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SMi is delighted to announce its 3rd Annual Highly Potent Active Pharmaceutical Ingredients conference coming to London on the 13th-14th May 2019.

The HPAPI global market has developed rapidly in the past year and is continuing to expand into the future, with over a quarter of drugs in development worldwide being classified as highly potent. As a result, there is a growing demand for both pharmaceutical and contracted manufacturers to adapt to the evolving HPAPI landscape.

The event will explore current market trends, challenges of correctly assessing hazard, the use of innovative containment solutions to minimize risk and advanced manufacturing processes. In addition, the conference aims to guide attendees through novel regulatory updates for each stage of HPAPI development.

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.

 

  • Learn from the MHRA about the evolving regulatory landscape and its impact on the development of ADCs
  • Explore the risk of cross contamination in shared facilities
  • Evaluate the discrepancies of control banding and the importance of the updated EN689 statistical tool
  • Discover the innovative solutions at AstraZeneca, predicted to direct the future of containment
  • Discuss the challenges of reconstructing existing facilities in alignment with GMPs
     

We Are One of A Kind...

Networking: We keep networking at the forefront when it comes to our attendees. Expand your community with every part of the industry and with the right people to benefit your company and develop your career.

The Agenda: Be sure to have your pen and pad ready at all times! A valuable time is spent to discover the latest trends and hottest topics in the industry to provide the best possible agenda for our attendees.

Location/Venue: Being held in the heart of London, Holiday Inn, London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a few minutes’ walk from High Street Kensington underground station, making exploring easy. See the wonderful sights of Kensington, by visiting Kensington Palace, the historical Museums, or take a stroll in Kyoto Garden!

Onsite: Our knowledgeable events team will provide you with an exceptional service onsite. They will answer any questions you may have and inform you about any changes to the agenda.
 

API specialists, Containment engineers, Senior Scientists, Head of Scale-up Processings, Occupational Health Officers, Industrial Hygiene Leads, Head of Bioconjugations, Sales Directors, Marketing Managers, Course Directors/ Lecturers

AbbVie; Accord Healthcare; ACRAF S.P.A; ADC Biotechnology; ADC Biotechnology Ltd; Affygility Solutions; Antikor Biopharma; ARCINOVA; Astrazenecaá; Bayer Pharma; BSP Pharmaceuticals S.p.A.; CARBOGEN AMCIS AG; Cortex Consultancy; Cristalia Produtos Quimicos Farmaceuticos; Dec Group; Dishman Europe Limited; DSTL; Egis Pharmaceuticals PLC; Ferring Pharmaceuticals; Ferring Pharmaceuticals A/S; Gedeon Richter Plc.; Genentech; GlaxoSmithKline; Glythera; HPAPI Project Services Limited; Ipsen; Merck; Merck Group; Merck Serono GmbH; MINAKEM SAS; Nicomac Europe; Oncogen Pharma; Oril Industrie; Roche Pharma Research & Early Development; SafeBridge Consultants, Inc; SafeBridge Europe Ltd; SK Biotek; Skyepharma S A; Swish Tech Limited; The University of Edinburgh;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

 Mr Justin Mason-Home

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

9:10 Practical Elements in Rolling Out HPAPI Projects

  • Hazard assessment and strategic business matters
  • Proper risk assessment
  • Containment and control "hardware" and "software"
  • Dealing with engineers and equipment vendors
  • Verification of a safe working environment
     
  •  Mr Justin Mason-Home

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

    9:50 Session Details to be Confirmed

    Ms Ester Lovsin Barle

    Ms Ester Lovsin Barle, Head of Corperate Toxicology, Lonza

    10:30 Morning Coffee

    11:00 Demonstrating that Exposure Controls are Effective

    Mr Martin Axon

    Mr Martin Axon, Principal Occupational Hygienist, SafeBridge Europe Ltd
    View Bio

  •   Examples of control devices and their performance.
  • Where does the data come from?
  • ADCs – can we really measure nanogramme concentrations?
  •  

    11:40 OH/Containment Strategy and NPI at AbbVie

    Dr Olindo Lazzaro

    Dr Olindo Lazzaro, Director, Global EHS Technical Operations, AbbVie
    View Bio

  • OH/ Containment improvement Targets and LRP
  • OH exposure risk assessment and Improvement projects
  • NPI and Tech Transfer
  • Team Approach - Community of Practice
  • OH Metrics  
  • 12:20 Networking Lunch

    13:20 Panel Discussion: Control Matrices, Control Algorithms, Containment Guides and Confidence

    14:00 Internal Procedure Guide in Handling High Potent Compounds

    Dr Thomas Adam

    Dr Thomas Adam, Head of Global Quality Assurance Chemical APIs, Bayer
    View Bio

     

  • Bayer quality organisation guidelines
  • Internal procedures to minimise the risk of handling HPAPIs to workers
  •  Deciding the correct control based on a correctly identified hazard

     

     

  • 14:40 Afternoon Tea

    15:10 Risk Assessment of Highly Potent APIs: Cross-Contamination and Transportation Parameters

    Dr Ildiko Ziegler

    Dr Ildiko Ziegler, Distinguished Validation Expert, Gedeon Richter Plc.
    View Bio

  • Guidelines regarding Quality Risk Management
  • Case study 1: technical aspects and complexity in cross contamination risk analysis
  • Case study 2: temperature deviation during transportation
  • 15:50 Design and Innovation of a New Compound Facility

    Dr Jack Brown

    Dr Jack Brown, Senior Principal Scientist, Boehringer Ingelheim Pharmaceuticals, Inc.

  • Reconstruction guidelines for adapting existing facilities to meet the needs of HPAPIs
  • Ensuring facility reconstruction meets GMPs
  • Additional assets required for HPAPI adaptation
  • Designing controls and training to address worker safety
  • 16:30 Chairman’s Closing Remarks and Close of Day One

     Mr Justin Mason-Home

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

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

     Mr Justin Mason-Home

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

    9:10 Principles of Pharmaceutical Containment in Isolator Designs

    Mr Peter Marshall

    Mr Peter Marshall, Associate Engineer Director, AstraZeneca
    View Bio

    • Innovative solutions to dealing with the increasing toxicity of ADCs
    • Designing single use systems
    • Considerations when choosing between single use Vs traditional use systems
    • Real world examples of single use systems in industry
     

    9:50 Antibody Drug Conjugate Manufacturing – Coordination of Linker-payload synthesis and Antibody Conjugation

    Dr Thomas Nittoli

    Dr Thomas Nittoli, Director, Regeneron Inc
    View Bio

    • Technology transfer
    • Scale-up
    • Qualification
    • ADC Toxicology lot
    • ADC GMP lot
     

    10:30 Morning Coffee

    11:00 Adaptation of Containment Designs to Cope with the High Demands of HPAPIs

    Mr Jeff Parry

    Mr Jeff Parry, senior formulation scientist, Astrazeneca
    View Bio

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

    11:40 Session Details to be Confirmed

    Mr Nigel Saunders

    Mr Nigel Saunders, SME Containment, GSK

    12:20 Networking Lunch

    13:20 Session Reserved for the MHRA

    14:00 Outsourcing Late Stage CMC Development and Bio-Manufacturing for Fast Track Projects with Accelerated Timeline – the Challenges and Needs

    Dr Ulrich Ruemenapp

    Dr Ulrich Ruemenapp, Head of Launch Preparation and Coordination, Bayer Pharma
    View Bio

    • Drivers for accelerated CMC development
    • Pathways open for expedited regulatory review and approval
    • Considerations for CMC development and regulatory submission
    • Challenges and risks of accelerated projects, especially when outsourcing bio-manufacturing

    14:40 Afternoon Tea

    15:10 Respiratory APIs: Peculiarities of Development and Formulation

    Dr Enrico Bettetini

    Dr Enrico Bettetini, R&D Technology and Pilot Manager, Teva Pharmaceuticals Ltd
    View Bio

    • Purpose & target of a respiratory API
    • Equipment & analytical instruments in containment grade
    • Strategy for the development & for industrialization
    • New trends
     

    15:50 Panel Discussion: CMO Outsourcing Options and Selection Methodologies

    16:30 Chairman’s Closing Remarks and Close of Day Two

     Mr Justin Mason-Home

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

    +

    FEATURED SPEAKERS

     Mr Justin Mason-Home

    Mr Justin Mason-Home

    Director, HPAPI Project Services Limited
    Dr Thomas Nittoli

    Dr Thomas Nittoli

    Director, Regeneron Inc
    Mr Peter Marshall

    Mr Peter Marshall

    Associate Engineer Director, AstraZeneca

    Mr Justin Mason-Home

    Director, HPAPI Project Services Limited
     Mr 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.

    Dr Enrico Bettetini

    R&D Technology and Pilot Manager, Teva Pharmaceuticals Ltd
    Dr Enrico Bettetini

    Enrico has held positions in CMOs and generics API Companies for 25 years. During the last decade as EU & South America TEVA expert for the engineering of HPAPI bulk properties, he leaded the research of innovative technologies for the formulation of respiratory. He developed micronized steroids or LABA/LAMA molecules mainly for dry powder inhalers (DPI) and controlled dosage drugs with TEVA and Third Parties. He has been Manager for technology transfer and GMP industrialization focused on advanced analytical techniques, protocols, PAT, DoE and route cause methodologies with worldwide sites and CMOs.
    Before joining Teva Enrico, organic chemist (Università di Milano), was involved in several HPAPI chemical plants start up. He was Head for the design of equipment and software, quality and safety risk assessments and HAZOPs.
    Sterility of HPAPIs without the use of filtration or irradiation has been the last challenge.
    Fifteen years ago he cofounded a contract GLP laboratory for Pharma, Cosmetic & Food

    Dr Ildiko Ziegler

    Distinguished Validation Expert, Gedeon Richter Plc.
    Dr Ildiko Ziegler

    Dr. Ildiko Ziegler has been a professional at Gedeon Richter for 15 years and leading different projects in her field for 5 years. She has been a distinguished validation expert since Jan 2014, specialised for cleaning validation and quality risk assessment in the pharma industry. Ildiko obtained M.Sc. in chemical engineering at the Budapest University of Technology and Economics (BUTE) in 1996. She recieved licentiate degree at the Luleå University of Technology (Sweden) in 2000. She defended Ph. D. at the BUTE in 2000 and obtained the Géza Schay Award for the achievments in the field of physical and theoretical chemistry.

    Dr Jack Brown

    Senior Principal Scientist, Boehringer Ingelheim Pharmaceuticals, Inc.
    Dr Jack Brown

    Dr Olindo Lazzaro

    Director, Global EHS Technical Operations, AbbVie
    Dr Olindo Lazzaro

    Olindo Lazzaro is Director, Global EHS Technical Operations at AbbVie, Responsible for Global EHS Technical Centers of Excellence at AbbVie supporting both R&D and Manufacturing. Key areas of as follows: Process Safety Management, Loss Prevention and Fire Protection, OH/Containment, Chemical Safety and GHS, PiE, Green Chemistry/Ecoefficiency, N2/Inert gas handling, EHS New Product Introduction and EHS Technical Transfer.
    Also responsible of AbbVie Environmental and OH Labs ((both ISO 17025 accredited). Lead for Prevention of Catastrophic Incidents (PCI) Strategy at AbbVie. EHS Approver for AbbVie Engineering Standards. Champion of Manufacturing Containment Capital Improvement Long Plan, OH/Containment Engineering Community of Practice and of the AbbVie Pharma In the Environment (PiE) team. He is EHS representative in the Abbvie Operations Pipeline Teams.

    Dr Thomas Adam

    Head of Global Quality Assurance Chemical APIs, Bayer
    Dr Thomas Adam

    Thomas Adam studied Chemistry at the University in Saarbruecken and Mainz, Germany. After post-doc at Novartis, Switzerland, he joined Bayer AG. He worked in different Q-functions. Since 2011 he is Head of GQA-Chemical APIs within Chemical Development Department at Bayer AG and responsible for the release of APIs for clinical trials, Qualification,Validation and Supplier Qualification.

    Dr Thomas Nittoli

    Director, Regeneron Inc
    Dr Thomas Nittoli


    Tom Nittoli has over 20 years of experience in the pharmaceutical industry and is currently Director of R&D Chemistry. Tom joined Regeneron in 2010 to advance conjugated antibodies and proteins from discovery to development. Since joining Regeneron, he has developed a variety of small molecules for protein conjugation, lead diverse teams of discovery ADC scientists, and lead cGMP synthesis and conjugation campaigns.
    Prior to Regeneron, Tom held positions at Pfizer, Wyeth, and CIBA-Giegy. He holds a PhD from the department of chemistry SUNY Stony Brook and was a post-doctoral fellow at the University of Pennsylvania.
     

    Dr Ulrich Ruemenapp

    Head of Launch Preparation and Coordination, Bayer Pharma
    Dr Ulrich Ruemenapp

    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.

    To correspond with Dr. Rümenapp, please contact him at: ulrich.ruemenapp@bayer.com
     

    Mr Jeff Parry

    senior formulation scientist, Astrazeneca
    Mr Jeff Parry

    After graduating, Jeff Parry spent 5 years as an industrial hygienist before joining Astrazeneca as a First Line Manager in the Tablets Pilot Plant at Macclesfield. During the following 18 years, he has worked within various Astrazeneca pilot plants producing both sterile parenteral, and oral solid dosage forms.
    Most recently, he has been responsible for representing R&D in the refurbishment of a dedicated building for the formulation science department at Macclesfield – using this opportunity to change the ways of working with high potent API’s, from containing people to working with contained equipment.
     

    Mr Martin Axon

    Principal Occupational Hygienist, SafeBridge Europe Ltd
    Mr Martin Axon

    Martin commenced his career working as analytical chemist for a multinational pharmaceutical company; there he qualified as an occupational hygienist which he put into practice at primary and secondary manufacturing at several international sites.  Following a break from the pharmaceutical industry (5 years working in academia), he joined SafeBridge in 2005.  He is now responsible for the SafeBridge Certification programme in Europe; he provides advice on the safe handling of potent APIs to clients throughout Europe.

    Mr Nigel Saunders

    SME Containment, GSK
    Mr Nigel Saunders

    Mr Peter Marshall

    Associate Engineer Director, AstraZeneca
    Mr Peter Marshall

    Trained as a Biochemical Engineer at UCL, Peter has worked for ICI/Zeneca/AstraZeneca for 33 years, with 25 years working with high hazard chemicals.
    Responsibilities include global Subject Matter Expert for containment systems, Technical Lead for multiple international OSD developments, and support to multiple emerging market CMOs in areas of technical transfer and worker safety.
    Co-chair ISPE Containment CoP Committee 2006-9, current member.
    Member of Author teams for
    ‘SMEPAC’ containment system testing GPG (1st and 2nd Edns),
    Cross Contamination Baseline guide (RiskMAPP) (1st/2nd Edns)
    OSD Baseline Guide 3rd Edition.
     

    Ms Ester Lovsin Barle

    Head of Corperate Toxicology, Lonza
    Ms Ester Lovsin Barle

    Sponsors and Exhibitors

    VENUE

    Holiday Inn Kensington Forum

    97 Cromwell Road , London, United Kingdom

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    HOTEL BOOKING FORM

    Sponsors and Exhibitors


    PCI Pharma Services

    Sponsors and Exhibitors
    http://www.pciservices.com

    PCI Pharma Services is an integrated full service provider, a proven and trusted partner to leading companies in the global healthcare industry. We offer unparalleled expertise and experience in taking compounds from the earliest stages of development through to successful commercialization, delivering speed-to-market and commercial success for our customers. Our core services support each stage of the product lifecycle, including drug development, clinical trial supply, commercial launch and ongoing commercial supply. We partner with clients in providing innovative technologies, flexible solutions, and an integrated supply network supporting lifesaving medicines destined to over 100 countries around the world. We support clients with a dedication to providing the industry’s leading experience, exemplified in our operational flexibility, delivery, and commitment to safety, supported by industry leading technologies and an exemplary quality and regulatory record. This has allowed us to be the partner of choice for leading pharmaceutical companies around the world, operating as a seamless extension of their business.


    SafeBridge

    Sponsors and Exhibitors
    https://www.safebridge.com/

    SafeBridge is a unique team of occupational and environmental toxicologists, industrial hygienists, chemists and safety and environmental professionals with extensive experience inside the pharmaceutical industry. SafeBridge provides professional consulting services and analytical support to clients across the United States and internationally including the United Kingdom, Ireland, continental Europe, and Canada.

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    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    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, 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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