24-25 September 2019, Berlin/Germany
Dr. John Ayres received his undergraduate degree in chemistry from Butler University then received his Doctor of Medicine degree from Indiana University School of Medicine. He completed his residency at the Indiana University Medical Center and is Board Certified in Internal Medicine. He obtained his Doctor of Jurisprudence from Indiana University-Bloomington and is admitted to practice law in both Indiana state and Federal courts.
For 15 years, Dr. Ayres served as the Health Hazard Evaluation physician and Sr. Medical Fellow, Product Safety Assessments for a multi-national pharmaceutical company. In this role he worked closely with product development, manufacturing, quality, and pharmacovigilance to evaluate the human safety risk potentially associated with Critical Quality Attributes (CQAs), manufacturing and environmental excursions, linked to product complaints, or related to counterfeit medication issues including surveillance, risk assessment and management, and regulatory-compliance functions.
Dr. Ayres now provides limited consultative assessments on issues related to the clinical implications of product quality attributes and variability surrounding CQAs with biopharmaceuticals in addition to safety-related compliance matters. He currently serves on the USP Visual Inspection Expert Panel and PDA’s Scientific Advisory Board.
Stephen Langille received his B.S. in biology from the University of Massachusetts and his Ph.D. in microbiology from the University of Maryland.
He joined ValSource in 2019 as Senior Microbiology Consultant. Prior to this Stephen has been with the US FDA as a Branch Chief in the Office of Pharmaceutical Quality’s Division of Microbiology Assessment. He has worked on several USP expert committees to develop and improve compendial standards for visible and sub-visible particulate matter in injectable drug products.
Markus is one of the co-founders of MIBIC GmbH that develops rapid bacteria identification systems. Within MIBIC Markus is responsible for research and development of new spectroscopic methods for bacteria analysis. He has 25 years of experience in the field of particle identification. In 2002 he founded rap.ID Particle Systems GmbH and served as Managing Director until the sale of the company in 2018. Prior to this position, he worked as a scientist in different development departments at Schering AG, Berlin, Germany.
Markus holds a diploma in Chemistry and a Ph.D. in Physical Chemistry from the University of Würzburg. He is an active member of the Parenteral Drug Association (PDA). Since 2003, he has supported the ‘Visual Inspection of Parenterals’ Interest Group in Europe as Interest Group Leader.
He has served as program co-chair for the PDA Visual Inspection Forum from 2001 to 2018 in Europe and the USA.
Dr. Klaus Wormuth has a Ph.D. in Chemical Engineering from the University of Washington and 30 years of R&D experience in a variety of fields, primarily in medical devices and most recently single-use technologies. He is currently Lead Scientist, a global specialist for particles topics at Sartorius Stedim Biotech GmbH.
Tia Bush is the Vice President of Site Operations at Amgen Rhode Island. She is responsible for all operations at Amgen’s 75-acre West Greenwich, RI campus where staff contribute to the manufacture of Enbrel, Vectibix and Repatha and clinical trial materials. She started her career at Amgen in 1992, after obtaining her Biological Sciences and Chemistry degree from the University of Southern California. She is the recipient of Amgen’s Excellence in Quality Award, Providence News “Women in Business-Industry Leader” Award, 2012 Healthcare Business Association Rising Star Award, and in 2017 received Providence Business News’ Outstanding Mentor recognition and in that same year received an award from Governor Raimondo and Million Women Mentors Rhode Island with a Stand Up for Stem award.
Pascal holds a degree as a chemist from the University of Haute Alsace, France. He aquired his PhD thesis, focused on applying near-infrared spectroscopy and innovative chemometrical tools for determination of drug content in low-dosed narcotics tablets, at F. Hoffman-La Roche.
Pascal stayed with F. Hoffman-La Roche the following 9 years and worked in small molecule development, implementing vibrational spectroscopies and imaging technologies in drug product development. He then focused on the spectroscopy and chemometrics in the frame of the implementation of PAT (Process Analytical Technology) in Roche’s small molecule drug development. Pascal joined LONZA’s Drug Product Services department in October 2017, specifically the Forensic Chemistry group. Together with his his co-workers he supports Lonza in troubleshooting and foreign particles investigations. He also supports external companies in their process understanding, troubleshooting and foreign matter identification.
Pascal is a member of the society of applied spectroscopy and leads the Basel group of experience exchange analytical imaging experts.
Amber received her Ph.D. in Chemical Engineering within the Pharmaceutical Biotechnology Program with a specialization in the field of immunogenicity of therapeutic protein aggregates at the University of Colorado at Boulder. Amber also holds a Masters in Science from the University of Colorado at Boulder plus a Bachelors of Science from the Colorado School of Mines. Amber currently holds the position of Director at KBI Biopharma where she manages the Particle Characterization Core that specializes in analytical methods for quantifying, characterizing and identifying submicron, subvisible and visible particulates. Previously, at Amgen, Amber was a Scientist within the biomolecular structures and interactions group where she supported biophysical characterization of protein products with a specialty in subvisible particle characterization and identification. She managed subvisible particle characterization for all commercial and late stage clinical products and authored particle characterization sections of numerous regulatory filings. She has over 12 years of experience (8 years industry) with analytical method development and validation, formulation and stability strategy, and protein biophysical characterization. Prior to Amgen, Amber’s experiences include analytical and formulation development for Merck & Co. and collaborations with BaroFold, Inc. to employ high hydrostatic pressure to refold proteins and control subvisible particles.
Cornelia M. Keck is a pharmacist and obtained her PhD in 2006 from the Freie Universität (FU) in Berlin. In 2009 she was appointed as Adjunct Professor for Pharmaceutical and Nutritional Nanotechnology at the University Putra Malaysia (UPM) and in 2011 she obtained her Venia legendi (Habilitation) at the Freie Universität Berlin and was appointed as a Professor for Pharmacology and Pharmaceutics at the University of Applied Sciences Kaiserslautern. Since 2016 she is Professor of Pharmaceutics and
Biopharmaceutics at the Philipps-Universität Marburg.
Her field of research is the development and characterization of innovative nanocarriers for improved delivery of poorly soluble actives for healthcare and cosmetics. Prof. Keck is executive board member of the German Association of Nanotechnology (Deutscher Verband Nanotechnologie), Vize-chairman of the unit„Dermocosmetics“ at the German Society of Dermopharmacy, active member in
many pharmaceutical societies and member of the BfR Committee for Cosmetics at the Federal Institute for Risk Assessment (BfR).
Jörg Lümkemann is pharmacist by training and received his PhD in Pharmaceutical Technology from the University of Münster.
He joined F. Hoffmann La Roche in Basel in 2001, developing parenteral dosage forms (focus freeze dried products). In his current role, he is responsible for the execution of investment projects and is leading the evaluation and implementation of technical innovations within the development department.
His team is supporting Roche commercial Manufacturing Sites in the context of technical and product related challenges.
Since 2008, Markus works as a Groupmanager for Cleanliness Technology in the Department Ultraclean Technology and Micromanufacturing at the Fraunhofer IPA in Stuttgart with a team of twelve scienticts on topics of clean production for a wide range of customer branches. Before he has worked as a scientist in cleanroom production. Since 2000 he is responsible for setting up the topic of Technical Cleanliness in laboratory analysis, industrial training courses and consulting. The valid standards of Technical Cleanliness VDA 19 Part 1 and 2 as well as the ISO 16232 have been compiled under his direction. Current topics of his work are the control of filmic/chemical residues on surfaces as well as the Cleanliness of Medical Products in the Manufacturing Process which is described now in the guidline VDI 2083 Part 21.
Markus Rochowicz studied Pysics at the University of Stuttgart and received a PhD in engineering technology.
Dr. Michael Sasse completed his medical studies at the University of Giessen. After two years of training in the Department of Cardiology and Cardiac Surgery of the Max Planck Institute in Bad Nauheim, he moved to the Children's Hospital of Hannover Medical School. Since 1999 he is the chief physician of the pediatric intensive care unit of the MHH. As the founder of the pediatric intensive network in Northern Germany (PIN), he has overseen the same since 2003. Dr. Sasse is head of the Standardization Expert Council (SET) Infusion Management of the MHH. Its aim is to bring together and coordinate all departments of the clinic involved in infusion therapy. In addition to his clinical work on the Children's Intensive Care Unit, his scientific focus is on infection and inflammation research as well as in various areas of infusion management. He heads the department's own Academy of Pediatric Intensive Care Medicine, which covers the further education and training of all areas of pediatric intensive care medicine. Dr. Michael Sasse is a member of the Society for Pediatrics and Adolescent Medicine, the Society for Neonatology and Pediatric Intensive Care Medicine (GNPI), the German Interdisciplinary Society for Intensive Care Medicine (DIVI), the German Council for Revival (GRC), the German Sepsis Society (DSG) and European emergency and intensive care societies.
Gianluca holds a Master in Biostatistics for clinical research from the University of Padua and a Medical Degree from the University of Florence. In 2015 he obtained his postgraduate degree in Anesthesiology and Intensive Care, at the University of Florence. Since 2016 Gianluca is a research fellow at the Department of Health Science, Section of Anaesthesiology, Intensive Care and Pain Therapy at the University of Florence. He is part of the fellowship program 'Extracorporeal blood purification therapies in the intensive care unit and perioperative medicine: effects on immunological and inflammatory homeostasis in surgical and critically ill patients'.