and Critical Care Medicine.

Medicine Development Leader, GlaxoSmithKline Pharmaceuticals (GSK)

Ms. Laura Clow is the Medicine Development Lead for global respiratory products at GSK. She leads R&D teams to develop a number of inhaled medicines for asthma and COPD, including the company’s ambitious program to reduce the environmental impact of metered dose inhalers. She is steering the company as it navigates new global clinical and regulatory pathways and the need to deliver different clinical packages that demonstrate safety and efficacy data alongside sustainable medicine design. She has direct experience of the challenges and the opportunities in clinical trials and how we can work together to encourage sustainable innovation.

Laura joined GSK in 2004, beginning her career in analytical chemistry before moving to lead CMC teams to develop medicines in oncology and respiratory. Subsequently, she joined the leadership team in the Clinical Supply Chain, focusing on optimizing trial operations through comparator supplies. Then, she moved to GSK’s cell and gene therapy group to lead the CMC and supply chain teams to develop the company’s first cell therapies. She is now the MDL for several GSK’s inhaled medicines, focusing on global respiratory disease and reducing GSK’s carbon footprint.

Laura lives in Hertfordshire, UK, and in her spare time, she is a keen runner and volunteers for an animal rescue charity, traveling the world at every opportunity.

Senior Staff Fellow, DIIP, OCP, OTS, CDER, FDA

Dr. Sneha Dhapare currently serves as a Senior Pharmacologist in the Office of Clinical Pharmacology (OCP) in the Center of Drug Evaluation and Research (CDER) at the FDA. In her role, she reviews New Drug Applications (NDAs) and Biologics License Applications (BLAs), including inhalation and nasal products. She provides recommendations for clinical pharmacology programs in investigational new drug (IND) settings, covering all phases of product development. In a previous role, Sneha contributed to the FDA’s Office of Generic Drugs (OGD), where she supported generic drug development by developing product-specific guidances (PSGs) through GDUFA-funded research with the goal of increasing access to affordable and safer inhaled and nasal products.

Sneha has over ten years of research experience in inhalation and nasal drug delivery. She has worked on NIH-supported projects developing novel inhalation devices and formulations and conducted in vitro and in vivo evaluations with a focus on lung delivery. She has authored numerous peer-reviewed manuscripts and abstracts and has served on the editorial boards and as a scientific reviewer for prestigious journals in aerosol science and pharmaceutics. Sneha earned her Bachelor of Pharmacy degree in 2011 from the University of Mumbai, India, her Master of Science in Pharmaceutical Sciences in 2013 from Creighton University, and her Ph.D. in Pharmaceutical Sciences from Virginia Commonwealth University in 2017.

Regulatory Counsel, DPD, OGDP, OGD, CDER, FDA

Dr. Rachael Dippold serves as regulatory counsel in the Office of Generic Drug Policy at the FDA, where she works on legal, regulatory, and policy matters related to generic drugs. Rachael holds a Ph.D. in molecular cell biology from Thomas Jefferson University and a J.D. from the Georgetown University Law Center.

Before joining the FDA, Rachael worked in private practice on patents and intellectual property matters in the pharmaceutical, biologics, gene therapy, biotechnology, and agricultural fields. Prior to her legal career, Rachael was a postdoctoral researcher, focusing mainly on regulating gene expression via transcriptional and post-transcriptional mechanisms in alcoholic liver disease and smooth muscle contractility, respectively.

Assoc. Physician, Div. of Pulmonary and Critical Care Med Faculty, Regulation Program, Therapeutics and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Associate Director, Ethics Service, Brigham and Women’s Hospital, Assistant Professor, Harvard Medical School

Dr. William Feldman is a pulmonologist, intensivist, and health services researcher at Harvard Medical School and Brigham and Women’s Hospital, where he has joint appointments in the Division of Pharmacoepidemiology and Pharmacoeconomics and the Division of Pulmonary and Critical Care Medicine. He completed his undergraduate degree in philosophy at Duke University, his medical degree at the University of California San Francisco, his doctorate in political theory at the University of Oxford, and his master’s in public health at the Harvard TH Chan School of Public Health. He also trained in Internal Medicine and Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital. Dr. Feldman’s research focuses on drug pricing, pharmaceutical policy, and COPD outcomes.

Supervisory Pharmaceutical Scientist, DPQA V, OPQA I, OPQ, CDER, FDA

Mr. Dhaval Gaglani started his FDA career as a Review Chemist in the Office of Generic Drugs (OGD) in 2010, and since then served multiple roles in OGD and OPQ with increasing responsibilities. He currently serves as the Supervisory Pharmaceutical Scientist in the Office of Product Quality Assessment I (OPQA I)/Division of Product Quality Assessment V. His unit is responsible for drug product quality assessment of Abbreviated New Drug Applications (ANDAs) for pre-marketing and post-marketing applications. Dhaval and members of his unit are Subject Matter Experts in quality assessment of Generic Inhalation products (DPIs, MDIs, Nasal Powders, and Soft mist inhalers). In his role, he oversees and provides pre-submission advice on complex generics, including inhalation products through pre-ANDA (Abbreviated New Drug Application) meeting requests and controlled correspondence response. He and his work unit also participate in guidance development, regulatory science research, USP liaison for the Aerosol subcommittee, and working group activities associated with Inhalation products. Prior to joining the FDA in 2010, he spent 12 years in the pharmaceutical industry (both brand and generic) with industrial experience in product development, process development, product scale-up, process validation, and technology transfer. Dhaval earned his master’s degree in Pharmaceutics and Industrial Pharmacy from Long Island University and a bachelor’s degree in pharmacy from the University of Pune, India.

Associate Director, Project and Product Leadership, CMC Regulatory Affairs, AstraZeneca

Ms. Christy Gilbert is an inhalation product expert with over 20 years in the industry. She supported both early and late-stage development of multiple orally inhaled and nasal products through her tenure at Catalent before focusing on MDI product development and characterization at Pearl Therapeutics. Upon AstraZeneca’s acquisition of Pearl Therapeutics, Christy joined CMC Regulatory Affairs and now leads strategic efforts for CMC aspects of clinical trial and marketing applications for inhalation drug products globally. She is co-chairperson of the IPAC-RS Global Regulatory Review and Outreach (GRRO) Working Group for Alternate Propellants, as well as a member of the IPAC-RS GRRO-North America Working Group. Christy received her Bachelor’s degree in Chemistry from North Carolina State University.

Senior Director & Team Lead, Global Regulatory Affairs, GSK

Dr. Poonam Gulati holds a B.Sc. in Pharmacology (University of Strathclyde) and a Ph.D. (University of Glasgow) in Hepatic Drug and Steroid Metabolism), together with an Executive M.B.A. from Judge Business School at the University of Cambridge. She has over 30 years of experience in clinical drug development. Notably, more than 25 years have been at AstraZeneca, where she has held various project and leadership roles across multiple therapy areas (Cardiovascular, Diabetes, Oncology), leading global regulatory submissions to achieve marketing approvals. Most recently, she has served as the Global Regulatory Lead for the Next Generation Propellant program across the inhaled portfolio. Poonam recently joined GSK as a Global Regulatory Lead, Respiratory for the transition of MDI products to LGWP propellants and, therefore has a strong interest in this field.

Supervisory Environmental Policy Analyst, Phasedown Implementation Branch, U.S. Environmental Protection Agency

Mr. Luke Hall-Jordan leads the Phasedown Implementation Branch in the U.S. Environmental Protection Agency’s Stratospheric Protection Division. He leads a diverse team of experienced regulators, domestic and international policy experts, and analysts responsible for U.S. efforts to phase down the production and import of hydrofluorocarbons (HFCs) and ozone-depleting substances (ODS). These efforts include developing and implementing regulations that address HFCs and ODS; allocating annual production, consumption, and application-specific allowances for regulated substances; closely monitoring trade in HFCs and ODS; and coordinating efforts across the U.S. government to detect, deter and prevent illegal trade in HFCs and ODS. Mr. Hall-Jordan has represented the United States on international delegations, including under the Montreal Protocol on Substances that Deplete the Ozone Layer, and was instrumental in the establishment of the U.S. phasedown of HFCs under the American Innovation and Manufacturing (AIM) Act of 2020. He joined EPA in 2004 and has worked on a number of programs to protect public health, the ozone layer, and climate system. Mr. Hall-Jordan earned his Master’s in Public Health from George Washington University and his Bachelor’s in Economics and Environmental Policy from American University.

CMC Regulatory Consultant, Sue Holmes CMC Consulting LLC

Ms. Sue Holmes has over 35 years of experience in the pharmaceutical industry, leading cross-functional teams in product development and regulatory-focused activities. She started her career as an analytical chemist with GSK and quickly moved into the analytical development of inhaled products. Then, in 2001, she moved into CMC Regulatory Affairs, with a continued focus on inhaled products. Sue has experience working on clinical trials and global marketing applications. From 2019 to 2023, she led GSK’s CMC Regulatory Mature Product Respiratory team responsible for the company’s global post-approval change programs for the respiratory portfolio and, initially, for medical devices. Since July 2023, Sue has been working as a CMC Regulatory Consultant and continues to represent GSK in IPAC-RS activities. Within IPAC-RS, Sue was GSK’s board representative for sixteen years. She participated in and/or led various Working Groups and is currently the co-chair of the Global Regulatory Outreach on Alternate Propellants Working Group.

Associate Director, Stakeholder and Global Engagement, OGD, CDER, FDA

Dr. Sarah Ibrahim serves as the Associate Director for Stakeholder and Global Engagement at the Office of Generic Drugs (OGD) within the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). In this role, Dr. Ibrahim formulates strategies to address both current and emerging regulatory challenges related to the global generic drug industry. She founded the OGD Global Affairs Program and the FDA Global Generic Drug Cluster, the first forum to bring together leading regulatory agencies worldwide. Additionally, Dr. Ibrahim initiated the OGD Patient Engagement Program and launched its first Patient Listening Session series. Collaborating with other CDER and FDA offices, she facilitates stakeholder engagement on issues pertaining to the globalization of the generic pharmaceutical supply chain and the harmonization of regulatory standards for generic drugs.

Dr. Ibrahim earned her Ph.D. in Biopharmaceutics/Pharmaceutics from the University of Cincinnati, College of Pharmacy, and holds a B.S. in Pharmacy and Pharmaceutical Sciences from Cairo University, Egypt. She joined the FDA in 2014 as a scientific reviewer in the Office of Pharmaceutical Quality. Before her tenure at the FDA, Dr. Ibrahim accrued extensive experience in the U.S. pharmaceutical industry, focusing on pharmaceutical development. As an assistant professor, she was instrumental in establishing the pharmaceutical sciences department at New Jersey’s second pharmacy school, working alongside the founding faculty.

Senior Director, Inhalation Product Development, Pharmaceutical Technology and Development, AstraZeneca

Ms. Shyamala Ivatury possesses over 23 years of extensive expertise in the development of inhalation drugs, encompassing pMDIs, DPIs, and Inhalation solutions. For the past 11 years, Shyamala has been an integral part of AstraZeneca, focusing on the advancement of the Aerosphere platform and leading regulatory submissions, including Bevespi Aerosphere pMDI, Breztri Aerosphere pMDI, AirSupra Aerosphere pMDI, Symbicort Aerosphere pMDI, and the Next Generation Propellent programs. Shyamala’s career also features pivotal contributions to prominent projects, including Atrovent HFA pMDI, Exubera, Xopenex HFA pMDI, Brovana Inhalation Solution, Lunesta, and Latuda.

Deputy Director, OGD, CDER, FDA

Dr. Darby Kozak is the Deputy Director for the Office of Generic Drugs (OGD) where he serves as a senior agency advisor in the development and implementation of FDA policies and long-range objectives for generic drug scientific programs and activities, including the development of a strategic plan for the Generic Drug Program. Dr. Kozak started his FDA career in April 2015 as a reviewer, team lead, and then deputy division director in OGD’s Office and Research and Standards where he helped develop new analytical methods and equivalence evaluation methodologies for complex generic drug substances and parenteral, ophthalmic, otic, and inhalation formulations. Prior to joining the FDA, Dr. Kozak was Chief Scientist for Izon Science and a Research Fellow at The University of Queensland’s Australian Institute for Bioengineering and Nanotechnology. Dr. Kozak has a B.Sc. in Chemical Engineering from the University of Washington (Seattle, WA) and a Ph.D. in Chemistry from the University of Bristol (United Kingdom).

Head, Innovation for Inhalation Product Development, AstraZeneca Pharmaceuticals LP

Dr. David Lechuga-Ballesteros is the Head of Innovation for Inhalation Product Development at AstraZeneca Pharmaceuticals LP and a leading industrial scientist in formulation sciences and particle engineering via spray drying. He earned his B.S. from the National University of Mexico in 1984 and his Ph.D. in Pharmaceutics from the University of Michigan in 1993. Dr. Lechuga has contributed to the development of several medicines, including Exubera, an inhaled insulin for diabetes, and Bevespi, Breztri, and Airsupra, Aerosphere co-suspension MDIs for treating COPD and asthma. Currently, he is focused on transitioning these products to low global warming potential propellants. Dr. Lechuga has co-authored over 100 publications, including peer-reviewed articles, book chapters, and abstracts; he is listed as an inventor on more than 15 patents that describe innovations in drug crystal forms, novel formulations, and specialized processing equipment. He recently co-edited a book on biotechnology and pharmaceutical drying technologies. Dr. Lechuga has served on the Editorial Advisory Boards of the Journal of Pharmaceutical Sciences, Pharmaceutical Research, and Molecular Pharmaceutics and was a guest editor for a special issue discussing advances in respiratory and nasal drug delivery.

Associate Director for Science, OB, OGD, CDER, FDA

Dr. Bing V. Li serves as Associate Director for Science for the Office of Bioequivalence within the Office of Generic Drugs. In this role, she provides scientific leadership and expertise for assessing bioequivalence studies submitted by the pharmaceutical industry through Abbreviated New Drug Applications (ANDAs). She oversees the scientific programs, including guidance development and implementation in the Office of Bioequivalence. Dr. Li is an Expert Pharmacologist at the FDA in bioequivalence of aerosolized drug products. Prior to joining the FDA in 2004, she was a Research Investigator at Bristol Myers Squibb, where her responsibilities included formulation identification, development, and optimization for oral solid dosage form formulations. Dr. Bing V. Li received her Ph.D. in Pharmaceutical Sciences from the University of Wisconsin at Madison in 2001 and a bachelor’s degree in Medicinal Chemistry in 1990 at Beijing University, China.

Director, ORS, OGD, CDER, FDA

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 Generic Drug User Fee Amendments (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-Abbreviated New Drug Application (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 18 years ago, Dr. Lionberger was an Assistant Professor of Chemical Engineering at the University of Michigan.

Consultant, Lostritto Consulting, LLC

After retiring from the FDA in 2022, Dr. Richard (Rik) Lostritto now works as an independent consultant in Maitland, Florida (Lostritto Consulting, LLC) and as a Science Advisor to IPAC-RS. While at the FDA (1995-2022), he held several key roles, including Chemistry Reviewer, Team Leader, Division Director, Acting Biopharmaceutics Lead, and from 2015-2022 as the Associate Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). During his FDA career, he received 47 individual or group awards (11 of which were from 2020 and 2021) in multiple areas, including COVID-related activities, novel or expedited drug approvals, drug shortage mitigation, complex generics, guidance development, etc.

Prior to the FDA, Dr. Lostritto served as the Pulmonary Formulations Team Leader at Boehringer Ingelheim Pharmaceuticals, Inc. (1992-95), led to the eventual approval of an HFA-based MDI which included a patent (as a co-inventor) for a novel stainless steel canister alloy. Dr. Lostritto also served as Assistant/Associate Professor of Pharmacy at the University of Connecticut (1983-1992,) where he received national-level teaching awards in 1987 and 1990 from the National Association of Colleges of Pharmacy (NACP). His published academic research includes drug release from polymeric prodrugs, constant activity drug delivery systems, and research into the mass transport properties of drug release from sub-micron emulsions. This latter work fueled his interest in HFA-based MDIs. Dr. Lostritto received his B.S. in Pharmacy from The University of Connecticut, an M.S. in Pharmaceutical Chemistry, and a Ph.D in Pharmaceutics from The University of Michigan.

A recent publication by Dr. Lostritto of relevance to this CRCG/FDA conference is titled ‘Point of View: MDI Propellant Switching in the 2020s vs.1990s: Commentary, Perspective, and Recommendations’, found here: https://www.inhalationmag.com/article/point-of-view-mdi-propellant-switching-in-the-2020s-vs-1990s-commentary-perspective-and-recommendations/. Related and additional aspects of this work were presented at the RDD 2024 Conference and the IPAC-RS October 2023 Workshop.

Director, DTP I, ORS, OGD, CDER, FDA

Dr. Markham C. Luke serves as FDA Supervisory Physician (Dermatology) and Director of the Division of Therapeutic Performance 1 (DTP1) in the Office of Research and Standards, Office of Generic Drugs at FDA. DTP1 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 MD and a PhD 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.

R&D Global Technical Leader, CHIESI Farmaceutici

Mr. Angelo Matturro completed his studies in Pharmaceutical Chemistry and Technologies at the University of Salerno in Italy. He then gained five years of experience at Genetic S.P.A., focusing on the development of equivalent drugs in different dosage forms for ophthalmic and inhalation therapies. In 2017, Angelo joined Chiesi as a CMC Analytical Scientist in R&D, concentrating on drug development in the inhalation field.

In 2023, he successfully completed the European Course of Pharmaceutical Medicine (ECPM) at the University of Basel, expanding his knowledge of cutting-edge developments in MedTech, Pharma, and Biotech.

His expertise lies in the inhalation field, particularly in pMDI drug development. He oversees and supports analytical activities, primarily for clinical late-phase development up to market launch and life cycle management of pharmaceutical products. His current role is as an R&D Strategic Technical Leader, responsible for defining the CMC strategic plan for NCEs and late-stage projects.

Expert Medical Assessor, Medicines and Healthcare Products Regulatory Agency (MHRA)

Dr. Nithyanandan Nagercoil graduated with a degree in Medicine from Bangalore Medical College, India, and received his M.D. in Pharmacology from the All India Institute of Medical Sciences, New Delhi, India. Finally, he completed his higher medical training in the United Kingdom (U.K.) in Pharmaceutical Medicine.

He is currently an Expert Medical Assessor at the MHRA who has widely contributed to the scientific advice in developing medicines and led the benefit-risk assessment of many medicines across different therapeutic areas. Before joining the MHRA, he worked in a clinical development role in a pharmaceutical company and subsequently in a Contract Research Organization. In these roles, he conducted many Phase I, II, and III clinical studies as a Principal Investigator, with the Phase II/III studies mainly in respiratory medicine and dermatology.

Nithyanandan has considerable experience in regulating medicines both at the national U.K. level and at the European level. He has more than 16 years of experience as a Medical Assessor at the MHRA, evaluating medicines across a broad therapeutic range, including respiratory medicines. During this period, he was a U.K. delegate to the Scientific Advice Working Party (SAWP) of the European Medicines Agency from 2013 to 2015 and a U.K. delegate to the Committee of Human Medicinal Products (CHMP) of the European Medicines Agency for a period of four years from 2016 until the U.K. exit from the European Union in 2020.

Lead Pharmacologist, DTP I, ORS, OGD, CDER, FDA

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

Head of Respiratory & Biologics Regulatory Strategy, Viatris

Dr. Uwe Niesner is the Head of Respiratory & Biologics Regulatory Strategy at Viatris. In his role, Uwe leads a team specialized in developing and leading global regulatory strategies for Viatris’ respiratory and biologics product portfolio. He has more than 15 years of experience in Global Regulatory Affairs covering innovator molecules and biologics in various stages of development, generic programs, biosimilars, and established brands. Prior to joining Viatris in 2015, Uwe worked for Abbott and Solvay Pharmaceuticals in various regulatory roles of increasing responsibility. Uwe holds a Dr. rer. nat. degree (a PhD) in biochemistry from the Humboldt University in Berlin, Germany. He employs his significant regulatory expertise to help guide submissions of complex pharmaceuticals, including respiratory products, and is dedicated to identifying viable science-based regulatory approaches tailored to transition MDIs to LGWP propellants while ensuring uninterrupted patient access to these critical medicines.

Senior Pharmaceutical Assessor, Medicines & Healthcare Products Regulatory Agency (MHRA)

Dr. Orla Ní Ógáin graduated with her B.Sc. in Pharmacy from Trinity College in Dublin, Ireland, and subsequently completed a Ph.D. in pharmaceutical sciences and a postgraduate diploma in statistics and quality improvement. Her postgraduate research focused on a novel inhalation delivery platform for proteins and peptides. She is a UK-registered pharmacist. Orla has been a Pharmaceutical Assessor at the MHRA since 2015. She is currently a Senior Pharmaceutical Assessor and is responsible for assessing the chemical and pharmaceutical data about the applications for medicines and variations to medicines licenses. She has been involved in the assessment of applications for pressurized Metered Dose Inhalers and the provision of Scientific Advice for both national and European procedures. She is currently a member of the EDQM Inhalanda Working Party.

Senior Director, Respiratory R&D Project Leader, Respiratory R&D, Viatris

Dr. Rupi Pannu has 28 years of experience in the pharmaceutical industry, working primarily on the Chemistry, Manufacturing, and Control aspects of developing pressurized metered dose inhalers. She started her career at Astra, later AstraZeneca. She was involved in the 1990s propellant transition from CFCs to HFAs, including formulation and container closure system development, and progressing a product through the pharmaceutical development cycle to its launch on the market. Currently, she works on generic orally inhaled drug products in the Respiratory Scientific Affairs Group at Viatris. Dr Rupi Pannu holds a Bachelor’s in Pharmacy and a Ph.D. in Pharmaceutics from the University of Manchester, U.K.

Master Pharmacologist, DPT II, OII, OND, CDER, FDA

Dr. Luqi Pei conducts nonclinical safety evaluations of human drug products. These drugs are indicated for respiratory, immunological, and inflammatory disorders. Dr. Pei provides advice and consultations to the Agency’s staff on issues in inhalation toxicology and the nonclinical safety evaluation of inhalation drug products.

Dr. Pei completed his postdoctoral training at the Lovelace Inhalation Toxicology Institute. He received degrees of D.V.M. from the Gansu Agricultural University in China, an M.S. in Environmental Toxicology from Colorado State University, and a Ph.D. in Pharmacology and Toxicology from Texas A&M University.

Co-Director of CRCG, Professor of Pharmaceutical Sciences, Ralph F. Shangraw/Noxell Endowed Professor, Industrial Pharmacy and Pharmaceutics, University of Maryland

Dr. James Polli is Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at University of Maryland. His research interest is oral drug absorption, involving laboratory and clinical research. He has served as the advisor to 25 Ph.D. graduates. He is co-Director of the University of Maryland Center of Excellence in Regulatory Science and Innovation and the Center for Research on Complex Generics, each an FDA-funded collaborative agreement with the Agency. He is Director of the online M.S. in Regulatory Science program. He is a fellow of the American Association for Pharmaceutical Scientists (AAPS) and served as an editor of Pharmaceutical Research for 12 years. He is the 14th recipient of the American Pharmacists Association Takeru Higuchi Research Prize. He was the recipient of the 2024 American Association of Colleges of Pharmacy Volwiler Research Achievement Award, the 2022 AAPS Global Leadership Award, and the 2021 TOPRA Education Award. He is a member of the University of Maryland General Clinical Research Center Advisory Committee and the University of Maryland institutional review board (IRB).

Regulatory Affairs Director, Kindeva Drug Delivery

Ms. Ann Purrington is a Regulatory Affairs Director at Kindeva Drug Delivery L.P. In this role, Ann develops regulatory strategies and submissions for Kindeva and their partners’ regulatory filings to ensure continued patient access to (hydrofluoroalkane) HFA oral inhalation aerosols for asthma and COPD. She received her B.S. in Pharmacy from the University of Minnesota College of Pharmacy. Her 30+ year career in industry as a pharmaceutical scientist and regulatory affairs professional includes developing and registering multiple HFA inhalation aerosols in response to the Montreal Protocol’s requirements to phase out CFC inhalers. Ann is a board member of the International Pharmaceutical Aerosol Consortium for Regulation and Science (IPAC-RS) and a U.S. subteam co-lead of the related environmental policy organization International Pharmaceutical Aerosol Consortium (IPAC). In these roles she is presently focused on initiatives and strategies to bring awareness to the regulations and need for understanding the submission requirements as HFA inhalers transition to lower GWP inhalation aerosols

Senior Vice President, Sciences and Regulatory Affairs Association for Accessible Medicines (AAM)

Mr. Giuseppe Randazzo is Senior Vice President of Sciences and Regulatory Affairs at the Association for Accessible Medicines. Prior to joining AAM, Giuseppe worked on Novartis’ and Sandoz’s policy and regulatory affairs team. Before this, Giuseppe spent nearly 15 years at the Food and Drug Administration (FDA), where he last served as an Office Director in CDER’s Office of Product Quality. While at the FDA, he also held several positions in OND and the Office of Compliance.

Giuseppe earned his master’s degree in Regulatory Science from The Johns Hopkins University and a bachelor’s degree in Chemistry and Physical Science Education from The Pennsylvania State University.

Co-Director of CRCG, Larry and Ann Hsu Professor of Pharmacy, Chair, Department of Pharmaceutical Sciences, Biointerfaces, College of Pharmacy, University of Michigan

Dr. Anna Schwendeman is a Larry and Ann Hsu Collegiate Professor and Chair of the Department of Pharmaceutical Sciences at the University of Michigan. Her research focus is on optimization of 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 discovery and translation HDL drugs to clinical trials. She successfully submitted FDA INDs for seven 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.

Director, DPACC, OII, OND, CDER, FDA

Dr. Sally Seymour is the Director of the Division of Pulmonology, Allergy, and Critical Care (DPACC) in the Office of New Drugs at the Food and Drug Administration (FDA). She received a B.S. in chemical engineering from Case Western Reserve University and an M.D. from the University of Cincinnati. She trained in internal medicine, pulmonary, and critical care medicine at the University of Cincinnati. In 2003, she joined the FDA as a medical officer in the pulmonary and allergy drug review division. Over the past 20 years, Dr. Seymour has served in different roles in the same review division, including primary reviewer, team leader, and Deputy Director for Safety. In 2018, she assumed the role of Director. She has experience in development programs for inhalation products, including metered dose inhalers (MDIs), and the transition to HFA propellants in MDIs during the CFC phase out.

Senior Specialist, Molecular and Cellular Biology, Analytical Development, Nanopharm, An Aptar Pharma Company

Ms. Lucas Silva is a Molecular and Cellular Biologist with academic training from the University of Lisbon (NOVA) and currently works as a Senior Specialist leading the Analytical services department at Nanopharm, an Aptar Pharma company.

Prior to his experience in Nanopharm, Lucas did a research internship at University College in London, focusing on developing particle-engineered Dry Powder Inhalers (DPIs) for pulmonary infections.

With over eight years of immersion in the pharmaceutical industry, Lucas has cultivated his expertise, spanning analytical services, formulation technology, and drug delivery devices, predominantly in the research and development of orally inhaled and nasal drug products.
His key research areas are developing more realistic respiratory and nasal analytical methods and applying specialized in vitro performance data to de-risk and accelerate drug product development.

Lucas has showcased his research findings at numerous international conferences, including poster presentations and podium talks. Additionally, he has contributed as a co-author to a peer-reviewed paper centered on enhancing impactor testing for assessing the bioequivalence of DPIs.

In his current role, Lucas actively engages in discussions within the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), contributing valuable insights to navigate the evolving landscape of inhaled and nasal drug products.

Scientific Director, Inhalation Product Development, Kindeva Drug Delivery

Mr. Steven Stein is a scientist who has been working in the field of respiratory drug delivery for 28 years at Kindeva Drug Delivery Systems, which used to be 3M Drug Delivery Systems. He received a B.A. in Physics in 1991 from Bethel University in St. Paul, MN. He studied Aerosol Science and received an M.S. in Mechanical Engineering from the University of Minnesota in 1993. His research has focused on the development and characterization of inhalation products with an emphasis on MDI products and technologies. He has more than 100 published papers and conference presentations in the areas of MDI and DPI delivery as well as on cascade impactor testing and has more than 20 granted US patents. He has been involved with the development of the first HFA MDIs, generic pMDIs and is currently working on the development of pMDIs using low GWP propellants.

Senior Statistical Consultant, Manufacturing Science and Technical, GlaxoSmithKline (GSK)

Ms. Helen N. Strickland is the Senior Statistical Consultant in the Manufacturing Science and Technical (MSAT) department in GSK. She has a Bachelor’s of Science in Analytical Chemistry and a Master’s in Statistics from North Carolina State University. Helen has over 30 years of Product Quality CMC experience with the statistical aspects of product specification setting, in vitro equivalence testing and quality assessment methods for inhalation aerosols. Helen has served on multiple Working Groups over the last 20 years. She currently serves as the Product Quality Demonstration Strategy Working Group chair for the International Pharmaceutical Aerosol Consortium for Regulatory Science (IPAC-RS). Helen has been a member of the AAPS since 2011 has previously served as CMC Statistics community Chair. Currently, she serves as a steering committee member for the AAPS CMC Statistics community and the CMC community.

Assistant Professor and Senior Clinical Assessor, Swedish Medical Products Agency

Dr. Karolina Törneke is a pharmacologist employed as a clinical assessor at the Medicinal Products Agency (MPA) since 2002. She is a senior expert, working mainly with supervision and quality assessment. Her main interest is respiratory medicine, including approval of orally inhaled products. Karolina is also vice chair of the Rheumatology and Immunology Working Party at the European Medicines Agency, and she is acting Rapporteur for the revision of the guideline on therapeutic equivalence for orally inhaled products and the Q&A document on the transitioning to low global warming potential propellants.

Senior Vice President/Head of US Regulatory Affairs, Cipla, Ltd

Dr. Siva Vaithiyalingam currently serves as Senior Vice President/Head of U.S. Regulatory Affairs at Cipla, LTD. His expertise includes Pharmaceutical Research, Product Development, ANDA Review, NDA Review, Generic and 505b2/b1 strategies, Regulatory Initiatives, and Regulatory Affairs.

Previously, He served in organizations such as Teva Pharmaceuticals, the Office of Generic Drugs at the FDA, and Barr Laboratories. He graduated from the School of Pharmacy at Texas Tech University (2001) with a Ph.D. in Pharmaceutical Sciences and an M.S. in Pharmaceutics from the Institute of Technology, BHU.

Chief Scientific Officer & EVP Inhaled Technology Platforms, Vectura Group

Dr. Geraldine Venthoye is an executive leader of the Vectura Group and a board director of its subsidiary companies in Switzerland and Hong Kong. She leads the Pharmaceutical Development and Medical Device Development departments responsible for the strategic and technical advancement of the company’s inhalation products, development services, technology platforms, and innovations. Geraldine is a UK registered pharmacist and holds a doctorate in pharmaceutics from the University of London.

Geraldine joined Vectura in June 2016 upon completion of their merger with Skyepharma PLC, where she had been Executive Vice President of pharmaceutical development since 2013, having joined Skyepharma as head of the inhalation business unit in September 2003. Geraldine previously held leadership and scientific roles in Nektar Therapeutics (San Carlos, California, US) and the UK at Vandsons Research and Norton Healthcare. During her >30 years of inhalation product research and development, she has worked on a range of products from generics to novel repurposed and new chemical entity inhalables. This includes Flutiform® pMDI and Generic Advair® DPI for asthma and COPD, Breelib™ nebulizer for PAH, TOBI® DPI anti-infective for cystic fibrosis, as well as numerous biologic and botanical aerosol products using novel particle engineering to treat systemic diseases.

Senior Chemical Engineer, DQMM, ORS, OGD, CDER, FDA

Dr. Ross Walenga joined the FDA in 2015 as an Oak Ridge Institute for Science and Education (ORISE) Fellow. He is currently a Senior Chemical Engineer in the Division of Quantitative Methods and Modeling at the Office of Research and Standards. He began his career at Virginia Polytechnic Institute and State University (Virginia Tech,) where he earned his Bachelors of Science in Aerospace Engineering. He later earned his Ph.D. in Engineering (mechanical track) from Virginia Commonwealth University in 2014, where he also spent seven months as a postdoctoral fellow prior to joining the FDA. His research interests include computational fluid dynamics modeling of orally inhaled, nasal, ophthalmic, and dermal drug products to answer questions pertaining to bioequivalence.

Acting Deputy Director, DTP I, ORS, OGD, CDER, FDA

Dr. Yan Wang is the Acting Deputy Director in the Division of Therapeutic Performance I (DTP I), Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). DTP I is responsible for facilitating the 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. Dr. Yan has been at the U.S. Food and Drug Administration (FDA) since 2013, serving in various roles, including as the subject matter expert in the area of complex long-acting drug products and as the Team Lead for the Complex Drug Substance and Complex Formulation Team in ORS/DTP 1. In her current role, Dr. Yan leads a group of interdisciplinary scientists in the development of new analytical methods and equivalence evaluation methodologies for complex drug substances and parenteral, ophthalmic, otic, intrauterine, and intravaginal formulations. Yan has research interests in developing new analytical methods, in vitro characterization, and drug release testing methodologies for complex drug products. She specializes in complex parenteral, ophthalmic, otic, intravaginal, and intrauterine formulations.

Senior Drug Evaluator, Division of Biopharmaceutics Evaluation, Health Canada

Mr. Paul Wielowieyski is a Senior Drug Evaluator in the Division of Biopharmaceutics Evaluation with Health Canada. His division has the regulatory responsibility for assessing comparative bioavailability and bioequivalence studies provided in support of generic products, line extensions of innovator products, and bridging studies of formulations used in early clinical development through commercialization and post-approval changes.

Over the last 25 years with Health Canada, Paul has participated with them on emerging BA/BE topics as well as ICH working groups. Paul was Health Canada’s deputy topic leader of the ICH M09 expert working group and played an active role in the development of Health Canada’s Guidance Document “Comparative Pharmacokinetic Studies for Orally Inhaled Products (2020),” which delineates the PK pathway for the approval of subsequent market entry of orally inhaled products (OIPs), bridging of formulations, support of post-approval-changes and line extensions of OIPs.

Division Director, DPQA XII, OPQA II, OPQ, CDER, FDA

Dr. Hailing Zhang is the Division Director of Division of Product Quality Assessment XII (DPQA XII) in Office of Product Quality Assessment II (OPQA II), Office of Pharmaceutical Quality (OPQ). Dr. Hailing Zhang obtained her Ph.D. in Organic Chemistry and Physical organic chemistry from Emory University (Atlanta, GA). She was an associate professor of Pharmaceutical Science in College of Pharmacy at Mercer University (Atlanta, GA) before joining the FDA in 2014. In her current role as the Division Director of DPQA XII in OPQA II, Hailing leads a team of talented Pharmacokineticists to provide Biopharmaceutic assessment and approval for various submissions.

Deputy Director, ORS, OGD, CDER, FDA

Dr. Lei Zhang is Deputy Director in the Office of Research and Standards (ORS), OGD, CDER, U.S. FDA. ORS implements the Generic Drug User Fee Amendments (GDUFA) science and research commitments to ensure the therapeutic equivalence of generic drug products. She is an accomplished professional with more than 26 years of combined experience in the areas of drug research, development, and regulatory review and approval. In addition to regulatory reviews, Dr. Zhang has contributed to numerous guidance development and research projects focused on science-based regulatory decision-making, including drug-drug interactions, specific populations, and PBPK modeling. Before joining the FDA in 2002, she worked at Bristol-Meyers Squibb Company as a Research Investigator and Preclinical Candidate Optimization Team Leader. Dr. Zhang is an Adjunct Professor in the Department of Bioengineering and Therapeutic Sciences, University of California at San Francisco, Schools of Pharmacy and Medicine. She received her Ph.D. in Biopharmaceutical Sciences from UCSF. She is the Rapporteur for the ICH M13 Expert Working Group which is developing the ICH M13 guideline series to harmonize bioequivalence (BE) study design and data analysis for immediate-release solid oral dosage form drugs. She was a member of the ICH Generic Drug Discussion Group (GDG), serving as the U.S. FDA Topic Leader. Additionally, Dr. Zhang was named an American Association of Pharmaceutical Scientists (AAPS) Fellow in 2013. She has published more than 130 journal articles and book chapters.