PDA Honor Awards

Martin VanTrieste

Martin VanTrieste is the CEO of Civica Rx who was recently named a “Champion of Change” on The Medicine Maker’s Power List for his role in leading Civica, a new, nonprofit enterprise created to stabilize the supply of essential generic medications. Martin brings over 36 years in the industry, with comprehensive experience in biopharmaceutical manufacturing, quality systems and related government regulations in the US and around the world.

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  He was the former chief quality officer at Amgen. Prior to joining Amgen, Mr. VanTrieste was with Bayer Healthcare’s Biological Products Division as vice president of worldwide quality and Abbott Laboratories as the vice president of quality assurance for the Hospital Products Division.

  Mr. VanTrieste is the founder of Rx-360, an international nonprofit organization that enhances patient safety by increasing security and quality in the biopharmaceutical supply chain. He has also served as the Chairman and Board Member of the Parenteral Drug Association (PDA) Board of Directors.

  PharmaVoice has named Mr. VanTrieste one of the 100 most inspiring people in the pharmaceutical industry, calling him “a man with a mission.” The Medicine Maker has previously named him one of the most influential people in the world of drug development and manufacture saying he “is known throughout industry as a change agent and influencer for his work on advancing pharmaceutical manufacturing, quality and helping to ensure a more reliable supply of high-quality medicines.”

  He was honored in 2013 by Parenteral Drug Association (PDA), naming an annual award the Martin VanTrieste Pharmaceutical Science Award. He has delivered numerous presentations and authored articles on pharmaceutical quality and the security and robustness of supply chain.

  Mr. VanTrieste earned a Pharmacy degree in 1983 from Temple University School of Pharmacy.

Joyce E. Bloomfield

I have been so fortunate to work with the very best scientists, quality and compliance professionals, regulators, and educators in the industry throughout my 25 years in the Sterile Pharmaceutical Sciences. I always strived to do what’s right for the patient as an FDA Investigator and Compliance Officer for the Center for Drug Evaluation and Research, as a Senior Consultant with PAREXEL Consulting and as a Pharmaceutical Executive in Global Quality Assurance at Cardinal Health and Merck, Sharp and Dohme. Most rewarding to me personally and professionally has been as a PDA volunteer serving as PDA Board Director, Chair of PDA’s Science Advisory Board, Co-chair and contributor to multiple conference planning and steering committees in the areas of quality systems for sterile drug manufacturing, glass quality, and quality metrics. I am currently a dedicated happy retiree enjoying family and nature in the Georgia countryside.

Véronique D. Davoust, PharmD

Véronique Davoust has over 20 years experience in the pharmaceutical industry, both in Regulatory Affairs and Manufacturing, for Pfizer Inc. In her current position she is responsible for the monitoring and analysis of global and European emerging regulations and guidelines that impact manufacturing sites, especially focusing on Good Manufacturing and Distribution Practices, security of the supply chain, product shortages, serialisation and registration of the Quality section of Marketing Authorization dossier throughout the product life cycle.

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  Furthermore, she ensures the communication and implementation of the guidelines and regulations within the firm, as well as the coordination of responses to competent authorities. Ten years ago, she performed a one-year-secondment mission at the European Federation of Pharmaceutical Industries and Associations (EFPIA) based in Brussels, supporting the Technical and Development Operations committee. She is deeply involved in Trade Associations activities (EFPIA, PDA, GS1), serving on leadership teams (eg past Board member of the Parenteral Drug Association, RAQAB until 2019, Vice-President of the LEEM Quality Committee).

  Véronique is a pharmacist and earned a Doctorate in Pharmacy at the University of Rouen in Normandie, France, and is based in Paris.

Morten Munk

Morten Munk’s focus and success in making pharmaceutical products available for patients, is founded on more than 30 years of industry experience in biopharmaceutical development and manufacturing, which has made him a globally recognized technical expert in the field.

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  One common denominator for his work has been to use his business and quality mindset in combination with a broad perspective on biomanufacturing, to support all stages of development and the full supply chain of high-quality pharmaceuticals. This includes experience in addressing the areas critical for commercial manufacturing during the process development and subsequent scale-up stages, as well as handling drug product operations and distribution aspects.

  Morten joined FUJIFILM Diosynth Biotechnologies (FDB) in 2020 as Alliance Manager, supporting the strategic partnership with several FDB’s key partners. Prior to this position and since 2015 he held a role as Global Technology Partner, supporting all aspects around biopharmaceutical development and manufacturing. In 2001 he co-founded CMC Biologics (now AGC Biologics), where he held a position as Vice President for Operations and later Business Development. Prior to founding CMC Biologics, Morten held a position as Principal Scientist at Novo Nordisk A/S which include being Project Manager for the CMC part of several projects, which have been commercialized successfully, including development of the blockbuster insulin analogue, named Levemir / Detemir.

  Furthermore, Morten has authored or co-authored several technical articles and guidelines. Due to his technology expertise coupled with thorough business understanding, Morten is frequently invited to give scientific and technical presentations at international conferences. In addition, Morten is active in the biopharmaceutical community as member of scientific committees for various international conferences and as volunteer in international industry organizations such as PDA, ISPE and BPOG. Moreover, Morten is chair of PDA Biotechnology Advisory Board, and member of the Advisory Board for Master studies at Copenhagen University.

Ivy Louis

Ivy Louis is the Founder of VIENNI TRAINING & CONSULTING LLP, holds a Master's degree in Pharmaceutical Sciences and an MBA in Human Resource Management.

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  Ivy's combined 32 years spanning across teaching, pharmaceutical manufacturing/quality (CIPLA, & ASTRA-IDL), and service provider's (MILLIPORE-MERCK) experience is distilled into the consultative and educational approaches that her organization-VIENNI Training & Consulting LLP has adopted from 2010 onwards. The areas of support for pharmaceutical and biopharmaceutical operations, are in technical operations for manufacturing, aseptic simulations based on principles of Quality Risk Management, operational quality management/assurance activities, catering to the learning requirements through education and skill building with hands-on activities.

  Ivy has been associated with PDA Inc.(www.pda.org) from 2003, as a member. She has been extremely active, as a volunteer, in spearheading the activities of the Parenteral Drug Association Chapter in India, from 2013 onwards. Ivy has been contributing in the various capacities as a PDA India Chapter Board member between 2013-2019 and is the current past President of the Chapter. She has also been a Member of the Steering Committee for Awards in 2017, currently, a Member of the Steering Committee for the PDA letter Editorial Committee and a member of the Task Force that is working on an ANSI standard for Quality Risk Management for Aseptic Processing. She is also a member of the Science Advisory Board for PDA Inc.

Marc Glogovsky, MS

Marc Glogovsky, MS, S.M. (NRCM) has over 20 years' experience in the pharmaceutical industry, specializing in aseptic operations, contamination control strategies, and risk-based environmental monitoring. He has written a number of publications related to rapid microbiology, environmental monitoring, Mycoplasma testing and microbial identification. Currently, he is a Senior Microbiology Consultant with ValSource. Prior to joining ValSource, he was responsible for managing the Environmental Monitoring division at Veltek Associates, Inc., and has spent over 10 years as a senior microbiology specialist at Merck KGaA. Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology from Rutgers University.

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  Marc is actively involved with the Parenteral Drug Association, where he serves on PDA's Science, ATMP and Education Advisory Boards, is the North American chair of the Microbiology/EM Interest Group, is a faculty member at the PDA Training and Research Institute (TRI) and has contributed to a number of Technical Report committees and is currently co-chairing the Microbial Data Deviation Investigations and the revised Environmental Monitoring (TR #13) Technical Reports.

Romain Veillon

Romain Veillon is Senior Manager Visual Inspection & Leak Testing at GSK Vaccines, in Global MSAT Manufacturing Technologies. As global expert he is leading Visual Inspection performance and expertise network on multiple sites.

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  He now focuses on Quality Integration Lead, New Technology Development, Validation Strategy, Capability assessment, Asset Management programs, Technical Watch, Performance Improvement and Develop Equipment strategy within network. He manages a network of vision experts to develop visual Inspection expertise within GSK Vaccines. Romain is now focusing in machine learning and innovation management with new AVI-LT asset deployment.

  Last past 22 years he has worked in parenteral manufacturing, he has gained experience at Sanofi Pasteur, Eli Lilly and GSK Vaccines, in support to production and secondary operations projects for filling and freeze-drying.

  He also developed innovative vision systems with some academic collaborations and regular presentation to PDA conferences.

  In 2017, Romain developed a PDA course "Mastering AVI". Since 2018 Romain is Interest Group Leader for Visual Inspection in PDA Europe. Since 2019, Romain co lead task force to prepare a point to consider document for AI applied to Visual Inspection.

  In 2020 Romain received PDA James P. Agalloco Award for educational training.

Edward H. Trappler

Edward Trappler has over 40 years of experience that includes product development, toxicology and clinical supply manufacturing, and parenteral production. In 1992 he founded Lyophilization Technology, Inc. as a source of scientific and technical services, with the ambition of expanding the knowledge and understanding of lyophilization throughout the healthcare product industry.

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  Ed has contributed to six books, authored and presented numerous papers and courses internationally. He is an active member of the Parenteral Drug Association, serving as chairperson of the Lyophilization Interest Group, Validation Task Force, and Education Advisory Board. He has lectured for the AAPS, ISPE and PDA. He has received numerous recognitions and the PDA awarded him the Gordon Personeous Award for his contribution to the PDA and the James Agalloco Award for Education.

Roman Mathaes, PhD

Roman Mathaes is Senior Group Leader Pharmaceutical Services at Lonza. In this role he leads the packaging and combination product development for injectables at Lonza as well as DP manufacturing for technical batches.

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  Roman is a 4-year consecutive chair of the PDA Primary Packaging Conference and chaired the Universe of Pre-Filled Syringes US Conference. Currently he leads the European industry focus group for packaging testing and is a member of the BPOG CCI workstream. He lectures biopharmaceutical product development and combination product development at the University Basel.

  Before joining Lonza Roman worked at Roche/Genentech.

  Roman studied pharmacy in Marburg and received a PhD in pharmaceutical science at the University of Munich. He holds an MBA from the University of Cardiff and a degree in mathematics from University of Bern.

John D. Ayres, MD

Dr. John Ayres received his undergraduate degree in chemistry from Butler University and a Doctor of Medicine degree from Indiana University School of Medicine. He completed his residency at the Indiana University Medical Center and is Board Certified in Internal Medicine. He obtained his Doctor of Jurisprudence from Indiana University-Bloomington and is admitted to practice law in both Indiana state and Federal courts.

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  For 15 years, Dr. Ayres served as the Health Hazard Evaluation physician and Sr. Medical Fellow, Product Safety Assessments for a multi-national pharmaceutical company. In this role he worked closely with product development, manufacturing, quality, and pharmacovigilance to evaluate the human safety risk potentially associated with Critical Quality Attributes (CQAs), manufacturing and environmental excursions, linked to product complaints, or related to counterfeit medication issues including surveillance, risk assessment and management, and regulatory-compliance functions.

  Dr. Ayres now provides limited consultative assessments on issues related to the clinical implications of product quality attributes and variability surrounding CQAs with biopharmaceuticals in addition to safety-related compliance matters. He currently serves on the USP Visual Inspection Expert Panel and PDA's Scientific Advisory Board.

Jason Kerr

Jason Kerr is an experienced quality and regulatory professional and has been a champion in engaging, connecting, and promoting regulatory compliance in the dynamic biopharmaceutical landscape. Driven by data, he takes pride in providing the best possible outcome while remaining compliant and efficient. As a GXP Senior Specialist at Redica Systems, Jason's goals include enhancing the quality and regulatory knowledge and advancing key topics, such as data integrity, throughout the industry. He previously worked at Amgen where he monitored global regulatory intelligence and identified quality requirements to be triaged, assessed, and implemented to ensure compliance. This included designing and implementing a system to track changes being implemented and provide regular updates to key stakeholders.

Dinesh R. Khokal, PhD

Dinesh is the Director, External Affairs Quality, at Amgen Biotechnology Singapore supporting Amgen's outward facing efforts in Japan Asia Pacific and Latin America. He collaborates effectively with industry peers and regulators to engage, understand, translate, and deliver impact in the evolving external GxP landscape. Additionally, Dinesh currently holds the position of Adjunct Associate Professor at the Faculty of Health and Medical Sciences, Taylor's University, Malaysia.

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  Prior to Amgen, Dinesh held the role of Director of Therapeutic Products Branch at the Singapore Medicine Regulatory Agency, Health Sciences Authority (HSA). During his 10 years tenure in HSA, his main role was to manage, oversee and drive the key development, review, licensure and administer the pre-market regulatory framework for western medicines covering innovative drugs, generics, biologics including, biotherapeutics, vaccines, combination products and biosimilars. He has also played several key roles in multiagency consortiums and WHO initiatives working towards capability building, shaping regulatory landscape, regulatory harmonisation and mutual reliance.

  Prior to the roles in the regulatory agency, Dinesh held many positions in Biopharmaceutical and Medical Device industries as well as in Academia for over 20 years.

  Dinesh received his Ph.D. in Cell and Molecular Biology from the National University of Singapore. He is an American Society for Quality Certified Quality Auditor and Biomedical Auditor. He has also earned certifications in Clinical Trials Management and Healthcare Policy and Governance.

  Dinesh is the immediate past President of PDA Singapore Chapter and he is currently on the PDA Regulatory Affairs and Quality Advisory Board (RAQAB). Dinesh has been a frequent speaker at PDA events in Asia-Pacific.

Amanda McFarland, MS

Amanda is a Senior Consultant for ValSource, Inc and in this role assists companies with the design and implementation of CGMPs, Microbiology, and Quality Risk Management (QRM) programs. She specializes in the creation and implementation of risk management programs and training, developing risk-based strategies for contamination control and risk facilitation. While she spends great deal of time in QRM, Amanda is a Life Scientist at heart. She holds a BS in Entomology and a MS in Entomology, both from the University of Florida.

Eiji Watanabe

Eiji Watanabe worked for Terumo for 44 years and retired last year. He has been involved in the laboratory for many years in the design of infusions, syringes, topical formulation, peritoneal dialysis solutions, and product development of combination products. Currently, he uses his experience as a consultant.

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  He joined PDA in 1999 and has been active in the leadership of the Japan Chapter including the establishment of the QAQC Committee in 2002. Since then, he has been active, since their establishment, in the Aseptic Products GMP Committee and the Medical Devices Committee. He hosts the Prefilled Syringe Seminar Tokyo every year with people from overseas. He is also a member of the Annual Meeting and the Editorial Board of Academic Journals at the Japan Chapter and was appointed Special Advisor last year.

Marine Marius

Marine is Senior Scientist in the Analytical Sciences department of Sanofi Pasteur. She leads the development, validation, and implementation of alternative and rapid microbiology methods (bacteriology and molecular biology) for commercial and investigational products to improve lab efficiency. She is an internal SME in endotoxin, mycoplasma, and mycobacteria testing.

Frédéric Vacher

Frédéric is technologist in the Analytical Sciences department of Sanofi Pasteur. With +20 years of experience in microbiology, he has a strong background in endotoxin testing. As an internal technical endotoxin SME, Frédéric participates to complex troubleshooting, screening, and implementation of new technologies.

Thierry Bonnevay

Thierry is currently Global Analytical Microbiology Expert in Analytical Sciences in Sanofi Pasteur. He joined Sanofi Pasteur in 1997 and have different previous experiences in R&D and Industrial Operations with compendial but also Alternative and Rapid Microbiological Methods. He is part of the USP expert panel in Modern Microbiological Methods (MMM) since 2015 and member of Groups of Experts at the European Pharmacopoeia EDQM Group 1 Microbiology and Working Party Bacterial Endotoxin Test as well as Mycoplasma WP.

Oliver Stauffer, "Industry Must Move Away from Dye Ingress Test"

Oliver Stauffer received his Bachelor of Science degree from the University of Michigan and completed his MBA at Georgetown University. He began his career in analytical and R & D laboratories, with a focus on sensory technologies, physio-chemical measurement, and test method development specific to package testing. Stauffer joined PTI in 2005 as a member of the research and development team working on non-destructive testing of high-risk pharmaceutical packaging. In 2006, he joined the sales team as applications engineer for PTI Inspection Systems. He held the position of International Business Development Manager for PTI through 2010, followed by COO through 2015, focusing on global quality solutions for package inspection that provide the highest level of measurement accuracy and reliability. During his time with PTI he has developed several technology platforms, measurement methodologies, and technology patents. In 2016, he was appointed as CEO.

James L. Vesper, "Root Cause Investigations for CAPA: Clear and Simple"

James Vesper, Ph.D., MPH, has worked in the pharma/biopharma industry for more than 35 years, starting out at Eli Lilly and Company where his last position was leading Lilly's GMP Training and Education group. For 24 years, he was President of Learning Plus, a consultancy that provided training and performance solutions to the pharma and biopharma industry. In 2017, he joined ValSource as Director of Learning Solutions. His professional interests are in the areas of learning/education, learning course design, risk management, and incident investigations related to the category of "human error."

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  Dr. Vesper has written numerous books, book chapters, and articles. He also speaks and teaches at international conferences and workshops, as well as has consulted for the World Health Organization (WHO) and conducted training on risk management for PIC/S.

  He holds a B.S. in Biology (Wheaton College, Illinois, USA), Masters of Public Health (University of Michigan School of Public Health), and Ph.D. in Education (Murdoch University, Perth, Western Australia).

Cristiana Campa, PhD

Cristiana Campa, PhD, is currently a Technical R&D Advisor and Fellow at GSK Vaccines, with more than 20 years’ experience in biologics and related analytical and development strategies, gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing on development, validation and transfer of analytical methods for release and characterization of several vaccine products, first as senior manager and then as Head of Analytical Development, Italy. Since 2012, Cristiana has worked on Quality by Design (QbD) principles implementation for vaccines. After acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation, Knowledge Management and Development roadmaps. Cristiana has actively worked on the organization/ co- chairing of several PDA Europe Conferences and Vaccine Interest Group events. She received the PDA Michael S. Korczynski Award in 2020, recognizing contributions made toward the development of PDA’s international activities.

Masahiro Akimoto, Board Member

Masahiro Akimoto is the senior manager of the R&D and Quality Assurance Division at Otsuka Pharmaceutical Factory, Inc., responsible for supervising the quality assurance and ensuring regulatory compliance for innovative product development.

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  In his approximately 25 years in the field, Masahiro has been involved with CMC development, strategic quality planning for CTM production of both sterile and oral-solid dosages, technical transfer managements to U.S. and EU CMOs, preparation of the quality sections of the marketing authorization dossier, and quality assurance for system audits for regulatory compliance and continuous improvement.

  Masahiro earned his master's degree in pharmaceutical science (physical chemistry) from the graduate school of the Pharmaceutical Institute, Tohoku University in 1987. He has been a registered pharmacist and an ASQ certified quality engineer.

  An active member of PDA for 20 years, Masahiro has been a member of the Board of the Japan Chapter since 2009 and the Annual Meeting Program Planning Committee since 2012. He was instrumental in the arranging speakers for successful collaborative meetings with the PDA-EU Chapter and PDA Global. He is also a member of PDA's Science Advisory Board (SAB), the Aseptic Processing Points to Consider Task Force (2016) and the Sterile Product GMP and development QA committees of the Japan Chapter.

Ursula Busse, PhD MBA, Regulatory Affairs IG Leader

Ursula is currently the Global Head of Quality Intelligence and External Affairs at Novartis. She drives the Novartis external engagement strategy for Quality relevant topics and leads global GxP regulatory intelligence. Prior to her current role, Ursula held leadership roles in CMC Regulatory Affairs for biologics and Biopharmaceutical Operations. Before joining Novartis in 2006, she worked for startup biotechnology companies in Canada for 10 years, in R&D, Quality Assurance and CMC Regulatory Affairs. She holds a master’s degree in Biology from Tübingen University (Germany) and a PhD in Cellular and Molecular Biology from Laval University (Québec, Canada), coupled with an MBA she earned with honors.

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  Ursula has been a long-time member and volunteer of PDA. She served on PDA’s Board of Directors from 2012 to 2017 and was involved in numerous PDA initiatives and strategic committees.

Fabio De Martino, West Coast Chapter President

Fabio De Martino is currently Associate Director of Finance and Information Management Process Improvement at BioMarin Pharmaceutical. In this role, his main responsibilities are identifying, launching, leading and delivering critical projects, across all company functions, with significant tangible monetary impacts.

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  Prior to this role he worked at Genentech in the Global Quality function, where he managed global projects and programs in the continuous improvements space, and at Novartis Vaccines and Diagnostics, where he led critical projects and investigations in compliance with FDA regulations and international quality standards, managing projects across Europe, Asia and the US.

  Fabio holds a Bachelor's degree in Chemical Engineering from the University of Salerno and a Master's degree in Chemical Engineering from Pisa University, Italy. He is a licensed/registered engineer (Italy), a certified Lean Manufacturing Six-Sigma Black Belt and a Project Management Professional (PMP).

  Fabio is an active Board Member of the West Coast PDA and Lecturer Faculty of Business & Management at San Francisco State University, UC Berkeley Extensions and Northeastern University.

Randy George, Southern California Chapter President

Randy George is Sales Director at ValGenesis, Inc, the leading supplier of digital validation enterprise systems to the life science industry, and is responsible for sales and account management in the Western US, offering paperless validation software (eVLMS), monitor manager (electronic logbooks), and related validation and automation products supporting Pharma 4.0 "Factory of the Future." Before joining ValGenesis, Randy has over 15 years of sales, business development, and account management experience, working in the Life Science Industry with domestic and foreign companies providing capital equipment, automation, consulting services, and software systems.

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  Randy has been a member of PDA since 2005, holding various SoCal PDA Chapter board positions, and most recently served as President of the SoCal Chapter from 2018-2020. During Randy's presidency, he helped the chapter build a strong foundation for on-going chapter success and growth. The SoCal PDA Chapter experienced its most successful years, with new programs, initiatives, increased membership, collaboration, diversity, industry outreach, vendor sponsorship, in-person and virtual events, philanthropy donations, board member recognition, student chapter participation, and more.

  Also, Randy established the PDA Chapter Council Steering Committee in 2019 at the national level, as a cross-functional group of chapter representatives looking for ways to harmonize chapter systems, processes, and procedures by utilizing the strengths of all the PDA Chapters to sustain growth, programs, and initiatives as volunteers. Randy was the Chairperson of the PDA Chapter Council Steering Committee from 2019-2020.

  Currently, Randy is involved in various associations supporting the life science industry worldwide and keeps-up with the SoCal PDA Chapter as an ad-hoc board member.

Dinesh R. Khokal, PhD

Dinesh is the Director, External Affairs Quality, at Amgen Biotechnology Singapore supporting Amgen's outward facing efforts in Japan Asia Pacific and Latin America. He collaborates effectively with industry peers and regulators to engage, understand, translate, and deliver impact in the evolving external GxP landscape. Additionally, Dinesh currently holds the position of Adjunct Associate Professor at the Faculty of Health and Medical Sciences, Taylor's University, Malaysia.

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  Prior to Amgen, Dinesh held the role of Director of Therapeutic Products Branch at the Singapore Medicine Regulatory Agency, Health Sciences Authority (HSA). During his 10 years tenure in HSA, his main role was to manage, oversee and drive the key development, review, licensure and administer the pre-market regulatory framework for western medicines covering innovative drugs, generics, biologics including, biotherapeutics, vaccines, combination products and biosimilars. He has also played several key roles in multiagency consortiums and WHO initiatives working towards capability building, shaping regulatory landscape, regulatory harmonisation and mutual reliance.

  Prior to the roles in the regulatory agency, Dinesh held many positions in Biopharmaceutical and Medical Device industries as well as in Academia for over 20 years.

  Dinesh received his Ph.D. in Cell and Molecular Biology from the National University of Singapore. He is an American Society for Quality Certified Quality Auditor and Biomedical Auditor. He has also earned certifications in Clinical Trials Management and Healthcare Policy and Governance.

  Dinesh is the immediate past President of PDA Singapore Chapter and he is currently on the PDA Regulatory Affairs and Quality Advisory Board (RAQAB). Dinesh has been a frequent speaker at PDA events in Asia-Pacific.

Michael Long, Applied Statistics IG Leader

Mike is Director of Consulting Services ValSource . Mike Long has over two decades of experience leading product, process and validation development efforts on a wide range of pharmaceutical, bio pharm, medical device, and combination products. He has significant expertise in applying risk management techniques to aseptic products and processes. Mike has also lead Lean/SS efforts as a process owner and as consultant.

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  He is a past member of the PDAs Science Advisory Board, co-leader of the PDA's QRM interest group, and applied statistics.

  Dr. Long is a frequent industry speaker/writer who has instructed courses in Data Analysis at Tufts University's Graduate Engineering Management Program and taught Risk Management and Quality Systems in Regis College's Graduate Program in Regulatory and Clinical Research Management. Mike is a Master Black Belt who earned a bachelor's degree from Worcester Polytechnic Institute, a Masters degree from Tufts University and a Doctorate from Northeastern University.

Anette Yan Marcussen, Pharmacopeial IG Leader

Mrs. Anette Yan Marcussen, Master of Pharmacy by education, has been working in the pharmaceutical industry for +30 years in managerial positions within parenteral and solid drug manufacturing as well as Medical devices. Mrs. Marcussen has profound and proven leadership and management skills and experience in pharmaceutical production, process management and quality management. She has been employed in various international companies and some of her achievements and competences are:

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  • Implemented a corporate process to ensure capture and implementation of external authority requirements
  • Aseptic Quality Release of 1/3 of the world markets insulin and ensuring License to operate at 3 factories at Novo Nordisk
  • Experience with designing, living and complying with the Pharmaceutical Quality system
  • Has been driving a strategic global project from France, where the goal was to increase the supply chain flexibility and still be in full regulatory compliance.
  • Quality assurance of finished production of aseptic products. Experience with isolators and production in classified areas

  She is motivated by sharing knowledge and experiences in how best to meet key objectives of the pharmaceutical industry, which is why she prioritizes and appreciates being actively involved in international industry organizations such as PDA. She has contributed in PDA in various task forces, interest groups, conference planning committees, and is now serving as Vice Chair and Chair Elect in Regulatory and Quality Advisory Board (RAQAB).

Laurie Masiello, New England Chapter President

I met my husband of 46 years when we were teenagers in high school. John and I built our first house together, we started our business together, and we remodeled our lake house as our permanent year-round home. I have been the President of our family owned business, Masy Systems, Inc., since 1995. I work side by side with my husband, our two sons and their wives, my brother and his wife, my brother-in-law and his wife, other extended family members, and those I fondly refer to as our "adopted" family members. Future Masy employees include our three grandsons, Jay, Bryant and Brian, and our granddaughter, Emily - our four angels.

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  Giving back to the community is a priority in my life. I was the first woman President and now the Immediate Past President of the New England Chapter of PDA (NE PDA); an active committee member at the National Conference of Standards Laboratories (NCSL); a board member of the Nashoba Valley Chamber of Commerce (NVCoC); a Lomar Park Trustee; and a Corporator at Main Street Bank. Being recognized for my accomplishments and contributions, I was honored by the Worcester Business Journal in 2018 as an Outstanding Woman in Business.

  I am 100% vested in any project I take on, doing the best possible job I can, and I've taken on a lot of projects. I'm a strong contributor to community and industry organizations and events, taking a vested interest in their success and frequently propelling them to new heights. One of my strong beliefs is "together we make a better product", and I draw the best out of the members of the team so we all contribute to that win. Professionally, I believe that excellence is the level of service our customers need and our job is to always deliver that high level. I created and foster our company's tag line, "Raising the bar for excellence".

  I am excited to have earned a place in the exclusive "NE PDA Past Presidents Club". Thank you Bob Pazzano and Tim Leahy, our first Chapter Presidents for starting this organization and Mark Staples, Myron Dittmer, Louis Zaczkiewicz, Jerry Boudreault, Rusty Morrison, Jonathan Morse, Roland Bizanek and Amnon Eylath for developing our chapter over the years, and for trusting and supporting me during my tenure.

Dr. -Ing. Stephan K. Rönninger, Board Member

Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. He represents Amgen in EFPIA MQEG and represents EFPIA on GMPs/inspections, in ICH training and ICH-QDG and before on ICHQ9, ICH Q-IWG on Q8/Q9/Q10 and ICHQ7-IWG. In PDA he was at the board and chaired RAQAB.

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  Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from PDA and regulators incl. FDA and PIC/S.

Lisa Rutter, Pacific Northwest Chapter President

Lisa Rutter currently is the Senior Director – Quality Head of Quality at Partner Therapeutics, a position she has held since 2017. Partner Therapeutics is devoted to developing and commercializing cancer medicines and combination therapies that can make a meaningful difference in the lives of cancer patients.

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  Lisa previously held positions as Associate Director of Quality Control and Quality Systems Manager. She managed and was responsible for testing related to the manufacturing and release of Leukine, testing and release of raw materials, microbiological control of the utility systems and the manufacturing environment, program/system management of Deviation/CAPA, Change Control, Training and Document Management.

  Prior to Sanofi, Lisa worked for Dendreon, Genentech, Amgen, and a contract research organization where she performed analytical method development, managed product testing laboratories conducting analytical release and stability testing of biological products and the implementation and administration of quality systems. Lisa has a bachelor's degree in Biology from Washington State University and brings 30 years of experience in biopharmaceuticals, including testing of clinical and commercial products and the development and management of Quality Systems with a focus on operational efficiencies using six sigma techniques and tools.

Karen M. Walker, BioAB Vice-Chair

Karen Walker, Sr. Advisor Cell and Gene Therapy Manufacturing at Roche/GNE.  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 Seattle Genetics, Novartis, Amgen, Bayer, and several other small to mid-sized biotech companies.

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  Prior to joining Roche/GNE, she served as Global Quality Head for Seattle Genetics (2017-2020). Her experience with Cell and Gene Therapies includes serving in the role of VP and Global Head of 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 through the pivotal trial stage and to filing of the first CAR-T BLA in Pediatric ALL.

  Karen’s years of experience in Biopharma Technical Development, Quality, Regulatory CMC, and Manufacturing (including Cell and Gene Therapy), both within the US and Europe have contributed to honing a mind-set and approach that is strategic, forward looking and adaptive.  The challenges that are here in the Drug Development space, including shortened development time (4 years faster), complex supply chains, implementation of new and enabling technology and changes to the way we work, are all inspiring and energizing to Karen as the Pharma/BioPharm Industry evolves in the 21st Century.

  Karen has been an active member of PDA since 1996 and most recently served as Vice Chair of the Bio Advisory Board.

Jesse Baker

Jesse Baker is an IT Systems Analyst with a dozen years’ experience in using and administering data management systems. He has been working in the nonprofit association space in the education, housing, and small business industries before joining PDA. A strong believer in providing a positive user experience, Jesse’s professional focus is seeking solutions that automate and simplify business processes. His currently social-distanced lifestyle includes shared supervision of his three elementary-age children and their constant scholastic, gastric, and entertainment needs.

Dirk Stelling

Dirk has worked at PDA Europe in the position of Director Finance and Administration for 13 years. He passed away unexpectedly in January 2021 at the age of 46 years. With him, we have lost a colleague who will always be remembered with his competence and collegial nature.