Fabio is responsible of Environment, Health and Safety at BSP Pharmaceuticals S.p.A., Latina Italy, a Contract Development and Manufacturing Organization focused on anticancer product, small molecules and ADC compounds. He is a Pharmaceutical Chemist and has over 25 years of experience in pharmaceutical industries as Serono, Bristol-Myers Squibb and Intervet, in Manufacturing, Quality Assurance, Technical Operations and EHS.
Stefano Butti studied Mechanical Engineering at university of Milan and graduated in 2000. ISPE member since 2002 he participated as speaker to different congress and seminar on Containment and Micronisation topic both for HPAPI and Sterile application as well as published different articles on technical newspaper.
He worked as project and process manager in the Chemical and Pharmaceutical business following Containment and Micronisation system installation worldwide. He also took direct role in the definition of containment system upgrade and optimization for the handling of products with OEL down to ng level with successful results. Also few projects where combination of sterile and toxic compound handling were successfully coordinated during the nearly 20 years spent in this business.
He Joined FPS company in 2008 starting as Technical Sales Manager and he is now head of the Sales group for the company Containment and Micronisation system provided worldwide.
Ester Lovsin Barle, DVM, MSc, PhD, MScTox is the Head of Product Stewardship and Health at Takeda, reporting to the Corporate head of Environmental Health and Safety, Deborah Donovan. She is in Zurich, Switzerland. Her responsibilities include Safety Data Sheet process, maintaining article and material regulatory complaince and scientific development and cross-organizational implementation of health based exposure limits (HBEL) in support of research and manufacturing in Takeda globally, as well as global implementation of occupational hygiene. Previously she has held corporate positions at Lonza and Novartis. She received her PhD in veterinary sciences from University of Ljubljana, Slovenia and a second masters degree in toxicology and risk assessment from Medical University in Vienna.
As Affygility Solutions’ Founder and CEO, Dean does much more than wrestle industrial hygiene pumps, he leads people, teams, and companies in solving their toughest potent compound safety challenges. With over 35 years of professional experience, Dean created and led the vision for OEL Fastrac – the award-winning online platform for obtaining high-quality OEL and ADE monographs. Additionally, Dean has performed numerous potent compound safety assignments throughout the world, helping these companies greatly improve their potent compound safety systems.
As an invited speaker, Dean has spoken at numerous events throughout the world including the HPAPI Summit, CPhI, AIHce, and many others. Dean is an American Board of Industrial Hygiene CIH, and is a member of AIHA, BOHS, ISPE, and SCHC. Dean is also a Fast Company executive board member.
Martin Kohan has done his BSc/MSc in Biochemistry from La Plata National University, Argentina; MSc in Pharmacology and PhD in Medical Sciences both from the Hebrew University of Jerusalem, Israel. Over 9 years of industry experience in the field of Toxicology conducting and managing over 900 hazard assessments, including calculation of exposure limits and/or determination of exposure control bands of drug substances and of their intermediates for Teva (2010 to 2018) and AstraZeneca (2018 to present). Diplomate of the American Board of Toxicology (DABT), European Registered Toxicologist (ERT), and Member of the UK Register of Toxicologists and of the British Toxicology Society.
Dr. Ildiko Ziegler has been a professional for more than 15 years in the pharmaceutical industry, has extensive experience in QA, fulfills the QA manager role at Vanessa Research. She has been a validation and quality risk expert for almost 10 years. Ildiko obtained M.Sc. in chemical engineering at the Budapest University of Technology and Economics (BUTE) in 1996. She recieved licentiate degree at the Luleå University of Technology (Sweden) in 2000. She defended Ph. D. at the BUTE in 2000 and obtained the Géza Schay Award for the achievments in the field of physical and theoretical chemistry.
Raised in Idaho and earned a BS and Ph.D.in Chemistry at Utah State University in Logan, Utah. Continued studies under the direction of Professor Albert I. Meyers at Colorado State University Fort Collins, Colorado. Started professional career at Syntex Chemicals, as a Principle Scientist followed by working for Hoffmann La Roche, until 2002 and rose to the rank of Distinguished Scientist while working on multiple projects, such as Naproxen®, Saquinavir®, Tamiflu®. In 2002 moved to Boehringer Ingelheim Chemicals in Petersburg, Virginia as the Manager of Process Chemistry and stayed there until 2014. Between 2014 to 2019 worked at Boehringer Ingelheim Pharmaceuticals in Ridgefield Connecticut as a Principle Research Scientist and retired in September 2019 as a Senior Research Fellow. Recently elected to the Vice Chair of the Virginia Section of the American Chemical Society and have been consulting in the areas of process safety, HPAPIs, and Process Development.
Currently Manager, Industrial Hygiene & Toxicology at Pharmascience Inc., Rich leads a team tasked with determining HBEL’s and collaborating with the various functional areas to ensure safe product manipulation. Prior to joining Pharmascience, Rich held different roles in IH and Production management for solid dose & injectable products at Uman Pharma.
Rich began his career at Merck Frosst Canada in 1998 supporting the formulation/process development, scale-up and tech-transfer of numerous dosage forms while executing the manufacture of worldwide clinical supplies for various Merck programs. While at Merck, Rich held several positions of increasing responsibility, including leading the Canadian GMP Pilot Plant Operations.
Dr. Claudia Sehner is Senior Toxicologist at Boehringer Ingelheim Pharma GmbH & Co. KG in Biberach (Germany). She is responsible for Occupational Exposure Limits (OELs) and Permitted Daily Exposure Limits (PDEs) setting and leads the respective committee at Boehringer Ingelheim. She is (co-) author of several scientific publications on health-based exposure limits. Besides >15 years of experience in toxicological risk assessment/limit setting, Claudia Sehner has expertise as project toxicologist and in the fields of in vitro toxicology and toxicogenomics. Claudia Sehner graduated with a Diploma in Chemistry from the Johannes Gutenberg University, Mainz, earned her doctorate at the Institute of Toxicology (Mainz), and is a board certified toxicologist (DGPT).
