Skip To The Main Content
Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Europe Particles in Injectables - Exchange Series

24-25 September 2019, Berlin/Germany

  • John Ayres

    John D. Ayres, MD

    Pharma Safety Solutions, LLC

    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

    Stephen E. Langille, PhD

    ValSource

    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 Lankers

    Markus Lankers, PhD

    MIBIC GmbH & Co KG

    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.  

  • Klaus Wormuth

    Klaus Wormuth, PhD

    Sartorius Stedim Biotech GmbH

    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

    Tia L. Bush

    Amgen Inc.

    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 Chalus

    Pascal Chalus, PhD

    LONZA

    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.

  • Alexis Flaquière

    Alexis Flaquière

    GSK Vaccines
    Alexis Flaquière is Manager, Head of Visual Inspection Center of Competencies at GSK Vaccines, in Global MSAT Manufacturing Technologies department. He had more than 15 years' experience in pharma operations and quality assurance, mostly in productions of parenteral. Currently Alexis is occupying a global function to support and advice sites in Visual Inspection field, such as test kit for process qualification, defect management, control strategy for visible particles.
  • Amber Fradkin

    Amber H. Fradkin, PhD

    KBI Biopharma, Inc.

    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.

  • Stephanie Genay

    Stéphanie Genay, PhD

    University of Lille
    Stéphanie is an assistant professor at the university of Lille in France. She holds a PharmD and a PhD and she is a clinical pharmacist for ICU and surgery patients. Her research focuses on injectable drugs: infusion medical devices and drug incompatibilities in order to optimize the administration of injectable drugs and to limit the exposition of patients to particles.
  • Cornelia Keck

    Cornelia M. Keck, Prof.

    Philipps-Universität Marburg

    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

    Jörg Lümkemann, PhD

    F. Hoffmann - La Roche

    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.

  • Hanns-Christian Mahler

    Hanns-Christian Mahler, PhD

    Lonza AG
    Since September 2015, Dr. Mahler has been leading the product development organization at Lonza AG. Prior this position, he led the department Pharmaceutical Development & Supplies, Biologics EU at Roche, Basel, Switzerland from 2010 to 2015 and as Head of Formulation R&D Biologics, Roche, Basel, from 2005 to 2010. From 2000-2005, Dr. Mahler was working at Merck KGaA, Darmstadt, Germany as Principal Formulation Scientist, Lab Manager for Protein Formulation Development and Clinical Trial Manufacturing and CMC Team leader for Erbitux during its submission and launch phase. Dr. Mahler studied Pharmacy at the University of Mainz, Germany, holds in Ph.D. in Toxicology from the Institute of Pharmacy, University of Mainz and Pharmacist specialization degrees in Toxicology & Ecology and Pharmaceutical Technology. He was further trained in Economy and Marketing. Dr. Mahler obtained his venia legendi (German Habilitation) from the University of Frankfurt/Germany in 2010 and is adjunct faculty and lecturer at the universities of Frankfurt (Germany), Kansas (Lawrence, US) and Basel (Switzerland). He was elected an AAPS Fellow in November 2013. His work experience includes early- and late-stage/commercial and line extension formulation development, primary packaging and device development, drug delivery, Drug Product process development, process characterization and validation, transfer to clinical and commercial drug product production and production support and preclinical and clinical (phase 1-3) Drug Product GMP manufacturing of parenteral dosage forms of biologics, small molecules, peptides and oligonucleotides.
  • Markus Rochowicz

    Markus Rochowicz, PhD

    Fraunhofer IPA

    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.

  • Michael Sasse

    Michael Sasse, MD

    Medical School Hannover

    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.

  • Anthony Vico

    Anthony Vico

    OMPI - Stevanato Group
    Anthony Vico is with US Customer Technical Service at Ompi of America, Stevanato Group. He moved to the U.S. to support SG Ompi’s growth in glass primary packaging. In his previous role, he had been working for five years as the Technical & Quality Assurance Front End team at SG Ompi in Italy. He gained an abundance of experience in glass container technology for pharmaceutical use, supporting design, development, and manufacturing of ready-to-fill glass containers (syringes, cartridges, vials, special containers). He is an expert on technical and quality support (including regulatory and compliance) to pharmaceutical companies from early-stage development to life-cycle management, dealing with parenteral medicines in drug delivery systems based on pre-filled glass containers. He received both his M.S. in mechanical engineering, thermodynamics and heat transfer, Cum Laude, in 2011 and his B.S. in mechanical engineering, Cum Laude, in 2009 from the University of Padua, Italy.
  • Gianluca Villa

    Gianluca Villa, PhD

    Università degli Studi di Firenze

    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'.