Welcome to the 6th edition of the Highly Potent Active Pharmaceutical Ingredients Summit, this time online.
This event provides its participants access to other industry leaders and an environment to discuss process innovation and technology and safety perspectives for highly potent active pharmaceutical ingredient (HPAPI) manufacturers and outsourcers.Read more
This event will enable the participants to learn about the latest developments in the HPAPI Industry. This Summit will be focusing on latest market development trends in the highly potent active pharmaceutical ingredients, global standards, innovation challenges & expectations, sustainability, emerging markets, future trends & technological developments, etc.
Who Should Attend
Chief Executives, Vice Presidents, Directors, Department Heads, Leaders, Senior Managers, Principal Scientists, Principal Toxicologists, Fellows and Investigators specializing in:
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.
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 University of Applied Sciences in Albstadt/Sigmaringen, Germany. Richard works at SKAN AG, headquartered in Allschwil, as the head of sales containment. He founded the expert containment group of the ISPE DACH eight years ago. The containment group published the containment manual in September 2015. Richard has spent nearly 20 years working with highly active/highly hazardous substances and has developed the containment pyramid.
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.
BSc/MSc in Biochemistry from La Plata National University, Argentina; MSc in Pharmacology and Ph.D. in Medical Sciences both from the Hebrew University of Jerusalem, Israel. Over 10 years of industry experience in the field of Toxicology conducting and managing over 1000 hazard and risk assessments, including calculation of exposure limits and/or determination of exposure control bands for drug substances and isolated intermediates and quality deviations (impurities and extractables & leachables) for Teva (2010 to 2018) and AstraZeneca (2018 to present). Diplomate of the American Board of Toxicology (DABT), European Registered Toxicologist (ERT), and Member of the UK Register of Toxicologists and the British Toxicology Society.
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.
Jack Brown was raised in Idaho (USA) and earned a BS and PhD in chemistry at Utah State University in Logan, Utah. He continued studies under the direction of Professor Albert I. Meyers at Colorado State University in Fort Collins, Colorado. Jack started his professional career at Syntex Chemicals, as a principle scientist followed by working for Hoffmann La Roche, until 2002, and rose to the rank of distinguished scientist while working on multiple projects, such as Naproxen®, Saquinavir®, and Tamiflu®. In 2002, he moved to Boehringer Ingelheim Chemicals in Petersburg, Virginia, as the manager of process chemistry and stayed there until 2014. From 2014-19 he worked at Boehringer Ingelheim Pharmaceuticals in Ridgefield, Connecticut, as a principle research scientist and retired in September 2019 as a senior research fellow. Recently, he was elected to the vice chair of the Virginia section of the American Chemical Society and has been consulting in the areas of process safety, HPAPIs, and process development.
Dr. Vincenzo De Sio, MSc, Ph.D., has extensive experience in organic chemistry and handling of highly potent compounds. He worked as a researcher for the HPAPIs R&D department of Chemi-ITF (Frosinone, Italy) and responsible for the technology and methodology transfer. From 2014 to 2018, he collaborated on the designing and start-up of Cristalia´s new plant for HPAPIs. He is currently Head of Cristalia’s HPAPIs department (R&D and Manufacturing) in Itapira/SP – Brazil. He is responsible for the Cristália’s plant of HPAPIs and for the deactivation system of wasting residues. He is the author of several scientific publications and patents.
Dr. Ildiko Ziegler has been a professional for more than 15 years in the pharmaceutical industry, has extensive experience in QA, fulfills the QA manager role at Vanessa Research. She has been a validation and quality risk expert for almost 10 years. Ildiko obtained M.Sc. 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 Ph.D. at the BUTE in 2000 and obtained the Géza Schay Award for the achievements in the field of physical and theoretical chemistry.
Andreas Schreiner graduated from the University of Erlangen, Germany, in 1996 in Chemical Engineering. After a Ph.D. and a scholarship at the University College London, he joined Roche Vitamins as Head of Solids Processing. Since 2006 Andreas Schreiner worked for Novartis in various departments with increasing responsibilities from project leader to global technology platform leader; currently, he is heading the validation activities for pharmaceutical production of solid dosage forms. Andreas Schreiner is appointed board member at various scientific organisations (Executive Board of European Federation of Chemical Engineers (EFCE), Swiss Society for Process Engineers (SGVC), Industrial Society for Pharmaceutical Engineering (ISPE), Swiss Laboratory of Material Science and Technology (EMPA)). Since 2013 he works for the Manufacturing Science & Technology Department as Validation Head for Solid Dosage Forms.
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.
Stefano Butti has studied Mechanical Engineering at the 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 various articles in a 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 a direct role in the definition of containment system upgrade and optimization for the handling of products with OEL down to ng level w ith successful results. During nearly 19 years spent in this field he has also successfully coordinated several projects, handling a combination of a sterile and toxic compounds.
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.
Guy Samburski is VP for business development in Superfine LTD. He is also a lecturer at the chemical engineering faculty in the Israeli Institute of Technology (Technion). With over 20 years of experience in the pharmaceutical industry, he held various positions of R&D and marketing in Teva Pharmaceuticals. As senior director for Technology, he led the implementation of new manufacturing technologies in Teva’s chemical business.
Guy holds an MSC in Chemical engineering and an MBA. He specializes in crystallization and powder technology. He has 11 approved patents in the fields of chemistry, crystallization, and processing methods.
Scott Patterson is the Subject Matter Expert for ILC Dover in containment applications as well as powder processing solutions. With a diverse background covering 42 years of process knowledge, including pharmaceutical, biopharmaceutical, food, and plastics processing systems, he supports global innovation and implementation for single use products when handling HPAPI. With a focus on containment, he has written a series of papers on the effectiveness of flexible single use technology to achieve operator safety and mitigate cross-contamination risks.
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"Thanks for giving me the chance to talk about my view about Containment and GMP and how we have to work on it to fulfill future needs."
Senior Consultant Aseptic Processing & Containment at SKAN AG
"We had very interesting discussions with the different participants about our industry and the latest trends. Thanks to Vonlanthen for organizing another great HPAPI."
Regional Sales Manager at ILC Dover
"Big thank you to all the speakers at the #5VLHPAPI Summit in Rome. Fantastic insights from a diverse group of industry experts and great presentations from all involved."
Occupational Hygiene Consultant at Armstrong Environmental Limited
Oct 17, 2018
4th Annual Highly Potent Active Pharmaceutical Ingredients Summit