Justin Mason-Home is an organic chemist with extensive health, safety, environmental, and chemical engineering experience in senior technical, legal, and commercial aspects of the pharmaceutical, biochemical, chemical, and other industries. He is a Fellow of the Royal Society of Chemistry in the United Kingdom.

Justin started as a research chemist in the flavour and fragrance sector, researching and discovering new chemical synthetic routes to produce nature-identical flavour and fragrance components. In the fine chemical sector, he worked through scale-up (Kilo Lab then Pilot Plant) to full-scale manufacture. After a move to corporate environmental management, Justin was head-hunted into environmental consulting, heading a technical environmental engineering function.

He has since held senior positions and worked globally in potent biopharmaceutical occupational health and safety global environmental consulting, he's held a board level position in a biotechnology company, and has worked in corporate environmental management. Justin has been involved in and worked on potent and highly-potent API projects for more than 22 years and specialises in technical complex and strategic projects, including unique experience in managing sensitive highly-potent and toxic biopharmaceutical compound matters. Justin has chaired, presented at, and attended many HPAPI events and is a recognised expert in this area.

Dr. Reinhold Maeck is the head of corporate EHS regulatory intelligence at Boehringer Ingelheim Germany. He has more than 20 years of experience in the pharmaceutical industry with key functions in chemical production as well as EHS and has worked many years in China and US.

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.

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.

Timo Rosvall is an experienced engineer and project manager with 25 years of experi­ence in the manufacturing industry and service companies. He has been responsible for a number of containment projects in API, R&D and formulation. Timo is currently work­ing as a senior containment engineer for AstraZeneca.

Dr. Ulrich Rümenapp works within the biological development organisation of Bayer AG, where he is responsible for the transfer of Bayer’s pipeline candidates (antibodies and antibody drug conjugates) to external manufacturing partners and regulatory submission and launch preparations. Prior to working in development, Ulrich was head of biotech projects in product supply biotech at Bayer, where he was responsible for contract manu­facturing partnerships in the field of biotech¬nological drug substances, drug products and interdisciplinary project management with the goal to ensure market supply. Before it was acquired by Bayer, he held a similar position at Schering AG, and before that he worked in the production and logistics department of Schering. Ulrich studied chemistry and holds a PhD in biosciences. He has several years of experience in academic research in the field of signal transduction and as an assistant teacher in the field of general pharmacology. Currently, his area of expertise is the setup and management of external relationships for the development and supply of bio-pharmaceutical products.

Dr. Lorna Swinburn is a professional at Fujifilm Diosynth Biotechnologies in Billingham, UK, with over 18 years of experience in the biotechnology sector. She obtained a bach­elor’s in chemical engineering at Loughborough University in 1996 and continued in aca­demic research to obtain a PhD in protein adsorption onto ultrafiltration membranes. Her current role is as a project manager specialising in the implementation of risk-based approaches to contamination and cross-contamination control within multi-product facili­ties, technology transfer, capital project management, process performance qualification (PPQ) execution, facility operation, maintenance and compliance.

Dr. Ildiko Ziegler has been a professional at Gedeon Richter for 14 years and has been leading different projects in her field for four years. She has been a distinguished valida­tion expert since January 2014, specialising in cleaning validation and quality risk as­sessment in the pharma industry. Ildiko obtained a master’s in chemical engineering at the Budapest University of Technology and Economics (BUTE) in 1996. She received a licentiate degree at the Luleå University of Technology (Sweden) in 2000. She defended her PhD at the BUTE in 2000 and obtained the Géza Schay Award for her achievements in the field of physical and theoretical chemistry.

Jessica Redmer has been an expert for pharmaceutical development, specifically cGMP, at AiCuris since 2017. In this position, she is responsible for the CMC, managing rela­tionships with partner CROs/CMOs and oversight of drug development process. Jessica has more than 15 years of experience in the pharmaceutical industry. At CordenPharma she established a new GMP system for the development department and planned and launched a new development area for highly potent substances. She is part of the expert containment group ISPE D/A/CH.

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.

Dr. Ulrich Scholz is currently the head of scale-up and processing in the chemical develop­ment department of the pharmaceutical business unit of Bayer AG. He is responsible for the pilot plant, GMP kg labs, technical labs and process technology labs; all capable of handling highly potent APIs. Ulrich has a total of 17 years of industrial experience in various companies as well as various countries and holds a PhD in synthetic organic chemistry from the University of Hannover in Ger¬many. With growing regulatory and safety demands in the handling of highly potent active ingredients, clear trends in pharmaceutical research to develop candidates with high potency and portfolio strategies to engage in breakthrough designation therapies, many challenges of these trends have to be taken care of in the scale-up and late development stage phase. How these challenges are coped with inside of Bayer AG will be subject of the talk.

Silke Büchl is an experienced IOHA certified occupational hygienist with about 20 years of experience in occupational hygiene. 

She became an IOHA certified occupational hygienist after her postgraduate studies for work and health at ETH Zürich and Uni Lausanne in 2003.  

Before she started as an occupational hygienist and deputy of the managing director at Praevena in 2014, she gained experiences in different fields of occupational hygiene, safety data sheets, hazard communication with the focus on occupational hygiene topics as well as participation in the internal board to define occupational exposure limits at Novartis. 

Praevena is a company that provides services such as: Exposure monitoring with regards to occupational hygiene and SMEPAC, customised training, customised concepts (PPE, work processes, OEL classification, etc.), workplace health risk assessment, performing quantitative fit testing. 

Paolo Moretti is an organic chemist with extensive environmental, health and safety experi­ence within international pharmaceutical companies. In his career he conducted multiple studies or coordination of EHS projects. After moving to global roles in EHS technical sup­port in 2006, he was part of the drug handling committee looking after EHS aspects during HPAPI technology product transfer projects, including minimisation of potential environ­mental impacts. In his current role as environmental TAPI director, he is involved in multiple projects aiming to reduce Teva’s environmental footprint and improve EHS performance.

Claudio Salvagnini has a PhD in organic chemistry from Louvain University in Belgium. He has worked for several fine chemical companies in business development and sales roles in the pharmaceutical field, and in 2015 he joined Minakem as the head of the sales and marketing department for highly potent APIs and custom development and manufacturing markets.

Steve Marnach has a master’s degree in business administration and joined DuPont in 1995. After having held various positions within the company, he is currently the EMEA training manager and critical environments marketing specialist for DuPont Personal Protection, the chemical protective garments business that Steve has been working for since 2003. In his current role, Steve is providing training sessions on the selection and safe handling of chemical protective garments used in, amongst others, pharmaceutical production and GMP grade B, C and D clean room operations as well as giving technical support to health and safety specialists.

Andreia Ferreira graduated with a degree in chemical engineering from Instituto Superior Técnico, Universidade de Lisboa and has a diploma in health and safety management. In 2011, Andreia joined Hovione as an HSEE technical expert and a year later she was appointed head of HSEE, responsible for the HSE management systems, the operational safety of the site, training and HSEE assessments for new processes and installations. Since 2015, Andreia has been the head of HSEE management systems at Hovione, being responsible for the health, safety and environmental certification of the site as well as the occupational hygiene monitoring.

João Reis is a senior engineer at the tech transfer group of R&D pilot plant operations at Hovione FarmaCiencia SA. João joined Hovione in 2010 and, since then, has worked as a process engineer at different sites (Loures, Portugal and New Jersey, US). He received a bachelor’s degree in chemical engineering a master’s in process, environment and energy, both from the University of Coimbra, Portugal. Currently, he handles the start-up of opera­tions in new equipment/buildings, introduction of new technologies and enhancement of containment solutions across a wide range of manufacturing processes (API synthesis, intermediate drug product and final dosage forms).