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Committee & Speaker Biographies

Committee & Speaker Biographies

2020 PDA Advanced Therapy Medicinal Products Conference

June 24-25, 2020

  • 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.
  • 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 specialized in microbiology for cell and gene therapy companies for the last ten years.

    Marsha has a Bachelors in Biology from Western New England University in Springfield, MA. 

    Marsha is the Director of Global Microbiology for bluebird bio and in this role leads contamination control efforts for the internal and external manufacturing sites.  Marsha leads efforts to implement microbial control strategies utilizing quality risk management at the manufacturing sites.  Marsha specializes in developing risk based environmental monitoring programs and performing microbial risk assessments.

    Marsha performs many training courses and webinars for aseptic processing, cleanroom classification and facility start-up.  Marsha is active in industry and currently serves on the Parenteral Drug Association (PDA) Science Advisory Board (SAB) and the Education Advisory Board (EAB); serves on the PDA Task Force on Microbial Investigations; serves on the PDA Microbiology Meeting Planning Committee and has been the chair of the PDA Annual Meeting.  Marsha is a former notified body ISO auditor.

  • 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.

  • 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 specialized in microbiology for cell and gene therapy companies for the last ten years.

    Marsha has a Bachelors in Biology from Western New England University in Springfield, MA. 

    Marsha is the Director of Global Microbiology for bluebird bio and in this role leads contamination control efforts for the internal and external manufacturing sites.  Marsha leads efforts to implement microbial control strategies utilizing quality risk management at the manufacturing sites.  Marsha specializes in developing risk based environmental monitoring programs and performing microbial risk assessments.

    Marsha performs many training courses and webinars for aseptic processing, cleanroom classification and facility start-up.  Marsha is active in industry and currently serves on the Parenteral Drug Association (PDA) Science Advisory Board (SAB) and the Education Advisory Board (EAB); serves on the PDA Task Force on Microbial Investigations; serves on the PDA Microbiology Meeting Planning Committee and has been the chair of the PDA Annual Meeting.  Marsha is a former notified body ISO auditor.

  • 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.