2018 Speakers

Hans de Brouwer holds a PhD in Polymer Chemistry from Eindhoven University of Technology. He has been active in material impurity analysis for a variety of plastics and leans on a background of over 15 years of product development expertise in thermoplastics and coating resins. More recently he has been leading SABIC’s innovation efforts for the healthcare industry focussing on drug delivery and renal care segments. Hans is the author of 13 scientific papers and inventor on 17 granted patents.

Ron Brown is a board-certified toxicologist who recently retired from the US FDA Center for Devices and Radiological Health.   At FDA, his research efforts focused on the developing new methods to assess the risk posed by patient exposure to extractable and leachable compounds released from medical device materials.   He is active in both domestic and international standards committees related to the biocompatibility of medical devices.  Until recently, he served as the co-chair of the US TAG for TC194 (Biological Evaluation of Medical Devices) and as convener of ISO/TC194/WG11 (Allowable Limits for Leachable Substances).  Ron is a founding member and former president of the Medical Device Specialty Section of the Society of Toxicology.  He previously held leadership roles in the Society for Risk Analysis and the Association of Government Toxicologists.  Prior to joining FDA, he was a Senior Associate at the ILSI Risk Science Institute in Washington, DC.

Raymond Colton is the founder and president of VR Analytical, a CRO that specializes in extractables and leachables testing (E/L).  He has been working in the E/L field for over 17 years. 

He is the author of a book chapter, numerous presentations, and published papers. He was also the lead author of the first two papers about extractables and leachables published by the Bio-Process Systems Alliance in Bio-Process International.

Colton earned his Bachelor of Science degree in Chemical Engineering from Clarkson University in New York, and a Master of Science in Chemical Engineering from the University of Washington. He also obtained a Masters of Business Administration from New York University.

He is a member of the Parenteral Drug Association, the BioProcess Systems Alliance and the Oregon Bioscience Association.

Dr. Michael Eakins is the Founder and Principal Consultant of Eakins & Associates with over 25 years experience in pharmaceutical research and development.  At Eakins and Associates, Michael provides experience and advice on parenteral primary packaging, especially on glass delamination and glass defects, the selection and product development in glass and plastic pre-filled syringes, and on extractables and leachables for parenteral packaging components. He regularly lectures on these topics worldwide for the USP.

Michael was responsible for the pharmaceutical development of diagnostic radiology products at E. R. Squibb and Bristol-Myers Squibb and for global packaging initiatives for contrast media at Bracco SpA. 

Michael was the Vice-Chair of the USP Packaging, Storage and Distribution Expert Committee in the 2005-2010 and 2010-2015 cycles and is currently a committee member for the 2015-2020 cycle. He is an active member of the Parenteral Drug Association, being the co-chair of the Glass Defects Task Force that revised Technical Report 43 and is a member of the Elastomers and Seals Defects Task Force. He obtained his Ph.D. from London University and has contributed to over 60 publications and 8 USA patents.

Biography to follow...

Dr. Clemens Günther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany.

From 1990 to 2006 he started his professional career at Schering AG, Berlin-Germany.

From 2007 to 2013, Dr. Clemens Günther was Director and Head of Global Preclinical Development at Intendis GmbH, branded later-on as Bayer Dermatology. In this position, he was responsible for Nonclinical Safety for the marketed product portfolio of Bayer Dermatology as well as the global preclinical development strategy including human DMPK for development and life cycle management projects.

Since integration of Intendis into Bayer in 2013, he became Director Nonclinical Safety Consumer Care within the Division of Bayer Pharmaceuticals.

Meanwhile Dr. Clemens Günther has gained over 25 years experience in nonclinical safety. He has been involved in nonclinical development and regulatory toxicology of small molecules, biologics, medical devices and drug device combination products.

Armin started his career at Ciba in Basel, Switzerland 1995. He was responsible for the GLP & GMP lab for organic analysis, migration studies, E&L investigations, development of GMP QC methods and stability testing. After 2010 Armin worked as consultant and Qualified Person (QP) for Intertek in Basel. Since 2016 Armin has a position at Sartorius Stedim Biotech as Lead Scientist. Armin is lecturer and trainer in E&L conferences and seminars since more than 15 years. He is delegate of the German BfArM in the Pharmacopeia expert group 16 of the European Directorate for Quality of Medicines (EDQM).

After an academic career in synthetic bio-organometallic chemistry, James joined Shell's polypropylene company, Montell in 1999.  Through successor companies, he held technical, commercial and business development roles in both Europe and the US.  Since 2008, his specialist area has been the Healthcare market, joining Borealis in 2012 as Healthcare Application Marketing Manager, ultimately heading up their Healthcare team.  

In 2017, James joined Albis, leading their Global Healthcare Business Development team.  His main activity is engagement with key industry decision makers to further develop the support and portfolio offered for Healthcare applications.  

James is the President of MedPharmPlast Europe group, as well as a member of their Regulatory Working group.  MPPE is an EuPC sector group focusing on issues regarding plastics used in medical devices and Pharma packaging.

Alexander Körner is a chemist with specialization in biomedical chemistry (diploma) and biophysical chemistry (PhD). He started his career as subject matter expert for biocompatibility, sterilization and insulin-compatibility supporting development projects at Roche Diabetes Care in Mannheim (Germany).

Since 2016, Alexander is responsible for the biocompatibility assessment of  the insulin delivery systems portfolio. In his position he has to define the biocompatibility strategy for product care changes as well as for new development projects.

Ivan Kourtchev is a Scientist in the Trace Analysis team at GlaxoSmithKline. Ivan has a strong interest in trace analysis method development for extractables and leachables.  Ivan obtained his PhD in Chemistry from University of Antwerp (Belgium) with an emphasis on organic trace analysis, molecular characterisation and speciation of environmental samples using mass spectrometry techniques. Prior joining GSK, Ivan worked first as a Marie Curie Fellow and then as a Senior Research Associate at University of Cambridge on the development of novel analytical approaches for analysis of complex environmental mixtures using ultra-high resolution mass spectrometry.  

Biography to follow...

Melanie Pires obtained her Pharmacy degree (B Pharm) and her PhD at King’s College London, United Kingdom. After a period of working in hospital pharmacy and as a postdoctoral researcher she joined the Medicines and Healthcare products Regulatory Agency (MHRA) based in London in 2003. She has also worked as a community pharmacist.

Her current role at the MHRA is as a Senior Pharmaceutical Assessor within the Licensing Division’s Product Lifecycle Assessment Team where she is responsible for evaluating, assessing and providing scientific advice on both UK (national) and European Marketing Authorisation Applications (centralised, decentralised, mutual recognition) and post-approval variations for anti-infectives, products used in obstetrics and gynaecology and products for treatment of genitourinary conditions. In addition, she is responsible for assessment of applications for herbal products. She also has experience in assessing dermatology, drug-device combinations, CNS, musculoskeletal and over the counter products.

Albrecht Poth is Senior Toxicologist and head of business development for medical devices. He is responsible for customer collaborations focusing on the global registration and certification of medical devices.

He has over 25 years’ experience in the field of medical devices. He served for over 10 years as chairman of the ISO technical committee 194 (Pre-clinical and clinical evaluation of medical devices) and he is currently chairman of the national mirror committee to ISO TC 194 and acting chairman of an expert working group within ISO TC 194. His functional experience includes technical, scientific and general management at several different contract research organizations active in the field of medical device testing and consulting.

Rick Reiley is a Senior Scientist Extractables and Leachables in the Analytical Sciences and Technology team at GlaxoSmithKline.  Rick has background in analytical chemistry using chromatography with mass spectrometry.  He has worked broadly across the pharmaceutical industry, including parenterals, inhalation and oral solid dosage forms, supporting both research and manufacturing.  He began working on E&L in 2007 on sterile single use packs for radiopharmaceuticals at GSK’s Clinical Imaging Centre.  Rick moved on to manage an Incoming Materials QC laboratory at GSK Ware, and became involved in inhalation and oral solid dose raw material and packaging testing.  He moved to PepTCell as an Analytical Chemistry Manager, providing analytical support to early stage research through product launch.  Rick returned to GSK to lead the E&L team supporting consumer health products for the GSK/Novartis joint venture; his role has expanded to provide E&L support for existing packaging across GSK Pharmaceuticals and Consumer Health divisions.

1998 PhD in Biology, Engelhard Institute of Molecular Biology, Moscow, Russia.; 1998-2004 Holland Laboratory of the American Red Cross (Rockville, MD); 2004-2006 University of Maryland School of Medicine (Baltimore, MD); 2006-2008 Armed Forces Institute of Pathology (Washington, DC); 2008-present U.S. FDA

• Regulatory activities: Review of drug products to treat deficiencies in blood coagulation.
• Research interests: Biochemistry of blood coagulation

Dr. Parker has over 19 years of toxicology and medical device research experience, and is an expert in the biological evaluation and toxicological risk assessment of medical devices and combination products.  Dr. Parker graduated with a Doctorate Degree in Molecular and Cellular Pharmacology at University of Miami, has since obtained toxicology experience in academia, government, contract research and medical device industries. In her current position, she is the Toxicology Director at Fresenius Medical Care working in global research and development.   Dr. Parker is a US Delegate in multiple AAMI working groups for ISO/TC194 (the technical committee for ISO 10993), and is an international ISO expert on three working groups (WG 1, 11, and 15). She is the current Vice-President (2018-2019) and soon to be President (2019-2020) for the Medical Device and Combination Products Specialty Section, of the Society of Toxicology.

Andrew Teasdale PhD is a Senior Principal Scientist - Impurity management and External Advocacy at AstraZeneca. Andrew has over 20 years’ experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his current role he chairs AstraZeneca’s Impurity Advisory Group. Dr Teasdale has published a number of papers relating to genotoxic and elemental impurities and other impurity related matters and has been a speaker at many international conferences. Dr Teasdale has also led a number of industry expert groups; these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI) and the Extractables and Leachables safety Information exchange (ELSIE).  He led the recent development of the ICH M7 addendum table and was the inventor of the purge tool concept, Mirabilis.™  He also published 2 books the first (published 2010) addressing Genotoxic Impurities – Genotoxic Impurities Strategies for Identification and Control (Wiley and Son) more recently (Nov 2017) a book focused on practical implementation of ICH Quality Guidelines.   

 

Biography to follow ...

Graham joined Mylan’s Global Respiratory Group as their extractable and leachable specialist in 2016 and leads the development and execution of E&L strategies required for global registration of Mylan’s inhaled products, including Dry Powder Inhalers, Metered Dose Inhalers and Inhalation Solutions. Prior to joining Mylan, Graham worked for GlaxoSmithKline R&D for 16 years, designing and managing E&L work programs to gain regulatory approvals of a range of inhaled and parenteral drug products. Before this, Graham worked for 7 years as an Analytical Chemist for Bespak plc, providing assessment and control of extractables in pMDI’s and DPI’s to pharmaceutical companies. Graham has authored multiple E&L sections of regulatory submissions and has a particular interest in the application of Quality by Design principles to the evaluation and control of extractables and leachables.