Peter J. Hotez, MD, PhD
Baylor College of Medicine
Peter Hotez MD Ph.D. is a professor of pediatrics and molecular virology at Baylor College of Medicine, where he is also co-director of the Texas Children’s Center for Vaccine Development and Endowed Chair in Tropical Pediatrics. He is a vaccine scientist who led the development of vaccines to prevent and treat neglected tropical diseases and coronavirus infections. A new Texas Children’s COVID19 vaccine is being accelerated in India now undergoing clinical testing.
Prof. Hotez obtained his undergraduate degree from Yale University and his MD and Ph.D. from Weil Cornell Medical College and Rockefeller University. He is the author of more than 550 scientific articles indexed on PubMed, and 4 single-author books. He is an elected member of the National Academy of Medicine and American Academy of Arts & Sciences, and has been honored by PAHO/WHO, Research America, B’nai Brith, American Society of Tropical Medicine & Hygiene, and other organizations. He appears frequently on major news outlets promoting global health, and vaccines and immunizations, countering antivaccine and Antiscience movements.
Laura S. Huffman, MS
Laura Huffman joined the FDA in 2004 and is currently a Master Microbiology Reviewer in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at CVM. Her roles include pre-approval inspection and mutual recognition policy for CVM. She also serves as CVM’s representative to USP’s Expert Committee for Microbiology. Prior to joining the FDA, Laura worked in regulation and manufacturing of food and biologics.
Laura received a Bachelor of Science in Biology and a Master of Science in Food Science and Technology, both with microbiology focus, from Virginia Tech.
Maik W. Jornitz, MSEng
G-CON Manufacturing Inc
Maik W. Jornitz, President and CEO of G-CON Manufacturing Inc., is a technical expert with close to 35 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. Jornitz has published multiple books and book chapters and over 100 scientific papers. He is the former Chair of the PDA Board of Directors and Science Advisory Board, and member of multiple PDA Task Forces. He is working member of Biophorum, ASTM, an advisory board member of the Biotechnology Industry Council, ICAV and multiple science journals. He recently has been recognized as one of the top ten global industry influencers. As a faculty member of various training activities, including PDA TRI, he trains members of the industry and regulatory authorities on a frequent basis. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland
Amin Khan, PhD
GreenLight Biosciences, Inc.
Dr. Amin Khan joined GreenLight Biosciences in April, 2021 as Chief Science Officer, Human Health. Prior to joining this mRNA-based biotech company, he spent 25+ years in pharmaceutical and vaccines R&D, encompassing small and large molecule drugs, biologics and vaccines. Most recently, he has led technical R&D teams at Novartis and GSK, where his teams's contributions enabled the development and launch of Bexsero® and Shingrix®, vaccines, and the accelerated development of mid-stage vaccine assets, including for RSV, HSV, and CMV. He also held accountability for scientific gating and prioritization of GSK’s vaccine discovery portfolio.
Dr. Khan led GSK Vaccines R&D Acceleration (March 2019 – March 2021) with accountability for end-to-end acceleration of the vaccine portfolio. He joined GSK (2015) to head Global Vaccines Technical R&D, having held an equivalent position at Novartis Vaccines (2011-2015). Prior to joining the vaccines industry, Dr. Khan spent more than 20 years working on small molecule drug, and biotherapeutic product, process and analytical development; Trinity Biosystems, Inc (2008-2010), Eli Lilly and Company (1998-2008), West Pharmaceutical Services (1993-1998), and Enzytech, Inc (1989-1993). He holds a Ph.D., in Pharmaceutical Sciences from the University of Nottingham, U.K.
Lily Y. Koo, PhD
Lily Koo is a biomedical engineer working in the Office of Director at FDA’s Center for Biologics Evaluation and Research (CBER). Previously, she worked as a Consumer Safety Officer in the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance and Biologics Quality (OCBQ) in CBER where she was responsible for the review of facility and equipment information in license applications and supplements and conducted pre-license and pre-approval inspections of biologics manufacturing facilities. Prior to joining CBER, she worked at the Center for Device and Radiological Health and the National Institutes of Health. Lily received her B.S. in bioengineering from University of Pennsylvania and her Ph.D. in chemical engineering from Massachusetts Institute of Technology.
Thomas R. Kreil, PhD
Beyond his work at Takeda, he is Chairman of the Plasma Protein Therapeutics Association’s (PPTA) Pathogen Safety Steering Committee, a Steering Committee member of the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) as coordinated by the Massachusetts Institute of Technology (MIT), and an Associate Professor at the Institute of Virology, Medical University of Vienna.
Stephen E. Langille, PhD
Dr. Stephen Langille is a Senior Microbiology Consultant at ValSource, Inc. He specializes in microbiological and particulate matter contamination control of drug, device, and biological products. He holds a B.S. degree in Biology from the University of Massachusetts and a Ph.D.in Microbiology from the University of Maryland. Prior to joining ValSource in 2019, he spent 19 years with the FDA as a Microbiology Reviewer, Branch Chief, and Director of the Division of Microbiology assessment in the Center for Drug Evaluation and Research. He currently serves as a member of the United States Pharmacopoeia’s Visual Inspection of Parenterals Expert Panel as well as several Parenteral Drug Association technical committees.
Michele Lastro, MS, PhD
Regeneron Pharmaceuticals, Inc.
Michele Lastro received her B.S., M.S., and Ph.D. from Cornell University. Michele joined Regeneron Pharmaceuticals, Inc. in 2007 and is currently Executive Director, CMC Regulatory Sciences within the Industrial Operations and Product Supply organization. She directs a CMC Regulatory Sciences group responsible for the preparation and management of CMC content for global clinical and commercial regulatory submissions. Within CMC Regulatory Sciences, she also directs a sciences and engineering group responsible for product comparability.
Prior to joining Regeneron, Michele was a post-doctoral associate at the State University of New York’s Ge*NY*sis Center for Excellence in Cancer Genomics where she performed mid to high-throughput RNA interference-based functional genomic screens to identify novel regulatory mechanisms in mammalian cell cycle progression and cancer development.
Sau (Larry) Lee, PhD
Dr. Sau (Larry) Lee is the Deputy Super Office Director of Science in the Office of Pharmaceutical Quality. He directs the activities of staff members in OPQ sub-offices responsible for the quality assessment of regulatory submissions (OBP, OLDP, ONDP and OPMA). He represents OPQ in programs and activities that impact quality assessments by coordinating with OPQ, CDER, and ORA. He also serves as the point person for the pharmaceutical industry and scientific/academic groups in developing programs to support science- and risk-based application assessment and approval.
Dr. Lee has been with the FDA since 2005, serving as a regulatory scientist, team lead, Associate Director for Science, Deputy Office Director, and Office Director. He has provided exemplary leadership in developing OPQ science, research and testing programs to support quality assessment, inspection, surveillance and policy. In 2016, Dr. Lee was appointed to the Senior Biomedical Research Service (SBRS) because of his extensive regulatory and scientific contributions to manufacturing science, complex drug substances and products, and emerging pharmaceutical technologies. Prior to joining the FDA, Dr. Lee received a B.S. degree in Chemical Engineering from the University of Virginia with a minor in Materials Science and a Ph.D. in Chemical Engineering from Princeton University.
Matthew A. Lucia, DVM
Dr. Matthew Lucia received his Bachelor of Arts in Biology from Colgate University, and his Doctorate of Veterinary Medicine from the Virginia-Maryland College of Veterinary Medicine. Dr. Lucia practiced small animal clinical medicine for five years before joining the Center for Veterinary Medicine, Office of New Animal Drug Evaluation (ONADE) in 2006, where he worked as a reviewer in the Division of Therapeutic Drugs for Food Animals first on the Aquaculture Drugs Team and then on the Antiparasitic and Physiologic Drugs Team. In September 2010, he became the Team Leader for the Swine and Poultry Drugs Team in the Division of Production Drugs and in August 2016, he became the Director of the Division of Generic Animal Drugs. In June 2018, he took on his current role as the Director, ONADE.
Nichols F. Lyons, MS
Nicholas F. Lyons, Director of Compliance for Office of Regulatory Affairs’ Office of Pharmaceutical Products, Division III
Scholastically graduated with a M.S. degree, in science from the Illinois Institute of Technology, Chicago Illinois.
Six years of industry experience prior to joining the Agency focusing in antiviral drug research and development.
Roughly 25 years of experience with the Food & Drug Administration. Essentially, I started out as a consumer safety officer within the Chicago District Office and transitioned to management. In 2013, I had the opportunity to become the FDA import supervisor for the Port of O’Hare and the International Mail Facility.
In 2014, I became the Director of Compliance (DCB) within Chicago District and was responsible for Illinois domestic cases and all import cases through the Port of O’Hare that included the International Mail Facility. In May of 2017, I became the Director of Compliance for Pharma Division III, focusing on the pharma program area, foreign and domestic. I have been involved with numerous warning letters and judicial actions while serving as the DCB for Chicago District and the Pharma Program area. Many of these actions assisted in moving the quality of manufactured products into compliance and ensuring public health.
Peter W. Marks, MD, PhD
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.
Dr. McMeekin is the Associate Commissioner for Regulatory Affairs (ACRA) within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). She has responsibility for over 5,000 staff and operations in ORA. ORA is FDA’s “field force” supporting FDA’s product centers through responsibilities including, inspections and investigations, including criminal investigations, compliance and enforcement, import operations, regulatory science and field laboratory operations. ORA also works closely with global, federal, state, local, tribal and territorial partners, and administers contracts, grants and cooperative agreements to advance an integrated system and ensure an effective public health safety net.
Prior to becoming ACRA, Dr. McMeekin served as the Deputy Associate Commissioner for Regulatory Affairs, Acting Director of ORA’s Office of Strategic Planning and Operational Policy and as the Director, Division of Operational Policy. Dr. McMeekin began her FDA career in the Center for Drug Evaluation and Research in the Office of Compliance, eventually serving as the Director, Division of Prescription Drugs. Before joining FDA, she worked for the United States Pharmacopeia, and several health systems as a clinical pharmacist.
Dr. McMeekin received her Bachelor of Science degree in pharmacy and her Doctor of Pharmacy degree from Northeastern University in Boston, MA.
John M. McShane, MBA
Lachman Consultant Services, Inc.
John McShane is a Vice President at Lachman Consultants. Before consulting, he spent 37 years between Abbott Laboratories and Genentech. He has demonstrated expertise in critical Quality remediation and Quality System implementation, manufacturing operations, pharmaceutical validation and technical transfer.
Steven R. Mendivil, BS
Steven Mendivil is currently a part time contractor and Senior Advisor for Amgen in International Quality. He had been with Amgen for 19 years and was Executive Director of International Quality, External Affairs. He was previously head of Corporate Quality GMP & EHS and was on the ICH Q11 Expert Working Group and on the ICH Q7 Implementation Working Group. Prior to Amgen, Steve worked for 5 years at Genentech in Quality and 10 years at Syntex in Regulatory Affairs, Quality and Manufacturing. Steve also consults for a number of companies.
He was on the PDA Board of Directors as an Executive Officer and has led various external committees on GMP related topics. Steve is currently PDA’s Quality Metric /Culture Task Force leader.
He has also taught at UC Berkley extension course on Biotechnology and at USC graduate school for Regulatory Affairs.
Steve holds a BS from University of California at Davis and is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society.
Melissa J. Mendoza, JD
Melissa Mendoza is the Deputy Director of the Office of Compliance and Biologics Quality (OCBQ) in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration. OCBQ is responsible for ensuring the quality of products regulated by CBER over their entire lifecycle, from pre-market review and inspection to post-market review, surveillance, inspection, outreach, and compliance. Before joining CBER, Melissa served for eight years in FDA’s Office of the Chief Counsel where she was an Associate Chief Counsel for Enforcement.
LCDR Jeffrey D. Meng
Lieutenant Commander Jeffrey Meng is an engineer officer in the U.S. Public Health Service and currently serves as the Director of Investigations Branch for the Division of Pharmaceutical Quality Operations III within the ORA Office of Pharmaceutical Quality Operations. LCDR Meng leads a team of nearly 60 FDA pharmaceutical investigators, supervisors, and support staff conducting facility inspections and investigations throughout the US Midwest and internationally in support of FDA’s mission to provide safe and effective pharmaceuticals for the American public.
LCDR Meng began his FDA career in 2009 as an Investigator with advancing roles as a Drug Specialist and Supervisory Investigator prior to his current position as the Director of Investigations Branch while leveraging broad experiences including rotations to the FDA China Office in Shanghai and to the Center for Drug Evaluation and Research (CDER) within what is now the Office of Quality Surveillance (OQS). He continues to be heavily involved in major Agency initiatives such as the New Inspection Protocol Project, Compounding Center of Excellence, and the Pharmaceutical Investigator Course Advisory Group. LCDR Meng obtained his B.S.E. and M.S.E. in Biomedical Engineering from the University of Michigan.
Frank Montgomery, PhD
Frank Montgomery was awarded his PhD in Synthetic Organic Chemistry at Imperial College London and completed Post Doctoral studies at Ohio State University. He is now Global Head Regulatory CMC for AstraZeneca.
Frank is a member of ICH Implementation Working Group (IWG) as EFPIA Expert for ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management working alongside ICH regulatory agency members drafting the guideline. He has been a member of the IWG since its initiation in 2014 and has been responsible for leading teams drafting several sections of the guideline.
He has presented and organised several international conferences on implementation of QbD & ICH Q12 for DIA, ISPE, PDA, CASSS, facilitated training activities for a number of regulatory agencies and joint workshops with regulatory agencies EMA/FDA/ PMDA on learning from implementation of ICH Q8-11 and opportunities for ICH Q12.
Lisa C. Newcombe-Dierl
Lisa Newcombe-Dierl has led the Corporate Quality team at Amgen since 2019 which encompasses overseeing the Quality Management System, External Supplier Quality, International & Distribution Quality, Learning & Performance, GxP Validation/Data Integrity and last year took over leading Amgen’s Combo Product Development and Manufacturing (CPDM) Initiative. Prior to joining Amgen, for the past 25 years, Lisa has held diverse leadership roles in operations, quality, and regulatory within the pharmaceutical, medical device and other industries driving exemplary compliance and business results. Prior to this Lisa was an entrepreneur running her own network of analytical laboratories which she sold to what is now Thermo Fisher. She holds a B.S. in Physiology and a B.A. in Microbiology from the University of Minnesota.
Roger Nosal, MA
Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. He is accountable for development, preparation & prosecution of regulatory CMC applications for new commercial products & investigational applications (small & large molecules, combination products, vaccines, gene/cell therapies) globally. Roger was instrumental in development & implementation of Quality by Design & has advocated for global regulatory harmonization & mutual reliance as PhRMA representative to several ICH Expert & Implementation Working Groups since 1997 & through more than 190 presentations at technical conferences. He is currently Rapporteur for ICH QDG & PhRMA lead to ICH M9 EWG, BCS Biowaivers, & PhRMA CMC expert for ICH Q12 IWG & the 2013-2014 QDG. Roger served as Chair to several PhRMA, ICH, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees. In 2013 Roger was awarded the Pharmaceutical Discovery, Development and Manufacturing Forum Award from the American Institute of Chemical Engineers (AIChE) for outstanding contributions to advancing QbD.
Roger’s 40 years of experience at G. D. Searle, Monsanto, Pharmacia & Pfizer, includes 27 years in regulatory affairs & 13 as a Medicinal & Process Chemist and author of 24 patents.