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Highly Potent Active Pharmaceutical Ingredients
10 May - 11 May 2023
Highly Potent Active Pharmaceutical Ingredients

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.
 

FEATURED SPEAKERS

Andreas Schreiner

Andreas Schreiner

Global Network Validation Leader, Novartis
Anna Kulesza

Anna Kulesza

Director Pharmaceutical Development, Clovis Oncology
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

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

Francois D Hooge

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

Justin Mason-Home

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

Martin Hogan

Managing Director , Corporate Health Ireland
Martin Hogan

Martin Kohan

Managing , AstraZeneca
Martin Kohan

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.
 

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

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9:10

Essential Elements of HPAPI Projects: Operator and Patient Safety

Justin Mason-Home

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

  •  Increasing trends toward high potency APIs: managing patient and worker safety
  •  HPAPIs handling – a truly risky undertaking
  •  Exploring that handling HPAPIs is fundamentally high risk and involves high uncertainty
  •  Designing facilities that are fit-for-purpose
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    9:50

    Overcoming containment challenges in HPAPI manufacture with respirator innovation

    Martin Kohan

    Martin Kohan, Managing , AstraZeneca

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    10:30

    Morning Coffee

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    11:00

    HPAPI Handling from Lab Bench to Pilot Plant within Chemical Development (case studies)

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

  •  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
     
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    11:40

    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, HPAPI Project Services Limited

    Christophe Dehondt

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

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    12:40

    Networking Lunch

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    14:00

    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
     
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    14:40

    Afternoon Tea

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    15:10

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

    Richard Arnett

    Richard Arnett, Manager, Industrial Hygiene, Pharmascience

  • Guidelines and Practices for the most cost-effective large-scale production of HPAPI products
  • Understand how the large initial investment into HPAPI containment will return value on the long term
  • Implementing an pilot plant that is ready to meet GMP requirements 
  • Learn of the common pitfalls in industrial hygiene with highly potent APIs and the means to avoid them
     
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    15:50

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    clock

    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
  •  

    clock

    9:50

    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
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    10:30

    Morning Coffee

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    11:00

    Putting the worker at the centre of facility design for HPAPI manufacturing

    Richard Denk

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

  •  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

     

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    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
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    12:20

    Networking Lunch

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    13:20

    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
     
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    14:00

    Afternoon Tea

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    14:50

    How to maintain and manage cleaning programs for HPAPI whilst meeting regulatory requirements

  •  Expectations from health authorities and regulators for contaminant clean-up
  • Preventing cross-contamination in shared facilities
  • Case Studies from Novartis’s HPAPI manufacturing plants
  • Andreas Schreiner

    Andreas Schreiner, Global Network Validation Leader, Novartis

    Francois D Hooge

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

    clock

    15:10

    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
  • clock

    15:50

    Chairman’s Closing Remarks and Close of Day Two


    Global Network Validation Leader
    Novartis
    Director Pharmaceutical Development
    Clovis Oncology
    Chair
    CIEHF
    Global Lead - Occupational Hygiene
    Takeda
    Global Head of EHS and BCM
    Novartis, Advanced Accelerator Applications
    Senior Manager, CMC Management
    Daiichi Sankyo Europe GmbH
    FRSC, Director/Owner
    HPAPI Project Services Limited
    Managing Director
    Corporate Health Ireland
    Managing
    AstraZeneca
    Global Head, EHS by Design
    CSL Behring
    Manager, Industrial Hygiene
    Pharmascience
    Senior Consultant Aseptic Processing & Containment
    SKAN AG
    Head of Environmental Health and Safety
    MeiraGTx
    Head of GQA-Chemical APIs
    Bayer AG, R&D, Pharmaceutical

    Exhibitors

    Official Media Partner

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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 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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    Exhibitors


    AbbVie

    Exhibitors
    https://www.abbvie.co.uk/

    Vision. Expertise. Success.

    AbbVie Contract Manufacturing partners with companies across the globe to develop, scale and manufacture pharmaceutical products and bring them successfully to market.

    Drawing on more than four decades of success as the manufacturing division of AbbVie, we have the depth of experience and the technical knowledge to navigate issues and deliver the innovative solutions customers need. We are much more than a CMO – we are your partner for success.

    With foresight, scientific expertise and passion we anticipate the technical and compliance challenges along the entire pharmaceutical development journey through to commercialization. We see the complete picture to deliver our customer's vision. With full access to global state-of the-art facilities and world-class talent, our customers have come to depend on our service and quality to deliver real-world results.

    Visit abbviecontractmfg.com for more information.


    Media Partners


    Pharma network magazine

    Official Media Partner
    https://www.pharmanetwork.digital

    PHARMAnetwork is a company specialized in publishing for the pharmaceutical industry. PHARMAnetwork has developed publications for CMO, CDMO and professionals working in the life sciences. PHARMAnetwork designs specialized studies for pharmaceutical companies, contract service providers and investment firms. PHARMAnetwork magazine covers, every aspect of pharmaceutical value chain, the change and developments in the intersection between pharmaceutical industry and outsourcing industry. We perform interviews and write articles whose thematic strategies, organizations, mergers and acquisitions, regulatory, innovation in the pharmaceutical development and contract manufacturing. https://www.pharmanetwork.digital

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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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