Meet 2016 – 2017 ISPE International Board of Directors
This group of distinguished strategic leaders represents a variety of pharmaceutical industry sectors. The ISPE International Board of Directors is responsbile for the goverance and startegic direction of the Society and will assume their elected positions at the 2016 ISPE Annual Meeting & Expo on 18 – 21 September in Atlanta, Georgia USA.
Chair: Michael A. Arnold, RPh, Business Process Owner for Investigational Products and Senior Director of Strategic Partnerships, Global Clinical Supply Chain, Pfizer
Michael A. Arnold is the Business Process Owner for Investigational Products and Senior Director of Strategic Partnerships for Pfizer’s Global Clinical Supply Chain. He has worked in the Pharmaceutical Industry for the past 34 years. Mr. Arnold is the current Chair of the ISPE New Content Advisory Group, a member and Past Chair of the ISPE Investigational Products Community of Practice, a member of the ISPE Regulatory Subcommittee, a member and Past Chair of the ISPE Community of Practice Council, Chairman of the ISPE Quality Metrics Governance Team, and a member of the Global Pharmaceutical Manufacturing Leadership Forum (GPMLF). He was elected to the ISPE International Board of Directors in 2012 and currently serves as Board Vice Chair. He is a contributing author to ISPE’s Good Practice Guide on Interactive Response Technology and has been a speaker at local and international educational events. In 2011 ISPE named him its Member of the Year. Mr. Arnold holds a BS in Pharmacy from the University of Rhode Island College of Pharmacy and is a licensed and registered pharmacist in the state of Connecticut. In 2012 he was elected “Pharmacist of the Year” by the Connecticut Society of Health Systems Pharmacists.
Vice Chair: Timothy P. Howard, CPIP, PE, Vice President of Global Operations, Commissioning Agents, Inc.
Timothy P. Howard, CPIP, PE is a Vice President of Strategy and Development at Commissioning Agents, Inc. His responsibilities include oversight of talent acquisition and development, organizational development, marketing/sales support, and company internal projects. He consults on a range of topics including quality risk management, C&Q program implementation, and risk-based validation programs. Mr. Howard has been on the International Board of Directors at ISPE since 2011. An ISPE Member since 1994, his service to ISPE includes Past Chair of the ISPE University Committee, Co-Chair of the C&Q CoP, and CaSA Chapter Board member. He was a long-time member of ISPE’s Continuing Education Committees, having served as Chair and Co-Chair for three years. Mr. Howard was a member of the ISPE Task Team that developed the ASTM standard E2500 and a contributing author to ISPE Guidance Documents on ASTM E2500 Implementation. He is a qualified trainer for the ISPE training course on C&Q applications, regularly speaks at conference seminars worldwide, and is published in Pharmaceutical Engineering. He is a former naval nuclear submarine officer, and was previously licensed as a senior reactor operator on a commercial nuclear power plant. Mr. Howard earned a B.S. degree in Mechanical Engineering from N.C. State University, is a Certified Pharmaceutical Industry Professional, and a licensed Professional Engineer in North Carolina.
Treasurer: James Breen Jr, PE, Vice President, Worldwide Engineering and Technical Operations, Johnson & Johnson
James A. Breen Jr, PE, is the Vice President, Worldwide Engineering and Technical Operations in Johnson & Johnson’s Supply Chain group based in New Brunswick, New Jersey. He has been employed by Johnson & Johnson for 15 years. Prior to this he worked for the General Electric Company and for Hercules Incorporated in both domestic and international assignments. He is Past President of the ISPE New Jersey Chapter, a member of the ISPE Facility of the Year Award judging team, and a member of the Global Pharmaceutical Manufacturing Leadership Forum (GPMLF). Mr. Breen holds a Bachelor of Engineering from Stevens Institute of Technology, an MBA from Drexel University, and a Masters of Engineering in Technology Management from the University of Pennsylvania Wharton School. He is a registered Professional Engineer and LEED AP. Mr. Breen is an Adjunct Professor for Drexel University in the Graduate Engineering Department.
Secretary: Frances (Fran) M. Zipp, President & CEO, Lachman Consultant Services, Inc.
Frances (Fran) M. Zipp is President & CEO of Lachman Consultant Services, Inc. Lachman Consultants provides compliance, regulatory and technical consulting services to the global pharmaceutical and related industries and Ms. Zipp delivers the strategic guidance and direction toward implementation of effective solutions to client needs. As an expert in compliance enhancement, she develops program solutions to meet GXP compliance requirements. Ms. Zipp has extensive experience in the pharmaceutical, biologic and biotechnology industries from R&D through post-market approval. She assists and counsels Senior-level management in areas of Corporate Governance, Corporate Integrity Agreement Compliance, Consent Decree Negotiations and Resolutions, Application Integrity Policy resolution, Due Diligence evaluations (facilities; products; technologies), and more.
For more than 30 years, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology.
The following individual served in 2014 – 2016 and has been re-elected to a second two-year term:
Joanne R. Barrick, RPh, Advisor in Global Validation Support, Eli Lilly and Company
Joanne R. Barrick is an Advisor – in Global Validation Support at Eli Lilly and Company where she provides process, cleaning and packaging validation support and training to Lilly sites throughout the world. She has over 30 years of experience in Technical Services, Validation, Manufacturing and Packaging Operations, holding positions of increasing responsibility at Upjohn/Pharmacia/Pfizer prior to joining Eli Lilly and Company in 2003. Joanne has been an ISPE Member for over 17 years, was named Member of the Year in 2012 and was elected to ISPE International Board of Directors in 2014. She chairs the ISPE PQLI® Lifecycle Approach to PV Implementation Team and has chaired numerous ISPE process validation conferences and conference tracks. She has been a member of the ISPE PQLI® Technical Committee for seven years and was previously a member of the PQLI® Criticality Task team which authored the Criticality section of the PQLI® Good Practice Guide Series Part 1: Product Realization using QbD, Concepts. Joanne Barrick holds a Bachelor of Science in Pharmacy from Purdue University, is a member of the Purdue Pharmacy Alumni Board and received the Purdue Women in Pharmacy Leadership Award in 2015.
Peter S. Carbone, Vice President, Global Head External Relations, Group Quality, Novartis
Peter Carbone is Vice President, Global Head External Relations, Group Quality at Novartis since April 2014. Prior to joining Novartis, Peter worked for Allergan for 7 years in a variety of senior quality leadership roles including Vice President Biologics. Peter has over 30 years of leadership and experience in the engineering, quality, and technical management fields. During his career, he has led engineering and quality teams for several major pharmaceutical companies supporting operational excellence, quality improvement, and compliance initiatives in complex biotechnology, pharmaceutical, and medical device manufacturing environments. Peter has been an ISPE Member for over 15 years. He has presented at a number of ISPE conferences and is the Industry Co-Chair of the 2016 ISPE/FDA/PQRI Quality Manufacturing Conference. He is a member of the ISPE Quality Metrics Steering Committee, GAMP® Data Integrity SIG and Regulatory and Compliance Committee North America Focus Group. Peter holds a BS in Chemical Engineering from Rensselaer Polytechnic Institute.
Christine M.V. Moore, PhD, Global Head and Executive Director, GRACS CMC – Policy, Merck
Dr. Christine Moore is Global Head and Executive Director, GRACS CMC – Policy at Merck. Christine recently joined Merck after 11 years in various positions at FDA, including Acting Director of the Office of New Drug Quality Assessment and of the Office of Process and Facilities. Her background is in chemical and biochemical engineering with 10 years of industry experience in API development, scale-up and tech transfer. Throughout her career, Christine has focused on the development of scientific and regulatory approaches for advancing pharmaceutical manufacturing technologies, modernizing regulatory approaches and progressing international harmonization. She has presented at numerous ISPE conferences and Co-Chaired the 2015 ISPE-FDA-PQRI Quality Manufacturing Conference. Christine has been recognized with external industry awards as well as internal agency awards during her tenure at FDA. Christine holds a PhD in Chemical Engineering from MIT and a BS in Chemical Engineering from Northwestern University.
Fatma Taman, General Manager, PharmaVision
Fatma Taman holds the position of General Manager at PharmaVision in Istanbul, Turkey. She has more than 20 years of experience in pharmaceutical manufacturing and management. In addition to her experience on various technologies on API and drug product manufacturing, she has also managed research and development departments in several pharmaceutical companies in Turkey. Ms. Taman is a frequent guest lecturer at universities including Istanbul University and has presented at a number of events for organizations such as ISPE, PDA, CpHI and Controlled Release Society’s Turkey Affiliate. Ms. Taman has been an ISPE Member for 11 years. She served as Vice-Chair of ISPE Turkey Affiliate 2011-2014 and is the current Affiliate Chair. She also serves as a member of the ISPE PAT CoP Steering Committee, EuroForum, the RCC Europe Focus Group and is Vice Chair of ISPE’s European Affiliate Council. Following her study at Westfalische Wilhelms University in Germany, she completed her Pharmacy study at Istanbul University.
Jörg Zimmermann, Vice President of Vetter Development Services, Vetter Pharma Fertigung GmbH&Co KG
Jörg Zimmermann is currently Vice President of Vetter Development Services for Vetter Pharma Fertigung GmbH&Co KG, Ravensburg, Germany. In this role, he is responsible for manufacturing science & process development, technology & process transfers, project & service analytics and drug delivery systems. Within Vetter, Jörg has held various positions in process implementation, new product introduction, lyophilisation process development and as production manager before becoming Director of Production of Vetter’s production site at Lake Constance in 2000. There he managed 5 production lines for aseptically prefilled injection systems. In September 2010 he became responsible for the process development and process introduction group at Vetter before being promoted to Vice President in November 2014. Jörg has volunteered as track leader and speaker at conferences by ISPE, PDA, and Concept Heidelberg for over 15 years and served as the PDA-representative at the “interested parties meeting” at the EMA on the revision of Annex 1 in 2006. Jörg studied pharmacy in Freiburg, Germany and Cardiff, Wales and is a registered pharmacist.
Continuing Board Members:
In addition to those named above, the following Directors were elected in 2015 to serve a two-year term and will continue their service on the Board:
Tony (Antonio) Crincoli, PE, Executive Director and Head of Global Engineering Services, Bristol-Myers Squibb
Tony (Antonio) Crincoli is Executive Director and Head of Global Engineering Services at Bristol-Myers Squibb with oversight over all major capital projects, strategic project planning, project governance and execution and Technical Services. He has over 30 years of experience in the pharmaceutical, biotech, and device industries with Pfizer, Hoffman LaRoche and Becton Dickinson. In various roles as team leader, design engineer, site engineering or project manager, he has operated and completed a wide variety of projects from design through commissioning in pharmaceutical manufacturing, R&D, laboratories, facilities and infrastructure throughout the globe. Mr. Crincoli is fluent in Spanish, Italian and English. He has been an ISPE Member for over 10 years, served on the ISPE New Jersey Chapter Board, most recently as President, and has contributed to articles, standards, local and international committees, mentoring and development programs. Mr. Crincoli holds a BSME from New Jersey Institute of Technology, and an MBA in Management from Seton Hall University. He is a registered Professional Engineer in New Jersey and 14 other states, and is also recognized by NCEES’s International Engineering Registry.
Thomas Hartman, Vice President of GMP Operations, Biopharm CMC, GlaxoSmithKline
Thomas Hartman is Vice President of GMP Operations, Biopharm CMC, for GlaxoSmithKline, where he leads GMP manufacturing, QC testing and support operations, and engineering for Clinical Trial Material (CTM) production of biopharmaceutical assets within the CMC group. Prior to his 14 year tenure with GSK, he worked for ARCO Chemical Company for 22 years in various engineering and operational roles within the US and Europe. Mr. Hartman has been a Member of ISPE for 14 years. He serves as an industry advisor to the Delaware Valley Chapter, participates in the Chapter’s annual Owners Advisory Forum and hosts Chapter educational events on the GSK campus. He was elected to the ISPE Board of Directors in 2013. He is active in an industry liaison and mentor role for the Mechanical Engineering Department at Villanova University. Mr. Hartman earned a BME from Villanova University and an MBA from Eastern University.
Robert (Bob) Matje, PE, CPIP, Principal, RemTech, LLC
Robert (Bob) Matje, PE, CPIP is Principal at RemTech. Previously, he was Vice President of Technical Operations at Qualitest, Endo’s Generic Manufacturing division, where he was responsible for Technical Services, Process Excellence, and Reliability for the entire Supply Operations. Prior to that he was the Vice President and General Manager of both Oral Solid Dosage facilities within Qualitest where he had full responsibility for manufacturing, materials management, site engineering, and site EH&S. He has also held the position of Senior Director of Engineering at Endo which included reliability and maintenance, environmental, health and safety, automation, capital and qualification. Robert Matje worked at Pfizer (then Wyeth) between 1999 and 2012. He held numerous positions, including Program Manager for Pfizer’s Global Serialization Project Management Office and Program Director for PNS Projects in Puerto Rico. Mr. Matje has been a Member of ISPE for 14 years and is Past President of the Delaware Valley Chapter. He currently chairs the ISPE Awards Committee and serves on the Quality Metrics Team and the Oral Solid Dosage CoP Steering Committee. He is also is an author of the Oral Solid Dosage Baseline® Guide. He was elected to the ISPE Board of Directors in 2013. Mr. Matje earned a BS in Engineering at Lafayette College and an MS in Engineering at Villanova University. He is a Registered Professional Engineer in Pennsylvania and was awarded his CPIP designation in 2012.
Antonio (Tony) R. Moreira, PhD, Vice Provost for Academic Affairs at the University of Maryland, Baltimore County (UMBC)
Antonio (Tony) R. Moreira, PhD is Vice Provost for Academic Affairs at the University of Maryland, Baltimore County (UMBC) and is responsible for academic affairs matters within the Provost’s Office. In addition to his administrative responsibilities, he has maintained an active teaching and research program in bioprocessing, regulatory science and engineering. He frequently presents short courses in biotechnology topics for industry as well as regulatory agencies. Dr. Moreira has over 30 years experience in the biopharma sector and spent nearly 10 years in management positions in the private sector with International Flavors and Frangrances and with Schering-Plough Corp. (now Merck). He has been an ISPE Member for over 20 years and is the founding President of the ISPE Chesapeake Bay Area Chapter. He has also been active in the Parenteral Drug Association, Biotechnology Industry Organization (Chairman of the Council of Biotechnology Centers), American Chemical Society and American Institute of Chemical Engineers. He is published in many peer-reviewed publications, is a co-editor for several books and is a frequent speaker at national and international conferences. Dr. Moreira holds a BS in Chemical Engineering from the University of Oporto, an MS and PhD in Chemical and Biochemical Engineering from the University of Pennsylvania.
Christopher Reid, CEO, Integrity Solutions Limited
Christopher Reid is CEO of Integrity Solutions Limited, a provider of Quality and Compliance solutions to regulated companies globally with locations in the UK, Tokyo and North Carolina. Mr. Reid’s responsibilities include all aspects of business management, financial management, resourcing and product / service development. He has worked for over 50 regulated companies from small local companies to multinational pharmaceutical enterprises. He has worked in Life science industries over 20 years, prior to which he was a computerised system development engineer. Mr. Reid currently works with leading global organisations developing and implementing quality and compliance solutions including defining and implementing strategic quality initiatives, implementing corporate quality policies and standards, skills development and system validation. He works with a variety of organisations and disciplines including IS/IT, Engineering, Business, QA and Suppliers. He has worked across pharmaceuticals, biotechnology, medical devices and cosmetic industries and all regulatory domains including clinical, laboratories, manufacturing, distribution and pharmacovigilance. Mr. Reid is a member of ISPE’s International Board of Directors, European Forum, European Leadership Team, Co-chair of the Knowledge Network Council and member of the Global and European GAMP® Steering Committees. He has contributed to the development of GAMP 5 and a variety of GAMP® Good Practice Guides. Mr. Reid holds a BSc (Hons) in Computing Science from Staffordshire University.
The 2015 – 2016 Board Chair will continue service on the Board in 2016 – 2017 as Immediate Past Chair:
Immediate Past Chair: Joseph Famulare, Vice President – Global Quality Compliance and External Collaboration, Genentech/Roche, Pharma Technical Operations
Joseph Famulare is Vice President – Global Quality Compliance and External Collaboration at Genentech/Roche, Pharma Technical Operations. He is active in aligning industry and international regulatory authorities around policy and harmonization, and also heads the company’s inspection readiness, GMP auditing and is integral to determining the company’s compliance strategies, among other duties. Mr. Famulare joined Genentech in 2009 as the Senior Director of Genentech’s Quality and Compliance External Collaboration function after a 32-year career at FDA. He is the former Deputy Director, CDER Office of Compliance, FDA, where he led an extensive team heading GMP, GCP, and GLP Compliance programs. He was a founding member and served on the Council of Pharmaceutical Quality. He also held a number of progressive roles at FDA throughout years of public service. As a Member of ISPE for more than 15 years, he has led ISPE’s PQLI® Initiative, serves on the Regulatory Compliance Committee and Drug Shortages and Quality Metrics Initiatives. He is active in ISPE global activities as a speaker and panelist, chaired the 2013 ISPE Pharmaceutical Quality System (ICH Q10) Conference in China and has co-chaired successive ISPE/FDA co-sponsored conferences over the past 5 years. Mr. Famulare has actively participated on the Global Pharmaceutical Manufacturing Leadership Forum (GPMLF). He recently co-led the publication of PQLI®’s Quality System Guideline on Process Performance and Product Quality Monitoring. He currently serves as the Chair of the ISPE International Board of Directors. Mr. Famulare has a BS in Biology and Environmental Studies from St. John’s University and extensive training in manufacturing, microbiology and chemistry, regulatory risk management and leadership.
Congratulations to the 2016 – 2017 ISPE International Board of Directors!