Jean-René Authelin, PhD
Jean René Authelin is the Global Head of Pharmaceutical Engineering at Sanofi-Aventis. Jean René holds an Engineer degree in chemical Engineering from ENSIC (Nancy, France), and a PhD from The Institut National Polytechnique de Lorraine (France).
He joined Rhone Poulenc in 1988 as a Chemical Engineer. In the 90s, he founded the Physical Quality function, dedicated to the API crystallization, drying, polymorphism for which he was Global Head in Rhone Poulenc Rorer, Aventis and finally Sanofi for 10 years.
In 2008, JR Authelin was nominated Global Head of Pharmaceutical Engineering. Domains of interest include: solid state physics, particle engineering, pharmaceutical engineering, fill& finish, freeze drying, primary packaging and devices. Jean René is the author or co-author of 27 publications, book chapters, and the co-inventor of 11 patents.
Ahmed Besheer, PhD
Ahmed Besheer holds a PhD in Pharmaceutical technology from Martin-Luther University, Halle, Germany. He did a Postdoc at Merck Serono in Darmstadt, Germany for 1 year, then worked as assistant professor in Ludwig-Maxmilian University in Munich, Germany for 3 years, before joining Novartis in Basel, Switzerland. Ahmed’s tenure at Novartis lasted 6 years, and his latest position was Group head for NBE formulation development.
Ahmed joined Lonza Drug product services in July 2018. He is Head of Formulation development for Non-Platform projects, where his team is responsible for early and late phase formulation development of various biologics formats, small molecules as well as CGTs.
Massimo Consolaro has 10+ years of professional experience in Blow Fill Seal machines manufacturing. After his graduation at University of Padova in Electronic Engineering, he started his professional career in Brevetti Angela - Italy. He is currently Head of Automation Department with focus on developing equipment for modern primary packaging for parenteral solutions.
Javad Eshraghi is a PhD student of Mechanical Engineering at Purdue University and a member of American Physical Society. As a fluid dynamicist, he has worked on multi-phase flows, air-liquid interface, measurement science, and particle image velocimetry (PIV), and now focuses on the analysis of cavitation phenomenon in biological environments with both experimental and theoretical approaches.
His research is concerned with fluid dynamics problems, the application of developed experimental measurement tools to problems arising in the physical sciences. His interests lie in physical systems that can be readily observed in either natural or laboratory settings. His research has both experimental and theoretical components, the goal being to assimilate the two until consistent physical pictures and theoretical models emerge by using data fusion techniques and system identification tools.
TUEV Sued Product Services
At TÜV SÜD Product Service GmbH, Stephanie Göbel has been Quality Manager QMT MHS since January 2019 and is going to be Product Specialist for Art. 117 starting December 1st 2019.
She has re-joined TÜV SÜD Product Service GmbH – from April 2015 to December 2016 she already worked as auditor within the department of active medical devices.
Apart from her role as auditor, Stephanie has gained experience in various positions within the medical device and pharmaceutical industry for more than 10 years: as development engineer in the field of bioresorbable implants and as quality manager in the field of in-vitro diagnostic devices and drug-device combination products.
Regarding her educational background, Stephanie studied medical engineering at the Technical University Munich (Germany), at the University of Applied Sciences Ulm (Germany) and at the University of Bradford (UK); She holds a diploma engineering degree in medical engineering.
Katharina Golly holds a Medical Engineering degree (Dipl. Ing.) from the University of Applied Sciences, Ulm, Germany and has 10+ years’ experience in the development of vials, glass and plastic PFS and their silicone-based coatings. During her studies she gained insights into the industrialization of an autoinjector at Ypsomed and published an article on medical gases. In 2010, she started as a Development Engineer at SCHOTT Pharmaceutical Packaging in Switzerland, responsible for the design and industrialization of two new silicone coatings for both, plastic and glass PFS. Before joining Novartis’ Device Development and Commercialization Group in 2015, Katharina has supported PFS projects such as Lucentis® prior to setting up the Delivery System for vials & kits.
Anja Gottschalk joined Borealis in June 2016 as Application Development Engineer Healthcare, responsible for the European and Asian market. She already has more than 20 years of experience in the plastics industry in application development, technical service and material management in Automotive, Packaging and Healthcare based on her degree in plastics engineering. She is based in her home office near Frankfurt, Germany.
Jeremy Hemingway, P.E.
Stress Engineering Services
Jeremy Hemingway has 15+ years of experience developing product, equipment, and processes from feasibility through launch in the pharmaceutical and medical device industries. Jeremy has served various roles including design and risk leads, program management, and technical consulting for a range of products including drug delivery, surgical devices, catheters, capital equipment, and connected devices. Jeremy has led the technical development of 10+ product lines and provides a focus on integrating robust engineering into an efficient prototype/test development cycle. Jeremy graduated with a BS and MS from the University of Cincinnati and is a registered Professional Engineer in the state of Ohio.
Susanne Jörg, PhD
Susanne Jörg joined Lonza, Switzerland, in 2006 as Head of Pharmaceutical Development, Drug Product Services. Her team is responsible for formulation and process development for customers' projects and related analytical testing, manufacturing of preclinical drug product supplies, process transfer to the GMP manufacturing site, and primary packaging and device functionality testing.
Prior to joining Lonza, Susanne worked for 10 years in leadership roles at Novartis, most recently as Group Head Early Phase Pharmaceutical Development. She was involved into the development of Cosentyx as well as several product IND/IMPD submissions of monoclonal antibodies, recombinant protein, fusion proteins, bioconjugates, antibody fragments, nanobodies, and antibody-drug-conjugates for parenterals for various administration routes. Susanne studied pharmacy and holds a Ph.D from the Ludwig Maximillians University, Munich, Germany. In collaboration with Merck KGaA, Darmstadt (DE), she developed liquid high-concentration mAb formulations, and supported the registration filing of Erbitux®.
Simon Kervyn, PhD
Simon Kervyn graduated as a PhD in organic chemistry and materials from the University of Namur, Belgium in 2012. After research stays at National Institute of Materials Sciences in Tokyo and at UCLA, Los Angeles, he worked at the Coatings Research Institute in Belgium.
He is now working for Datwyler as manager materials development. In this position he performs customer’s dedicated research to optimize the selection of rubber components to their applications. Furthermore, he works on the development of coated products for the Datwyler portfolio.
Donald Klein, PhD
DLK Consulting Services
Donald N. Klein, Ph.D., is a CMC Consultant with DLK Consulting Services, Inc., a small business incorporated in July, 2019. Don provides CMC consulting and advisory services for pre-IND, IND, NDA, ANDA, BLA, PMA, and/or DMF (Type II, III, IV, and V). He retired from the FDA in September, 2017 after a total of 23 years as a Senior Review Chemist (new drugs) and 5 years as post-marketing CMC Lead (2013 – 2017). Starting in 1997 Don contributed to the following CDER packaging projects: Committee Chair (2000 – 2003); 3 Guidances (1997 – 2003); comparability protocols (1999 – 2017); DMF Strike Force (2000 – 2004); FDA Liaison to the USP for <659>; <660>; <671>; and <1660>; USP PDEC Member (2015 – 2017); and internal FDA training seminars (2000 – 2017). Don’s public service accomplishments were recognized by the FDA Commissioner (Dr. Gottlieb) via the FDA Distinguished Career Award (2017). Don brings CMC consulting experience through his work with a large CRO organization from 2017 – 2019 where his work resulted in an approved NME NDA, an NDA under review, a PAS approval (NME NDA) to support a multimillion dollar investment, and 2 NME, pre-IND – IND submissions permitted to initiate clinical studies.
Songping Liao, PhD
Dr. Songping Liao is the Head of China R&D Center of Baxter Healthcare. The center supports Baxter China patients and market in both drug and medical device development and sustaining. Its capabilities include analytical chemistry, material assessment, extractable and leachable, as well as toxicology assessment, etc. Dr. Liao and his team pioneered in drug packaging compatibility, medical device material and safety assessment in China, and introduced the methodologies and global best practices to Chinese authorities and industries. He facilitated several international exchanges and collaborations, and co-authored/translated four books in the field with other Chinese experts. He is a member of the 11th Chinese Pharmacopoeia Commission (CPC) and its committee of Pharmaceutical Excipients and Packaging Materials. He also serves as the Vice Chairman of the Standard Committee of China National Pharmaceutical Packaging Association (CNPPA). In these roles, he works on national and industrial standards and guidelines. Dr. Liao obtained his BS in Chemistry from Peking University, and his MS and PhD in Chemistry from Cornell University. He also holds EMBA degree from China Europe International Business School (CEIBS).
Nipro Technical Services
Dave Lisman graduated with a Chemical Engineering degree from Bucknell University and later added an MBA from the Indiana University Kelley School of Business with a major in Finance. Dave has held several key positions over his career with Nipro that have led him to his current position as Technical Director with oversight of the Nipro Technical Services Glass Laboratory and Engineering department. In this position, Dave is also responsible for technology development and global sharing of advances within the Nipro PharmaPackaging group, along with leading integral projects with customers focusing on chemical durability enhancements, throughput optimization, and design optimization. Dave also leads glass school events at pharmaceutical company locations to educate and align groups from various backgrounds on glass production & converting, highlighting ways to address and improve performance in the total lifecycle of the product and its packaging.
Diana Löber is Global Product Manager Vials at SCHOTT AG. Diana started her career in the medical device industry before she came to SCHOTT 1,5 years ago. In her role as Product Manager for bulk vials, she is responsible for the product strategy, including the identification of new market opportunities and the development and launch of innovative products.
Juha Mattila is Director, Sterilization Technologies, and responsible for STERIS Finn-Aqua steam and low temperature sterilization and biodecontamination technologies. He has B. Sc. with Hons in HVAC and process engineering, and M. Eng. in Business Informatics, both from Helsinki University of Applied Sciences. He joined STERIS in 2000 and has nearly 20 years of experience with pharmaceutical and research process equipment and applications, including several years in R&D, engineering and product management. He has led several new product development projects, worked on many customer projects in Europe, North America and Asia, is an active conference presenter, and contributes to industry articles in professional journals. Juha is a member of PDA, ISPE and Finnish Biosafety Network and a member of two ISO and CEN standard work groups, representing Finland.
Alex is an Applications Engineer working in the R&D and Samples Team at OpTek Systems. He works on creating techniques for laser micromachining applications and small hole drilling of glass, polymers and metals. Primarily focussing on the material interaction between short pulsed lasers and these material in whilst developing techniques for large scale production. Alex is also active in laser cleaving of optical fibres and glass capillaries.
Maury Mossman is a graduate of Electrical Engineering from Purdue University and began his professional career in the field of factory automation, first working for Cincinnati Inc. and followed by Litton Industrial Automation. In 1991, Mr. Mossman came to Genentech and has held positons of increasing responsibility in Automation & Plant Engineering, Manufacturing Science and Technology, and Process Development, currently holding the position of Principal Engineer and Group Leader in the Roche Pharma Technical Development division.
West Pharmaceutical Services
Mr. Patel has 19 years of experience in the pharmaceutical industry and 15 years of experience in the packaging and drug delivery industry with West Pharmaceutical Services. As a scientist, he was responsible for completing customer complaint investigations. After several years, he transitioned to the role of Validation Engineer for Quality Assurance, where he was able to continue building a foundational knowledge base of elastomeric manufacturing and systems qualification. After returning to Customer Complaints as a senior scientist, he was promoted to manager of the corporate customer complaints team. In order to more effectively coordinate global quality, his focus was allocated to manage Quality Systems projects. Upon conclusion of a two year term he was promoted to the role of Manager, Quality Engineering, where he and his group have supported a wide breadth of optimization projects West Elastomer and Metals manufacturing. In addition, they’re in the process of obtaining US and European patents for a unique 2D, 360 perspective and harmonizing/improving in-house capabilities of metrology methods within the West organization.
Mr. Rech has ten years of experience in the pharmaceutical industry and eight years of experience in the packaging and drug delivery industry with West Pharmaceutical Services. As a senior scientist, his areas of focus were centered around customer complaint and plant investigations as well as particle analysis. After several years in this role, he transitioned to the role of Technology Manager for Particle Testing, where he is currently leading method development and validation projects and is responsible for bringing new capabilities and technology into the West organization.
Christophe Riedel has a master of Food Engineering and MBA. After 12 years spent in a technical center developing innovative technologies for food production, and 2 years as GM of a fresh-cut fruit company, he joined Claranor as business development manager. In 2010, he was appointed as CEO. After bringing Claranor to the breakeven on food packaging decontamination, Christophe is focused on investigating new applications for the pulsed light decontamination, and developing new markets especially with joint projects with partner companies.
Robert A. Schaut, PhD
Robert Schaut is a Scientific Director for Pharmaceutical Technologies in the Science & Technology division at Corning Incorporated. In this role, he brings materials science expertise to meet customer needs, address manufacturing challenges, and garner regulatory support. He specializes in the study of chemical and physical properties of glass surfaces.
Since joining Corning in 2008, Robert has conducted research in glass ceramics, Gorilla® Glasses, and borosilicate and aluminosilicate glasses for pharmaceutical packaging. He is a co-inventor of Valor® Glass and is responsible for many technical presentations and publications for Corning Pharmaceutical Technologies.
Robert earned his B.S. in Ceramic Engineering & Glass Science from Alfred University in 2002 and his Ph.D. in Materials Science and Engineering from The Pennsylvania State University in 2008. He has co-authored 11 peer-reviewed articles, 90 technical reports, and more than 70 patent applications. Robert has been granted 41 patents and is a member of the American Ceramics Society and the Parenteral Drug Association.
Wolfram Schindler, PhD
Wolfram Schindler is a specialist in container closure integrity testing (CCIT) with strong background in physics. As post-doctoral researcher at Helmholtz Zentrum Berlin, he worked on the characterization of organic solar cells before joining Bosch Packaging Technology, now Syntegon in 2014. Here, he is responsible for the measurement processes in machines for headspace analysis, high voltage leak detection and vacuum decay test. Based on the experience gained in a large variety of projects and studies, he enjoys to elaborate together with the customers the best solution for their CCIT applications.
Ahmad Sediq, PhD
Ahmad Sediq is a pharmacist with a PhD degree in pharmaceutical technology from Leiden University, the group of Prof.Dr. Wim Jiskoot. He has worked for 2 years as formulation scientist in Janssen Vaccines in the Netherlands. He was responsible for late stage development of AAV-vector based vaccine products, among others, for Ebola and HIV. Ahmad joined Lonza Drug Product Services in May 2018. He is Principal Scientist/Group Leader in the Formulation Development group, where his team is responsible for early and late stage formulation development of various biologics formats.
With 30 years of experience in the field of Medical Devices, In-Vitro Diagnostic and Pharmaceutical Packaging, Pascal Sircoulomb has been holding sales, marketing and management positions within large international companies (BD, Danaher/Leica) as well as start-up biotechs. He has joined ARaymondlife in 2018 as Business Development Director
Karthik Vaideeswaran, PhD
Eli Lilly and Company
Dr. Karthik Vaideeswaran leads the integrated Surface/Polymer Science, Packaging Systems, Materials Engineering and Performance Testing groups focused on primary containers innovation as well as materials engineering and test methods development for combination-product delivery system development and commercialization.
Dr. Vaideeswaran earned his Ph.D. in Polymer Science and Engineering from the University of Connecticut in 1997 and completed his post-doctoral fellowship in Surface Science at the University of Cincinnati in 1998. Additionally, Karthik earned an MBA from the University of Kentucky in 2004.
Karthik has gained significant industrial experience of 20+ years in the areas of polymer engineering and advanced materials technologies while working at Lexmark International, Saint-Gobain Corporation, Celanese Corporation and now, Eli Lilly and Company; in diverse roles encompassing increasing technical and people responsibilities.
Sean Werner, PhD
Sean Werner is President of Sexton Biotechnologies, a manufacturer of processing and handling solutions and reagents for the development and manufacture of cell and gene therapies. Prior to his current role he spent 11 years with Cook Medical and Cook Regentec filling various roles in the global regulatory and general management functions supporting medical device, cell therapy, and single use disposable development programs. Sean received his PhD from Purdue University in Biology followed by post-doctoral positions at the Indiana University School of Medicine and Eli Lilly. In his role as regulatory scientist at Cook, he guided test and submission strategies for product development and clinical trial and participated as a member of the US TAG for ISO 10993, Biological Evaluation of Medical Devices.
Cathy Xia Zhao, PhD
West Pharmaceutical Services
Cathy Zhao (Formal Name Xia Zhao) has over 18 years of experience in the medical/pharmaceutical industry. She is currently the Director of Scientific Insights Lab in West Pharmaceutical Services, Inc, and leads SIL to differentiate West products and services. Prior to this role, she held various positions in West, such as Global PPS Research Director. Prior to West, Cathy worked for BD as a Principal Materials Scientist. She received her Ph.D in polymer chemistry from City University of New York and her BS in Polymer chemistry from the University of Science and technology of China. Cathy is the inventor of many US and European patents, and is an active presenter in conferences.