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SAE Media Group’s 7th Annual Conference
Highly Potent Active Pharmaceutical Ingredients 
10 - 11 May, 2023 | 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.
 

  • EARN how to ensure advanced therapeutic manufacturing is safe for workers and patients
  • INCREASE the e ectiveness of your engineering containment controls by improving harmony between the worker engineer and toxicologist to ensures cost-e ective design choices
  • UNCOVER the best practises & opportunities for pharmaceutical companies to work alongside CMOs to effectively and efficiently scale-up HPAPI manufacturing
  • REVIEW case studies on the implementation of risk-based hazard identification strategies from leading pharmaceutical companies including AstraZeneca, CSL Behring and Merck
  • DISCOVER future trends in containment and control technologies to future-proof your HPAPI manufacturing plant to maximise operator safety

 

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/Manage
  • Scale-up Operations Manager
     

Previous Attendees Include:

 

Astrazeneca; Bayer AG; Bayer AG, R&D, Pharmaceutical; Boehringer Ingelheim; BSP Pharmaceuticals S.p.A.; CatSci Ltd; Clovis Oncology; CTS Europe Ltd; Custom Pharmaceuticals Limited; Eurofins PHAST GmbH; Extract Technology Limited; FPS Pharma; GSK; HPAPI Project Services Limited; Institut Vert; Ipsen Ltd; Lonza Biologics Plc; MedinCell; MSD; National Safety Council - ORCHSE (Eherts Consulting LLC); Novartis, Advanced Accelerator Applications; PharmaCircle LLC; Pharmadagio Limited; Safebridge; SKAN AG; Takeda; Team Consulting Ltd; Trinity Consultants - SafeBridge® Regulatory & Life Sciences Group;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

9:10 The essential elements of HPAPI manufacture: operator and patient safety

Justin Mason-Home

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

  • The increasing trend toward high potency powders: balancing patient outcome with occupational risk
  • Introducing the hierarchy of reaction to risk: Elimination, Substitution, Engineering, Procedure, and PPE
  • Understanding that handling HPAPis is fundamentally both high risk and high uncertainty
  • Ensuring that facility design is up to the required task
  • 9:50 How to maintain and manage cleaning programs for HPAPI whilst meeting regulatory requirements

    Andreas Schreiner

    Andreas Schreiner, Global Network Validation Leader, Novartis

  •  Expectations from health authorities and regulators for contaminant clean-up
  • Preventing cross-contamination in shared facilities
  • Case Studies from Novartis’s HPAPI manufacturing plants
  • 10:30 Morning Coffee

    11:00 Overcoming containment challenges in HPAPI manufacture with respirator innovation

    Toral Mehta

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

  • Eliminating potential containment breaches with improved understanding of novel vs traditional compounds 
  • Improving plant containment by integrating isolators, different pressure gradients and PPE.
  • Developing a HPAPI handling plan to maximise the potential of small molecule 
  • Integrating an QC Lab design the R&D teams to reduce biosafety impact
     
  • 11:40 HPAPI Handling from Lab Bench to Pilot Plant 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
  •  Risk Assessments & Decision Tree
  •  Prevention of Cross-Contamination in Shared Facilities
  •  Handling of HPAPIs in technical labs and HPAPI facilities
     
  • 12:20 Networking Lunch

    13:20 Applying our current understandings with HPAPI controls to improve safety, sustainability and streamlined production

  • With the rise of ATMPs, and radiopharmaceuticals, how does the exposure risk differ from that of traditional drugs?
  • Cost Vs Risk Vs Benefits- Integrating sustainability goals into potent product manufacturing 
  • Ensuring safety and vigilance in designing facilities, training and data analytics
  • Implying with GMP and Quality Guidelines alongside worker safety requirements and exploring how harmonisation improves all aspects of the manufacturing process.
  • Justin Mason-Home

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

    Christophe Dehondt

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

    Thomas Adam

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

    Anna Kulesza

    Anna Kulesza, Director Pharmaceutical Development, Clovis Oncology

    14:00 The business case for risk assessment led manufacturing of highly potent active pharmaceuticals

    Anna Kulesza

    Anna Kulesza, Director Pharmaceutical Development, Clovis Oncology

  •  Designing a risk-informed hazard management procedure
  •  Understanding how appropriate risk-managed containment approaches ensure the business case for HPAPI manufacturing 
  • Optimizing technology transfer to ensure innovation HPAPI manufacturing
     
  • 14:40 Afternoon Tea

    15:10 Incorporating HSE risk mitigation into the manufacturing process and supply chain

    Christophe Dehondt

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

  • The design and implementation of a HSE risk mitigation strategy 
  • HSE aspects of radioligand supply chain 
  • Considerations from other product types and how to bring these into radiopharma
  • Opportunities for digitalisation and the future of pharmaceutical containment
  • 15:50 Improving efficiency and overcoming challenges associated with ADC manufacturing

    Francois D Hooge

    Francois D Hooge, Senior Manager, CMC Management, Daiichi Sankyo Europe GmbH

  •  Overview of ADC modes of action and production steps 
  • CMC strategies for the containment of ADCs during manufacture 
  • Examples with PBD payload synthesis and conjugation 
  • Considerations for the future of ADC manufacturer
     
  • 16:30 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    9:10 Current trends and future outlooks for high potent ingredient containment

    Richard Denk

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

  •  What are the current and future trends in containment creating cross benefit analysis to translate containment strategy into deployed isolator technology 
  • Fully automated gloveless robotic aseptic filling line high potent substances 
  • Preparing for the future with ultra-potent compounds in mind
  •  

    9:50 Integrating design and EHS together when building and redesigning facilities

    Olindo Lazzaro

    Olindo Lazzaro, Global Head, EHS by Design, CSL Behring

  •  Risk Reduction and EHS Management Elements
  •  Containment Targets and Occupational Hygiene (OH) Long Range Plan
  •  New Product Introduction and Tech Transfer
  •  Risk Mitigation and Risk Assessment-based Strategies
     
  • 10:30 Morning Coffee

    11:00 Psychological Safety and Stress – Hidden determinants of Safety Culture

    Rosie Russell

    Rosie Russell, Head of Environmental Health and Safety, MeiraGTx

  • Theoretical basis for measuring Safety Culture and Occupational Stress
  • Case Study – The link between Safety Climate and Occupational Stress
  •  Impact of Occupational Stress on Safety Climate and Culture
  •  Improving Employee Mental Health and Wellbeing – Towards a Psychologically safe workplace
  •  Can it be done? – A Case Study
     
  • 11:40 The impact of HPAPI manufacturing on occupational and reproductive health

    Martin Hogan

    Martin Hogan, Managing Director , Corporate Health Ireland

  •  Concerns regarding potency of product etc (carcinogens, mutagens etc.)
  •  Reproductive issues in both males and females 
  • How to ensure pregnant employees are safe and happy in HPAPI plants
  •  Looking forward to changes to drug product type
  • 12:20 Networking Lunch

    13:20 Putting the worker at the centre of facility design for HPAPI manufacturing

    Brian Edwards

    Brian Edwards, Chair, CIEHF

  •  Understanding the role human factors play in pharmaceutical manufacturing. 
  • Outlining key principles how the tools and technologies, workplace or system can be designed and adapted to suit the people who need to use it
  •  Advanced technologies require advanced thinking- How human factors underpin design

     

  • 14:00 Transforming facilities from a hygienist’s perspective to manage exposure

    Brian Schmidt

    Brian Schmidt, Global Lead - Occupational Hygiene, Takeda

  • Understanding HPAPI handling from an Occupational Hygiene
  • Ventilation requirements for occupational hygiene exposure
  • Reducing the environmental impact with optimised ventilation design
  • Case study from Takeda’s implementation programme- Benefi ts and Challenges
  • 14:40 Afternoon Tea

    15:10 Effectively planning out your plant, considerations for the goals and collaboration with the hygienists

    15:50 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Andreas Schreiner

    Andreas Schreiner

    Global Network Validation Leader, Novartis
    Anna Kulesza

    Anna Kulesza

    Director Pharmaceutical Development, Clovis Oncology
    Justin Mason-Home

    Justin Mason-Home

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

    Martin Hogan

    Managing Director , Corporate Health Ireland
    Richard Denk

    Richard Denk

    Senior Consultant Aseptic Processing & Containment, SKAN AG
    Rosie Russell

    Rosie Russell

    Head of Environmental Health and Safety, MeiraGTx
    Toral Mehta

    Toral Mehta

    Industrial Hygienist and Containment Expert, GSE - Global Safety & Environment EHS, MSD

    Andreas Schreiner

    Global Network Validation Leader, Novartis
    Andreas Schreiner

    Anna Kulesza

    Director Pharmaceutical Development, Clovis Oncology
    Anna Kulesza

    Brian Edwards

    Chair, CIEHF
    Brian Edwards

    Brian Schmidt

    Global Lead - Occupational Hygiene, Takeda
    Brian Schmidt

    Christophe Dehondt

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

    Justin Mason-Home

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

    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 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.

    Martin Hogan

    Managing Director , Corporate Health Ireland
    Martin Hogan

    Olindo Lazzaro

    Global Head, EHS by Design, CSL Behring
    Olindo Lazzaro

    Richard Arnett

    Manager, Industrial Hygiene, Pharmascience
    Richard Arnett

    Richard Denk

    Senior Consultant Aseptic Processing & Containment, SKAN AG
    Richard Denk

    Rosie Russell

    Head of Environmental Health and Safety, MeiraGTx
    Rosie Russell

    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
    Toral Mehta

    VENUE

    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 SMi Group. SMi 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

    Past Attendee List

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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.

     

    HOTEL BOOKING FORM

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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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