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 15 years, focused exclusively on the safe handling of potent pharmaceuticals for a wide range of European clients. Martin is also a senior assessor for the SafeBridge Potent Compound Manufacturing Certification Program.

Ester Lovsin Barle, DVM, MSc, PhD, MScTox is the global head of product sustainability and stewardship and at Takeda Pharmaceuticals. She lives in Zurich, Switzerland.

Ester is passionate about generating value with product safety and sustainability. She is leading the cross-organizational product sustainability workstream sustainability by design for the planet pillar of purpose-led sustainability in Takeda. Her responsibilities also include product stewardship topics, such as safety data sheet process, maintaining article and material regulatory compliance and scientific development and cross-organisational implementation of health-based exposure limits (HBEL) in support of research and manufacturing in Takeda globally. Previously she has held corporate positions at Lonza and Novartis. She has been working in the pharmaceutical industry for over 15 years. She received her PhD in veterinary sciences from University of Ljubljana, Slovenia, and a second master’s degree in toxicology and risk assessment from Medical University in Vienna. Ester is a certified toxicologist.

Andrea Messori is leading process engineering design activities for pharmaceuti­cal and fine chemicals at Process Service – an Italian engineering company. He has more than 20 years of expertise in API 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 (API production facilities, HPAPI, fermentation and DSP biotechnologies, utility systems) and fine chemicals. In the last eight years he has managed HPAPI projects for more than six different main pharma companies in Italy and abroad dealing with HPAPI up to a few tens of nanograms CPT with investments ranging from a few million to many tens of millions, achieving a significant expertise in HPAPI facility design and containment strategies. Andrea graduated in chemical engineering in 1995 at Politecnico di Milano.

Martyn Ryder is director of Solo Containment, based in Greater Manchester, UK. Since establishing Extract Technology in 1981, Martyn has worked across the pharmaceutical containment industry but has focussed his expertise to single-use, flexible film containment since launching Solo in 2011. Across his career, Martyn has been involved in developing HPLC surrogate API containment test methodology and co-authored the IchemE Containment Design Guide in 1999. Part of the remit of Solo Containment is to push the capabilities of flexible film containment and as such, Martyn developed the first ADC compounding isolator in 2016.

Olindo Lazzaro is director of global EHS technical operations at AbbVie, responsi­ble for global EHS technical centres of excellence at AbbVie supporting both R&D and manufacturing. Key areas are as follows: process safety management, loss prevention and fire protection, OH/containment, chemical safety and GHS, PiE, green chemistry/ecoefficiency, N2/inert gas handling, EHS new product introduc­tion and EHS technical transfer. He’s also responsible for AbbVie environmental and OH labs (both are ISO 17025 accredited), leads prevention of catastrophic incidents (PCI) strategy and is an EHS approver for AbbVie engineering stan­dards. Olindo’s a champion of manufacturing containment capital improvement long plan, OH/containment engineering community of practice and of the AbbVie pharma in the environment (PiE) team. He is EHS representative in the AbbVie operations pipeline teams. Olindo holds a master’s degree with honours in envi­ronmental engineering with a specialisation in process safety management and major hazard control from the University of Roma La Sapienza and an EMBA in pharmaceutical administration from LUISS University Business School, Italy. He is registered as a professional engineer and fire protection expert in Italy. He is a certified occupational health and safety manager, construction safety man­ager and energy manager. Olindo is also qualified as an evaluator of environment management systems according to ISO14000 and EMAS rules and as internal auditor for the health and safety management system according to OHSAS 18001 and UNI 10617.

Martyn Ryder is director of Solo Containment, based in Greater Manchester, UK. Since establishing Extract Technology in 1981, Martyn has worked across the pharmaceutical containment industry but has focussed his expertise to single-use, flexible film containment since launching Solo in 2011. Across his career, Martyn has been involved in developing HPLC surrogate API containment test methodol­ogy and co-authored the IchemE Containment Design Guide in 1999. Part of the remit of Solo Containment is to push the capabilities of flexible film containment and as such, Martyn developed the first ADC compounding isolator in 2016.

Dr. Firelli Alonso is senior director of external supply at Pfizer, Inc. She heads the biotherapeutics and vaccines outsourcing group in worldwide research and development. Fi has 35 years of combined experience in research, development and cGMP production of biological products and vaccines, and 15 years of experi­ence in outsourcing, project and contract management and technology transfer to qualified third parties. Her areas of expertise include viral vectors and viral vaccine development, recombinant proteins, vaccine process development and cGMP pro­duction, project management, technology transfer and outsourcing. She obtained her PhD in microbiology/virology from the University of Alabama in Birmingham, followed by postdoctoral research at the U.S. Army Medical Research Institute for Infectious Diseases, Sloan-Kettering Institute for Cancer Research and Rutgers University’s Center for Advanced Biotechnology and Medicine. Prior to joining Wy­eth/Pfizer in 1996, Fi worked at The Salk Institute/Government Services Division, a vaccine contract manufacturer for the U.S. Armed Forces.

Deputy head of CMC licensing, sourcing and collaborations, Denis Croisat has more than 20 years of experience in the field of outsourcing and CMO manage­ment, technologies scouting and drug delivery technologies. After completing a PhD in organic chemistry at the University of Paris, in 1991 Denis joined Sanofi- Aventis and held different positions in process development and industrial af­fairs. Denis is managing the sourcing and outsourcing related activities within research and development. In his role, Denis is responsible for all sourcing related activities, encompassing sourcing and outsourcing activities within CMC depart­ments: chemical and process development departments, biotechnology depart­ment, pharmaceutical sciences development department and analytical sciences development department.

Toral Mehta is EHS professional with more than 18 years of international ex­periencein the core areas of occupational hygiene and occupational safety. She is a certified industrial hygienist (CIH) and certified safety professional (CSP) from American boards. In her professional tenure of 18-plus years, Toral worked with a large number of multinational pharmaceutical companies in more than 35 countries. Her contribution to the workplaces includes innovative methods of risk evaluations, prioritisation and controlling employee exposures with best contain­ment technologies.

Stefano Butti studied mechanical engineering at the University of Milan and gradu­ated in 2000. He has been an ISPE member since 2002. He has participated as a speaker at different congresses and seminars on containment and micronisation; topics have been for both HPAPI and sterile application. Adding to that, he has published different articles in technical newspapers. Stefano worked as a project and process manager in the chemical and pharmaceutical business following con­tainment and micronisation system installation worldwide. He took a 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. He also worked on a few projects where the combination of sterile and toxic compound handling was successfully coordinated, spending close to 18 years in this business area. He joined FPS in 2008, starting as a technical sales manager and he is now the head of the sales group for the company’s containment and micronisation system that is provided worldwide.

Jörg Herbst is a board-certified toxicologist (DABT and ERT) and biopharmaceuti­cal manager with nearly 20 years of industry experience. He has worked for a range of biotech companies as an expert in the field of non-clinical development and safety evaluation of biopharmaceuticals and small molecules. Jörg has consid­erable experience in development and execution of non-clinical safety risk assess­ment strategies, including regulatory considerations, selection of appropriately skilled CROs and proposing program budgets and timing of toxicology studies in support of clinical programs in a broad range of indications. In 2013, he joined Molecular Partners, located in Zurich, Switzerland, as their director of toxicology. Molecular Partners is pioneering the development of a novel class of targeted protein therapeutics termed DARPins. Jörg holds a diploma in chemistry and re­ceived his PhD in toxicology from the Institute of Toxicology at the University of Würzburg. Since 2008, he has been a full member of the advisory committee for pharmacologically active substances and veterinary drugs of the German Federal Institute for Risk Assessment.

Helsinn Birex

Dr. Friederike Hermann is Head of Occupational Hygiene at Lonza Visp. She ob­tained her doctorate in the field of Analytical Chemistry with an emphasis on Element Speciation. In 2001, Dr. Hermann started as an Analytical Chemist in the Environmental Department and eventually transitioned into the field of Occupational Hygiene. She was significantly involved in the setup of high potent compound production at Lonza. She completed her Master of Advanced Stud­ies (MAS) degree on Work and Health at the ETH Zürich and the University of Lausanne. Dr. Hermann is a certified hygienist through the Swiss Society of Occupational Hygiene. She is a member of the steering committee of COP Con­tainment ISPE Affiliate DACH. She is also a member of the MAK Commission Switzerland and actively participates in a network of Occupational Hygienists, Physicians and Toxicologists, which form the Basel Chemical Industry (BCI). She is also a member of the Health Commission for the Lonza Visp site, which has over 3,000 employees. She lives in Wallis, Switzerland, where she enjoys run­ning, cycling and hiking.

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.

Marina has the responsibility to coordinate the Environment, Health and Safety department at BSP Pharmaceuticals S.p.A., Latina Italy, a Contract Development and Manufacturing Organization focused on anticancer product, small molecules and ADC compounds. She is an Environmental Engineer with several years of experience in the Pharmaceutical make sites, including multinational companies such as Janssen Cilag Spa, pharmaceutical branch owned by Johnson & Johnson.

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