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 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.
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.
Paola Devoti has been a Corporate Project Engineer at Olon Group since 2018. In her experience in Olon, location-based in Rodano site (Milano, Italy), she has developed a remarkable expertise in high containment technology applied to API production. She has followed several steps of expansion of high containment lines, both in Italian and international sites of the Group. Paola Devoti graduated at Politecnico di Milano, in Chemical Engineering, with a dissertation about Modified clay systems for a controlled drug release
Kenneth Farrugia is a Subject Matter Expert in Cleaning Validation and the prevention of Cross-Contamination. He is a versatile and highly innovative individual with a passion to lead and work with people at all levels. Assuming an array of roles within the pharmaceutical sector, and engaging in the most challenging projects, Kenneth has attained invaluable experience in the holistic management of pharmaceutical business operations. Kenneth is currently the Operations Manager for Mint Health Ltd., a young pharmaceutical distribution company with great potential to excel, while at the same time offering consulting services to the pharmaceutical industry on sustainable cross-contamination prevention. Kenneth is currently pursuing MBA with focus on Total Quality Management and Operational Excellence, aiming to strengthen his skills in the field. Preserving very strong family values, Kenneth is also a very dedicated family person and a proud father of two boys. Well… life becomes boring without adding that spice here and there!
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.
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.
William A. Hawkins BSc (Hons), MSc, CBiol, MSOB, ERT is a Managing Toxicologist for SafeBridge Regulatory and Life Sciences Group. He has spent over 21-years working in toxicology, with experience in REACH, GHS and SDSs, as a study director and a consumer safety toxicologist. He has practiced as an Occupational Toxicologist within the pharmaceutical industry for the last 11-years. Professional recognition of current practice in toxicology is recognized by the award of UK Chartered Biologist and European Registered Toxicologist.
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.
David O’Connell is the Director of Scientific Affairs at PCI Pharma Services, an integrated full service provider expertly delivering a seamless transition from development to commercialization. After graduating from Glasgow Caledonian University with a BSc. in Applied Bioscience, David spent seven years as a Supervisory Scientist working for Aptuit in Edinburgh before moving to Penn Pharma as Head of Formulation Development in 2009. Here he played a vital part in the design of the potent Contained Manufacturing Facility (CMF), which won the ISPE Facility of the Year award for Facility Integration (2014). In 2013 David took on the role of Director, Pharmaceutical Development at the PCI site in Tredegar and in 2017 became PCIs Director of Scientific Affairs.