Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Head Containment. Mr. Denk founded 10 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the ISPE Containment Manual Mr. Denk was responsible for in September 2015. He is Member of the ISPE SIG Biotech Group in Europe and Steering Committee Member of the ISPE SPP CoP. Mr. Denk is co Autor of the ISPE OSD Baseline Guide Volume 2 and Volume 3. Mr. Denk has spent nearly 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.
Brian has worked in the field of occupational hygiene for over a decade, primarily within chemical and pharmaceutical multinational companies, coordinating and developing occupational hygiene programs, including exposure risk assessment, control strategies and occupational health management. He is currently the corporate Industrial Hygiene Lead at Takeda Pharmaceuticals, having previously held similar roles at Merck and Syngenta. Brian is a chartered occupational hygienist through the British Occupational Hygiene Society and holds two masters degrees on the topics of occupational hygiene and toxicology. Originally from South Africa, he now lives in Switzerland with his wife and young daughter. In his spare time, he is an avid golfer and a fan of the South African rugby team, the Springboks.
Richard Denk is working at the company SKAN AG, headquartered in Allschwil in the position Head Containment. Mr. Denk founded 10 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the ISPE Containment Manual Mr. Denk was responsible for in September 2015. He is Member of the ISPE SIG Biotech Group in Europe and Steering Committee Member of the ISPE SPP CoP. Mr. Denk is co Autor of the ISPE OSD Baseline Guide Volume 2 and Volume 3. Mr. Denk has spent nearly 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.
Brian has worked in the field of occupational hygiene for over a decade, primarily within chemical and pharmaceutical multinational companies, coordinating and developing occupational hygiene programs, including exposure risk assessment, control strategies and occupational health management. He is currently the corporate Industrial Hygiene Lead at Takeda Pharmaceuticals, having previously held similar roles at Merck and Syngenta. Brian is a chartered occupational hygienist through the British Occupational Hygiene Society and holds two masters degrees on the topics of occupational hygiene and toxicology. Originally from South Africa, he now lives in Switzerland with his wife and young daughter. In his spare time, he is an avid golfer and a fan of the South African rugby team, the Springboks.
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.
Andreas Schreiner graduated from the University Erlangen, Germany in 1996 in Chemical Engineering. After a Ph.D. and a scholarship at the University College London he joint Roche Vitamins as Head of Solids Processing. He moved in 2006 to Novartis and worked in various departments with increasing responsibilities from project leader to global technology platform leader. Since 2013 he is Head of Validation for Solid Dosage Forms.
Andreas Schreiner is appointed board and steering committee member at various scientific organisations (ISPE DACH Containment, EMPA Swiss Material Science Technology, School for Life Sciences) and President of the Swiss Society for Process Engineers.
Martin Axon is Senior Principal Occupational Hygienist for SafeBridge and is a Chartered Fellow of the Faculty of Occupational Hygiene; he has degrees in Industrial Chemistry and Environmental Pollution Science. He spent the majority of his 35-year career in the pharmaceutical industry and has worked in both primary and secondary production environments at facilities in the UK, the USA and the Bahamas. During mid-career, Martin was a Course Director, for several years, responsible for a postgraduate program in Occupational Hygiene, Health and Safety, at London South Bank University. Martin joined SafeBridge Europe in 2005 and has, for the past 17 years, focused exclusively on the safe handling of potent pharmaceuticals supporting clients in Europe and the UK. Martin is a senior assessor for the SafeBridge Potent Compound Safety Certification Program.
Michel Crevoisier holds a Ph.D. in Chemistry from the University of Berne in Switzerland. He has thirty years of experience in manufacturing of intermediates and API in pharmaceutical and in custom manufacturing companies. In his last position he was senior quality expert for cleaning validation with chemical manufacturing at Novartis Pharma in Switzerland. He retired from Novartis in summer of 2015 and works as a freelance QA specialist
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.
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.
I am a chemical engineer who wants to increase the positive impact of chemistry while negating its drawbacks. I believe that working with HPAPI can be such a challenge that any company producing them should consider whether they want and can involve their workforce in it.
My main experiences are with Sanofi in API production facilities. I have participated in the design of laboratories, small and large scale production workshops. I managed the impacts of HPAPI in such facilities on the workforce thanks to measuring, trainings, maintenance and in depths investigations.
Dr. Thomas Adam is currently the head of global quality assurance chemical APIs in the chemical development department of the pharmaceutical business unit of Bayer. He is responsible for the release of chemical APIs for clinical trials, the GMP-Quality system and the QA-oversight of the pilot plants and analytical development laboratories. Thomas holds a PhD in analytical chemistry from the University of Mainz in Germany. He has about 20 years of industrial experience at Bayer in different QC/QA-functions and a two years Post-Doc experience at Novartis, Switzerland.
He is and was involved in many technical (transfer)-projects so as the planning and launching of the new GMP-kg lab for highly potent APIs and establishing a cleaning concept for the chemical development department.
Fred Ohsiek is the Sr Validation Manager, Life Science for Ecolab. He earned his bachelor’s in chemistry from University of South Florida. His professional work experience includes over 23 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Boehringer Ingelheim, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), Novo Nordisk, and Ecolab. He has extensive risk assessment; cleaning development and validation; project start-up; legacy remediation and justification; creating/improving routine monitoring programs; and increasing manufacturing capability experience in small molecule and large molecule API and finished product manufacturing. He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.
