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.
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.
Tara is the Occupational Hygiene Manager for SafeBridge Europe, the European operation of SafeBridge Regulatory & Life Sciences Group which specialises in occupational health and hygiene consulting to the pharmaceutical industry. She holds a Certificate of Operational Competence from the BOHS and has master’s degrees in both Environmental Science and Occupational Health and Ergonomics. Tara has over 18 years’ experience in the broad field of occupational hygiene and joined SafeBridge in 2020.
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.
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.
Sean Codling is the Managing Director and Owner of CTS Europe Ltd. CTS was formed in 2010 by Sean to focus on building containment solutions for Pharmaceutical laboratories. Sean studied as a Mechanical Engineer and has over the past 20 years has been involved in the design and Fabrication of Enclosure systems in the Pharmaceutical industry. Sean has some good knowledge on how laboratory equipment works and how the users need to use them, this knowledge is used to find the best overall solution to meet laboratory scale containment needs.
Andrea Messori is leading process engineering design activities for Pharmaceutical and Fine Chemicals in Process Service – Italian Engineering Company. He has more than 20 years of expertise in APIs production facilities design starting from feasibility and conceptual design, basic design development and complete detailed engineering project management. He joined Process Service in 1997 and in those years, he increased his knowledge developing many projects for Pharma (APIs production facilities, HPAPIs, Fermentation and DSP Biotechnologies, utility systems) and Fine Chemicals. In the last 8 years he has managed HPAPIs projects for more than six different main Pharma Companies in Italy and abroad dealing with High Potent APIs up to few tens of nanograms CPT with investments ranging from few millions to many tens of millions, achieving a significant expertise in High Potent APIs facility design and containment strategies. Andrea Messori graduated in Chemical Engineering in 1995 at Politecnico di Milano.
Michael Schweizer grew up in the beautiful Valais mountains, where he now works as a sales manager and board member at Lugaia. He's a dedicated family man, enjoying outdoor activities like cycling, motorcycling, and skiing. Starting with an apprenticeship in pharmaceutical engineering, he later studied business administration. Since 2015, with his expertise in Single-Use Containment Solutions for powder handling, he's been an essential part of Lugaia, crafting technical and commercial proposals, advising clients, and contributing to the company's growth and management.
Joined the MilliporeSigma team in 2004, working in operations and tech transfer of HPAPI projects, where he was involved in the scale up and tech transfer of GMP HPAPI programs as well as several HPAPI facility projects. Master's degree from the University of Wisconsin. Currently supports the MilliporeSigma Life Science Services Commercial team.
Filippo Saleri is graduated in Pharmacheutical Chemistry and Technology at State University of Milan (Università degli Sudi di Milano) in 2016 and the same year passed the bar exam for pharmacist. Since 2016 he worked in QA department of manufacturing plants for Zambon, GSK and Monteresearch covering different roles as QA specialist, GMP auditor for self-inspection and qualification of API and excipient suppliers. In 2021 he joined Recordati as Quality Assurance for CMO managing all quality related topic regarding subcontracted production, evaluation of new suppliers and set-up for the manufacturing (Agreements, Tech-Transfer, qualification etc). Currently he is working in Ferring, with the role of Subject Matter Expert for CMO, with a focus on a global project for the implementation of the new ERP system worldwide and in specific the successful integration of all CMO process.
For the past 25 years Christian has been creating innovative solutions for the Pharmaceutical, Biotech, Cell Therapy and Fine Chemical industries in the form of High Containment and Aseptic process solutions, working with OEM’s, Engineering Consultancy’s and direct with End Users. Christian’s technical expertise and experience includes supplying High Containment Isolators down to low nanogram levels; Grade A (ISO5) Sampling & Dispensing facilities, together with R&D / Production filling line RABs & Sterile Isolators.
Previously held positions - Design engineer for process equipment, European Sales Manager ,Global Product Manager Aseptic and now Business Development Director for ChargePoint Technology. Member and speaker at both ISPE and the PDA.
Mr. Pietro Virgilio has more than 25 years professional experience in the design of pharmaceutical facilities, especially in isolator technology, containment processes, decontamination and sterilization. He has been working for different equipment manufacturers and engineering companies, all in the GMP regulated business. Pietro’s current position is Process Manager for Biopharma applications at Exyte Italy.
