Committee & Presenter Biographies

A member of PDA since approximately 1996, he is currently the SVP Technical Operations at Elektrofi. Prior to joining Elektrofi, Michael had roles in Quality, Operations, and Manufacturing over a career spanning 30 years with experience in monoclonal antibodies, small molecules, medical devices, and advanced therapies. Prior to his role at Elektrofi, Michael served as SVP of Cell Therapy Manufacturing at Nurix where he was Product Team Lead for cell therapy assets. Prior to Nurix, Michael was Global Head of Quality at Adaptimmune after spending 12 years working at Eli Lilly where his recent role was AVP Facilitities and Maintenance for Eli Lilly’s locations in New York and New Jersey.  Prior to Eli Lilly, Michael worked at Millennium Pharmaceuticals and Biomarin. Michael started his biotech career at IDEC Pharmaceuticals (Now Biogen) where he developed downstream processing methodologies for Rituxan.  Michael is active in the Parenteral Drug Association where he is a past Board Member and the immediate past chair and co-founder of the ATMP Advisory Board, co-founder of the ATMP Interest Group, a past member of the Biopharmaceutical Advisory Board, and co-contributor to several PDA Technical Reports dealing with lifecycle, steam in place, cell therapy, and oral solid dosage forms.

Andy Case is a Supply Chain and Supply Chain Technology professional in the Bio-Pharmaceutical space. He is a subject matter expert in Chain of Identity and Chain of Custody for individualized cell therapies and the orchestration platforms designed to control COI/COC and End-to-End Value chain activities for these therapies. Andy worked for four years at Novartis as Sr. Director of Supply Chain Technology and as a member of the team that launched Kymriah where he was also the System Owner for CellChain the orchestration platform established by Novartis for its Cell and Gene therapies business.

Andy joined Genentech/Roche in May 2020 as Head of Supply Chain, Cell and Gene Therapies (PTC-S) where he has been establishing supply chain capabilities globally for an emerging portfolio of individualized cell therapies and gene therapies that range from pre-clinical to preparing for commercial launch.

Andy has a BS in Civil Engineering from Texas A&M University and a MBA from IMD in Lausanne, Switzerland.

Dayue Chen received his PhD from Baylor College of Medicine and did his postdoctoral training in Northwestern University. Dr. Chen is currently a staff scientist and the Head of Cell Therapy and Engineering Development at Genentech. He is a trained virologist and molecular biologist with extensive experience in biopharmaceutical industry. He was a research fellow in the Bioproduct Research and Development Division at Eli Lilly and Company before joining Genentech in 2019.

Dr. Chen has published 40+ research articles in peer reviewed journals and currently serves on the editorial boards for the PDA Journal of Pharmaceutical Science and Technology, and the Journal of Biotechnology and Applied Biochemistry. He is an enthusiastic allurophile and amateur marathoner.

Heidi Davis is the Executive Director Quality Systems & Compliance, Cell Therapy Global Quality, at Bristol Myers Squibb. She is accomplished at establishing and integrating Quality Management Systems at various biopharma companies. Heidi is the Quality Sponsor for Bristol Myers Squibb’s Cell Therapy Expanded Access Programs and played a key role in design and implementation of the program.

Richard Denk is working at the company SKAN AG, headquartered in Allschwil/Switzerland  in the position Senior Consultant Aseptic Processing & Containment. Richard was member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard founded 15 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2021 Richard has spent more than 30 years with the subject production of aseptic processing and highly active / highly hazardous substances and has developed the containment pyramid.

Lori Dingledine is currently working in Quality Control at Spark Therapeutics, responsible for Microbial Control and Compendial Testing.  Lori has over 20 years of experience in the gene therapy, biopharmaceutical, and medical device industries in management roles in Quality Control laboratories responsible for analytical, bioanalytical, microbiology, physical testing, and QC inspection.

Eric Dollins, PhD has been in the field of cell & gene therapies for the last almost 15 years in a variety of capacities, including at roles at a health authority (US FDA) and in industry. After completing a PhD in biochemistry and a post-doc in molecular cancer biology, Eric joined FDA’s CBER/OTP/Division of Cellular & Gene Therapies first as a Commissioner's Fellow, then as product reviewer, and finally as team lead before transitioning to industry. Within industry, Eric has had numerous roles in both global biopharma and biotech, as well as independent regulatory affairs consultancy. In global biopharma these roles have included: Global Regulatory Lead (GRL), GRA Interim Therapeutic Area Head, and Head of Search & Evaluation, CMC Biologics and Early Development Technologies within External Innovation. As an independent regulatory affairs consultant, Eric has had the opportunity to provide expert scientific, regulatory, and strategic advice for the development of a variety of cell & gene therapy products. Mostly recently, Eric has served as Head of Global Regulatory Affairs at two different biotechs, including his current role at Adaptimmune.

Philip "Phil" Garibaldi serves as QC Raw Materials Manager at Lonza - Houston Cell and Gene Therapy Facility for which he has worked since 2020. He is a native of New Orleans, La and holds a B.S. degree in Biochemistry from Xavier University of Louisiana. He has 15 years of industry experience across Contract Research, BioAg, Government Contract, Pharma and CGT. When not spending time with family, he enjoys rooting for his favorite New Orleans area sports teams(Saints, LSU and Pelicans) as well as outdoor activities.

David P. Geoghegan has over 30 years of experience in the biopharm industry. He has worked for both large pharma companies as well as small research stage organizations. He has held roles in Quality, Manufacturing, Supply Chain and CMC at various points in his career. The last five years David has lead Quality teams in both cell and gene therapy advanced therapy companies, first as Head of Quality for Tmunity Therapeutics, Inc, a clinical stage company focused on developing CAR-T cell therapies in solid tumor cancers and currently for Spark Therapeutics.

Stephan O. Krause, PhD, is the Executive Director, Analytical Science and Technology, Cell Therapy Global Quality, at Bristol Myers Squibb.  He is an accomplished advocate for advancing industry best practices. He is currently a member of PDA’s Borard of Directors, chair of PDA’s ATMP Advisory Board, and chair of the ANSI task force (ANS-007) for analytical lifecycle steps. He has won numerous innovation, advocating, and publication awards. Based on his work and leadership, Stephan was invited and presented an industry perspective to major regulatory agencies for the analytical lifecycle and control strategies to support the implementation of ICH Q2(R2), Q12, and Q14.

Darrin Kuijstermans has over 20+ years of experience in bioprocess development that includes his work at Lonza in the Cell and Gene Therapy (CGT) space. His background spans both the biologics and cell and gene therapy development and manufacturing industries gaining experience in managing development projects in bioreactor based processes, process analytical technologies and quality by design. Dr. Kuijstermans joined Lonza in Q1 2018 and lead the build-out of the cell therapy process development labs at their Houston site, at the time the world’s largest dedicated cell and gene therapies (CGT) manufacturing facility, now a commercial cell and gene therapy manufacturing site. As the Associate Director of Process Development, he leads multiple development projects focused on platforms and services centered around allogeneic and autologous applications. His experience in Cell & Gene Therapy space covers all facets involved in the development of cGMP manufacturing processes from phase I to commercial readiness implementation.

Dr. Tiffany Lucas joined FDA as a Gene Therapy Reviewer in 2018. She works on all lifecycle stages with gene therapy products, including commercial, BLA, IND, and preIND phases. Her interests include ex vivo modified cellular gene therapy products, lentiviral vector engineering, and rare disease. Prior to joining FDA, Dr. Lucas was an investment analyst for a biotech group focused on each stage biotechnology development and she also worked in technology evaluation, IP, and licensing. She completed postdoctoral studies at Washington University-St. Louis Medical School studying virus-immune interactions and earned her PhD at University of Missouri for her research on retroviral vector engineering.

Dr. Brent McCright received his BS degree in electrical engineering from the University of Maryland and his PhD degree in molecular biology from the University of Utah. The focus of his thesis work was the identification and characterization of novel PP2A regulatory subunits that are involved in controlling cell proliferation. Dr. McCright then studied developmental biology and mammalian genetics during a post-doctoral fellowship research at The Jackson Laboratory. Dr. McCright joined the Division of Cellular and Gene Therapies, in the Office of Cellular, Tissue, and Gene Therapies, at the Center for Biologics Evaluation and Research of the FDA as a Principle Investigator in 2002. Dr. McCright’s lab investigates the function of key signaling molecules during organogenesis and tissue repair using a variety of methods, including MRI. The main goal of Dr McCright’s current research is to identify methods that can be used to predict the safety and effectiveness of cellular therapies. Dr. McCright is also a Product/CMC reviewer for cellular therapy INDs, BLAs, and works on policy development for cellular therapies.

Ryan Murray is a quality and manufacturing science Senior Consultant with ValSource, Inc. He is primarily focused in the areas of quality and regulatory compliance, facility design and control, technology transfer, process qualification, and aseptic risk management of both biologics and advanced therapy medicinal products (ATMPs). Ryan is an active member of the Parenteral Drug Association’s Texas Chapter and the International Society for Pharmaceutical Engineering (ISPE). He has a BS in biomedical science and MS in biochemistry and biophysics from Texas A&M University.

Scott Nichols graduated from the University of Iowa with a BS in Biochemistry, continued as a Fulbright Scholar in Microbiology at the Pasteur Institute, and earned a PhD at Johns Hopkins in Molecular Biophysics. He worked as a microbial control and sterility assurance lead reviewer and lead inspector at the FDA for CDER-regulated BLAs. Following this time at the FDA, he worked and as a consultant for regulatory and compliance issues for biotechnology and cell therapy clients; he advised clients on cGMP compliance issues for small molecule nonsterile drugs, biotechnology drug substance, and all forms of sterile drug product manufacture. He advised regulatory clients on submissions of INDs and BLAs for biotechnology products and vaccines. He started in 2020 working as the Senior Compliance Lead at Kite's new CAR-T manufacturing facility, later leading Kite's Global Quality Compliacne Program. He currently serves at a Product Quality Leader supporting regulatory CMC submissions and overseeing quality data.

Kimberly Noonan, PhD  is a scientific co-founder of marrow infiltrating lymphocyte (MIL) technology. Dr. Noonan, along with Ivan Borrello, MD have pioneered the use of MILs cell therapy. This therapy is showing promise for patients with multiple myeloma, but their research indicates that this personalized cell therapy would be beneficial in treating a variety of blood and bone marrow cancers as well as solid tumors. Dr. Noonan received her BS in Microbiology and PhD in Immunology from the University of Pittsburgh. She also holds an MPH from Johns Hopkins University. Dr. Noonan is published author on many peer-reviewed papers, review articles and book chapters and holds many patents. She joined the faculty of Johns Hopkins University in 2004. Along with being the founder, EVP and CSO and current CEO of  WindMIL Therapeutics, Dr. Noonan has also founded two other biopharma startups in the cancer vaccine and bispecific spaces as well as two in the cell manufacturing space. She has served as an consulting advisor to several mid to large biopharma companies. Dr. Noonan currently serves as the CEO of WindMIL Therapeutics, CSO of Nacelle Bio and is a consultant for several other groups in the cell and gene therapy space.

Dr. Mikhail Ovanesov is a Branch Chief and Principal Investigator in the Office of Therapeutic Products of the Center for Biologics Evaluation and Research, US Food and Drug Administration. Dr. Ovanesov is a biophysicist who joined the Agency in 2009 after postdoctoral fellowships with the American Red Cross, Johns Hopkins University and Howard Hughes Medical Institute. He oversees regulatory reviews and conducts manufacturing site inspections for a variety of biological products, including plasma derived and recombinant protein therapeutics, dried plasma and platelets for transfusion, and gene therapies for hemophilia. His research laboratory is investigating safety and efficacy of hemostasis products and represents Agency in international collaborative laboratory studies on biological standards for the World Health Organization. Dr. Ovanesov also serves as Government Liaison to standards development organizations European Pharmacopeia, US Pharmacopeia and International Society for Thrombosis and Haemostasis.

Krisha Patel is a co-founder of Assurea LLC, which is a boutique consulting firm serving as a Quality and Computer System Validation Unit for fast growing companies in life sciences industry. With a degree in Bioprocessing Science from North Carolina State University, Krisha has expertise in building quality management systems and validation programs for the pharmaceutical and biotech industry.

Darius Pillsbury is a senior consultant at ValSource. He holds a Bachelor of Science in Chemical Engineering from Tufts University and has more than 20 years of experience working within the Biotech/Pharmaceutical industry. Darius worked on the development and validation of manufacturing processes in the Manufacturing Science and Technology group at ImClone Systems and Eli Lilly. He subsequently worked as the Director of Validation at the rare disease company, Ultragenyx, and as the Director of Quality Lifecycle Management at the cell therapy company, Adaptimmune. Darius has extensive experience in the establishment and implementation of science-driven and risk-based Control Strategies as a part of the overall process validation lifecycle approach. Darius is a member of the PDA ATMP Advisory Board and leads the PDA Cell & Gene Therapy Interest Group. Darius has many additional contributions to PDA including as an author of the PDA Technical Report 60-2 and in the current revision to TR60 Process Validation Lifecycle Approach, as well as a contributor to the PDA Annex 1 commenting team and the working groups for the standards for both the Cryopreservation of Cells for Use in Cell Therapies and Regenerative Medicine and Apheresis Cell Collection.

Friedrich is QC Lead of the iNeST (individualized Neoantigen Specific Therapy) program at Roche-Genentech.

Friedrich joined Roche-Genentech after earning his PhD in Microbiology and has over 20 years of experience in Quality Control and Quality Assurance in the biopharmaceutical industry, working on various topics including microbiological testing, material specifications, environmental monitoring, cleaning analytics, and analytics for release.

Friedrich has led several global technical teams (e.g. microbial identification, microbiological testing, endotoxin testing, and Low Endotoxin Recovery/LER) at Roche-Genentech. He co-chaired the PDA Low Endotoxin Recovery Task Force, which authored PDA Technical Report No 82 on LER. He is also a member of the PDA ATMP advisory board.

Carmen Warren is currently the Director of Immune Cell Attribute Sciences within Analytical Development at Kite, a Gilead Company. Carmen leads a team that establishes the analytical control strategy, including identification of Critical Quality Attributes, which informs specification development, comparability, and process validation campaigns to support product development and lifecycle management. Her team drives the continued study of apheresis starting material to understand its impact on autologous cell therapy process and product performance and to identify opportunities for process improvements. Carmen joined Kite in 2019 and has contributed to multiple IND, BLA and PAS filings. Prior to joining Kite, she worked on the development of antibody drug conjugates at Agensys, an affiliate of Astellas Pharma. Carmen obtained a BS in Biochemistry and Cell Biology from the University of California, San Diego and a PhD in Biological Chemistry from the University of California, Los Angeles.