Pharma
This event provides the appropriate platform for industry leaders to discuss process innovation and technical and safety perspectives for both Highly Potent Active Pharmaceutical Ingredient (HPAPI) manufacturers and outsourcers.
Read moreThis summit will be focusing on the latest market trends for HPAPIs; process development and scale-up; cost-effective production; containment innovations; best manufacturing practices; as well as regulatory updates.
Chief Executives, Vice Presidents, Directors, Department Heads, Leaders, Senior Managers, Principal Scientists, Principal Toxicologists, Fellows and Investigators Specialising in:
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Alessandro Brigo is a senior principal scientist and toxicology project leader in the pharmaceutical sciences organisation at the Roche Innovation Center Basel, Switzerland. In this role, Alessandro leads drug discovery and development programs from a toxicology perspective to provide expert support through all development phases and for marketed products.
In addition, Alessandro has been working in the field of computational toxicology since 2006, with great emphasis on the assessment of potential genotoxic impurities in active pharmaceutical ingredients at development and marketing stages. On the topic, Alessandro authored and co-authored six peer-reviewed articles and three book chapters.
Alessandro is a pharmacist by training with a PhD in pharmaceutical sciences obtained at the University of Padua, Italy, and he's a board-certified toxicologist (DABT).
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.
Ester Lovsin Barle, DVM, MSc, PhD, MScTox is corporate occupational toxicologist in the global safety, health and environment at Lonza, since September 2017. Previously, she has been the head of health hazard assessment in Novartis Global HSE & BCM, where she was responsible for scientific development and cross-organisational implementation of health based exposure limits (HBEL), and compiling global policy on occupational toxicology and patient safety related process in support of manufacturing in Novartis globally. She had been with Novartis for the past 10 years, where she received two awards for knowledge sharing and collaboration. She received her Ph.D. in veterinary sciences from the University of Ljubljana, Slovenia and a second master’s degree in toxicology and risk assessment from the Medical University in Vienna. Dr. Lovsin Barle is an author/co-author of over 60 publications including peer-reviewed articles and book chapters. She is a member of several toxicological associations and boards and has served as the president of the Slovenian Society of Toxicology. She lectures at several universities and is a frequent invited speaker at congresses and conferences related to chemical safety and occupational toxicology.
Richard Denk has studied mechanical engineering and did an examination on experts of GMP, qualification and validation, pharmaceutical auditing, pharmaceutical engineering and quality control at the Albstadt-Sigmaringen University of Applied Sciences in Germany. Richard works at SKAN AG, headquartered in Allschwil, as the head of sales containment. Eight years ago he founded the expert containment group of the ISPE D/A/CH, and in 2015 they published the Containment Manual. Richard has spent nearly 20 years with the production of highly active and highly hazardous substances and has developed the containment pyramid.
A European Registered toxicologist with over 40-years of experience in the pharmaceutical industry. Providing services for toxicological hazard assessment and communication, particularly with respect toxicological risk assessment contributing to articles on derivation of Occupational Exposure Limits (OELs) and Occupational Exposure Bands (OEBs), Acceptable Daily Exposure (ADE)/Permissible Daily Exposure (PDE) values for cross-contamination. With considerable experience in classification and labelling, SDS production and toxicity testing including replacement, reduction and refinement of animal tests.’
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.
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.
Graham Box is the Strategic Venture Manager at Fujifilm Diosynth Biotechnologies, Billingham, UK site. He has receive a B.S. in Pharmacology and B.A. in Business Management from the University of Sunderland. With 20 years experience in pharmaceuticals encompassing an expansive set of roles ranging from QA, QC to Manufacturing, Project and Capital Management. He has delivered GMP operational HPAPI facilities for multiple biologic derived therapeutics at Fujifilm. His current role involves implementation of key strategic projects to meet the needs of clients requiring a Contact Development and Manufacturing Organisation in both Microbial and Mammalian biotechnology platforms.
Dr. Alexandru Gheorghe is a Group Leader and Senior Project Manager at Evonik Nutrition & Care GmbH. Alex has a background in organic synthetic chemistry. He joined Evonik in 2006 as a Head of Laboratory, working in the process development department with focus on transferring chemical synthesis into production plants. He has expertise in project management and optimization of manufacturing processes for intermediates and APIs. He spent five years at several Evonik’s locations in the UK, Canada and France, where he successfully completed various projects. He is currently leading the HPAPI laboratory in Hanau and was project responsible for the cGMP qualification of the HPAPI Lab. He is member of Evonik’s HPAPI core team which developed a harmonized internal global OEL banding system, and provides global best practice procedures in accordance to the OEBs for drug substances and products.
Director of Toxicology Services at Patheon, with over 14 years experience in the pharmaceutical industry, in particular in the field of occupational toxicology. Involved in assessing the toxicity of active pharmaceutical ingredients in order to assign appropriate categorizations/bands and develop occupational exposure limits. Also involved in reviewing whether the handling of compounds complies with the requirements for Good Manufacturing Practice (GMP) in a multi-product facility. A full member of the U.S. Society of Toxicology, and a member of the Society of Toxicology of Canada, with a Ph.D. in Pharmacology and Molecular Toxicology from the University of Toronto. Also, an author of several peer-reviewed publications, a frequent guest lecturer at the University of Toronto, and a presenter at various international scientific meetings, conferences, and universities, in North America and Europe.
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.
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.
Tim Briggs is a Past President of the Institution of Occupational Safety and Health (IOSH). He has been involved with IOSH in many different roles. Tim was employed at Leeds Beckett University as the Course Director for the BSc Hons Safety Health and Environmental Management Degree, the Post Graduate Diploma in Occupational Safety and Health and MSc in Occupational Safety and Health until retirement through ill health in 2020. He has since returned on a part time basis, to assist the University using his knowledge, experience, and skills to deliver teaching. He has acted as an external examiner and external advisor to many Universities in the UK and worldwide in helping develop advanced Health and Safety courses. His wide involvement in developing Safety Practitioner knowledge and skills in the international arena has allowed Tim to work and develop Health and Safety courses not only in Singapore but also in Malaysia and Hong Kong. Tim has spoken at many international events on his favorite topic of helping organizations develop whilst keeping the workforce safe. He is a graduate of Huddersfield, Nottingham Trent University, and Leeds Beckett University.
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.
Michael graduated with a BEng Mechanical Engineering in 1990 and since progressed through a range of industries, including Engineering, Petrochemical and for the last 20 years, the Pharmaceutical Industry. With his expertise and knowledge of the Pharmaceutical industry, Michael has been instrumental in the design of turnkey containment systems, integrating an array of process equipment, whilst innovating and directing the development of new high containment split valve technology to service the handling of HPAPI’s. During his time at ChargePoint, Michael lead the innovation of products and process accessories during the early development of ChargePoint and has since been responsible for the development and evolution of the ChargePoint split butterfly valve. Michael is principally involved in technical discussions with process and containment specialists at a corporate level, within pharmaceutical organizations including GSK, AstraZeneca, Pfizer and Roche. He is also responsible for consulting with senior process specialists at global pharmaceutical facilities, OEM’s and engineering organisations within the USA, Europe, China, Singapore, India and Japan, to review, support and identify appropriate process containment solutions, process requirements and provide optimised containment options. With Michael’s knowledge and industry expertise, he has been chosen to speak on diverse containment related topics within various industry forums and events across the globe.
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