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SAE Media Group’s 6th Annual Conference
Highly Potent Active Pharmaceutical Ingredients
9 - 10 May, 2022 | London, UK
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The Global High Potency API/HPAPI Market is projected to reach 37 billion USD by 2027, growing at an ever-increasing CAGR of 8.43%. The expanding production of high potency APIs, along with the increase in associated toxicities, are driving requirements for more effective containment solutions and much-needed guidelines to ensure worker safety. The conference will encompass the critical topics including risk assessment, occupational toxicology, engineering controls for containment, facility design, and the impact of pharmaceutical manufacture on the environment.

 

This two-day agenda offers you peer-to-peer networking with industry experts including heads and directors of EHS, Occupational Hygiene, Quality Assurance and more. Expand your community and explore the latest developments in the industry at this two-day event, including key regulatory updates, and leading case studies from leading pharmaceutical and biotechnology companies.
 

 

  • Dissect comprehensive hazard assessment and occupational exposure limit determination
  • Evaluate the increasing trend toward more potent therapies and the consequences of the changing face of pharma
  • Assess engineering containment controls, from isolators and barriers to fully automated lines
  • Explore the employment of cleaning validation, organisational controls, and facility as key measure to tackle cross contamination

     

 

Key job titles include:

Head of Occupational hygiene
Head of Industrial hygiene
Head of Containment
Head of Corporate Toxicology
Head of Validation
Director of Operation Quality
Director of EHS
Director of Drug Safety Evaluation
Industrial Engineer
Validation Expert
Manufacturing Specialist
QA Specialist/Manager
Scale-up Operations Manager
 

AbbVie; AstraZeneca; Bayer AG, R&D, Pharmaceutical; Boehringer Ingelheim; Boehringer Ingelheim GmbH; Boehringer Ingelheim GmbH & Co. KG; Bristol Myers Squibb; Bristol-Myers Squibb; Catalent Pharma Solutions; Colorcon; F. Hoffmann-La Roche Ltd.; F.P.S. Food and Pharma Systems Srl; Ferring Controlled Therapeutics ; Formerly of Boehringer Ingelheim Pharmaceuticals; FPS America LLC; Genentech; GSK; HPAPI Project Services Limited; IES Engineers; Novartis; Novartis Pharmaceuticals; Novo Nordisk; Pharmadagio Limited; Regeneron Pharmaceuticals; SKAN AG; Takeda; Takeda (Shire); Takeda Pharmaceutical Company Limited; Takeda Pharmaceuticals; Takeda Pharmaceuticals Company Limited; Vanessa Research; ZF Polpharma SA;

Conference programme

8:00 Registration & Coffee

9:00 Chairman's Opening Remarks

Justin Mason-Home

Justin Mason-Home, FRSC, Director/Owner, HPAPI Project Services Limited
View Bio

9:10 Key Elements of [Highly] Potent API Projects

Justin Mason-Home

Justin Mason-Home, FRSC, Director/Owner, HPAPI Project Services Limited
View Bio

• What is more Important? Product Safety or Worker Safety?
• Higher Potency and Toxicity in Drug Pipelines
• Is SARS-CoV-2 and/or its Vaccines ‘Potent’?
• Hazard, Risk and Control (and uncertainty)
• Potent Drug Facility Design
 

9:50 Human behaviours leading to safe & successful potent product manufacturing

Damien Boyd

Damien Boyd, EHS Specialist Occupational Hygiene, MSD
View Bio

• There have been progressive improvements in potent compound containment in Pharma within the last 20 years
• Great sharing of ‘best practice’, resulting in similar approaches across the sector,
• A degree of ‘health & safety anxiety’ is observed when the API OELs go below 10 mcg/m3
• Expensive Containment infrastructure is only as useful as the human capability interacting with it
• Do we need to look at how we prepare workers handling extremely active, harmful chemical agents?
• This talk examines some of the key human factors that can influence a successful approach to handling potent compounds
 

10:30 Morning Coffee

11:00 Guidance for establishing Health-Based Exposure Limits (HBELs)

Martin Kohan

Martin Kohan, Senior Occupational Toxicologist, AstraZeneca
View Bio

• Demonstrating the need for a qualified expert to establish HBELs
• Differences between an identified hazard and a perceived risk
• Compounds with limited data - Occupational Exposure Bands as initial guidance
 

11:40 Manufacturing of oncological products by a CDMO

Fabio  Zenobi

Fabio Zenobi, Director, BSP Pharmaceuticals S.p.A.
View Bio

  • Company presentation 
  • New Product Introduction evaluation
  • Case study 
  • Environmental control
  • 12:20 Networking Lunch

    13:20 Hazards and Potency of new therapeutic modalities

    Ester Lovsin Barle

    Ester Lovsin Barle, Head of Product Stewardship and Health, cEHS, Takeda Pharmaceutical Company Limited
    View Bio

    • Assessment of data relevancy, adequacy, reliability
    • Determination of exposure limits in the absence of data
    • Case study of nucleic acids
     

    14:00 Engaging in proper risk assessment for contract manufacturing of highly potent APIs

    Anna Kulesza

    Anna Kulesza, Director Pharmaceutical Development, Clovis Oncology
    View Bio

    • Assessing safety profile of drug substances for quality risk management programs
    • The business case for containment: improvements in drug quality and yield, and productivity
    • Applying cross-benefit analysis to showcase the ROI gained from effective risk mitigation
     

    14:40 Afternoon Tea

    15:10 Legal aspects on handling highly potent active pharmaceutical ingredients and the need to combine GMP and EHS considerations

    Reinhold Maeck

    Reinhold Maeck, Head of Corporation EH&S Regulatory Intelligence, Boehringer Ingelheim
    View Bio

  • Containment Strategy options
  • New Containment Handbook
  • From an effect of an API to PDE,OEL, OEB and even PNEC
  • GMP Regulations for Multi Purpose units and the effect on HSE
  • Palm of the hand concept for “non product contact surfaces”
  • Ideas for room concepts
  • 15:50 How to handle HPAPIs within Chemical Development (case studies)

    Thomas Adam

    Thomas Adam, Head of GQA-Chemical APIs, Bayer AG, R&D, Pharmaceutical
    View Bio

    • GMP-Compliance and Regulatory Environment
    • Cleaning of Equipment in the Manufacturing of HPAPIs
    • Prevention of Cross-Contamination in Shared Facilities
     

    16:30 Chair’s Closing Remarks and Close of Day One

    Justin Mason-Home

    Justin Mason-Home, FRSC, Director/Owner, HPAPI Project Services Limited
    View Bio

    8:30 Registration & Coffee

    9:00 Chair's Opening Remarks

    Justin Mason-Home

    Justin Mason-Home, FRSC, Director/Owner, HPAPI Project Services Limited
    View Bio

    9:10 Trends and Outlook on Containment

    Richard Denk

    Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
    View Bio

    • What are the current and future trends in Containment
    • Fully automated Gloveless Robotic Aseptic Filling Line for high potent substances
    • Clean to prevent Cross Contamination
    • New ISPE DACH Containment Handbook introduction
     

    9:50 Measuring containment performance in devices designed for ULTRA-potent APIs: Is a low LOQ enough?

    Robert Sussman

    Robert Sussman, Managing Director, Trinity Consultants - SafeBridge® Regulatory & Life Sciences Group
    View Bio

  • Establishing containment performance targets (CPT) for devices handling ultra-potent compounds – what are the expectations?
  • Limits of quantitation (LOQ) currently available for surrogate materials
  • Probability of particle capture as a function of particle size
  • Measuring airborne concentrations of ultra-potent compounds
  • 10:30 Morning Coffee

    11:00 PANEL DISCUSSION: Highly Potent APIs in Pharma

    • How can we ensure compliance with both Good Manufacturing Practice (GMP) and Environmental Health and Safety (EHS)? 
             o Could there be a conflict, and how would we solve it then?
             o Is there a business case for containment controls?
    • When should engineering controls be employed?
             o Is establishing human behavioural controls more important than using PPE?
    • How should Risk, Hazard, and Uncertainty be treated in this field?
     

    Justin Mason-Home

    Justin Mason-Home, FRSC, Director/Owner, HPAPI Project Services Limited
    View Bio

    Damien Boyd

    Damien Boyd, EHS Specialist Occupational Hygiene, MSD
    View Bio

    Richard Denk

    Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
    View Bio

    11:40 HSE Risks Mitigation Measures in Novartis AAA radioligand Supply Chain

    Christophe Dehondt

    Christophe Dehondt, Global Head of EHS and BCM, Novartis, Advanced Accelerator Applications
    View Bio

    • Drugs for targeted radioligand therapy
    • AAA technology platform
    • HSE Hazards of radioligands
    • Manufacturing Process and Supply Chain: HSE Aspects
    • HSE Risks Mitigation Strategy
     

    12:20 Antibody-Drug Conjugates (ADCs) – antibodies meeting HPAPIs for specific and efficient bio-pharmaceutical drugs

    • The manufacture of ADCs - challenges and solutions
    • The make-or-buy question - deciding to manufacture in-house or outsource
    • Bayer’s ADC production concept using HPAPIs
    • Best practices for CDMO selection and outsourcing ADC development and manufacturing
    • Understanding the success factors, risks and mitigations in externalisation of ADCs
     

    Ulrich Rumenapp

    Ulrich Rumenapp, Head of Launch Preparation, Bayer AG
    View Bio

    13:00 Networking Lunch

    14:00 Policy measures at the EU level on pharmaceuticals in the environment

    Adela Maghear

    Adela Maghear, President, Institut Vert
    View Bio

    • In March 2019, the Commission adopted the long-awaited strategic approach to pharmaceuticals in the environment, as required by Article 8c of Directive 2008/105/EC as amended by Directive 2013/39/EU
    • The approach covers all stages of the lifecycle of pharmaceuticals, from design and production through use to disposal
    • While progress has been made in implementing the actions of the EU Strategic Approach to Pharmaceuticals in the Environment, several Green Deal Initiatives and the EU Pharmaceutical Strategy are aimed to pave the way towards making the EU the first region to legislate on pharmaceuticals in the environment
     

    14:40 Establishing the business case for containment

    David Eherts

    David Eherts, Principal Consultant, National Safety Council - ORCHSE (Eherts Consulting LLC)
    View Bio

  • How to sell a containment investment to a customer, manager, engineering or finance department
  • Discovering ALL the benefits of a containment investment
  • Completing and presenting a convincing Quantitative Cost-Benefit Analysis
  • Includes access to software fit for this purpose
  • 15:20 Afternoon Tea

    15:50 Achieving Containment Performance Targets in Practice – A Five Year Review of Industry Data

    Michael Perry

    Michael Perry, Director, Pharmadagio Limited
    View Bio

  • An analytical review of over 3600 air sampling performance data points, collected over five years from a variety of pharmaceutical potent compound settings.
  • Graphical presentation and comparison of personal and static data against various performance targets reveals the overall success of common containment solutions.
  • Discussion of technical, operational and human factors which frequently impact containment performance in practice.
  • 16:30 Adaptation of containment designs to cope with the high demands of HPAPIs

    Jeff Parry

    Jeff Parry, Senior Formulation Scientist, Astrazeneca

    • Overview of up-to-date containment manuals
    • Containment for HPAPIs with low OELs
    • Challenges of reconstructing new facilities in alignment with GMPs
     

    17:10 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Adela Maghear

    Adela Maghear

    President, Institut Vert
    Anna Kulesza

    Anna Kulesza

    Director Pharmaceutical Development, Clovis Oncology
    Christophe Dehondt

    Christophe Dehondt

    Global Head of EHS and BCM, Novartis, Advanced Accelerator Applications
    Damien Boyd

    Damien Boyd

    EHS Specialist Occupational Hygiene, MSD
    David Eherts

    David Eherts

    Principal Consultant, National Safety Council - ORCHSE (Eherts Consulting LLC)
    Ester Lovsin Barle

    Ester Lovsin Barle

    Head of Product Stewardship and Health, cEHS, Takeda Pharmaceutical Company Limited
    Fabio  Zenobi

    Fabio Zenobi

    Director, BSP Pharmaceuticals S.p.A.
    Jeff Parry

    Jeff Parry

    Senior Formulation Scientist, Astrazeneca
    Justin Mason-Home

    Justin Mason-Home

    FRSC, Director/Owner, HPAPI Project Services Limited
    Martin Kohan

    Martin Kohan

    Senior Occupational Toxicologist, AstraZeneca
    Michael Perry

    Michael Perry

    Director, Pharmadagio Limited
    Reinhold Maeck

    Reinhold Maeck

    Head of Corporation EH&S Regulatory Intelligence, Boehringer Ingelheim
    Richard Denk

    Richard Denk

    Senior Consultant Aseptic Processing & Containment, SKAN AG
    Robert Sussman

    Robert Sussman

    Managing Director, Trinity Consultants - SafeBridge® Regulatory & Life Sciences Group
    Thomas Adam

    Thomas Adam

    Head of GQA-Chemical APIs, Bayer AG, R&D, Pharmaceutical
    Toral Mehta

    Toral Mehta

    Industrial Hygienist and Containment Expert, GSE - Global Safety & Environment, EHS, MSD Animal Health
    Ulrich Rumenapp

    Ulrich Rumenapp

    Head of Launch Preparation, Bayer AG

    Adela Maghear

    President, Institut Vert
    Adela Maghear

    Adela is a graduate in pharmacy studies and holds two PhD degrees; one in Medical Sciences (Field of Pharmacy) and another in Chemistry awarded by the University of Medicine and Pharmacy Cluj-Napoca (Romania) and University of Lorraine (France), respectively.

    With a strong focus on environmental safety, her research work and scientific publications have dealt with a wide range of subjects. In 2015, she changed career paths when she received the Robert Schuman scholarship at the European Parliament Research Service in Brussels. Her career within the field of health policies continued as she became a member of the European Health Parliament, Antimicrobial Resistance Committee, that same year.

    In 2016, she ushered her skills and expertise in the fields of health and environment to ‘Health Care Without Harm Europe’ where she spearheaded the organisation’s policy work related to pharmaceuticals in the environment and antimicrobial resistance. She developed and led the Safer Pharma Campaign, aimed to make the EU the first region in the world to legislate on pharmaceutical pollution and its consequent contribution to the spread of AMR.

    Her work has been cited in international journals such as The Telegraph, ChemicalWatch UK, Pharmaceutical Technology, Market Business News, Pharma Technology Focus and Health Europa.

    In 2020, she co-founded “Institut Vert” – a non-profit association that aims to foster greater involvement by citizens in South-Eastern countries in European politics to ensure a common green and sustainable vision that could benefit all.

     

    Anna Kulesza

    Director Pharmaceutical Development, Clovis Oncology
    Anna Kulesza

    Currently Director CMC Pharmaceutical development at Clovis Oncology Switzerland GmbH Responsible for definition and management of contractor activities related to development and manufacturing of drug substances and/or drug products, and development and validation of analytical methods. The scope of work will support products at all stages of development up to and including commercialization. Past experience includes program management and innovation management in contract manufacturing at Lonza AG for drug substance development, validation and manufacturing for clinical phases and commercialization.

    Christophe Dehondt

    Global Head of EHS and BCM, Novartis, Advanced Accelerator Applications
    Christophe Dehondt

    27 years of experience in heavy industry supporting management teams in the areas of QSE, maintenance and infrastructure / projects and more than 17 years of experience as a team leader.
    In international companies or SMI in chemical, petrochemical, pharmaceutical, microelectronics, construction, from B to B or B to C business types

    HSE Lead auditor in European (UK, Germany, Belgium, Spain, Poland, Hungary) and Asian (Sri Lanka, Indonesia, Philippines, Bangladesh) countries.
     

    Damien Boyd

    EHS Specialist Occupational Hygiene, MSD
    Damien Boyd

    Dr. Damien Boyd is an Analytical Chemist who changed career to re-train as an Occupational Hygienist. He completed the British Occupational Hygiene Society (BOHS) programme to become a Chartered member (‘the CMFOH’ level). He was winner of the annual David Hickish award, presented by the Society, in 2012.
    He is presently working in the Pharma sector in a regional, advising role. He also teaches Occupational Hygiene, Chemistry and Toxicology, part time, at University College Cork, Ireland.
    He has been an advisor of safe work practice with handling potent compounds over a 22-year period.
    He is particularly interested in the specific human mind-set, required by employees, to work in the more rigid and specialised field of potent compound manufacture.
     

    David Eherts

    Principal Consultant, National Safety Council - ORCHSE (Eherts Consulting LLC)
    David Eherts

    Dr. Eherts retired from Allergan Pharmaceuticals at the end of 2020 and is currently consulting for NSC-ORCHSE and teaching at Tulane University’s School of Public Health.
    David has enjoyed 40-year career in the fields of Safety Assessment, EHS, Sustainability and Employee Health starting as a toxicologist in Pre-Clinical Drug Safety Assessment at Merck. He moved to EHS and has held positions of increasing responsibility in the pharmaceutical, healthcare and aviation industries most recently at Allergan as their Global Vice President for EHS and immediately prior to that at Sikorsky Aircraft as the Vice President and Chief Safety Officer leading their EHS, Aviation and Product Safety, Medical and Government Security functions.
    Dave holds Bachelor’s degrees in Chemistry and Biology and a Masters and PhD in Environmental Toxicology from Drexel University.
    Related to professional societies, organizations and awards, David was recently honored by NAEM (the National Association of EHS Management) with their Lifetime Achievement Award in 2019 and as the National Safety Council (ORCHSE) Innovation Award Winner in 2018. Under the Obama administration, David was appointed by the US Secretary of Labor to serve on the Federal Whistleblower Protection Advisory Committee (heading the 11c Subcommittee) from 2014-2018. He’s chaired the ISPE Containment CoP (2016-2020), served on the Board of Directors of Occupational Knowledge International, on the Board and chaired the Environmental Business Committee at SoundWaters and on the advisory board for the ORC Executive Business Issues Forum where he led the Return-on-HSE-Investment (ROHSEI) Taskforce.
     

    Ester Lovsin Barle

    Head of Product Stewardship and Health, cEHS, Takeda Pharmaceutical Company Limited
    Ester Lovsin Barle

    Ester Lovsin Barle, DVM, MSc, PhD, MScTox is the Head of Product Stewardship and Health at Takeda. She lives in Zurich, Switzerland.
    Her responsibilities include Safety Data Sheet process, maintaining article and material regulatory compliance and scientific development and cross-organizational implementation of health based exposure limits (HBEL) in support of research and manufacturing in Takeda globally, global implementation of occupational hygiene and product stewardship sustainability activities. Previously she has held corporate positions at Lonza and Novartis. 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.
     

    Fabio Zenobi

    Director, BSP Pharmaceuticals S.p.A.
    Fabio  Zenobi

    EHS Director, BSP Pharmaceuticals S.p.A.
    Fabio is responsible of Environment, Health and Safety at BSP Pharmaceuticals S.p.A., Latina Italy, a Contract Development and Manufacturing Organization focused on anticancer product, small molecules and ADC compounds. He is a Pharmaceutical Chemist and has over 20 years of experience in pharmaceutical industries as Serono, Bristol-Myers Squibb and Intervet, in Manufacturing, Quality Assurance, Technical Operations and EHS.
     

    Jeff Parry

    Senior Formulation Scientist, Astrazeneca
    Jeff Parry

    Justin Mason-Home

    FRSC, Director/Owner, HPAPI Project Services Limited
    Justin Mason-Home

    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, board level position in a biotechnology company and corporate environmental management. Mr Mason-Home has been involved in and worked on potent and highly potent API projects over 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.
     

    Martin Kohan

    Senior Occupational Toxicologist, AstraZeneca
    Martin Kohan

    Martin Kohan PhD, ERT, DABT
    Position: Senior Occupational Toxicologist, AstraZeneca UK.

    BSc/MSc in Biochemistry from La Plata National University, Argentina; MSc in Pharmacology and PhD 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 of the British Toxicology Society.
     

    Michael Perry

    Director, Pharmadagio Limited
    Michael Perry

    Mike Perry CMFOH
    Mike Perry is a chartered occupational hygienist and director of Pharmadagio Limited. Mike has been specialising in the field of potent compound safety for the last 15 years, providing consultancy services throughout Europe and the UK. His company continues to gain presence within the industry with particular focus on pharmaceutical exposure control and assessment strategies, containment performance verification, and ongoing development of procedures for optimisation of controls through all stages of the drug development cycle.

    Reinhold Maeck

    Head of Corporation EH&S Regulatory Intelligence, Boehringer Ingelheim
    Reinhold Maeck

    Large international experience by living for several years in China, US, and several European countries as well as by auditing and interacting with the production network and suppliers of Boehringer Ingelheim.
    Extensive experience in Corporate Headquarters as well as in direct operational responsibility of large chemical plants.
    Co-Author of the Containment Handbook -actual working on a new revised version and steering committee member at ISPE DACH Containment and representing BI from an EHS perspective at various organisations and associations such as (AMR Alliance, EFPIA…)
    Head of Corporate EHS&S Regulatory Intelligence 2014-actual
    Boehringer Ingelheim Corporate Center GmbH, Ingelheim Germany)
    Understandings of regulations and upcoming regulations worldwide in the field of environmental and safety topics with a strong impact on the business of BI. This does include regulations relevant for sustainability and for the integrity of the supply chain. Representing BI in associations and/ or briefing of top management for all EHS topics in such associations. In this corporate function closely linked to the managements as well as to the Corporate Public Affairs. In addition, lead auditor for critical supply chain topics.
     

    Richard Denk

    Senior Consultant Aseptic Processing & Containment, SKAN AG
    Richard Denk

    Richard Denk is working at the company SKAN AG, headquartered in Allschwil Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard is member of the PDA Isolator Expert Group, ISPE Sterile Product Processing Group, Chair of the ISPE Containment DACH, Chair of the ISPE DACH Containment Manual and Richard developed the Containment Pyramid. Richard is co-founder and chair of the ISPE SIG Future Robotic and Co-Chair ISPE SIG Bio on Innovations and Technology. Furthermore, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group.

    Robert Sussman

    Managing Director, Trinity Consultants - SafeBridge® Regulatory & Life Sciences Group
    Robert Sussman

    Robert G. Sussman, Ph.D., DABT is one of the Managing Directors of SafeBridge® Regulatory & Life Sciences Group and has over 30 years’ experience in the pharmaceutical industry as a toxicologist performing risk assessments. He is certified by the American Board of Toxicology and holds a Ph.D. from New York University. He has several publications and has given numerous presentations on the topics of occupational toxicology, product safety, and industrial hygiene in the pharmaceutical industry. Prior to working at SafeBridge, Dr. Sussman served as a Director at pharmaceutical companies such as Warner Lambert and Pfizer.

    Thomas Adam

    Head of GQA-Chemical APIs, Bayer AG, R&D, Pharmaceutical
    Thomas Adam

    Dr. Thomas Adam is currently the head of global quality assurance chemical APIs in the chemical development department of the pharmaceutical business unit of Bayer.
    He is responsible for the release of chemical APIs for clinical trials, the GMP-Quality system and
    the QA-oversight of the pilot plants and analytical development laboratories.

    Thomas holds a PhD in analytical chemistry from the University of Mainz in Germany.
    He has about 20 years of industrial experience at Bayer AG in different QC/QA-functions and a two years Post-Doc experience at Novartis, Switzerland.
    He is and was involved in many technical (transfer)-projects so as the planning and launching of the new GMP-kg lab for highly potent APIs and establishing a cleaning concept for the chemical development department.
     

    Toral Mehta

    Industrial Hygienist and Containment Expert, GSE - Global Safety & Environment, EHS, MSD Animal Health
    Toral Mehta

    In her 22+ years of global EHS professional career, Toral lived and worked in 3 continents and worked in @ 40+ countries. From beginning of her career, Toral worked closely with multinational pharmaceuticals. Since last 7.5 years she has been part of Global EHS Team in multinational Pharma - Novartis and now at MSD/Merck. Currently she is in Vienna, Austria working at a high potent API (HPAPI) facility focused on establishing robust IH program and major capital investment projects related to Industrial Hygiene and Containment.
     

    Ulrich Rumenapp

    Head of Launch Preparation, Bayer AG
    Ulrich Rumenapp

    Dr. Rümenapp is based in Wuppertal, Germany and working within the Product Supply Pharmaceuticals, Biological Development organization, 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 Projects in Product Supply Biotech at Bayer, where he was responsible for contract manufacturing partnerships in the field of biotechnological drug substances and drug products and interdisciplinary project management with the goal to ensure market supply.

    Before it was acquired by Bayer, Dr. Rümenapp hold 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 worked several years in academic research in the field of signal transduction and as an assistant teacher in the field of general pharmacology.
    Dr. Rümenapp is based in Wuppertal, Germany and working within the Product Supply Pharmaceuticals, Biological Development organization, 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 Projects in Product Supply Biotech at Bayer, where he was responsible for contract manufacturing partnerships in the field of biotechnological drug substances and drug products and interdisciplinary project management with the goal to ensure market supply.

    Before it was acquired by Bayer, Dr. Rümenapp hold 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 worked several years in academic research in the field of signal transduction and as an assistant teacher in the field of general pharmacology.
     

    Sponsors

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    Copthorne Tara Hotel

    Scarsdale Place, Kensington, London, United Kingdom

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SAE Media Group. SAE Media Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Highly Potent Active Pharmaceutical Ingredients Brochure 2022

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    Preliminary Attendees

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    Speaker Interview - Ester Lovsin Barle, Takeda Pharmaceutical Company Limited

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    Speaker Interview - Damien Boyd, MSD

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    Conference Chair Letter

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    Workshop A & B Agenda

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    Speaker Biographies

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    Past Attendees

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    Past Presentation - Olindo Lazzaro & Salvatore Sorrentino, ABBVIE

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    Past Presentation - Richard Denk, SKAN AG

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    Past Presentation - Dr. Reinhold Maeck, Boehringer Ingelheim

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    Past Presentation - Ester Lovsin Barle, Takeda

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    Past Presentation - Dr Ildikó Ziegler, Vanessa Research

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    Sponsors
    http://www.bsppharmaceuticals.com

    BSP is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxic characteristics for the pharmaceutical industry. With its state-of-the-art technology and highly skilled personnel, BSP sets out to be a valuable point of reference to serve the principal actors of the pharmaceutical field involved in research on new generation anticancer therapies. BSP has been at the forefront in the fight against cancer since 2006. Innovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant. The BSP industrial building covers an area of 30,000 m2 in a campus of approximately 20 hectares, 60 km to the south of Rome, ranking it in the world today as one of the most important Contract Development and Manufacturing Organization (CDMOs) for anticancer drugs.


    CTS Europe Limited

    Sponsors
    http://www.containment-technology.co.uk/

    Containment Technology Services - CTS Europe Ltd, Manufacture Laboratory Containment systems that are designed to provide operator protection when handling Active Pharmaceutical Powders. We supply containment solutions to Pharmaceutical Laboratories worldwide, we have built up a significant amount of experience in dealing with many different powder handling activities. Our products will provide safe handling environments for laboratory activities such as Weighing, Milling. Sieving, Particle sizing, Bulk Powder dispensing, Inhalation testing, Spray Drying and Karl Fisher analysis. We design and manufacture our products here in the UK and are able to offer service and training for all our products worldwide. CTS Europe was founded in 2010 by its owner and Managing Director Sean Codling who has over 20 years’ experience within the Laboratory Containment Market and associated Exposure Controls.


    Dec Group

    Sponsors
    https://www.dec-group.net/fillinglines

    Dec is a leading global provider of contained powder handling systems and is recognized as a world-leading expert in process containment technologies. It has been supplying the pharmaceutical, chemical, food and cosmetic industries for more than 30 years. In excess of 600 companies worldwide have successfully integrated more than 10,000 Dec systems and concepts into their production sites, always enhancing safety, containment and productivity. Dec offers innovative approaches across the range of powder handling and process containment applications, including transfer, micronizing/milling, bulk handling, sampling, blending, dosing, aseptic fill-finish solutions, process isolators and containment solutions as well as advanced cleaning (CIP/SIP) features.


    FPS

    Sponsors
    https://bit.ly/34sRyo3

    FPS is an Italian company specialized in the design and manufacture of containment & isolation systems (toxix and sterile) and micronization solutions for the handling and production of active and sterile pharmaceutical ingredients; it is mainly addressed to pharmaceutical, chemical and cosmetic companies all over the world. With more than 1,400 systems in operation worldwide for handling pharmaceutical substances, FPS presents itself on the market as an international company, extremely flexible and able to adapt to different customer's needs. The pride and joy of the company is the recently implemented Test and R&D Centre, where three ISO8 clean rooms are available dedicated to performing technical micronization tests for small quantities up to large batches.



    SafeBridge Consultants, Inc.

    Sponsors
    http://www.safebridge.com

    SafeBridge Consultants, Inc. is the premier resource for high level safety, health and environmental support to the pharmaceutical and biotechnology industries. We provide services in occupational and environmental toxicology, risk assessment, product safety, industrial hygiene and analytical chemistry to clients worldwide from offices in California, New York and Liverpool, UK.

    Media Partners


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    European Biopharmaceutical Review

    Supporters
    http://www.samedanltd.com/

    EBR is well-recognised for providing beneficial information to players in the bio-industry including entrepreneurial biopharmaceutical and life science companies.


    Mednous

    Supporters
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    IPI

    Supporters
    http://international-pharma.com/

    International Pharmaceutical Industry is a peer-reviewed journal. We are committed to editorial integrity. Supported by an elite group of reviewers and industry experts, IPI brings you contemporary and authoritative articles which will guide the industry in the best practice in regulatory issues, market analysis, drug discovery, development, delivery methods, clinical research, laboratories, analytical testing, custom and contract manufacturing, primary and secondary packaging, logistics and supply chain management.


    Technology Networks

    Supporters
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    pharmaphorum

    Supporters
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    Biocompare

    Supporters
    http://www.biocompare.com

    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    pharmanews hq

    Supporters
    http://http://pharmanewshq.com

    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


    American Pharmaceutical Review

    Supporters
    http://www.americanpharmaceuticalreview.com

    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


    Pharmaceutical Outsourcing

    Supporters
    http://www.pharmoutsourcing.com

    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.


    Pharmiweb

    Supporters
    http://www.pharmiweb.com

    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


    ASD MEDIA

    Supporters
    http://www.asd-network.com

    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
    • Be informed on the latest market developments; www.asd-network.com
    • Find the latest business news; www.asd-network.com
    • Find the upcoming events; www.asd-network.com
    • Find companies and organizations; www.asdsource.com
    • Distribute news globally. www.asdwire.com
    The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

    For more detailed information please contact with: ASD MEDIA
    Stefan.koopman@asdmedia.nl

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




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