David L. Jones, PhD
Rapid Micro Biosystems
Biochemistry degree from Brunel University in London and a PhD in steroid endocrinology from London University. Work experience split between product development for the diagnostics industry specializing in tangential flow technology combining instrument to wet chemistry interaction with Unipath and Anagen then rapid microbiology with Chemunex in Paris, Wyeth Biopharma in Dublin and the last 16 years with Rapid Micro Biosystems in Boston where he is Director of Industry Affairs. Was a team member for TR33 Rapid Methods document.
Maik W. Jornitz
G-CON Manufacturing, Inc.
Maik W. Jornitz, President and CEO of G-CON Manufacturing Inc., is a 35-year veteran of the industry. He is a highly experienced in single-use bioprocesses, aseptic processing, and a subject matter expert in sterilizing grade filtration. He has published multiple books and book chapters and over 100 scientific papers on various bioprocessing and facility design topics. He is the former Chair of the PDA Board of Directors and Science Advisory Board, and member of multiple PDA Task Forces, including the EU Annex I response team. He is working member of ASTM E55, an advisory board member of the Biotechnology Industry Council, ICAV, Bondwell and board member of DIANT Pharma and Sunflower Therapeutics. As a faculty member of various training activities, including PDA TRI, he trains members of the industry and regulatory authorities frequently.
Before joining G-CON end 2012, he worked 26 years for Sartorius, with his last role being the SVP for Global Product and Marketing Management Bioprocess. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.
Stefan R. Kappeler, PhD
Exyte Central Europe GmbH
Dr. Stefan R. Kappeler works for the Exyte Global Business Unit as Senior Director Biopharma & Regulatory. After obtaining a PhD from the Swiss Federal Institute of Technology in Zurich in molecular biotechnology, he conducted various industrial projects in the areas of molecular biology and biochemical research, clinical trial development, biotechnological process development, technology transfer, upstream and downstream manufacturing of biologics, quality control and assurance, as well as plant planning and design, commissioning and qualification.
He has been involved in bioscience for over 30 years and is a recognized expert in the field. His main interests are trends in pharmaceutical research and development, the implementation of advanced technologies in pharmaceutical production, the understanding and appropriate implementation of regulatory requirements, as well as future-oriented plant concepts.
Ulrich Köllisch, PhD
Dr. Ulrich Koellisch has been on the forefront of the data integrity initiatives and in his previous 6 years has supported many organizations in the pharmaceutical and biotech sector executing Data Integrity campaigns. Ulrich has experience in consulting for audit preparation and conduction in the GMP and the GCP area, is co-heading a PDA special interest group and is an active participant in other industry knowledge groups.
Kelvin H. Lee, PhD
National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
Kelvin H. Lee is Gore Professor of Chemical and Biomolecular Engineering at the University of Delaware and is Director of NIIMBL: the National Institute for Innovation in Manufacturing Biopharmaceuticals, one of 16 Manufacturing USA Institutes. He previously served as Director of the Delaware Biotechnology Institute. He received a BSE in Chemical Engineering from Princeton and PhD in Chemical Engineering from Caltech. He spent several years in the Biotechnology Institute at the ETH in Zurich, Switzerland and also completed a postdoc in Caltech's Biology Division. Prior to his current appointment, he was on the faculty at Cornell University where he held the titles of: Samuel C. and Nancy M. Fleming Chair Professor, Professor in the School of Chemical and Biomolecular Engineering, Director of the Cornell Institute for Biotechnology, and Director of the New York State Center for Life Science Enterprise. He has been recognized with a number of awards including: AIMBE Fellow, AAAS Fellow, Fellow of the National Academy of Inventors, Inaugural Winner of the American Electrophoresis Society Lifetime Achievement Award, AIChE Professional Progress Award, Biotechnology and Bioengineering Elmer Gaden Award, and the ACS BIOT Marvin Johnson Award.
John Lewin, III, PharmD, MBA, BCCCP, FASHP, FCCM, FNCS
On Demand Pharmaceuticals Inc.
Dr. Lewin is the Chief Medical Officer of On Demand Pharmaceuticals (ODP). ODP is an innovative company transforming how medicines are made, creating a fully automated, deployable, on-demand capability that does not exist anywhere in the world today. He is also an associate professor of anesthesiology & critical care medicine at Johns Hopkins where he maintains a part-time clinical pharmacy practice in the neurosciences critical care unit. Dr. Lewin was previously the director of the Critical Care & Surgery pharmacy at Johns Hopkins for 11 years, and has held clinical specialist positions at Johns Hopkins and University of Maryland Shock Trauma Center. Dr. Lewin earned his PharmD degree from Temple University School of Pharmacy and his MBA from Johns Hopkins. He completed a PGY1 and PGY2 critical care residency at the Medical University of South Carolina. He has over 19 years of critical care pharmacy experience, with a primary focus on neurological critical care, and is a board certified critical care pharmacy specialist. He is a past-president of the Maryland Society of Health-System Pharmacists, and has been recognized as a Fellow of the American Society of Health-System Pharmacists, the American College of Critical Care Medicine and the Neurocritical Care Society.
Morcos Mikhail Fahmy Loka, MBA, CMQ/OE, CQA, CPGP, CPIP
Morcos Loka, CMQ/OE, CQA, CPGP, CPIP Morcos Loka is Training Manager & GMP Advisor at Minapharm. Over 20+ years, Morcos played different production and quality roles in pharmaceutical & biopharmaceutical industry. His experience includes manufacture of sterile and non-sterile products, handling of regulatory and customer audits, conducting internal & supplier audits, GMP gap analysis, GMP training, GMP consultation, establishing quality management system, management review, quality metrics, establishing quality risk management system, QRM studies including manufacturing of HPAPIs in shared facilities and design of pharmaceutical and biopharmaceutical manufacturing facilities. Morcos has B.Sc. in Pharmaceutical Sciences, two postgraduate diplomas in Total Quality Management (TQM) and Train of Trainer (ToT) and four professional certificates: ASQ Certified Manager of Quality / Organizational Excellence (CMQ/OE), Certified Quality Auditor (CQA) & Certified Pharmaceutical GMP Professional (CPGP) and ISPE Certified Pharmaceutical Industry Professional (CPIP). Morcos is ASQ, ISPE and PDA member. He participated in different ISPE and PDA publications. He also participated as a speaker in different IVT, PDA and ISPE pharmaceutical industry conferences.
Paul Lopolito is a senior technical services manager for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). He currently provides global technical support related to process cleaning, cleaning validation and contamination control, which includes field support, site audits, training presentations and educational seminars. Paul has over 25 years of industry experience and has held positions as a technical services manager, manufacturing manager and laboratory manager. Paul is a frequent speaker at industry events and has published several articles and book-chapters related to cleaning validation and contamination control. He earned a B.A. in Biological Sciences from Goucher College in Towson, MD.
Bruce is a Senior GMP Compliance Advisor working for GSK Vaccines. In addition to providing compliance advice and quality assessments to the business, he also provides regional and global auditing services for GSK Vaccines and third party provider sites and functions.
Bruce has 30 years in the Pharma and Vaccines businesses, variety of roles in Validation and Compliance in both Drug Substance and Drug Product Manufacturing in UK, France and Singapore.
Bruce has been a PDA Singapore Chapter member since 2014. Since February 2020 he has been PDA Singapore Chapter President
Bruce holds a Bachelor in Applied Science (Applied Chemistry) from Curtin University of Technology, Perth, Australia
Alex Lyness, PhD
West Pharmaceutical Services, Inc.
Dr Alex Lyness joined West in 2016 and is based at the Global Headquarters in Exton, PA. He is responsible for identifying and evaluating new technologies and ideas that are transformational to West’s core drug containment and delivery platforms. He leads a dynamic interdisciplinary research team that collaborate internationally with high-calibre academic institutions and medtech start-ups to bring their technologies from potential, through feasibility to be integrated into next generation drug delivery systems.
Prior to West, Alex worked at Loughborough University after being awarded an Enterprise Fellowship and led the research and development of several delivery systems intended to deliver regenerative medicines. Whilst in academia he also consulted for 2 years as a Technical Lead on a collaborative-project with Cell and Gene Therapy Catapult (London) that led to a CE-marked, patented a device capable of delivering cells to the upper layers of the skin to treat a rare genetic disease.
He gained his PhD in Mechanical Engineering whilst working as a Medical Device Engineer at Glide Pharmaceutical Technologies (Oxford) where he optimised their needle-free solid dose injection system that was later shown to be successful at a clinical trial. Alex is a Chartered Engineer with the Institution of Mechanical Engineers.
Steven Lynn, MS
Regulatory Compliance Associates Inc.
Steven Lynn has 24 years of quality & regulatory compliance experience in the pharma, biopharma, medical device, and biologics industries. He served <br>in executive leadership roles with global accountability in both the private sector, as well as at the U.S. FDA. Steve is an expert in GxPs. He is currently the Executive VP of Pharmaceuticals at Regulatory Compliance Associates (RCA). Before consulting, Steve was the VP, Global Head of Corporate GxP Compliance & Audit at Novartis AG. Prior to Novartis, Steve was the VP of Global Quality Compliance at Mylan, Inc. Steve also spent nearly a decade at the FDA in roles of increasing responsibility, including the Office Director of the CDER's Office of Manufacturing and Product Quality, where he was responsible for the global CGMP oversight of all drugs manufactured and/or imported into the U.S. Additionally, he was the Operations Transition Lead for CDER’s Office of Pharmaceutical Quality reporting to CDER’s Center Director where he was responsible for setting up OPQ operations. Steve has a BS in Biology and a MS in Quality Systems Management. He is an Eagle Scout, Senior Member of the American Society for Quality and an Excellence in Government Program Senior Fellow.
Toni is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-chair of the Biomanufacturing IG and co-chair of the CPV of the Future initiative at the PDA, active collaborator in the AI initiative for AFDO and he teaches AI subjects at the Universities (UAB and OBS), member of the Science Experts in the Spanish Parliament on big data and artificial intelligence topic and collaborator with the UN in AI subjects. He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud. Toni is Physicist, Master in Information and Knowledge Society and post graduated in quality systems for manufacturing and research pharmaceutical processes.
Kevin J. McMurtrie
Veltek Associates, Inc.
Kevin McMurtrie is the Global Business Manager for VAI’s Documentation, Transfer Systems, and RFID Tracking Solutions division. Kevin has been with VAI since 2016, and was specifically brought on board to promote and grow these specialty lines. Kevin’s primary focus with these product lines, is to help VAI become more of a total-solutions-provider to the pharma-biotech industry. VAI continues to increase their horizontal product offerings into the cleanroom space, and Kevin is there to support Veltek account managers, VAI distributors, and VAI clients in all areas related to Core2Write, Cart2Core, and Core2Scan.
Jeanne E. Moldenhauer, MS
Excellent Pharma Consulting
Jeanne Moldenhauer has been a frequent speaker at PDA. She has authored many books and articles' for PDA and other organization. She is a former member of the Science Advisory Board and a current member of the RA/QA Board. She has worked in the pharmaceutical industry for over 25 years and has been very involved with new methods, technologies, and processes.
Jason J. Orloff, ChE
Jason J. Orloff, Chemical Eng & M.S. Applied Statistics, has worked in the pharmaceutical industry since 1999. He is the Principal Statistician at PharmStat, which he started in 2010. Most recently he consulted with the World Health Organization on implementing QbD in vaccine manufacturing development. He specializies in CMC statistics and the design of experiments for development, quality assurance, quality control, validation, and production under the cGXP's. Current activities include an author of ISPE’s Baseline Guide for Q10 chapter “Process Performance and Product Quality Monitoring”, contributing authorship of the PDA’s Technical Report 59 on “Utilization of Statistical Methods for Production and Business Processes”, and publications in the Journal of Pharmaceutical Technology. Areas of expertise include Sampling, OOS, SQC, SPC, assay validation and setting specification criteria. A Chemical Engineer with real-life expertise at applying statistics in a highly regulated environment, Mr. Orloff is able to work effectively across all levels of an organization as well as make high level concepts accessible to a variety of audiences. Mr. Orloff has worked with a wide variety of companies including parenterals, solid oral dose, capsues, biotechnology, fine chemicals, medical devices, food, and nanotechnology.
Doug Paradis, MS
Veltek Associates, Inc.
As CTO, Doug is responsible for helping Veltek launch a series of software and technology products that support their mission to enable biotech companies to successfully develop and manufacture their products. Veltek utilizes leading edge technologies to monitor, control, and track key elements of the pharma/biotech development process allowing customers to remain compliant and focus on the life changing solutions.
Prior to Veltek, he has spent his career developing innovative technology solutions for life science and other industries utilizing leading edge technologies to transform how business gets done. Doug graduated from University of Michigan with a BS in Aerospace Engineering and later received a MS degree in Systems Engineering from the University of Pennsylvania.
Nitin Rathore, PhD
Nitin Rathore, Ph.D., is currently an Executive Director of Drug Product Technologies, Process Development organization at Amgen Inc., Thousand Oaks, California. Dr. Rathore has over 15 years of experience in process development and leads the late stage drug product development group at Amgen including biologics, synthetic and biosimilar portfolio. His function focusses on commercialization of Amgen’s multi-modality portfolio covering formulation development, process design, technology transfer and new product launches. Dr. Rathore also has experience in advancing next-gen technologies including automation and digital technologies both in development and manufacturing space. He has authored numerous publications including original research articles, book chapters and scientific presentations on drug product development and innovation in biomanufacturing. Prior to Amgen, he worked in the process optimization group at Novozymes, North America. Dr. Rathore received his Ph.D. degree in Chemical and Biological Engineering from University of Wisconsin-Madison, Madison, WI.
Sabrina Restrepo, PhD
Merck & Co., Inc.
Sabrina's responsibilities at Merck have included technical operations support in several areas such as deployment of single-use systems in vaccine manufacturing, process improvements, technical collaborations with single-use systems’ suppliers, regulatory remediation plans, vaccines localization technology transfers, cell culture media and drug substance manufacturing. She is the recipient of the 2018 Frost & Sullivan Manufacturing Leadership Award in the Engineering and Production Technology Leadership category for the Design, Evaluation and Implementation of Single-Use Components for Ebola Zaire Vaccines Drug Substance Manufacturing, 2020 PDA Distinguished Service Award and 2020 Merck Manufacturing Science & Technology Big Innovation Award. Currently, she is the co-lead of the PDA Vaccines Interest Group and member of the PDA Biopharmaceutical Advisory Board.
Prior to joining Merck, she worked at Irvine Scientific, Allergan and the Instituto Colombiano del Petróleo where she contributed to the development and manufacturing of cell culture media products, process characterization and improvement of Botox® and development of biological wastewater technologies, respectively.
Sabrina has published four technical publications, co-authored three BioPhorum Industry documents, and presented at numerous conferences.
She holds a BS and MSc degrees in Chemical Engineering from Universidad Nacional de Colombia and PhD degree in Engineering from the University of Akron, Ohio.
Elizabeth Rivera is a technical service manager for the Scientific Division of STERIS Corporation (Mentor, Ohio). Currently, she provides technical assistance in the areas of selection of detergents, disinfectants and sterilization assurance products including the application and use of these in the pharmaceutical, biopharmaceutical, cosmetics, medical devices, dietary supplements and related industries. In addition, she is responsible for assisting Customers with their supplier qualification requirements including paper surveys, onsite audits, quality agreements and others. She offers conferences and exhibits on educational technical forums such as IPA, Interphex, ExpoFYBI, ETIF, PDA, ISPE, Expofarma, OMICS, Executive Conference and more. She has a bachelors and masters degree in Chemical Engineering from the University of Puerto Rico. Elizabeth has 20 years of experience and travels to places in North America, Latin America and elsewhere to support customers in various aspects of cleaning and decontamination. Previously, she held positions at pharmaceutical companies. She has extensive experience in cleanup of active pharmaceutical programs.
Yash Sabharwal, PhD
Co-founder, CEO, and Product Visionary at QbDVision, Yash Sabharwal, is a successful serial entrepreneur tackling complex problems in the life sciences industry. In his previous role as a pharma executive overseeing product development activities, Yash realized the industry had a data culture problem, especially within the CMC workstreams of product development. There were no software tools to aggregate and consolidate all of the CMC data and information generated over the development lifecycle. Yash started the QbDVision project in 2017 to tackle this problem. Today, QbDVision is a rapidly growing, cloud-based software platform solving the operational challenges of process development, scale-up and optimization, characterization, and tech transfer into commercial manufacturing operations with special attention to data culture and data integrity.
Prior to starting QbDVision, Yash was a co-founder at Xeris Pharmaceuticals which is a public company today with registered products for the treatment of severe hypoglycemia and Cushing's disease. Yash co-founded his first company, Optical Insights, in 1997 to solve imaging challenges in biomedical applications. Optical Insights was acquired by Roper Industries in 2005.
Yash has a B.S. in Optics from the University of Rochester and an M.S. and Ph.D. in Optical Sciences from the University of Arizona.