Vice President, Quality Biologics
Anders is quality responsible for the Biologics Technical Operations at Roche and Genentech. This includes operational quality leadership for 10 Biologics sites and for Roche and Genentech’s biologics products.
Previous to this role he led the Global Quality System and Processes organization in Genentech & Roche. In that role areas of responsibility included developing and overseeing implementation of the Pharmaceutical Quality System (PQS) at Roche, Quality Risk Management, Operational Excellence, Portfolio Management, Computer Systems and Inspection Management.
Previously he was the co-founder and Chief Quality Officer of the contract manufacturing organization CMC Biologics, where his responsibilities on the Board of Management included QA, QC, IT, Human Resources and Strategic Planning.
Anders holds a PhD in Chemicaal Engineering from the Technical University of Denmark and has 20+ years of business and biopharmaceutical experience, including research and development, quality assurance and control, compliance, regulatory affairs and senior management.
At PDA he is currently Chairman of the Board and Quality Systems Interest Group Leader.
Merck Sharp & Dohme
Chris Smalley has recently joined Merck where he has responsibility for innovative processes and biotechnology implementation and validation and single-use-systems worldwide in the vaccine and pharmaceutical businesses of the organization. Previously, he had been the Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and conducting validation activities globally in the pharmaceutical, biotechnology, consumer health and nutritional businesses. His research experience includes responsibility for Quality in the United States operations of the Sanofi Research Division. He has also worked for the Johnson & Johnson, where he was the Plant Manager for the Parenterals facility for Janssen Pharmaceutical. Chris retired from the United States Air Force as a Lt. Col where he practiced as a pharmacist and healthcare administrator and is a graduate of the Philadelphia College of Pharmacy of the University of the Sciences in Philadelphia, Pa. His graduate education includes a MBA from Temple University Fox School of Business and a Masters of Science in Pharmaceutical Chemistry from Temple University School of Pharmacy. He has performed post-graduate work with the United States Navy at the Monterey, Calif. Post-Graduate School.
Chris is currently a member of the PDA Board of Directors as well as a member of the Science Advisory Board.
Novartis Vaccines and Diagnostics
Cristiana Campa joined Novartis Vaccines and Diagnostics in December, 2006, as an analytical project manager in Technical Development (Siena, Italy), working on analytical activities for glycoconjugate- and protein- based vaccines, leading investigations, characterization studies and methods development/ validation. Since 2012, she has been the technical lead for the implementation of Quality by Design in Technical Development and Manufacturing Science and Technology. She has a PhD in Chemistry (2000, Department of Chemistry, University of Basilicata, Italy) on analytical chemistry of carbohydrates; she then worked as a Post-Doc in Chemistry (2000-2002, Department of Biochemistry, Biophysics and Macromolecular Chemistry, University of Trieste, Italy), studying enzymatic/ chemical synthetic approaches for carbohydrates and glycoconjugates, together with their structural characterization. She subsequently moved to the Research Unit of Bracco Imaging SpA in Trieste, Italy (AREA Science Park), first as a senior researcher (2002-2005) and then as laboratory leader (2006), being involved in the research of new contrast agents (based on the glycobiology of several pathologies) and their characterization. She is co-author of several publications (mainly in the field of glycoscience), and reviewer for some international journals.
Sr. Program Manager
Cyndi is a Sr. Program Manager responsible for Enterprise Serialization at Abbott. Cyndi joined Abbott in 1990 as an IT Analyst. Over the years she’s worked in a variety of IT roles supporting R&D, Medical and Regulatory systems, QA and E-Commerce. Prior to Abbott she worked at Motorola, Inc as an Industrial Engineer. She holds a BS degree in Industrial Engineering from University of Illinois with emphasis in Computer aided Manufacturing. Cyndi received her PMP certification in 2007.
Damon Asher is a Senior Scientist with the EMD Millipore Processing Technologies Virology Group. He is currently engaged in the development of numerous virus clearance, virus detection, and virus purification technologies. He is the lead scientist for EMD Millipore’s initiative to develop highly purified virus preparations for use in virus spiking studies as well as an author of PDA Technical Report No. 47: Preparation of Virus Spikes Used for Virus Clearance Studies (2010) and a contributor to PDA Technical Report No. 41: Virus Filtration (2008). Damon holds a Ph.D. in Immunology from Harvard University and a Master’s Degree in Biomedical Sciences from Harvard Medical School.
Director of Sales
Robert Bosch Packaging Technology, Inc.
Mr. Cousins has been with the Liquid Pharma Division of Bosch for 18 years, in sales, marketing and business development functions. He is a member of ISPE, PDA B.A. Microbiology – University of Minnesota 1984 M.S. Food Science & Engineering – University of Minnesota 1987 MBA – University of St. Thomas 2004
David Cutler has developed an impressive record of achievement in both academia and the public sector. He served as Assistant Professor of Economics from 1991 to 1995, was named John L. Loeb Associate Professor of Social Sciences in 1995, and received tenure in 1997. He is currently the Otto Eckstein Professor of Applied Economics in the Department of Economics and holds secondary appointments at the Kennedy School of Government and the School of Public Health. Professor Cutler was associate dean of the Faculty of Arts and Sciences for Social Sciences from 2003-2008.
Honored for his scholarly work and singled out for outstanding mentorship of graduate students, Professor Cutler's work in health economics and public economics has earned him significant academic and public acclaim. Professor Cutler served on the Council of Economic Advisers and the National Economic Council during the Clinton Administration and has advised the Presidential campaigns of Bill Bradley, John Kerry, and Barack Obama as well as being Senior Health Care Advisor for the Obama Presidential Campaign and a Senior Fellow for the Center for American Progress. Among other affiliations, Professor Cutler has held positions with the National Institutes of Health and the National Academy of Sciences. Currently, Professor Cutler is a Research Associate at the National Bureau of Economic Research, a member of the Institute of Medicine, and a Fellow of the Employee Benefit Research Institute. He serves on advisory board of Fidelity Biosciences.
Professor Cutler was a key advisor in the formulation of the recent cost control legislation in Massachusetts, and is one of the members of the Health Policy Commission created to help reduce medical spending in that state. Professor Cutler is author of two books, several chapters in edited books, and many of published papers on the topic s of health care and other public policy topics. Author of Your Money Or Your Life: Strong Medicine for America's Health Care System, published by Oxford University Press, this book, and Professor Cutler's ideas, were the subject of a feature article in the New York Times Magazine, The Quality Cure, by Roger Lowenstein. Cutler was recently named one of the 30 people who could have a powerful impact on healthcare by Modern Healthcare magazine and one of the 50 most influential men aged 45 and younger by Details magazine.
Professor Cutler received an AB from Harvard University (1987) and a PhD in Economics from MIT (1991).
Director of Engineering
Debashis Sahoo earned his B.Tech. degree from Aerospace Engineering Department of IIT Kharagpur (India) in 1998; M.S. degree in 2000 and Ph.D. degree in 2005 from MIT’s Aeronautics and Astronautics Department (in Cambridge, MA). Between 1995 and 1998, he interned at IIT Kharagpur, IIT Kanpur, and at Aeronautical Development Agency in India and worked on diverse topics such as flight motion characterization, virtual reality and CAD interface design, and Milky Way evolution simulation. He began his career as a Research Assistant at MIT where he worked on diverse topics such as design tools for an unmanned aircraft and noise control in supersonic aircraft cavities. This work eventually led to a doctorate degree after which he joined MEDinstill as a Senior R&D Engineer in 2005. During this period, he worked on closed vial needle filling, laser resealing, UV curing, material development, FEA and experimental modeling, sterilization methods, and their impact on design and functionality of a variety of devices. Since September 2008, he managed concept validation briefs for FDA/NSF approval of a MEDinstill’s PureDoseTM valve based device, intended for the food industry. As the Director of Engineering since 2010, he is responsible for preparing concept validation briefs for regulatory approval of: (1) other MEDInstill’s PureDoseTM valve based devices, and (2) MEDinstill containers filled using second generation INTACTTM Filling Technology. The products are intended for the food, skincare and pharmaceutical industries.
Packaging Science Resources, LLC
Pharmaceutical Packaging Consulting and Training Ed Smith is Principal at Packaging Science Resources LLC which provides consulting and training in packaging for the pharmaceutical, biotechnology, and medical device industries. Services include:
- Development of Extractables and Leachables Management Strategies
- Total Package Development for Parenteral Drug Products
- Specification and Test Protocol Development for Packaging Materials and Components
- DMF Preparation and Filing
- Guidance on Compliance with FDA, USP, Ph. Eur., JP, and ISO
- Training on Packaging Principles, Practices, and Regulations
- Guidance on Cold Chain Transport and Storage for Temperature-Sensitive Vaccines, Pharmaceuticals and Diagnostics
Ed is a member of the PDA and American Chemical Society. Within PDA, he leads the Packaging Science Interest Group, and served on the Steering Committee of the Pharmaceutical Cold Chain Interest Group (PCCIG) where he co-authored PDA Technical Reports 39 & 46 on cold chain best practices. He is also a member of the PQRI Working Group on Parenteral & Ophthalmic Drug Products (Extractables/Leachables). He is a member of the faculty of the PDA Training and Research Institute. He is also a member of the ACS Consultants Network. He has published many articles and chapters on pharmaceutical packaging and is a frequent speaker at industry meetings and courses related to extractables/leachables and cold chain. Prior to forming his consulting practice, Ed was associated with Wyeth Pharmaceuticals where he headed a team responsible for the development and qualification of cold chain packaging systems for transporting temperature-sensitive drug products. He also served as a technical expert on parenteral packaging issues particularly with respect to the management of extractables and leachables. Before that, he was associated with Helvoet Pharma Inc. and West Pharmaceutical Services in various technical management positions. He holds a B.S. in Chemistry from Villanova University and received his M.S. & Ph.D. in Analytical Chemistry from Seton Hall University (So. Orange, NJ).
Vice President, U.S. Quality Liaison, Global Quality
Mr. Rivera Martinez has been with Sanofi since January 2012 in Global Quality. He serves as the focus point between Chief Quality Officer, the FDA, professional associations and internal quality entities in the United States and ensures alignment of the Sanofi-Aventis Quality System with the evolution of regulations and guidances. Before joining Sanofi, he worked with PAREXEL as a Vice President, Technical, providing cGMP compliance services to clients in the United States, Europe and Japan. Previously, he worked with the U.S. FDA for 33 years, most recently as the Branch Chief, International Compliance Branch, in CDER’s Office of Compliance where he was responsible for the group reviewing inspection reports of human drug inspections conducted outside of the United States. He also served as the Branch Chief for the Manufacturing and Preapproval Compliance Branch where he managed the human drug pre-approval inspection program in CDER for 10 years. He holds a B.S. degree from Inter American University of Puerto Rico and an MBA from the University of Turabo in Puerto Rico.
Dr. Firelli Alonso-Caplen is a Senior Director at Pfizer, Inc. She heads the Biotherapeutics and Vaccines Outsourcing group within the BioTherapeutics Pharmaceutical Sciences organization of Worldwide Research and Development. Fi has more than 28 years of combined experience in research, development, and cGMP production of biological products and vaccines, and more than 8 years experience in outsourcing, project / contract management, and technology transfer to qualified third parties. Her areas of expertise include viral vectors and vaccine development, biotherapeutics and vaccine process development and cGMP production, project management, technology transfer, outsourcing, and budget and operations.
She obtained her Ph.D. in Microbiology from the University of Alabama in Birmingham, followed by postdoctoral research at the U.S. Army Medical Research Institute for Infectious Diseases, Sloan-Kettering Institute for Cancer Research, and Rutgers University Center for Advanced Biotechnology and Medicine. Prior to working for Wyeth / Pfizer in 1996, Fi was at The Salk Institute (Government Services Division), a vaccine contract manufacturer for the U.S. Army.
FSK Associates, Inc.
Frank S. Kohn is president of FSK ASSOCIATES, INC., an international consulting company providing services to the pharmaceutical, biotechnology, and vaccine industry. Frank worked for Wyeth, where he was Director of Manufacturing at the Sanford, N.C. location. Dr. Kohn has more than thirty years of industry experience working in various technical, quality, and management positions for Schering Plough Corp., Armour Pharmaceutical, Sanofi, and Wyeth Vaccines. He holds graduate degrees in environmental microbiology and operations management. In additional, he has taken additional courses in cGMP regulation and has had several years of direct contact with FDA and various Boards of Health. Frank is a Specialist Microbiologist by the National Registry of Certified Microbiology (American Academy of Microbiology). He was on the Publication/Internet committee of ISPE and chair of ISPE discussion forum on technology transfer. Also, he is Chair for the Vaccine Interest Group for PDA. Dr. Kohn is the co author of the book, “Isolation Technology in Pharmaceuticals: Selection, Validation and Use” and has presented numerous technical papers, seminars, and lectures. He is a frequent speaker and course leader in the U.S. and Europe. Frank has taught courses for the past fifteen years via The Center for Professional Advancement and PDA in US and Europe. He provides consulting services in microbial control, technology transfer, new technology, technical marketing support, GMP training, audits, cleaning validation, regulatory submissions and master validation planning.
Head, Drug Substance Development
Fred Porter, Ph.D. is the Head of Drug Substance Development at Novartis. He completed his Ph.D. and post-doctoral work in the field of virology at the University of Wisconsin, Madison. His experience in the field bioprocess development includes production and characterization of replication deficient adenovirus gene therapy vectors, development of production processes for Fc-fusion therapeutics and support of commercial launch for monoclonal antibody therapeutics. At Novartis he has led efforts to optimize numerous aspects of cell culture based influenza vaccine production and currently lead a multidisciplinary team responsible for bioprocess development of new viral vaccine candidates.
Professor, Chemical & Biochemical Engineering
Director, Center for Advanced Sensor Technology
University of Maryland, Baltimore County
Govind Rao is Professor of Chemical & Biochemical Engineering and Director of the Center for Advanced Sensor Technology at the University of Maryland, Baltimore County. He obtained his Bachelor of Science degree in Chemical Engineering from the Indian Institute of Technology, Madras. His Ph.D. degree was from Drexel University in Chemical Engineering. He has been a faculty member at UMBC since 1987.
Dr. Rao’s research has focused on applications of fluorescence spectroscopy to create novel low-cost sensors for bioprocess, biomedical and environmental applications. His lab has developed next-generation sensors for low-cost non-invasive monitoring of oxygen, pH and pCO2 in bioreactors. In addition, novel sensors for glucose and glutamine have been developed. These sensors have led to a paradigm shift in bioprocess technology, as they collectively enable High Throughput Bioprocessing. Recently, the Rao lab has started developing the next generation of sensors based on surface plasmon coupled fluorescence. These promise to lead to ultra-sensitive and ultra-fast sensors but at low-cost. In addition, novel low-cost sensors for water quality monitoring for third world applications are being developed. Recently, the research is focused on developing low-cost sensors for neonatal monitoring. He has published over 150 papers in professional journals.
He has received several awards. These include the Presidential Young Investigator Award from the National Science Foundation, Outstanding Teaching and Research Awards from UMBC, the Van Lanen Award from the American Chemical Society, the Gaden Award from Biotechnology & Bioengineering, the University System of Maryland Regents Award for Excellence in Research and he has been named a 2003 Innovator of the Year by the Maryland Daily Record. Dr. Rao has several patents and these have been licensed to Fluorometrix, which he co-founded. He serves as a consultant to several companies. Dr. Rao has served as the Chair of the Biotechnology Division of the American Chemical Society and on the Editorial Board of several prominent journals. He is currently an Associate Editor of Biotechnology & Bioengineering. In 2007, he was elected as a Fellow of the American Association for the Advancement of Science. In 2009, he was named as Editor of the PDA Journal of Pharmaceutical Science and Technology.
Process and Risk Analysis
Greg Flexman has over 20 years in engineering and technical support of manufacturing. He has worked in a variety of automation, equipment design, and production troubleshooting/support roles. His current position is with the Process and Risk Analysis Technical Operations Support group of Grifols. He has a BS in Industrial Engineering from North Carolina State University and is a six sigma black belt.
Containment Technologies Group, Inc.
Mr. Rahe has over forty years experience in the pharmaceutical industry, four years in academia and twenty years plus in contamination control in pharmacy applications. At Eli Lilly, he headed up the technology group for advanced sterile processing and containment of hazardous drugs.
Chief Operating Officer
Hal Baseman is a Principal and Chief Operating Officer for ValSource LLC. Mr. Baseman has held technical and executive management positions with several operating and consulting companies. He is a member and the Co-Chair of the PDA Science Advisory Board, the Co-Chair of the PDA Risk Management for Aseptic Processing Task Force, the Co-Chair of the PDA Technical Report #22 (Aseptic Process Simulation) revision team, Co-Leader of the PDA Process Validation Interest Group, and a member of the PDA TRI Faculty. Mr. Baseman holds a Bachelor of Science Degree in Biology from Ursinus College in Collegeville, PA and a Masters in Business Administration in Management from La Salle University in Philadelphia, PA.
Director of Quality
FPC of Atlanta
Ira Mann leads nationwide Biotechnology, Pharmaceutical and Medical Device contingent and retained searches as the Director of Executive Search for FPC of Atlanta. With more than 13 years in the recruiting industry, Ira is an expert at placing top professionals in the Quality, Validation, Regulatory Affairs, Cold Chain, Environmental Monitoring and Sterilization specialties, and is strategically aligned with experts conducting searches in Engineering, R&D and Manufacturing Management.
He is particularly known for leading referral based searches, executive coaching, recruiting strategy, and career counseling. Ira upholds a continuing commitment to ethics, honesty, and professionalism in executive recruiting. He has been a valued partner to many industry leaders throughout the years, and his clients frequently cite his depth of industry knowledge, high integrity, and skill at finding top talent for hard-to-fill and extremely specialized positions. His client and candidate network ranges from start-up and pre-clinical phase through multi-national industry leaders.
Ira hails from Queens County in NYC, earned his BS degree from SUNY Albany and has been living in Atlanta for over 15 years.
Director, Qualtiy Strategy
Ms. Skutnik-Wilkinson is the Director of Quality Strategy at Pfizer, in that role she is responsible for working with various trade associations and also developing Pfizer Positions on Quality and CMC issues on a global scale. Previously she was been the Leader of the Technical Affairs group at Pfizer.
She has over 15 years experience and expertise in compendial activities and quality and regulatory policy, spanning two companies. She has held a variety of positions spanning from responsibilities in documentation, change control, analytical method validation, and product launch.
Ms. Skutnik earned a Bachelors of Science from the University of Connecticut in 1994. Ms. Skutnik is currently Chair of the International Pharmaceutical Excipients Federation (IPEC Fed). Ms. Skutnik is past -Chair of the IPEC-Americas and served as Chair of IPEC Compendial Review/Harmonization Workgroup (1999 – 2007). She also represents IPEC as a member of the ICH Q3D (Elemental Impurities) EWG. She was Chair of PhRMA’s Compendial Liaison Team from 1998 – 2009, and is now the leader of the PhRMA Compendial Support Function; she is also the PhRMA Topic Leader for the ICH Topic – Q4B Regulatory Acceptance of Pharmacopoeial Interchangeability. She is a member of the PDA RAQAB (Regulatory Affairs and Quality Advisory Board), has severed on the planning committees and as a speaker for many PDA, IPEC, DIA, PhRMA and AAPS meetings.
Director, Validation Quality Assurance
Mr. Jeffrey L. Hartman has over 30 years experience in the Pharmaceutical industry, supporting API, pharmaceutical and vaccine manufacturing. His expertise spans all areas of validation (Cleaning, Sterilization, Process, Sterile/Aseptic Operations, and Computer/Automation) as well as regulatory science, facility start-up, and fermentation. Currently, Jeff is a Director in divisional validation Quality Assurance, MERCK. His responsibilities include development of Merck Manufacturing Division guidelines / policies, Quality System requirements and support of validation activities worldwide. With hands-on, consulting, and publication experience, he is considered a leading Subject Matter Expert within Merck.
Senior Director, Regulatory Policy and Intelligence
Dr. Finkbohner joined the regulatory affairs department at MedImmune in 2006 and led the regulatory support efforts for investigational vaccine development for nearly six years. In early 2012, he transitioned to leading the Regulatory Policy and Intelligence function at MedImmune where he is responsible for driving regulatory policy development and advocacy in the US region in cooperation with key stakeholders across the Global Regulatory Affairs organization with particular focus on articulating a consolidated view on regulatory issues relevant to the biologics business. In this role he engages external trade organizations, such as BIO and PhRMA, and he led the regulatory team in developing MedImmune positions around PDUFA V reauthorization and served as an innovator industry representative during the BSUFA negotiations with the FDA. In the broader professional community, he is an adjunct on the graduate program faculty at Johns Hopkins University and serves on the Board of Directors for the Parenteral Drug Association (PDA) after being an active member for many years. In addition, he holds US certification from the Regulatory Affairs Professional Society (RAPS) and has presented at conferences, published articles, and contributed book chapters in the arena of biopharmaceutical and vaccine production.
Prior to joining MedImmune in May 2006, Dr. Finkbohner served in the FDA for 13 years as a CMC reviewer and establishment inspector with increasing levels of authority. His last position in FDA was with CBER as Deputy Director of the Division of Manufacturing and Product Quality with responsibilities in oversight of CMC and ED section reviews for BLAs, conduct of pre-approval inspections for biologics, the CBER lot release program, and policy development in the biologics manufacturing arena. Prior to joining the FDA, Dr. Finkbohner performed research in protein purification and characterization using both microbial and invertebrate model systems and held a faculty position with the University of Maryland, University College. Dr. Finkbohner received his bachelor's degree from the University of Central Florida, and both his masters and doctoral degrees from The Pennsylvania State University.
Sr. Manager / Team Leader Pfizer, Inc.
John is currently Sr. Manager/Team Leader in Pfizer’s Global Quality Operations responsible for providing microbiology and aseptic manufacturing technical support to manufacturing sites worldwide. He began his career in the pharmaceutical industry as a Research Scientist with The Upjohn Company responsible for development projects in the areas of Process Analytical Technology (PAT) and visual inspection. With the formation of Pharmacia and Upjohn, he became the Director of Technical Support and Engineering with responsibility for sterile and non-sterile technology transfer and process improvement, package engineering, automation and documentation. He was subsequently promoted to the position of Business Unit Director of the Center for Advanced Sterile Technology (CAST), Pharmacia’s sterile isolator production facility. John holds a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University. He is an active member of the Parenteral Drug Association (PDA), having served on the Board of Directors (2003-2011) and as Chair (2008-2009) and currently serving as Chair of the Science Advisory Board (SAB) and the leader of the Visual Inspection Interest Group. He is also an instructor at PDA's Training and Research Institute (TRI). John serves on the USP Dosage Forms Expert Committee and Visual Inspection of Parenterals Expert Panel. He is also a member of the American Chemical Society (ACS). He has published and presented numerous papers on the subjects of spectroscopic analysis, process analytical technology (PAT), rapid microbiological test methods and visual inspection of pharmaceutical products.
Vice Chair, Department of Neurosurgery
Director, Surgical Neuro-oncology
Medical Director, Brain Tumor Center
Neurosurgical Director, Gamma Knife Program
John S. Yu, MD is the Director of Surgical Neuro-oncology, Medical Director of the Brain Tumor Center, and the Neurosurgical Director of the Gamma Knife Program at Cedars-Sinai Medical Center. He is Vice Chair in the Department of Neurosurgery. An internationally renowned neurosurgeon, Dr. Yu's clinical focus is on the treatment of malignant and benign brain and spinal tumors. He is also conducting extensive research in immune and stem cell therapy for brain tumors.
Dr. Yu is currently the Principal Investigator of immune therapies to treat patients with malignant brain tumors. His National Institutes of Health -funded laboratory studies stem cell therapies for neurological disorders and mechanisms of stem cell tropism and cancer stem cell invasion.
In 1996, he received the Academy Award from the American Academy of Neurological Surgery at its annual meeting. That same year, he presented his research on immunologic gene therapy for brain tumors at the American Association of Neurological Surgeons.
Dr. Yu has published articles in several prestigious journals, including The Lancet, Cancer Research, Stem Cells, and Journal of Neurosurgery. He is the editor of Cancer Stem Cells from Humana Press.
Dr. Yu earned his bachelor's degree from Stanford University and spent a year at the Sorbonne in Paris studying French literature. He completed his fellowship in immunology at the Institut Pasteur in Paris. He earned his medical degree from Harvard Medical School and master's degree from the Harvard University Department of Genetics. He completed his neurosurgical residency at Massachusetts General Hospital in Boston. In addition, he was a neuroscience fellow at the National Institute of Mental Health in the Neuroimmunology Unit at Massachusetts General Hospital, and he was a Culpeper Scholar at the Molecular Neurogenetics Unit at that hospital. Other honors include the Preuss Award, Joint Section on Tumors, American Association of Neurological Surgeons and Congress of Neurologic Surgeons.
Director, Quality Engineering
DSM Pharmaceuticals, Inc
Johnnie W Williams is a Director of Quality Engineering/Quality Systems at DSM Pharmaceuticals, Inc. Prior to this position, Johnnie was Director of Manufacturing Quality Assurance-Steriles, where he was responsible for manufacturing oversight. Prior to joining DSM in 2011, he was the Six Sigma Manager for Hospira and held various positions in Quality Assurance with Abbott Laboratories.
Johnnie holds a B.S. in Industrial Technology from Elizabeth City State University, M.S. in Industrial Technology from East Carolina University. He is a certified Six Sigma black belt and Lean facilitator.
Merck Sharp & Dohme Corp.
Ms. Bloomfield has been with Merck Sharp & Dohme Corp. since 2008 in the Merck Manufacturing Division. She has held multiple positions in the pharmaceutical industry responsible for providing strategic direction in Global GMP Systems and Compliance, Quality Operations and Quality Management Systems. She was previously head of External Manufacturing Quality Assurance and Quality Management Systems at Merck. She directed the development and implementation of a new harmonized Quality Management System after the Schering Plough and Merck merger. Most recently, she has responsibility for several divisional Quality Assurance groups including Quality Management Systems, Global Regulatory Surveillance, Auditing, Labeling, Stability, Computer and Process Validation where she has oversight of global quality and compliance standards. She has more than 22 years combined pharmaceutical, consulting, and regulatory expertise where she provided strategic and technical solutions to senior management on complex regulatory, compliance and cGMP issues for pharmaceutical, medical device and biologic companies. Ms. Bloomfield has held executive roles in Cardinal Health’s Pharmaceutical & Technology Services, and Corporate Quality Compliance Branch, was a Senior Consultant with KMI/PAREXEL Consulting, a Compliance Officer in CDER’s Division of Manufacturing and Product Quality, and a Parenteral Drug Investigator with FDA’s ORA. She holds a B.A. degree from Murray State University and is a certified Medical Technologist of the American Society of Clinical Pathology.
Merck Sharp & Dohme
Julia O’Neill is responsible for the development and installation of Continued Process Verification for all Merck vaccines sites. Her team integrates data management, analytic expertise, and process knowledge, to identify opportunities and drive improvements in supply reliability. She is a certified Master Black Belt with degrees in Chemical Engineering (B.S., University of Maine) and Statistics (M.S., University of Wisconsin). Her previous experience includes over 20 years of process engineering and statistical support for specialty chemicals and paper manufacturing. Julia is a Senior Member of the American Society for Quality (ASQ), a member of the American Statistical Association, a Past Chair of the Chemical & Process Industries Division of ASQ, and serves on the Editorial Board for Quality Engineering. She is a three-time winner of the Shewell Award for best presentation at the Fall Technical Conference of the ASA and ASQ, and recipient of the 2004 Irwin S. Hoffer Award presented by the Philadelphia Section of the ASQ for significant contribution to the understanding, application, and promotion of the philosophy of Statistical Thinking to improve business processes. She draws on her extensive network and experience in process monitoring to introduce methods not yet commonly employed in pharmaceuticals. She is recognized for leadership of successful complex investigations within Merck, based on extracting information from data to build consensus and determine directions for action. Julia has developed and taught many workplace courses on statistical methods for process improvement, design of experiments, and data mining, as well as a Six Sigma course as Adjunct Professor din Drexel University’s Department of Decision Sciences.
Micro-Reliance LLC Ken Muhvich is the Principal Consultant for Micro-Reliance LLC, which specializes in Microbiology and Regulatory Compliance Consulting. He has more than 35 years experience as a microbiologist. Prior to formation of Micro-Reliance in 2002, Ken was Senior Vice President of Regulatory Compliance for The Validation Group, Inc. During his four years at TVG Inc. he provided sterility assurance advice to more than seventy pharmaceutical companies. He has conducted numerous Pre-Approval type audits of sterile manufacturing facilities, including their microbiology laboratories.
He is also frequently involved in guiding companies in sterile process design and validation. He is often called upon to investigate batch sterility failures or to review completed sterility failure investigations. From 1992 to 1997 Ken was a Review Microbiologist at the U.S. Food & Drug Administration’s Office of Generic Drugs. While at the FDA, he performed more than six hundred sterility assurance reviews. He is a recognized expert in aseptic processing of sterile drug products. He holds a Bachelors degree in Health Science from the University of Delaware. He holds a Masters degree in Medical Microbiology from West Virginia University. He supervised the Clinical Microbiology Laboratory at Sinai Hospital in Baltimore, Maryland for a decade. He holds a Doctor of Philosophy degree in Experimental Pathology from the University of Maryland. He has recently served as member of Scientific Advisory Board of the Parenteral Drug Association and is Co-Leader of their Sterile Processing Interest Group.
Sterilization Technology and Compliance
Over 34 years of Pharmaceutical Engineering experience and prior to retiring from Hospira, he had global responsibility for the selection and application of sterilization technology for aseptic and terminally sterilized drugs and devices. His background includes the implementation of process equipment and controls related capital projects for pharmaceutical water systems, solution preparation/delivery systems, filling systems (including Isolators), sterilizing equipment and lyophilization systems. Has significant experience with aseptic and terminally sterilized parenteral IV solutions in flex, rigid and plastic containers. He is a member of various PDA task forces and has conducted numerous training sessions for PDA, FDA and others.
Manger of Laboratory Services and Validation
Meissner Filtration Products, Inc.
Leesa McBurnie is the Manger of Laboratory Services and Validation for Meissner Filtration Products, Inc. She has worked in laboratories for over thirty years, the last 17 involved with filter validations with Meissner. She is a California licensed Clinical Laboratory Scientist and a member of the Canadian Society of Medical Laboratory Science. Leesa holds a B.Sc. in Biology from the University of Toronto and an MLT from the Michener Institute. Leesa is an active member of ISPE and PDA. Current projects for PDA include the SIP Task Force and the Mycoplasma Task Force.
Vice President Business Development
G-Con Manufacturing LLC
With over 25 years of experience, Mr. Jornitz supports the biopharmaceutical industry on a world-wide basis, in particular in process and facility design, single-use technologies, membrane filtration of air and liquids. As Immediate Past Chair of PDA, Jornitz has been part of multiple PDA task forces (TR #26, #40, #41 and#45), committee member (Awards, Journal Editorial, Strategic Planning, Chapter) and committee chair (PDA Annual 2008, Strategic Planning). He is also member of ISPE, DIA and ASTM. Jornitz is the author and co-author of over 100 scientific papers. Additionally he is author and co-author of 9 books, for example Filtration and Purification in the Biopharmaceutical Industry, and 12 book chapters on aseptic process, single-use technologies and regulatory requirements. As faculty member of PDA TRI and Compliance Online, he trains industry members and regulators on a frequent basis. He holds over 30 patents related to single-use equipment, integrity testing and filter housing designs and is the founder of Bioprocess Resources LLC. Mr. Jornitz received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished his PED at the IMD Business School, Lausanne, Switzerland.
Director of Marketing – Filtration Technologies, North America
Sartorius Stedim Biotech
Mandar Dixit has over 17 years of experience in filtration and separation technologies. He currently supports the North American Biopharmaceutical market for Filtration Technologies with special focus on Sterilizing Grade Filters, Prefilters & Air/vent filters. He is a member of PDA and ISPE. Mr. Dixit has co-authored papers in trade journals on Prefiltration as well as Filter Optimization and Scale-up studies. He received his Bachelor's Degree in Chemical Engineering from IIT-Bombay in India and his Master's Degree in Chemical Engineering from Louisiana State University in Baton Rouge, Louisiana.
Senior Vice President, Quality
Martin VanTrieste is the senior vice president of Quality at Amgen. He is responsible for all aspects of Quality Assurance, Quality Control, Compliance, Environment, Health and Safety along with Training at Amgen.
Prior to joining Amgen, 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 (now known as Hospira). While at Abbott, VanTrieste held various positions in Quality, Operations, and Research and Development. He started his career at Abbott in 1983 after obtaining his Pharmacy degree from Temple University School of Pharmacy.
VanTrieste has been actively involved with various professional and trade organizations, including United States Pharmacopeia (USP), Pharmaceutical Quality Research Institute (PQRI), Pharmaceutical Research and Manufacturers of America (PhRMA), and AdvaMed, and he is a member of the Board of Directors of the Parenteral Drug Associations (PDA). He partnered with PDA, PQRI, and the U.S. Food and Drug Administration (FDA) on the development and roll out of the FDA Aseptic Guidance Document and its related compliance tool. Currently, he is actively participating in the formation of Rx-360, a nonprofit international supply chain organization that will enhance patient safety by increasing the security and quality of all parts of the supply chain.
Marty Nealey is currently Vice President of Operations and Plant Manager for Hospira responsible for the Rocky Mount, NC manufacturing site. Marty joined Hospira in January 2012 bringing 24 years of experience from the Pharmaceutical Industry in the areas of Quality, Process Development, Engineering, Facility Management, Contract Operations, and Manufacturing Site Leadership.
Abbott Medical Optics Inc.
Dr. Miguel Nogueras is currently the global manager of Quality Assurance-Microbiology for the division of ophthalmic products for Abbott Laboratories (Abbott Medical Optics). Miguel Nogueras served in the capacity of the director of the division of microbiological and virology testing at BioReliance® after serving in the capacity of lead microbiologist at AMGEN and Genentech (Tanox, Inc). Miguel has extensive experience in the clinical pharmaceutical/biotech industry, specifically in the creation and implementation of microbiological, diagnostics and quality systems in support of production of parenteral drugs, medical devices, clinical and product development. He is very knowledgeable of areas such as: Aseptic processing, Final Sterilization, Clinical Diagnostics, Viral pathology, Microbial Identification, Environmental Controls, Start Up of New Laboratories & Production Facilities. In addition Miguel has vast experience in the areas of assay development and final product testing within the areas of Virology, Bacteriology, Mycoplasma and Sterility testing. He has provided support to different institutions including but not limited to: development, improvement and implementation of cGCP, cGTP, cGLP and cGMP; quality systems; cGMP and cGLP improvements plans, preparation of manufacturing sites for regulatory, health agencies and notified body inspections. As a member of the quality and compliance organization Dr. Nogueras has aided in leading investigations, BPDRs and MDRs for root cause analysis and implementation of CAPA programs and Compliance, in addition to field actions.
Monica Cardona has been with the Pall Corporation for 15 years. She worked as a laboratory analyst and as a senior laboratory analyst in the Microbiology laboratory. She then joined the Validation group as a Validation Project Manager for compatibility and extractables projects. Today, Ms.Cardona is a Marketing Product Manager with Global Responsibility for air/vent filtration and responsibility for virus filtration in the Americas. She holds a Bachelors in Biology from Hofstra University and a Masters in Biology from Adelphi University.
Ms. Cardona publishes & lectures internationally on a wide range of separation, purification and filtration topics.
Research Fellow Bausch & Lomb Pat McCormick has been with Bausch and Lomb, Inc. since 1998 in Research & Development responsible for sterilization supporting the Vision Care, Pharmaceutical, and Surgical divisions. Prior to joining Bausch & Lomb he was with Getinge where he was responsible for the development of sterilization processes and monitors. He has thirty years of experience in industrial and healthcare sterilization and participates on various sterilization committees including AAMI/ISO and CSA. He has published several book chapters, papers, presentations, and patents relative to sterilization, rapid microbiological methods, the cleaning of surgical instruments and biological indicators. He has a Ph.D. from the University of Notre Dame and BS degree from Villanova University. He currently serves as co-chair of CSA Z262.25 Technical Subcommittee on Biological Indicators and co-chair of AAMI WG13 Washer-Disinfectors and participated on the ASCSR TASS Task Force on Ophthalmic Sterilization.
Field Applications Scientist
Azbil BioVigilant, Inc. (ABV)
Peter Noverini is a Field Applications Scientist at Azbil BioVigilant, Inc. (ABV), a company focused on delivering real-time detection technologies to empower users in the pharmaceutical and life science industries. He joined the company in 2010 after working for over ten years in the parenteral drug and medical device industries, specializing in the microbiological aspects of environmental monitoring, bioburden in evaluation, and validation of sterilization processes. The Applications Engineering group at ABV (a subsidiary of Azbil Corporation) acts as the technical liaison between internal teams, test facilities, end-users, and regulatory bodies, synthesizing the knowledge base crucial for IMD-A implementation. This knowledge base includes the fields of aerosol science and testing, environmental monitoring and regulations, RMMs and pharmaceutical applications, optics and fluorescence research, microbiology, and statistics. Peter graduated with a degree in General Biology from the University of Illinois at Urbana-Champaign.
ESBATech, a Novartis company LLC
Dr. Steiner is a Director at ESBATech, a Novartis company LLC which is a member of the Novartis Institutes for Biomedical Research (NIBR). After joining in 2004 as Senior Scientist Fermentation, he established and headed the Production & Processes group that is responsible for development of microbial manufacturing processes, analytical method development and production of early clinical trial material for ESBATech’s single-chain antibody fragments (scFv). His responsibilities cover high-throughput production of product candidates, process development and pilot manufacturing as well as tech transfer, scale-up and CMO management for scFv production under GMP.
Previously, Dr. Steiner headed the Metabolic Engineering group at Insilico Biotechnology working on metabolic engineering and in-silico modeling of microbial and mammalian production systems. He holds a PhD in Biology from the Swiss Federal Institute of Technology.
Senior Director, External Affairs and Biosimilar Strategy
Pfizer BioTherapeutics Pharmaceutical Sciences
Robert Repetto is Senior Director, External Affairs, Technical Advocacy function focused on industry and regulatory trends that enable the BioTherapeutics and Vaccine portfolio. Robert also leads Pfizer’s contract manufacturing strategy for Biosimilar’s.
Technical Advocacy Topics of interests include: Single Use Systems, QbD, Risk Management, Biosimilar, and Innovative new therapies.
Prior to this position Bob was Director of Technology and Innovation for Wyeth Biotech, where he was responsible for development of strategies focused on new technologies, innovation, risk management, process technology, and real time process monitoring. Robert has over 20 years of process development, manufacturing and clinical production experience with mammalian, insect and bacterial expression systems. He holds a B.E. in Chemical Engineering from Manhattan College, M.S. in Bioengineering from Polytechnic University of New York, and a MBA from Iona College.
Robert is Chairman of the PDA’s Global Taskforce for Single Use Systems.
The Williamsburg Group, LLC
Mr. Madsen is President of The Williamsburg Group, LLC, Gaithersburg, Maryland, engaged in pharmaceutical consulting in the areas of CGMP compliance and auditing, quality systems, design review, aseptic processing and sterilization technology, sterile filtration, due diligence evaluation, process validation, regulatory liaison and general technical services. Most recently, he had served PDA as Acting President and was Senior VP Science and Technology, responsible for the overall scientific, technical and regulatory affairs activities of the association. Before joining PDA, he was employed by Bristol-Myers Squibb Company as Director, Technical Services, providing technical and general consulting services to Bristol-Myers Squibb pharmaceutical, medical device, nutritional, and cosmetic operations, worldwide. He currently is Vice-Chairman of ASTM E55.03 General Pharmaceutical Standards, serves as a member of the USP Microbiology Expert Committee, is Chairman of the USP Visual Inspection of Parenterals Expert Panel, is a member of Pharmaceutical Technology’s Editorial Advisory Board and is a member of PDA’s Science Advisory Board. Madsen holds a B.S. from St. Lawrence University and a M.S. in Chemistry from Rensselaer Polytechnic Institute.
Scott Bozzone is a Senior Manager in Quality Systems and Technical Services-Validation for Pfizer in New Jersey. He has been at Pfizer for 26 years in Quality Operations and Research- Process Development, spending over 4 yrs in the Global Employee program. He possesses a doctorial degree in industrial pharmacy from St. Johns University. Prior to Pfizer, Scott worked at Revlon Health Care Group (Armour/USV) for several years. He is also the author or co-author of two book chapters (one in print) and an article on process validation.
In his current position he is responsible for site support and guidance concentrating on cleaning and process validation, and leads Pfizer’s global Validation Community of Practice.
Head of Bioprocesses
Thierry Ziegler has been working with sanofi since 2009 as Head of Bioprocesses within the Biologics Platform located in Vitry sur Seine (France). The Bioprocesses department is in charge of the generation of stable mammalian cell lines, Upstream and Downstream process development as well as material supply to support preclinical studies for monoclonal antibodies and recombinant proteins. His previous assignments were Head of Cell Culture Unit, then Head of Process Development at Merck-Serono. Thierry has a strong expertise in early process development for recombinant proteins and especially with regards to fast-track process set-up, generic platform development in both upstream and downstream fields.
He holds a PhD degree in Mechanical Engineering from the Georgia Institute of Technology (USA) with strong emphasis on Bioengineering.
Scientific and Regulatory Affairs
Parenteral Drug Association
Vince Anicetti is a Fellow in Scientific and Regulatory Affairs with the Parenteral Drug Association. He is also an Adjunct Professor with the Keck Graduate Institute (KGI) of Applied Life Sciences teaching in the area of Biopharmaceutical Quality. Prior to joining PDA and KGI, Vince enjoyed a highly successful 30-year career with Genentech. During this time Vince held a variety of leadership roles within Genentech and pharmaceutical professional associations. Most recently, he served as Head of Biologics Quality for the Roche/ Genentech Biologics’ manufacturing network comprising 10 large-scale Biotech product sites in North America, Europe and Asia. In this role Vince was responsible for Quality Assurance and Quality Control operations at each site and regulatory compliance to cGMP’s. Prior to this role in Quality, Vince was a key leader in Product Development and Regulatory Affairs Vince has worked closely with regulatory agencies in the development and approval of new biotech products and application of cGMP (current Good Manufactur- ing Practices) for Biotech operations. Vince Anicetti holds a BS in microbiology and MS in clinical chemistry from San Francisco State University. He serves as an editor/reviewer for BioQuality, and is a past chairman and member of the Executive Committee of the Parenteral Drug Association (PDA). Currently, Vince is leader of the PDA Biotech Interest group, an editor of the PDA letter, and Co-chair of the 2012 PDA Annual Meeting Program Planning Committee.