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2nd Annual
HIGHLY POTENTAPIsSUMMIT2020February 19-21, 2020 | Prague, Czech RepublicNovotel Praha Wenceslas Square HotelKaterinska 38, 120 00 Prague
◆ 14+ Program Hours | 8+ Networking Hours◆ Refreshments & Coffee Breaks◆ Business Lunches & Dinner ◆ Case Studies & Workshops◆ Roundtable Discussions | Q & A
SILVER SPONSOR
BRONZE SPONSOR
BRONZE SPONSOR
BRONZE SPONSOR
Ester Lovsin Barle, PhD, MScTox, ERTHead Product stewardship and Health Takeda, CH
CHAIR DAY 1Jeremy Justin Mason-Home, BSc (Hons), FRSCDirector HPAPI Project Services Limited, UK
CHAIR DAY 2 & DAY 3
Dr. Ulrich RümenappHead of Launch Preparation and CoordinationBayer AG, DE
Silke BuechlDeputy Managing Director, Occupational HygienistPraevena AG, CH
Dr. Thomas AdamHead of GQA Chemical APIsBayer AG, DE
Dr. Ramona LabatzkeChemistPraevena AG, CH
Dr. Andreas Flueckiger Consultant Occupational Toxicology and Containment, Head of Occupational Health @ Roche (retired), Andreas Flueckiger Consulting, CH
David Eherts PhD CIHVice President Global EHSAllergan plc, USA
Dr. Ildikó Ziegler Quality Assurance ManagerVanessa Research, HU
Dr. Florian GrundmannMSAT Team Leader Cleaning Validation F. Hoffmann-La Roche AG, CH
Martin Axon, CFFOH, CMIOSHPrincipal Occupational HygienistSafeBridge Europe, Ltd., UK
Dean CalhounPresident and CEOAffygility Solutions, USA
Maurits Janssen, Ph.D.Vice President, Head of Commercial Development, API Development & ManufacturingLonza AG, CH
Scott PattersonVice President Pharma/BioPharma Technical Support ILC Dover, USA
Patrick ScanlonGlobal Product Director Hebeler Process Solutions LLC, USA
Dr. Ing. Olindo Lazzaro, PE, CSP, MBADirector, Global EHS Technical OperationsAbbVie, IT
INDUSTRIES◆ Pharmaceutical◆ Biotechnology◆ Chemical◆ CMOs/CDMOs◆ CROs ◆ NOPs
COMPANIES◆ API & HPAPI manufacturers & suppliers◆ Bioprocessing services and equipment◆ EHS consultancies◆ Engineering contractors◆ Equipment suppliers◆ Exposure and containment solution providers◆ Finance and investment institutions◆ Handling and containment services◆ Occupational and industrial health & safety advisors◆ PPE manufacturers◆ Raw materials suppliers◆ Safety services◆ Training providers
◆ Other
POSITIONS◆ C-Level, Presidents, Chairs, Members of the Board & VPs◆ Vice presidents, Directors, & Heads◆ Leaders & Managers◆ Principals, Engineers, Analysts & Scientists◆ Instructors & Trainers & Teachers◆ Advisors, Coordinators, Auditors & Consultants◆ Toxicologists, Chemists, Hygienists Physicians, & Engineers◆ Coaches, Consultants, Supervisors, & Advisers◆ Other Professionals, Experts & Specialists
DIVISIONS◆ Plant & Site Management◆ Process Chemistry◆ Process Development & Engineering◆ Quality Control & Assurance◆ Raw Materials◆ Regulatory◆ Research & Development◆ Risk Assessment, Evaluation & Mitigation◆ Sales Development◆ Strategic Development◆ Toxicology◆ Validation◆ Other
◆ Extraction◆ Facility Design & Equipment Selection◆ Formulation Development◆ Hazard Assessments◆ Industrial Hygiene◆ Isolation◆ Laboratory Services◆ Manufacturing◆ Marketing◆ Materials Management◆ New Technologies◆ Occupational Toxicology◆ Outsourcing◆ Partnerships & Alliances
◆ ADC & New Molecules◆ ADE, PDE, OELs, OEBs◆ API, HPAPI & Impurities◆ Aseptic Processing◆ Chemical Manufacturing, Processes & Synthesis◆ Cleanrooms◆ CMC◆ Compounds Manufacturing◆ Containment◆ Contamination◆ Corporate & Business Development◆ Drug Process Development◆ Environmental, Health & Safety◆ External Supply
🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]
SNAPSHOT OF ATTENDEES - Highly Potent APIs Summit 2019:- Affygility Solutions - Ardena - ARTeSYN Biosolutions - Bayer AG - Bayer Consumer Care AG - Biocon - Bristol Myers Squibb - Celgene - ChargePoint Technology Ltd - EVER Pharma Jena GmbH - Gedeon Richter - GlaxoSmithKline - Guido Maik Consulting - Hebeler Process Solution LLC - HPAPI Project Services Limited - ILC Dover - Ipsen - JLS International Germany - Krka, d.d., Novo mesto - Leeds Beckett University - Lonza - Lonza Pharma & Biotech - Lusochimica SpA - Merck Group - Minaken - Mitsui & Co. Italia S.P.A. - MSD - Novartis - Novasep - Oriento SA - Patheon, part of Thermo Fisher Scientific - Piramal Pharma Solutions - Pliva Croatia Ltd, TAPI Croatia - Praevena AG - Regeneron Pharmaceuticals, Inc - Skan AG - Takeda Ireland Limited - Umicore AG & Co KG - OthersAgenda: https://qepler.com/pdf/hpapi.pdf
SNAPSHOT OF ATTENDEES - Genotoxic Impurities in Pharmaceuticals Summit 2019:Abbott Healthcare Products B.V. - Alkaloid AD - Angelini - Astellas Pharma Europe BV - AstraZeneca - Bayer AG - Bristol-Myers Squibb - Charles River Laboratories - Cipla Limited - Elanco Animal Health - Elpen Pharmaceutical Co.Inc. - Eurofarma labs - F. Hoffmann-La Roche Ltd - Fresenius Kabi Deutschland GmbH - GlaxoSmithKline - Intertek (Schweiz) AG - Lhasa Limited - Merck & Co., Inc. - Nelson Labs Europe - S-IN Soluzioni Informatiche Srl - SCIEX - Smithers Rapra Ltd. - Teva - Teva Pharmaceutical Industries Ltd. - ToxMinds BVBA - UCB Biopharma sprl. - OthersAgenda: https://qepler.com/pdf/genetoxic.pdf
SNAPSHOT OF ATTENDEES - Extractables & Leachables Summit 2019:Abbvie - Bayer AG - AiCuris Anti-infective Cures GmbH - Datwyler Pharma Packaging International NV - GlaxoSmithKline - Merck - Nelson Labs - Novartis Institutes for BioMedical Research - Novo Nordisk A/S - Pall Biotech - Sanofi - Sartorius Stedim Biotech - SCHOTT AG - SGS Institut Fresenius GmbH - Smithers Rapra Ltd. - West Pharmaceutical Services GmbH & Co. KG - Angelini ACRAF s.p.a. - B. Braun - Borealis Polymere GmbH - Claudia Heldt - Daicel Chiral Technologies (India) Pvt Ltd - Datwyler Sealing Solutions - EirGen Pharma - GSK - Hall Analytical Laboratories Limited - HTL-Strefa S.A. - Iterum Therapeutics - Lyomark Pharma GmbH - Medichem - Novo Nordisk - PHARMIDEA SIA - RMS Foundation - Sandoz - SAS Laboratoire Aguettant - SE Tylose GmbH & Co. KG - Vifor (International) AG - ZETA GmbH - Intertek (Schweiz) AG - Purus Plastics - F. Hoffmann-La Roche Ltd - Maven E&L Ltd - Safetree Consulting e.U. - Patheon, by Thermo Fisher Scientific - Brooks Life Sciences - Lek Pharmaceuticals d.d. - Medicom Healthcare Limited - OthersAgenda: https://qepler.com/pdf/enl.pdf
WHO YOU WILL MEET
🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]
SILVER SPONSOR
Beyond Boundaries™.Innovators at our core, we developengineered solutions for ourcustomers’ complex problems.Recognized globally for ourflexible containment solutions,ILC Dover serves customers ina diverse range of industries,including pharmaceutical andbiopharmaceutical manufacturing,personal care, food and beverage,chemical, aerospace, healthcareand government agencies. At ILCDover, quality is a culture, not ameasurement. Our customerswill tell you that we cater to theirevery need and that we’re highlyinnovative, responsive, dedicatedand competitive. We have beeninnovating since 1947. ILC Dover’svisionary solutions improveefficiency, safeguard workers andproduct, and prevent disasters –proof that we are on the front line ofbusiness excellence.Engineering evolution beyondboundaries.
OUR SPONSORS
BRONZE SPONSOR
Specialty expertise in highly potent
APIs Identifying a collaboration partner that can meet the aggressive timelines often associated with highly potent drug candidates is critical. At Lonza Pharma & Biotech, we offer the necessary development, upscalingand manufacturing capabilities under full containment that support API handling to exposure levels to 1ng/m3.
We also offer particle engineering(particle size reduction and spray drying) under isolation as well as specialized dosage forms designed for highly potent, low dose applications. We have more than 20 years’ track record in HPAPI manufacturing and compressed scale-up timelines.
A partner that you can count on for all aspects of your drug program – Lonza.
Visit pharma.lonza.comEmail [email protected]© 2020 Lonza. All rights reserved.
HIGHLY POTENTAPIs
SUMMIT2020
February 19 | Prague, Czech Republic08:00 - 08:30 ✍ Registration and Welcome Coffee
08:30 - 08:40 🎤 Opening Address from the Chairman
09:20 - 10:00 🤝 Speed Networking
08:40 - 09:20
10:00 - 10:40
11:10 - 11:50
11:50 - 12:30
10:40 - 11:10 🍵 Morning coffee and networking break
12:30 - 13:30 🍽 Business lunch
🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]
Containment Targets, Occupational Hygiene (OH) Long Range Plan & Pharmaceuticals in the Environment (PiE) Strategy at AbbVie
◆ High Containment Compounds and AbbVie Pipeline◆ Containment Targets and Occupational Hygiene (OH) Long Range Plan◆ Risk Assessment and Occupational Hygiene (OH)Metrics ◆ Pharmaceuticals in the Environment (PiE) Strategy ◆ New Product Introduction and Tech Transfer
Dr. Ing. Olindo Lazzaro PE, CSP, MBA | Director, Global EHS Technical Operations | AbbVie, IT
APIs and Toxins/Linkers for Antibody Drug Conjugates: A Vision on Highly Potent Development, Scale-up and Manufacturing
Drug product development based on potent compounds can be quite challenging. Complications with the interface between operations in drug substance and drug product handling can also result in increased program complexity and cost. This also applies when the potent compound is used as toxin/linker for application in ADCs.In this presentation, we will elaborate on best practices and requirements that facilitate accelerated timelines to clinic & market:
◆ Internal procedure GMP-guide in handling high potent compounds◆ Internal procedures to minimise the risk of handling HPAPIs to workers◆ Deciding the correct control based on a correctly identified hazard
Maurits Janssen, Ph.D. | Vice President, Head of Commercial Development, API Development & Manufacturing | Lonza AG, CH
HPAPI Handling from Lab Bench to Pilot Plant
◆ Internal procedure GMP-guide in handling high potent compounds◆ Internal procedures to minimise the risk of handling HPAPIs to workers◆ Deciding the correct control based on a correctly identified hazard
Dr. Thomas Adam | Head of GQA Chemical APIs | Bayer AG, DE
BRONZE SPONSOR
Versatility when implementing Flexible Containment Systems for HPAPI handling
In this presentation the benefits of using flexible containment systems are discussed. The benefits explored will include ergonomics, retrofitting of existing equipment, adaptability for process changes, and ownership costs. Flexible isolator systems will be presented along with powder transfer technology. Performance data will also be discussed to demonstrate the value of flexible containment systems includes the ability to meet nanogram level containment.
Scott Patterson | Vice President Pharma/BioPharma Technical Support | ILC Dover, USA
SILVER SPONSOR
HIGHLY POTENTAPIs
SUMMIT2020
February 19 | Prague, Czech Republic
14:50 - 15:20 🍵 Afternoon coffee and networking break
17:40 - 18:00 🎤 Chairman’s closing remarks and end of day one
19:00 - 21:00 🥂 Business dinner
14:10 - 14:50
15:20 - 16:40
16:40 -17:40 💡 Panel Discussion
🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]
The Value of Containment Technology: A Comprehensive Business Case for Driving Implementation
◆ Describe quantitatively, the value that Containment brings beyond simply employee exposure control◆ Explain how containment advances a manufacturing process from “Stable” to “Robust and Resilient”◆ Specifically identify the benefits to (1) Patients, (2) Regulators, (3) Company Leadership and (4) Shareholders
David Eherts PhD CIH | Vice President Global EHS | Allergan plc, USA
PDE evaluation and OEL setting in an HPAPI environment, regulatory considerations
◆ Health Based Exposure Limits (HBELs): what are they, how are they defined, why are they needed?◆ PDEs in addition to or instead of the old standards for calculating GMP cleaning limits? ◆ When are PDEs needed in GMP? Available guidance for setting such limits◆ Common pitfalls when setting HBELs Dr. Andreas Flueckiger | Consultant Occupational Toxicology and Containment, Head of Occupational Health @ Roche (retired) | Andreas Flueckiger Consulting, CH
13:30 - 14:10
Assessing Containment Performance of Continuous Table Coating Equipment
◆ Operation of the GEA tablet coater. ◆ Working with GEA to make preparations for the project.◆ Assessments during operation and during disassembly/cleaning.◆ Outcomes: suitability of the equipment to process tablets containing potent API.
Martin Axon, CFFOH, CMIOSH | Principal Occupational Hygienist | SafeBridge Europe, Ltd., UK
HIGHLY POTENTAPIs
SUMMIT2020
February 20 | Prague, Czech Republic08:00 - 08:30 ✍ Registration and Welcome Coffee
08:30 - 08:40 🎤 Opening Address from the Chairman
08:40 - 09:40
11:10 - 11:30
09:40 - 10:40
🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]
10:40 - 11:10 🍵 Morning coffee and networking break
11:30 - 12:10
Health Based Exposure Limits 2020: Do we have 2020 vision now?
In this 20-minute presentation, Dean Calhoun, President and CEO of Affygility Solutions will discuss the brief history of health based exposure limits since its June 2015 effective team; common challenges and misunderstandings regarding HBELs; and future trends and where we are heading with HBELs.
Dean Calhoun | President and CEO | Affygility Solutions, USA
12:10 - 13:10 🍽 Business lunch
13:10 - 13:30 Vacuum Drum Drying For HPAPI Application Streams
◆ Hebeler Process Solutions, Buflovak and PK introduction ◆ Applying Vacuum Drum Drying Technology to HPAPI Application Streams ◆ Operation, Containment, and Performance During the HPAPI Drying Process ◆ Laboratory to Production Scale-Up Synopsis
Patrick Scanlon | Global Product Director | Hebeler Process Solutions LLC, USA
Production of Highly Active Substances in Shared Facilities - A Risk for Patients?
◆ Cross-contamination risk in the manufacture of HPAPIs◆ Risk mitigation measures according to ch. 5 of EMA’s GMP Guidelines◆ Examples from oral and parenteral drug manufacture
Dr. Andreas Flueckiger | Consultant Occupational Toxicology and Containment, Head of Occupational Health @ Roche (retired) | Andreas Flueckiger Consulting, CH
Workshop - Skills of an occupational hygienist
◆ How to do exposure measurement ?◆ How to observe processes ?◆ How to write a report ?◆ Which other skills are needed for an occupational hygienist with focus on exposure measurement ?
Silke Buechl | Deputy Managing Director, Occupational Hygienist | Praevena AG, CHDr. Ramona Labatzke | Chemist | Praevena AG, CH
Workshop - Components of successful hazard communication
◆ Where is the data◆ Best practices in communicating the hazards◆ Making decisions based on poor datasets
Ester Lovsin Barle, PhD, MScTox, ERT | Head Product stewardship and Health | Takeda, CH
BRONZE SPONSOR
BRONZE SPONSOR
HIGHLY POTENTAPIs
SUMMIT2020
February 20 | Prague, Czech Republic
14:50 - 15:20 🍵 Afternoon coffee and networking break
16:50 - 17:00 🎤 Chairman’s closing remarks and end of day two
15:20 - 16:20
14:10 - 14:50
13:30 -14:10
16:20 - 16:50 💡 Q & A
🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]
Mitigation of cross contamination risk in pharmaceutical production
◆ Guidelines regarding Pharmaceutical Quality Risk Management◆ Technical aspects and complexity in cross contamination risk analysis◆ Case studies
Dr. Ildikó Ziegler | Quality Assurance Manager | Vanessa Research, HU
Antibody-Drug Conjugates – antibodies meeting HPAPIs for specific and efficient bio-pharmaceutical drugs
◆ ADCs - conjugation of antibodies with small molecule toxins◆ The manufacture of ADCs - challenges and solutions◆ Bayer’s ADC production concept using HPAPIs
Dr. Ulrich Rümenapp | Head of Launch Preparation and Coordination | Bayer AG, DE
Challenges of introducing an ADC into a multi-purpose Drug Product facility
◆ Cross Contamination Control Concept ◆ Cleaning Validation and Monitoring Strategy ◆ Deriving most stringent Acceptance criteria ◆ Challenges in production routine
Dr. Florian Grundmann | MSAT Team Leader Cleaning Validation | F. Hoffmann-La Roche AG, CH
HIGHLY POTENTAPIs
SUMMIT2020
WORKSHOPS | February 21 | Prague, Czech Republic08:00 - 08:30 ✍ Registration and Welcome Coffee
08:30 - 08:40 🎤 Opening Address from the Chairman
10:10 - 10:40 🍵 Morning coffee and networking break
08:40 - 10:10
10:40 - 12:10
13:10 - 14:40
Workshop: How to make a Valid/Convincing Business Case to justify Containment and other Process Investments
◆ Dr. Eherts teaches a graduate level course at Tulane University entitled Financial Aspects of EHS Management◆ It includes a number of lectures teaching students how to complete Quantitative Cost-Benefit Analysis◆ The method will be presented and a number of case studies completed so that attendees leave with a solid understanding of the process and the ability to convince leadership to make all necessary capital investments
David Eherts PhD CIH | Vice President Global EHS | Allergan plc, USA
12:10 - 13:10 🍽 Business lunch
15:20 - 16:00 🍵 Afternoon coffee and networking break
🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]
A Hard Business-Focussed Approach to HPAPI Projects
◆ Key HPAPI project strategic business decisions◆ Fundamental project skills underpinning HPAPI projects◆ HPAPI project design elements◆ Capital facility and equipment “hardware”◆ Project revenue elements and their costs◆ Pitfalls and how to avoid them
Jeremy Justin Mason-Home, BSc (Hons), FRSC | Director | HPAPI Project Services Limited, UK
15:10 - 15:20 🎤 Chairman’s closing remarks
14:40 - 15:10 💡 Q & A
Workshop 2 - SMEPAC Monitoring
◆ What is SMEPAC about ?◆ How to execute SMEPAC Monitoring ?◆ How to judge results from SMEPAC monitoring ?◆ What are the challenges of SMEPAC monitoring ?
Silke Buechl | Deputy Managing Director, Occupational Hygienist | Praevena AG, CHDr. Ramona Labatzke | Chemist | Praevena AG, CH
HIGHLY POTENTAPIs
SUMMIT2020
February 19-21 | Prague, Czech Republic
BIOGRAPHIES
🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]
Jeremy Justin Mason-Home, BSc (Hons), FRSCDirectorHPAPI Project Services Limited, UK
Jeremy Justin Mason-Home, BSc (Hons), FRSCDirector, HPAPI Project Services LimitedJustin Mason-Home is an organic chemist with extensive health, safety, environmental and chemical engineering experience in senior technical, legal and commercial aspects of the biopharmaceutical, industries. He has held senior positions and worked globally in potent biopharmaceutical occupational health and safety global environmental consulting, board level positions in a biotechnology company and corporate environmental management. Mr Mason-Home specialises in technical complex and strategic projects, including unique experience in managing sensitive highly potent and toxic biopharmaceutical compound matters.
Dr. Ulrich RümenappHead of Launch Preparation and CoordinationBayer AG, DE
Dr. Rümenapp is based in Wuppertal, Germany and 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, Dr. Rümenapp was head of biotech projects in Product Supply Biotech at Bayer, where he was responsible for contract manufacturing partnerships in the field of biotechnological drug substances, drug products, and interdisciplinary project management with the goal to ensure market supply. Before it was acquired by Bayer, Dr. Rümenapp held a similar position at Schering AG, and before that, he worked in the production & logistics department of Schering, where he was responsible for production aspects of in-and-out-licensing deals, due diligences, and product acquisitions of small molecule products and biologics. Dr. Rümenapp studied chemistry and holds a Ph.D. 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, Dr. Rümenapp’s area of expertise is the set-up and management of external relationships for the development and supply of bio-pharmaceutical products. He has more than 15 years of experience in the bio-pharmaceutical industry.
Ester Lovsin Barle, PhD, MScTox, ERTHead Product stewardship and Health Takeda, CH
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.
Silke BuechlDeputy Managing Director, Occupational hygienistPraevena AG, CH
Silke Büchl is an experienced IOHA certified Occupational hygienist with about 20 years of experience in occupational hygiene.She received the IOHA certified Occupational Hygienist after the postgraduate studies for work and health at ETH Zürich and Uni Lausanne in 2003. Bevor she started as Occupational Hygienist and deputy of the managing director at Praevena in 2014 she gained experiences in the 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 of Occupational Exposure Limits at Novartis.Praevena is a company which provides services in all topics of Occupational Hygiene as well as exposure monitoring.
Dr. Ramona LabatzkeChemistPraevena AG, CH
Ramona Labatzke graduated in chemistry at the Albert-Ludwigs-University in Freiburg (Germany) in 2008. She finished her dissertation in biochemistry on crystal structure determination of a protein subfragment at the Albert-Ludwigs-University in Freiburg in 2011. Part of her work was published in the professional journal Biochemistry. Further education in toxicology and knowledge of the law relevant for scientist was acquired during her dissertation. Since 2013 her field of work is in occupational hygiene at Praevena AG in Rheinfelden (Switzerland). She gained professional knowledge regarding occupational hygiene and safety at work with focus in pharmaceutical and chemical industries. The wide knowledge and the regular exchange of information with professionals allows her to provide profound counselling.
Dr. Thomas AdamHead of GQA Chemical APIsBayer AG, DE
Thomas Adam studied Chemistry at the University in Saarbruecken and Mainz, Germany. After post-doc at Novartis, Switzerland, he joined Bayer AG. He worked in different Q-functions. Since 2011 he is Head of GQA-Chemical APIs within Chemical Development Department at Bayer AG and responsible for the release of APIs for clinical trials, Qualification,Validation and Supplier Qualification.
HIGHLY POTENTAPIs
SUMMIT2020
February 19-21 | Prague, Czech Republic
BIOGRAPHIES
🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]
Dr. Andreas FlueckigerConsultant Occupational Toxicology and Containment,
Andreas Flückiger, MD, holds Swiss Governmental certifications in General Internal and Occupational Medicine. Before his retirement from the company in 2018, he was Chief Occupational Health Officer for the Roche Group for over 32 years. In this corporate function, he managed Roche’s occupational health and it its hazard assessment programs. This activity included standard-setting, auditing and teaching activities in the broader field of SHE, but in particular in occupational health. Between 1986 and 2018, he and his team have set health-based exposure limits for over 2000 molecules. He is has participated in numerous training courses on the GMP context in which these limits are used, in particular quality risk management in multi-product facilities. Andreas Flückiger is a member or honorary member in several professional organizations.He now continues to work as a consultant mainly in the areas of occupational toxicology, exposure control and general EHS matters.
David Eherts PhD CIHVice President Global EHSAllergan plc, USA
Dr. Eherts joined Allergan (then Actavis) Pharmaceuticals in March of 2014 as Vice President of Global EHS. Allergan is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.Prior to Allergan, David has worked over 30 years in the fields of Safety and EHS starting as a toxicologist in Pre-Clinical Drug Safety Assessment at Merck. He moved to EHS and has held positions of increasing responsibility at Merck, Sanofi-Aventis, Purdue Pharmaceuticals and just prior to Allergan, he led Aviation and Product Safety at Sikorsky Aircraft as their Vice President and Chief Safety Officer. His experience and expertise span aviation, human and organizational performance (HOP), environmental toxicology, occupational health, potent compound control and management systems in the aerospace, healthcare and pharmaceutical industries. Dave holds Bachelor’s degrees in Chemistry and Biology and a Masters and PhD in Environmental Toxicology from Drexel University.In addition to his day job, David was recently appointed by the US Secretary of Labor to the Federal Whistleblower Protection Advisory Committee. Less controversially, he’s served on advisory boards for ORCHSE’s Executive Business Issues Forum, CAE Flight Training and the board of directors for Occupational Knowledge International (an NGO dedicated to preventing overexposures to toxic chemicals in developing countries) and SoundWaters (protecting the environment of Long Island Sound). In his spare time, he’s an adjunct professor at New York Medical College and at Tulane University where he teaches courses in EHS Management, Finance, Environmental Toxicology, Industrial Hygiene and Occupational Health.
Dr. Florian GrundmannMSAT Team Leader Cleaning ValidationF. Hoffmann-La Roche AG, CH
Dr. Florian Grundmann is currently Group Lead Cleaning Validation, Manufacturing Science and Technology at the Roche Kaiseraugst Sterile Production.Dr. Grundmann studied Pharmacy and earned his Ph.D in molecular biotechnology from Frankfurt University in Germany und subsequently fulfilled several functions with increasing responsibility in pharma manufacturing. He started in the production department of Novartis Pharma Stein AG where he obtained his Lean Six Sigma Green Belt with the technical stabilization of a prototype capsule filler (MG2 Multiflexa) for new inhalation drugs. At Roche in Basel he continued in small molecules drug product Manufacturing Science and Technology with focus on transfers, cleaning validation, cleaning process development and the implementation of continued process verification. After a global assignment where he was responsible, to improve DMS and CAPA performance at the Roche small molecules manufacturing network he worked in the biologics drug substance quality department responsible for the quality oversight for validations. In his latest position as Group Lead Cleaning Validation for steriles manufacturing (biologics and small molecules drug product) he and his team are responsible for cleaning validation oversight & execution from conception to implementation to realization to documentation to life cycle management as well as ensuring compliance to cGMP, PQS and Health authority requirements.
Maurits Janssen, Ph.D.Vice President, Head of Commercial Development, API Development & ManufacturingLonza AG, CH
Maurits Janssen is currently Vice President, Head of Commercial Development for the Active Pharmaceutical Ingredient (API) Business Unit at Lonza.Mr. Janssen earned his Ph.D. in organic chemistry from Utrecht University in The Netherlands (1996) and subsequently fulfilled several functions with increasing responsibility in consulting, marketing & sales and research & development.Mr. Janssen has over 20 year experience in chemical and pharmaceutical industry and over 15 years in the custom manufacturing of active pharmaceutical ingredients.Throughout his career, Mr. Janssen worked across a broad portfolio of technologies in cGMP Chemical & Biological custom manufacturing from early stage to late phase/commercial and gained significant experience and published and presented regularly on Highly Potent Active Pharmaceutical Ingredients (HPAPI, incl. ADC). Mr. Janssen progressed a number of HPAPI programs from the clinic into the market and successfully managed capital investment strategies to enable this.Mr. Janssen will present how a fully integrated service offering can be beneficial to drug developers in achieving their goals for delivering a cost-efficient final product.
HIGHLY POTENTAPIs
SUMMIT2020
February 19-21 | Prague, Czech Republic
BIOGRAPHIES
🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]
Scott PattersonVice President Pharma/BioPharma Technical Support ILC Dover, USA
Scott Patterson is the Vice President of Commercial Sales with ILC Dover, a diversified manufacturing company that provides engineered products to a range of markets from aerospace to pharmaceutical manufacturing. He has been with ILC Dover for 13 years working in the global pharmaceutical marketfor high containment solutions. Prior to the current assignment he was in executive management for capital equipment suppliers including milling, roll compaction, metal detection and x-ray systems. He is active with multiple industry groups promoting containment technology with an emphasis on flexible single use systems that achieve nanogram level containment.
Dean CalhounPresident and CEOAffygility Solutions, USA
Dean Calhoun is an American Board of Industrial Hygiene Certified Industrial Hygienist (CIH). He has been an environmental health and safety professional for over 33 years.Prior to starting Affygility Solutions, Dean was the Associate Director of Environmental Health and Safety for Gilead Sciences, Inc., a biopharmaceutical company focused on developing pharmaceuticals for infectious, viral, and oncology applications. His experiences including development and implementation of global EHS guidelines, implementation and coordination of an executive management EHS Steering Committee, establishment of occupational exposure limits for pharmaceutical active ingredients, industrial hygiene program management, and EH&S auditing of research, manufacturing and contract manufacturing facilities.Dean is an international speaker on the topic of potent compound safety and has presented at conferences throughout the United States, Europe, and Asia.Dean graduated with a B.Sc. degree in Engineering from the University of Wyoming and has dual master degrees in Environmental Policy and Management, and Technology Management from the University of Denver. He is a member of AIHA, ISPE, and NAEM
Dr. Ildikó ZieglerQuality Assurance Manager Vanessa Research, HU
Dr. Ildiko Ziegler has been a professional for more than 15 years in the pharmaceutical industry, has extensive experience in QA and 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 recieved licentiate degree at the Luleå University of Technology (Sweden) in 2000. She defended Ph. D. at the BUTE in 2000 and obtained the Géza Schay Award for the achievments in the field of physical and theoretical chemistry.
Dr. Ing. Olindo Lazzaro, PE, CSP, MBADirector, Global EHS Technical OperationsAbbVie, IT
Olindo Lazzaro, PE, MSc COHSP, EMBA, is Director Global EHS Technical Operations at AbbVie, responsible for Global EHS Technical Centers of Excellence supporting both R&D and Manufacturing at Global Level. His key areas of focus are: Process Safety Management, Loss Prevention and Fire Protection, SIF prevention, OH/Containment, Chemical Safety and GHS, Pharmaceuticals In the Environment (PiE), Environmental Best Available Techniques (BAT)/Ecoefficiency, and EHS New Product Introduction/EHS Technical Transfer process.Previously he has been the Director, EHS, Global Manufacturing & TPMs at Abbott then AbbVie, with Direct accountability for Environment, Health, Safety & Energy (EHS&E) performance and compliance throughout AbbVie’s manufacturing sites and TPMs Globally, Olindo has 25 years of experience in EHS and Pharmaceutical & Chemical Operations, including international experience in EHS management, Technical Transfer, network optimization and post M&A EHS integration.
His core expertise are: • Major Risks Control, Hazard identification and Risk Assessment including: FMEA, HAZOP, QRA, SIL, LOPA, land use planning, dispersion modeling and consequence assessment.• Process Safety Management (PSM)/Auditing of PSM systems.• Fire Protection Engineering, Fire Safety Strategy, Emergency Planning & Response.• Occupational Hygiene/Containment, Potent Drugs & Antibody Drug Conjugates (ADCs)-• Pollution Prevention (PP) Environmental Best Available Techniques (BAT) assessment, Eco Management and Audit.• World Class Safety Culture. Lost Time Accident Reduction. Behavioral Based Safety (BBS).• EHS Business Integration and EHS Performance Improvement. EHS Management Systems (ISO 14001, EMAS, ISO 45001, ISO 50001).• Lean Manufacturing and Change Management.
Olindo holds a Master Degree with honors in Environmental Engineering from the Faculty of Engineering, University of Roma La Sapienza, a Specialization in Process Safety and Major Hazard Control from School of Industrial Safety and Protection, University of Roma La Sapienza and an EMBA in Pharmaceutical Administration from LUISS University Business School, ItalyHe is registered as Professional Engineer and Fire Protection Expert in Italy. He is a Certified Occupational Health and Safety Manager, Energy Manager and he is qualified as 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/ISO 45001 and UNI 10617.Privately he is happily married, he is a proud father of two children and he enjoys track and field, outdoor activities including mountain hiking.
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Highly Potent APIs Summit 2020
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REGISTRATION & PAYMENTUpon receiving the signed registration form, we will process your application. The registration confirmation and the invoice will be sent to you within one (1) working day with the relevant payment instructions and terms. The registration fee includes access to all sessions, coffee breaks, lunches, dinner and conference materials. Payment is due 10 working days from the invoice date. Payment should be made by Credit Card, Pay Pall or by Bank Transfer. The delegate is responsible for any bank charges/fees associated with the payment.
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TERMS & CONDITIONS
PACKAGE NAME Register by 6.12.2019 Register by 17.01.2019 Register by 7.02.2020 Standard price
Individual ticket (3 Days) €1595 (save €300) €1695 (save €200) €1795 (save €100) €1895
Group ticket (2-3 delegates - 3 Days) €1395 (save €400) €1495 (save €300) €1595 (save €200) €1795
Group ticket (4+ delegates - 3 Days) €1195 (save €500) €1295 (save €400) €1395 (save €300) €1695
Individual ticket (2 Days - Feb 19-20) €1095 (save €300) €1195 (save €200) €1295 (save €100) €1395
Group ticket (2-3 delegates - 2 Days - Feb 19-20) €895 (save €400) €995 (save €300) €1095 (save €200) €1295
Group ticket (4+ delegates - 2 Days - Feb 19-20) €695 (save €500) €795 (save €400) €895 (save €300) €1195
Workshops (1 Day - Feb 21) €495 (save €300) €595 (save €200) €695 (save €100) €795
Individual ticket (1 Day - Feb 19) €495 (save €300) €595 (save €200) €695 (save €100) €795
Individual ticket (1 Day - Feb 20) €495 (save €300) €595 (save €200) €695 (save €100) €795
Documentation €499 Promotional materials distribution €699 Speaker €2495 Pop up stand €3495 Bronze €4095
Booth €5495 Silver €6995 Gold €7995
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MARKETING CAMPAIGN✓Website ✓Email Marketing ✓Digital Advertising ✓Social Marketing ✓Press ✓Direct SalesPARTICIPATION FEEFees are inclusive of the 2-day summit, materials, online post-event documentation/presentation package, lunches, snacks, refreshments and business dinner. TRAVEL AND ACCOMMODATIONHotel accommodation and travel expenses are not included in the fee. Special rates for the event venue will be sent upon availability. VENUEEvent venue will be announced online and sent to the delegates within a reasonable period before the summit start date.POST-EVENT DOCUMENTATIONPresentations and other materials will be sent to the attendees within 72 hours after the event. Presentation content is subject to speaker's approval for distribution.DISCOUNTSEarly booking discounts are not valid in conjunction with any other offer.
SPONSORSHIP PACKAGES
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€2495POP UP STAND€3495
BRONZE€4095
BOOTH€5495
SILVER€6995
GOLD€7995
Number of passes included 1 1 2 2 3 4
Registration fee for additional company representatives €1295 €1295 €1195 €1195 €1095 €1095
Coupon (1 free pass for the other Qepler events) ● ●Pop up stand in the break area (3m wide x 3m height; includes 1 table, chairs, 1 electrical socket) ● ●Exhibition booth with LCD monitor for video presentations in the break area (3m wide x 3m deep; includes 1 table, chairs, 1 electrical socket)
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Pull-up banner at the entrance to the auditorium (to be provided by sponsor) ● ●Speaking slot 20 min 20 min 20 min 30 min 30 min
Workshop - February 19th 60 min 90 min
Opening keynote presentation 15 min
Recognition in chairman’s opening address ● ● ● ● ● ●Seat on a panel discussion ● ● ● ●Opening & closing speech ●Chairman of Day 1 ●Chairman of Day 2 ●Logo and URL on summit website, agenda and pre/post-summit communication activities ● ● ● ● ● ●Recognition on Qepler social media channels (LinkedIn/Facebook/Twitter/Instagram) ● ● ● ● ● ●Colour advert in placed in agenda 1/4 Page 1/4 Page 1/2 Page 1 Page
Company flyer/brochure included in conference folder (to be provided by sponsor) ● ● ● ●Online distribution of your company’s promotional materials to all attendees ● ● ● ●Lanyards for summit badges, notepads, pens and other promotional materials (max. 5) given to all participants and speakers (to be provided by sponsor)
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ONLINE PACKAGES
If you are unable to attend, you may purchase these packages:
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DOCUMENTATIONPost-event presentations and other materials. Presentation content is subject to speaker's approval for distribution.
€499
PROMOTIONAL MATERIALS DISTRIBUTION(Distribution of your company’s promotional materials to all attendees)
€699
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