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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA Sterile Medicinal Products Manufacturing Conference

May 14-15, 2018, Bethesda, MD

Committee & Speaker Biographies

  • Gabriele Gori

    GSK Vaccines

    Mr. Gabriele Gori has been in the sterile Pharmaceutical / Vaccine/Medical Device business since 1994 – in different local and global roles in multinational companies, including, but not limited to, Bausch & Lomb, Novartis and GlaxoSmithKline.

    His experience covers R&D, Engineering, Quality Control, Quality Assurance and GXP Compliance:  since September 2015 he has been in role as Vice President, Global Head of Audit and Risk Management at GlaxoSmithKline Vaccines.

    Sterility Assurance expert,  from  2012 to  2015 he chaired the Novartis Sterility Assurance Expert Network (SAEN) – a multidivisional and multifunctional team of experts aimed at providing direction to the Novartis Group as regards Sterility Assurance matters.  Invited speaker in international conferences and workshops on topics dealing with Aseptic Processing,  Quality Systems and GMP Compliance, he also provided training to inspectors  of  European National  Health Authorities  on  Aseptic Processing and Quality Systems related matters. Most recently, he has been the co-chair of the Parenteral Drug Association (PDA) task force in charge of developing a “Points to Consider“ document for modern aseptic manufacturing (the part 1 of the document has been published by PDA in  March 2015, the part 2 in April 2016) and co-chair of the task force in charge to develop the PDA comments to the revised draft of the European GMP – Annex 1 – “Manufacture of Sterile Medicinal Products” (2018).

    A member elected of the PDA Board of Directors from 2010 through 2015, he is now part of the Science Advisory Board of the association.  In 2016-2017 he has been the representative of Vaccines Europe, a trade association of the European manufacturers of Vaccines, in the Technical Development Expert Group (TDEG) of the European Federation of Pharmaceutical Industries and Associations  (EFPIA).

    Mr Gabriele Gori holds a bachelor in Chemistry (University of Florence – Italy) and a master in Quality Management (University of Pisa – Italy).

  • Frederic Ayers

    Frederic B. Ayers

    Eli Lilly and Company

    Mr. Frederic B. Ayers earned a bachelor’s degree in Biology, from Franklin College of Indiana in 1999. Before joining Eli Lilly and Company in 2001, he worked in quality control in various industries. Fred has held various quality and technical positions from which he has helped advance Lilly's state of regulatory compliance. Since October 2018, he has served as a Sterility Assurance Steward for Indianapolis Parenteral Manufacturing. He is responsible for developing, influencing and ensuring implementation of the sterility assurance technical and strategic agenda at Lilly’s Indianapolis parenteral manufacturing site.

    Fred has multiple professional affiliations (e.g., ISPE, PDA, etc.), and has been an active member in the PDA Midwest Chapter since 2014 currently serving as the President-Elect. Through his local and national affiliations, he has driven solutions for PDA members, along with the development of content and delivery of industry learning sessions for industry colleagues.

  • Geert Vandenbossche

    Geert Vandenbossche, PhD

    Novartis

    Geert Vandenbossche was recently appointed as Global Head NTO QA Strategic Initiatives. In this role he is Chairman of the Sterility Assurance Expert Network (SAEN) and leading the Novartis aseptic processing continual improvement program as well as the Data Integrity project covering all Novartis Manufacturing sites.

    Geert has served Novartis for more than 20 years in leadership roles in Alcon Puurs, Alcon Barcelona, Sandoz Global Holzkirchen and Novartis BTDM Basel. He did lead Manufacturing Science and Technology, Engineering, Quality, Regulatory Affairs. He was Plant Manager in Alcon Puurs, responsible for procedure packs, prefilled syringes and sterile ointments. Prior to his current role he was in global quality roles, responsible for Sandoz Sterile and Special Technology sites as well as Biological Drug Product sites with Novartis.

    Geert received his degree in Pharmacy and Ph.D. from the University of Gent in Belgium. He has the Belgian nationality.

  • Kenneth Boone

    Kenneth Boone

    Merck & Co., Inc.

    Ken Boone has been with Merck and Co., Inc. since 2013 in Global Quality Compliance - Sterile & Microbiology Quality Assurance.  He has responsibility for setting Merck’s global standards for process simulations, sterile filtration, and terminal sterilization. He has over 20 years’ experience in aseptic processing and sterility assurance with Pfizer, Cardinal Health, Mallinckrodt, and Novartis.  Ken was a founding member of the Missouri Valley Chapter of the PDA.

  • David Hussong

    David Hussong, PhD

    Eagle

    David Hussong is the Chief Technical Officer at Eagle Analytical Services (Houston, TX).  He also had been a consultant with ValSource, LLC., specializing in regulatory microbiology issues.  In 2014, David retired from the Commissioned Corps Officer of the US Public Health Service after 30 years with the Food and Drug Administration (FDA).  In addition, David is currently the chair of the USP Microbiology Expert Committee for the 2015 – 2020 cycle. 

    David earned his Ph.D. in microbiology from the University of Maryland (UM) and has served as a research microbiologist at UM, the US Department of Agriculture and the US Naval Medical Research Institute.  Dave has been a member of the Parenteral Drug Association since 1993, and a member of the American Society for Microbiology since 1975.

  • Brian Joseph

    Brian Joseph

    Pall Life Sciences

    Brian Joseph started his professional career at Pall as a Laboratory Scientist in the Microbiology Lab, after earning his Bachelor of Science degree in Biology from Hofstra University, and an Associate’s degree in Applied Science from Farmingdale State University.  During his tenure in the Microbiology Laboratory, he learned all aspects of filter testing including integrity testing, bacterial challenge, LAL, and filterability testing.

    After gaining experience in the lab, he was promoted to the position of Validation Specialist where he focused on customer’s process-specific filter validation testing as part of their NDA filings, as well as addressing customer concerns on integrity testing.  Currently, he is a Senior Scientist, and a member of Pall’s Regulatory and Validation Consultancy group, where he is involved in preparing filter quality dossiers and consultancy for complex filtration issues.  He has over 30 years of experience in integrity testing.

  • James Klein

    James Klein, PhD

    Merck & Co., Inc.

    Jim Klein is Associate Vice President of the Global Technical Operations – Sterile & Validation Center of Excellence at Merck & Co, Inc.  He has over 20 years of experience in pharmaceutical development and manufacturing.  He has worked in a variety of roles including technical operations, process and analytical development, and regulatory affairs.  Areas of expertise include process validation, sterile/aseptic operations, and quality systems.  His current responsibilities include technical oversight and support for sterile/aseptic technical operations globally.

  • Roy McLean

    Roy McLean

    Baxter Healthcare Corporation
    Roy McLean is a Senior Manager with Baxter Healthcare Sterility Assurance R&D.  Since 1991, he has held positions in corporate quality, site quality, research and international medical affairs with Baxter, Pfizer, Hospira and Abbott.  He took a 9-year hiatus from the industry to teach high school science in Chicago.  He holds a Bachelor of Science in Food Science from the University of Illinois and a Master of Science in Food Science and Technology from Texas A&M University.
  • Sangeetha Ravindran-Nair

    Sangeetha R. Nair

    Baxter Healthcare Corporation

    Sangeetha Nair has been employed with Baxter Healthcare Corporation since 2011. During her tenure at Baxter she has worked with multiple groups like Exploratory Sciences, Medication Delivery, R & D Sterility Assurance and Global Quality. Some of her notable projects include risk based microbiological testing for raw materials, establishment of Quality Lab Metrics for manufacturing labs and evaluation of new container closure integrity test methods for flexible pharmaceutical containers. She served as a working group member for the re-write of PDA Technical Report-27 and also co-authored an article on Container Closure Integrity in the December-2017 issue of the Healthcare Packaging magazine

    Sangeetha currently works for Baxter’s Corporate Global Quality group and is responsible for working with all quality partners, serving as a liaison worldwide to support the implementation of industry best demonstrated practices and test methods across Baxter Labs. Her duties include executing quality assurance, continuous improvement initiatives, regulatory strategies & programs under GMP and GLP environments. She holds a Master’s degree in Biotechnology from the University of Pennsylvania, Philadelphia and Master’s degree in Microbiology from the University of Madras, India.

  • Terrence Rindler

    Terrence J. Rindler

    Juno Therapeutics

    Mr. Rindler has been with Juno Therapeutics since 2014, establishing the initial validation programs for the company with responsibilities that included qualification of equipment, computer systems, packaging, and aseptic processes.  Today, he leads the Validation group at Juno’s multi-product clinical production facility for CAR-T cell therapies. Prior to joining Juno, he managed multiple Validation responsibilities, including aseptic process validation, for the Dendreon Corporation through the startup and approval of three commercial cellular immunotherapy facilities.   

  • Henrietta Vinnerås

    Henrietta Vinnerås

    Fresenius Kabi

    Mrs Vinnerås has been with Fresenius Kabi since 2017, and previous to that since year 2000 worked for pharmaceutical and medical device companies such as Abbott and Pfizer within different quality departments and holding various management responsibilities and positions. Recently, as an associated senior quality consultant at ÅF Life Science she had assignments within the areas of quality assurance, risk management, validation and education at clients such as GE Healthcare, Thermo Fisher Scientific, Fresenius Kabi and smaller life science companies. Currently Mrs Vinnerås is part of a global competence center within Fresenius Kabi, supporting the companys’ pharmaceutical manufacturing operations world-wide with e.g. on-site assessments, trouble shooting, root cause investigations, CAPAs and continuous improvement projects; specifically within the areas of microbiology and aseptic technique.