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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA/FDA Joint Regulatory Conference

September 24-26, 2018, Washington, DC

Committee & Speaker Biographies

  • Rebecca Devine

    Rebecca Devine, PhD

    Biopharmaceutical Consultant

    Rebecca (Becky) Devine, PhD is an independent regulatory consultant with over 30 years of experience in the regulation of biological products. She began consulting in 1999 after leaving the U.S. Food and Drug Administration (FDA). She joined the FDA in 1979 as a Microbiologist, and held various positions in the Center for Biologics Evaluation and Research (CBER) throughout her 20-year FDA career. From April 1994 until June 1999, she was the Associate Director for Policy at CBER. In that position she was responsible for the development and implementation of all regulations, policy and guidance for CBER regulated products.  From 1993 to 1994 she was the Associate Director for Regulatory Policy in the Office of Vaccines Research Review, CBER. From 1987 until 1991 she was a reviewer in the Division of Product Certification, and Branch Chief of the Vaccines and Therapeutic Products Branch from 1991 to 1993.  This included oversight all license applications for vaccines and therapeutic biological products.  Throughout her CBER tenure and recent consulting career, she has been involved in the review of license applications, inspections, and quality control of vaccine, therapeutic, and biotechnology derived biological products.  Dr. Devine earned her BS and PhD degrees in microbiology from the University of Maryland.  She is currently an active member of the Parenteral Drug Association (PDA) previously serving as Secretary and Treasurer of the Board of Directors, and is the Board Liaison to the PDA Biotechnology Advisory Board.  She is currently the Chair of the PDA Board.  She was a member of the task forces for process validation technical reports including TR42, TR14, and TR60, and is currently leading the effort to revise TR42.

  • Lucy Cabral

    Lucy Cabral

    Roche - Genentech

    Lucy has twenty-five years of experience at Genentech and Roche in the Quality Assurance, Operations, Compliance, and Quality Control groups as part of the plant quality functions.

    Lucy has extensive experience managing commercial and clinical contract manufacturers and material suppliers operating worldwide, US, Europe, and Asia. Lucy holds a Bachelor of Sciences in Biology ad she is an expert in auditing raw material suppliers.

    Currently Lucy is the Head of Supplier Quality Management, for the Roche Pharma worldwide responsible for the management of materials (chemicals and components).  The team is responsible for qualifying and monitoring Roche suppliers worldwide of clinical and commercial material for biologics and small molecule products and for Material Specifications lifecycle management used globally as well as the responsibility of expiry date assignment of Roche products.

    Lucy is the Secretary of the Board of Directors of RX360 Industry Consortium and is the leader of the PDA Supply Chain Interest Group.

  • Douglas A. Campbell

    InterPro QRA

    I am currently a Senior Consultant with InterPro QRA, providing technical services and CGMP guidance to the pharmaceutical industry.  In 2012, I completed 14 years of service with the USFDA as a Senior Policy Advisor and Compliance Officer in the International Compliance Branch at CDER Office of Compliance.  I also served as the Drug Specialist and a Consumer Safety Officer in the Baltimore District.  I was a member of the International Inspection Cadre since 2001, and I have conducted inspections and audits of pharmaceutical manufacturers throughout North and South America, Europe, Asia, and Australia.

    I graduated from Virginia Polytechnic Institute & State University with a B.S. in Science of Food, Nutrition, and Exercise (Pre-Med).  I served three years on Active Duty in the U.S. Army.

  • Reyes Candau-Chacon

    Reyes Candau-Chacon, PhD

    FDA

    Reyes Candau-Chacon, PhD is currently Quality Assessment Lead in Branch IV of the Division of Microbiology Assessment (Office of Pharmaceutical Quality, CDER). Branch IV evaluates the microbial quality and sterility assurance of biological license applications. This is conducted in a comprehensive manner and includes reviewing the microbiology aspects of the BLA as well as inspecting the manufacturing facilities. In addition, the branch participates in writing guidelines, policies, and procedures.

    Prior to her current position, Reyes worked in the diagnostic industry developing methods to detect genetic biomarkers in blood circulating DNA and before that, she worked in the Biotech industry developing Molecular Biology tools. Reyes hold a PhD in Biology from the University of Sevilla, Spain and conducted post-doctoral research in Marburg, Germany and at the University of Pennsylvania on transcriptional regulation in yeast and mammalian cells.

  • David Chesney

    David L. Chesney, MSJ

    DL Chesney Consulting, LLC

    David Chesney is an independent consultant with 47 years’ experience (FDA and private sector). His FDA experience was in the field organization, beginning in the “Boston” District, ending as the District Director in San Francisco, moving on to become VP and Practice Lead for PAREXEL Consulting. In 2016 he formed DL Chesney Consulting, LLC. Dave has an MS in Jurisprudence in Pharma and Medical Device Law (Seton Hall University Law School), a BS in Biology (CSU, Northridge), and postgraduate work in biology at CSU, San Diego. Dave teaches for PDA’s Training and Research Institute, the Food and Drug Law Institute, and serves as adjunct faculty for the Maine Regulatory Training and Ethics Center, University of Maine Law School.

  • Enrique Dilone

    Enrique Diloné, PhD, RAC

    Amicus Therapeutics

    Enrique Diloné joined Amicus in August 2009 and currently serves as Senior Vice President, Technical Operations. Dr. Diloné has over 25 years of experience in the pharmaceutical and biotechnology industries. Prior to joining Amicus, Dr. Diloné served as Executive Director of Quality and Analytics at NovaDel Pharma Inc., a specialty pharmaceutical company developing oral spray formulations, from February 2007 to August 2009. He served as Senior Director/Director of Analytical Operations at OSI/Eyetech Pharmaceuticals from February 2002 to December 2006. He also worked in several pharmaceutical development departments at Wyeth and Hoffmann-La Roche. Dr. Diloné received a B.A. in Chemistry from New York University, and a M.S. and a Ph.D., both in Chemistry, from Seton Hall University. He is a graduate of the General Management Program at Harvard Business School, and is certified in U.S. Regulatory Affairs.

  • Tara Gooen Bizjack

    Tara Gooen Bizjak, MS

    US FDA

    Tara Gooen Bizjak, is an engineering officer in the United States Public Health Service and a Senior Science Policy Advisor at the US FDA. She works in the Office of Policy for Pharmaceutical Quality in the area of developing new regulations, guidance, and standards.

    Commander Bizjak has been with the US FDA for 15 years, starting as a field investigator in the New Jersey District, primarily focusing on drug manufacturing and current good manufacturing practice (CGMP) inspections.

    In 2007, she transferred to CDER to the area of a manufacturing and product quality and was a subject matter contact for several CGMP topics, including pre-approval inspections, continuous manufacturing, pharmaceutical quality systems, water quality, and scale-up issues.

    Prior to her current role, she served in multiple roles, including branch chief and senior advisor.

    LCDR Bizjak received a B.S. in Chemical Engineering from Cornell University, a Masters in Biomedical Sciences from the University of Medicine and Dentistry of New Jersey, and is an ASQ (American Society for Quality) Certified Quality Engineer.

  • Clarice Haigh Hutchens, PhD

    Pfizer Inc.

    Director in GCMC Regulatory with 27 years of experience leading regulatory advocacy and global CMC regulatory strategies for submissions within Pfizer, Pharmacia, Glaxo Wellcome and Mallinckrodt.  Current position at Pfizer is in GCMC Advisory Office working on external advocacy and on Biologics Licensing and Due Diligence.  Areas of external advocacy to include PDA, IQ, ISPE, BPOG, and Nanomedicine Alliance, where I served as the chairperson of the Board of Directors.  Submission expertise in small molecule and biologics covering lifecycle submissions globally. 

    Education: Doctorate in Management, focus in Environmental and Social Sustainability, Masters in Tropical Ecology and Conservation, Masters in Biotechnology, and B.S. in Chemistry and Biology.

    Serve as the WRD representative to the Global Environmental Sustainability Council and am a biologics representative on Pfizer’s Green Chemistry Network.  Represent Pfizer on the ACS Green Chemistry Initiative’s Biologics Roundtable.

  • Mai X. Huynh, MS

    FDA

    Mai Huynh joined the FDA in 1987 as a manufacturing reviewer in the Office of New Animal Drug Evaluation. Prior to joining the FDA, Mai worked as a scientist for research laboratories in the GLP work for pesticide registration and later joined the USDA/Food Safety and Inspection Service (FSIS) as a QA Officer. Mai is currently the Team Leader of the Antimicrobial Team, and a Master Reviewer in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at CVM.

    Mai is an active member of the Parenteral Drug Association, International Society of Pharmaceutical Engineers and Controlled Release Society. Mai is a member of several FDA inter-centers working groups, and CVM’s representative of VICH for manufacturing topics. Mai’s expertise is in the evaluation of sterility assurance validation information and manufacturing information of sustained-release injectables.

    Mai received a Bachelor of Science in Chemistry, a Bachelor of Arts in Information Management, and a Master of Science in Biomedical Medical Sciences.

  • David Jaworski

    David J. Jaworski, MBA

    FDA

    David Jaworski is currently a Senior Policy Advisor in CDER’s Office of Compliance in the Office of Manufacturing Quality and Co-Chair of the PDA FDA Joint Regulatory conference.

    Prior to rejoining the FDA, David worked at Lachman Consultants as a Director in their compliance practice.  Previously at FDA, David worked in the Divisions of Domestic Drug Quality and the International Drug Quality where he was a Consumer Safety Officer, Team Leader, and Acting Branch Chief.  David also had a distinguished 36 year career in the pharmaceutical and biotech industries where he worked for large pharmaceutical companies as well as small start-up companies. He has broad experience in all aspects of drug product manufacturing, including biotech and small molecule manufacturing, operation of plants, quality management, large project management, and P & L management. He has worked on state of the art technology development projects, and design and construction of world class pharmaceutical plants.

    David received his B.S. in Microbiology from Penn State University, and MBA in Operations & Management from Syracuse University.

  • Shane Killian, MS

    Johnson & Johnson

    Shane has over 16 years of experience supporting businesses across the Pharmaceutical, Medical Device, and Consumer business units. Shane is currently the Cross Therapeutic Area Early Development and Licensing & Acquisition Head for Janssen Pharmaceutical Companies of Johnson & Johnson. Shane holds a Bachelor of Arts in Biology from Arcadia University and a Master of Science in Quality Assurance/Regulatory Affairs from Temple University.

  • Tim Kilroy

    Tim G. Kilroy, PhD

    Bristol-Myers Squibb Company

    Tim Kilroy is Director of GMP/GDP Audits for clinical and commercial portfolios in Bristol-Myers Squibb Company (BMS). Tim is based in Dublin, Ireland and has been with BMS for 6 years in a variety of roles including QA Supplier Manager at the Swords Manufacturing site, QA Associate Director for API CMOs in External Manufacturing, Business Continuity Lead for the Pharmaceutical Network before moving into Quality Auditing in 2016.

    Before BMS Tim was with Pfizer in Cork, Ireland and had responsibility for Technical Support to the API manufacturing sites for New product introduction and Process Development. Tim holds a PhD in Organic Chemistry from University College Dublin and an MBA from Smurfit Business School.

  • Jacqueline Kunzler

    Jacqueline A. Kunzler, MBA, PhD

    Baxter Healthcare Corporation

    Jacqueline (Jackie) Kunzler, Senior Vice President, Chief Quality Officer, Baxter Healthcare Corporation is the Global Head of Quality and Compounding Services, with an organization of 5,500 employees.

    Kunzler joined Baxter in 1993 and has served in roles of increasing responsibility across Baxter’s Research & Development, International Marketing, Quality and Compounding organizations.

    Kunzler obtained her bachelor’s degrees in Biology and Medical Technology (Laboratory Medicine) from University of Iowa. She also received an MS in Toxicology from the University of Florida School of Veterinary Medicine, an MBA from Benedictine University with continuing education at Harvard and Wharton Business Schools, and a Ph.D. in Neuroscience/ Cell Biology from the University of Illinois College of Medicine. She serves on several industry committees and on the Board of Directors of two organizations.

  • Renee Kyro

    Renée Kyro, MBA

    AbbVie, Inc.

    Renée Kyro is currently Director, Shared Services Product QA at AbbVie in North Chicago, Ill. supporting multiple elements of the quality system including change management, management responsibilities, complaints, CAPA and product actions. She has 24 years of experience in the pharmaceutical industry starting at Abbott in 1994 as a QA lab analyst, and has held various positions in QA, Compliance and Regulatory Affairs.  Her experience includes: global project management, RA CMC marketed products support, Drug Master Files, recalls and field reporting, Operations QA/QC and laboratory management in a Class A environment.

    She earned her BS in Chemistry and MBA degrees from the University of Wisconsin – Parkside. Her interests outside of work include her children and grandchildren, music, travel, cooking and physical fitness. Renée has been a member of the PDA/FDA Joint Planning Committee since 2012.

  • Paul Perdue

    Paul Perdue, Jr.

    FDA

    Paul Perdue, Jr. currently serves as Branch Chief in FDA’s Pharmaceutical Quality Programs Branch.  Mr. Perdue has 20 years of experience in FDA’s oversight of medical products and tobacco.  His current responsibilities include coordinating, directing, and assisting the field and headquarters with domestic and international investigative activities related to pharmaceutical products.  This Branch serves as subject matter experts on field operations relative to pharmaceutical quality on external and internal cross Agency committees, workgroups, and task forces. 

    Mr. Perdue serves on the 2019 PDA/FDA Joint Regulatory Conference Program Planning Committee

  • Carol L. Rehkopf, MS

    FDA

    Carol has worked at FDA for 28 years and is currently Deputy Associate Director for Review Management in CBER. She has experience working in CBER, CDER, ORA & industry leading regulatory experts to develop and execute effective policy and regulatory approaches to submission review, quality systems, and inspections and audits. She holds a Master of Science degree in Regulatory Science from the University of Maryland School of Pharmacy, a Master's Certificate in Project Management from the University of Pittsburgh Katz School of Business, and a Bachelor of Science degree from the University of Maryland University College.

  • Susan Schniepp

    Susan J. Schniepp

    Regulatory Compliance Associates Inc.

    Susan Schniepp has 35 years experience in Quality Assurance. She is a Distinguished Fellow with Regulatory Compliance Associates Inc. advising clients on overall Quality and Compliance strategies. She was previously Vice President of Quality and Regulatory Affairs for Allergy Laboratories, Inc. and OsoBio Pharmaceuticals, LLC where she oversaw the activities of the Quality Assurance, Quality Control and Regulatory Affairs operations for the companies.  She has had responsibilities for laboratory analysis, method validation, complaints, labeling, investigations, compendial affairs, and other quality systems during her 35 years in the industry.  As an active member of PDA, Sue served on the Board of Directors from 2011-2014 and has been a member of the PDA/FDA Joint Regulatory Conference since 2001, chairing the conference in 2007 and co-chairing it from 2010 through 2014.  In addition to her involvement with PDA/FDA Joint Regulatory Affairs Conference, Sue is Chair of PDA’s Regulatory Affairs/Quality Advisory Board and has presented at many PDA venues.  In 2007 she was the recipient of PDA’s Distinguished Author Award for the book Understanding the United States Pharmacopeia and the National Formulary:  Demystifying the Standards-Setting Process, in 2008 she received PDA’s Distinguished Service Award and in 2009 she was presented the PDA Gordon R. Personeus Award.  Since 2007, Sue has served as a member of the editorial advisory board for Pharmaceutical Technology Magazine as well as authoring a quarterly column called “Insider Solutions”.  Sue was Chair of a USP Monograph Development Expert Committee from 2005-2010.

  • Myriam Sosa

    Myriam M. Sosa, MS

    Merck & Co.

    Myriam Sosa is the Executive Director, QA GMP Compliance at Merck, as well as serving as the current president of the PDA Puerto Rico Chapter. Prior to joining Merck she was the Site Quality Head of Novartis ExLax, Inc as well as a Director, Investigations Branch, of the US FDA, New Jersey District Office. She holds a Master in Public Health, Environmental Health from the University of Puerto Rico Medical Science Campus and a Bachelor of Science Degree from University of Puerto Rico, Rio Piedras.

  • Valerie Whelan

    Valerie Whelan, BSc

    Amgen Inc.

    Valerie assumed the role of Head of Quality for R&D in April 2018 with responsibility for Quality, Compliance, Audit, Computer Related Systems and Learning & Performance across all aspects of Amgen’s Research & Development activities.

    Immediately prior to this, Valerie was the Head of Corporate Quality for Amgen Operations with responsibility for Operations L&P, Corporate QA, Contract Manufacturing Quality, Device Quality, Supplier Quality Management, GxP Computer Related Systems, External Affairs, Partnerships & Alliance Management and Quality oversight of the ATO Manufacturing Site. Prior to this role, she held the role of Site Quality Head for Amgen’s Thousand Oaks manufacturing facility.

    Valerie has over 20 years’ experience in the industry covering a diverse range of pharmaceutical and biotechnology areas both in Europe and the US.

    Prior to joining Amgen in 2011, Valerie held a variety of roles of increasing responsibility within the Quality functions of Pfizer, Bimeda and Takeda. She has accumulated experience in site start up and shut down activities, ongoing new product introduction together with interfacing with a diverse range of Global Inspectorate groups over the course of her career.

  • Maria Anderson

    Maria C. H. Anderson, MS

    FDA

    Maria C. H. Anderson works for the U. S. Food and Drug Administration in the Center for Biologics Evaluation and Research (CBER).  She has worked in CBER’s Office of Compliance and Biologics Quality for fourteen years.  Since 2012, she has served as the Chief of the Biological Drug and Device Compliance Branch within the Division of Case Management.  Her branch is responsible for the review and evaluation of compliance and enforcement actions for biological products, drugs, and devices regulated by CBER.  The branch also provides assessments of the compliance status of regulated establishments within CBER’s purview, and the branch coordinates CBER’s import and export programs, including review of requests for export of unapproved biological products.  Prior to joining FDA, Mrs. Anderson worked as a Biologist with the National Institutes of Health (NIH).  During her career at NIH, she earned her Master of Science degree in Biotechnology from Johns Hopkins University.  Mrs. Anderson earned her Bachelor of Science degree in Zoology from Howard University.

  • Donald Ashley

    Donald D. Ashley, JD

    FDA

    As Director of CDER's Office of Compliance, Donald D. Ashley, J.D., leads efforts to shield the American public from unsafe, ineffective and low-quality drug products through measures designed to assist industry-wide compliance with federal standards for quality and safety, as well as regulatory and enforcement measures to address violations of those standards.

    Mr. Ashley joined FDA after more than 18 years of criminal enforcement and investigation experience with the Department of Justice. His positions included serving as a Trial Attorney in the Office of Consumer Litigation (now the Consumer Protection Branch), prosecuting consumer fraud offenses and violations of the Food Drug and Cosmetic Act, as Associate Director of the Office of International Affairs, and as the DOJ Attaché stationed at the U.S. Embassy in Rome and at the U.S. Embassy in Manila, Philippines.

    Before joining DOJ, Mr. Ashley served as senior litigation associate with a major D.C. law firm, representing clients under investigation for FD&C Act violations. He also served on active duty as an Army captain assigned to the Office of General Counsel, Department of the Army. Mr. Ashley was an adjunct professor of law at Georgetown, George Washington, American and Catholic Universities.

    Mr. Ashley earned his law degree from Harvard Law School.

  • Ronald Berk

    Ronald A. Berk

    Hyde Engineering + Consulting

    Ronald Berk joined Hyde Engineering + Consulting in 1999. Ronald has extensive experience in capital project management and bioprocess engineering of biotech facilities and equipment; including start-ups, commissioning and qualification. He has worked on design of fill finish, biotherapeutic and vaccine manufacturing facilities. His design experience includes implementation of hybrid design utilizing an optimum mix of stainless steel reusable equipment and single use equipment.

    Ronald’s career began in Nuclear Power, as a Process and Layout Engineer with Stork Engineers and Contractors. In addition to his depth of experience in design and project management, Ronald provided expert witness analyses and consulted on complex litigation cases for large construction projects.

    Ronald graduated from the Higher Technical College Amsterdam with a B.S. in Chemical Engineering in 1987 with a minor in Business Management.

  • Sean Boyd

    CAPT Sean Boyd, MPH

    FDA

    CAPT Sean M. Boyd serves as the Deputy Director for Regulatory Affairs in the Office of Compliance at FDA’s Center for Devices and Radiological Health (CDRH).  In this capacity he is responsible for managing the Center’s quality initiatives, as well as regulatory compliance and enforcement programs for the medical device industry.

    Over the course of his career, CAPT Boyd’s experience includes that of a regulatory researcher and engineering analyst, compliance reviewer, and manager of several organizations within FDA.  He has been responsible for all aspects of medical device premarket, postmarket and compliance activities and, prior to joining the Office of Compliance in 2015, led and transformed many aspects of CDRH’s electronic product radiation control program.  He is an expert in FDA’s requirements for a variety of consumer, commercial and industrial electronic products, as well as radiation-emitting medical devices.  He received his undergraduate degree in Biomedical Engineering from Boston University and his Masters in Public Health from the Uniformed Services University of the Health Sciences.

    CAPT Boyd is an active duty commissioned officer in the United States Public Health Service (USPHS).  He is a former Team Commander for one of two Washington DC-based medical response teams (PHS-1 Rapid Deployment Force); and has deployed in response to several disasters and crises, both domestically and abroad. Most recently, this includes response to Hurricanes Irma and Maria, where officers provided medical care to individuals displaced from the Florida Keys and U.S. Virgin Islands, and Puerto Rico. His experience also includes serving as Executive Officer of the Monrovia Medical Unit (an Ebola Treatment Unit) in Liberia, Africa; where the USPHS Commissioned Corps provided care to healthcare workers infected with Ebola Virus Disease.

  • Virginia Carroll

    Virginia A. Carroll, PhD

    FDA

    Dr. Virginia Carroll is a microbiology reviewer in the Division of Microbiology Assessment in FDA’s Center for Drug Evaluation and Research. As a reviewer of Biologics License Applications, she has expertise in aseptic processing and microbial control in drug product manufacturing and has participated on pre-approval inspections of drug manufacturing sites. Dr. Carroll has over 12 years biomedical research experience with a focus on autoimmune disease as well as lymphoma associated with HIV infection. She also has experience teaching college courses in basic microbiology and genetics.

  • Bo Chi

    Bo Chi, PhD

    FDA

    Bo Chi is currently a reviewer in Branch IV in the Division of Microbiology Assessment, Office of Process and Facilities, Office of Product Quality in CDER/FDA. The branch is responsible for microbiology quality review and pre-license and pre-approval inspections of biotech products. Bo has been with the FDA for more than 15 years. She has a Ph.D. in Microbiology.

  • Scott Colburn

    CAPT Scott A. Colburn, MS

    FDA

    CAPT Scott A. Colburn is the Director of the Standards and Conformity Assessment Program at the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).

    In this role, Scott is responsible for the Center’s standards recognition and related development activities in ~600 national and international consensus standards committees. In addition, Scott oversees the programs new Accreditation Scheme for Conformity Assessment [ASCA] pilot program and the Center's efforts in harmonizing standards within the International Medical Device Regulators Forum (IMDRF).

    Scott has served in numerous roles as a lead nurse consultant in the area of premarket review and voluntary consensus standards development and implementation for medical devices. Scott is a member to numerous national and international standards organizations and sits on several policy and leadership committees.

    Scott earned his BSN from Marquette University in 1999 where he then received his commission in the US Army. Scott transferred to the U.S. Public Health Service Commissioned Corps in January 2004 where he began his career with the FDA. Since then, he has earned a MS in Biomedical Technology Development and Management from Georgetown University and Virginia Polytechnic Institute and State University.

  • Mary Collins

    Mary Collins, PhD

    BristolMyersSquibb

    Mary Collins is an established leader with over 25 years experience in the Pharmaceutical manufacturing business across a number of functions including Development, Operations, and Quality.  Mary has been responsible for the Quality oversight of external Pharma manufacturing in BMS for 6 years and is currently Head of Quality for Global External Manufacturing at BMS with responsibility for quality oversight of Contract Manufacturing Organisations supplying BMS with of commercial products from regulatory starting materials, API and Drug Substance through Drug Product and Packaging. She holds a PhD in Chemistry and an MBA from Henley Management College.

  • Alonza Cruse

    Alonza E. Cruse

    FDA

    Alonza Cruse is Director, Office of Pharmaceutical Quality Operations (OPQO) within the FDA Office of Regulatory Affairs (ORA). His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with FDA's Center for Drug Evaluation & Research (CDER) and Center for Veterinary Medicine (CVM). Additionally, Mr. Cruse continues to lead ORA's pharmaceutical collaboration efforts under the program alignment initiative.

    From 2013 - 2015 Mr. Cruse served as the Director (Acting) of the Office of Medical Products & Tobacco Operations (OMPTO) within ORA, overseeing activities such as Generic Drug User Fee Amendments (GDUFA) implementation, pharmacy compounding, and the development of a New Inspection Protocols Program (NIPP). From 2000 - 2015, Mr. Cruse was the Director, FDA’s Los Angeles District Office, where his responsibilities included providing executive leadership to implementing, managing and evaluating FDA's regulatory operations. Mr. Cruse first joined ORA in 1983 as a microbiologist.  He received his Bachelor of Science degree in Medical Technology from York College (City University of New York).

  • Ian F. Deveau, PhD

    FDA

    Ian Deveau, Ph.D., Supervisory Consumer Safety Officer, Office of Manufacturing Quality, Office of Compliance, CDER.

    As a Supervisory Consumer Safety Officer within the Office of Manufacturing Quality, Dr. Deveau oversees the efforts to protect the American public from poor quality drug products and ensure compliance of firms authorized by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FDCA).

    Dr. Deveau is a subject matter expert on sterile drug production, Current Good Manufacturing Practices (21 CFR 210, 211 & 212), and pharmacy compounding practices (USP <795> and <797>).

    Dr. Deveau holds a Bachelor’s degree in Biology from State University of New York, Buffalo; and a Ph.D. in Biology from The Pennsylvania State University with minors in Microbiology, Chemistry, and Biochemistry.

    Prior to joining CDER, he was a chemist and GLP Study Director at FDA’s Center for Veterinary Medicine, followed by 9 years at the U.S. Pharmacopeia involved in developing standards for microbial control of drug manufacturing, blood and blood products, vaccines, biologics and biotechnology products, radiopharmaceuticals & medical imaging agents, and veterinary drugs.

  • Karen D’Orazio

    Karen E. D'Orazio, MS

    FDA

    Karen D’Orazio has worked at the FDA for over 16 years.  She currently works as a Consumer Safety Officer for CDER’s Office of Compliance, Office of Manufacturing Quality (OMQ).  Mrs. D’Orazio’s responsibilities within OMQ include compliance review for advisory and judicial actions based on the regulatory significance of CGMPs; support of emerging issues and incidents to evaluate risk and product quality; and guidance to investigators during ongoing inspection.  Prior to her work with CDER Mrs. D’Orazio was a Level III Pharmaceutical Inspectorate Investigator, Field Alert Monitor, and Pre-Approval Manager for the Office of Regulatory Affairs, New Jersey District.  Mrs. D’Orazio holds a Master of Science in Public Health from the University of Massachusetts Amherst.

  • James L. Dunnie

    FDA

    Jim started with FDA in 1983 as an Investigator (CSO) in the Dallas District/Houston Station Office. In 1989, he was promoted and transferred to the San Juan District Office as a Drug and Biologics Specialist. In 1991, Jim was promoted and become a Supervisory Investigator and transferred to the Baltimore District Office. In 1994, he accepted a lateral transfer to FDA/ORA Headquarters – the Division of Field Investigations, as a Drug Program Expert. In 2009, Jim was promoted to a Senior Drug Program Expert. He became a member of FDA’s foreign drug inspection cadre in 1993 and has been involved with national FDA/ORA training of field drug investigators since 1996. Jim is also the ORA inspectional representative to the FDA Inter-Agency Combination Products cGMP Workgroup. Jim earned a B.S. in Environmental Science (with a Technical Writing Option) from The Pennsylvania State University in 1982. In 1989, he completed all the coursework for a M.B.A. from the University of Houston. Jim is a past recipient of FDA’s Award of Merit.

  • Donald Ertel

    Donald Ertel, MS

    FDA

    Donald Ertel is a Commander in the United States Public Health Service working as a Regulatory Officer for the Division of Manufacturing and Product Quality at the FDA’s Center for Biologics Research and Evaluation. CDR Ertel holds a B.S. Degree in Medical Technology from the University of Maryland and a Master’s Degree in Regulatory Affairs / Quality Assurance from Temple University School of Pharmacy. Additionally, he is certified as a Quality Auditor with ASQ. For over eight years, CDR Ertel’s primary duty has been scientific review (CMC) of BLAs and PMAs. As a CBER lead inspector, he performs, and trains new inspectors in, pre-license/approval inspections for BLAs and supplements; and has performed numerous facility inspections, domestically and internationally. CDR Ertel has over 26 years of experience working in quality assurance and compliance in and with regulated industries of blood banking & cell therapy (prior employment at Johns Hopkins Hospital), biotechnology, and pharmaceuticals (prior employment at Shire Pharmaceuticals). When he is not performing duties to promote and protect the health and safety of our nation, Donald is pursuing nonstop activities with his wife and three daughters and his musical endeavors as a tenor in the USPHS Choral Ensemble and bass player.

  • Carl Fischer

    Carl Fischer, PhD

    FDA

    Carl Fischer is a Senior Advisor with FDA’s Center for Devices and Radiological Health, Office of Compliance, providing guidance on complex regulatory and scientific issues. Carl joined the FDA in 2009 as a biomedical engineer in the Office of Compliance’s Ob/Gyn, Gastroenterology & Urology Devices Branch. Since then, he has held various positions throughout FDA’s Office of Compliance, including Chief of General Hospital Devices Branch and Director of the Division of International Compliance Operations. He has broad experience with a wide variety of devices and combination products and has had extensive involvement with major FDA medical device cases and policy initiatives. Over the last few years he has been particularly involved in the evolution and implementation of the Medical Device Single Audit Program (MDSAP) at FDA. Carl received his B.S. in Biomedical Engineering from Johns Hopkins University and his M.S. and Ph.D. in Biomedical Engineering from the University of Texas at Arlington and University of Texas Southwestern Medical Center joint program in Biomedical Engineering.

  • Kara Follmann

    Kara Follmann, PhD

    Pfizer, Inc.

    Dr. Kara Follmann received her Ph.D. in Biochemistry from the Philipps University in Marburg, Germany. After that she completed a post-doctorate assignment at Aventis Research & Technology studying the regulation of proteins by active pharmaceutical substances to predict their mode of action at a protein level (Proteomics). She then moved to Regulatory Affairs / Chemistry, Manufacturing and Controls (CMC) and is currently the Head of Pfizer’s Essential Health Brands CMC group. She has more than 15 years of global CMC experience across the lifecycle and a variety of pharmatherapeutic dosage forms.

  • James Fries

    James Fries

    Rx-360

    Jim Fries is CEO of Rx-360, located in New Market, MD. Rx-360 has a mission to protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of it’s materials. Rx-360 Members are deeply involved in the organizations working groups, audit programs and educational opportunities that are aligned with its mission as well as the betterment of the pharmaceutical and medical device industries.

    Jim has a long history of success in the medical device, diagnostic, and life science industries, helping grow and lead organizations such as VNUS Medical, LipoScience, Vascular insights, OrthoForge, and Novasys Medical. Jim has also been a delegate to the World Health Organization as well as part of many FDA Pathway Teams, and Clinical Guideline Committees.

    Jim received his B.A in Organizational Behavior and his MBA from Eastern University in St. David’s, PA. He resides in suburban Philadelphia with his wife and three children. Jim truly has a personal mission to enhance the world of patient safety, and is dedicated to serving Rx-360 and it’s membership.

  • Karolyn Gale

    Karolyn Gale

    Emergent BioSolutions

    Karolyn Gale, BSc, Hons., RAQC, is a Senior Manager, Regulatory Affairs at Emergent BioSolutions Inc. With more than 18 years of pharmaceutical experience, she has in-depth chemistry and manufacturing/clinical/regulatory knowledge in pharmaceutical drug development and license maintenance in a wide range of therapeutic areas for both prescription pharmaceuticals and biologics. In addition, she has a proven track record in preparing, submitting and negotiating new drug and biologic license approvals, other marketing authorizations, and post approval changes with both Health Canada and the Food and Drug Administration. Karolyn has extensive experience in novel and expedited regulatory pathways, including Animal Rule, Extraordinary Use New Drug Applications, Fast Track, and Priority Review applications. She has been an active member of the PDAs Post-Approval Changes for Innovation in Availability of Medicines (PAC iAM) Task Force, including co-chair and co-author for an upcoming technical report on post approval change and leading a team to provide comments on the draft ICHQ12 document. Karolyn holds a BSc. from McMaster University and a post-graduate certificate in Regulatory Affairs and Quality Operations from Seneca College.

  • Merle Goddard

    Merle C. Goddard, MS

    Baxter Healthcare Corporation

    Merle Goddard is Sr. Quality Director for Baxter Healthcare responsible to implement the globally harmonized Quality Management System for Hospital Products sites that clarifies, simplifies and brings efficiencies to critical product and life-cycle management for all product types: active devices (electromechanical), passive devices (disposables), implantables (bio-surgery), therapeutics (drugs and therapies) and application software (class 1 and non-medical devices).

    Previously, Merle was Director of the Master of Science program at Northwestern University and has worked in the community as a dietician specializing in enteral/parenteral nutrition, geriatric, heart health and diabetes management. She was previously with Abbott Laboratories involved in Pharma, Device and Nutrition manufacturing businesses. Locations included Canada, EU, Asia and US with global responsibility. Managerial areas included R&D, Manufacturing/Supply Chain/Distribution, Quality Control and Systems Assurance, Supplier management, Commercial and Engineering Assurance. She is active in American Society for Quality (ASQ), Pharmaceutical Industry Association (PIA), Medical Device Innovation Consortium (MDIC) and National Standards Laboratories (NCLSI).

  • Francis Godwin

    Francis Godwin, MBA

    FDA

    Francis Godwin received his undergraduate degree from MIT in Chemical Engineering in 2001. After graduation he worked as a process engineer designing, building, and optimizing chemical plants. He was certified as a Black Belt in Six Sigma performing quality improvement projects and teaching Six Sigma principals. He then worked in pharmaceutical process validation for both batch and continuous processes for APIs and finished dosage manufacturing operations. Later, he managed an analytical chemistry laboratory conducting analyses for production, QA, and research testing. In 2009 he received an MBA from Georgetown University and since then, has been working at FDA in CDER's Office of Compliance. He has served in various functions within compliance, and is currently the Acting Director for the Office of Manufacturing Quality, overseeing regulatory and enforcement actions for both foreign and domestic drug GMP cases.

  • Jennifer Gogley

    Jennifer M. Gogley

    FDA

    Jennifer Gogley is a pharmaceutical microbiologist with the U.S. Food and Drug Administration where she has worked for over 18 years. Since joining the agency Jennifer has actively participated in numerous pharmaceutical inspections covering both the microbiology laboratory and production system focusing on current Good Manufacturing Practices. In addition to conducting inspections Jennifer is actively engaged in analysis of a variety of pharmaceutical products. Jennifer is an instructor for several U.S. FDA national training courses and is on the editorial board of the Pharmaceutical Microbiology Manual used by U.S. FDA laboratories. Jennifer has a Master of Science Degree in Microbiology from the University of California, Riverside.

  • Christine Harman

    Christine Harman, PhD

    FDA

    Dr. Christine Harman is a CMC/facilities reviewer in the Division of Manufacturing and Product Quality (DMPQ), in the Office of Compliance and Biologics Quality/CBER/FDA.  Dr. Harman received B.Sc. Degrees in Chemistry and Biology at Wright State University and received her Ph.D. in Biochemistry and Molecular Biology from Michigan State University.  In 2009, she joined CBER in the Office of Blood Research and Review (OBRR) in which she performed regulatory review, in addition to conducting research.  Her research area focused on antibody neutralization of the Hepatitis C virus, resulting in several publications including a first author publication.  In 2014, Dr. Harman moved to OCBQ in which she is responsible for the review of INDs, license applications and supplements for a range of biologics, which include bacterial and viral vaccines, cellular and gene therapies, hematologic recombinants, blood fractionation products, and in-vitro diagnostic kits.  In addition to regulatory review, Dr. Harman also performs inspections of biological manufacturing facilities.

  • Marea Harmon

    Marea K. Harmon

    FDA

    Marea Harmon began her FDA career with the Philadelphia District Laboratory as a cooperative education student and later became an FDA Chemist.  As a Chemist in the laboratory, her work included analyzing pharmaceutical dosage forms, training other analysts, and conducting inspections.  In 2000, Marea became a New Jersey District Investigator at the Voorhees Resident Post.  There she conducted pharmaceutical establishment and laboratory inspections.  Later in her career in 2007, Marea worked as the Drug Training Officer at the Division of Human Resource Development in Rockville, MD.  In 2008, Marea was hired to work at the Center for Veterinary Medicine (CVM), also located in Rockville, MD.   To date, Marea Harmon continues her work at CVM as a Compliance Officer on the Post Market Drug Compliance Team.   

  • Martine L. Hartogensis, DVM

    FDA

    Dr. Martine Hartogensis is the Deputy Director of CVM’s Office of Surveillance and Compliance.  Martine also leads the Science Policy Team for the office which functions to coordinate scientific and communications efforts throughout the office.  Martine previously served as CVM’s Promotion and Advertising Liaison from 2002 to 2007 and was a reviewer in the Division of Surveillance.  Dr. Hartogensis received her D.V.M. from the Virginia-Maryland Regional College of Veterinary Medicine in 1999 and spent several years in private clinical practice prior to beginning employment at the FDA in 2001.

  • Brooke K. Higgins, MS

    FDA

    Brooke K. Higgins is a Senior Policy Advisor for the Global Compliance Branch 1 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance at FDA Center for Drug Safety and Evaluation.  Ms. Higgins is responsible for evaluating domestic and international pharmaceutical inspection reports, reviewing responses from industry, and preparing associated regulatory actions. She has also served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, Ms. Higgins spent 12 years with the Office of Regulatory Affairs, first as an Investigator and later as a Pre-Approval Manager, both for the Baltimore District.  While working as the Pre-Approval Manager, she continued performing drug manufacturing inspections, both domestically and internationally, became a member of the Pharmaceutical Inspectorate, and was a Level II drug certification auditor. Ms. Higgins received a M.S. in Food Science, focusing on food microbiology, and a B.S. in Biology from Virginia Tech.

  • Kenneth D. Hinds, PhD

    Janssen R&D, LLC

    Dr. Hinds has been with Centocor/Janssen since 2004 in the Drug Product Development area, responsible for formulation, fill-finish process and combination product development. Today, Dr. Hinds is responsible for the development of new drug delivery systems and drug-device combination products across Janssen’s product portfolio.

  • Shannon Holmes

    Shannon F. Holmes, PhD, RAC

    Biogen Inc.

    Shannon is the Director of Product Development Quality at Biogen, based in Research Triangle Park, NC. She leads a team responsible for quality oversight and strategy of all products and devices in clinical development phases leading up to commercialization. Prior to this role, Shannon was a member of the Regulatory Affairs CMC team at Biogen and led a global team responsible for early phase and commercial biological products as well as change management/compliance activities. While at Biogen, Shannon has led successful submissions for clinical, licensed, and post-marketing regulatory applications for biological and combination products. Shannon has been an active member of the PhRMA ICH Coordinating Working Group, the BIO International Regulatory Committee, and the BPDG Regulatory CMC workstream. Prior to Biogen, Shannon worked in regulatory roles at Synthon Pharmaceuticals and Merz Pharma supporting small molecules, biosimilars, and medical devices. Shannon received her PhD in Chemistry from the University of North Carolina and a BS degree in Chemistry from Davidson College.

  • Anne Huffman

    Anne Huffman

    Fresenius Kabi USA, LLC

    Anne Huffman is Vice President, Quality Assurance - Plant Operations, with responsibility for the three Fresenius Kabi sites that make up Global Operations North America. She joined the company as part of the APP Pharmaceuticals acquisition in 2008 when she was then site Quality Director at the sterile injectables plant in the Chicago area. Anne has led local Quality System upgrades as well as been responsible for regional and global alignment within the Pharmaceuticals Division.

    Anne holds a B.S. in Biology from North Carolina State University and has more than 30 years in industry. She started her career as a QC microbiologist at contract testing laboratories and has also served as a consultant in QA/QC and aseptic manufacturing and training.

  • Valerie Jensen

    CAPT Valerie E. Jensen, R.Ph.

    FDA

    CAPT Valerie Jensen is Associate Director of the Drug Shortage Program at the Food and Drug Administration. She received a B.S. degree in Pharmacy from the University of Iowa in 1990. She completed an American Society of Health-System Pharmacists Specialized Residency in Ambulatory Care at the White River Indian Health Service hospital in White River, Arizona in 1991. She worked as a clinical pharmacist for Indian Health Service hospitals in Arizona and New Mexico for nine years before joining FDA. She has been with the Drug Shortage Program at FDA for the past eighteen years.

  • Christopher Jones

    Christopher M. Jones, MBA

    Baxter Healthcare Corporation

    Mr. Christopher Jones holds the position of Vice President-Operations for Baxter Healthcare Corporation. He has spent fifteen years in the healthcare industry, with extensive experience in manufacturing operations. At Baxter, Mr. Jones leads the team responsible for strategy and planning related to Baxter's global capacity investments, as well as projects related to cost and risk reduction. He also leads the External Contract Manufacturing team responsible for relationships with suppliers who provide finished goods to Baxter.

    Prior to joining Baxter, Mr. Jones worked for General Electric Healthcare as an Executive in the Global Supply Chain group. His supply chain experience includes leading GE Healthcare's Global Supply Chain Strategy team in supply chain optimization and simplification, as well as long term capacity utilization planning to address changing market dynamics. Mr. Jones also has experience managing teams responsible for all manufacturing aspects of new product introductions.

    At GE Healthcare, he also worked in the areas of product quality and test engineering. Examples of this work include the management of global product quality initiatives and the development and implementation of best practices for manufacturing tests.

    Mr. Jones holds a B.S. in Electrical Engineering from Northwestern University and an M.B.A. from DePaul University.

  • Connie T. Jung, RPh, PhD

    FDA

    Dr. Jung is currently Senior Advisor for Policy in the Office of Drug Security, Integrity, and Response (ODSIR) in FDA’s Center for Drug Evaluation and Research, Office of Compliance.  Her work focuses on development of policy and regulatory strategies to improve the security and integrity of the U.S. drug supply. She received her B.S. in Pharmacy from The Ohio State University and her Ph. D. in Pharmaceutical Sciences from the University of Cincinnati.  Dr. Jung joined the FDA in 1999 as a researcher in the Center for Food Safety and Applied Nutrition, conducting toxicology research involving skin absorption and metabolism of topically applied compounds, and later served as a Regulatory Reviewer in the Division of Bioequivalence in the Office of Generic Drugs where she analyzed bioequivalence studies of generic products before working on supply chain issues.

  • Alexey Khrenov

    Alexey Khrenov, PhD

    FDA

    Dr. Alexey Khrenov is CMC reviewer in the Division of Plasma Protein Therapeutics (DPPT), in the Office of Tissues and Advanced Therapies (OTAT), CBER/ FDA. Dr. Khrenov’s review responsibilities are focused on the plasma-derived and recombinant blood coagulation products.

    Dr. Khrenov received his Ph.D. in Biochemistry from the Institute of Biochemical Physics of Russian Academy of Sciences in Moscow, Russia and did post-doctoral research in the laboratory of Dr. Saenko at the American Red Cross Holland Laboratory focusing on the biochemistry of coagulation factor VIII. Prior to joining the FDA Dr. Khrenov worked in the United States Pharmacopeia and National Institutes of Health.

  • Joan Kwong

    Joan C. Kwong, MS

    Pfizer Inc.

    Joan Kwong has nearly 20 years of industry experience supporting the development of large molecule products, including the past 11 years developing CMC regulatory strategies and global regulatory submissions across the product lifecycle for biosimilars, monoclonal antibodies, and vaccines. Joan joined Pfizer Inc. in 2004 and is currently a Senior Manager within the Global Regulatory Affairs biosimilar team, most recently leading the preparation of drug product dossier content for global license applications from initial submission through approval. She began her career in the pharmaceutical industry in cell culture and purification manufacturing process development for live virus vaccines at Merck and monoclonal antibodies at Pfizer, including manufacture of clinical supplies and start-up of a new commercial manufacturing facility.

    Joan obtained her BSE in chemical engineering at Princeton University and her MS in quality assurance/regulatory affairs from Temple University.

  • Anthony Lorenzo

    Anthony F. Lorenzo

    FDA

    Mr. Lorenzo has been with the FDA since March 2010 in the Office of Compliance and Biologics Quality (OCBQ), Division of' Manufacturing and Product Quality (DMPQ), Manufacturing Branch 2 (MRB 2), Center for Biologics Evaluation and Research (CBER). Prior to joining the Agency, he had 20 years of experience in CGMP manufacturing; designing, building, commissioning, and validating biologic manufacturing facilities; and scaling up pilot scale to large scale manufacturing. Today, Mr. Lorenzo is the Team Lead responsible for planning, coordinating, and evaluating the overall review and approval process for BLAs and supplements in the branch.

  • John Lunger

    John S. Lunger, MBA

    Adaptimmune Therapeutics

    John Lunger has been Vice President, Manufacturing and Supply Chain at Adaptimmune since March of 2017. John is responsible for clinical manufacturing and global supply of Adaptimmune's autologous T-cell therapy products. From 2015 through 2016 John was Head of Supply Chain and Commercial Product Supply at Merrimack Pharmaceuticals where he led clinical and commercial supply chain as well as the cross functional supply team for Onivyde, Merrimack’s first commercial product launched in October of 2015. Earlier in his career, he held various senior manufacturing, operational, and strategy roles with VWR International, Pfizer, and Wyeth Pharmaceuticals. In his nearly 10 years with Wyeth he had a number of leadership positions, including operations and supply chain strategy, supply management, procurement and strategic sourcing, business systems implementation, generic pharmaceutical business management, marketing, and site operations management in a pharmaceutical manufacturing plant in Ireland. John began his career serving as a nuclear trained officer on a U.S. Navy submarine, strategic supply chain consulting with Accenture, and business development with a start-up procurement services company.

    John holds a Bachelor of Science degree (with distinction) in Ocean Engineering from the U.S. Naval Academy and an MBA in economics and operations management from the University of Chicago’s Booth School of Business.

  • John Lynch

    John Lynch, MSc, MPSI

    Health Products Regulatory Authority, Ireland

    John is a pharmacist. Between 1980 and 1987 he worked in product development and quality roles with a manufacturer of medicines. In 1987 he joined the National Drugs Advisory Board (NDAB), which was then responsible for the authorisation of medicines for human and veterinary use, as a GMP inspector.

    In 1996, he became Director of Inspection when the Irish Medicines Board (IMB) succeeded the NDAB. The job title later changed to the Director of Compliance. In 2014, the IMB became the Health Products Regulatory Authority (HPRA).

    Compliance functions include inspection, audit and licensing activities across human and veterinary medicines, good clinical practice and pharmacovigiliance, medical devices, blood, tissues & cells and organs for transplantation. Also included are sampling and analysis of medicines, quality defects and recalls, export certification, controlled drugs licensing, unlicensed medicines, cosmetics and enforcement of legislation.

    John has previously represented the HPRA on the GMP inspection working groups at the European Medicines Agency and European Commission. He has also been a member of the Committee of Officials of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and is the current alternate.

  • Peter Marks

    Peter W. Marks, MD, PhD

    U.S. FDA

    Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development.  He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.

  • Grace E. McNally

    FDA

    Ms. McNally is the Director, Division of Regulations, Guidance and Standards, in CDER’s Office of Policy for Pharmaceutical Quality (OPPQ). OPPQ is responsible for developing and communicating science- and risk-based policies & standards related to drug product quality, including application assessment & inspection. She oversees the development of regulations and guidance governing the drug quality lifecycle as well as a team managing CDER’s interactions with USP and standards development organizations.

    Grace previously served as an acting Branch Chief in OPQ’s Office of Process and Facilities (OPF). Prior to OPQ Grace held various positions within CDER’s Office of Compliance, including Compliance Officer, Sr. Policy Advisory and acting Branch Chief for policy within Compliance. During her time in Compliance she developed CGMP cases, and led or participated in policy and regulation workgroups in the areas of process validation, combination products, CGMP/quality systems, and manufacturing science.

    Grace began her FDA career as a field investigator in Philadelphia District and later joined Denver District specializing in pharmaceutical and medical device inspections. She graduated with a B.S. in Physics from Boston College, Chestnut Hill, MA.

  • José E. Melendez

    FDA

    José E. Meléndez is an FDA Drug National Expert Investigator from ORA Office Pharmaceutical Quality Operations.  Mr. Meléndez has served in several working groups related to laboratory and inspection programs since he joined FDA in 1996, details as Pre-approval manager and in the center for drugs, as well as acting manager.  His positions have included San Juan District Laboratory Regulatory Program Expert and Drug Specialist Investigator since 2005.  He also has 5 years of experience as a Chemist and Validation Technician for the pharmaceutical companies before joining FDA.  He received his BS in Industrial Chemistry from the University of Puerto Rico.  He has been a member of FDA’s Foreign Inspection Cadre since 2004, and has conducted foreign inspections of pharmaceutical manufacturers throughout Europe, Asia, Africa, Australia North and South America.  Since 2010 Melendez is certified as member of FDA’s Pharmaceutical Inspectorate and continuously recertifies as Level III.

  • Melissa Mendoza

    Melissa J. Mendoza

    FDA

    Melissa Mendoza is the Deputy Director of the Office of Compliance and Biologics Quality (OCBQ) in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration. OCBQ is responsible for ensuring the quality of products regulated by CBER over their entire lifecycle, from pre-market review and inspection to post-market review, surveillance, inspection, outreach, and compliance. Before joining CBER, Melissa served for eight years in FDA's Office of the Chief Counsel where she was a litigator and Associate Chief Counsel for Enforcement.

  • Tracy Moore

    Tracy Moore

    Medicines and Healthcare products Regulatory Agency (MHRA)

    Tracy has been with the MHRA GMP Inspectorate since 2011 and before joining the MHRA had worked in the pharmaceutical industry for over 22 years. She worked across all dosage forms, predominantly within a sterile products manufacturing environment and is eligible to act as an European Qualified Person under directive 2001/83/EC. Tracy supported the internal drafting group of Annex 1 but with a specific focus on Blow Fill Seal. Tracy is the lead for the MHRA GXP team responsible for delivering data integrity strategy, publications and training.

  • Scott Nickerson

    Scott C. Nickerson

    Moderna Therapeutics

    Scott Nickerson joined Moderna in May 2016 as Head of Quality accountable for all aspects of GxP Quality. Scott joined Moderna from Alexion Pharmaceuticals, where he served as Vice President of Quality Assurance and Quality Control supporting biotech manufacturing for both commercial and clinical products. Scott led Quality efforts supporting commercialization of two new rare disease therapies in multiple countries. Prior to Alexion, Scott spent 14 years at Eli Lilly and Company in various roles of ascending responsibility in Quality Assurance and Quality Control supporting the commercial and clinical large molecule platform. As part of his experience at Eli Lilly, Scott spent time at Imclone Systems integrating them into the Lilly large molecule network and leading GMP quality efforts to further the late stage pipeline.

    Scott holds a B.S. in Chemistry from Hampden-Sydney College and an M.S. in Analytical Chemistry from the University of Arizona.

  • Thomas O'Connor, PhD

    FDA

    Dr. O’Connor is a senior chemical engineer in Division of Product Quality Research in the OPQ’s Office of Testing and Research and is a member of CDER’s Emerging Technology Team. His responsibilities included coordinating and directing regulatory science projects to support the implementation of emerging technologies in pharmaceutical manufacturing. His team’s independent research has centered on advancing the utilization models to aid the risk assessment of advanced manufacturing processes. He originally joined the FDA as chemistry reviewer in the Office Generic Drugs and has served as a primary and secondary reviewer for ANDAs and controlled correspondence. Tom is a co-author of several papers and book chapters on continuous manufacturing and emerging technology.

    Prior to joining the FDA, Tom worked at ExxonMobil Research and Engineering where he held job functions in both process analytical technology and process control. Before leaving he was the technology owner for a set of operator guidance tools including fault detection. 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.

  • Simone Pitts

    Simone E. Pitts

    FDA

    Simone Pitts is a National Expert Drug Investigator in FDA’s Office of Regulatory Affairs. Her +20 years of regulatory experience at FDA spans working as a Microbiologist, Domestic Investigator, Foreign Drug Cadre Investigator, and Team Biologics Investigator to her current position as a National Expert Drug Investigator. Ms. Pitts is recognized as a global Subject Matter Expert in Biologics, Pharmaceutical, and Active Pharmaceutical Ingredients (API) inspections; and a global industry thought leader in inspectional areas including Process Validation and Data Integrity.

    Over the course of her career, Ms. Pitts developed specialized expertise to conduct and direct highly technical, complex, multi-faceted and in-depth domestic and international inspections and investigations of active pharmaceutical ingredients and finished drug products with extensive experience in areas including but not limited to vaccines, allergenic extract products, antivenins, plasma derived products (and their recombinant analogues), licensed IVD products, gene/cellular therapy products and human cells, tissues and cellular and tissue based products. She holds a bachelor’s degree in Biology and a master’s degree in Microbiology.  Ms. Pitts also serves as a training resource for FDA.

  • Tom Polton

    Tom Polton, MS

    Pfizer, Inc.

    Tom Polton was appointed to lead Pfizer's Environmental Sustainability program in 2010. Together with his responsibilities for Product Stewardship, he oversees efforts to manage Pfizer’s environmental impacts throughout the product life cycle – from procurement, to manufacturing, to product disposal.

    Previously Tom directed Pfizer’s global health and safety programs for process safety, fleet safety, fire life safety, occupational medicine and occupational hygiene.

    Tom joined Pfizer after finishing his master's degree from the Department of Environmental Health Sciences at the Harvard School of Public Health. Tom has a Bachelors degree in Biochemistry from Brandeis University. He chairs the Pharmaceutical Product Stewardship Working Group, a coalition of 200 industry members for the responsible collection and disposal of unwanted medicine.

  • Michael Popek

    Michael J. Popek

    FDA

    Mr. Popek has been with the Center for Veterinary Medicine (CVM) since 2001. He started as a Review Microbiologist in the Division of Manufacturing Technologies (DMT) Antimicrobial Team and then became Supervisory Microbiologist of the Biotherapeutics Team in 2005. The Biotherapeutics Team reviews the chemistry, manufacturing, and controls technical sections for biotechnology, Minor Use and Minor Species (MUMS), phage, competitive exclusion, etc. products submitted in new animal drug applications (NADA). CVM's DMT requests PAI inspections, provides scientific support during inspections, reviews foreign 483 responses, and provides post-PAI support for compliance issues. He holds a B.S. in Biological Sciences (Molecular Genetics) from The Ohio State University, and a M.S. in Microbiology from the University of Maryland, College Park.

  • Ralph Quadflieg

    Ralph Quadflieg, PhD

    Roche

    Master Degree in Pharmaceutical Sciences from the University of Marburg, Germany (Pharmacist) in 1996 and Ph.D. in Industrial and Clinical Pharmacy from the University of Bonn, Germany in 1999.

    Employment at Bayer, Leverkusen as Laboratory Manager in Quality Control for Solid Oral Dosage Forms and recognition as Qualified Person in the EU and Switzerland in 2001. Employment at TEVA, Germany as Qualified Person for Parenteral, Liquid and Semi-Liquid Drug Products and switch to Roche Basel as Group Head MQA in 2004.

    Integrating Roche and Genentech Technical Operation’s Supplier Quality Management in 2010 and leading the European Region with various different areas of responsibility reaching from Primary and Secondary Packaging Materials, Medical Devices, Chemicals and Biologics until 04.2018. Current role is Global Head Lean Production System for Global Supplier Quality and External Quality at Roche.

  • Saritza Rios-Sola

    Saritza E. Ríos-Solá

    AbbVie Ltd.

    Saritza began career with Abbott/AbbVie Ltd. back in 1989. Currently she is the Quality Assurance Director with twenty-nine (29) years of experience in Quality/Regulatory functions for APL . She holds a Bachelors Degree in Natural Science (BA) from University of PR from Mayaguez Campus.

    She has held several positions within Operations, Quality Assurance and Regulatory areas. Solid knowledge and experience on Medical Devices. Most currently she’s responsible of the Quality Organization at AbbVie Ltd. PR solid dosage plant. She leads a group five managers with a complement of 98 employees. Management representative responsible for the implementation of the APL Quality System.

  • Natasha Rivas

    Natasha L. Rivas

    Vetter Development Services USA, Inc.

    Natasha Rivas is the Director, Quality Assurance and Quality Control at Vetter Development Services USA, Inc. She has over seventeen years of experience in the pharmaceutical and medical device industry in various roles of increasing responsibility including quality control, quality assurance and regulatory affairs. Her current responsibilities include providing quality control and quality assurance oversight for clinical contract manufacturing services as part of Vetter’s Development Services in the United States. Natasha holds a Bachelor of Science in Molecular Biology and is an active member of PDA.

  • Carmelo Rosa, BS, MS, PsyD

    FDA

    Carmelo Rosa has a B.S., M.S., Psy.D. He started with the FDA in May 1990 as an Investigator for the Los Angeles District. Dr. Rosa later transferred to the San Juan District, where for 13 years he served as a pharmaceutical drug Investigator and 6 years as a Compliance Officer. He is member of the foreign drug inspection cadre. He has conducted many inspections of complex pharmaceutical inspections and other commodities regulated by the FDA that have resulted in significant regulatory actions initiated by the FDA. In August 2008 relocated to Maryland to work for CDER as Compliance Officer. In 2009 he was promoted to Team Leader at CDER/DMPQ/OC/ICB, and then to Branch Chief for the International Compliance Branch. He currently serves as the Director for the Division of International Drug Quality I. Dr. Rosa is one of the FDA officials responsible for the review of non-compliant inspections (domestic and foreign), and is involved in FDA’s decision to initiate an enforcement action against pharmaceutical manufacturing and testing facilities that fail to comply with CGMPs. Dr. Rosa has served as an invited Professor at the University of Puerto Rico, School of Law, where he teaches a course on Federal Regulations Enforced by FDA and a General Overview to the FD&C Act. He works very closely with International Regulatory Authorities in different collaboration initiatives. Dr. Rosa is the former Chair for the PIC/S API Expert Circle.

  • Jason A. Rossi, MS

    FDA

    Jason has been with the Food and Drug Administration, Center for Veterinary Medicine since 2011. He is currently a Chemist on the Antimicrobial Team in the Division of Manufacturing Technologies. He is responsible for the review of the chemistry, manufacturing, and controls information for sterile injectable drug products. Prior to joining the FDA, he worked as a medicinal chemist for 11 years at GlaxoSmithKline. He received his Master’s Degree in Chemistry from the University of Virginia.

  • Esteban Santos

    Esteban Santos, MS

    Amgen Inc.

    Esteban Santos serves as Executive Vice President, Operations. Esteban is responsible for the Operations organization, which encompasses Manufacturing, Process Development, Quality, Engineering and Global Supply Chain.

    Prior to this role, Santos was Senior Vice President, Manufacturing, responsible for operations at Amgen's commercial manufacturing locations in the U.S., Puerto Rico, Ireland, the Netherlands, and Singapore. He held various leadership roles, including Vice President, Drug Product; Vice President, Site Operations; Vice President, Manufacturing; and Vice President, Engineering. Mr. Santos joined Amgen in 2007 as Executive Director, Manufacturing Technologies.

    Before joining Amgen, Santos was site general manager for the Johnson & Johnson (J&J) Cordis operation in Puerto Rico. Prior to J&J, Mr. Santos held several management positions in General Electric’s industrial and transportation businesses in Puerto Rico, Connecticut and Pennsylvania.

    Mr. Santos holds a Bachelor of Science degree in Electrical Engineering from the University of Puerto Rico – Mayagüez, and a Master of Science in Management from the Rensselaer Polytechnic Institute, Hartford, Connecticut.

  • Anthony Schaff

    Anthony L. Schaff, Sr., P.E.

    Eli Lilly and Company

    Mr. Schaff has been with Lilly since 2002, in a variety of Leadership roles in Device development, including Innovation, Program Management and Product Commercialization. He is currently providing technical guidance across Lilly’s broadening portfolio of delivery systems supporting everything from pre-diligence opportunities through innovation, development, and into Regulatory submission and approval.

    Prior to joining Lilly, Tony served as Process and Facilities Engineering Manager at Ethicon-JnJ, manufacturing surgical needles/sutures.  He also worked a combined 12 years at Alcon Labs and Abbott Labs in parental process development, CT Production, facility construction/validation, and plant engineering.

    Mr. Schaff obtained a B.S.in General Engineering from the University of Illinois.  He is a certified Six Sigma Black Belt and also holds Professional Engineer licenses in the states of Indiana and Texas as a Mechanical Engineer.

  • Donald Singer

    Donald C. Singer

    GlaxoSmithKline
    Don Singer is a GSK Senior Fellow, an American Society for Quality Fellow and Manager, Biopharmaceutical GMP Ops at GSK.  Don has been a member of the USP Microbiology Committee of Experts since 2000.  He is currently chair of the PDA Task Force for the revision of TR 27-“Pharmaceutical Package Integrity”.  He is a Certified Specialist Microbiologist (NRCM) and Certified Pharmaceutical GMP Professional (ASQ), and has been a Malcolm Baldrige National Quality Award Examiner. Don’s career spans over 35 years of research, quality control, quality assurance experience in the pharmaceutical, cosmetic, and food industries.  He is also currently an adjunct instructor in the Biopharmaceutical Quality graduate program at University of Maryland Baltimore County.
  • Laura Singer

    Laura A. Singer

    Amicus Therapeutics

    Laura Singer is the Vice President of Global Quality at Amicus Therapeutics headquartered in Cranbury, NJ with responsibility for all aspects of clinical development and commercial Quality.  She joined Amicus in 2015 to lead the Quality organization through the design and build of their Quality Systems to support the anticipated launch of their first commercial product.  Laura has worked in the rare disease field for the last seven years and was previously with Shire through the acquisition of NPS Pharmaceuticals.  Laura has been in the Pharmaceutical/Biotechnology industry for 28 years and much of that time she has spent spearheading the development and organizational design of Quality functions and Quality systems to effectively support various business models and programs.  Her expertise and interests includes Quality Systems, organizational design and inspection management.

  • Steven Solomon

    Steven M. Solomon, DVM, MPH

    FDA

    Dr. Steven Solomon was appointed Director of the Food and Drug Administration’s Center for Veterinary Medicine in January 2017. Dr. Solomon previously served as the Deputy Associate Commissioner for Regulatory Affairs within the Food and Drug Administration’s Office of Regulatory Affairs.

    He joined FDA in 1990 as a Veterinary Medical Officer in the Center for Veterinary Medicine, and has served in various policy and leadership positions in the Office of Regulatory Affairs’ Office of Enforcement, Office of Regional Operations, and as the Assistant Commissioner for Compliance Policy.

    He also served in the Office of Global Regulatory Operations and Policy. Dr. Solomon has a Doctor of Veterinary Medicine from Ohio State University and a Master’s in Public Health from Johns Hopkins University.

  • Brad Stanard

    Brad Stanard, MPH, PhD

    AstraZeneca

    Dr. Stanard currently leads Occupational Toxicology and Product Quality as part of the Global Sustainability organization at AstraZeneca and previously held roles within the Environment, Health and Safety groups at Amgen and Amylin Pharmaceuticals. Dr. Stanard has over 18 years of experience in the biopharmaceutical industry covering a broad spectrum of responsibilities in the drug development process within R&D, clinical and commercial manufacturing operations. During this time, his primary focus has been on hazard identification and hazard/risk assessment, including occupational exposure limits and derivation of permitted daily exposure values for extractables and leachables, APIs, intermediates and impurities. Dr. Stanard received his PhD in toxicology from Colorado State University and an MPH in toxicology from San Diego State University.

  • Marla Stevens-Riley, PhD

    FDA

    Dr. Stevens-Riley is currently a master microbiology reviewer and Quality Assessment Lead (acting) in the Division of Microbiology Assessment in the Office of Process and Facilities, within the Office of Pharmaceutical Quality (OPQ). Previously, she was a senior microbiology reviewer in the Office of Policy for Pharmaceutical Quality. Prior to the formation of the OPQ, she was a Team Leader in the Division of Microbiology in the Office of Pharmaceutical Science, and a Team Leader and senior microbiology reviewer in the Office of Generic Drugs. She is a Center for Drug Evaluation Research (CDER) liaison to the United States Pharmacopeia General Chapters- Microbiology Expert Committee, and a co-leader on the Parenteral Drug Association (PDA) Task Force responsible for the revision of PDA Technical Report 27: Pharmaceutical Package Integrity.  She was lead author on the Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes. Her recently published papers include, Parametric Release: A Regulatory Perspective (American Pharmaceutical Review), and Regulatory Pathways for Parametric Release (BioPharm Asia). During her scientific career, she has co-authored over 15 peer-reviewed scientific publications. Dr. Stevens-Riley holds a B.S. in Biology from the College of William and Mary, and a Ph.D. in Microbiology from the University of Georgia. She completed her post-doctoral training in the Department of Microbiology and Immunology at the University of Texas Southwestern Medical Center in Dallas.

  • Paul Stinavage

    Paul Stinavage, PhD

    Pfizer Inc.

    Paul received his doctoral degree from Cornell University Graduate School of Medical Sciences in 1986. Following post-doctoral training at Emory University in Salmonella pathogenesis, he worked as Microbiology Laboratory Manager/Staff Scientist with Pall Corporation in Glen Cove, New York. Upon leaving Pall, he was employed by Calgon Corporation in the industrial biocides area. He joined the FDA in August 1994 working as a Senior Product Quality Microbiology Reviewer for 10 years. Paul joined Pfizer as a Senior Manager/Team Leader in July 2004 where he is currently employed. He served as a member of the USP Pharmaceutical Waters Committee from 2000 to 2005 and is currently a member of the USP Microbiology Expert Committee.

  • Wayne Taylor

    Wayne A. Taylor, PhD

    Taylor Enterprises, Inc. - VARIATION.COM

    Dr. Taylor is the founder and chairman of Taylor Enterprises, Inc. where he is responsible for the development of the ValTran®, Change-Point Analyzer, Sampling Plan Analyzer, and Distribution Analyzer software packages as well as providing consulting and training to the FDA regulated industries in Statistics.  He is author of the books Optimization and Variation Reduction in Quality and Guide to Acceptance Sampling. He is a leading expert in acceptance sampling, process validation, trending and CAPA problem solving.

    Dr. Taylor received his Ph.D. in Statistics from Purdue University and is an Accredited Professional Statistician. He is a Fellow of the American Society for Quality, recognized as one of 100 Notable People in the Medical Device Industry by MD&DI Magazine and received the Distinguished Science Alumni Award from Purdue University. Dr. Taylor is retired from his position as Director of Quality Technologies at Baxter Healthcare Corporation where he was responsible for Baxter's Six Sigma program.

  • Douglas Throckmorton

    Douglas R. Throckmorton, MD

    FDA

    As Deputy Director for Regulatory Programs, Dr. Throckmorton shares the responsibility for overseeing the regulation of research, development, manufacture and marketing of prescription, over-the-counter, and generic drugs in the United States. He is committed to ensuring that the benefits of approved drugs outweigh their known risks.

    Dr. Throckmorton received his medical degree from the University of Nebraska Medical School and completed his residency and fellowship at Case Western Reserve University and Yale University, respectively. Prior to coming to the FDA in 1997, he conducted basic science research and practiced medicine at the Medical College of Georgia, Augusta, Georgia and Augusta Veterans Administration Hospital.

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    Chikako Torigoe, PhD

    FDA

    Chikako Torigoe graduated from University of Tokyo in Japan and came to the US as a post-doctoral fellow in the NIH. After working in University New Mexico and Cornell University, she joined FDA in 2007. After 10 years of experience as a product quality reviewer in CDER for biotechnology products that include therapeutic monoclonal antibodies, she joined CBER in 2018. Her current responsibilities include development of CMC policy and guidance for biological products. She is also a member of the Expert Working Group for ICH Q12.

  • Brandon Varnau

    Brandon Varnau

    Sanofi

    Brandon Varnau is Head of Biologics Platform Global Quality Operations for Sanofi. He utilizes 25 years of experience in Biologics to lead all aspects of Quality Assurance, Quality Control and Compliance for nine Biologics sites in the US and EU. Prior to his current position, Brandon was Vice President of Biological Operations Quality and prior to this he was Vice President of Quality at Genzyme’s Allston plant where Brandon joined Genzyme in 2011 just after this site received a FDA consent decree. Prior to Genzyme, Brandon was Vice President of Quality for Bayer Health Care.

  • Nicholas Violand

    Nicholas A. Violand

    FDA

    Nicholas A. Violand began his career with FDA in 2008 as an Investigator in the New Jersey District, which is now part of the Office of Pharmaceutical Quality Operations, Division I, within ORA.  Focusing primarily on drug CGMP and pre-approval inspections both domestically and internationally, as well as inspections of compounding pharmacies in the State of New Jersey, he has experience with a wide variety of sterile and non-sterile dosage forms, and his work has resulted in many significant regulatory actions.  He became a Drug Specialist in 2014, training and mentoring newer Investigators, and in 2018, a Drug National Expert within the Pharmaceutical Quality Programs Branch, where he continues inspectional work and a focus on training and inspection-related projects.  Mr. Violand received a B.S. in Biotechnology from the School of Environmental and Biological Sciences at Rutgers University. 

  • Kristy Zielny

    Kristy A. Zielny

    Sun Pharmaceutical Industries Inc.

    Ms. Kristy Zielny is currently the Site Quality Head for Sun Pharmaceutical Industries, Inc., Cranbury, NJ. She has been with Sun for a little under two years, serving most of that time as Director, Regional Quality Compliance – North America. Kristy is a highly accomplished quality management professional with 18 years of combined FDA and industry experience. She started her career as an FDA ORA Investigator and subsequently served as a CDER Compliance Officer prior to making the move to industry where she has held several roles in Quality Management.

    Kristy earned a B.A., Biological Sciences, Psychology Minor from Rutgers University and Certificate in Public Health from the University of Medicine and Dentistry of New Jersey.

  • Jan Paul Zonnenberg

    Jan Paul Zonnenberg

    PriceWaterhouseCoopers, LLC

    JP co-leads PwC’s QMS practice and has been with PwC for 5 years and was with PRTM Management Consultants for 15 years prior to its acquisition by PWC.

    He has been a leader in developing methodologies for helping his clients remediate warning letters and consent decrees.   However, his real passion is for helping companies proactively develop effective and efficient quality systems to ensure highly predictable manufacturing processes and highly reliable product quality.

    JP has been active in the PDA quality culture initiative and will be talking about the initiative today.