LeeAnn Chambers has been a Regulatory Affairs professional at Eli Lilly and Company for 22 years. She assists teams in developing global registration strategies for medical devices and drug / device combination products. She has guided the preparation of device content in US IND, NDA, and BLA submissions, EU Marketing Authorization Applications, US 510(k) submissions, CE Marking documentation, Japan device submissions and other global registration documents.

Dr. Andrew Chang is a multifaceted quality and CMC leader with 28 years well-rounded medical product regulatory and industry experiences. He is a board director for CASSS-Sharing Science Solutions and PDA, respectively. Andrew has served as a member of the planning committee for DIA global annual conferences from 2019 to 2023. At his current capacity as a VP, Quality and Regulatory Compliance, Global Regulatory Affairs, Novo Nordisk, Inc., he provides strategic leadership on Regulatory and Quality related Policy, External Affairs, strategic advice and solutions to quality and regulatory related challenges. Prior to industry, Andrew served more than 11 years in US FDA most recently as an Associate Director for Policy and Regulation, DH/CBER

Dr. Chi-wan Chen is Executive Director in Global CMC, Pfizer, responsible for regulatory CMC policies and strategies with a focus on China and Asia Pacific. She has made numerous presentations on regulatory and CMC topics on China in these countries. Prior to joining Pfizer in 2008, Dr. Chen had served in the U.S. FDA for more than 21 years and held several management positions in the Center for Drug Evaluation and Research (CDER), including Deputy Director in the Office of New Drug Quality Assessment. She represented CDER on the ICH Q1AR, Q3AR/Q3BR, and Q8R Expert Working Groups between 1998 and 2008 and managed the CDER Quality-by-Design Pilot Program in 2005-08.

Dr. Gold has 27 years of experience in the pharmaceutical industry as a contributor in big pharma, specialty pharma and the pharmaceutical service industry. She began her career in research and development for Fresenius Kabi (formerly Pharmacia and Pharmacia & Upjohn). In 2003 Dr. Gold joined Warner Chilcott Laboratories managing pharmaceutical development in woman’s heathcare and dermatology. Dr. Gold joined Sonus Pharmaceuticals as VP of Research and Process Development in 2004 and joined Camargo Pharmaceutical Services in 2008 and is currently VP of Scientific and Regulatory Affairs. Dr. Gold earned a B.S. in Chemistry from SUNY at Buffalo and a Ph.D. in Physical Organic Chemistry from the University of Rochester.

Christine Moore is a founding member of Organon where she leads Global External Advocacy and Standards, with oversight for new GMP-related policy, analytical standards and compendial affairs. Christine started her career as a process development engineer, after which she moved to US FDA where she led the offices responsible for small molecule new drug review and manufacturing process assessment. Followingly, she returned to industry to advance regulatory policy and innovation at Merck and now Organon. Christine is a global thought leader in scientific and regulatory approaches for advancing pharmaceutical manufacturing technologies. She holds a PhD in Chemical Engineering from MIT and a BS from Northwestern University.

Dr. Elaine Morefield is the Vice President, Regulatory Affairs for Vaxform,LLC. where she provides regulatory and development consulting services to clients. She also is working for Aclaris Therapeutics Inc., as the director of Product Quality, She obtained her BS pharmacy and her PhD in industrial and physical pharmacy from Purdue University. Dr. Morefield worked in the Office of New Drug Quality Assessment at the US FDA where she was the deputy office director for review and administration. Dr. Morefield has over 30 years of product development experience with pharmaceutical companies Wyeth, Schering-Plough and DSM and has developed over 100 pharmaceutical products.

Dr. Nasr is responsible for the development and the execution of CMC regulatory strategy at GSK. Prior to joining GSK, he spent over 22 yrs at FDA and established and led the Office of New Drug Quality Assessment (ONDQA). Dr. Nasr was instrumental in the development of QbD concept and several ICH guidelines and continues to play a leading role in global regulatory harmonization. Dr. Nasr is currently the rapporteur of ICH Q12

Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several ICH, PhRMA, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees. He is currently the Rapporteur for ICH QDG and recently the PhRMA Topic Leader for ICH M9.

Terry established PharmTree Consultants, LLC, to help bio and pharma companies develop strong regulatory strategies and submissions. He served as a reviewer and Division Director at FDA, worked as a pharmacist and developed and manufactured most types of dosage forms, including combination products. He has been active in DIA, ISPE, BIO, PhRMA, EFPIA, IFPMA and commenting on WHO guidances. He earned a BS in Pharmacy and PhD in Pharmaceutics. He enjoys spending time with his children and fishing.

Dr Richardson is a pharmacist, with a Ph.D. in pharmaceutics from The Queens University, Belfast. He worked in industry in the area of formulation research and on drug delivery and controlled release systems for small and large molecules. He has worked for the UK MHRA as a pharmaceutical assessor prior to joining the European Medicines Agency, where he now has the role of Head of Quality.

Dr. Ridgway completed his Ph.D. at McGill and spent 5 yrs as Assistant Professor at U. of Western Ontario with research activities on oncogenes, retroviral & HIV regulatory elements/genes, and inducible expression vectors. Since joining Health Canada in 1991 he has held several positions covering regulation of a wide range of products; and various supervisory and advisory responsibilities. He is currently the Acting Director of the Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics. Active with ICH since 1993 on quality of biotechnology products, he is currently on the Q12 EWG. Since 2000, he has served on successive USP Committees of Experts.

Dr Robert studied chemistry and obtained his PhD from the University of Basel in 1976. He had a post-doctoral training at ETH Zurich. He spent one year with a pharmaceutical company before joining the National Health Laboratory (LNS) in Luxembourg, where he was head of the Unit Pharmaceutical Chemistry, an Official Medicines Control Laboratory (OMCL). He retired in March 2015. He was a member of the CHMP at EMA since 1995 (co-opted member: 2004-2017) and chairman of the CHMP/CVMP Quality Working Party (1995-2017). He is currently EC topic leader for ICH Q12 (Lifecycle Management). He was chair of the European Pharmacopoeia Commission (2013-2016) and a member of the group of experts 10 B. Currently he is chair of the CEP Steering Committee.

Bekki E. Komas is Director of Chemistry, Manufacturing and Controls, Regulatory Affairs Advocacy and Intelligence at GlaxoSmithKline, Research Triangle Park, NC. She has been employed by GlaxoSmithKline for twenty seven years is currently Director of CMC Advocacy and Intelligence.

Christine Anderson is a Senior Research Scientist, Global Regulatory Affairs CMC at Eli Lilly and Company, where she is responsible for global regulatory submissions to support clinical trials and market registrations for new products. She has, in the past 20 years, supported the CMC development for more than 50 new chemical entities including small molecule compounds and drug/device combination products. Additionally, in her earlier assignments with Lilly she became an experienced corporate auditor conducting GMP inspections worldwide. Prior to joining Lilly, Christine held quality control management positions with Key Pharmaceuticals and Baxter Diagnostics, Inc. in Miami, FL, US.

13+ years in the Multinational Pharmaceutical industry, being able to combine the commercial skills in business with the technical skills in Regulatory. Bachelor of Pharmaceutical Science, Egypt. Started my Career back in 2002 in Merck, Egypt working in Sales department before moving to GSK Qatar, Schering plough Dubai, and Novartis Dubai. Joined Eli Lilly Dubai in 2008. In 2010 was promoted to Regulatory Manager Gulf. In 2012 took a broader responsibility for Gulf and Near East. In 2014 took additional responsibility of establishing the Pharmacovigilance department in Middle East. In the same year, I was elected as PhRMA-G, Regulatory Affairs Working Group (RAWG) chair. Since 2016 I am the Regulatory Director for Middle East Affiliate.

Dr. Zedong Dong is currently a Quality Assessment Lead (Acting) in the Office of Pharmaceutical Quality in FDA. During his tenure at the Agency, Dr. Dong has been extensively involved in the regulatory review activities through the life cycle of drug product development. Prior to joining the Agency, he was a formulation scientist supporting drug discovery and development.

Michael Jenkins, PhD, Senior Consultant at BPTC, has over twenty years of experience in the biotechnology industry. Prior to joining BioProcess Technology Consultants, Dr, Jenkins was Site Director at IDT Biologika, and General Manager at Catalent Pharma solutions’ Madison site. He carried out site expansion projects with both organizations and has extensive Business Development experience at CDMOs Dr. Jenkins earned his BS in Microbiology from the University of Illinois and his PhD in Molecular and Cellular Biology with a minor in Biochemistry from the University of Arizona, Tucson.

Silke Klick is an analytical chemist with a degree from University of Münster, Germany and a PhD from University of Hannover, Germany. After a post-doctoral fellowship at University of Gothenburg, Sweden she joined AstraZeneca in 1991 and held manager positions within Pharmaceutical Development before moving into Regulatory Affairs in 2010. She is currently a Director in Regulatory CMC based in Gothenburg. With this background she has participated in the development of a considerable number of drugs.

Doug Mead is Senior Director, Global Regulatory Affairs, Medical Devices and Combination Products, for Janssen Research & Development LLC, and is responsible for establishing and implementing the worldwide regulatory strategy for the development of drug delivery systems and drug-device combination products. Before joining J&J’s Centocor in 2006, he held positions at a regulatory law firm, a pharmaceutical company specializing in drug delivery, various surgical instrument companies, and a medical device testing laboratory. He has an M.S. Degree in Biomedical Engineering from Drexel University and over 35 years of experience in the medical device, pharmaceutical, and combination products industries.

Dr. Yu Chung Tsang is currently working at Apotex Inc. as Chief Scientific Officer, Biopharmaceutics and Biostatistics. He obtained his Ph.D. degree in Pharmacokinetics in 1990 from the University of Toronto. To date, he has been involved with the design and data analysis of over a thousand bioequivalence/clinical endpoint studies for the registration of over 300 drugs or biosimilar products in Canada, US, EU and many other international marketplaces. He also provides statistical support in clinical trials of new chemical entities at ApoPharma. Dr. Tsang is currently the Chair of the Bioequivalence Committee in the Canadian Generic Pharmaceutical Association.

Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

Eleni Anagnostiadis, a Commander (CDR) with the U.S. Public Health Service, joined FDA in March 2010 and is the Director of the Division of Supply Chain Integrity (DSCI) in the Center for Drug Evaluation and Research’s Office of Drug Security, Integrity, and Response (ODSIR). She oversees a Division whose primary goals include: reducing the likelihood that unsafe, ineffective, and poor quality drug products will enter the U.S. supply chain; and, raising public awareness of drug security threats and vulnerabilities in the supply chain. She has presented both domestically and internationally on drug supply chain issues and is FDA’s point of contact for the World Health Organization’s Global Surveillance and Monitoring System.

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.

Sharmista Chatterjee is currently the Division Director in Division of Pharmaceutical Manufacturing II, within FDA’s Office of Pharmaceutical Manufacturing Assessment (OPMA), in CDER, FDA. She has been with the FDA since 2006. During her tenure she has been actively involved in many agency initiatives that include Quality by Design efforts, FDA-EMA QbD pilot program, KASA, NIR guidance, Continuous Manufacturing, and in the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) . She has served in many roles of increasing responsibility including serving as the CMC Lead for QbD (Quality by Design) in the Office of New Drug Quality Assessment (ONDQA) and as the technical lead for the FDA-EMA QbD pilot.

Jack Cook, Ph.D. is a Vice President in the Clinical Pharmacology Department of the Global Product Development unit at Pfizer, Inc. Dr. Cook holds adjunct faculty positions at the Universities of Michigan and Florida Colleges of Pharmacy. He received B.S. degrees in Applied Mathematics and Pharmacy from Ferris State College, and his Ph.D. in Pharmaceutics from the University of Michigan. He has authored/co-authored over 50 peer-reviewed publications. He is a fellow of the AAPS. His current interests include improving therapy by optimizing drug delivery and the use of modeling and simulation to make rational decisions in the development of drugs.

I am currently the Global Head of Compliance and External Collaboration. I am responsible for the company's internal audit program, inspection management, and health authority relations and policy. I have worked 32 years in the FDA in CDER's Office of Compliance and in the field organization.

Ms. Kemme has more than 18 years of experience providing project management, CMC (Chemistry, Manufacturing, and Controls), and technical leadership to both large and small pharmaceutical organizations. Ms. Kemme joined Camargo Pharmaceutical Services in 2014 as Associate Director of Chemistry, Manufacturing, and Controls. In this role, she uses her manufacturing, project management, and regulatory expertise to support pharmaceutical development programs.

Jaap Laufer, MD, PharmD is Vice President of Regulatory & Clinical Affairs at Emergo. Dr. Laufer has over 30 years of experience in the medical device and pharmaceuticals industries. He previously held executive and senior regulatory positions at Pfizer, Abbott Laboratories, LipoMatrix, and others. He holds a PharmD in Pharmacy from the University of Groningen and is an MD from the Medical School of the University of Nijmegen, both in The Netherlands. Dr. Laufer is a member of the Medical Devices Expert Group to the EU Commission and teaches at the University of Southern California in Los Angeles, USA.

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.

Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad Nacional Autonoma de Mexico where she got her Pharmacy Degree and a Masters in Industrial Administration.

Thuy Thanh Nguyen is the Quality Assessment Lead (Acting) and a primary reviewer in the FDA’s Office of Pharmaceutical Quality, Office of Process and Facilities. She held positions as ORA Investigator and CDER Compliance Officer since joining the FDA in 2009.

Mr. Ochoa serves as Chief Business Officer of IDT Biologika Corporation located in Rockville, Maryland, a subsidiary of IDT Biologika GmbH, with global responsibilities for leading corporate development, partnering and evaluating and executing growth opportunities including the PROVEO™ alliance established to manufacture antibody drug conjugates and the contract award from the Biomedical Advanced Research and Development Authority (BARDA). As head of the Animal Health Americas business unit, Mr. Ochoa is also responsible for leading this new organization in addressing animal health needs of veterinarians, farmer and government agencies. Mr. Ochoa is a graduate of the University of Virginia College of Arts & Sciences and School of Law.

Sarah Pope Miksinski has been with Gilead since July 2023 and is currently an Executive Director in CMC Regulatory Affairs. She represents Gilead in various external capacities In 2021, she was appointed as the PhRMA Topic Lead for ICH M4Q(R2) and was appointed to the ISPE Board of Directors in 2022. She concurrently serves as the Rapporteur of the ICH Quality Discussion Group (QDG). Previously, Sarah served at AstraZeneca for over 5 years, holding roles in the CMC Regulatory Affairs space. Prior to that, she held a lengthy tenure at FDA, lasting from 2002-2018.

Suzette Roan joined Sanofi as Sr Director, Device Reg Affairs in Sept. 2017 and is responsible for combination product and diagnostic device regulatory strategies for products in the portfolio. Prior to Sanofi, Suzette worked at Biogen for 3 years leading the combination product regulatory team. Previous to her time at Biogen, Suzette was with Pfizer for 19 years, with roles in Analytical Development, Outsourcing and Reg CMC. She has experience with pulmonary inhaler, prefilled syringe, autoinjector and on body delivery systems. Suzette holds a BS in Chem from Univ of CT, a MS in Mgmt from Albertus Magnus College and a JD from Univ of CT School of Law. She active member in ISO/TC 84 and is chair of the CPC Submissions working grou

Xiling has 15 years of pharmaceutical industry experience. She is currently an Associate Regulatory Program Director in Small Molecule Pharma Technical Regulatory at Genentech (a member of the Roche group), responsible for global CMC regulatory filing strategies specializing in Asia Pacific region. Prior to work as regulatory professional, Xiling was in analytical development in Genentech and Boehringer Ingelheim. She was the lead for analytical development of Erivedge® from pre-IND to NDA.

Dr. Issei Takayama is a reviewer in PMDA, Japan regulatory autority.The review team which Dr. Takayama belongs to conducts scientific reviews and consultations of marketing authorization application of antibiotics and antivirals. He is mainly responsible for the assessment of the data on pharmaceutical quality. From 2016, Dr. Takayama has joined the Innovative Manufacturing Technology WG, one of the projects across Multi-Offices in PMDA. In this WG, he contributes to establish PMDA’s perspective on the latest technologies of pharmaceutical quality control, especially the continuous manufacturing of pharmaceutical products.

Dr. Stelios Tsinontides is the Office Director of the Office of Pharmaceutical Manufacturing Assessment (OPMA). OPMA evaluates facilities, process design, and control strategies to assess capabilities of manufacturers to produce quality pharmaceutical and biotechnology products at commercial scale and provides leadership and technical expertise to Agency components internal and external to the Office of Pharmaceutical Quality regarding manufacturing quality issues.

Dr. Olu Aloba is Senior Director, Pharmaceutics at Camargo Pharmaceutical Services. In this role, he provides pharmaceutical and regulatory consulting expertise for Camargo’s clients. Dr. Aloba has more than 25 years experience in pharmaceutical research and development, technology transfer, and regulatory submissions. He is a subject matter expert for various types of dosage forms with expertise in quality-by-design (QbD) formulation and process development, analytical development, technology transfers and development strategy using Quality Risk Management (QRM) principles.

Peter Bøge is employed with Novo Nordisk A/S and has for a number of years worked with design controls for medical devices, both the internal compliance and within international standardization. In this capacity he is a member of the ISO work group for ISO14971 Risk Management, the IEC group for IEC62366 Usability for Medical Devices and the AAMI HFE Committee.

Winston R. Brown works for Phillips-Medisize Corporation, as their Vice President of Global Quality and Regulatory Affairs. Winston has worked in the pharmaceutical, medical device and biologics industries for 20+ years. Subsequent to serving in the United States Army, he has held positions of increasing responsibility in quality, regulatory, and operations at Johnson & Johnson Consumer Pharmaceuticals, Holopack, USA, Bausch & Lomb, Baxter Healthcare and Alcon, a division of Novartis.

James holds a B.S. in Biochemistry from Union College and recently completed his M.B.A. from Babson College. He has over 11 years of pharma industry experience with a successful track record as an Analytical Chemist and as a CMC Regulatory Affairs professional. He takes a strategic approach to decision making and emphasizes sound scientific principles. James played an integral part in the successful commercialization of four products and has introduced and managed multiple compounds in various phases of global development. James began his career in Pharmaceuticals as an Analytical Chemist and subsequently transitioned in to a CMC Regulatory Affairs professional.

Holder of Pharmacy diploma, and Master in EU and International Regulation and Healthcare Laws. Currently heading the regulatory department for MENA region in Novartis. She has 15 years’ experience and expertise in the European and Emergent markets regulations; worked for various MNCs. Inas is an active member in the EFPIA Middle East Regulatory Network group, and of the Programme Committee of the MERC and DIA Middle East since 2008. She has participated as a speaker in several international and regional conferences. Inas is a member in the MEA Regulatory Working Group, under the PhARMA association umbrella. Her focus and interest is the healthcare reforms and legislations to accelerate patient access to innovative medicines.

Earl Dye is Director of Technical Regulatory Policy in Genentech’s Washington, DC Regulatory Affairs Office, and the FDA Liaison for Roche Global Technical Regulatory Policy Group. He is responsible for evaluating proposed biotechnology/biologic CMC regulations, guidelines, policies and practices of US FDA and other federal government agencies. Prior to joining Genentech Dr. Dye was the Director of the Division of Application Review and Policy in CDER’s ODE 6 He joined the FDA in 1992, and became a regulatory expert for therapeutic biologics, participated in foreign and domestic inspections of licensed manufacturers, and was actively involved in developing policy for review of therapeutic proteins.

Tatiana Gaban has the role of CMC LATAM Lead at Merck, and is based at MSD Sao Paulo, Brazil Office. She is graduated in Pharmacy & Biochemistry (Pharm D), with International Executive MBA and Management Practices Certification. Tatiana has previously worked for Roche Brazil, Pfizer Brazil and HQ, Novartis and Janssen-Cilag, building over 19 years’ experience with regulatory affairs activities and Latin American countries. Tatiana’s main current activities include support for CMC-related projects in LATAM, collaboration and management of strategic and operational CMC processes, liaising with CMC HQ and Country Regulatory Affairs in LATAM and regional CMC Policy & Advocacy.

Vivian Gray has spent the last 40 years involved in all aspects of dissolution testing. She was employed by USP for 23 years and worked at DuPont–Merck Pharmaceuticals Company as Head of the Analytical R & D Dissolution Group. Vivian now serves on the USP Pharmaceutical Dosage Form Expert Committee. She has authored over 50 articles, including 6 book chapters. She is presently a consultant in dissolution testing. The company name is V. A. Gray Consulting, Inc., www.vagrayconsulting.net. She is also Managing Director of, Dissolution Technologies, www.dissolutiontech.com, a quarterly, international peer-reviewed journal.

Sau (Larry) Lee is a Senior Biomedical Research Scientist (SBRS). He is a Deputy Director of the Office of Testing and Research in the Office of Pharmaceutical Quality (OPQ), and the chair of the OPQ Emerging Technology Team. He is leading the effort in advancing OPQ research and in manufacturing science, complex drug substances and products, as well as in developing the regulatory policy, scientific standards as well as computational and modeling tools supporting quality review and inspection in OPQ. In early 2013, Larry was promoted to Expert Regulatory Scientist in recognition of his expertise in evaluation of complex drug substances and products.

Dr. Juhong Liu received his Ph.D. in Biochemistry and Molecular Biology in Peking Union Medical College. He obtained research training in Laboratory of Pathology of the National Cancer Institute where he worked on characterization of transcription factors. He joined the Division of Therapeutic Proteins, Office of Biotechnology Products (OBP) in 2008 and is now a Lead Biologist in Division of Biotechnology Review and Research II of OBP. He has involved in reviews of regulatory submissions of a variety of protein products, including monoclonal antibodies, enzyme replacement therapy products, cytokines, and hormones.

Eric Marshall is a senior director in the Washington, D.C. office of Leavitt Partners, a health intelligence and consulting firm. Eric is an industry specialist in the areas of domestic and international supply chain security; drug, device, and diagnostics regulation; and health care compliance. Eric advises complex health care alliances on health policy, including multiple industry alliances related to domestic and global serialization issues. Eric is a graduate of the University of Minnesota Law School and has a bachelor’s degree in economics and finance from the University of Northern Iowa.

Dr. Mehta is the Director, DCP I (Division of Clinical Pharmacology I), OCP (Office of Clinical Pharmacology), in CDER (Center for Drug Evaluation and Research), FDA. His division is responsible for reviewing the clinical pharmacology and biopharmaceutical aspects of the Cardio-Renal, Neuropharmacological and Psychiatric drug products. He obtained his M.Sc. from University of Bombay in Synthetic Organic Chemistry in 1979, M.S. from University of Houston in Medicinal Chemistry in 1981, and his Ph.D. in Pharmacokinetics from the University of Pittsburgh in 1986 and joined FDA as a reviewer the same year.

Dr. Thoma worked as a hospital pharmacist prior to joining the US Public Health Service 11/1987. She was initially assigned to Indian Health Service and has worked with FDA since 11/1989. She's held positions as Pre-Approval Manager, Senior Drug Investigator and in 3/2007 accepted a position with ORA in the Division of Field Investigations, Rockville, MD as a National Expert of Pharmaceutical Inspections. Dr. Thoma provides presentations at FDA’s Basic and Advanced Drug School courses. She’s appeared as a fact witness and provided depositions during FDA court testimonies. She’s obtained extensive documentation to support injunctions, seizures, and other regulatory actions over her 27 plus years with FDA.

Christina Capacci-Daniel is the Quality Assessment Lead and a primary reviewer in the FDA’s Office of Pharmaceutical Quality, Office of Process and Facilities. She has a PhD in Organic Chemistry from Georgetown University where she studied crystallization process design and polymorphic control. As part of the early technical research and development group at Novartis Pharmaceuticals, she developed analytical methods, designed drug products for clinical trials, and worked on innovative drug delivery and manufacturing technology. Since joining the FDA in 2013, she has reviewed manufacturing facilities for new and generic drug applications in addition to performing pre-approval inspections and inspectional review.

Yang (Frank) Gao, Associate Regulatory Affairs Director-CMC in Eli Lilly China. Chairman of CMC working group in R&D-based Pharmaceutical Association Committee (RDPAC), lead the multinational pharmaceutical companies together to facilitate CFDA recent regulatory environment transform by providing industry's position paper and comments. Before joining Lilly, 8 years as CFDA CMC reviewer in small molecular area, with practical evaluation experience on IND, NDA, ANDA, Post-approval Supplement and bioequivalence evaluation. Yang got pharmacy bachelor in Shandong University, pharmaceutical science master in China Pharmaceutical University.

Dr. Ajaz Hussain is a globally recognized leader in pharmaceutical quality and is one of the most influential ‘Medicine Maker’ (named in the 100 Power list by the UK’s Medicine Maker magazine in 2015). In 1995 he moved to the US FDA CDER as Branch Chief for Biopharmaceutics Research and thereafter was rapidly promoted. In October 2014 he was also appointed as the Executive Director of the National Institute for Pharmaceutical Technology and Education, a collaboration among pharmaceutical science and engineering programs at 15 major universities in the USA. He was elected President of NIPTE in February 2016.

Becky Leibowitz, Ph.D. is Associate Director, Global Regulatory Affairs, Medical Devices and Combination Products, for Janssen Research & Development LLC, responsible for worldwide regulatory activities related to Janssen’s drug delivery devices and combination products. Becky joined Janssen in 2015 following 16 years in R&D and Quality at ETHICON where she conducted human factors studies during development of various surgical products including biologic-device combination products. Becky earned a B.S. in Mechanical Engineering from Cornell University and a Ph.D. in Mechanical Engineering from the University of Pittsburgh, and was a postdoctoral Research Fellow at the Hospital for Special Surgery in NYC.

Lloyd has over 30 years of experience in the pharmaceutical industry with 10 of those years spent working on product traceability. In his current role he leads AbbVie’s global effort to align the company’s products for serialization compliance maintaining market continuity. In this capacity he is responsible for strategies and tactics and execution of these efforts. Lloyd served as a member of the GS1 Global Healthcare Leadership Team and is a board member of the Prescription Drug Security Alliance. Lloyd is involved with many other organizations working on product traceability and security such as NCPDP, HDMA, PhRMA, APEC, EFPIA, and Rx360

Dr. Marroum obtained his pharmacy degree from the University of Pittsburgh in 1984 and a PhD in pharmacokinetics from the University of Florida in 1990. In 2008 Dr. Marroum became the Head of the Biopharmaceutics Group in the Office of New Drug Quality where he was responsible for all the review, policy and research activities related to Biopharmaceutics and evaluation of the quality of the formulation. In 2011, Dr. Marroum became an independent consultant for the pharmaceutical industry. In April 2014, Dr. Marroum took a director position in Clinical Pharmacology and Pharmacometrics at Abbvie. In August 2016, Dr. Marroum became a Senior Research Fellow within Abbvie.

Manoj K. Menon, PhD is Director, New Products, Biologics Global Technical Operations at AstraZeneca (AZ). He serves on Global Product Development Teams for multiple late and mid-phase pipeline products in in multiple therapeutic areas and provides strategic and technical leadership and expertise to the PDTs to ensure delivery of a robust, cost-effective commercial manufacturing process. Prior to this he worked at Lonza Biologics Singapore and Genzyme, involving biopharmaceutical manufacturing process and product development, international technology transfer, large-scale manufacturing facility start-up, validation, and commercial licensure by FDA, EMA, and other global regulatory agencies.

Kevin earned his PhD in Chemical Engineering and has over 20 years’ experience working in small molecule synthesis with Merck and Eli Lilly. He has worked on the process development and optimization of many early as well as late phase products and led the technology transfer, validation, and launch of several marketed compounds. Kevin has also led initiatives for developing enhanced filings in support of the ICH Q8, Q9, Q10 and Q11 guidelines. Kevin has co-authored many refereed publications and conference presentations in the area of criticality assessment, design space mapping and implementation of Quality by Design principles.

Mr. Thomas has been with Lilly since 1999 in the Packaging Design and Development organization responsible for design and development of container-closure systems for pipeline products. He has provided technical leadership for several new product launches through qualification and technical transfer phases with an emphasis on primary and critical secondary packaging materials. He received his masters degree in Packaging from Michigan State University in 2000. Prior to receiving his masters degree, he received a bachelors degree in Chemistry from Midwestern State University (Wichita Falls, TX) in 1993 and worked for the Perrigo Company as a pharmaceutical quality chemist until 1997.

Head RegCMC Immunology Products, Sandoz Biopharmaceuticals, Austria

Diane Zezza is Vice President and Global Head Regulatory Affairs, CMC at Novartis Pharmaceuticals. Diane has global responsibilities for CMC regulatory strategies/submissions for all development and lifecycle products. Diane has been a speaker at conferences on regulatory topics including Global Harmonization, Risk-Based Regulatory Approaches, Breakthrough Therapy Products, and Continuous Manufacturing. Diane holds a BS in Biology and a PhD in Molecular Biology.

Dr. Eradiri joined FDA in 2012 and is an Acting Quality Assessment Lead in the Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research. Dr. Okpo Eradiri obtained his PhD in Pharmaceutical Sciences from the University of Alberta, Canada. He is a licensed Pharmacist in Canada and Nigeria and served as Lecturer and Acting Head, Department of Pharmaceutics in the University of Jos, Nigeria, from 1988 to 1990. Before joining FDA, Dr. Eradiri worked in the pharmaceutical industry for 20 years, principally in the area of clinical pharmacology.

Laurie Graham is currently the Director of the Division of Internal Policies and Programs (DIPAP) in the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) at the Center for Drugs Evaluation and Research (CDER). DIPAP is responsible for the development and evaluation of CDER internal policies and programs related to pharmaceutical quality, including application assessment and inspection. Prior to joining OPPQ, Laurie had more than 20 years of experience at the FDA, including application assessments and inspections for biotechnology products regulated by CDER.

John Groskoph leads the PTx CMC function at Pfizer and has over 25 years of pharmaceutical industry experience. John has worked in a variety of regulatory, quality and production assignments and brings experience in Quality & Compliance Systems, clinical trial submissions through post-approval change management. John has a particular focus on bringing new technologies and new approaches through the CMC regulatory approval process. John holds a B.S. in Electrical Engineering from Lafayette College, Pennsylvania and an M.B.A. from Columbia University, New York, USA.

I have worked in industry and at Amgen for fourteen years in roles spanning pre-pivotal and pivotal stages of process/product development, technology transfer, life cycle management, process validation, and commercial manufacturing support. Currently I lead a team of cell culture and purification scientists and engineers who conduct process design, develop control strategies, and author marketing applications for Amgen's late-stage biologics pipeline.

Patricia Seymour, M.B.A., CSCP, is a Senior Consultant with BioProcess Technology Consultants and has over 25 years of experience in the biotechnology industry. Her expertise spans the development and commercialization spectrum, including biologics and small molecule development and manufacturing, supply chain strategy, and management and operations leadership. Ms. Seymour was formerly Sr. Director, Global Investigational Supply Operations at Millennium. She previously held positions at Covance, Collaborative BioAlliance, ImmunoGen, Dana Farber Cancer Institute and Sloan Kettering. Ms. Seymour received her B.S. from Villanova University and her M.B.A. from Boston University and is a Certified Supply Chain Professional (APICS).

Dr. Matsuda is a pharmacist and a senior scientist for Quality, Pharmaceuticals and Medical Devices Agency (PMDA). He received Ph.D. degree in Medicine from Tokyo Medical and Dental University in 2003. He joined the Pharmaceuticals and Medical devices Evaluation Center, the predecessor of PMDA, in 2003 and he is currently responsible for quality assessment of medicines. He was a member of ICH Q9 Expert Working Group, ICH Quality Implementation Working Group (Q-IWG) and ICH Informal Quality Discussion Group (IQDG). He leads Innovative Manufacturing Technology Working Group (IMT-WG) at PMDA and he is a regulatory chair of ICH Q13.

CAPTAIN Helen Saccone serves as a Senior Advisor within CDER’s Office of Strategic Programs (OSP). In this role, she manages the strategic development and implementation of CDER priorities including PDUFA VII technological commitments and CDER’s Artificial Intelligence Steering Committee. CAPT Saccone was also a member of the inaugural team that initiated the US-EU Mutual Reliance Initiative in 2014, that led to the negotiations and implementation of an international trade agreement for the FDA.