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Meet Our Board of Directors
| John M. Lewis - AGXPE President Merck & Co., Inc. John is one of the original founders of AGXPE and has over 25 years of leadership experience overseeing organizational strategy, planning, and workplace culture. John is well versed in International, Federal, State, and Local quality and compliance standards and regulations within the life science industries. He holds a Master of Science in Quality Engineering from Lehigh University with an undergraduate in Biology from Trenton State College. Major certifications held by John are Master BlackBelt - Six Sigma and Agile Scrum Master. He is working with the Board of Directors, uniting individuals with a passion and concern for quality, compliance, education, and training. John was the former CEO and Chairman of the Board of the GMPTEA and BOD Member at Large of the American Red Cross, Jersey Coast Chapter. |
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Bill Beyer - AGXPE Chairman of the Board
Bill is a business-builder, educator, and fan of all things that help others advance their careers. As founder and Managing Director of the Life Science Training Institute (LSTI), he has overseen the training of over 100,000 pharmaceutical, medical device, and biotech personnel since 2013. Prior to founding LSTI, Bill was Marketing Director for the Center for Professional Innovation & Education (CfPIE). During his time there, Bill developed eight industry-recognized certification programs spanning the GxP spectrum, and guided the company to significant revenue growth. Earlier in his career, Bill held sales management positions with Learning Tree International and FDAnews. Bill also spent five years with The Princeton Review, a leading standardized test preparation company. As the Director of Graduate Programs, Bill developed Princeton Review’s MCAT verbal and USMLE Step 1 & 2 preparation courses. Bill has a BS in Biological and Cultural Anthropology from Hartwick College in Oneonta, NY. When he is not running LSTI, Bill likes to spend quality time with his family and is a horrible fisherman. |
| John Constantine John is a veteran of over 30 years in the life sciences industry, first at GlaxoSmithKline, then at Merck as Executive Director, Merck Polytechnic Institute in 2008, and joining Orchestrall, Inc. as Senior VP, Talent Solutions in 2016. His background includes Sales, Marketing, Corporate Staffs, Information Technology, Human Resources, Research and Development, and over 25 years in Learning & Development. John's expertise lies in the application of learning to business strategy to drive workforce effectiveness and the application of technology to learning to drive learning effectiveness and efficiency. Other areas of expertise include:
He is a long-term member and served on the Board of Directors of the Life Sciences Trainers and Educators Network (LTEN) for 14 years, including 2 years as president. He is also a Board of Directors member of the Association for GxP Excellence (AGXPE), Association for Talent Development, the Society of Human Resources Management, Chair of the Board of the Asia (Global) Training Consortium, served as Advisor, National Board of Medical Examiners Clinical Research Certification, and is an advisor to the Smart Healthy City Alliance. He previously served as Senior Advisor, China Sourcing Working Committee, China Council for International Investment Promotion. |
| Tammy Cullen CLO - Tammy has a PhD in Instructional Systems Technology from Indiana University and over 25 years of experience creating and conducting performance improvement programs. Currently she is a Manager of Learning & Development with Eli Lilly, with a team that supports the Product Research and Development. She began her career in public education as a mathematics teacher and Staff Development Coordinator. |
| Michelle Durcholz Michelle joined PTC Therapeutics in March of
2020. Her primary responsibilities currently center around the implementation and validation of a new Learning Management System (LMS) and the migration from the current LMS. Since joining the pharma industry in 2002, she has supported
quality, manufacturing, laboratories, and business functions. Michelle’s areas
of expertise include the Usage of Learning Managements Systems & Document
Management Systems, Audit Readiness & Support, and Training Program
Support. Her experience at Baxter, Bristol Myers Squibb, and now, PTC, has
provided exposure to a broad range of process, practices, and
information. In her free time, Michelle enjoys spending time with her
family, bicycling, swimming, working in her garden, and researching topics
of interest. She is a graduate of the University of Evansville. |
| Chrissy Frey CMO - Chrissy Frey graduated with her Executive MBA from the Jack Welch Management Institute (JWMI) and earned her Bachelor Science in Biology from Pennsylvania State University (PSU). In addition, Chrissy has a secondary teaching certificate from York College. Combining this education with over 20 years of pharmaceutical experience, ranging from large to start-up biological and pharmaceutical companies, she brings a plethora of experience, knowledge, and excitement to evaluating business and learning opportunities. She is a motivating and proven leader that successfully implements strategic goals and visions while aligning with business needs. Chrissy’s personal philosophy in life is that continuous improvement is mandatory for success and is a life-long process. Seeking new opportunities and challenges, as well as, growth and development learnings for her teams and self are just one of the many facets of her ideology. |
| Vince Ranieri - AGXPE CFO CFO - Vincent A. Ranieri has recently joined Spark Therapeutics as the Associate Director of QA Training. He began his JNJ career as an Assistant Scientist in 1999 with Janssen Pharmaceutica and, before leaving JNJ, was the manager of the Laboratory Analyst Training & Certification Program, LATCP. In 2022, Vince started his education in gene therapy, accepting a role at PTC Therapeutics. He has over 25 years of medical, environmental, and pharmaceutical analytical chemistry experience. Vince has over ten years of pharmaceutical sector experience as a dissolution testing leader. He has earned a dissolution certification from United States Pharmacopoeia (USP) and has over 40 hours of outside dissolution training. From 2009 – 2012, Vince accepted a role as QA Training Manager in medical devices working for Integra LifeSciences, putting together a compliant training system that passed challenges from the U.S. FDA and several notified body assessments. A key strength is being the voice of quality and driving the importance of GMPs. He has participated in and facilitated data integrity (DI) panel discussions and strives to be a leader in DI. |
| Jesús A, Rivera Before joining BMS, Jesús founded a consultant practice entitled Mustard Seed Publications & Consulting and served as a senior consultant to Fortune 500 clients, including repeat consulting engagements with BMS to provide a range of services and solutions, including Strategic Planning, Competency Models & Frameworks, Project/Change Management, Instructional Design, Coaching, and Mentoring. He holds a Bachelor of Science in Business Management & Computer Applications from the State University of New York, and a Master of Science in Narrative Medicine from Columbia University. |
| Judy Carmody, Ph.D. Judy Carmody, Ph.D., is the Founder and Principal Consultant of Carmody Quality Solutions, LLC, a quality solutions provider to life science startups and global Fortune 500 organizations who are as passionate as we are about keeping patients safe and delivering quality products. Dr. Carmody has 25+ years of specific expertise driving vision in quality and operations. She is the former founder and president of Avatar Pharmaceutical Services, an FDA-registered contract research organization and manufacturer that was acquired by Vertex Pharmaceuticals in 2010. Prior to founding Avatar, Dr. Carmody spent 10 years in the Life Sciences industry, developing and validating methods for small molecules and oligonucleotides and managing QC, Analytical, and Validation groups. Dr. Carmody holds a Bachelor of Science degree in Chemistry from Worcester State University, a Master of Science degree, and a Ph.D. in Analytical Chemistry from Clark University in Worcester, Massachusetts. |
| Jamie Toth Jamie is a Steering Committee member on the CDISC TMF Reference Model Working Group, and the Chair of the Operations Committee and a Director for the Health Sciences Records and Archives Association (HSRAA). She is also on the Board of Directors for the Association for GxP Excellence (AGxPE). In addition, she has led many industry workstreams for TMF/eTMF including the clinical trials email guidance and the TMF Plan Template with industry colleagues and is currently a member of the Standards Committee as part of CDISC. Jamie is a Certified Project Manager (CPM), a trained Six Sigma Green Belt, and is PROSCI certified. She received her master’s degree in clinical research & organizational management from Drexel University College of Medicine, holds a Bachelor of Arts in Business and Technology from Fairleigh Dickinson University, and an Associates of Applied Sciences in Computer Systems & Technology from Mercer County Community College. In her spare time, she enjoys family time - watching her youngest son play football and lacrosse, and boating, swimming, fishing and attending professional football games – Go Giants! |
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| Trina Lima Trina Lima has over 30 years of experience in the pharmaceutical industry with experience in learning, change management and quality assurance. Currently, Trina is the Senior Director, Global Learning Strategy Lead responsible for driving and embedding a clear global learning strategy across Sanofi. Prior to this role Trina served as the Head of Site Training department for the Sanofi Swiftwater Vaccines manufacturing site; in this role she drove a learning culture by leading the development of innovative blended learning solutions and implemented a new on-the-job instructional (JI) methodology to ensure effectiveness and reduce upskill time by 68%. Before Trina joined Sanofi, she was the Executive Director, Global Learning & Change Management organization at LapCorp Drug Development (previously known as Covance). In this role, she led a global department in providing learning consulting, innovative learning design & development, learning operations and change management support. Trina is a dynamic, results-driven leader, with a successful record of delivering impactful and successful learning solutions and driving change adoption to diverse and globally dispersed audiences. Prior to joining Covance, Trina held several L&D roles for 10 years at Merck, supporting R&D, Manufacturing, and the entire Merck enterprise; she also had a Compliance Role at Hoffman-La Roche for 14 years. |
