Nagesh Bandi is currently an Executive Director of Pre-Approval regulatory CMC (New Products) at Merck & Co, wherein he is responsible for driving CMC regulatory strategy (early phase to post approval) and external advocacy-related. Nagesh is the past Chair of American Association of Pharmaceutical Sciences (AAPS) Regulatory Sciences (RS) section and is the recipient of several AAPS awards including the Regulatory Sciences Recognition Award and Regulatory Sciences Service Award. He also served on the DIA-CMC workshop organizing team for three terms (2011, 2013, and 2015) heavily contributed to the programming. Nagesh has a Ph.D. from the University of Nebraska (Pharmaceutical Sciences).

Phil Borman is a fellow of the Royal Society of Chemistry with more than 22 years of experience in the pharmaceutical industry, having obtained Masters degrees in Chemistry and Applied Statistics and a Doctorate of Sciences. Phil is a Director at GSK where he is accountable for QbD for Small Molecules. Phil pioneered the adaptation of QbD principles to analytical methods and has published widely in the field of Analytical Chemistry (>40 papers). He is a member of various analytical teams (e.g. EFPIA, USP and BP) supporting the development of ICHQ2(R2)/Q14.

Cheryl W. Emery is currently an Associate Vice President in Global Regulatory Affairs and Clinical Safety and Global Head of Pre-Approval Pharmaceutical CMC at Merck. She has a Master’s Degree in Regulatory Affairs and Quality Assurance from Temple University and a Bachelor’s Degree in Chemistry from Lafayette College. Cheryl worked as a protein analytical chemist at Sanofi before embarking on her Regulatory CMC career, also at Sanofi. In 1995, Cheryl joined Merck in Regulatory CMC and has held increasing roles of accountability. In 2005, Cheryl spent a few years at Wyeth (now Pfizer) in CMC before returning to Merck. While Cheryl has worked on the full life cycle of products at Merck, her expertise is with product development.

Scott Furness, Ph.D., Deputy Director, ONDP, OPQ, joined CDER’s OPS/OGD in 2000, serving as a Chemistry reviewer and team leader. In 2007, he was named Director of the Division of Nonprescription Regulation Development in the Office of New Drugs’ (OND). During his time in OND, Dr. Furness led several initiatives to modernize the over-the-counter (OTC) monograph system in areas pertaining to biopharmaceutics and product quality. In 2013, he returned to OPS as the ONDQA Deputy Director for Operations, and he has been the Deputy Director of ONDP since the stand-up of OPQ in 2015. In addition to his Deputy Director duties, Dr. Furness is also the supervisor of the Environmental Assessment Team and the Botanical Review Team within ONDP.

Annie Sturgess, PhD is currently Vice President of Global Regulatory Sciences-CMC at Bristol Myers Squibb (BMS). Annie joined BMS in 2012 where she was head of the Biologics group in GRS-CMC until 2016. Prior to joining BMS, Annie was head of the Regulatory CMC for Vaccines at Merck. She has a Ph.D. in Biochemistry from University of Arkansas and was a post-doctoral fellow at Hahnemann University and Northwestern University.

James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Nutritional, Cosmetic, Branded Pharmaceutical, Generic, Biologic, Medical Device and Combination Product areas. James received his undergraduate and graduate degrees from Duquesne University and received his Health Care Compliance Certificate from Seton Hall University Law School. He is a member of various regulatory and quality work groups including RAPS, OCRA and the ASQ Orange Empire Section.

Cheryl S. Watson has over 20 years of experience in the pharmaceutical industry, supporting the development and manufacture of small molecule products, biotechnology products, and vaccines.For the past 18 years, Cheryl has been working in regulatory affairs supporting the global registration of medicinal products, including life cycle support associated with manufacturing changes for authorized products. Currently, she is Director at Bristol-Myers Squibb Company in Global Regulatory Science and Biometrics, where she is supporting registrational activities and lifecycle management for biotherapeutic medicines.

Director, Global Regulatory Affairs, CMC Biologics - Merck, United States

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. Judy Chou has more than 20 years of experience in drug development and biomanufacturing. Before joining AltruBio, she headed the global biotech organization at Bayer Pharmaceuticals overseeing the manufacturing and distribution of Bayer’s $3+ billion per year biotechnology product portfolio & 2000+ employees and leading the drug development activities for Biologics pipeline including cell and gene therapies. Prior to Bayer she has held leadership and drug development roles at Pfizer, Genentech, Wyeth and Abbott. Dr. Chou received her Ph.D. from Yale University, and was named one of the most influential women in business in 2018.

Dr. Hayakawa is a Guest Professor of Graduate School of Medicine,Osaka University and the Emeritus investigator of the National Institute of Health Sciences (NIHS) of Japan. He was the Division Director of Biological Chemistry and Biologicals and Deputy Director General of NIHS, and a senior advisor of PMDA. Internationally, Dr Hayakawa has played an active role as an ICH/EWG member on Q5B, Q5C, Q5D, Q6B, CTD,Q4B, ICH/rapporteur for Q5A and Q5E, a member of PDG (USP/EP/JP), a temporal adviser of WHO, and a board member and the chair of the Cell/Gene Therapy Committee of IABS. In Spring of 2012, a royal decoration was conferred on Dr. Hayakawa by Japanese Emperor.

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

She went on to complete her PhD in organic chemistry at Monash University, Australia. Sarah worked at Dow Agrosciences from 2015 to 2016, after which time she joined Eli Lilly as a member of the Commercial Manufacture and Control organization. Sarah has had a number of scientific roles supporting both early and late phase molecule development. In her current position, Sarah is responsible for early phase development activities and strategies for both small molecule and synthetic peptide assets. Her interests include synthetic route development as well as phase appropriate control strategy and analytical development, and leveraging these strategies to reduce CMC costs and overall cycle times.

Derek is an Associate Director of Global CMC Regulatory Affairs Strategy at Vertex, where he has worked for the past 7 years. Derek currently manages post approval activities in 7 regions. The product was developed under a Quality by Design (QbD) methodology and is manufactured continuously. Derek is active on teams covering topics such as QbD and Brexit. Prior to working for Vertex, Derek worked as a medicinal chemist for 5 years and a process chemist for 8 years with Pfizer. Derek holds a master’s degree in regulatory affairs from Temple University and a bachelor’s degree in chemistry from Calvin College.

Ashley serves as Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including application assessment and inspection. Prior to joining CDER, Ashley spent nearly 20 years in the Center for Devices and Radiological Health. She holds bachelor's and master's degrees in biomedical engineering.

Greg Connelly is a Director in Continuous Manufacturing at Vertex Pharmaceuticals. He has guided the successful development of several products which have been approved as fully continuous processes. His team works to increase fundamental understanding of the various unit operations which comprise Vertex’s Drug Product CM rig, and they manage all design, testing and qualification of process equipment and software changes on the system. Greg holds a BS in Physics and Mathematics from Loyola University and a PhD in Biophysics from the University of Pennsylvania.

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.

Dr. Diane Harper has more than twenty years of experience in the regulation and development of drug-device combination products and pharmaceuticals. In her current role as Director of Regulatory Affairs CMC for combination products at Merck, she is responsible for providing regulatory lifecycle and compliance strategy for respiratory drug delivery devices, nasal sprays, subdermal implants, pen injectors, pre-filled syringes and co-packaged pediatric products. Prior to joining Merck, Dr. Harper has held positions in Regulatory-CMC and product development for Teva Pharmaceuticals, Merial, and Gilead, along with other small biotechnology companies with US and international responsibilities.

Brian Hasselbalch is currently acting Deputy Director in CDER OPQ’s Office of Policy for Pharmaceutical Quality. OPPQ is responsible for the development and implementation of regulations, policies, and programs governing the quality ‘lifecycle’--pre-market through commercialization. Mr. Hasselbalch has been with FDA since 1990, when he began his career in FDA’s San Francisco District Office inspecting drug operations there and overseas. He transferred to CDER in 1995 to work on enforcement actions and drug quality policy.

Diane Hustead is an advanced regulatory affairs expert and drug shortage industry leader with enthusiasm and dedication to pharmaceutical manufacturing excellence. With a diverse career path and continuously increasing responsibility over her 25 years at Merck, she has developed expertise within US Regulatory Affairs, Global Labeling, Global Chemistry Manufacturing & Controls (CMC), Regulatory Operations, and Quality Auditing (Manufacturing). She has directly supported supply recovery efforts and developed business continuity plans for large-scale disruptive events. Additionally, she is the chair of the ISPE Drug Shortage Initiative Team.

Kirsten Paulson, RAC, is the Senior Director, Global CMC-Medical Devices at Pfizer Inc., with the lead for Combination Products, diagnostics and software medical devices. She was previously the Senior Officer, Medical Device Initiative of The Pew Charitable Trusts and Head of the PPD Medical Device and Diagnostics group. She began her career as an FDA medical device reviewer. Kirsten has a BS from Boston University and an MS in Bioengineering from Penn State.

Roger Quan is currently a Senior Director in the Regulatory Affairs CMC organization. In his current role, Roger leads a group of regulatory professionals supporting both small molecule and biologic programs. Prior to joining the regulatory affairs CMC group, Roger’s work experience at Abbott/AbbVie also included the R&D and manufacturing organizations.Roger received a B.S. (Honors) in Chemistry from the University of Michigan and a Ph.D. in Chemistry from California Institute of Technology. After spending two years as a post-doctoral scholar at Harvard, Roger was employed at Amoco Chemical Company for three years.

Acting Director for the Division of Inspection Assessment within OPQ/OPF. His division is primarily responsible for the center level discipline review of facilities and inspections in support of drug applications. He joined the Agency in November 2009 after graduating with his PharmD from the University of Maryland and his MBA from the University of Baltimore. Prior to FDA, he had experience in the generic pharmaceuticals industry. He continues to practice pharmacy in the community setting.

Xianglin Shi went on to Emory University, Atlanta, Georgia for his Ph.D. under the direction of Prof. Lanny S. Liebeskind and received his Ph.D. in 2000. He held positions of increasing responsibility in process R&D and scale-up for drug intermediates and candidates in early and late stage development. Since 2006, he has been a senior and principal scientist in the process chemistry group for small molecules at Biogen, Cambridge, Massachusetts and been involved in process R&D, scale-up, and CMC activities. Recently, he has been engaged in oligonucleotide API process development, validation, CMC, and Spinraza worldwide NDA. He is responsible for the oligonucleotide synthesis process development and scale-up for manufacturing.

Dr. Ramesh K. Sood is a Division Director (Acting) in the Office of New Drug Quality Assessment, Food and Drug Administration, Silver Spring. He received his Ph.D. in organic chemistry from the Queen’s University, Kingston, Canada. Prior to joining the FDA, he has worked for several years in biopharmaceutical industry as a research scientist. He joined the FDA in 2001 as a review chemist. During the last twelve years at the FDA he has held positions of a Team Leader and a Branch Chief.

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

Zhengyu WU, is Regulatory Affairs Director, Novo Nordisk. Zhengyu WU is responsible for Regulatory Policy & Intelligence, Regulatory CMC, and clinical trial applications, new drug applications and product lifecycle maintenance of some Diabetes Finished Products in China. Zhengyu WU has been dedicating to activities between industry associations and regulatory authorities, especially focusing on the advocacy and negotiation on regulatory reform of QC test / method verification for regulatory approval, Chinese Pharmacopeia, Drug Master File, CMC relevant guidelines and CMC dossier requirements for biologics, he is a council member of CMC working group, and the leader of Drug Master File taskforce of RDPAC.

Dr. Buhse joined OTR in 2001 as Deputy Director of Division of Pharmaceutical Analysis. She was promoted to Division Director in 2004 and has been Director of Office of Testing and Research since 2013. Dr. Buhse received a B.A. in Chemistry from Grinnell College and a Ph.D. in Physical Chemistry from the University of California, Berkeley. Before joining FDA, she worked in management positions in Production, Validation and Analytical Services at Sigma Aldrich Corporation and as a Senior Research Scientist for Rohm & Haas Company. She leads a laboratory based office in the CDER responsible for supporting FDA review, investigation and enforcement actions and for conducting research programs to advance the science of human drug quality.

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.

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.

Jennifer Groh is a process development engineer with Eli Lilly and Company. She joined Lilly in 2009 after graduating from Rose-Hulman Institute of Technology with a BS in chemical engineering and began working in small molecule design and development. The focus of her work has been developing continuous processes for small molecule drug substance. This includes three GMP, multi-step, continuous processes featuring PFRs, CSTRs, distillation, crystallization, and liquid-liquid extractions. The first small volume continuous process, comprising a complete registered sequence, was published in Science in June 2017. Recently she has transitioned to peptide process development.

Pramod Kotwal, PhD Director, CMC Policy Merck & Co., Inc., West Point, PA Pramod is a seasoned Pharmaceutical CMC regulatory professional with global CMC regulatory, quality compliance and pharmaceutical development experience. He is a Director in the CMC Policy group at Merck & Co., Inc. and supports activities related to review of global draft and final policies impacting CMC and Quality and associated internal communications as well as stakeholder training. Pramod also serves as an advisor to small molecule CMC teams for developing CMC regulatory strategies and dossiers content for global registrations. Pramod holds a Ph.D. in Pharmaceutical Chemistry from the Univ. of Kansas and did his thesis work under Prof Takeru Higuchi.

Connie Langer is a Senior Director at Pfizer who leads a team that monitors and advises on regulatory changes and impacts. She collaborates with experts to communicate Pfizer's feedback and position to health authorities on regulations and guidance documents. She also has experience implementing science- and risk-based approaches and recommending strategic regulatory options to achieve product approvals globally. She is a member of the ISPE PQLI® ICH Q12 Working Team and chair of the IQ ICH Q12 Working Group. She holds BS in Chemical Engineering and an MS in Chemical Oceanography both from the University of Connecticut, and a Drug Development Certificate from Temple University.

Dr. Mire-Sluis is currently Head of Global Quality at AstraZeneca. He was previously Vice President, Quality at Amgen Inc. Prior to working at Amgen, he was Principal Advisor, OBP, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA. He was Director of BioAnalytical Sciences at Genentech prior to joining FDA. Dr. Mire-Sluis was the Head of the Cytokine Group at NIBSC in the UK. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry.

CDR QuynhNhu Nguyen is an engineer officer and has been with FDA for more than 13 years. She began her work at FDA evaluating human factors (HF) and use safety of medical products with the MedSun project in Office of Surveillance and Biometrics, then with the Human Factors Premarket Evaluation Team in Office of Device Evaluation within the Center for Devices and Radiological Health, and now with the Division of Medication Error Prevention and Analysis (DMEPA).She currently serves as the Associate Director for Human Factors for DMPEA and her current responsibilities include developing policy and best practices for HF reviews to ensure clarity and consistency within the Division.

Scott Nichols graduated from the University of Iowa with Honors BS in Biochemistry with research expertise in biochemical protein:endotoxin interactions. He continued as a Fulbright Scholar in the Microbiology Division at the Pasteur Institute in Paris, France and subsequently worked in a Structural Biology laboratory at Brown University in Providence, RI. He completed his Ph.D. in Molecular Biophysics at Johns Hopkins University in Baltimore, MD. He currently works as a Microbiology reviewer of biotechnology drugs and an inspector of biotechnology drug manufacturing facilities for the Division of Microbiology at the FDA/CDER/OPQ/OPF.

Dr. Hasmukh Patel is the Division Director in the Division of Post-Marketing Activities 1 (for NDAs) in the Office of Lifecycle Drug Products (OLDP), OPQ, CDER. He is with the FDA for more than 20 years. Pharmaceutical Science (OPS). Dr. Patel has extensive technical, regulatory and managerial experience. His work experience includes review of Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and NDA supplements for a wide variety of dosage forms and drug products. He has also served on various technical committees at CDER. Currently he is a member of the Emerging Technology Team (ETT) at CDER. He received his Ph.D. degree in Organic Chemistry from the University of Georgia, Athens, Georgia and M.Sc. in chemistr

Dr. Mary Beth Pelletier is currently the Associate Director of QC Analytical Technology at Biogen in Research Triangle Park, NC, where her team supports development, optimization, validation, transfer, troubleshooting, and lifecycle maintenance of analytical methods for Biogen’s biologics and gene therapy portfolio from Phase 1 throughout the commercial lifecycle. Mary Beth is also a member of the ICH Expert Working Group for Q2(R2) and Q14. She received her bachelor’s degree in chemistry from Northwestern University in Evanston, IL and her Ph.D. in chemistry from The Scripps Research Institute in La Jolla, CA. Prior to her positions at Biogen, Mary Beth held positions in biologics formulation development and analytical development.

Dr. Prasad Peri is currently Senior Director of Regulatory Affairs CMC for US based submissions at Teva Branded Pharmaceutical Products R&D Inc. based on Frazer, PA. His responsibilities include applications that are within the modalities of small molecules, biologics and medical devices. Prior to joining Teva, he was a director within Global Regulatory Affairs and Safety responsible for CMC of combination products at Merck & Co. at West Point, PA. Prior to joining Merck, he was a Branch Chief for the review division within Office of New Drug Quality Assessment (now part of OPQ) responsible for the applications supporting the Divisions of Pulmonary, Allergy, Rheumatology, Anesthesia, Analgesia and Addiction Products.

Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. He represents Amgen in EFPIA MQEG and represents EFPIA on GMPs/inspections, in ICH training and ICH-QDG and before on ICHQ9, ICH Q-IWG and ICHQ7-IWG. In PDA he was at the board and chaired RAQAB.

Kimber Barnett, Ph.D. is a Research Fellow with more than 20 years of experience working in Analytical Research and Development at Pfizer in Groton, CT. In her current role, Kimber serves as a technical team leader responsible for late stage analytical development of small molecule drug substances and drug products as well as the late stage HPLC Method Development Group. She has been active in the Analytical QbD/Method Lifecycle area for nearly 10 years and is a member of the USP Validation and Verification Expert Panel and the British Pharmacopoeia Analytical QbD Expert Working Party.

Jennifer L. Brown is a Director in the Global Chemistry, Manufacturing and Controls group within Global Regulatory Affairs at Pfizer Inc in Groton, CT. She and her team are responsible for CMC strategy for a global portfolio of investigational and commercial products. Jen received her B.S. in Chemistry from Muhlenberg College in Allentown, PA and an M.S. in Regulatory Affairs/Quality Assurance from Temple University. Jen started at Pfizer in Analytical R&D and has worked in Regulatory CMC for the past 18 years.

Andrew Kuzmission is a Senior Director in Global Regulatory Affairs CMC at Vertex Pharmaceuticals providing CMC regulatory strategy for multiple small molecule programs in late development. Prior to transitioning to Regulatory CMC Andrew spent 20 years in Analytical Development supporting late development small molecule programs in multiple therapeutic areas. He received a BS degree in chemistry from Bucknell University and a PhD in Analytical Chemistry from The Ohio State University. Prior to joining Vertex Pharmaceuticals in 2010 Andrew worked at Johnson & Johnson for 13 years within the Analytical Development group in positions of increasing responsibility.

Ingrid Markovic, Ph.D. serves as the CMC Policy Lead in the CBER Office of the Center Director where she spearheads CMC Policy activities partnering with internal and external stakeholders to ensure consistent interpretation and application of CMC policies and programs. In the international arena, Ingrid was/is ICH Quality Lead for CBER, and additionally, FDA topic co-lead for QDG, M4Q and Q12. She had opportunity to briefly serve as Q3E Rapporteur. Ingrid worked in industry leading US & EU CMC Reg Policy efforts focusing on Manufacturing Innovation and Cell & Gene Therapies. She collaborated with Trade Associations (PhRMA & BIO) supporting continual improvement and innovation of Biopharmaceutical sector.

Raj K. Puri, M.D., Ph.D. is a director of the Division of Cellular and Gene Therapies (DCGT) in the Office of Tissues and Advanced Therapies (OTAT) at FDA’s Center for Biologics Evaluation and Research (CBER). He has been directing this division for more than16 years. He is also a Chief of Tumor Vaccines and Biotechnology Branch within the same division. Dr. Puri has held various positions in CBER as a reviewer and laboratory chief prior to selection as a division director. Prior to joining FDA/CBER, Dr. Puri was trained at National Cancer Institute’s Surgery Branch in immunotherapy approaches for cancer and at Mayo Clinic, Rochester, Minnesota. At CBER, Dr. Puri oversees evaluation and regulation of advanced therapies including cell and

Norman R. Schmuff joined the FDA in 1990. For more than 20 years, he has participated in ICH as a member of several Expert Working Groups. He was the Rapporteur for the M4 CTD (eCTD) – Quality Implementation Working Group. He is involved in many FDA electronic submission initiatives, including the Pharmaceutical Quality/Chemistry, Manufacturing, and Controls structured data project. He is also serves as a delegate to the International Organization for Standardization's (ISO) Technical Committee (TC 215) on health informatics which deals with the IDMP standards. Currently he is Associate Director in FDA’s Office of Process and Facilities in CDER. He has never served time in prison.

Dr. Schwartz, the Director of the Division of Post-Marketing Activities II in the Office of Lifecycle Drug Products, received a Ph.D. in chemistry from the City University of New York. He did post-doctoral research in the Biophysics Department of Michigan State University in the area of anticancer cisplatin drugs. He continued research in this field on a National Cancer Institute contract with the pharmacology department at Veterans Administration Medical Center in Charleston, South Carolina. His work led to a number of patents and publications and he was presented with the Inventors Award for Federal scientists by the Department of Commerce.

John Towns PhD is Senior Research Fellow at Eli Lilly with responsibilities for Lilly’s portfolio of stand-alone devices and combination products. John’s prior experiences include Senior Director of CMC Regulatory Affairs and Head, Bioanalytical Development. John has presented/published on injectable combination products and his research interests center on the requirements for delivery systems entering into clinical trials and reduction of medication errors through clarity of instructions, appropriate user training and clear product differentiation. John received his BS in Chemistry from Cal Poly, CA and his PhD in Analytical Chemistry from Purdue.

Lawrence X. Yu, Ph.D., is the Director, Office of New Drug Products, Food and Drug Administration and Rapporteur, ICH M4Q(R2) Expert Working Group. Dr. Yu is also an adjunct Professor at the University of Michigan. Dr. Yu is an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored over 150 papers and given over 400 invited presentations. He is a co-editor of the books entitled “Biopharmaceutics Applications in Drug Development”, “FDA Bioequivalence Standards”, and “Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, 2nd Ed.”

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.

Fubin Wu is the co-founder and president of GessNet™, providing consulting and software tools for medical device and combination product risk management, safety assurance cases and cybersecurity. Having served for over 30 companies, Fubin has the experience with a broad range of medical products including drug delivery combination products, infusion pumps, mobile medical applications, implantable devices, remote monitoring systems, and standalone software devices. He also teaches public courses on risk management, safety assurance cases and cybersecurity at PDA, AAMI and Xavier Health university.

Commander Geoffrey Wu, Ph.D., PMP, CPH, Deputy Office Director, Office of Lifecycle Drug Products (OLDP), Office of Pharmaceutical Quality (OPQ), joined the FDA’s Office of Testing and Research (OTR) in 2010, has served as research scientist, science staff, chemistry reviewer, special assistant to the Office Director, staff supervisor (Division Director equivalent), Associate Director of Sciences and Communication (ADSC), acting Division Director, and Deputy Office Director. He is a scientist officer in the United States Public Health Service. Throughout his FDA tenure, he has been deeply involved, leading or co-leading regulatory review and research for generic drugs premarketing assessment, post-approval changes for new and generic drugs