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Committee & Speaker Biographies

Committee & Presenter Biographies

2021 PDA Advanced Therapy Medicinal Products Conference

26-27 October 2021

  • Lori Daane

    Lori Daane, PhD

    bioMerieux, Inc
    Lori Daane is the Sr. Director of Scientific Affairs at bioMérieux and has over 30 years’ experience in clinical, environmental and industrial microbiology. She is a technical expert on rapid and alternative microbiological methods and provides scientific support to the Healthcare Business in North America. Prior to joining bioMérieux, Lori worked for 11 years at Celsis in a variety of technical roles including VP of Scientific Affairs and Reagent Development. Lori received her Ph.D. from the University of Minnesota in Microbial Ecology studying the influence of earthworm activity on microbial gene transfer in the environment. She performed postdoctoral research at Rutgers University focusing on phytoremediation of polyaromatic hydrocarbons and at the Los Alamos National Laboratory studying microbial communities associated with cryptobiotic soil crusts. She also holds a Master’s degree in Limnology and a Bachelor’s degree in Medical Technology.
  • Dayue Chen PhD

    Dayue Chen, PhD

    Genentech, Inc.

    Dayue Chen received his Ph.D. 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.

  • Irving Ford

    Irving Ford, MSc

    Adaptimmune

    Irving Ford is currently the VP of Quality at Adaptimmune.

    Irving has over 29 years of QA/QC experience in pharmaceutical/biotechnology and cell/gene therapies industries.

    Prior to joining Adaptimmune, Irving was a significant contributor for activities supporting the regulatory filings and commercial approval of BMS’ CAR T products Abecma and Breyanzi as well as Novartis’ CAR T product Kymriah.

    Irving is an active member of PDA and has served on several planning committees for various PDA Conferences. Irving is a co-author of PDA TR-13- EM of Low Bioburden Facilities and for the published White Paper – Risk Assessment Approach to Microbiological Controls of Cellular Therapies. Irving is currently co-authoring a PDA ATMP Points to Consider document for ATMPs.

  • David Geoghegan MBA

    David Geoghegan, MBA

    Tmunity Therapeutics, Inc.

    David Geoghegan is the Vice President at Tmunity Therapeutics, Inc., located in East Norriton, Pennsylvania.

  • Katherine Giacoletti

    Katherine E. Giacoletti, M. Statistics

    Merck & Co., Inc.
    Katherine has worked as a statistician in the Pharmaceutical industry for 20 years and has expertise across the product lifecycle, from non-clinical product and process development through validation and commercial supply, as well as all stages of clinical development from First in Human through licensure and beyond. Katherine is highly skilled in a wide range of statistical methodologies, including Bayesian modeling and prediction, and has the expertise to choose the best methodology to meet both scientific and business demands. She earned her Masters of Statistics at North Carolina State University, with a focus in biostatistics, and before starting in Pharma she worked in survey research at the Research Triangle Institute. Katherine lives in the Philadelphia suburbs with her husband and daughter and 2 cats, and in her spare time is a dancer and a teacher of Scottish dancing.
  • Peter Makowenskyj

    Peter J. Makowenskyj, MEng

    G-CON Manufacturing, Inc.

    Peter has over 18 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various roles within industry, primarily around process solutions and engineering for drug substance facilities. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their cGMP facilities utilizing G-CON’s pre-fabricated autonomous clean rooms by capitalizing on his process and regulatory know how.

    Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received is M. Eng in Chemical Engineering from Cornell University. He is also very active within the PDA where he currently sits on the PDA BioAB, co-Leads the Biopharmaceutical Manufacturing IG, and  Mobile Manufacturing Task Force.

  • Darius Pillsbury

    Darius Pillsbury

    ValSource, Inc.

    Darius Pillsbury is a senior consultant at Valsource.  He holds a Bachelor of Science in Chemical Engineering from Tufts University and has over 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 then 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 risk- and science-based Control Strategies for products as part of the lifecycle approach to process validation.

    Darius has many contributions to PDA including supporting PDA Technical Report 60-2, the Annex 1 commenting team, and the standard for Cryopreservation of Cells for Use in Cell Therapies and Regenerative Medicine (in development now). Currently, Darius is the lead for the PDA Cell & Gene Therapy Interest Group.

  • MaryEllen Usarzewicz

    MaryEllen E. Usarzewicz, MS

    Bristol-Myers Squibb
    MaryEllen E. Usarzewicz received her M.S. in Microbiology from Wagner College in 2000 . After several years working in CRO’s, she joined BMS in 2007, initially in the analytical space providing microbiological support to the clinical supply operations and has recently transitioned to the cell therapy organization in BMS, where she is the Director of QC Microbiology. She is active in several teams in the Parenteral Drug Association and in her spare time she is busy raising two children.
  • Joy Aho

    Joy L. Aho, PhD

    Be The Match Biotherapies

    Joy Aho, PhD, is the Senior Product Manager at Be The Match BioTherapies®, where she develops innovative products and best-in-class services for the cell and gene therapy industry. Prior to joining the team, she worked in product development and management at Bio-Techne for 13 years designing pioneering clinical and discovery tools for the development of cell and gene therapies. Aho received her PhD in Molecular, Cellular, and Developmental Biology & Genetics from the University of Minnesota, and her research led her to studying the role of TGFβ family proteins during embryonic development utilizing stem cells and developmental models.

  • Virginia Andreotti Jones

    Virginia Andreotti-Jones

    ValSource

    Virginia Andreotti-Jones is a consultant with ValSource, focused on providing innovative approaches to Quality Risk Management (QRM). Throughout her career, Virginia has played a key role in Quality Risk Management, Quality Event Investigations, and Quality Systems. Virginia is highly skilled with a well-rounded expertise in the Quality organization. In addition to QRM, her expertise specifically includes, Quality Event Investigations, Quality Systems, Human Error Reduction (Human Performance), QC Equipment Qualification, Change Control, and Project Management. Virginia currently serves on the Board for the Pacific Northwest Chapter of PDA. She holds a BA in Chemistry from Gonzaga University.

  • Behnam Baghbaderani

    Behnam A. Baghbaderani

    Lonza

    Dr. Baghbaderani is the global head of Process Development, Cell and Gene Technologies at Lonza. He has over 18 years of experience in development of cell and gene therapies for clinical and commercial applications . Dr. Baghbaderani holds a PhD degree in Biomedical Engineering from the University of Calgary (Canada), where he developed bioreactor protocols for large-scale expansion of human neural stem cells for clinical applications. He completed nearly three years of postdoctoral program including a two-year postdoctoral fellowship at the NIH focusing on generation of human induced pluripotent stem cells (iPSCs), bioprocessing of human embryonic stem cells and human iPSCs and controlled differentiation into neuronal lineage. Since joining Lonza in 2011, he started to lead a group of scientists in process development, establishing pluripotent stem cell platform technologies and a cGMP compliant manufacturing process for iPSCs. Dr. Baghbaderani then led the cell therapy development department, focusing on development of cGMP compliant processes and analytical methods for different autologous and allogeneic cell therapy applications. In his current role, Dr. Baghbaderani has been leading a global organization offering development services for a wide range of viral vector- and cell therapy-based applications at Lonza, Cell and Gene Technologies.

  • G David Booth

    G. David Booth, MS

    Be The Match Therapies

    G. David Booth, MS Statistics is the Vice President, Quality and Regulatory Affairs National Marrow Donor Program at Be The Match Therapies.

  • Monica M. Commerford

    Monica M. Commerford, Ph.D.

    Thermo Fisher Scientific Patheon

    Monica Markovski Commerford, Ph.D., is currently the Manager of Regulatory Affairs at Brammer Bio in Cambridge, MA, part of Thermo Fisher Scientific. She previously worked as a Microbiologist and Consumer Safety Officer in Branch IV in the Division of Microbiology Assessment, Office of Process and Facilities, Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research at the Food and Drug Administration. She is an expert in the microbial control, product quality microbiology, and sterility assurance of Investigational New Drug Applications and Biological License Applications submitted to CDER and performed pre-license inspections of biological product manufacturing facilities. In addition, she has participated in writing policies and a draft guidance document. Dr. Commerford earned her B.S. in Biochemistry and Molecular Biology from Michigan State University and her Ph.D. in Microbiology and Molecular Genetics from Harvard University. In addition to her regulatory experience, she was also a Sallie Rosen Kaplan post-doctoral research fellow in the Laboratory of Molecular Biology at the National Institutes of Health.

  • Tony Cundell

    Tony Cundell, PhD

    Microbiological Consulting, LLC

    Dr. Tony Cundell consults with a number of pharmaceutical, consumer health and dietary supplement companies, microbiology instrument manufacturers, contract testing laboratories and sterile compounding pharmacies in the areas of microbial risk assessment, regulatory affairs, and microbiological testing. Prior to November 2013 he worked for Merck Research Laboratories in Summit, New Jersey, as the Senior Principal Scientist in early phase drug development. Earlier in his career, Tony Cundell worked at a director level in Quality Control and Product Development organizations at the New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough.

    Tony Cundell chaired the PDA Task Force responsible for the publication of the original 2000 PDA Technical Report N0. 33.  He is a member of the 2020-2025 U.S.P. Microbiology Committee of Experts where he takes a leadership role in the area of modern microbiology methods.

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    Semsi Ensari, PhD

    Kite Pharma

    Currently, Semsi Ensari is a Senior Director at Kite Pharma leading Process Technology and Materials Development team which is responsible to develop and evaluate new technology, materials, and process automation for introduction into clinical and commercial manufacturing of cell and gene therapies. Previously, Semsi built and led a team of Southern California MSAT leads in support of clinical and commercial manufacturing of cell therapy and viral vector manufacturing operations. Prior joining Kite, Semsi held positions with increasing responsibilities in Research, Process Development and Manufacturing at Schering-Plough, Ambrx, and Genentech. Over the course of 20 years of service, Semsi has a proven track record in successfully developing, implementing and maintaining processes for clinical and commercial production of cell and gene therapies, therapeutic proteins, and antibodies. Semsi holds a Bachelor of Science in Chemical Engineering from Bogazici University in Turkey, Master’s and PhD in Biochemical Engineering from University of California, Irvine.

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    Mark Galbraith, PhD

    Transposon Consulting Group

    Former Head of QC/AS, Spark Therapeutics and Founder, Transposon Consulting Group

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    Jackie Kim

    Kite Pharma

    Jackie Kim is a Sr. Associate Scientist at Kite pharma, a Gilead Company. She finished her bachelors degree of Biochemistry at Arizona State University. She is pursuing a MS degree of Biotechnology at Johns Hopkins University and expecting to graduate in May 2022. Jackie started her career as a Quality Control associate and grew out of the role to become a method developing scientist. Currently she is a analytical tech transfer lead for commercial and clinical products.

  • Anna Kwilas

    Anna Kwilas, PhD

    FDA

    Dr. Anna Kwilas received her Ph.D. in Biomedical Science from The Ohio State University in 2010 with an emphasis in Molecular Virology & Gene Therapy and Translational Science. She performed her graduate research at The Research Institute at Nationwide Children’s Hospital examining the potential application of respiratory syncytial virus as a gene therapy vector for the treatment of cystic fibrosis. Dr. Kwilas performed her post-doctoral research at the National Cancer Institute investigating the efficacy of modified vaccinia virus Ankara and adenovirus-based cancer vaccines alone and in combination with other approved and investigational cancer therapeutics. Dr. Kwilas joined FDA in 2015 on an Interagency Oncology Task Force Fellowship. During her fellowship she was involved in the CMC review of gene therapy products and the generation of safer vector producing cells with the use of CRISPR/Cas9 genome editing technology. In 2016, Dr. Kwilas became a full-time gene therapy CMC reviewer in the Gene Therapy Branch of CBER OTAT and in 2019 was promoted to a Team Lead in the Gene Therapy Branch.

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    Bogna Lasia-Szkaradkiewicz

    Health Canada

    Ms. Bogna Lasia-Szkaradkiewicz is a Senior Corporate Regulatory Compliance and Enforcement Advisor within the Regulatory Operations and Enforcement Branch of Health Canada. The Health Product Inspection and Licensing Division within this branch supports the assessment of GMP compliance of establishments engaged in various licensable activities relating to veterinary drugs, human drugs, and active pharmaceutical ingredients. Bogna obtained a Master of Science in Microbiology and Immunology from the University of Ottawa, as well as a Master of Science in Molecular Biology from the Department of Biopolymer Biochemistry at A. Mickiewicz University. She is well versed in cell biology, molecular biology of prokaryotic and eukaryotic cells, gene expression, virology, immunology and microbiology. Bogna has 14 years of experience in different departments of Health Canada, complemented with 5 years of laboratory research experience. She has developed an expertise in Canadian regulatory frameworks for natural health products and biologics including gene, cell and tissue therapies along with a working knowledge of the Food and Drugs Act, Food and Drug Regulations, Blood Regulations, Natural Health Products Regulation, related guidance documents and good manufacturing practises (GMP).

  • Anna Lau

    Anna F. Lau, PhD, D(ABMM)

    National Institutes of Health

    Dr. Lau received her Ph.D. from the University of Sydney, Australia, where her research focused on the development of novel diagnostic platforms for invasive fungal diseases. She completed her CPEP Clinical Microbiology Fellowship training at the NIH and is board-certified through the American Board of Medical Microbiology. In 2013, she joined the Clinical Microbiology Service at the NIH Clinical Center where she co-directed the Bacteriology, Specimen Processing, Parasitology, and Molecular Epidemiology sections. In 2018, Dr. Lau was promoted to Chief of the newly created Sterility Testing Service to support the NIH-wide cGMP aseptic processing and manufacturing of cellular therapy and drug pharmaceuticals for NIH clinical protocols.

    Dr. Lau's translational research has focused on the development of rapid diagnostic platforms using molecular-based techniques and mass spectrometry. In her current role, Dr. Lau champions the education of clinical and pharmaceutical colleagues for GMP testing within a hospital environment. Her current research involves advancing testing platforms used in the pharmaceutical setting whilst also meeting FDA requirements for quality and patient safety.

  • Matthew Lunning

    Matthew Lunning, D.O. FACP

    University of Nebraska Medical Center

    Matthew Lunning D.O., FACP, is an Associate Professor in the Division of Hematology/Oncology and was recently appointed as an Associate Vice Chair of Research for the Department of Internal Medicine and Medical Director of the Clinical Research Center (CRC). He received his medical degree from Des Moines University in 2006. Dr. Lunning completed his internal medicine residency at UNMC where he served as Chief Medical Resident. He completed his Hematology/Oncology fellowship and served as the Hematology Chief Fellow at Memorial Sloan-Kettering Cancer Center. Dr. Lunning returned to UNMC in 2013 and been active in clinic research, research mentoring, education, and patient care. Dr. Lunning was the recipient of the Distinguish Scientist Award in 2019. Dr. Lunning has served on several National Comprehensive Cancer Network’s guidelines committees including the Immunotherapy Toxicity & T-cell lymphoma panels. He has served as an invited member of ASCO’s Cancer Education Committee on the Non-Hodgkin Lymphoma. He is the co-organizer of the Pan Pacific Lymphoma Conference

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    Christina Meissner

    AGES - Austrian Agency for Health and Food Safety

    Christina Meissner is an EU GMP inspector at the Austrian Agency for Health and Food safety since 2013.

    Prior she worked as a Quality Assessor for clinical trials and at the Department of Medical Virology at the Charite University Hospital in Berlin.

    Christina Meissner was involved in the drafting of the Eudralex Volume IV Part IV - GMP requirements for Advanced Therapy Medicinal Products and the Q&A on "the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMP".

    Christina Meissner was the Chair of the PIC/S Drafting Group on Annex 2A and 2B published in May 2021.

  • Andrea Moore

    Andrea Moore, PhD

    Tmunity Therapeutics

    Andrea Moore is the Executive Director of Analytical Sciences at Tmunity Therapeutics. After joining the team in July 2018, Andrea has been leading the development of all core analytical functions for Tmunity including product characterization, method development, and functional assessment strategies. Previously, Andrea was a leader in the Analytical Development group at WuXi Advanced Therapies, where she led an integrated team to develop novel assays for a wide variety of cell and gene therapies. Andrea earned her bachelor’s in Biology from King’s College in Wilkes Barre, PA and her Ph.D. in Microbiology and Immunology from Temple University.

  • Tara Scherder

    Tara M. Scherder, MS

    SynoloStats

    Tara Scherder has over 20 years of experience in the pharmaceutical and biopharmaceutical industries as a statistician, process engineer, and master black belt. Her motto is “statistics can’t be performed in a vacuum” and combines expertise in manufacturing and analytical processes, statistics, and business context to meet goals. She has functioned as both an in-house and external statistical consultant to drug substance and drug product teams from product development through commercial supply for the spectrum of product platforms. She frequently speaks at industry forums and publishes on the practical incorporation of statistical methods for Lifecycle Process Validation. Tara earned a BS degree in Chemical Engineering from the University of Pittsburgh and a MS degree in Statistics from Carnegie Mellon University. As partner at SynoloStats, she passionately shares the opportunity for patient and business benefit through the powerful combination of statistics and process.

  • Faraz Siddiqui

    Faraz Siddiqui, MBA

    Instil Bio

    Faraz Siddiqui is responsible for process development and manufacturing operations in US and UK, at Instil Bio. Along with CMC development for Instil Bio’s pipeline and supplying the clinical demand, Faraz’s team is currently focused on bringing a network of internal clinical and commercial facilities online globally. He has over 24 years of biotech experience with supply chaing, manufacturing, facility startup, technology transfers, operational excellence, process development and technology development. Passionate for operations, innovation and influential leadership, Faraz has been recognized for achieving transformational results, impactful change management and key contributions throughout his career. Prior to Instil Bio, he lead a Technology Excellence team within PD at Kite, responsible for Technology Development, Materials Sciences, Technology Transfers and Business Operations. His team developed and implemented the next generation of automation technology leading to better quality and lower cost. His team also transferred Kite products in various phases to multiple sites and locations across the globe. Prior to Kite, Faraz was a global head of biologics tech transfers at Genentech/Roche where his team lead more than 50 biologics tech transfers. Faraz holds an executive MBA with Honors from Saint Mary’s College and BS in Biochemistry from University of California, Davis.

  • Kelly Waldron

    Kelly Waldron, PhD

    ValSource Inc.

    Dr. Kelly Waldron manages the Quality business unit within the consulting division at ValSource, where she also serves as a senior consultant, and is a member of the Pharmaceutical Regulatory Science Team (PRST) at the Technological University Dublin (formerly Dublin Institute of Technology) in Dublin, Ireland. Dr. Waldron has particular expertise and a specialized focus on the development and implementation of innovative approaches to quality risk management (QRM) and has authored numerous industry and academic papers on the topic. Her expertise extends to various quality functions in the pharmaceutical, biopharmaceutical, and medical device industries, including quality system design, quality strategy and planning, deviations/investigations, CAPA, change management, data integrity, audit and inspection programs and response, and design control. She holds a BA in biology from Boston University, an MBA in pharmaceutical management from Fairleigh Dickinson University, and a Ph.D. in pharmaceutical regulatory science (thesis in QRM) from the Dublin Institute of Technology. She currently resides in New Jersey, USA.

  • Karen Walker

    Karen Walker

    Kyverna Therapeutics

    Karen Walker, Chief Technology Officer, Kyverna Therapeutics. Karen brings >30 years’ experience in the biotech industry, holding positions in Technical Development, Regulatory Affairs and Quality. She has worked in a number of companies including Roche/Genentech, Seattle Genetics, Novartis, Amgen, Bayer, and several other small to mid-sized biotech companies.

    Her experience with Cell and Gene Therapies includes the role of Senior Advisor for Cell and Gene Therapy at RGNE, focused on aspects of development and industrialization of ATMPs. Topics include patient engagement, supply management, control strategy development and data and analytics that incluse research, clinical development and CMC to gain insight into how the products perform with respect to safety, efficacy and durability of benefit. Prior experience included VP Technical Development and Manufacturing for Novartis’ Cell and Gene Therapy Unit where she led the CMC teams through the formation of the strategies and the execution of those strategies to develop Kymriah rusulting in the filing of the first CAR-T BLA. A strong focus for Karen has been active external engagement with industry/trade organizations and dialogue with Health Authorities to influence the regulatory framework for these products and advocating for stronger harmonization across regions.

  • William Whitford

    Bill (William) G. Whitford

    DPS Group

    Bill Whitford is the Life Science Strategic Solutions Leader for DPS Group Strategic Consulting Team, supporting innovative therapeutic development and manufacturing processes. He had been an R&D Leader, developing products supporting biomanufacturing. An invited lecturer at international conferences, Bill has published over 300 articles, book chapters and patents in the bioproduction arena. He now enjoys serving on such boards and committees as the Editorial Advisory Board of BioProcess International. Bill’s recent publications involve processes and facilities supporting sustainable biomanufacturing, Industry 4.0, bioprocess intensification, continuous biomanufacturing, ATMP and exosome production, 3D bioprinting, and biointelligent manufacturing.