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6th Annual Highly Potent Active Pharmaceutical Ingredients Online Summit

  • 10th – 11th March 2021
  • Hopin flag Hopin
  • ONLINE

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.

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About the 6th Annual Highly Potent Active Pharmaceutical Ingredients Online Summit

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:

  • Business Development
  • Engineering
  • External Supply
  • Formulation Development
  • Health, Safety & Environment (HSE) 
  • Industrial Hygiene 
  • Laboratory Services 
  • Manufacturing
  • New Products
  • New Technologies
  • Outsourcing
  • Occupational Toxicology
  • Process Development
  • Product Quality
  • Regulatory
  • Research & Development
  • Risk Assessments
  • Sales Development
  • Strategic Development
  • Validation

Key Practical Learning Points

  • EMA requirements and considerations
  • Assuring regulatory compliance with the permitted daily exposure
  • Avoiding major HPAPI project issues
  • Dealing with containment challenges
  • HPAPI facilities and process equipment design
  • Cleaning validation as one driver to prevent cross-contamination
  • How to ensure safe HPAPI handling?
  • Enhance every stage of a potent compound development strategy
  • How to improve safety and maximize manufacturing efficiencies for highly potent medicines
  • The unique Challenges in the transfer of HPAPI processes

Justin Mason-Home, UK

Director

HPAPI Project Services Limited

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 has worked glob­ally and held senior positions in potent biopharmaceutical occupational health and safety global environmental consulting, board level positions in a biotechnology company and also been involved in corporate environmental management. Justin has worked on mul­tiple ADC projects and specialises in technically complex and strategic projects, including unique experiences in managing sensitive highly potent and toxic biopharmaceutical compound matters.

Richard Denk, CH

Senior Consultant Aseptic Processing & Containment

Skan AG

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.

Dr. Ester Lovsin, CH

Head Product Stewardship and Health

Takeda

Ester Lovsin Barle, DVM, MSc, PhD, MScTox is the Head of Product Stewardship and Health at Takeda. Previously she has held corporate positions at Lonza and Novartis. Her responsibilities include regulatory and SDS related topics, scientific development and cross-organizational implementation of health based exposure limits (HBEL), compiling global policy product stewardship related process in sup­port of manufacturing in Takeda globally, as well as global implementation of industrial hygiene. She received her PhD in veterinary sciences from University of Ljubljana, Slovenia and a second masters degree in toxicology and risk assess­ment from Medical University in Vienna.Dr. Lovsin Barle is author/co-author of over 70 publications including peer-reviewed articles and book chapters. She is a member of several pharma industry and toxicological associations and boards and has served as the president of the Slovenian Society of toxicology. She lec­tures at several universities. Privately she is a mother of two and is enthusias­tic about balanced and healthy lifestyle which includes components of triathlon, mountain hiking and good food.

Martin Kohan, UK

Senior Occupational Toxicologist

AstraZeneca

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, UK

Senior Principal Occupational Hygienist

SafeBridge Europe

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, US

Senior Research Fellow

Boehringer Ingelheim

Raised in Idaho and earned a BS and Ph.D.in Chemistry at Utah State University in Logan, Utah. Continued studies under the direction of Professor Albert I. Meyers at Colorado State University Fort Collins, Colorado. Started 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®, Tamiflu®. In 2002 moved to Boehringer Ingelheim Chemicals in Petersburg, Virginia as the Manager of Process Chemistry and stayed there until 2014. Between 2014 to 2019 worked at Boehringer Ingelheim Pharmaceuticals in Ridgefield, Connecticut, as a Principle Research Scientist and retired in September 2019 as a Senior Research Fellow. Recently elected to the Vice Chair of the Virginia Section of the American Chemical Society and have been consulting in the areas of process safety, HPAPIs, and Process Development.

Dr. Vincenzo De Sio, BR

Manufacturing Manager

Cristalia Prod. Quim. Farm. Ltda

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. Ildikó Ziegler, HU

Quality Assurance Manager

Vanessa Research Magyarország Kft.

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, CH

Director of Validation, Manufacturing Science & Technology

Novartis 

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, CH

Occupational Hygienist

Praevena AG

Silke Büchl is an experienced IOHA-certified occupational hygienist with about 20 years of experience in occupational hygiene. She received her IOHA certification after completing her postgraduate studies in work and health at ETH Zürich and the University of Lausanne in 2003. Before working as an occupational hygienist and deputy of the managing director at Praevena in 2014, she gained experience in the different fields of occupational hygiene, safety data sheets and hazard communication as well as participating in the internal board of OELs at Novartis.

Stefano Butti, IT

Head of Sales Group

F.P.S. 

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, IL

Powder technology – Consultant & Lecturer – Technion, Israel Institute of technology VP, business development

Superfine LTD

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, US

VP Technical Support, PharmBio

ILC Dover


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.

Martyn Ryder, UK

Business Development Manager

Solo Containment

Justin Mason-Home, UK

Director

HPAPI Project Services Limited

Richard Denk, CH

Senior Consultant Aseptic Processing & Containment

Skan AG

Dr. Ester Lovsin, CH

Head Product Stewardship and Health

Takeda

Martin Kohan, UK

Senior Occupational Toxicologist

AstraZeneca

Martin Axon, UK

Senior Principal Occupational Hygienist

SafeBridge Europe

Jack Brown, US

Senior Research Fellow

Boehringer Ingelheim

Dr. Vincenzo De Sio, BR

Manufacturing Manager

Cristalia Prod. Quim. Farm. Ltda

Dr. Ildikó Ziegler, HU

Quality Assurance Manager

Vanessa Research Magyarország Kft.

Andreas Schreiner, CH

Director of Validation, Manufacturing Science & Technology

Novartis 

Silke Büchl, CH

Occupational Hygienist

Praevena AG

Stefano Butti, IT

Head of Sales Group

F.P.S. 

Guy Samburski, IL

Powder technology – Consultant & Lecturer – Technion, Israel Institute of technology VP, business development

Superfine LTD

Scott Patterson, US

VP Technical Support, PharmBio

ILC Dover

Martyn Ryder, UK

Business Development Manager

Solo Containment

RECORDING 

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What our
participants
are saying

"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."

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Richard Denk

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."

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Paolo Bento

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."

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Jessica Pearson

Occupational Hygiene Consultant at Armstrong Environmental Limited