Speakers

Regulation of Pharmaceuticals: A Global Perspective Speakers
Jon Clark

Jon Clark, MS

Associate Director for Program Policy
Office of Pharmaceutical Science
CDER, FDA

Jon Clark is an Associate Director for Program Policy, Office of Pharmaceutical Science (OPS), CDER.

After 12 years experience working in Industry, Jon joined the Agency in 1992.

Jon received his Bachelor in Chemistry at the University of Michigan in 1980

And his Master in Chemistry at Rutgers University in 1987

From 1980 to 1992 he was employed in manufacturing support at Beecham Laboratories then in manufacturing research at Schering Plough Research. He is co inventor of the processes for manufacturing of API for Claritin and Nuflor.

Jon is in the CDER Office of Pharmaceutical Science. He is engaged in Pharmaceutical Quality CGMPs for the 21st Century program, Critical Path Initiative, Quality by Design and the International Conference on Harmonization (ICH). He develops guidance documents, is a policy expert, contracts strategic research programs and manages the compendial operations. He is currently acting as the Deputy Director of OPS, directed by Helen Winkle.

Clark

Robert B. Clark

Vice President, Worldwide Regulatory Strategy US
Pfizer Inc.

Robert Clark has been working in the pharmaceutical industry for over 28 years – starting in the labs as an analytical chemist and then moving on to regulatory affairs for the last 26 years.  He started at Pfizer in 1992 as an Associate Director, Drug Regulatory Affairs and now is the Vice President, Worldwide Regulatory Strategy.  Robert Clark is experienced in all phases of drug development and has led teams that have gained approval of numerous NDAs/MAAs in many therapeutic areas, including cardiovascular, CNS, pain and anti-infective drugs.  He has led teams in preparation for successful US FDA Advisory Committees in both the pre-approval and post-approval setting.  He has spoken at numerous external pharma conferences and is a recognized expert in advertising and promotion practices for human pharmaceuticals.  He holds a BS degree in Biology and an MS degree in Pharmacology.

Rick Friedman

Richard L. Friedman, MS

Associate Director Risk Science, Intelligence and Prioritization
Office of Manufacturing and Product Quality
CDER, FDA

Associate Director for Risk Science, Intelligence & Prioritization, Office of Manufacturing and Product Quality (OMPQ), CDER

FDA

Richard L. Friedman is the Associate Director, Office of Manufacturing and Product Quality (acting), Center for Drug Evaluation and Research (CDER), Office of Compliance, FDA.  In this position, he is responsible for oversight of CGMP and drug quality programs to assure scientific and risk-based decisions.  This position includes review of major regulatory action recommendations regarding inspections and manufacturing site acceptability; promoting sound risk management of new defects (e.g., potential recalls); program prioritization, and analyzing emerging drug quality trends.  The latter function is a newly established program in CDER’s Office of Compliance that provides for quality vigilance through data mining, root cause analysis, and risk communication.

Mr. Friedman joined FDA in 1990 and his positions have included New Jersey District Drug Specialist, CDER Senior Compliance Officer, Team Leader of Guidance & Policy, and Division Director.  Mr. Friedman has authored several publications on topics including sterile drugs and quality systems, and was awarded The George M. Sykes Award by the Parenteral Society for outstanding journal paper for the year 2005.  Mr. Friedman was also awarded the 2011 Kenneth Chapman Achievement Award by Institute of Validation Technology.  Mr. Friedman is also an adjunct faculty member of Temple University School of Pharmacy in their QA/RA graduate program.  Prior to joining FDA, Mr. Friedman worked in the toxicology research division of an innovator pharmaceutical company.  Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989 and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.

Guilfoyle

Dr. Dennis E. Guilfoyle, Ph.D.

Pharmaceutical Microbiologist
Northeast Regional Laboratory
FDA

Dr. Guilfoyle has worked for the FDA for over 38 years and has been classified as a FDA international expert in pharmaceutical microbiology (Sterile and non-sterile products).  He serves as an instructor at both national and regional FDA training courses for Pharmaceutical, Medical Device and biotechnology issues.  He has assisted on over 150 team inspections that include Team Biologics.

Dr. Guilfoyle has testified and consulted as a government expert for the U.S. Attorney's Office on several FDA court cases (civil and criminal). He periodically assists FDA Compliance branch and the Office of General Counsel on regulatory interpretation of emerging microbiological problems.  He has co-authored 30 scientific publications and co-wrote/reviewed several FDA field guidelines for microbiological inspections as well as some industry technical baseline documents. He has been involved in the design, construction, and validation of three FDA bioclean rooms as well as a BSL level 3 containment laboratory for the testing of select agents. Dr Guilfoyle is an FDA liaison to the USP expert committee on Microbiology and Sterility Assurance. He is an active member of the CDER Pharmaceutical Quality Standards Working Group (PQSWG) and presently he is assigned to the USP Monograph modernization task force. Dr. Guilfoyle is an adjunct associate professor for St. John’s University in their graduate Pharmacy program. He teaches cGMPs and Process Validation.   Mr. Guilfoyle received his

Ph.D. in Biology (Molecular Microbiology) from St. John's University, Queens, NY

M.S. Microbiology from Wagner College, Staten Island, NY

B.A. Biology from Hunter College, City University of NY

Ruzicka

Connie M. Gryniewicz-Ruzicka, Ph.D.

Chemist
Division of Pharmaceutical Analysis
CDER, FDA

Connie Gryniewicz-Ruzicka earned her BA degree in chemistry from Wayne State University (1998) and a Ph.D. in Analytical Chemistry from the University of Missouri-Rolla (2005).  She joined the Food and Drug Administration in October 2005 as a chemist in the Division of Pharmaceutical Analysis (DPA), St. Louis, MO.  Dr. Ruzicka is a member of DPA’s Spectroscopy, Chemometrics and PAT group where her research interests include the application of rapid screening technologies to problems in regulatory pharmaceutical analysis, in particular the application of spectroscopic and chemometric methods for the determination of stability and authentication of pharmaceutical products.  She has presented her work at professional conferences, taught several pharmaceutical inspectorate courses on emerging technologies for pharmaceutical surveillance and has published several papers on the development and use of rapid spectroscopic screening methods for pharmaceutical applications in peer-reviewed journals.

Vijay

Vijay Kshirsagar, M.Sc., D.B.M., A.I.C.

Executive Vice President
Corporate Quality Assurance & Regulatory Affairs
Unichem Laboratories Limited (Mumbai, India)

MR Vijay Kshirsagar is a hard core Quality Assurance, Analytical & Regulatory professional with more than 35 years of rich & well diversified experience of working for the big names in Pharma sector of India. He is currently working for Unichem Laboratories Ltd, Mumbai as Executive Vice President for Corporate Quality, Regulatory & Analytical function for more than 5 years. Prior to this, he worked for reputed names like German Remedies, IPCA, Lupin, Ranbaxy & Sun Pharma.  MR Kshirsagar’s core exposure has been in the area of QA/QC/Regulatory/Analytical Services/Validation Studies/Training & Microbiology related to both formulations and API manufacturing.

Mr Kshirsagar has been a frequent trainer in number of international and national forums having spoken on wide range of topics related to GMP, GLP & Validations. He has done his graduation in Microbiology/Chemistry & post graduation in Organoanalytical Chemistry by Research from Mumbai University.

Mr. Kshirsagar has the vast experience of successfully facing several regulatory audits including US FDA, MHRA, MCC, ANVISA, WHO-Geneva, EDQM etc both for formulations and API’s. He has also successfully represented his company in US and UK courts for matters related to intellectual property. He is also the elected person on the board of Directors of ISPE, India Affiliate.  He has been conferred with a prestigious ‘Outstanding Analyst Award -2011’ by Indian Drug Manufacturers Association (IDMA). In the same year, Dr Roger Williams, CEO of USP was conferred with the highest ‘Eminent Analyst Award’.

Mr. Kshirsagar has a flair for writing having published number of articles on both technological and general topics in reputed journals/magazines including analytical research papers. He is also associated with USP as the Chairman of stake holder’s forum for western India.

Lumpkin

Murray M. Lumpkin, M.D., M.Sc.,

Commissioner’s Senior Advisor and Representative for Global Issues
Office of the Commissioner
FDA   

Dr. Lumpkin is a 22-year career senior official at the U.S. Food and Drug Administration (FDA) and was most recently promoted in July 2011 to be the FDA Commissioner’s Senior Advisor and Representative for Global Issues.  In this role, he is part of the Commissioner’s inner circle of senior political and career advisors and is tasked with helping the Commissioner develop and steer FDA’s role and leadership in the international public health regulatory and capacity building / technical assistance arena.  Working with the senior leadership of the FDA’s Office of International Programs and other senior agency leaders, he has a primary focus on all of the FDA’s international programs and activities and how they support and facilitate both the FDA’s overall domestic public health mission and a positive FDA leadership and engagement in the international regulatory arena.  Much of this work is accomplished through his leadership of FDA’s interactions with its counterpart foreign regulatory agencies, foreign embassies in Washington, and international multinational organizations (both public- sector and NGOs, such as WHO, PAHO, OECD, and the Bill and Melinda Gates Foundation), through the FDA’s harmonization and technical cooperation activities with its counterpart agencies, and through the activities of the FDA’s 13 permanent foreign posts in China, Europe, India, Latin America, the Middle East, and South Africa which he established during his time as the Deputy Commissioner for International and Special Programs and which, because of their successful implementation, were codified into the FDA primary federal statute in the recent food safety legislative amendments signed by President Obama in January 2011 (the Food Safety and Modernization Act). 

From September 2001 to July, 2011, under various Office of the Commissioner titles, he was responsible for the policy development and operational implementation aspects of the FDA’s international activities - most recently, from November 2005 to July 2011 doing such as the Deputy Commissioner for International Programs.  During this time he served in these capacities directly reporting to five Senate-confirmed FDA Commissioners and several acting commissioners.  As such, he was responsible for the management oversight and policy direction of the Office of International Programs and for overseeing all of the FDA's international activities, including its interactions with foreign counterparts and major multinational public health organizations, foreign confidentiality arrangements with counterpart agencies and other bilateral and multilateral arrangements, foreign technical cooperation and harmonization programs, interactions with foreign embassies in Washington, and the activities of the Office of International Programs, including the 13 new foreign FDA posts.  It was also under his leadership that the annual Summit of the Heads of Medicines Regulatory Agencies was established in 2006 on the occasion of the 100th anniversary of the founding of the FDA.

In addition, until August 2009, he was also responsible for the oversight of the Office of Pediatric Therapeutics and the Office of Combination Products, both of which he had overseen from the time of their creation by US Congressional legislation in the early 2000s.  For both of these offices, he was responsible for establishing the offices, hiring directors and other personnel, developing performance goals, performance plans, and standard operating and scientific procedures.  He relinquished oversight of these offices - at his request - in 2009 when he received the mandate to establish the new FDA foreign posts - a mandate that required a high degree of personal involvement of time.

He was recruited to the FDA in 1989 as Director of the Division of Anti-Infective Drug Products and served in this position until 1993. As Director of DAIDP, he was responsible for the scientific and regulatory decisions, as well as the management of a staff of approximately 70 individuals who included physicians, pharmacologists, chemists, microbiologists, toxicologists and project managers.

In 1993, Dr. Lumpkin was named Deputy Center Director (Review Management) for CDER and served in that position until October 2000. His main responsibilities included oversight and management of the then five Offices of Drug Evaluation and their then fifteen new drug review divisions, the Office of Biostatistics, the Office of Post-marketing Drug Risk Assessment, and the Advisory Committee Staff in CDER. There were approximately 900 staff working in these various components over which he had senior line management and senior scientific responsibilities. Under his direction, these components provided statutory oversight of the three major phases of the life of prescription and over-the-counter pharmaceutical products in the United States. In addition, he was primarily responsible for the creation and implementation of leadership and management initiatives to ensure that CDER met its product review performance goals established in conjunction with the Prescription Drug User Fee Act of 1992 (PDUFA), its reauthorization in 1997, and other CDER Office of Review Management provisions mandated in the Food and Drug Modernization Act of 1997 (including the provisions for creating economic incentives and for addressing clinical trial design and other scientific and ethical issues for pediatric research).  Through the efforts of the FDA drug and biologic review teams, the reform of the new drug review process under PDUFA won the 1997 Ford Foundation / Harvard University “Innovations in American Government” award.  In addition, he was responsible for overseeing the implementation of the pediatric study and labeling incentive provisions that were enacted into the statute in 1997, and, which, because of their success, have been reauthorized twice by Congress since that time and have formed the basis for a similar initiative in Europe

During Dr. Lumpkin’s tenure at FDA, he has served in numerous capacities representing FDA on various international working groups and commissions. He was one of the initial members of and FDA’s representative to the International Conference on Harmonization (a position he maintained for 10 years); and he was FDA’s representative for nine years to the World Health Organization’s CIOMS working groups on drug safety issues.  He was also on the regulatory advisory board for WHO’s INFOSAN.  He has represented FDA in numerous bilateral and multilateral initiatives with various governments and counterpart agencies around the world and with multilateral public health organizations.  He had the privilege of working in 2000 for three months at the European Medicines Agency as part of a staff exchange program between the EMA and the FDA.

In 1991, he received the FDA Commendable Service Award; in 1992, the Public Health Service’s Special Recognition Award for Productivity; numerous Commissioner’s Special Citation Awards; in 1996, the Presidential Senior Executive Meritorious Award from President Clinton, and in 2004 the Secretary’s Award for Distinguished Service (“For outstanding performance in the successful effort to assist Congress to develop and enact legislation to provide FDA with authority to require studies of drugs in children.”).

Dr. Lumpkin received his baccalaureate degree from Davidson College in 1975, majoring in German with a concentration in German linguistics which included a junior year spent at the University of Marburg in Germany. His medical doctorate degree was conferred by Wake Forest University in 1979. His medical school training included a rotation working at a refugee camp in Bangladesh. His postgraduate medical education consisted of a three-year residency in pediatrics at the Mayo Clinic in Rochester, Minnesota and a 2-year fellowship in pediatric infectious diseases also at the Mayo Clinic. In 1984, he attended the London School of Hygiene and Tropical Medicine as a Fulbright Scholar and received a Master of Science in Medical Parasitology from the University of London during that year. His professional certifications include pediatrics (U.S.) and tropical medicine and hygiene (U.K.).

His native language is English, and he is fluent in German.

Prior to his present appointment at the FDA, his professional experience included a three-year appointment as head of pediatric infectious diseases at East Tennessee Children’s Hospital in Knoxville; and a two-year appointment as a Medical Director at Abbott Laboratories in Chicago.

MObert

Michele L. Obert

Investigative Analyst
Kansas City District
FDA

Ms. Obert began her career with the FDA in December 1989 in the Kansas City District Office.  She began as a chemist in the laboratory primarily analyzing human and veterinary pharmaceutical samples for potency, identification, and other chemical requirements. In addition to testing samples, she has been participating in inspections since 1990.  In 2007, she became a certified drug investigator.  She was the first laboratory analyst to go through the certification process.

Domestically, Ms. Obert has inspected human and veterinary drug manufacturers, contract testing facilities, clinical research organization, and active pharmaceutical ingredient manufacturers. Internationally, she has performed 70 inspections in 22 different countries.  She has covered numerous dosage forms included, but not limited to, immediate release, delayed release, and extended release tablets and capsules; liquids; creams; ointments; nasal sprays; parenterals; and metered dose inhalers.   In 2009, she was a member of the inaugural group of investigators who were on the Dedicated Foreign Drug Cadre.  She performed 18 pharmaceutical inspections that year in addition to her training activities.

In addition to her inspectional activities, Ms. Obert participates as an instructor in several FDA training courses. Her area of expertise is inspections of chemistry laboratories and Out of Specification Investigations.  She had also served in temporary positions as a Compliance Officer as well as the Recall Coordinator for the Kansas City District.  She was also a key advisor to the Pharmaceutical Technical Exchange Association (PTEA) for approximately 15 years. PTEA is a not for profit organization comprised of human and veterinary pharmaceutical companies and associated companies in the Kansas City District.  PTEA holds hold two meeting per year and meeting topics are chosen based on industry trends and interests.

Ms. Obert received her Bachelor of Science in Education from Wayne State College in Chemistry and Physics.

giuseppe randazzo

Giuseppe Randazzo, MS

Regulatory Scientist
Office of New Drugs
Center for Drug Evaluation and Research
CDER, FDA

Giuseppe Randazzo is a Regulatory Scientist in the Office of New Drugs (OND) at FDA’s Center for Drug Evaluation and Research (CDER).  Specifically, Giuseppe works in the Office of Drug Evaluation III (ODEIII) within OND to help support three review divisions.

As a Regulatory Scientist, he serves in a similar capacity to the Associate Director of Regulatory Affairs.  His day-to-day responsibilities include, but are not limited to, providing expertise in regulatory matters, providing guidance and advice on procedural issues, facilitating and managing policy and guidance development, as well as, serving as a liaison to different parts of the Center to facilitate office level communications and applications.

Prior to joining FDA in 2005, Giuseppe owned and ran a small business, worked for a pharmaceutical company and taught high school chemistry.  Giuseppe earned his MS in Bioscience Regulatory Affairs from Johns Hopkins University and his BS in Chemistry Education from Pennsylvania State University.

Karen Russo

Karen A. Russo, Ph.D.

Vice President, Small Molecules Department
Documentary Standards Division
USP

Karen A. Russo is Vice President of the Small Molecules Department in USP's Documentary Standards Division and previously served as USP's Director of Small Molecules.  Dr. Russo leads USP's efforts to develop documentary standards for small molecular weight medicines intended for the United States Pharmacopeia and the USP Pending Monographs and Non-U.S. Monographs initiatives. She leads a team of scientists working with manufacturers of drug substances and dosage forms worldwide.

Since joining USP in 2002, Dr. Russo has held positions associated with monograph development and acquisition. As Director of Small Molecules from 2006 to 2011, Dr. Russo worked to obtain close to 475 new monographs for USP and led the development and publication of more than 120 new monographs for small molecules.

Ms. Russo has her B.S. in Chemistry and Biology from Murray State University and her Ph.D. in Pharmacology from the University of Missouri–Kansas City.

PaulSchwartz

Paul Schwartz, Ph.D.

Associate Director for Product Quality Coordination
Office of Generic Drugs
CDER, FDA

Dr. Schwartz graduated from the Bronx High School of Science and City College of New York and received his Ph.D. in organometallic chemistry from the City University of New York. He was a post doctoral fellow in the Biophysics Department at Michigan State University. working in the area of cisplatin anticancer drugs. He continued his research in pharmacology at the Veterans Administration Medical Center in Charleston, SC. This collaborative program with the National Cancer Institute led to a number of publications and patents. Paul joined the Office of Generic Drugs in 1990 as a reviewer and has served as Branch Chief/Team Leader, and as Deputy Division Director and Acting Division Director for a CMC review division. In 2011, he was appointed as OGD's Associate Director for Product Quality Coordination. During his tenure at FDA, Paul was the manager of the manufacturing research component of a University of Maryland School of Pharmacy contract with CDER to identify critical variables in drug manufacturing. On the international level, he has served as CDER's CMC expert at meetings in South Africa and Botswana for the PEPFAR program. He also presented a workshop on CMC issues and US regulatory requirements at the International Generic Pharmaceutical Alliance Conference in Mumbai, India in 2010.

Margolis

Vicki L. Seyfert-Margolis, Ph.D.

Senior Advisor for Science Innovation and Policy
Office of the Chief Scientist
FDA

Vicki L. Seyfert-Margolis, Ph.D. is the Senior Advisor for Science Innovation and Policy for the FDA Commissioner’s Office.  Dr. Seyfert-Margolis focuses on initiatives in regulatory science, personalized medicine and scientific computing and informatics.  Previously, she served as Chief Scientific Officer at Immune Tolerance Network (ITN), a non-profit consortium of researchers seeking new treatments for diseases of the immune system. At ITN, she oversaw the development of more than 20 centralized laboratory facilities, and the design and execution of biomarker discovery studies for over 25 Phase II clinical trials.  As part of the biomarker efforts, she established construction of a primer library of 1,000 genes that may be involved in establishing and maintaining immunologic tolerance and co-discovered genes that may mark kidney transplant tolerance. Dr. Seyfert-Margolis was also an Adjunct Associate Professor within the Department of Medicine at the University of California, San Francisco. Prior to academia, she served as Director of the Office of Innovative Scientific Research Technologies at the National Institute of Allergy and Infectious Diseases at NIH, where she worked to integrate emerging technologies into existing immunology and infectious disease programs. Dr. Seyfert-Margolis completed her Ph.D. in immunology at the University of Pennsylvania’s School of Medicine.  Dr. Seyfert-Margolis has co-authored numerous publications and has lectured internationally on various topics.

Tayor

John M. Taylor III, J.D.

Counselor to the Commissioner
Office of the Commissioner
FDA

John M. Taylor III is the Counselor to the Commissioner in the Office of the Commissioner at the Food and Drug Administration (FDA).

Mr. Taylor renders advice to the Commissioner on policy development, interpretation, and integration that cuts across program lines.  He provides leadership in advocating for and advancing the Commissioner’s priorities for the development and management of emergency and crisis management policies and programs for FDA and oversees the policy and planning functions, the Office of Legislation, and the Office of External Affairs.

He also leads the development and management of FDA’s emergency and crisis management policies and programs. In addition, he oversees FDA’s participation in counterterrorism and emergency exercises, and the coordination of the agency’s evaluation of emergency and crisis situations.

Mr. Taylor received his law degree in 1991 from the College of William and Mary.

He started his career with FDA in 1991 and has held various positions within the agency, including

  • Served as Acting Principal Deputy Commissioner from January through July 2011
  • Associate Commissioner for Regulatory Affairs, 2002 to 2005
  • Director of the Office of Enforcement, 2000 to 2002
  • Acting Director of the Office of Compliance in the Center for Drug Evaluation and Research, 2000
  • Special Assistant to the Associate Commissioner for Regulatory Affairs, 1999
  • Senior Advisor for Regulatory Policy within the Office of the Commissioner, 1996 to 1999
  • Attorney in the Office of the Chief Counsel, 1991 to 1996

In 2007, Mr. Taylor joined the Biotechnology Industry Organization (BIO) as the Executive Vice President for health. From 2005 to 2007, he was Divisional Vice President for federal government affairs at Abbott Laboratories

MichaelV

Michael S. Verlander, D.Phil. (Oxon)

President
PolyPeptide Laboratories, San Diego

Dr. Michael Verlander is the President of PolyPeptide Laboratories San Diego (www.polypeptide.com).  Prior to this, he was Executive Vice President and co-founder of PolyPeptide Laboratories, Inc., in Torrance, California, a position he held since 1996.  In this role, he had responsibility for the Quality and Regulatory Affairs functions in the company, and he guided the company through a number of successful Pre-Approval Inspections by the US FDA since the company’s inception.  PolyPeptide Laboratories, Inc. is a part of the PolyPeptide Group, which is one of the leading contract manufacturers of peptides for use as Active Pharmaceutical Ingredients.  Dr. Verlander has served as Director of Global Quality Assurance and Regulatory Affairs for the PolyPeptide Group since 2003 and, in this role, he has guided the Group through several successful Pre-Approval Inspections by FDA at their two manufacturing sites in Scandinavia.  He was closely involved in the design, construction and start-up of a new PolyPeptide Group manufacturing facility in India.

Dr. Verlander received his B.A. degree in Chemistry from the University of Oxford in 1967; his M.A. degree in Organic Chemistry from the University of Oxford in 1968 and his D.Phil. degree in Organic Chemistry from the University of Oxford in 1970.  He obtained his postdoctoral training at the Salk Institute for Biological Studies, La Jolla, California.  Dr. Verlander was subsequently a member of the research faculty at the University of California, San Diego, Department of Chemistry (1972 – 1978).  He has authored more than 50 scientific papers and numerous patents on peptides and related topics.

Prior to joining PolyPeptide Laboratories, Inc., Dr. Verlander was Vice President, Technical and Regulatory Affairs at Bachem California, Torrance, California (1986 – 1996); Director, Peptide Research and Peptide Production, Immunetech Pharmaceuticals, San Diego, California (1985 – 1986); and Research Director, BioResearch, Inc., San Diego, California (1978 – 1985).

For additional information see Agenda

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