6th Annual MarketsandMarkets High Potent Medicines Virtual Conference (TIME ZONE- CET)

18th - 19th November 2021
CONFERENCE SPEAKERS
Speakers
Fabio Zenobi
Fabio Zenobi
EHS Director,
BSP Pharmaceuticals, Italy


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 20 years of experience in pharmaceutical industries as Serono, Bristol-Myers Squibb and Intervet, in Manufacturing, Quality Assurance, Technical Operations and EHS.


Stefano Butti
Stefano Butti
Sales Director,
Food Pharma Systems, Italy


Stefano Butti has 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 15 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
Ester Lovsin Barle
Head, Product Stewardship and Health,
Takeda, Switzerland


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.


Dean Calhoun
Dean Calhoun
President, CEO,
Affygility Soultions, USA


Dean Calhoun is an American Board of Industrial Hygiene Certified Industrial Hygienist (CIH). He has been an environmental health and safety professional for over 33 years .Prior to starting Affygility Solutions, Dean was the Associate Director of Environmental Health and Safety for Gilead Sciences, Inc., a biopharmaceutical company focused on developing pharmaceuticals for infectious, viral, and oncology applications. His experiences including development and implementation of global EH&S guidelines, implementation and coordination of an executive management EH&S Steering Committee, establishment of occupational exposure limits for pharmaceutical active ingredients, industrial hygiene program management, and EHS auditing of research, manufacturing and contract manufacturing facilities.

Dean has performed high potency API safety audits at facilities throughout the world, including the United Kingdom, China, Saudi Arabia, and the United States.

Dean graduated with a B.Sc. degree in Engineering from the University of Wyoming and has dual master degrees in Environmental Policy and Management, and Technology Management from the University of Denver. He is a member of AIHA, ISPE, BOHS, and NAEM.


Martin Kohan
Martin Kohan
Senior Occupational Toxicologist,
AstraZeneca, UK


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.


Ildiko Ziegler
Ildiko Ziegler
Quality Assurance Manager,
Vanessa Research


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.


Andrew Lemaire
Andrew Lemaire
Technical Director, Containment and Micronisation ,
Dietrich Engineering Consultants, Switzerland


Pharmaceutical professional with nearly 30 years’ experience working on both sides of the industry. Lemaire’s career started with GlaxoWellcome in various production process engineering roles in OSD, Fine Chemicals and sterile products prior to transfer into their Produce Technology Division PTD were he was instrumental in the introduction and development of true process integrated containment technology into the Inhalation Division, which subsequently won GSK’s prestigious Chief Executive Award for Safety.

Lemaire was also instrumental in the technical transfer of GSK legacy Inhalation products Fluticasone and Salmeterol from research into production including Process and cleaning validation.

After leaving GSK. Lemaire was the Co-Founder of a UK based containment company were he continued to work with GSK, Pfizer, Takeda, AstraZeneca and others developing complex integrated containment solutions around cytotoxic blister lines, tablet presses and Pfizer inhaled Insulin.

In 2003, Lemaire merged companies with Jetpharma, a world leading CMO for contract micronization and became its technical director of the micronizing and containment equipment division. Since Jetpharma’s equipment division acquisition in 2008 by the Dec Group, he holds his current role as Technical Director of Containment & Micronization Technologies.


Jack Brown
Jack Brown
Consultant ,
Scale Up Solutions, USA


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.


Richard Arnett
Richard Arnett
Manager Industrial Hygiene and Toxicology ,
Pharmascience, Canada


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.


Claudia Sehner
Claudia Sehner
Principal Scientist, Toxicology ,
Boehringer Ingelheim, Germany


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).