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Remote Access Only Announcement

Due to ongoing concerns over COVID-19 we have now made this conference a virtual event. All speakers, attendees and sponsors will be able to access the full conference and its materials and will be able to log on remotely via the internet. Please contact a member of the SMi Team for more information customerservices@smi-online.co.uk

SMi is delighted to announce its 4th Annual Highly Potent Active Pharmaceutical Ingredients conference coming to London on the 11th-12th May 2020.

The increasing demand for medicines that target diseases more effectively and with fewer side effects is leading HPAPI market expansion with a CAGR of 10.3%. It is forecasted that by 2024, the HPAPI oncology market will be worth close to $100 billion.

As such, these highly potent substances predispose workers to higher risks of exposure and consequently, need to be manufactured according to strict criteria. Limiting exposure has become one of the biggest hurdles of the HPAPI industry resulting in an increasing need for containment solutions aimed to reduce the risk of hazard and to prevent cross-contamination. With elevated risk come stricter regulatory guidelines that pharmaceutical companies and contract manufacturers need to adhere to.

The 4th year of this conference series focuses on the growing HPAPI landscape driven by the demand for highly potent drugs in oncology, diabetes and autoimmune disease treatment. This event will address the biggest challenges the industry is facing with regards to determining toxicology limits, assessing hazards, implementing risk procures, translating risk assessment into facility engineering, preventing and dealing with cross-contamination and adhering to GMP regulatory guidelines.

Attend this conference and join our networking platform for industry professionals to provide you with the expertise to overcome the challenges of the HPAPI industry.

  • Explore HPAPI manufacturing with 8 big pharma from both the toxic substance and the employees’ perspective
  • Gain better understanding of human factors and ergonomics aspects and their role in improving production performance – NEW FOR 2020!
  • Deep dive into the oncology market and ADC production, the main driver of the HPAPI industry- NEW FOR 2020!
  • Learn what it takes to create a safety company culture and how to better train your employees on risk perception
     

Directors, Heads, Managers, Principal Scientists of :

  • Occupational Toxicology
  • Industrial Hygiene
  • EHS/ SHE
  • Validation
  • Risk Assessment
  • Containment Engineering
  • Manufacturing/ Production
  • Process Development
  • Supply Chain/ Operations
  • Product Quality
  • Formulation Development
  • Regulatory

3i France; 3P Innovation Ltd; AbbVie; Accord UK; ADC Biotechnology Ltd; Antikor Biopharma Ltd; Ascendis Pharmaceuticals; AstraZeneca; Bayer AG; Bayer Pharma; Boehringer Ingelheim Pharmaceuticals, Inc.; BSP Pharmaceuticals S.p.A.; Catalent Pharma Solutions Inc; Dec Group; DSTL; Egis Pharmaceuticals PLC; Ferring Pharmaceuticals A/S; Gedeon Richter Plc.; GSK; GVK Biosciences; HPAPI Project Services Limited; Ipsen Bionnovation Ltd; Laurus Synthesis; MedinCell; Minakem; NNE AG; Novartis Ag; Novo Nordisk; Novo Nordisk A / S; NPI & Product Technology; Oril Industrie; PCI Pharma Services; Pharmadagio Limited; Regeneron Inc; SafeBridge Consultants, Inc; SafeBridge Europe Ltd; SK Biotek; Solo Containment; Speciality Chemicals ; Takeda Pharmaceuticals;

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Justin Mason-Home

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

9:10 Characterizing Highly Potent APIs – Introduction to Occupational Toxicology

Martin Kohan

Martin Kohan, Senior Occupational Toxicologist, AstraZeneca
View Bio

• Toxicology – What makes a compound highly potent?
• Occupational Toxicology and Exposure Limits (OELs & PDEs) and Bands (OEBs)
• How are Exposure Limits and Bands established?
• Why we need Exposure Limits and Bands?

9:50 Occupational Banding Systems

William Hawkins

William Hawkins, Manager Occupational Toxicology, GSK
View Bio

• A brief history of occupational exposure banding.
• The use of Occupational Banding systems
• Toxicology of new compounds with novel mechanism of action – a case study

10:30 Morning Coffee

11:00 Technical elements of a successful cross contamination risk assessment

11:40 Respirators and their effectiveness in reducing particulate exposures

John Cherrie

John Cherrie, Professor of Human Health, Heriot-Watt University
View Bio

• Respirators are widely used to protect workers from inhaling airborne dusts, including APIs
• It is often said that respirators are ineffective, but if used properly they can offer a high degree of protection
• Selection of the right equipment and training of the workers to wear it correctly will ensure the best outcome
• Respirators should be used in conjunction with engineering measures in a comprehensive exposure control programme

12:20 Networking Lunch

13:20 PANEL DISCUSSION: Synchronizing pharma and CMOs – on the way to an ideal partnership

• What is essential for a good relationship between pharma and solution providers
• What are the challenges involved in incorporating outsourced manufacturing into the global pharma supply chain
• Addressing the need for transparency on the lack of data-driven approaches for managing occupational safety
• How could relationships be improved for achieving better workflow

Justin Mason-Home

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

Ulrich Rumenapp

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

Mike Perry

Mike Perry, Director, Pharmadagio Limited
View Bio

Richard Denk

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

14:00 ADC production - Cleaning and Cross-Contamination aspects

Richard Denk

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

-Overviewing cleaning requirements for ADCs
-Assessing the potential of robotics in containment
-Cleaning and Cross-Contamination control in ASDC production

14:40 Afternoon Tea

15:10 Performance Beyond ‘The Number’ – Exploring the Reliability of Containment Performance Data

Mike Perry

Mike Perry, Director, Pharmadagio Limited
View Bio

• The role, scope and limitations of containment performance testing explained
• Interpreting the ISPE Guide – how choice of sampling strategy, data interpretation, human factors and statistics will influence test outcomes
• Purchasing containment equipment and communication – examples of marketing language and finding the right questions to ask.
• Pushing the boundaries – the role of containment performance testing in HPAPI settings

15:50 Practical Steps for Delivering HPAPI Projects – part 1

Justin Mason-Home

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

  • Strategic HPAPI Project Considerations
  • Hazard Assessment - It All Starts with the Hazard
  • Process is Primary
  • Real Risk Assessment - Risk to Product and Risk to Workers
     
  • 16:10 Practical Steps for Delivering HPAPI Projects- part 2

    Justin Mason-Home

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

  • Facility Design Features
  • Containment for Higher Risk Activities and Control for Lower Risk Activities
  • Verification of Control/Containment Performance
  • Occupational health and safety management systems
  • 16:50 Chair's Closing Remarks and Close of Day One

    Justin Mason-Home

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

    8:30 Registration & Coffee

    9:00 Chair's Opening Remarks

    Justin Mason-Home

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

    9:10 Overview of ADC manufacturing

    Francois D Hooge

    Francois D Hooge, ADC Project Manager, Gamamabs Pharma
    View Bio

    • Overview of ADC mode of action and global pipeline
    • ADC production steps
    • Examples with PBD payload synthesis and conjugation

    9:50 CMC Strategies For The Timely Launch Preparation of Antibody-Drug-Conjugates as High Potent APIs

    Ulrich Rumenapp

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

    • The manufacture of highly potent ADCs - challenges and solutions
    • Deciding when to outsource and when to keep in-house
    • Bayer’s ADC production concept
    • Best practices for CMO selection and outsourcing ADC development and manufacture
    • The journey from development to launch - understanding the needs, solutions, risks and mitigations

    10:30 Morning Coffee

    11:00 Engineering in support of ADC containment – a case study

    Peter Marshall

    Peter Marshall, Associate Engineering Director, AstraZeneca
    View Bio

    • Innovative solutions to dealing with increasing toxicity of ADCs
    • Designing ADC containment systems
    • The containment of ADCs – a case study from AZ

    11:40 Manufacturing of Oncological Products: a perspective by a CDMO

    Fabio  Zenobi

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

    • New Product Introduction
    • Cross Contamination Risk Assessment & Environmental Risk Assessment
    • Case Study: ADC Manufacturing

    12:20 Networking Lunch

    13:20 Putting the human at the centre of system design in HPAPI manufacturing

    Brian Edwards

    Brian Edwards, Chair, Pharmaceutical Human Factors Group, CIEHF
    View Bio

    • Understanding the role human factors play in pharmaceutical manufacturing and how a novel UK group
    Is helping to drive change
    • 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
    • How human factors underpin all quality management systems

    14:00 HPAPI manufacturing; an outlook on Health

    Martin Hogan

    Martin Hogan, Managing Director , Corporate Health Ireland
    View Bio

    • Reproductive issues in both males and females
    • How to deal with pregnant employee
    • Concerns regarding potency of product etc (carcinogens, mutagens etc.)

    14:40 Afternoon Tea

    15:10 Developing Effective Guidelines and Training to prevent Potential Exposure to High Potent Compounds

    Michoux Pascal

    Michoux Pascal, Vice President, Global EHS Teva api & Biologics, Teva Api Italy
    View Bio

    • Setting the expectations and the provision of clear guidelines, standards and risk management tools
    • Developing employee awareness, technical capabilities and core competencies.
    • Measuring training and programme effectiveness for continuous improvement

    15:50 Chair's Closing Remarks

    Justin Mason-Home

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

    16:00 Close of Day Two

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    Sponsors

    Exhibitors

    Official Media Partner

    Key Media Partners

    Supporting Media Partners

    Workshops

    Practical Steps for Delivering HPAPI Projects
    Workshop

    Practical Steps for Delivering HPAPI Projects

    Copthorne Tara Hotel
    13th May 2020
    London, United Kingdom

    VENUE

    Remote UK

    United Kingdom

    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.
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    HPAPI 2019 Infographic

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    Remote Access 2020

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    Presentation by Frederic Le Pape, FPS

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    Presentation by Fabio Zenobi-EHS, BSP

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    Presentation by Charlyn Reihman, Safebridge Consultants

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    Speaker interview with Justin-Mason Home

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    Speaker interview Richard Denk

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    Speaker interview - Brian Edwards, CIEHF

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    HPAPI 2020 Brochure

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    HPAPI Attendees 2019

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    Workshop Programme

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    Presentation by David O'Connell, PCI

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    Presentation by Peter Marshall, AstraZeneca

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    Presentation by Ester Lovsin, Lonza

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    Presentation by Justin Mason-Home, FRSC

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    Highly Potent Active Pharmaceutical Ingredients Programme

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    Sponsors


    BSP Pharmaceuticals

    Sponsors
    http://www.bsppharmaceuticals.com

    BSP Pharmaceuticals S.p.A. is a CDMO (Contract Development and Manufacturing Organization), focused on the development and manufacturing of anticancer drugs with High Potency and Cytotoxic characteristic and It is specialized on formulation and manufacturing of Small Molecules and ADC products (Antibody Drug Conjugate). 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. 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 clients can avoil of this integrated services: • DEVELOPMENT SERVICES • CLINICAL SUPPLY • COMMERCIAL SUPPLY BSP has been conceived starting from a basic but essential operating requirement: segregate the high potent components from the surrounding and create a system suitable to manage pharmaceutical processes. With this primary idea in mind, layouts, flows of materials and personnel, air flows have been designed to minimize the risk of contamination for the environment, for the employees and for the product that is intended for patients with low level of immune defenses. The Manufacturing plant is located in Italy, 60 kilometers southbound of Rome. A single campus extended to more than 40 acres hosts all the main buildings supporting the capacities to manage a wide range of batch sizes: 2| DEVELOPMENT LABORATORIES 3| CONJUGATION SUITES 6| STERILE SUITES with more than 170 m2 fully dedicated to production anticancer and cytotoxic drugs 1| ORAL DEPARTMENT with multiple lines suitable to manufacture Clinical and Commercial products

    Exhibitors


    Dec Group

    Exhibitors
    www.dec-group.net

    Dec Group 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. Headquartered near Lausanne, Switzerland, Dec Group has a global presence with subsidiaries and agents in more than 30 countries including subsidiaries in the UK, Ireland, Germany, Poland, India, China and the USA. In excess of 600 companies worldwide have successfully integrated more than 9000 Dec systems into their production sites. These include a wide range of patented products that enhance safety, hygiene, containment, reliability and productivity in powder handling. Dec offers innovative approaches across the range of powder handling and process containment applications, including transfer, micronizing, filling/emptying, sampling, blending, dosing, aseptic solutions, milling, isolators and advanced cleaning (CIP/SIP) features.

    Media Partners


    Speciality Chemicals Online

    Official Media Partner
    https://www.specchemonline.com/

    Published continuously since 1981, Speciality Chemicals Magazine is the leading monthly magazine dedicated to covering business, markets and technology in the fine and speciality chemicals industries world-wide. We have over 50,000 readers and a calendar of features covering the full gamut of applications, including pharmaceuticals, agrochemicals, cosmetics and personal care, biobased chemicals, surfactants, biocides and much more.

    Media Partners


    pharmaphorum

    Key Media Partners
    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

    Media Partners


    Gate2Biotech

    Supporting Media Partners
    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


    Pharmalicensing

    Supporting Media Partners
    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.


    International Pharmaceutical Industry

    Supporting Media Partners
    http://www.ipimediaworld.com

    IPI gives you an insight into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. IPI provides a proven supportive means of communication to the Pharmaceutical, Bio Pharmaceutical, Nutraceutical and Medical Devices industry, incorporating the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies.


    Drug Discovery Today

    Supporting Media Partners
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    Pharma network magazine

    Supporting Media Partners
    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


    ASD MEDIA

    Supporting Media Partners
    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


    Mednous

    Supporting Media Partners
    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

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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, SMI 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@smi-online.co.uk

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