Skip To The Main Content
Committee & Speaker Biographies

Committee & Speaker Biographies

2020 PDA Advanced Therapy Medicinal Products Conference

June 24-25, 2020

  • Michael Blackton

    Michael N. Blackton, MBA

    Adaptimmune LLC

    Michael Blackton is responsible for the global quality organization at Adaptimmune inclusive of Quality Control, Analytical Development, Quality Assurance, and Quality Lifecycle Management spanning sites in the Philadelphia Navy Yard and Oxford, UK.  Michael's career spans over 25 years in biotechnology, medical device and pharmaceuticals where he has held leadership positions in manufacturing, quality, operations, and engineering. Prior to joining Adaptimmune, he spent 11 years with Eli Lilly and Company and ImClone in roles of increasing responsibility directing facilities maintenance operations, qualification, cleaning validation, multi-product strategies, regulatory documentation, and technology transfer initiatives supporting a portfolio of products and approvals, including CYRAMZA® (ramucirumab). Prior to joining Lilly, Mr. Blackton served in various quality management roles at Millennium Pharmaceuticals and Inhale Therapeutics. He earned his Master of Business Administration degree from New York University.

  • Darius Pillsbury

    Darius D. Pillsbury

    Valsource LLC
    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 and co-chair for the upcoming 2020 ATMP conference.
  • EJ Brandreth

    EJ Brandreth, III, MBA

    Inovio Pharmaceuticals

    E.J. has over 35 years in life sciences including small molecules, devices and pivotal biotechnology products, and is currently the Sr. Vice President of Quality for Inovio Pharmaceuticals, where he has quality oversight of a combination Medical Device and DNA therapeutic platform. He was previously Sr. Vice President of Quality and Regulatory Affairs at Ajinomoto Althea Technologies, specializing in CMO biotech processing and aseptic filling. He was the Sr. Director of Quality for BioMarin where he helped design the commercial orphan drug facility, and launched Aldurazyme® and Naglazyme®. During the startup of IDEC Pharmaceuticals he held various management positions in QA, Validation and Regulatory Affairs, and was a core team member for the development and launch of Rituxan® and Zevalin®. He is the past Chairman of the PDA Biotech Advisory Board, author of several PDA Technical Reports, and is the past President of ISPE, San Diego. He holds an MBA from UOP and a BA in Biology from UCSD.

  • Vijay R. Chiruvolu, PhD

    Kite Pharma, a Gilead Sciences Company

    Currently Senior Vice President of Process Development - Cell Theray at Kite Pharma, a Gilead Sciences company. Vijay has 25 years of biotech industry experience with companies like Scios, Avigen, Hoffmann-La Roche, Johnson & Johnson, Amgen and Kite Pharma.

  • Lori Daane

    Lori L. Daane, PhD

    bioMérieux

    Lori Daane is the Director of Scientific Affairs at bioMérieux and has experience in clinical, environmental and industrial microbiology.  She is a technical expert on rapid and alternative methods and provides scientific support to the Healthcare Business in North America.  Lori received her Ph.D. from the University of Minnesota in Microbial Ecology.  She also holds a Master’s degree in Limnology from the U of MN and a Bachelor’s degree in Medical Technology from Ferris State University.

  • Irving Ford

    Irving Ford, MSc

    Bristol-Myers Squibb
    Irving Ford is currently the Head of CAR T QC Laboratories at BMS. Prior to joining BMS, Irving was a significant contributor for activities supporting the BLA, PAI, and commercial approval of Novartis’ CAR T product Kymriah®.

    Irving has over 28 years of QA/QC experience in the pharmaceutical/biotechnology and cell and gene therapies industries including, but not limited to, non-sterile, sterile, and low bioburden manufacturing production. Irving has also designed, implemented and managed paperless laboratories.

    Irving has a successful track record developing personnel and working with laboratory, facilities, validation, manufacturing, regulatory, QA, R&D, and compliance personnel to manage and resolve complex quality and manufacturing issues.

    Irving served on the planning committee for the 2019 PDA Global Conference on Pharmaceutical Microbiology and 2019 PDA ATMP Conference. Irving is also a co-author/contributor for the PDA’s TR for EM of Low Bioburden Facilities. Irving is also a co-author of a White Paper for appropriate microbiological controls for ATMPs manufacturing that is being published in the PDA Journal.

    Irving is a member of a task force creating an ISO Standard for apheresis collection.
  • Melissa Gosse

    Melissa Gosse

    SwanBio Therapeutics, Inc
    More information coming soon.
  • Peter Makowenskyj

    Peter J. Makowenskyj, MEng

    G-CON Manufacturing

    Peter Makowenskyj has over 13 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various technical roles in process solutions for the biotech industry prior to moving into management positions in technical and sales roles. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities with single use technologies. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their facilities utilizing G-CON’s pre-fabricated autonomous clean rooms.

    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.

  • Stabler Hardiman

    Marsha L. Steed

    bluebird bio
    Marsha Steed has over 25 years of experience as a Microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields. Marsha has a Bachelors in Biology from Western New England University in Springfield, MA. Marsha is the Director of Microbiology and Contamination Control for bluebird bio.

    Marsha specializes in performing microbial risk assessments to design microbial control strategies for ATMP manufacturing as well as developing risk based environmental monitoring programs. She advises the bluebird bio contract manufacturing organizations on sterility assurance matters.

    Marsha is an expert contamination control for Cell and Gene Therapy. Marsha also performs training courses and webinars for microbial risk assessments, aseptic processing, cleanroom classification and facility start-up. Marsha is active in industry and has served on the Parenteral Drug Association (PDA) Science Advisory Board (SAB) and the Education Advisory Board (EAB); the PDA Task Force on Microbial Investigations; the PDA Microbiology Meeting Planning Committee and ATMP Planning Committee and has been the past chair of the PDA Annual Meeting. Marsha is a former notified body ISO auditor.

  • Allan Bream

    Allan J. Bream, MSChE

    CRB

    Allan Bream has more than 35 years of engineering and manufacturing experience, including 30 years in the biotechnology industry. His expertise includes viral vector & cell therapy manufacturing facility design, large-scale bacterial fermentation & mammalian cell culture, vaccines, downstream processing, protein purification and Current Good Manufacturing Practice facility design, operations and assessment. Bream’s facilities experience includes all phases of process design, including master planning, conceptual and detailed design, construction services and equipment procurement across the United States, Puerto Rico, Europe and Asia. His experience also includes biosafety level 2 & 3 facility design projects. He has also worked in corporate engineering, process development and biomanufacturing positions for Chiron Corp. and Baxter Healthcare. Bream has a Master of Science in biochemical engineering and a Bachelor of Science in chemical engineering from the University of Iowa.

  • 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 2015-2020 U.S.P. Microbiology Committee of Experts where he takes a leadership role in the area of modern microbiology methods, co-chairing the USP Expert Panel that published a stimuli article in the Sept-Oct. 2017 Pharmacopeial Forum entitled The Development of Compendial Rapid Sterility Tests.

  • Brian Hawkins

    Brian J. Hawkins, PhD

    Pluristyx, Inc.

    Dr. Hawkins is Chief Technology Officer at Pluristyx, Inc, which provides Ready-to-Differentiate, Ready-to-Use Pluripotent Stem Cells, cell line contract development and manufacturing services, and knowledge support to companies in the field of drug development, regenerative medicine, and cellular therapies.  Dr. Hawkins received his Ph.D. in Molecular Cell Biology and Biotechnology from Virginia Tech and completed his postdoctoral training at the University of Pennsylvania.  He began his career as an assistant professor and founding member of the Mitochondria and Metabolism Center in the University of Washington School of Medicine, where he investigated how alterations in cell metabolism influence both health and disease.  Dr. Hawkins transitioned to industry in 2014 and served as Scientific Applications Director at BioLife Solutions, where he applied cell metabolism expertise to the study of cryopreservation, and helped guide numerous academic and industrial groups on steps to optimize cryopreservation processes for multiple cell types. Dr. Hawkins is currently President-elect of the PDA Pacific Northwest Chapter and team lead on the PDA Cryopreservation Standards Task Force, and is active in the PDA Biopharmaceutical Advisory Board and PDA Letter Editorial Committees.  He retains an affiliate faculty position in the Department of Anesthesiology and Pain Medicine at the University of Washington.

  • Scott Jeffers

    Scott Jeffers, PhD

    uniQure

    Scott received his PhD in Biology and Virology from Purdue University where he built lentiviral and retroviral gene therapy vectors pseduotyped with various viral glycoproteins, most notably Ebola virus gp. Following this, he did a stint as a post-doctoral fellow at the University of Colorado where he discovered a novel receptor for the SARS-CoV 1 coronavirus. He then moved to Paris, France, where he drank wine, ate cheese and bread, and worked from time to time in the lab at the Pasteur Institute as a post-doctoral fellow and research scientist where he studied the structure of viral glycoproteins. He entered industry working for Brammer bio and has held increasing responsibility positions within Brammer, at Selecta Bio, and most recently at uniQure where he is the Director of Process Development.

  • Kelly Kemp

    Kelly Kemp, PhD

    ViaCyte

    Kelly Kemp, PhD is the Director of Process Development at ViaCyte, working to characterize and optimize the manufacturing process of an innovative stem cell derived product aiming to treate diabetes. With a passion for biology and technology, as well as a proficient understanding of GMP and regulatory requirements, Kelly has had a strong career focus on scaling-up cell production processes and implementing process improvements.

    Kelly earned her Ph.D. in Developmental Biology from the Free University of Brussels, Belgium and continued her training, as a postdoctoral fellow at the Salk Institute for Biological Studies in La Jolla, CA, focusing on the transcriptional regulation of human pluripotent stem cells. Kelly has led process development teams for cell-based products at Shire, Stemedica Cell Technologies, and Vital Therapies.

  • 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 the diagnosis of invasive fungal diseases. She completed her CPEP Clinical Microbiology Fellowship training at the NIH Clinical Center and is board-certified through the American Board of Medical Microbiology. In 2013, she joined the Clinical Microbiology Service in the Department of Laboratory Medicine of 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 Sterility Testing Service in DLM 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 focus on the development of new rapid diagnostic platforms for microbial identification and the detection of resistance mechanisms using molecular-based techniques and mass spectrometry. In 2014, Dr. Lau was recognized with the prestigious Forbes 30 Under 30 award in Science and Healthcare for her development of the NIH Mold MALDI-TOF MS Database.

    More recently, Dr. Lau has branched into the field of current good manufacturing practice (cGMP) product sterility testing, where she leads a team of 11 to support the NIH intramural cGMP program for cell-, gene-, and immunotherapy, as well as drug development. In this role, Dr. Lau applies her research interests of rapid diagnostics to evaluate system performances within the cGMP setting. Her expertise in this unique area of regulatory microbiology is readily sought in the clinical microbiology field, where requests for sterility testing of biopharmaceutical products is becoming more widespread as cellular therapies become the norm for the treatment of a variety of acquired and/or genetic diseases.

  • Bruce Levine

    Bruce L. Levine, PhD

    University of Pennsylvania

    Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, is Founding Director of the Clinical Cell and Vaccine Production Facility at the University of Pennsylvania. He received a B.A. (Biology) from Penn and Ph.D. (Immunology and Infectious Diseases) from Johns Hopkins. First-in-human clinical trials include the first use of a lentiviral vector and first infusions of gene edited cells. Dr. Levine has overseen the production of 3,000 cellular products administered to >1,200 patients since 1996. He is co-inventor of the first FDA approved gene therapy (Kymriah), chimeric antigen receptor T cells for leukemia and lymphoma. Dr. Levine is co-inventor on 26 issued US patents and co-author of >180 manuscripts and book chapters with a Google Scholar citation h-index of 83. He is a Co-Founder of Tmunity Therapeutics, a spinout of the University of Pennsylvania. Dr. Levine has received the William Osler Patient Oriented Research Award, the Wallace Coulter Award for Healthcare Innovation, will serve as President Elect of the International Society for Cell and Gene Therapy (2020-2022). He has written for Scientific American and Wired and has been interviewed by the NY Times, Wall Street Journal, Washington Post, NPR, BBC, Time, National Geographic, Bloomberg, and Forbes.

  • 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.

  • Laura Moody

    Laura R. Moody, PhD

    Syntegon Pharma Technology

    Laura Moody earned her Ph.D. in cellular and molecular biology at the University of Wisconsin – Madison.  Her postdoctoral training focused on the identification of FDA-approved drugs for the treatment of the rare, genetic neurodegenerative disorder, Alexander disease. Laura worked for three years as the technical lead for the cell-based drug screening, manufacturing and custom cell-based services group at Thermo Fisher Scientific, specializing in large scale cell-based initiatives.  Since 2018, she has been the North American product manager for single-use systems and primary packaging at Robert Bosch Packaging Technology (now renamed Syntegon Pharma Technology), with a focus on pharmaceutical liquid packaging for fill/finish applications.

  • Stabler Hardiman

    Marsha L. Steed

    bluebird bio
    Marsha Steed has over 25 years of experience as a Microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields. Marsha has a Bachelors in Biology from Western New England University in Springfield, MA. Marsha is the Director of Microbiology and Contamination Control for bluebird bio.

    Marsha specializes in performing microbial risk assessments to design microbial control strategies for ATMP manufacturing as well as developing risk based environmental monitoring programs. She advises the bluebird bio contract manufacturing organizations on sterility assurance matters.

    Marsha is an expert contamination control for Cell and Gene Therapy. Marsha also performs training courses and webinars for microbial risk assessments, aseptic processing, cleanroom classification and facility start-up. Marsha is active in industry and has served on the Parenteral Drug Association (PDA) Science Advisory Board (SAB) and the Education Advisory Board (EAB); the PDA Task Force on Microbial Investigations; the PDA Microbiology Meeting Planning Committee and ATMP Planning Committee and has been the past chair of the PDA Annual Meeting. Marsha is a former notified body ISO auditor.

  • Rob Tenerowicz

    Rob Tenerowicz

    BioMarin Pharmaceutical Inc.

    Rob Tenerowicz joined BioMarin in September 2011 and serves as Group Vice President of Global Supply Chain and Planning. His responsibilities include technical operations strategic planning, production planning, logistics, business technology management, program management, corporate engineering, business process improvements, and procurement.  Mr. Tenerowicz brings almost 35 years of biotechnology industry and product development experience, which includes his time working for XOMA as Vice President of Operations and Bio-defense, GenVec as Vice President of Clinical Manufacturing and Process Development, Abgenix as an Associate Director of Project Management/Quality/Regulatory Affairs, Cell Genesys as an Associate Director of Project Management, and Genentech in Product Development and several manufacturing roles.  He has experience managing a broad range of line functions including project management, process development, manufacturing, facilities, engineering, analytical development, formulation development, materials control, supply chain and logistics. He also has experience overseeing successful government contracting business units.  He holds a BS in Physiology from the University of California at Davis and a MBA in Operations Management from Golden Gate University.

  • Emily Thompson

    Emily L. Thompson, PE

    CRB

    Emily Thompson is a Process Engineer and Associate at CRB, specializing in biological process and facility design.  Over the last 18 years working in the biotechnology industry, she has gained expertise in designing facilities for monoclonal antibodies, vaccines, and cell and gene therapy production, both in stainless steel and single-use. Emily’s facilities experience includes all phases of process design, including master planning, conceptual and detailed design, construction services and equipment procurement. Emily is a specialist in process simulation and modeling and experienced in a number of different software programs.  A graduate of North Carolina State University, Emily holds two degrees: a Bachelor of Science in Chemical Engineering and Bachelor of Science in Biochemistry. She is also a licensed Professional Engineer in the state of North Carolina.

  • Stephen Westover

    Stephen P. Westover

    Cook MyoSite Incorporated
    Stephen Westover is the Director of Regulatory Affairs at Cook MyoSite Incorporated, where he is the point of contact with health authorities for the clinical investigation and eventual commercial licensing of cellular therapy products and oversees the regulatory interactions and submissions to health authorities including the Food and Drug Administration (FDA), Health Canada, and European competent authorities.
    Stephen started his career with manufacture of influenza vaccine at Wyeth Pharmaceuticals. At Cook MyoSite, he has directed the development of a pharmaceutical quality management system, quality control testing laboratory, and validation activities. Stephen has led compliance efforts in Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). Stephen is a certified manager of quality and operational excellence through the American Society of Quality (ASQ) and is certified in RAC Drugs through the Regulatory Affairs Professionals Society (RAPS). Stephen is using his quality experiences to balance the liabilities of commitments in regulatory submissions with actions of the pharmaceutical quality management system.
  • Dennis Williams

    Dennis Williams, PharmD

    Adaptimmune LLC

    Dennis Williams has served as Senior Vice President, Late Stage Development at Adaptimmune since December 2019. He is responsible for overseeing the late stage pipeline activities, including Phase 2/3 clinical trials through market application submission and approval.

    Dr. Williams joined Adaptimmune in 2015 and served as Vice President, Global Regulatory Affairs. He has also led the ADP-A2M4 development program and previously led the NY-ESO development program prior to the transition of NY-ESO to GSK. 

    Prior to joining Adaptimmune, Dr. Williams served as Director and Global Regulatory Lead at GSK Oncology, where he was instrumental in the development and approval of innovative products.

    Dr. Williams has 20 years of experience in the pharmaceutical and biotech industries and started his career in the pharmaceutical industry in 2000 at Teva Pharmaceuticals. Dr. Williams holds a Doctorate in Pharmacy (PharmD) from the University of Florida and a Bachelor of Science degree in Pharmacy from Temple University.