Carl-Helmut Coulon, PhD
Since 2015 Dr. Carl-Helmut Coulon heads the “Future Manufacturing Concepts” group at the Research Institute INVITE including the subarea “application-oriented robotics research”. After his PhD in artificial intelligence in 1997 he started at Bayer AG in the automation department followed by various functions around the production technology up to his switch to INVITE 2015.
Darrin J. Cowley, PhD
Darrin Cowley, PhD, is currently Head of Developmental Quality, Biologics & COVID Vaccine at AstraZeneca. He was previously Executive Director Product Quality at Amgen, Inc. He trained in Molecular and Cell Biology and has a PhD in Biochemistry and NIH Post-doctoral work in cell signaling and sorting. Darrin has extensive experience in the development, filing and commercialization of a wide range of synthetic and biological molecules including biosimilars and COVID vaccine. Darrin has experience with the development and approval of several types of combination products such as auto-injectors and on body injectors. Most recently, Darrin has served as quality lead supporting the global development and approval of AstraZeneca’s COVID vaccine.
Alonza E. Cruse
Alonza Cruse is Director, Pharmaceutical Quality Programs within the Office of Regulatory Affairs. His office is responsible for all pharmaceutical quality inspections & investigations, both foreign & domestic working in conjunction with FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine.
From 2013 - 2015 Mr. Cruse served as the Director, (Acting) of the Office of Medical Products & Tobacco Operations (OMPTO) within FDA’s Office of Regulatory Affairs where he coordinated ORA’s activities associated with the Generic Drug User Fee Act (GDUFA) implementation and oversaw headquarters inspectional operations associated with pharmacy compounding. Mr. Cruse worked with the Center for Drug Evaluation and Research (CDER)’s senior leadership on initializing ORA’s role in the new drug application review process and the development of a New Inspection Protocols Program.
In 2000, Mr. Cruse was named Director, FDA’s Los Angeles District Office, where his responsibilities included providing executive leadership to implementing, managing and evaluating FDA's regulatory operations. Prior to this Mr. Cruse was Director, New York District Import Operations.
Mr. Cruse first joined ORA in 1983 where he began as a microbiologist. He received his Bachelor of Science degree in Medical Technology from York College (City University of New York).
Biswarup DasGupta (Bis) is a Quality and Compliance leader with over 20 years of experience in QA, QC including contamination control. Currently, Bis is working as a QA Director for Sarepta's Gene Therapy program since July 2019. Before Sarepta, Bis assumed different roles in Quality organization with increasing responsibilities at Sanofi, GSK Biologics, and Altana Pharma. In these roles, he has developed effective contamination control programs, lead successful CD verification, implemented phase-appropriate GMPs, provided strategic leadership, and built a culture of quality and continuous improvement. Bis has a Master in Microbiology and BS in Chemistry, Biology, and Microbiology.
Bis has co-authored TR13-2 and currently co-leading the new TR on Contamination Control Strategy.
Pamela C. De Moor, MS, PhD
Vir Biotechnology, Inc
Pamela De Moor, MS/PhD is currently a Senior Director of Formulations and Drug Product at Vir Biotechnology and has been working at Vir for the past 2 years. She has been in the industry for 30 years and has worked on many modalities with focus on live attenuated virus, vaccines, and not least monoclonal antibodies. Pam is also an experienced process engineer with in-depth and hands on experience with all drug product processes. Pam has worked internationally spending 6 years in Novartis in Switzerland where she ran the Late-Stage Biologics group. Pam is a chemical engineer who graduated from California Institute of Technology and completed her MS/PhD from a joint Bioengineering program at UC San Francisco and UC Berkeley. From there she went on to modified atmosphere packaging, inhalation technology, drug delivery systems, and finally biopharmaceutics. She is very excited to share the experiences of developing a unique therapeutic for COVID-19 at a pandemic pace.
Kathy A. Demarest
Kathy joined Amgen in 2002 and is the Executive Director of Site Quality. Kathy was born in Providence, RI. She attended high school in nearby Cranston and attended Dickinson College in Carlisle, PA where she studied physics and mathematics and played on the volleyball team. Upon graduation, she attended the University of RI for graduate physics courses. She started her career as a GC/MS analyst for an environmental laboratory in Syracuse, NY. In 1992, Kathy began a ten year career in various roles in the laboratory and validation departments at Merck Pharmaceuticals in West Point, PA prior to coming to Amgen.
Kathy’s roles at Amgen have included computer validation, Lab QA, CMQA Disposition, AR5 Production, QC, Quality Operations and her current role as Executive Director of Site Quality. Kathy lives in Cranston, RI. Her only daughter Karen is a junior at Stonehill College in Easton, MA.
Andrew Dick, MS
Andrew Dick is a globally recognized leader, SME in industrial/pharmaceutical and cosmetic microbiology for both sterile and non-sterile products, intermediates, materials and manufacturing controls. In-depth knowledge and skills for non-sterile, aseptic processing and terminal sterilization production.
At KDC/One, Andrew is the Vice President of Global Hygiene and Microbiology since April 2020. Prior to KDC/One, Andrew was employed with Johnson and Johnson for 15 years.
Andrew's area of focus in on microbiologcial contamination prevention in nonsterile manufacturing. Focal points include sanitary equipment design, cleaning, sanitization, preventative maintenance, water, HVAC and compressed air systems and microbiology laboratory operations.
In 2018, Andrew worked with the PDA to publish a book titled "Contamination Prevention for Nonsterile Manufacturing".
Andrew also co-authored PDA Technical Report 67, Exclusion of Objectionable Microorganisms from Non-sterile Pharmaceuticals, Medical Devices and Cosmetics.
Andrew has been awarded Alumni Fellow at Wagner College in June 2018.
Derek I. Duncan, PhD
Dr. Derek Duncan began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He then moved into industry holding various Product & Application Development positions. Currently at LIGHTHOUSE and based in Amsterdam since 2003, Dr. Duncan is responsible for developing applications for pharmaceutical process monitoring and finished product inspection. These include using headspace analysis for container closure integrity testing, packaging permeation studies, lyo chamber moisture mapping, and automated media fill inspection.
Johnson & Johnson
Paul Edson’s career in the healthcare industry began as an Investigator for the US FDA in New Jersey’s District office. While in the FDA Paul participated in both Medical Device and Pharmaceutical inspections, including the inspections of Barr laboratories that ultimately resulted in the landmark Barr Decision. After leaving the FDA, Paul was employed by Hoffmann-La Roche prior to working for Johnson & Johnson. For the past 20 years, Paul has assumed a number of Quality and Compliance leadership roles within Johnson & Johnson’s family of companies. Paul is currently a member of J&J’s Global Quality & Compliance Leadership Team as the VP of Johnson & Johnson’s Regulatory Compliance function. This includes responsibility for the Compliance programs within our Medical Device, Pharmaceutical, Biologics, OTC and Consumer product businesses. Among the responsibilities of the role is the creation and management of the J&J Policy/Standards and the worldwide regulatory compliance oversight, auditing and inspectional activities for the J&J corporation.
Travis A. Frick, MSc
Mr. Frick is a technical operations and quality executive with extensive experience managing transformational change in business-critical settings. Hands on leader who enjoys working in a fast pace environment. His experience includes execution and delivery of strategic priorities across a global network and developing talent within the organization. Innovative change manager who drives metric-driven quality enhancements, process improvements and operational efficiencies. Travis exudes a passion for personnel and business development, data integrity, and manufacturing process execution (and continuous improvement).
Mirko Gabriele, PhD
Mirko Gabriele is currently the Sr Director, Global Sterile Strategy Technology And Innovation of the ThermoFisher Scientific. Mirko started his career in Quality Control as team leader and supervisor, he held then, the position of R&D Chemist working on new entities synthesis and analytical development. In 2008 he joined Patheon, Ferentino site as Technology Transfer Project Manager. In 2010 he joined the Business team as Business Manager, dealing with contract negotiation, budget and Client relationship. In 2012 he was Technology Transfer Manager controlling manufacturig site porfolio, then Global Technology Transfer covering TTs on the 11 NA and EU sites. Latest role in operations as Technical Operations Director. He has 17+ year of experience in pharma, with experiences in API and Finished Product. Mirko has a degree in Pharmaceutical Chemistry, an executive MBA and a PhD. He is QP as well. He collaborates with PDA since 2010. In 2014 he led the PMCO task force issuing the TR 65 on ; since September 2012 he is member of the PDA RAQAB and reviewer for PDA Letter Committee. Funder and Co-leader of the Interest Group on TT since August 2015 and PDA European Trainer in TT.
Victor R. Gaines
Ray Gaines is the Branch Chief of Global Compliance Branch 3 in CDER’s Office of Compliance, Office of Manufacturing Quality, Division of Drug Quality I. He has a background in chemistry and over 27 years’ experience between industry and FDA. He started his career as a chemist in a global pharmaceutical company in an R&D lab and moved to plant quality compliance and later managed global contract manufacturers. He was involved with due diligence audits, new business development, and quality and compliance activities. Ray joined FDA in 2011 as an Interdisciplinary Scientist and has also served as a Team Leader. As Branch Chief he oversees the review of violative (OAI) facility inspection reports. Ray holds BS degrees in Chemistry and Biology from Virginia Commonwealth University.
Milind Ganjawala, MS, MBA
Mr. Milind Ganjawala serves as the Director of the Division of Drug Quality 2 (DDQ2), Office of Manufacturing and Product Quality (OMPQ), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), FDA.
He began his service with FDA in 2009. Prior to coming to FDA, he had more than 20 years of experience in quality management positions within world-class Pharmaceutical/Biotech companies. He received a BS, M.S. and MBA degrees.
Francis RW Godwin, MBA
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 Director of the Office of Manufacturing Quality, overseeing regulatory and enforcement actions for both foreign and domestic drug CGMP cases.
CDR Tara Gooen Bizjak, MBS
CDR Tara Gooen Bizjak is the Director of the Manufacturing Quality Guidance and Policy Staff in CDER, Office of Compliance, Office of Manufacturing Quality and is an engineering officer in the United States Public Health Service. Tara has been with the FDA for 19 years and has focused in the area of drug manufacturing, current good manufacturing practice (CGMP) inspections, and related policy. She started as a field investigator in the New Jersey District and transferred to CDER in 2007. Prior to her current role, she was a senior science policy advisory in the Office of Pharmaceutical Quality in the area of quality metrics and emerging technology, branch chief in the area of drug manufacturing pre-approval inspections and a senior advisor in the Office of Regulatory Affair’s Office of Policy and Risk Management. CDR Bizjak is an ASQ (American Society for Quality) Certified Quality Engineer and Quality Improvement Associate. She received a B.S. in Chemical Engineering from Cornell University and a Masters in Biomedical Science from Rutgers University.
Dennis E. Guilfoyle, MS, PhD
Johnson & Johnson
For the last seven years, Dr. Guilfoyle has been happily employed as the Senior Director, Microbiology & Analytical Regulatory Compliance with Johnson & Johnson, Corporate Compliance and Quality Control. He is responsible to provide scientific and compliance expertise to the corporate GXP audit teams, compliance remediation, and regulatory Intelligence and outreach functions. Dr. Guilfoyle serves as the expert on matters related to laboratory test standards, compendia requirements, cGMP and rapid microbiological methods. Collaterally he helps foster meaningful, credible and strong partnerships with health authorities ensuring that J&J is at the frontline in developing appropriate global microbiological laboratory requirements. Prior to working in industry, he had worked for over 40 years with the U.S. Food & Drug Administration (FDA) and was classified as an international expert in the field of pharmaceutical microbiology. He is currently serving his 21th year as a member of the USP expert Microbiology committee and is a member of the PDA Science Advisory Board. Dr. Guilfoyle has been an Associate Professor for two graduate courses entitled “cGMP” and “Process Validation”. He would someday like to retire and fish from his dock at his dream lake house.
Maria T. Gutierrez Lugo, PhD
Dr. Gutierrez-Lugo is a Product Quality Review Chief in the Office of Biotechnology Products (OBP), CDER, FDA. Prior to joining the FDA in 2008, Dr. Gutierrez-Lugo conducted postdoctoral research at the NIH and at the University of Arizona. She holds a Ph.D. in Chemical Sciences (Pharmacy) from the National Autonomous University of Mexico.
Rachel C. Harrington
Rachel Harrington started her career with FDA in 2008 as an Investigator with the Office of Regulatory Affairs (ORA) in the Baltimore District Office. She received her Level III Drug Certification and became a member of the Pharmaceutical Inspectorate in 2011. Rachel transitioned into the position of District Drug Specialist in 2012, where she continued to perform domestic and international drug inspections. In 2014, Rachel accepted a Supervisory Investigator position with ORA’s newly formed GDUFA organization. After supervising a team of drug investigators for two years, Rachel went to ORA headquarters in 2016 where she was a member of the Medical Products and Tobacco Policy Staff within the Office of Strategic Planning and Operational Policy. In late 2018 she began a year-long detail working on the New Inspection Protocol Project (NIPP) for the Assistant Commissioner for Medical Products and Tobacco Operations before joining the Office of Medical Products and Tobacco Operations in late 2019.
Kir F. Henrici
The Henrici Group
Kir Henrici has extensive industry experience serving as a quality and compliance consultant with special expertise in the area of Data Governance + Data Integrity, IT and Enterprise Data Management, leading global and site level data governance programs to include designing and executing protocol driven DI assessments, risk analysis, remediation plans and process improvements throughout the organization to ensure a holistic integration of DI principles and controls. She has gained global and diverse perspective and working knowledge of quality, compliance and technical challenges and solutions impacting companies around the world; supporting a range of initiatives including global data organizational area quality system audits and assessments; complex risk management and remediation plans; technical reviews of GMP electronic and manual data related to manufacturing and laboratories; and the enterprise harmonization of policies and procedures.
Special achievements include the development and execution of product risk assessments driving the successful release of international drug product batches; the complex remediation for a generic drug company in receipt of a 483 and Untitled Letter which resulted in an NAI outcome for the subsequent FDA inspection; and Pre-Approval Inspection Readiness for a domestic biotech company and a medical device company, both of which yielded product approvals.
Brooke K. Higgins, MS
Brooke K. Higgins is a Senior Policy Advisor for the Global Compliance Branch 3 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance at FDA's Center for Drug Evaluation and Research. Ms. Higgins is responsible for evaluating domestic and international pharmaceutical inspection reports, reviewing responses from industry, preparing associated regulatory actions, and providing training to ORA and CDER personnel. 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 domestic and international drug manufacturing inspections, 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.