James Agalloco is President of Agalloco & Associates, which provides a range of technical services to the pharmaceutical and biotechnology industry. Since the company was established in 1991, he has assisted more than 200 pharmaceutical, biotechnology, medical device, equipment manufacturers, and bulk pharmaceutical firms with validation, sterilization, aseptic processing, compliance, and related areas. He has more than 40 years of industry experience. He was formerly Director, Worldwide Validation and Automated Technology, for Bristol-Myers Squibb, responsible for global process and computerized systems validation, as well as process automation efforts at several facilities. Before joining that company, he held a number of positions involving organic synthesis, pharmaceutical formulation, pharmaceutical production, and project and process engineering at Merck and Pfizer.
Jim has a BE in chemical engineering from The Pratt Institute and an MS in chemical engineering from The Polytechnic Institute of New York, as well as an MBA in pharmaceutical studies from Fairleigh Dickinson University. He is a past president of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993. He sits on the scientific advisory boards of Laureate Bioservices, a contract biological manufacturer; MEDInstill, an innovative drug delivery company; and VanRX, an isolator based filling technology firm. He has authored or co-authored more than 40 book chapters and over 100 papers and lectures extensively on sterilization, aseptic processing, and process.
William Botha is a trainer and mentor in lean leadership and manufacturing, with a focus on biopharmaceutical, pharmaceutical, and medical device processes. Formerly an officer in the South African Defense Force's Special Forces, he was trained as a kaizen leader in Japan, and is a certified Lean Master with a documented and consistent record of delivering significant sustained quality, production, financial, and safety benefits to employers and clients. He has demonstrated the ability to assist change agents to deliver lean cultural change within their organizations through engaging everyone from the corner office to the break room.
Jim Cahill is Chief Blogger and Head of Social Media for Emerson Process Management. He has worked for over 20 years at Emerson Process Management, in roles that include sales support, product application specialist, alliance manager, product manager for the DeltaV development, marketing communications manager, and now social media leader. Jim has a BS In electrical engineering from the University of Texas (Austin) and an MBA from the University of New Orleans. He started his career as a systems engineer with Conoco North American production in New Orleans.
Brian Carlin is Director of Open Innovation (Pharma) at FMC BioPolymer. He was previously the Global Manager Pharmaceutical R&D, and has been with FMC for 17 years. He chairs the IPEC Americas Quality by Design and Excipient Composition Committees, and also serves on the USP Excipient Committee. Prior to joining FMC, he worked at SmithKline and Richardson Vicks in new product development. He obtained his doctorate in Interfacial Rheology from the School of Pharmacy, University of London, and an Honours degree in Pharmacy from the University of Aston in Birmingham. Brian serves on the distance learning MSc course at De Montfort University, UK, where he is an Honorary Visiting Professor. He is the recipient of the 2012 IPEC Foundation Industry Research Achievement in Excipient Technology award.
Mr. Carroll develops and presents focused training programs for issues germane to the current needs of the pharmaceutical industry, including small-molecule, biologic, and nutraceutical manufacturing. He has a strong focus on business development for the analytical instrument industry. Among Cadrai successes are: ion-mobility spectrometry for cleaning verification, NIR dedicated to raw material verification, laser induced breakdown spectroscopy for depth penetration and analysis, NIR chemical imaging of tablets and capsules, and automated dissolution technology. As Pharmaceutical Business Unit Manager for Perstorp Analytical Instruments (now Foss), Mr. Carroll built a global, sustainable business that saw more than 8,000 NIR test instruments placed within the pharmaceutical manufacturing industry. He has a BAS in engineering technology/chemistry and an MBA in international marketing. He has authored 60 publications and numerous technical presentations, including The NIR Desk Reference and The Handbook of FTIR. He is also the editor of IR-MS: High Sensitivity and Selectivity for Organic Analysis. Professional memberships include AAPS, ACS, CNIRS, and ISPE.
Bikash Chatterjee is President and Chief Technology Officer of Pharmatech Associates. With over 30 years' experience in the pharmaceutical, biosciences, medical device/diagnostic, and nutraceutical/dietary supplement industries, he has held senior management positions in operating companies for more than a decade and has successfully brought multiple drug and product platforms through the FDA-regulated development process to market. Throughout his career, he has been responsible for product development, technology and process transfer and technology, and established global supply chain processes in over 40 different countries around the world and been responsible for the commercialization of more than a dozen products.
Mr. Chatterjee sits on several scientific advisory boards for pharmaceutical and medical device companies. He is a standing member of several prominent editorial advisory boards and contributes columns for key publications on industry trends and challenges. He has published over 60 articles and editorials throughout his career in peer reviewed journals. He is a Certified Lead Assessor and a Lean Six Sigma Master Black Belt. He holds a BA in biochemistry and a BS in chemical engineering from the University of California at San Diego.
Emil W. Ciurczak
Emil W. Ciurczak has advanced degrees in Chemistry from Rutgers and Seton Hall and has worked in the pharmaceutical industry since 1970 for companies that include Ciba-Geigy, Sandoz, Berlex, Merck, and Purdue Pharma, where he specialized in performing method development on most types of analytical equipment. In 1983, he introduced NIR spectroscopy to pharmaceutical applications, and is generally credited as one of the first to use process analytical technologies (PAT) in drug manufacturing and development. He has also consulted for Technicon (Bran & Leubbe), NIRSystems (FOSS), CDI Pharma, Infrared Fiber Systems, Brimrose, and Buchi. His research has focused on pharmaceutical applications of NIR, and he has published more than four dozen articles in refereed journals, over 150 magazine columns, and presented nearly two hundred technical papers.
Emil has written and edited several texts and chapters in Handbook of NIR Analysis (1st, 2nd, and 3rd editions), Pharmaceutical and Medical Applications of NIRS (2nd edition in progress), Molecular Spectroscopy Workbench, and chapters on NIR applications to life sciences. He sits on several magazine editorial boards, is active in SAS, is a founder of the Council for NIRS, and was the 2002 chair for IDRC (Chambersburg Conference). He has been teaching (college adjunct) since 1979: Stevens Tech, College of St. Elizabeth, Hood College, and Mount St. Mary's College; as well as short courses (in NIR and PAT/QbD) for the ACS, CfPA (US and Europe), SPIE, ASSA, and other organizations. He consults with various pharmaceutical companies, instrument manufacturers, and the FDA. He was a member of the PAT sub-committee (Validation) for the FDA and member of the PAT Expert Committee for the USP. He was the 2004 recipient of the EAS Achievements in NIR Award.
Robert F. Dream is an industry leader with 29-plus years of experience, including 15 years of executive leadership experience, in the consumer product, pharmaceutical, biotechnology, and life sciences industries. He has led projects, improved processes, and scaled up products through operational excellence strategies and technology knowledge and knowhow. He is business minded and has a functional knowledge of manufacturing, warehousing, logistics, supply chain, risk mitigation and risk management. He is experienced in therapeutic biotechnology and biologics products manufacturing environments, with extensive hands-on, senior managerial, and executive experience at world-leading organizations. He has made numerous publications and presentations. He is a registered professional engineer and an active member of the ISPE and the PDA. He is a member of the Pharmaceutical Processing Editorial Advisory Board, the Pharmaceutical Manufacturing Editorial Advisory Board, and the INTERPHEX Advisory Council. He is a graduate of the Illinois Institute of Technology (BS and MS) and Drexel University (PhD).
Barry A. Friedman
Barry A. Friedman, PhD, is a consultant in the biotechnology, regulatory compliance, and aseptic processing arenas. He's had more than 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices, including regulatory compliance, GLP/GMP, quality control, auditing, microbiology consulting, expert witness, sterility assurance, microbiological/analytical validations, and fermentation technology. Prior to becoming an independent consultant, he was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore. As the Director of Quality Control, he managed a multi-shift department of 31 individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry, and QC compliance for the production of Phase 1, 2, 3, and commercial products manufactured from bacteria, yeast, and mammalian cells. In this capacity, he enjoyed many client and regulatory interactions, both domestic and international.
Adele Graham-King works in product development specialising in the medical and health care sector. Her background is historically in Pharma, with a Degree in Applied Physiology and the past 6 years in Design Consultancy.
Adele is involved in business development, marketing, article writing and project management. Her education and healthcare background means that she has a solid understanding of most clinical therapeutic areas and interests lie in the usability focus of design, user experience, human factors and user research.
Michael J. Gregor
Michael J. Gregor is the President and CEO of Compliance Gurus, a leading FDA-compliance consulting firm. Prior to forming his own company, he acquired over 20 years of experience in FDA-regulated industries. His areas of compliance expertise include medical devices; biological, OTC, and pharmaceutical drugs; cosmetics; dietary supplements; tobacco; and food. He has consulted for several Fortune 500 companies, which include Pfizer, Schering-Plough, Monsanto, Wyeth, and Boston Scientific. In addition, he has authored several published articles and whitepapers concerning GCP, GLP, and GMP issues. Michael holds a B.S. in business management from National Louis University and a dual Master's in business administration and information systems management from DeVry University. He frequently lectures on compliance topics at industry conferences and events throughout the year.
Maik W. Jornitz
Maik W. Jornitz is the chief cperating officer at G-CON Manufacturing LLC. He is an active member and the immediate past chairman of the PDA. He has published multiple books, book chapters, and papers. He holds a variety of patents and is the founder of Bioprocess Resources LLC. He received his diploma in bioengineering at the College for Advanced Technology in Hamburg, Germany, and his PED at the IMD Business School in Lausanne, Switzerland.
Mike Long has two decades of experience leading product, process, and validation development efforts on a wide range of pharmaceutical, biopharm, medical device, and combination products. He is a frequent industry speaker/writer on topics such as risk management, quality systems, quality by design, process validation, and process robustness. He is an active member of industry committees, including the Parenteral Drug Association's Science Advisory Board, the International Society for Pharmaceutical Engineering's Boston Chapter Education and Training Committee, and the PDA's Risk Management Task Force (co-chair). He has contributed to a number of PDA technical reports on topics such as risk, validation, data analysis, and objectionable organisms. He also serves on the PDA Letter Editorial Committee. He has instructed courses in data analysis at Tufts University's Graduate Engineering Management Program and currently teaches risk management and quality systems at Regis College's Graduate Program in Regulatory and Clinical Research Management. He is a faculty member of the PDA's Training Research Institute and co-edited and co-authored the book Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing. A master black belt, he earned a bachelor's degree from Worcester Polytechnic Institute, a master's degree from Tufts University, and a doctorate from Northeastern University.
Dr. Line Lundsberg is a QbD and PAT Senior Consultant and holds a Master's degree in physics and a PhD in NIR spectroscopy. Before becoming a consultant, she was with Novo Nordisk and Lundbeck. She works not only for herself but serves also as a consultant for NNE Pharmaplan, NSF-DBA, and NDA regulatory services. She has many years of practical experience implementing PAT and QbD principles for both new products (NDA and MAA) and legacy products within innovator companies, and lately also generic companies (ANDA). Line is a well respected QbD trainer and speaker at international conferences. She is one of the co-authors of the ISPE Guides: PQLI from Concept to Continual Improvement Part 1 – Product Realization using QbD, Concepts and Principles and PQLI from Concept to Continual Improvement Part 2 – Product Realization using QbD, Illustrative Example.
Girish Malhotra, President and founder of Epcot International, has over 43 years of industrial experience in pharmaceuticals; specialty, custom, and fine chemicals; as well as coatings, resins and polymers, and additives. His expertise ranges from manufacturing to process and technology development and business development. The author of Chemical Process Simplification: Improving Productivity and Sustainability (Wiley 2011), Mr. Malhotra specializes in enhancing profitability by simplifying technology and manufacturing practices using engineering and science principles resulting in technology leadership. He accomplishes these goals through a combination of the following:
Mr. Malhotra also contributed a Chapter on Simplified Process Development and Commercialization, in Quality by Design – Putting Theory into Practice, which was published by the Parenteral Drug Association and DHL Publishing in 2011. He also wrote the research report, "Strategies to Enhance API Manufacturing Processes," published by Business Insights in 2011.
James Netterwald is a freelance biomedical writer who specializes in covering key issues pertinent to the pharmaceutical industry. He is based in New Jersey and writes for the publishing, pharmaceutical, biotechnology, and public relations industries. Previously, he was a senior editor for Drug Discovery & Development magazine and an oncology writer for chemotherapyadvisor.com. Dr. Netterwald received his PhD in Microbiology and Molecular Genetics from the University of Medicine and Dentistry of New Jersey.
Hedley Rees is Managing Consultant at PharmaFlow. A practicing consultant, coach, and trainer in pharmaceutical operations and supply chain management, his clients include pharmaceutical companies, ranging from large Top 10 firms to emerging biotech, private equity, a global strategic consultancy, contract manufactures, facility design and build specialists, and third/fourth-party logistics service providers. Assignments span early-stage clinical trial supply chains up to complex multi-product supply networks covering global territories. Prior to this, Hedley held senior positions at Bayer, British Biotech, Vernalis, Johnson & Johnson and OSI Pharmaceuticals. His skill set covers the range of competencies from strategic procurement, production and inventory control, and distribution logistics, to information systems and improvement. His early career was spent as an industrial engineer in the automotive, consumer durables, and FMCG sectors.
As an expert in lean thinking and production systems, Mr. Rees is a zealous advocate of the regulatory modernization frameworks of the FDA's 21st Century Modernization and ICH Q8 – Q11. He graduated from the University of Wales as a production engineer and holds an Executive MBA from Cranfield University School of Management. He is a corporate member of the Chartered Institute of Purchasing and Supply (MCIPS), a former member of the UK BioIndustry Association's Manufacturing Advisory Committee, and on the Advisory Boards of the International Institute for Advanced Purchasing & Supply (IIAPS) and Marken, the only supply chain service provider dedicated 100 percent to the pharmaceutical and life science industries.
Mr. Rees regularly delivers podcasts and webinars and speaks at international conferences and is co-chair of the highly regarded FDA/Xavier University sponsored PharmaLink Conference held in Cincinnati annually. In collaboration with Xavier Health, he works closely with industry, the FDA, patient advocacy, and other key stakeholders in finding solutions to today's supply chain integrity issues. His publications include Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics (John Wiley & Sons).
Agnes Shanley is Editor in Chief of PharmaEvolution.com. With over 20 years of experience in B2B media covering science, engineering, and the pharmaceutical and biopharmaceutical industries, she has previously worked as Editor in Chief of Pharmaceutical Manufacturing magazine and as Senior Editor for McGraw-Hill's Science and Technology group. You can reach her at Agnes.Shanley@UBM.com or via telephone at 212-600-3222.
Ed Silverman is a prize-winning journalist who has covered the pharmaceutical industry for the past 17 years. In addition to editing Pharmalot, he is currently an editor-at-large for Med Ad News. Previously, he was a bureau chief for The Pink Sheet, the venerable industry newsletter, and a contributor to its sister publication, In Vivo magazine. Before that, he worked as a business writer for The Star-Ledger of New Jersey, one of the nation's largest daily newspapers, where he conceived and launched Pharmalot. During his 13-year tenure, he closely followed a variety of topics of concern to those who work for, and with, drug makers – drug development, mergers and acquisitions, regulatory oversight, safety and pricing controversies, and marketing issues. Before joining The Star-Ledger, Silverman spent six years at New York Newsday and previously worked at Investor's Business Daily, among other newspapers. He has a Master's degree in journalism from New York University and a Bachelor's degree in accounting from Binghamton University. Tethered to his laptop and BlackBerry, he lives in suburban New Jersey with his wife, three children, a sizable Labrador retriever, and a sneaky beagle.
Ron Snee is Founder and President of Snee Associates LLC, a firm dedicated to the successful implementation of process and organizational improvement initiatives. He provides guidance to senior executives in their pursuit of improved business performance using Quality by Design, Lean Six Sigma, and other improvement approaches that produce bottom-line results. He has played a leadership role in 28 major improvement initiatives for firms such as Novartis, Schering Plough, Merck, Human Genome Sciences, Celgene, Boehringer-Ingelheim, and Kraft Foods. Ron has authored two books and several articles on Quality by Design. He also serves as Adjunct Professor in the Temple University School of Pharmacy and Rutgers University Pharmaceutical Engineering Program.
Douglas Stockdale is an international consultant to the life science industry and most recently the Senior Director of Contract Manufacturing with Inspiration Biopharmaceuticals Inc. He has a MBA from the University of La Verne and a Bachelor of Science from Michigan State University's School of Packaging Engineering. He has over 30 years of experience in the design, development, production, and qualification of sterile (aseptic) solutions, sterile lyophilization, and sterile medical packaging, including 20 years with Baxter Healthcare and responsibilities for the development and production of recombinant proteins, biologics, medical devices, and equipment and diagnostics. Stockdale has a patent for a medical device. As a life science consultant, Stockdale has also provided sterile solution, lyophilization and sterile medical packaging design, process development, compliance, CMC and operational strategies for early-stage, complex drug/device development to high volume commercial biopharmaceutical drugs. He is a regular speaker at international professional conferences and seminars on the design, compliance, production, and regulatory aspects of sterile solutions and medical packaging operations. He can be reached at firstname.lastname@example.org.
Sherry Yanez-Gregor is Vice-President of www.GregorLibrary.com, a free online research tool, which contains FDA, DOJ, and FTC citation documents, related to the life science industry. She possesses a Juris Doctorate from New England School of Law and a Master of Science degree in Regulatory Affairs for Drugs, Biologics & Medical Devices, from Northeastern University. Ms. Yanez-Gregor began her career as a criminal defense attorney and transitioned her research and regulatory skills into a successful consulting practice, as Director of Regulatory Affairs with Compliance Gurus Inc. In her current role, she serves as a product launch strategist, advertising and promotion reviewer, and first responder to regulatory and quality enforcement actions. In her free time, you can find her glued to her computer, playing with her English bulldog Annie, or reviewing the latest FDA Warning Letter. She currently resides on the north shore of Boston.
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