Speaker Bios 2nd FDA/PQRI Conference on Advancing Product … · 2015. 10. 1. · aaps. He is the recipient of the 2014 AAPS Research Achievement Award in Physical Pharmacy and Biopharmaceutics

Speaker Bios 2nd FDA/PQRI Conference on Advancing Product Quality

Professor Bertil Abrahamsson, Ph.D.

Dr. Abrahamsson has a broad experience of industrial drug development from more than 25 years of work with Astra and AstraZeneca. During this period he has had various line and project management positions. Presently he is a Senior Principal Scientist with emphasis on biopharmaceutics., In this role he is leading biopharmaceutics research and product development support on a global basis. In addition, as one

of the most senior scientists in AZ Pharmaceutical Development he is also a member of the local as well as the extended global leadership teams.

Dr. Abrahamsson is an internationally recognised scientist and he has published more than 80 papers in the area of oral biopharmaceutics and drug delivery. He is presently an adjunct Professor in Biopharmaceutics at Uppsala University. He initiated and is currently leading a major european private public partnership project in oral biopharmaceutics area ( http://www.orbitoproject.eu).

Ilgaz Akseli, Ph.D., MBA

Dr. Akseli is a Senior Associate Director in the Pharmaceutical Development department in Boehringer-Ingelheim Pharmaceuticals, Ridgefield, CT. He is the head of the Formulation Material Profiling and Computational Modeling Labs. Two labs are in the global level and his team is guiding and supporting the formulation and process development for drug candidates in assigned therapeutic areas. Dr. Akseli earned his BSc degree in Mechanical Engineering with a focus on Design of Powder Compaction.

He has two MSc degrees; one is in Materials Science and Engineering from University College London with a focus on Metal Powder Compaction and the other degree is in Business Management from London School of Economics with a focus on Lean Six Sigma implementations in the Pharmaceutical Industry. He earned his Ph.D. degree in Pharmaceutical Engineering from Clarkson University, USA. He did his Post-doctoral studies at Rutgers University in the Engineering Research Center (ERC) for Particulate Systems and Pharmaceuticals. He has authored of 36 refereed journal papers, 58 conference papers & presentations, 8 scientific magazine articles, 2 book chapters & 2 patents.

Barbara M. Allen, Ph.D.

Barbara Allen, Ph.D. is Head of Global Quality Systems for Eli Lilly and Company. Dr. Allen joined Eli Lilly and Company in 1991 in Ireland and has since held various assignments in API Manufacturing Technical Services, New Product Introduction, Quality Assurance, and Global Quality Systems, in Ireland and in the USA. In 2002, she began her current position in Global Quality Systems, where she is responsible for providing quality systems for Lilly and for ensuring that Quality Systems are integrated

across the corporation. Dr. Allen was a member of ICH Q10 EWG (Expert Working Group) representing PhRMA and currently serves as a member of IFPMA RPTS & EFPIA Efficiency in Operations Committee.

http://www.orbitoproject.eu/

2 | P a g e 2 n d F D A / P Q R I C o n f e r e n c e B i o s

Gregory E. Amidon, Ph.D

Dr. Amidon received his Bachelor of Science degree in Medicinal Chemistry (1974) and his Ph.D. in Pharmaceutical Chemistry (1979) from the University of Michigan at Ann Arbor, MI. He joined the University of Michigan, College of Pharmacy as Research Professor of Pharmaceutical Sciences after 28 years in the pharmaceutical industry. Prior to joining the University of Michigan in 2007, Dr. Amidon held research positions in pharmaceutical R&D for Pfizer, Pharmacia, Pharmacia & Upjohn, and The

Upjohn Company. His current research interests include oral bioperformance assessment and in vivo predictive dissolution. He is also recognized for his expertise in the physical, chemical and mechanical property characterization of active pharmaceutical ingredients, excipients, and products as well as the development of scientific strategies for oral solid dosage form development. Dr. Amidon has served in a number of leadership roles in the American Association of Pharmaceutical Scientists (AAPS) as well as the United States Pharmacopeia (USP). Dr. Amidon is a member, Fellow, and 2015 President-Elect of AAPS. He is the recipient of the 2014 AAPS Research Achievement Award in Physical Pharmacy and Biopharmaceutics as well as the 1983 Ebert Prize from the American Pharmaceutical Association. He has served as a member and Chair of several USP Expert Committees over the past 25 years and currently serves on the USP Board of Trustees representing pharmaceutical sciences.

Stefan Baier, Ph.D. Stefan Baier is a Senior Principal Scientist in the Measurement Sciences team, which is part of PepsiCo’s R&D Global Functions, Governance and Compliance. He leads global research projects around oral processing/material science analytics of reduced fat, sodium and sugar food and beverage products to increase consumer acceptability and implement reduction & nutrition strategies across PepsiCo. He received his

engineer's degree (Dipl.-Ing) from the Friedrich-Wilhelms University of Bonn, Germany in Food Technology and Engineering in 1999 and his Ph.D. in Food Science from the University of Massachusetts, Amherst, U.S.A. in 2003 in Food Colloids and Biopolymers. Before joining PepsiCo in 2010, he worked for Cargill, Inc. as a senior scientist from 2002-2008 and Frito-Lay North America (PepsiCo) from 2008-2010 as a project scientist for protein fortification of snack foods.

Alfred Berchielli, M.S.

Al Berchielli has been working in Drug Product Design group at Pfizer for the last twenty years and also worked in the Formulation group at Wyeth for 5 years. Al’s areas of expertise include development and scale-up of drug delivery systems (e.g., sustained release osmotic and matrix tablets). His research interests include IR/CR combinations, application of active ingredients in tablet coatings, controlled release functional coatings, and modeling of coating processes.

Al received his M.S. in Industrial Pharmacy from the Arnold and Marie Schwartz School of Pharmacy at Long Island University, New York, and his B.S. in Chemistry from the State University of New York College at Cortland. Al has several published patents / papers in the area of sustained release and tablet coating process modeling.


Professor Ecevit Bilgili

Dr. Ecevit Bilgili is an associate professor and associate chair of the Department of Chemical Engineering at New Jersey Institute of Technology (NJIT). After joining NJIT in Fall 2009, he established a Particle Engineering & Pharmaceutical Nanotechnology Laboratory, where his group conducts research in designing formulations and processes for high-value-added

products like pharmaceuticals with enhanced functionalities. Prior to this academic position, Dr. Bilgili worked as Principal Development Engineer within R&D and Pharmaceutical Commercialization Technology Department at Merck & Co., Inc during 2004–2009. He holds a B.S. degree from Bogazici University in Istanbul, Turkey and Ph.D. from the Illinois Institute of Technology, Chicago. He worked as a post-doctoral research associate at the Particle Engineering Research Center, University of Florida. Dr. Bilgili is a well-recognized member of the Particle Technology Community. He served as an elected Executive Committee Member of the Particle Technology Forum of AIChE and as the Chair of AIChE Area3a: Particle Production and Characterization. He is currently the leader of Project A1: Particle Formation within the NSF ERC for Structured Organic Particulate Systems. He also serves as the 2015 Programming Co-Chair (2016 Chair) of Pharmaceutical Development to Manufacturing Area of AIChE. Dr. Bilgili has authored 56 peer-reviewed journal articles, 3 U.S. patents (one recently filed), 2 provisional patents, and several invention disclosures. He delivered 70+ national/international presentations and 20+ invited talks. He has served as a guest editor to Powder Technology Journal and referee to 18 engineering and pharmaceutics journals, as a chair/co-chair in 24 sessions of national/international conferences, and as a member of AIChE and ACS. He was one of the organizers of the Topical Conference titled Pharmaceutical Engineering for the 21st Century at the AIChE Annual Meeting in 2007. Dr. Bilgili is the recipient of the Best PhD Thesis in Particle Technology Award from AIChE, Who’s Who in Science and Engineering, and NJIT’s Excellence in Teaching Award among many others. His research is funded by NSF ERC and several major pharmaceutical companies.

Ashley Boam, MSBE Ashley Boam currently serves as acting Director of the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER). OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including application review and inspection. This Office also

coordinates OPQ’s work with international regulatory authorities on quality issues, leads CDER’s compendial operations, coordinates CDER’s involvement in quality standard-setting organizations, and addresses policy issues related to drug-device combination products. Prior to joining CDER, Ashley spent nearly 20 years in the Office of Device Evaluation (ODE) in FDA’s Center for Devices and Radiological Health (CDRH), serving as a scientific reviewer, a Branch Chief in the Division of Cardiology Devices, and finally as Associate Director for Regulations and Guidance for ODE. Ashley received her MSBE from the University of Alabama at Birmingham and her BSE from Tulane University, both in Biomedical Engineering.


Lucinda Buhse, Ph.D. Dr. Buhse joined OTR in 2001 as Deputy Director of Division of Pharmaceutical Analysis. She was promoted to Division Director in June, 2004 and has been Director of Office of Testing and Research since June 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 under the direction of John H. Clark and George C.

Pimentel. Before joining FDA, Dr. Buhse worked in management positions in Production, Validation and Analytical Services at Sigma Aldrich Corporation and as a Senior Research Scientist for Rohm and Haas Company. She leads a laboratory based office in the Center for Drug Evaluation and Research (CDER) responsible for supporting FDA review, investigation and enforcement actions and for conducting research programs to advance the science of human drug quality.

Monica Cahilly

Monica Cahilly, President, Green Mountain Quality Assurance, LLC has been consulting nationally and internationally for 23 years, with specialized interest in Data Integrity Assurance, 21 CFR Part 11 and Computer Systems Validation.

Monica’s work includes data integrity inspections, application integrity policy, consent decree audits, preparing responses and corrective action plans for FDA

regulatory observations, developing global and site Data Integrity and computer / Part 11 compliance programs, and training. Monica was invited in February 2009 by U.S. FDA to present to CDER Offices of Compliance the topic of ‘Detecting Aberrant GxP Data and Handling Practices’ and has subsequently been invited to provide on-going training in 2010 through 2015 in the topic of Data Integrity Investigations to U.S. FDA as well as to the World Health Organization (WHO), the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the Chinese National Institute of Food and Drug Control (NIFDC), the Irish Health Products Regulatory Agency (HPRA), Health Canada, the European Medicines Agency (EMA), the Italian Medicines Agency (AIFA), China Food and Drug Administration (CFDA), the Swissmedic, and others. Monica’s most recent interests include working in healthcare policy to prevent and detect data integrity issues as these relate to safe, effective, and cost-effective medicines.

Monica has a bachelor’s degree in Biochemistry from Dartmouth College, a master’s degree in Genetic Toxicology from M.I.T., is a member of ISPE, PDA, DIA, and SQA and is RQAP-GLP.

Yanxi Tan Cain, Ph.D.

Yanxi is the Regional Head of Quality Operation, Novartis Pharma and the Pharma Quality lead for Continuous Manufacturing.

She joined Novartis in 2011, and has over 20 years of diverse global experience in the areas of drug research, development, technology transfer, commercial manufacturing, and global Quality Operations including Pfizer and Wyeth pharmaceutical companies.

Yanxi holds a PhD degree in Chemistry from McGill University, Montreal, Canada.


Jon Clark, M.S.

Jon Clark is Vice President, Chemical Medicines – External Development for the U.S. Pharmacopeia. Jon directs the efforts to develop monographs in the United States Pharmacopeia through close cooperation with manufacturers. Updating standards in the USP through the next 5 years is Jon’s leading priority.

Jon brings many years of experience in the global pharmaceutical industry and over 20 years of experience with the US Food & Drug Administration (FDA), coming to that institution in 1992. Jon held the title of Associate Director for Program Policy, Office of Pharmaceutical Science, in FDA’s Center for Drug Evaluation and Research for 10 years; advancing quality guidance and leading grant efforts that funded NIPTE, a consortium of research universities. Prior to this, he conducted reviews of the CMC portions of both NDA and ANDA applications, in the Offices of New Drug Chemistry and the Office of Generic Drugs, respectively. Prior to joining the Agency he was accomplished in developing drug substance synthesis processes over 12 years at Schering-Plough. Jon has a strong understanding of how USP–NF standards work in relation to the CMC part of a filing, and is cognizant as well of specific issues that are evolving at USP. These include monograph updating, the elemental impurity topic, ICH guidance, PDG, and allied areas of focus. In his roles at FDA, he had direct responsibility for advancing quality guidance, many of which speak to standards in USP–NF.

Jon was the FDA representative to the 1999 PQRI Blend Uniformity Working Group that resulted in 2003 PDA Journal article and influenced the draft FDA Guidance to Industry; “Powder Blends and Finished Dosage Units – Stratified In-Process Dosage Unit Sampling and Assessment” for which Jon was the lead and primary contact. He also facilitated FDA participation in development of ASTM 2709 and 2810. He continues to work with the evolution of that effort through ISPE in the Blend Uniformity and Dosage Unit (BUCU) discussion group which has published multiple papers on this topic.

Jon holds an M.S. in Chemistry from Rutgers University and a B.S. in Chemistry from University of Michigan Ann Arbor. Stephen Conway, Ph.D. Dr. Stephen Conway leads laboratory groups in the Center for Materials Science and Engineering at Merck, Manufacturing Division. The Center is comprised of a diverse group of materials scientists and engineers with specialization in molecular, particle-level and bulk characterization techniques. Steve supports Merck's oral solid dosage form development, specializing in physical characterization to ascertain material structure for excipients, active pharmaceutical ingredients, intermediates and drug products, relating structure to product performance and manufacturability. He currently shares his time between the West Point, Pennsylvania, and Rahway, New Jersey development facilities. Steve previously worked in manufacturing technical operations and process engineering functions at several of Merck's global small-molecule manufacturing sites. He holds chemical engineering degrees from the University of Birmingham (UK), MIT, and Rutgers. His PhD thesis was on the subject of “Instability and Segregation in Bounded Particulate Shear Flows” and fundamental aspects of flow and segregation processes remain a focus of his work in support of formulation and equipment design at Merck.


Tom Cosgrove Tom Cosgrove is the Director of the Office of Manufacturing Quality (OMQ) within FDA’s Center for Drug Evaluation and Research (CDER). In this role, he directs CDER’s compliance activities with respect to CGMP and product quality. Before OMQ, Tom led CDER’s Office of Unapproved Drugs and Labeling Compliance (OUDLC), where he was responsible for FDA’s compliance divisions covering drug approval and labeling

issues. Before joining CDER, Tom was a litigator in FDA’s Office of Chief Counsel, and prior to FDA, Tom was an attorney at Covington & Burling in Washington, D.C. Tom clerked for Judge Catherine Blake on the United States District Court for the District of Maryland and earned his law degree from The University of Michigan Law School.

James K. Drennen, III, Ph.D. Dr. Drennen received a B.S. in Pharmacy from Duquesne University in 1985 and a Ph.D. in Pharmaceutical Sciences from the University of Kentucky in 1990. He is presently Associate Dean for Research and Graduate Programs in the Mylan School of Pharmacy and Graduate School of Pharmaceutical Sciences at Duquesne University. He is a co-founder and former Director of the Duquesne University Center for Pharmaceutical Technology. Dr. Drennen was the recipient of the first

Buchi NIR Award, in September 2001 and the Duquesne University President’s Award for Excellence in Scholarship in 2011. Dr. Drennen is a founding partner in the consulting company Strategic Process Control Technologies, LLC, working with pharmaceutical manufacturers to improve quality and efficiency. He is Editor-in-Chief of the Journal of Pharmaceutical Innovation.

Joseph Famulare Joseph Famulare is Vice President - Global Quality Compliance and External Collaboration at Genentech/Roche, Pharma Technical Operations. He is active in aligning industry and international regulatory authorities around policy and harmonization, and also heads the company’s inspection readiness, GMP auditing and is integral to determining the company's compliance strategies, among other duties. Mr. Famulare

joined Genentech in 2009 as the Senior Director of Genentech's Quality and Compliance External Collaboration function after a 32-year career at FDA. He is the former Deputy Director, CDER Office of Compliance, FDA, where he led an extensive team heading GMP, GCP, and GLP Compliance programs. He was a founding member and served on the Council of Pharmaceutical Quality. He also held a number of progressive roles at FDA throughout years of public service. As a Member of ISPE for more than 15 years, he served as Industry Co-Chair of the ISPE/FDA/PQRI Quality Manufacturing Conference, and has led ISPE’s PQLI® Initiative, serves on the Regulatory Compliance Committee and Drug Shortages and Quality Metrics Initiatives. He is active in ISPE global activities as a speaker and panelist and chaired the 2013 ISPE Pharmaceutical Quality System (ICH Q10) Conference in China and has co-chaired successive ISPE/FDA co-sponsored conference over the past 5 years. Joe Famulare has actively participated on the International Leadership Forum (ILF). He recently co-led the publication of PQLI®'s Quality System Guideline on Process Performance and Product Quality Monitoring. He was elected to the ISPE International Board of Directors in 2010. Mr. Famulare has a BS in Biology and Environmental Studies from St. John's University and extensive training in manufacturing, microbiology and chemistry, regulatory risk management and leadership.


Liam Feely, Ph.D. Dr. Liam Feely is AbbVie’s Vice President of Manufacturing, Science and Technology. In this capacity he is responsible for the technology transfer of new products from R&D into commercial production and also the global technical support for currently marketed products. This covers drug substance, drug product, analytical methods and devices/combination products. He has a Degree in Pharmacy and a PhD in Pharmaceutics

from the University of Nottingham in the UK and 28 years of experience within the pharmaceutical industry. He has held a variety of CMC roles throughout his career including Director of Pharmaceutical Development in R&D and Division Vice President of Regulatory CMC before assuming his current position.

Professor Thomas Friedli

Thomas Friedli’s main research focus is the Management of Manufacturing Enterprises. His area of expertise is in Operational Excellence in the Pharmaceutical Industry, Collaboration Management, Management of Industrial Services, and Quality and Process Management.

He leads a group of postgraduate students who develop new management solutions for manufacturing companies in today’s business landscape. In 2007, he became an Associate Member to the International Academy for Quality (IAQ) and joined the SAQ (Swiss Association for Quality and Management Systems) as an advisory council in 2009. Furthermore, he is a member of the HSR Committee of Experts in Machinery/ Innovation. Since 2011 he is an Expert at the ‘Österreichischer Akkreditierungsrat’ and as of 2012, he is acting as president of the jury for the REHAU business award. Since 2014, he is an active member of the RUAG Holding Strategic Advisory Board.

He is teaching in several executive programmes in St. Gallen, Fribourg, Salzburg and Aachen. In fall 2008, he spent several weeks as Adjunct Associate Professor at the Purdue University in West Lafayette, USA. He is the editor, author or co-author of 13 books and various articles. Among his books are “Leading Operational Excellence in the Pharmaceutical Industry” published in 2013, "The Pathway to Operational Excellence in the Pharmaceutical Industry", published in 2010 as well as “Operational Excellence in the Pharmaceutical Industry”, published in 2006.

CDR Robert Gaines CDR Robert Gaines has been a pharmacist for more than 10 years. He has worked in various pharmacy roles with the Indian Health Service and the Substance Abuse and Mental Health Services Administration before joining the Food and Drug Administration in 2010. During his time at the FDA, he has worked as a Product Quality Regulatory Project Manager and a Regulatory Project Manager in the Office of Generic Drugs; a Senior Regulatory Review on the PDUFA user fee team in the Office of

Management; and the transition Quality Project Management Team Leader during the transition from Office of Pharmaceutical Sciences. CDR Gaines now serves as the Division Director for the Division of Regulatory and Business Process Management II in the Office of Program and Regulatory Operations in the new Office of Pharmaceutical Quality.


Mairead Goetz Mairead Goetz has over 25 years’ experience in the pharmaceutical industry including roles in all areas of Quality & Compliance over her time at Novartis, Merck and Schering Plough.

Mairead is currently Head of Compliance for Novartis in the Group Quality Compliance & Audit Organization. In this role Mairead has compliance oversight for Novartis across business units/divisions through risk based system assessments including Health Authority Inspections and quality metrics. Mairead has deep cross functional experience in quality and business process reengineering and is a Lean Six Sigma Certified Black Belt. Mairead currently leads ISPE’s Quality Metrics Team and formerly led their Quality Metrics Industry Engagement team . Mairead holds a Bachelor of Science in Chemistry from University College Cork, Ireland.

John Groskoph, B.S., M.B.A John Groskoph leads the New Products CMC function at Pfizer and has over 20 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.

Robert Iser Robert joined the FDA in 2003. He is currently the acting Senior Scientific Advisor in the Office of Process & Facilities (OPF), a part of the new Office of Pharmaceutical Quality (OPQ). Prior to the formation of OPQ, Robert was acting Associate Director for Policy Development in the Office of Pharmaceutical Science. He was also a Division Director and Team Leader in the Office of Generic Drugs. Robert is currently the FDA

Topic Lead on the ICH Q12 Expert Working Group. Prior to joining the FDA, Robert spent seven years in the pharmaceutical industry with industrial experience related to management of quality systems, analytical method development, and support of manufacturing process development, scale-up and validation. Robert has B.S and M.S. in Chemistry.


Orlando A. Jaquez Orlando Jaquez is Program Manager and Purification Lead, Biosimilars Technical Development at Biogen, based in Cambridge, MA, USA. With more than 10 years of experience in biotechnology, he has developed manufacturing processes for several complex originator biologics, including Avonex® (interferon beta 1a), Plegridy® (pegylated interferon beta 1a), Tysabri® (natalizumab), and BIIB033 (anti-Lingo-1 monoclonal antibody).

Mr. Jaquez was a founding member of Biogen’s Biosimilars Technical Development team, leading Biogen’s purification development activities for a portfolio of six biosimilar programs, in collaboration with partner Samsung Bioepis. In this capacity, Mr. Jaquez has overseen pre-clinical and commercial purification process development, technology transfer and process scale-up to Biogen’s global large scale manufacturing facilities, and the validation strategy to support aggressive regulatory filing timelines. Mr. Jaquez has focused his career in developing protein purification platforms to enable next generation drug substance manufacturing, including novel approaches to efficient non-chromatographic protein separations. He is an expert in Design of Experiments (DoE) methodology, and in defining process risk assessment and process control strategy at Biogen. Mr. Jaquez studied Biology and Finance at the Massachusetts Institute of Technology, where his research focused on X-ray protein crystallography of therapeutically-relevant flavoenzymes thioredoxin reductase and ribonucleotide reductase.

Bruce D. Johnson, Ph.D. Bruce D. Johnson, Ph.D. is Vice President of Consumer Healthcare (CHC) Research and Development for Perrigo Company plc. Perrigo is a leading global healthcare supplier and the world’s largest manufacturer of over-the-counter (OTC) pharmaceutical products for the store-brand market. Bruce oversees the company's pharmaceutical CHC product development activities for the U.S., India, Australia,

Mexico and UK sites. In this role, Bruce focuses on the development and commercialization of safe, high-quality, value-driven medicines and consumer products that are essential for better healthcare. As part of this, Bruce and his team have aligned Perrigo’s dosage form development process with the FDA’s expectations of Quality by Design. With more than 22 years of experience in the pharmaceutical industry, Bruce has held progressively increasing research and development leadership positions at Merck & Co., Inc., Pfizer Inc. and Perrigo. Bruce’s contributions to commercialized products via NDAs, ANDAs and DMFs include a diversity of dosage forms and active pharmaceutical ingredients. Bruce earned a Bachelor’s degree in Chemistry from Concordia College (Moorhead, MN), and a Ph.D. in Analytical Chemistry from the University of Minnesota.


Paula R. Katz, J.D. Paula Katz is the Director of Manufacturing Quality Guidance and Policy in the Office of Manufacturing Quality at CDER's Office of Compliance. Ms. Katz has served as Branch Chief, Senior Policy Advisor, and Regulatory Counsel in OMQ since 2009. She focuses on compliance and enforcement policy regarding CGMP and drug quality issues. Ms. Katz frequently advises management and colleagues and speaks and writes on matters related to supply chain controls, contract manufacturing, data and application integrity, administrative law and procedure, and regulatory policy

development and strategy. Ms. Katz has chaired intra-Agency working groups and directed the drafting and publication of numerous draft and final guidances for industry and staff, proposed and final regulations, and legislation; managed and responded to Congressional and stakeholder inquiries; and served as a case officer and investigator in domestic and international enforcement actions and case reviews. Prior to joining FDA, Ms. Katz was a litigation associate at a large law firm in Washington, D.C., where her practice included regulatory compliance, white-collar crime, and general commercial litigation, and where she represented food and drug manufacturers and retailers, medical doctors, investors in the health care industry, and other regulated businesses and individuals. Ms. Katz is a graduate of the University of Virginia and the University of Virginia School of Law.

Dr. A. Douglas Kinghorn Since 2004, Dr. A. Douglas Kinghorn has held the position of Professor and Jack L. Beal Chair in Natural Products Chemistry and Pharmacognosy at the College of Pharmacy, The Ohio State University. He received Ph.D. (1975) and D.Sc. (1990) degrees from The School of Pharmacy, University of London. From 1977-2004, he was a faculty member at the College of Pharmacy, University of Illinois at

Chicago. Dr. Kinghorn is a Fellow of five scientific and professional societies, and is also a Fellow of The School of Pharmacy, University of London. He received the 2010 Norman R. Farnsworth Research Achievement Award of the American Society of Pharmacognosy (ASP) for lifetime contributions to natural products research. In 2011, Dr. Kinghorn was awarded an honorary D.Sc. degree from the University of Bradford in the U.K. He has authored or co-authored over 500 peer-reviewed research articles, review articles, and book chapters. His research interests include the isolation and structural characterization of bioactive natural products from higher plants, particularly potential anticancer agents, antileishmanial compounds, cancer chemopreventives, and taste-modifying substances. Dr. Kinghorn is Principal Investigator of a program project award from the U.S. National Cancer Institute, NIH entitled “Discovery of Anticancer Agents of Diverse Natural Origin” (P01CA125066; 2007-2019). He is the Editor in Chief of the Journal of Natural Products and for the book series “Progress in the Chemistry of Organic Natural Products” (Springer-Verlag, Vienna and New York).


Lieutenant Commander Patric Klotzbuecher Born & raised in the Atlantic City area of New Jersey, Lieutenant Commander Patric Klotzbuecher began his service as an enlisted airman while pursuing undergraduate studies. Enlisting shortly after September 11, 2001, he served with the U.S. Air Force primarily as a weapons armament systems specialist and a tactical aircraft maintainer since 2002. Through several deployments, recalls to active duty, and special assignments in support of Operations Iraqi Freedom, Enduring Freedom, and Noble Eagle, he rose to the rank of Staff Sergeant. In balancing his responsibilities as

an active duty servicemember and a non-traditional student, he earned Bachelors' Degrees in Biomedical Engineering & Biomathematics from Rutgers University. Soon after conferring he continued with graduate studies, was offered a commission with the USAF, and was selected as a Special Tactics Air Liaison Officer. In late 2007, he was recruited by the U.S. Public Health Service (USPHS) Liaison to the U.S. Food and Drug Administration's Office of Regulatory Affairs. That November he transferred as an officer of the Commissioned Corps of the USPHS, accepting an assignment as an Investigator with the U.S. FDA's Baltimore District Office, based in the Northern Virginia Resident Post. He was later transferred to an overseas duty station supporting the drug program of FDA's San Juan District, then selected as a Senior Regulatory Operations Officer/Drug Specialist with the Division of Foreign Field Investigations’ Dedicated Drug Cadre, and in that time, conferred his MBA in Engineering Management from Drexel University. To date, LCDR Klotzbuecher has conducted operations in over 30 different countries to include the inspection of both small and large molecule manufacturers and all varieties of profile classes. He was presented with the opportunity to continue his work abroad, while sharing much of his knowledge gained with the domestic drug program, and in February 2014 accepted the position of Senior Regulatory Management Officer/Drug Specialist with the Generic Drug Program in the New York District Office. He is currently a candidate for an M.S. in Biochemical Engineering at the New Jersey Institute of Technology and recently sat for examination as a Certified Public Health Professional. As an officer, since joining the Corps, he has been charged with the rigors of training and deployment in support of a variety of health & medical response, public health outreach, events of national significance, and civil affairs missions as the Mobilization Branch Director of PHS-2 Rapid Deployment Force. He has served as the Acting Planning Chief of PHS-2 for specialized training and rural health & remote area missions, the Planning Chief of the Department of Health & Human Service's flagship Fusion Cell during Presidential inaugurations, and most-recently answered the call to be first in and lead the way as part of Monrovia Medical Unit Team-1's deployment to West Africa in support of the Commissioned Corps Ebola Response. With numerous deployments and field training missions accomplished over the course of his service career, his operational experience in high tempos, under hostile conditions, and in austere environments have made him an invaluable asset to both the agency's and Corps' emergency response capabilities.


Sau (Larry) Lee, Ph.D. Sau (Larry) Lee is currently the acting Associate Director for Science of the Office of Pharmaceutical Quality (OPQ), the acting Team Leader of the OPQ Botanical Review Team, and the chair of the OPQ Emerging Technology Team. Larry and his OPQ Scientific and Research Staff are leading the effort in advancing OPQ research and in manufacturing science, complex drug substances and products containing

nanomaterials, as well as in developing the regulatory policy, scientific standards as well as computational and modeling tools supporting quality review and inspection in OPQ. Larry joined the Office of Generic Drugs (OGD) in 2005 as a chemical engineer. In 2012 - 2013, Larry was the peptide team leader which specializes in CMC reviews of ANDAs for complex drug substances and products. As a member of the Office of Pharmaceutical Quality (OPQ) TAG Integrated Team-based Review Pilot, Larry led a team to evaluate OPQ’s vision for a team-based product and process/facility quality assessment approach. He also co-led the Risk Based Review Pilot which aimed to increase the review quality and efficiency of injectable products. In early 2013, Larry was promoted to Expert Regulatory Scientist in recognition of his expertise in evaluation of complex drug substances and products. Larry 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.

Julie Lorenz, Ph.D. Julie Lorenz is currently Associate Research Fellow and Head of Analytical Sciences at Zoetis, Inc. Since obtaining her PhD in Physical Chemistry from The University of Wisconsin – Madison, she has worked in analytical, product development and DMPK functions in the pharmaceutical, food and chemical industries.

Richard (Rik) Lostritto, Ph.D. Richard (Rik) Lostritto joined the FDA in 1995 and currently serves as Division Director and Acting Associate Office Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ). Previously, Rik served in the Office of New Drug Quality Assessment (ONDQA) as Acting Deputy Office Director for Science & Policy, Biopharmaceutics Lead, CMC Division Director (oncology, pulmonary,

allergy, hematology, cardio-renal, neurology, and psychiatric drug products), Team Leader (pulmonary, allergy, and oncology drug products), and Review Chemist in several therapeutic areas. Prior to joining the Agency, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals leading a group that developed medical aerosol combination drug products after previously serving as Assistant / Associate Professor of Pharmaceutics at The University of Connecticut School of Pharmacy.


Jennifer A. Maguire, Ph.D. Dr. Jennifer A. Maguire is currently an Acting Branch Chief in the Office of Process and Facilities within the newly formed Office of Pharmaceutical Quality. During her tenure at FDA, Jennifer has been involved in many working groups and has most recently been involved with writing the Established Conditions draft guidance. She is an integral part of the Question-based Review, Quality by Design and Risk-based Review initiatives.

Prior to joining the agency’s Office of Generic Drugs in 2010, Jennifer spent about 10 years in the scientific research and academic arenas. She started her career as a chemical engineer working on the development and scale-up of drug substance manufacturing processes and later transitioned to a role leading the drug product manufacturing of clinical and stability supplies of a novel cancer drug. Jennifer then put her industrial career on pause to pursue her doctorate degree and specialized in vaccine formulation with aluminum-containing adjuvants to optimize clinical performance. She received her B.S. in Chemical Engineering from the University of Virginia and her Ph.D. in Industrial and Physical Pharmacy from Purdue University.

Douglas Mans

Ingrid Markovic, Ph.D. Dr. Ingrid Markovic currently serves as a Special Advisor to the Associate Director for Review Management, Office of the Center Director, CBER, where she is responsible for developing CMC Regulatory Review Policy. Prior to her current position, Dr. Markovic served as an Expert Review Scientist for Extractables and Leachables in therapeutic biologic protein products in the Office of Biotechnology Products, CDER, FDA. During her tenure at the FDA, Ingrid was also involved in the CMC review, development of

agency-wide regulatory guidance documents, participation in the pre-approval and biennial inspections, and in the new reviewer training program. Dr. Markovic trained in biochemistry, virology and natural products chemistry. She received her Ph.D. degree from University of Wisconsin-Madison and her post-doctoral training was completed at the National Institutes of Health in the Laboratory of Cellular and Molecular Biophysics.


Mehul U. Mehta, Ph.D. 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. He has been with the Agency for last 29 years and in his current position for last 16 years. In addition to his review oversight, administrative, and management responsibilities, he continues to play a significant role in broad based regulatory needs. For example, currently he co-chairs the CDER BCS (Biopharmaceutics Classification System) Committee, is a member of the CDER Lifecycle Management Board, is a member of the FIP BCS SIG, and is the Chair of the OCP Working Group for revising the CDER ‘PK in Hepatic Impairment’ guidance issued in 2003. Current research interests include therapeutic equivalence of complex modified release products, disease progression modeling in Parkinson’s disease, efficacy extrapolation in pediatrics for epilepsy drugs, and possible extension of BCS based biowaivers. He has authored numerous publications, guidances and book chapters. He was recognized as AAPS Fellow in 2012.

Sarah Pope Miksinski, Ph.D. Sarah Pope Miksinski, Ph.D., is the Acting Director of the FDA's Office of New Drug Products (ONDP), in the Office of Pharmaceutical Quality (OPQ). She obtained her B.A. from Earlham College (1994), her doctorate in Organic Chemistry from Oklahoma State University (1999), and completed a postdoctoral fellowship from NIH (2000-2002). Sarah joined FDA nearly 13 years ago, serving initially as a Chemistry Reviewer for reproductive/urologic drugs. Since that time, she has held additional positions within

ONDQA including Chemistry, Manufacturing and Controls Lead as well as Branch Chief and Division Director. Sarah's areas of technical expertise include the characterization of complex drug substances/products, manufacture of injectable dosage forms, and spectroscopic methodology. During her years at FDA, she has been active in numerous quality initiatives including the integration of review/inspection, the development of the team review process, the Pharmaceutical Inspectorate, and the establishment of enhanced collaborative approaches to facilitate the review of urgently needed drugs.

Anthony Mire-Sluis, Ph.D. Dr. Mire-Sluis is currently Vice President, North America, Singapore, Abingdon, Contract and Product Quality at Amgen Inc. He was previously Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry. Dr

Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK. Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego. He is the Chairman of the IABS Biotherapeutics Committee, Vice Chairman of the USP Biologicals Characterization Expert Committee, an expert for the International Committee for Harmonization and on the board of the Journal of Immunological Methods.


Ganapathy Mohan, Ph.D. Ganapathy Mohan is the head of Small Molecule Development Quality, which is responsible for ensuring GMP compliance and release of all materials and investigational Medicinal Products for use in clinical trials. Prior to this he was the head of Global CMC regulatory Affairs (Small Molecules) at Merck. He leads a team of professionals that support global regulatory filings

in the area of pharmaceutical products and Medical Devices. Mohan's team supported Worldwide CMC registrations from early development through Life Cycle Management, support quality analytical standards and labeling development services. Prior to joining Merck, he was at Sanofi-aventis for over 23 years and his last position at Sanofi-aventis was Associate Vice President, Global Analytical Sciences Department. He had also held positions as head of Quality Control and Quality Assurance. Mohan has a Ph.D in Analytical Chemistry from Kansas State University and his area of interests are in separation sciences, application of PAT and science driven risk based approaches towards global registrations of pharmaceuticals and biologics. Mohan was past Chair of the AAPS Regulatory Sciences Section in 2014. He serves as a member of the Council of Experts for the United States Pharmacopeia (USP). He is also on the Editorial Board of the American Pharmaceutical Review and Journal of PAT.

Carlos Monteagudo Mr. Carlos Monteagudo has been with Amgen Inc. since 2003, where he has held positions of increasing responsibilities. Currently he is a Director of Quality Assurance responsible for the Management Review, In-Process Control, Product Quality Review and Quality Risk Management programs. Carlos has been involved in the development and implementation of the Quality Risk Management program

since 2006. As part of his role Carlos is responsible for the effective implementation of Quality Risk Management Quality System for Operations and provides subject matter expertise for the integration of risk management into other quality management systems. In 2012, he led the implementation of a Quality Risk Management program for Devices and Combination Products. Recently he managed the remediation of Risk Management File for multiple legacy combination products in the United States.


Ajit Narang, Ph.D. Ajit Narang works for the Drug Product Science & Technology Department of Bristol-Myers Squibb, Co. (BMS) in New Brunswick, NJ. He is a Principal Scientist involved in the development of oral solid dosage forms of small molecule drugs and parenteral solution dosage forms of antibodies and antibody-drug conjugates (ADCs). He also serves as Adjunct Faculty at the Universities of Tennessee and Phoenix; Industrial

Advisory Board member of Western Michigan University; Editor of Bentham Pharmaceutical Journal; and a panel member of the Biopharmaceutics Technical Committee (BTC) of the Pharmaceutical Quality Research Institute (PQRI) in Arlington, VA. Ajit is also a long standing AAPS member and has served the AAPS in different capacities including current Vice Chair of the FDD section and ex-Chair of the Excipients Focus Group.

Ajit earned his Ph.D. from the University of Tennessee in Memphis, Masters in Pharmaceutics from the Banaras Hindu University in India, and Bachelors in Pharmaceutical Sciences from the University of Delhi in India. He has over 14 years of pharmaceutical industry experience working for BMS, Ranabxy, and Morton Grove Pharmaceuticals in different capacities. Ajit has contributed to several commercialized drug products including ANDAs, 505B2, and NDA. He has published over 40 peer reviewed articles; 3 books; 7 patent applications; 20 invited talks; 60 presentations at various scientific meetings. His current research interests are QbD development of pharmaceutical products and the application of to connect CPPs with CQAs through material attributes and causative mechanistic understanding.

Moheb Nasr, Ph.D.

After 22 years at FDA, Dr. Nasr joined GlaxoSmithKline (GSK) in September 2011 as Vice President for Global CMC Strategy. Dr. Nasr is responsible for the development and the execution of GSK CMC regulatory strategy. Dr. Nasr is a member of GSK leadership and governance boards accountable for product development, manufacturing and supply, and regulatory oversight.

Prior to joining GSK, Dr. Nasr served as the Director of the Office of New Drug Quality Assessment (ONDQA), CDER, FDA. Dr. Nasr established and led ONDQA for 8 years. Dr. Nasr represented FDA at ICH and was instrumental in the development of QbD concept and several regulatory guidelines.

Dr. Nasr obtained his Ph.D. degree in Chemistry at the University of Minnesota in Minneapolis, USA. Dr. Nasr is an elected Fellow of the American Association of Pharmaceutical Scientists (AAPS) and the recipient of AAPS Regulatory Science Achievement Award, and University of Wisconsin Pharmaceutical Analysis Excellence Award.


Roger Nosal Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. He is accountable for investigational, commercial & post approval regulatory CMC submissions globally for new chemical, biological, vaccine & device candidates & consumer health products. Roger has contributed to the evolution of Quality by Design & has been an advocate for global regulatory harmonization through several technical PhRMA, ICH, ISPE, ILF, AAPS, IFPAC, ACS & DIA

committees. He is currently Chair of ISPE Pharmaceutical Engineering and DIA Program Committee - Quality Co-Chair. Roger’s 34 years of experience at G. D. Searle, Monsanto, Pharmacia & Pfizer, includes 21 years in regulatory CMC. Prior to his regulatory role, Roger was a Medicinal Chemist, author on 24 patents for several medicinal candidates (PAF, leukotriene, 5-HT3 & 5-HT4 antagonists & agonists, COX-2 & serotonin inhibitors) & a Process Chemist, focused on synthetic development & analytical control of derivatives of aspartame & manufacturing optimization of prostaglandin syntheses.

Mary Oates, Ph.D. Mary Oates is Vice President of Global Quality Operations and Environmental Health and Safety for Pfizer. In this role, she is responsible for Quality oversight of all products made by and for Pfizer for both clinical and commercial use. She is also responsible for Environmental Health and Safety for Pfizer. Mary holds an undergraduate degree in Biochemistry from Queens College and a Ph.D. in Analytical Chemistry from UNC-Chapel Hill.

Thomas O’Connor, Ph.D. Dr. O’Connor is the Manufacturing Science team leader for the Science Staff within the Office of Pharmaceutical Quality. His work at the FDA is focused on regulatory research in the area emerging technologies such as utilizing models to aid the risk assessment of continuous manufacturing processes. Prior to joining the FDA, Tom worked at ExxonMobil Research and Engineering where he was the technology program leader for operator guidance tools including abnormal event detection, alarm management, sequential control, and HMI development. He is an

experienced practitioner of advanced process control techniques including statistical process control and holds patents related to the development of statistical monitoring systems for industrial plants. Dr. O’Connor earned a B.S. in chemical engineering from the Cooper Union and a Ph.D. in chemical engineering from Princeton University.

Don Parsons, Ph.D. Don Parsons, Ph.D. is the Senior Director of Chemistry at BIND Therapeutics. He has been with BIND since January 2011. At BIND, Don leads the analytical and synthetic chemistry functions, including development of BIND’s Accurin characterization strategy and the development of novel targeting and materials chemistry activities. Don has over 20 years of experience in the pharmaceutical

industry, holding a variety of CMC positions at Warner Chilcott Pharmaceuticals and Procter & Gamble Pharmaceuticals. He received a Ph.D. in physical chemistry from the University of Wisconsin-Madison and an A.B. in Chemistry from Dartmouth College.


Daniel Peng, Ph.D. Dr. Daniel Peng is currently a Quality Assessment Lead in the Office of Process and Facility (OPF) within the Office of Pharmaceutical Quality (OPQ)/CDER/FDA. During his tenure at FDA, Daniel has served as both a primary and secondary CMC reviewer for NDAs, ANDAs, DMFs, Citizen Petitions and Controlled Correspondences. Daniel has also been involved in numerous OGD, OPQ and

CDER committees and working groups for guidance and new initiatives development as a Quality by Design (QbD) Liaison.

Prior to joining FDA in 2010, Daniel worked at AstraZeneca (Wilmington, DE) for five years as a Senior Formulation Scientist & Project Lead for Late Stage Product Development. Previously, he spent six years as a faculty member at College of Pharmacy, University of Tennessee Health Science Center (Memphis, TN). Daniel obtained his Ph.D. in Pharmaceutics from West China University of Medical Sciences (Chengdu, China). He has published 4 book chapters, 21 peer reviewed papers and 4 US patents. Daniel has extensive experience in formulation and process development for solid oral dosage forms and novel drug delivery systems. He is also skilled in applying Design of Experiments (DOE), Multivariate analysis (MVA), Statistical Process Control (SPC), and Artificial Neural Network (ANN) software to pharmaceutical product development.

Yihong Qiu, Ph.D. Dr. Yihong Qiu is currently Volwiler Senior Research Fellow, Oral Drug Products, Science and Technology, AbbVie. His in-depth knowledge and extensive experience encompass various phases of product development, including preformulation, drug delivery technology, product/process design, biopharmaceutics/pharmacokinetics, formulation/process development, scale-up and optimization, technical trouble-

shooting, intellectual property and regulatory registration for NCE’s, line-extension and marketed products. He also plays a key role in the product life cycle management, IP strategy, scientific and regulatory assessment of business opportunities. His work has resulted in successful commercial IR and MR products, patented drug delivery technologies, IVIVC’s and biowaivers approved by regulatory agencies. Dr. Qiu is an elected fellow of the American Association of Pharmaceutical Scientists (AAPS) and a member of USP Expert Committee. His research interests include modified-release delivery systems, dissolution, bioavailability, IVIVC, drug delivery technology and science-based regulation. He has more than 50 publications in journals and books, 30 patents granted or pending, and numerous invited presentations. He contributes routinely to professional organizations and universities through presenting, lecturing, editing/refereeing publications, and organizing meetings. Dr. Qiu received BS in Pharmacy, MS. in Pharmaceutics from China Pharmaceutical University, and Ph.D. in Pharmaceutics from The University of Iowa.


Barbara Rellahan, Ph.D. Dr. Rellahan holds a MS in Cell Biology, a PhD in Immunology and performed a post-doctoral fellowship in the Laboratory of Immune Cell Biology, National Cancer Institute, NIH. Dr. Rellahan joined the Division of Monoclonal Antibodies (DMA), Office of Biotechnology Products (OBP), FDA in 1995. She began her career with the FDA as a research scientist, was converted to a Staff Scientist in 1998, and a Principle Investigator in the Laboratory of Immunobiology in 2004. In 2008 she was promoted to a Product Quality Team Leader in DMA and supervised a team of regulator scientists with responsibility for review of CMC sections of regulatory filings including assessment of product comparability, manufacturing and testing. Dr. Rellahan was a member of the OBP QbD pilot working group and supervised review of the first successful QbD BLA submitted to DMA. She joined Amgen in 2013 as a Director of Product Quality and manages a group of Product Quality Leaders who have product quality oversight of Amgen biosimilar products.

Susan Rosencrance, Ph.D. Dr. Susan Rosencrance currently serves as acting Director for the Office of Lifecycle Drug Products in the newly formed Office of Pharmaceutical Quality (OPQ). In this capacity, she directs procedures and processes for evaluating and assessing drug product quality during the lifecycle of both brand name and generic drug products. Prior to joining the FDA, Susan worked at Merck & Co.'s R&D Laboratories in Rahway, New Jersey. She joined the Office of Generic Drugs (OGD) in 1991 and spent the

majority of her tenure in CDER working on generic drug products. She held various roles within OGD including chemistry reviewer, team leader, deputy division director; and served as OGD’s Deputy Director for Chemistry prior to joining OPQ. Susan holds a Ph.D. in Chemistry from American University and completed her dissertation research at the NIH Laboratory of Biophysical Chemistry conducting a molecular dynamics study on hydrophobic interactions in alpha-helical coiled coils found in proteins.

Mark Rosolowsky, Ph.D. Mark is the head of Global Regulatory Sciences Chemistry Manufacturing and Control for Bristol-Myers Squibb Company and is accountable for the regulatory CMC strategy for all small and large molecules in the BMS pipeline as well as for their marketed products. Mark has been with BMS for nine years. Prior to joining BMS, Mark spent 15 years at Merck & Co., Inc. and was the head of the Regulatory

& Analytical Sciences-CMC Biologics and oversaw the regulatory strategy for their vaccine portfolio. Currently, Mark is a member of PhRMA’s Technical Development and Operations Committee (TDOC). He had been actively involved in the ICH Q11 guidance on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), and several PhRMA LD-KITs which drafted position papers related to regulatory CMC strategies. He is currently the PhRMA Expert Working Group CMC member for the draft ICH Q12 guidance on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Mark was a member of the International Federation of Pharmaceutical Manufacturing Association (IFPMA) Biotherapeutics Group and a former co-chair of the ISPE Asia Pacific CMC Focus Group, as well as serving as a member of the PhRMA Biologics and Biotechnology Technical Leadership Committee. Mark earned his doctorate at Rutgers Medical School/University of Medicine and Dentistry of NJ and specialized in Cardiovascular Physiology. He was a post-doctoral fellow in the departments of Cardiology and Pharmacology at the University of Texas Southwestern Medical Center, Dallas, Texas, and he has published over two dozen peer-reviewed papers.


Mike Saleh, MS Mike Saleh is currently a Director, and team leader in New Products Regulatory – CMC at Pfizer. Mike previously held several positions in Regulatory Affairs at Bristol-Myers Squibb, Bracco Diagnostics and Daiichi-Sankyo. Mike holds an MS degree in Analytical Chemistry from U-Mass, and an MS degree in Organic Chemistry from the American University of Beirut.

Anna Schwendeman, Ph.D. Anna Schwendeman received her Bachelor of Science from Moscow Institute of Physics and Technology and PhD in Pharmaceutics from The Ohio State University. From 2000 to 2011 she has worked at Esperion Therapeutics, Pfizer and Cerenis Therapeutics on developing synthetic high-density lipoprotein (sHDL) drugs. She was part of the development teams that translated to clinic seven different products. She

was involved in development of cell culture and purification processes, analytical characterization, and formulation for recombinant Apolipoprotein A-I. She became Assistant Professor at Biointerfaces Institute and College of Pharmacy at the University of Michigan in 2012. Her research focus is on optimization sHDL nanoparticles for treatment of atherosclerosis, sepsis and autoimmune diseases as well as characterization of complex parenteral products including liposomes and recombinant proteins.

Vinod P. Shah, Ph. D. Dr. Shah is a pharmaceutical consultant. He is now Chair of Regulatory Sciences Special Interest Group of International Pharmaceutical Federation (FIP). Dr. Shah is a Steering Committee member of Non-Biological Complex Drugs (NBCD) hosted at Top Institute (TI) Pharma in The Netherlands and a Member of Board of Directors of Product Quality Research Institute (PQRI).

Dr. Shah retired from US FDA (Food and Drug Administration) as a Senior Research Scientist after 30 years of service in July 2005. While at FDA, he has developed several Regulatory Guidances for Pharmaceutical Industry in the area of dissolution, SUPAC, bioequivalence and biopharmaceutics. He has received several FDA Awards including Award of Merit, Scientific Achievement Award and Distinguished Career Service Award. Dr. Shah is author/co-author of over 290 scientific papers and is a co-editor of four books. Dr. Shah was the President of American Association of Pharmaceutical Scientist (AAPS) in 2003. He is a Fellow of AAPS and FIP. Dr. Shah is a recipient of AAPS Distinguished Service Award, Pharmaceutical Sciences World Congress (PSWC) Research Achievement Award, FIP Lifetime Achievement Award in Pharmaceutical Sciences and Honorary Doctorate from Semmelweis University, Hungary.


Marjorie Shapiro, Ph.D. Dr. Marjorie Shapiro received her Ph.D. in immunology in 1987 from the University of Pennsylvania where she studied molecular mechanisms underlying antibody diversity. Her current research continues towards understanding antibody repertoire development in natural and artificial systems and potential implications for therapeutic monoclonal antibodies.

She joined the Division of Monoclonal Antibodies in 1993. After the reorganization of the Office of Biotechnology Products, she is currently Chief of the Laboratory for Molecular and Developmental Immunology in the Division of Biotechnology Regulation and Review I, where she supervises regulation of novel and biosimilar monoclonal antibodies and Fc fusion proteins, as well as other therapeutic proteins.

Ambarish Singh, Ph.D. Ambarish Singh holds a PhD in Organic Chemistry from the State University of New York at Stony Brook. He served as a post-doctoral fellow at Fox Chase Cancer Center, Philadelphia and Memorial Sloan Kettering Cancer Center, New York. Dr. Singh started his industrial career by joining the Process Research and

Development department of Bristol-Myers Squibb Company and contributed heavily to the chemical process development of numerous commercial products, such as, Pravachol, Taxol and Baraclude. He led several successful "start-ups" to transfer laboratory processes to manufacturing sites in Ireland, Italy and Puerto Rico. In 2007, Ambarish transitioned into Global Regulatory Sciences-Chemistry, Manufacturing and Control (CMC) department, where he is a director and responsible for providing regulatory-CMC guidance and strategies for projects that are in development. He has interacted with FDA, EMA, Health-Canada and TGA on CMC filing strategies related to QbD/PAT/RTRt. Ambarish has received several BMS awards (President’s award, Triumph award, Ondetti & Cushman award) for his contributions to the advancement of Science and Technology in Process R&D. He has published >25 scientific articles and holds 6 patents. External to BMS, Ambarish has given several talks on topics related to chemical process development and QbD/PAT/RTRt at universities and conferences. He has served on the scientific advisory board of the Cambridge Healthtech Institute (CHI) and American Chemical Society local chapter-Regulatory-CMC.


Corinna Sonderegger, Ph.D. Corinna Sonderegger received her PhD in biochemistry and molecular biology at the University of Innsbruck/Austria in 1998. As a post-doc at The Scripps Research Institute in San Diego/California she developed high-throughput cell-based drug-screening assays and performed cancer research

applying virology, cell biology and protein chemistry. In 2002 she joined Sandoz Biopharmaceuticals, being responsible for cell culture derived drug substance upstream process development including QbD process characterization and process validation concepts, among others leading drug substance process development for Novartis’ Ilaris®. Since 2010 Corinna is leading the development of biosimilar drug products at Sandoz Biopharmaceuticals Austria as Head of Pharmaceutical Development. Corinna was strongly involved in the development and registration of Sandoz’s Zarxio®, the first US biosimilar.

David C. Sperry, Ph.D. Dr. Sperry is a Research Advisor in Small Molecule Drug Development at Lilly Research Laboratories. He obtained a B.S. degree in chemistry from Indiana University, Bloomington, IN and a Ph.D. degree in chemistry from the University of Rochester, Rochester, NY. After receiving his degree, he took a postdoctoral research scientist position at Pharmacia & Upjohn where he developed an Artificial Stomach Duodenum

model and studied its utility in drug development. Shortly thereafter, he accepted a research scientist position at Pharmacia (later Pfizer), working in the area of in vitro methods and biopharmaceutics. He then moved to Bausch and Lomb where he developed commercial ophthalmic formulations for late stage molecules. In 2007, Dr. Sperry joined Lilly Research Laboratories, where he created a group focusing on in vitro drug product performance techniques and predictions of in vivo performance. In 2013, Dr. Sperry joined a computational modeling group at Lilly. He now supports product development by using existing and creating new models to predict product performance and oral absorption of small molecule drug formulations.

Olen Stephens, Ph.D. Olen Stephens is the acting branch chief for the CMC branch that supports the Office of Hematology and Oncology Products. In his seven year career at the FDA, he has served as a reviewer, quality assessment lead, and acting branch chief to support over half the clinical division in the Office of New Drugs at CDER. Prior to joining the FDA, Dr. Stephens was an organic and biochemistry professor at Earlham College. His formal training began as an bioorganic chemist at the University of Utah for his Ph.D., where he studied double stranded RNA ● protein

interactions and continued as a post-doc at Yale in biophysical chemistry, designing de novo secondary structures using β-peptides.


Michael P. Thien, Sc.D. Dr. Thien has worked in new product and process development at Merck for over 25 years. After receiving his B.S. in Chemical Engineering from Caltech (1982), an Sc.D. from MIT in biochemical engineering (1988) and a post doc at the Whitehead Institute of Biomedical Research, Mike joined the Merck Research Labs, working in vaccines and recombinant proteins. In 1991, Dr. Thien led a process development

group for compounds made by organic synthesis, continuing in that capacity until 1997. During this time Dr. Thien was named a Merck Research Labs “Divisional Scientist” as a result of his development and plant start-up work on CRIXIVAN, one of the first HIV protease inhibitors in the marketplace. Between 1997 and 2003 Mike held roles of increasing responsibility including Senior Director of chemical pilot plant operations and Executive Director of chemical process development. Dr. Thien was named Vice President, Process R&D in 2003 covering analytical and engineering development of Merck's small molecules.

In 2005, Mike co-led a team to re-define the paradigm by which Merck brings new drugs to market. This effort resulted in the creation of a new function at Merck: the Global Pharmaceutical Commercialization organization. This group includes engineers and analysts from both R&D and manufacturing and reports up through manufacturing. In 2005 Mike was appointed to head this group and was made responsible for both late stage process development and the making of clinical and commercial launch supplies for all of Merck's new small molecule drugs, with responsibility for chemical and formulation development and manufacturing efforts at facilities in New Jersey, Pennsylvania and Ireland. In October of 2008 Mike took on the additional responsibilities of leading technical support for Merck's in-line small molecule products. In April of 2009, Dr. Thien was appointed to Senior Vice President, Global Science, Technology and Commercialization where he became additionally responsible for the analytical sciences, statistics and packaging technology for manufacturing. In 2012, he also took in responsibility for technical support of commercial sterile operations. In 2013, Mike's role added new product development and in-line support for therapeutic proteins, vaccines and Animal health products.

Mike has made numerous invited conference presentations and guest lectures on the pharmaceutical industry and has served on advisory boards for MIT and the U. Texas at Austin, serves on the board at Johns Hopkins and chairs a similar board for the Department of Chemical and Biomolecular Engineering at Tufts University. He is on the Board of Governors for the Robert Wood Johnson Rahway Hospital.

Hayden Thomas, Ph.D. Hayden Thomas is Vice President of Formulation & Chemical Process Development at Vertex Pharmaceuticals Inc., Boston, MA. His department is responsible for supplying API and drug product to support clinical development as well as developing the commercial manufacturing process for both API and drug product. Dr. Thomas leads the overall drug

manufacturing continuous manufacturing at Vertex. Prior to joining Vertex, Dr. Thomas worked at Pfizer and has a Ph.D. in Pharmaceutical Chemistry and more than 15 years’ experience in the pharmaceutical industry.


Bernhardt L. Trout, Ph.D. Bernhardt L. Trout is a Professor of Chemical Engineering at MIT. He is currently Director of the Novartis-MIT Center for Continuous Manufacturing and the Co-Chair of the Singapore-MIT Alliance Program on Chemical and Pharmaceutical Engineering. He received his S.B. and S.M. degrees from MIT and his Ph.D. from the University of California at Berkeley. In addition, he performed post-doctoral

research at the Max-Planck Institute. Trout’s research focuses on molecular engineering, specifically the development and application of both computational and experimental molecular-based methods to engineering pharmaceutical formulations and processes with unprecedented specificity. In 2007, with colleagues from Novartis and MIT, he set the Novartis-MIT Center for Continuous Manufacturing, a $85 million partnership with the objective of transforming pharmaceutical manufacturing. In 2012, the Center successfully ran at bench scale the first end-to-end continuous pharmaceutical process, which included three synthetic steps and went to final coated tablet. The Center has also been working on a variety of other technologies for maximizing the benefit of continuous manufacturing. In addition to Novartis, he has worked with many other pharmaceutical companies in research or consulting. He has published over 150 papers and currently has 21 patent applications. For more information on Prof. Trout and his research, please visit: http://web.mit.edu/troutgroup/. Yu Chung Tsang, Ph.D. Dr. Yu Chung Tsang is currently working at Apotex Inc. as Chief Scientific Officer, Biopharmaceutics and Biostatistics. He obtained his bachelor degree (1984) in Pharmacy and Ph.D. degree in the area of Pharmacokinetics in 1990 from the University of Toronto. He has been with Apotex since then. His main responsibility is to provide scientific expertise and strategic direction in the design of bioequivalence/clinical endpoint studies and the analysis of data for the development of pharmaceutical and biosimilar products in the Apotex group of companies. 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 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, and the Chair of the Generic Pharmaceuticals Focus Group of the American Association of Pharmaceutical Scientists. He is also a member of the Bioequivalence Working Group of the European Generic Medicines Association. He was a member of the Board of Directors for the Canadian Society of Pharmaceutical Sciences from 2008-2010. Aside from his industrial experience, he also holds an appointment (status only) at the Leslie Dan Faculty of Pharmacy, University of Toronto.

Katherine Tyner, Ph.D. Dr. Tyner is a chemist in the Science and Research Staff in the Office of Pharmaceutical Quality, CDER/FDA. She received her PhD in Chemistry from Cornell University and joined the Food and Drug Administration in 2007 as a chemist specializing in nanotechnology. While at the FDA, Dr. Tyner has investigated the quality, safety, and efficacy of drug products containing nanomaterials. Dr. Tyner

currently leads the CDER nanotechnology working group and is active in other CDER and FDA nanotechnology initiatives. Dr. Tyner is the author of multiple book chapters and journal articles concerning the appropriate characterization and biological impact of nanoparticle therapeutics

http://web.mit.edu/troutgroup/


Siva Vaithiyalingam, Ph.D.

Siva Vaithiyalingam is currently a Director, Regulatory Affairs at Teva Pharmaceuticals. He previously served as Senior CMC reviewer at Office of Generic Drugs, CDER, FDA, assessed ANDA, DMF and supplements. At FDA, He also took part in Regulatory initiatives for QbD, Stability Guidance and QbR revision. Prior to that Siva was at Barr Laboratories R&D, as a formulator: Developed immediate release and modified release drug products. He graduated from Texas Tech

University (2001) with a PhD in Pharmaceutical Sciences and with a MS degree in Pharmaceutics from Banarus Hindu University.

Martin G. VanTrieste

Martin VanTrieste is the senior vice president of Quality at Amgen. He is responsible for all aspects of Quality Assurance, Quality Control, Compliance, Operational Excellence, Environment, Health and Safety along with Training at Amgen.

Prior to joining Amgen, VanTrieste was with Bayer HealthCare’s Biological Products Division as vice president of Worldwide Quality and Abbott Laboratories as the vice president of Quality Assurance for the Hospital Products Division. While at Abbott, VanTrieste held various positions in Quality, Operations, and Research and Development. He started his career at Abbott in 1983 after obtaining his Pharmacy degree from Temple University School of Pharmacy.

VanTrieste has been actively involved with various professional and trade organizations, including United States Pharmacopeia (USP), Pharmaceutical Quality Research Institute (PQRI), Pharmaceutical Research and Manufacturers of America (PhRMA), and AdvaMed, and he is a member of the Board of Directors of the Parenteral Drug Associations (PDA). He is the founder and first Chairman of Rx-360 and is currently on their Board of Directors. Rx-360 is a nonprofit international supply chain organization that will enhance patient safety by increasing the security and quality of all parts of the supply chain. PharmaVoice in 2012 named VanTrieste as one of the 100 most inspiring people in the pharmaceutical industry and call him “a man with a mission”.

Alex Viehmann Alex Viehmann is currently an Operations Research Analyst in the Office of Surveillance – Quality Intelligence Branch where he provides statistical support for CMC review and post-market surveillance activities. The Quality Intelligence Branch manages the CDER Quality Metrics and facility dossier program and Alex is responsible for the data analytics portion. Prior to joining the Quality Intelligence

Branch, Alex worked as a statistician in the Science and Policy staff within the Office of Pharmaceutical Science where he developed policy and standards on sampling, test method evaluation and statistical quality control.


Ke Wang, Ph.D. Ke Wang is an Associate Director working in the Pharmaceutical Science and Manufacturing Statistics group at Pfizer Inc. in Groton, CT. Her primary responsibility is to provide statistical support to Chemical Research and Development in Groton and Sandwich as well as the Analytical Development of drug substance.

Ke joined Pfizer in 2008 after graduating that year with a PhD in statistics from Colorado State University. Ke has a MS and BS in Chemistry from Wuhan University in China. Statistical interest includes design of experiment, multivariate and predictive modeling, and probabilistic approach to Pharmaceutical Science.

Keith Webber, Ph.D. Keith Webber is the Sr. Director of Rx Regulatory Affairs at the Perrigo Company. Prior to joining industry, he served at the US Food and Drug Administration in both the Center for Drug Evaluation and Research and the Center for Biologics. During his 18 years with the Agency, his roles included Director of the Office of Pharmaceutical Science, Director of the Office of Generic Drugs, and Director of the Office of

Biotechnology Products. He holds a Bachelor of Science degree in Chemistry from the University of Denver, Colorado and a Doctorate in Biological Chemistry from the University of Michigan.

Paul Weninger Paul Weninger is the Senior Vice President of Quality Operations at Perrigo Company, plc. Perrigo is a global pharmaceutical company focused on providing high quality affordable healthcare products and is the largest manufacturer of over the counter (OTC) products for the store brand market. In his current role, Paul is responsible for the quality and compliance of the internal Perrigo sites

manufacturing products for the U.S. market including OTC, generic Rx, nutritional, and animal health products as well as the quality of the externally manufactured products for Perrigo marketed in the U.S. His experience includes operational and quality roles in pharmaceutical finished product, API, excipient and bulk chemical operations at Perrigo, CP Kelco, Monsanto, Merck and Pfizer. He earned a B.S. in Chemical Engineering from the University of Wisconsin and a MBA from National University in San Diego.

Bryan Winship Bryan’s career spans over thirty years in pharmaceuticals, biotechnology and medical device where he has held positions in Manufacturing, Quality, R&D, Metrology, IT, Strategic Planning and Operational Excellence. In his role as Senior Director for Quality Management at Mylan he is responsible for global quality council leadership, quality compliance risk management, and quality metrics

process and systems implementation. Prior to joining Mylan in 2014, he held site, regional and global leadership positions with Boehringer Ingelheim, GlaxoSmithKline, W.L. Gore and Johnson & Johnson. He is a Lean Six Sigma Master Black Belt and former life sciences consultant who developed and delivered many performance transformation and compliance remediation initiatives across the pharmaceutical industry.

https://www.linkedin.com/start/view-full-profile?_ed=0__FXlHAkIqKgX-NXENjNLjKjUqy8kRIodHI_QXudzDOmYnNWXWtW4G019ksFOBVzc&trk=pprof-0-ts-view_full-0


Marc Wolfgang Marc Wolfgang is the Vice President of CMC and Portfolio Management at Cerulean Pharma Inc. He has been with Cerulean for eight years and is responsible for CMC development and manufacture, and oversight of the portfolio/program management function. Marc has over 20 years of biotech/pharma experience, holding various positions in CMC, quality and regulatory affairs at Momenta Pharmaceuticals,

Millennium Pharmaceuticals, Biogen and Boehringer Ingelheim Pharmaceuticals. Marc has a B.S. degree in Biology and a M.S. degree in chemistry. He has been working in the nanopharmaceutical space for the past eight years and is currently the Vice Chair of the Nanomedicines Alliance.

Janet Woodcock, M.D. Janet Woodcock is Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). As of January 2015, Dr. Woodcock also assumed the role of Acting Director of CDER’s newly formed Office of Pharmaceutical Quality, (OPQ). Dr. Woodcock first joined CDER in 1994. For three years, from 2005 until 2008, she served FDA’s

Commissioner, holding several positions, including as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations, and Chief Operating Officer. Her responsibilities involved oversight of various aspects of scientific and medical regulatory operations. Before joining CDER, Dr. Woodcock served as Director, Office of Therapeutics Research and Review, and Acting Deputy Director in FDA’s Center for Biologics Evaluation and Research. Dr. Woodcock received her M.D. from Northwestern Medical School and completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco. She joined FDA in 1986.

Lawrence X. Yu, Ph.D. Lawrence X. Yu, Ph.D., is the Deputy Director, Office of Pharmaceutical Quality, Food and Drug Administration. He is also adjunct Professor of Pharmaceutical Engineering at the University of Michigan. Prior to joining the FDA, Dr. Yu had worked at Pfizer (Upjohn) and GlaxoWellcome for 8 years. Dr. Yu joined the FDA in 1999 and has served as Team Leader, Deputy Division Director, Division Director, Deputy Office Director,

and Office Director. Dr. Yu’s research interests have centered on the prediction of oral drug delivery and the development of pharmaceutical Quality by Design. His compartmental absorption and transit (CAT) model has laid the foundation for the commercial software, GastroPLUSTM and Simcyp®, which are being widely used in the pharmaceutical industry. Dr. Yu is a fellow and the past section Chair of the American Association of Pharmaceutical Scientists and an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored over 130 papers, and presented over 100 abstracts, and given over 200 invited presentations. He is a co-editor of the books entitled “Biopharmaceutics Applications in Drug Development” and “FDA Bioequivalence Standards”. Dr. Yu is the winner of numerous awards including AAPS Regulatory Science Achievement award, AIChE PD2M Drug Product QbD Achievement Award, Japan Naigai Foundation Distinguished Lectureship, China Beijing University IPEM graduation commencement address, Department of Health and Human Service Outstanding Leadership Award, FDA Commissioner’s Special Citation, Outstanding Achievement, Group Recognition, and Team Excellence awards.

Documents

Speaker Bios 2nd FDA/PQRI Conference on Advancing Product … · 2015. 10. 1. · aaps. He is the recipient of the 2014 AAPS Research Achievement Award in Physical Pharmacy and Biopharmaceutics