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Committee & Speaker Biographies

Committee & Presenter Biographies

2022 PDA Annual Meeting

04-06 April 2022

  • Joanny Salvas

    Joanny Salvas

    Pfizer Inc.
    Joanny Salvas is a senior manager at Pfizer, in the Global Technology and Engineering, Manufacturing Intelligence group. She has been developing and implementing Process Analytical Technologies and Rapid Micro Methods for more than 10 years, both in Solid Oral Dosages and Sterile Injectable / Bio processes. Her background in engineering, process control, and multivariate data analysis enabled her to support many successful implementations of advanced control strategies in the Pfizer network. She leads the Pfizer Rapid Micro Method steering team responsible for establishing the strategy, the evaluation and implementation as well as the development of future microbiology analytics. She has a passion to learn and continuously drives innovation forward; she strives to use the best science possible in her projects.
  • Vaishali Shah

    Vaishali Shah, MS

    Kite Pharma, A Gilead Company
    Vaishali Shah works at Kite Pharma- Clinical manufacturing Santa Monica, Los Angeles as head of Quality Systems and Compliance, and has collected, in the past 25 years, extended technical and leadership experience in Pharmaceutical/Biotechnology Quality with a focus on microbiology, and lately in the cell therapy commercial microbiology. Vaishali’s expertise is in process microbial control strategies and setting up microbiology labs using the latest rapid micro detection techniques while abiding to regulatory requirements on equipment qualification and method validation. She holds a Masters Degree in Microbiology from Sardar Patel University, India.
  • Mihaela Simianu

    Mihaela Simianu, PhD

    Merck & Co., Inc.

    Dr. Simianu is currently member of Merck’s Global Vaccines Technical Operations acceptable for Global Drug Product and Analytical Technology Operations. Prior to this role she served as head of Merck’s Sterile Products Commercialization. She advanced a portfolio of > 35 new pipeline products with complex and diverse modalities designed as vaccines, immune-oncologic and anti-infectious agents. She integrated Manufacturing Science and Technology along the clinical and commercial process design, characterization and qualification leading to successful market approval of 3 new products. She contributed to commercial manufacturing expansion at sites internal and external to Merck.

    Prior to Merck she holt different technical and leadership positions with at Eli Lilly and Co, Amgen, and Pharmatech Associates. She has a diverse and deep expertise in development, commercialization and international manufacturing of complex biopharmaceuticals used in the treatment of multiple forms of cancer and diseases associated with endocrine, cardiovascular, neurological, infectious diseases, and immunological disorders. Dr. Simianu holds a MS/BS in Chemical Engineering and Pharmaceutical Technology and a Doctorate Degree in Chemistry.

  • Benben Song

    Benben Song, PhD

    Pall Corporation
    Dr. Benben Song is the Global Product Manager for technical Services at Pall Biotech.  She is globally responsible for product management of Accelerator™ Process Development Services, Accelerator Validation Services, Regulatory Portal and Training Services. Benben joined Pall in 2015 and has held multiple roles in leading the extractables and leachables validation studies on Pall products to ensure compliance with the latest regulations and evolving expectations for drug safety purpose. Prior to joining Pall, she  managed government contracts on drug cardiotoxicity evaluation at the Stanford Research  Institute. Benben holds a PhD in Biochemistry from Stony Brook University and has over 13 years of experience in biotech. She has published over 18 articles in scientific journals and has been invited to present her work at many conferences.
  • Herve Soukiassian

    Hervé Soukiassian

    BD

    Hervé Soukiassian joined BD-Pharmaceutical Systems business 15 years ago and is currently the leader for Product Development pertaining to Prefillables Syringes for Chronic therapeutic segment. He has also contributed actively within the PDA – co-author of the TR85 “Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers” and the TR73 “Prefilled Syringe User Requirements for Biotechnology Applications”.

    Prior to joining BD, Herve worked for 13 years at Hewlett Packard in various positions gaining experience and developing expertise in the field of process engineering and product development. He later joined the board of Directors of ActiCM, a start-up company associated with the “Commissariat a l’Energie Atomique (CEA)” and specialized in optical Coordinate Measurement Machines.

    Herve graduated from the "Institut National des Sciences Appliquées" of Lyon as a mechanical & industrial engineer with a master’s degree in material sciences.

  • Humberto Vega

    Humberto Vega, PhD

    Bristol-Myers Squibb
    Dr. Humberto Vega is Sr. Director of Bristol Myers Squibb (BMS), Global Manufacturing Science and Technology, based in Summit NJ.  He has been in the pharmaceutical and food industries for over 32 years in multiple roles including Research Assistant, Process and Manufacturing Head of sterile and non-sterile pharmaceutical operations, Sr. Scientist and Associate Director of Validation, MS&T and Technology Head – Vaccine Manufacturing, and Head of CAR T MS&T and Lead of Cell Therapies Capability Center.  He holds BS and MS degrees in chemical engineering from the University of Puerto Rico and a PhD in engineering science from Washington State University.  He holds professional memberships in the Parenteral Drug Association, Institute of Food Technologists and ISPE.
  • James Vesper

    James L. Vesper, PhD, MPH

    ValSource, Inc.

    James Vesper designs and develops instructional courses and workshops for the pharmaceutical and biopharma industries. Beginning in March 2017, he became Director, ValSource Learning Solutions after establishing and being president of the firm, LearningPlus, Inc. At ValSource, he is leading a business unit that provides innovative learning solutions to pharma firms world-wide, leveraging the capabilities and expertise of ValSource consultants.

    He has had more than 35 years’ experience in the pharmaceutical industry. Dr. Vesper worked eleven years at Eli Lilly and Company, Indianapolis, Indiana. His first assignment was as corporate industrial hygienist, followed by three years in Corporate Quality Assurance. There, he was responsible for issues concerning the manufacture and testing of parenteral products made at Lilly facilities and third parties worldwide. His last assignment at Lilly was as Project Leader of GMP (Good Manufacturing Practice) Education and Instruction, establishing the department and its mission. Dr. Vesper is frequently asked to speak at conferences and technical meetings and present training courses and workshops on GMPs, Contamination Control, Quality Risk Management, Investigation Report Writing, and Learning & Performance solutions.

    Dr. Vesper teaches for the PDA Training and Research Institute, is on the PDA Q9 (R2) commenting team and is heading the Training and Learning Effectiveness working group for the Society of Sterility Assurance Professionals. He is an invited speaker for the PDA Annual Meeting in April 2022 and the Association for GXP Excellence in May 2022.

    Dr. Vesper has written six books, including Root Cause Investigations for CAPA (2020) and multiple technical articles. His 5th Edition of GMP in Practice, written with Tim Sandle was published in 2016 by PDA/DHI. He has received the PDA’s Agallico Award for Teaching Excellence and, in 2021, PDA’s Distinguished Author/Editor of the Year. He has also served as a consultant to World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities and has been a mentor on six of the WHO’s unique learning program, Pharmaceutical Cold Chain Management on Wheels. He has trained health authority inspectors through WHO and PIC/S in US, Taiwan, London, China, Greece, and Turkey.

    Dr. Vesper divides his time between Provincetown, Massachusetts and Rochester, New York. He has a BS in biology (Wheaton College) an MPH (University of Michigan School of Public Health), and a Ph.D. in Education from Murdoch University in Perth, Western Australia.

  • James Vesper

    ValSource Learning Solutions

    James Vesper designs and develops instructional courses and workshops for the pharmaceutical and biopharma industries. Beginning in March 2017, he became Director, ValSource Learning Solutions after establishing and being president of the firm, LearningPlus, Inc. At ValSource, he is leading a business unit that provides innovative learning solutions to pharma firms world-wide, leveraging the capabilities and expertise of ValSource consultants.

    He has had more than 35 years experience in the pharmaceutical industry. Dr. Vesper worked eleven years at Eli Lilly and Company, Indianapolis, Indiana. His first assignment was as corporate industrial hygienist, followed by three years in Corporate Quality Assurance. There, he was responsible for issues concerning the manufacture and testing of parenteral products made at Lilly facilities and third parties worldwide. His last assignment at Lilly was as Project Leader of GMP (Good Manufacturing Practice) Education and Instruction, establishing the department and its mission. Dr. Vesper is frequently asked to speak at conferences and technical meetings and present training courses and workshops on GMPs, Contamination Control, Quality Risk Management, Investigation Report Writing, and Learning & Performance solutions.

    Dr. Vesper has written six books, including Root Cause Investigations for CAPA (2020) and multiple technical articles. His 5th Edition of GMP in Practice, written with Tim Sandle published in 2016 by PDA/DHI. He has received the PDA’s Agallico Award for Teaching Excellence and, in 2021, PDA’s Distinguished Author of the Year. He has also served as a consultant to World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities and has been a mentor on six of the WHO’s unique learning program, Pharmaceutical Cold Chain Management on Wheels. He has trained health authority inspectors through WHO and PIC/S in US, Taiwan, London, China, Greece, and Turkey.

    Dr. Vesper divides his time between Provincetown, Massachusetts and Rochester, New York. He has a BS in biology (Wheaton College) an MPH (University of Michigan School of Public Health), and a Ph.D. in Education from Murdoch University in Perth, Western Australia.

    James Vesper, PhD, MPH
    [email protected]
    Mobile: +1 585.230.1145

  • Phillip Villari

    Philip A. Villari, III, MS

    Merck & Co., Inc.
    Philip A. Villari III has worked for Merck & Co., Inc. for over twenty-five years. Since 2000 he has worked in the Merck Research Laboratory Division performing microbiological testing for pharmaceutical, biological, and vaccine development products. Philip also collaborates cross-functionally with internal and external industry colleagues to bring Rapid Microbial Methods to the forefront of pharmaceutical microbial quality testing.
  • 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.

  • Sheba Zaman

    Sheba S. Zaman

    Novatek

    Sheba Zaman has been serving in a technical role at Novatek International for over 20 years. With degrees in both Health Science and Computer Science, she is an expert in the management of critical pharmaceutical computer systems such as LIMS, Stability, Contamination Control (Environmental/Utility Monitoring, Cleaning Validation) and Quality Management Systems. Currently Head of Product Specialists and Training Services, she is experienced in helping companies manage and analyze their analytical data. She has worked with clients globally for over a decade managing change and implementation of software solutions, including establishing procedures, work instructions, validation scripts and training programs. Key areas of expertise include Data Integrity, Process Improvement, Data Analysis/Trending, FDA compliance, Software Implementation and Optimization in a regulated environment.  She also teaches PDA/ISPE/KENX courses for various EM trending topics and is currently serving as the President of Parenteral Drug Association’s (PDA) Southern California Chapter.