Dr. Abraham joined Pluristem Therapeutics in 2010. Pluristem is a publicly traded bio-therapeutics company dedicated to the development and commercialization of allogeneic placenta-based cell therapy products for the treatment of severe degenerative, ischemic, and autoimmune disorders. The company recently opened a state-of-the-art, 40,000 square foot, cGMP manufacturing facility in Haifa, Israel. Dr. Abraham leads Pluristem's Product Innovation group, which develops the company's pipeline of cell therapies. He has extensive experience in molecular and developmental biology, in vitro assays, and animal models, as well as 2D/3D cell culture, bioreactors, bioprocessing, and commercialization. He conducted his post-doctoral training in cell therapy and tissue engineering at the Harvard-MIT Division of Health Sciences and Technology and at Harvard Medical School, supervised by Professor Elazer Edelman. He holds a PhD in developmental biology from the University of Maryland Biotechnology Institute.
James Agalloco is President of Agalloco & Associates, which provides a range of technical services to the pharmaceutical and biotechnology industry. Since the formation of Agalloco & Associates in 1991, Jim has assisted more than 200 pharmaceutical, biotechnology, medical device, equipment manufacturers and bulk pharmaceutical firms with validation, sterilization, aseptic processing, compliance and related areas. Jim has more than 40 years of industry experience. He was formerly Director, Worldwide Validation and Automated Technology for Bristol-Myers Squibb. In that capacity, Jim was responsible for global process and computerized systems validation, as well as process automation efforts at several facilities. Prior to joining Squibb in 1980, he was employed in a variety of positions involving organic synthesis, pharmaceutical formulation, pharmaceutical production, project and process engineering at Merck and Pfizer.
He received a BE in Chemical Engineering from Pratt Institute in 1968 and his MS, also in Chemical Engineering from Polytechnic Institute of New York in 1979. He received his MBA in Pharmaceutical Studies from Fairleigh Dickinson University in 1983.
Jim is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993. He has served as a chairman and member of numerous PDA committees and remains active on several committees. He was a charter member of the PMA's Computer Systems Validation Committee. He is a member of USP's Microbiology Expert Committee (2005-2015). He serves on the Editorial Advisory Boards of Pharmaceutical Technology and Pharmaceutical Manufacturing.
Jim participates 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, over 100 papers and has lectured extensively on sterilization, aseptic processing and process validation at various PDA, PMA, and PharmTech meetings, domestically as well as internationally. He is co-editor of "Validation of Pharmaceutical Processes", 3rd edition published in 2007. Co-editor of "Advanced Aseptic Processing Technology", first published in 2010.
Ram Balani is an entrepreneur who focuses on IT and technology solutions for pharmaceutical industry applications throughout the value chain, from clinical/R&D through cGMP/manufacturing. A former Cap Gemini consultant, he led a company that handled IT outsourcing and consulting for companies that include Pfizer and GSK. He is the founder and CEO of FDASmart, a consulting company that delivers regulatory and GMP services, intelligence, consulting, and training services to the pharmaceutical and biotech industry in the US and Asia.
Prabir Basu is an independent consultant advising on pharmaceutical manufacturing and cGMP issues. From 2005 until June 2013, he was the Executive Director of the National Institute for Pharmaceutical Technology and Education (NIPTE), which is a non-profit organization supported by 13 leading universities in the US. From 2004 to 2010, along with his role as Executive Director at NIPTE, he also served as Managing Director of the Pharmaceutical Technology Education Center at Purdue University's Discovery Park. Along with his colleagues at Purdue University, he founded NIPTE in 2005. Prior to joining Purdue University, Prabir worked in the pharmaceutical industry (Pfizer, Pharmacia, and Searle) for over 20 years in various capacities in research, development, and manufacturing. During that period, he had broad-ranging global senior management responsibilities for product development, manufacturing, and global outsourcing. Before joining Searle, he briefly taught chemical engineering at the Indian Institute of Technology and worked for Unilever PLC (UK) in India for about 10 years. He has co-authored several journal and conference papers and two patents. He has also co-edited two books on pharmaceutical operational excellence along with Prof. Thomas Friedli and his colleagues at University of St. Gallen, Switzerland. He is a Fellow of the American Institute of Chemical Engineers.
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).
Tim Freeman is Managing Director of powder characterization company Freeman Technology for whom he has worked since the mid 1990s. He was instrumental in the original design and continuing development of the FT4 Powder Rheometer® and through his work with various professional bodies, and involvement in industry initiatives, is an established contributor to wider developments in powder processing.Tim has a degree in Mechatronics from the University of Sussex in the UK. He is a mentor on a number of project groups for the Engineering Research Center for Structured Organic Particulate Systems in the US (http://ercforsops.org) and a frequent contributor to industry conferences in the area of powder characterisation and processing. He is past Chair of the American Association of Pharmaceutical Scientists (AAPS) Process Analytical Technology Focus Group.
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.
Ajaz S. Hussain
Trusted advisor to senior management guiding them to reduce risk of developmet failure and regulatory non-compliance. A unique/niche offering adressing the challenges in today's uncertain business environment.
Benoît Igne is an industrial research coordinator at Duquesne University in Pittsburgh. He received his PhD in agricultural engineering from Iowa State University in 2009 and completed an MBA from Duquesne in 2013. He specializes in the application of near-infrared and Raman spectroscopy to process analytical technologies in the pharmaceutical industry. Benoit also works for the consulting firm Strategic Process Control Technologies LLC, which helps pharmaceutical manufacturers implement PAT method to control their processes. He serves on the Council for Near Infrared Spectroscopy Board and is an active member of other professional analytical groups.
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.
Charanya Kannan is a Senior Product Manager in Global Pricing & Market Access Solutions at Model N. She manages the global pricing and international reference pricing solutions in addition to analytics on channel and pricing. Prior to Model N, she worked for Oracle and The McGraw Hill Companies and consulted with AT&T. Charanya earned a Master's in innovation management from Carnegie Mellon University, Pittsburgh.
Art Kerley is President of The Fairfield Factor Inc., a Brookfield, Conn.-based marketing counsel and communications agency serving high-technology and advanced manufacturing sectors. Medical device and other life science industries are a particular focus. He holds BA and MA degrees in psychology. Art has been a consultant with Canon Communications (now UBM Canon) since 1986, providing product design and marketing research for the Events division. He was also a regular contributor to MX, the magazine for medical device and diagnostics executives, which was subsequently rebranded in digital format as Medtech Executive. He has also provided consulting services to international pharmaceutical companies that participated in the Interphex Expo and Conference.
Eric Langer, President and Managing Partner of BioPlan Associates Inc., has more than 20 years' experience in biotechnology and life sciences international marketing, management, market assessment, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He is an experienced biotechnology strategist, marketing practitioner, publisher, and researcher. He has published, edited, and authored numerous books, reports, and major studies on topics including: Advances in Biopharmaceutical Technology in China, Advances in Large-Scale Biopharmaceutical Manufacturing, Biopharmaceuticals in the US Market, cell culture reports, media, sera, tissue engineering, stem cells, diagnostic products, blood products, genetics, DNA/PCR purification, blood components, and many others. Eric lectures extensively on marketing, pricing, and channel management topics, and teaches at Johns Hopkins University and American University: Biotechnology Marketing, Marketing Management, Services Marketing, Advertising Strategy, and Bioscience Communication. In 1989 he co-founded BioPlan Associates. He has launched and managed marketing programs for product lines ranging from $500,000 to $500 million.
Since joining Model N in 2001, Rene Larro has been instrumental in the identification of market opportunities in the life sciences vertical and in defining and building products to address them. Previously, he was a senior product manager at Digital Impact (now Acxiom Digital). Earlier in his career, he was a manager at Andersen Business Consulting where he led the delivery of consulting engagements in the financial services and telecom industries, and he began his career as an actuarial analyst with the Delta Dental Plan of California. Rene holds a BS in managerial economics from the University of California, Davis, and an MBA with distinction from the University of Michigan's Ross School of Business.
Dr. Ben Locwin is Principal, Applied Pharmaceutical Intelligence, and Head of Training and Development, Lonza Biopharmaceuticals. His focus is on strategic leadership, quality improvement, statistical process control, and interpersonal psychology. He also is an active professor of business management and psychology/neuroscience courses, and consults for a variety of industries. He has been elected to the Association for Psychological Science, the American Psychological Association, the American Society for Training and Development, the Society for Industrial and Organizational Psychology, and is on the board for the Association for Pharmaceutical Sciences Nutraceuticals and Natural Products Chemistry Focus Group. He has BS and MS degrees in astrophysics from the University of Massachusetts (Amherst); advanced degrees in organizational leadership from Southern New Hampshire University; an MBA from Franklin Pierce University; MS and Six Sigma Master Black Belt certification from Villanova University; and a PhD in Behavioral Neuroscience / Industrial/Organizational Psychology from Vanderbilt University School of Medicine, NCU School of Behavioral and Health Sciences. He also has certification in Risk Analysis and Decision Sciences from Stanford University's School of Professional Development.
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.
David Lowndes oversees product marketing strategy and business development for Iron Mountain Fulfillment Services in North America. His primary responsibilities include monitoring and evaluation of industry trends and prospect/client needs; evaluation, selection, and requirements development of appropriate products and services; development and execution of marketing strategies that promote both organic and new sales revenue growth; and overseeing sales support for both IMFS and Iron Mountain. He has been with the company since 2001. Prior to Iron Mountain, David held positions including Vice President of Strategic Development, Director of Client Services, and Account Director for an integrated call and fulfillment center, as well as a variety of management positions in his native country, England. He has published numerous articles on fulfillment, digital print, and communication optimization, and is frequently requested as a public speaker.
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.
JC Lupis is Communications Director at BioPlan Associates, where he manages the BioPlan blog. He is also the Editor of MarketingCharts, a respected marketing research trade publication with broad industry reach. He has published and distributed hundreds of data-driven articles across online and print media, and his work on marketing research has been picked up by various industry publications and seen him interviewed by BBC News. JC networks within and around the biopharmaceutical community and has professional experience across a range of industries. He has a BS from Georgetown University and a Master's in international affairs from Columbia University.
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).
Graham Reynolds is Vice President, Marketing and Innovation, West Pharmaceutical Services Inc. (www.westpharma.com), where he leads initiatives to market novel delivery systems and develop strategies for future growth, including the acquisition and development of new technologies to enhance West's portfolio. Graham holds a degree in polymer technology from Trowbridge College, UK.
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.
Irwin B. Silverstein
Dr. Irwin B. Silverstein is VP and Chief Operating Officer of IPEA, and President of IBM Consulting in Quality LLC.Heis a consultant in QA and regulatory compliance with an emphasis on pharmaceutical excipients. Formerly the ISP Corporate QA Director, he has worked since 1991 with IPEC to develop appropriate GMP requirements for excipients. Dr. Silverstein is a member of the NSF committee that is writing an American National Standard (ANSI) for Excipient GMP. He has been the VP and COO of IPEA since its founding in 2001 and achieved ANSI accreditation in 2010 for the IPEA Excipient GMP Certification program.
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 email@example.com.
Eyal Talor joined CEL-SCI in October 1993 as Senior Vice President for Research and Manufacturing and was promoted to Chief Scientific Officer in October 2009. He is a clinical immunologist with over 19 years of hands-on management of clinical research and drug development for immunotherapy application, pre-clinical to Phase III, in the biopharmaceutical industry. His expertise includes biopharmaceutical R&D and biologics product development, GMP (Good Manufacturing Practices) manufacture, Quality Control testing, and the design and building of GMP manufacturing and testing facilities. He served as Director of Clinical Laboratories (certified by the State of Maryland) and has experience in the design of clinical trials (Phase I - III) and GCP (Good Clinical Practices) requirements. He also has broad experience in the different aspects of biological assay development, analytical methods validation, raw material specifications, and QC test development under FDA/GMP, USP, and ICH guidelines. He has extensive experience in the preparation of documentation for IND and other regulatory submissions. His scientific area of expertise encompasses immune response assessment. Talor is the author of over 25 publications and has published a number of reviews on immune regulations in relation to clinical immunology. Before coming to CEL-SCI, he was Director of R&D and Clinical Development at CBL, Inc. and Clinical Laboratory Director at SRA Technologies, Inc. Prior to that he was a full-time faculty member at the Johns Hopkins University medical institutions. He has invented technologies that are covered by two US patents; one on Multikine's composition of matter and method of use in cancer, and one on a platform Peptide technology ("Adapt") for the treatment of autoimmune diseases, asthma, allergy, and transplantation rejection. He has patents issued on Multikine in the EU, Japan, and China. He also is responsible for numerous product and process inventions as well as a number of pending US and PCT patent applications. He received his PhD in Microbiology and Immunology from the University of Ottawa and had post-doctoral training in clinical and cellular immunology at the John Hopkins University. He holds an Adjunct Associate post-graduate teaching position at the Johns Hopkins University medical institutions.
Vimal Kumar - Vimal K. Puthiyadath
Vimal Kumar is an electronics engineer from India with 23 years of experience in electronic manufacturing (biomedical), program management of biomedical electronics, automated testing (aircraft engines and turbine), and techno-commercial aspects of business development (engineering design services). He has a post-graduate diploma in international business and a diploma in French. He also has a working knowledge in Spanish and German. Currently, Vimal is pursuing a PhD on structural health monitoring of aircraft. He is passionate about biomedical engineering, especially vital parameter monitoring, and holds an Indian patent for the smallest 3-lead ECG machine.
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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Attend CPhl events to connect with the global pharma industry and identify business opportunities around the world:
9-11 April 2014
16-17 April 2014
20-22 May 2014
4-6 June 2014
26-28 June 2014
5-7 August 2014
7-9 October 2014
2-4 December 2014
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