5th Annual MarketsandMarkets High Potent Medicines Virtual Conference (CET TIME ZONE)

23rd - 24th March 2021
CONFERENCE SPEAKERS
Advisors
Richard Denk
Richard Denk
Head Containment,
SKAN AG, Switzerland


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 Schmidt
Brian Schmidt
Global Head, Industrial Hygiene ,
Takeda, Switzerland


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.


Speakers
Richard Denk
Richard Denk
Head Containment,
SKAN AG, Switzerland


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 Schmidt
Brian Schmidt
Global Head, Industrial Hygiene ,
Takeda, Switzerland


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 Zenobi
Fabio Zenobi
EHS Director, QP ,
BSP Pharma


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 Enineering at university of Milan and graduated in 2000. ISPE member since 2002 he partecipated 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 optimisation 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 succesfully coordinated during the nearly 19 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
Andreas Schreiner
Head of Validation,
Novartis, Switzerland


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
Martin Axon
Principal Occupational Hygienist ,
SafeBridge


Martin Axon is Principal Occupational Hygienist for SafeBridge Europe and is a Chartered Fellow of the British Faculty of Occupational Hygiene; he has degrees in Industrial Chemistry and Environmental Pollution Science.  He has over 25 years of experience working in the pharmaceutical industry.  During mid-career he was Course Director for a postgraduate programme in Occupational Hygiene, Health and Safety, at London South Bank University. 


Michel Crevoisier
Michel Crevoisier
Consultant,
Ex-Novartis Consultant, Switzerland


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


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.


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.


Clement Enault
Clement Enault
EHS Manager ,
EX-Sanofi, France


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.


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.


Thomas Adam
Thomas Adam
Head of Global Quality Assurance Chemical APIs, ,
Bayer, Germany


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 AG. He is responsible for the release of chemical APIs for clinical trials and the GMP-Quality system. He has 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 AG 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
Fred Ohsiek
Senior Specialist, Cleaning Validation ,
Novo Nordisk, USA


Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC.  He earned his Bachelor in Chemistry from University of South Florida.  His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk. 

His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring cleaning processes for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products.  The scope of his work involved drug substance and drug product manufacturing start-up, remediation, legacy justification, and increasing manufacturing capability.  He has created lean CV strategies for document structure/flow and execution in every aspect of the cleaning validation process. 

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.