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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.

 

  • LISTEN to Gedeon Richter on the risk assessment of highly potent APIs; from cross-contamination to transportation parameters
  • LEARN from AbbVie about containment improvement strategies
  • ASSESS the challenges of verifying containment performance of a HPAPI OSD facility in GSK's presentation
  • REVIEW adaptation of containment designs with AstraZeneca to cope with the high demands of HPAPIs
  • ATTEND the post-conference workshop which is a step-by-step road map assessing how to successfully roll out highly potent API projects 

     

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 Occupational Exposure Limits - how are they derived and what do they say?

    Ms Ester Lovsin Barle

    Ms Ester Lovsin Barle, PhD, MScTox, ERT, Lonza
    View Bio

  • Do you have a highly potent drug and don’t know what it means for workers?
  • What goes into the OEL?
  • What are the limits of the OEL?
  • 10:30 Morning Coffee

    11:00 Manufacturing of Oncological Drug Products & Drug Substance by a CDMO

    Fabio  Zenobi

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

    • New Product Introduction
    • Case Study: ADC Manufacturing
    • Waste & Wastewater treatment
    • Project phase out

    11:40 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?

     

  • 12:20 Networking Lunch

    13:20 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  
  • 14:00 Panel Discussion: Control Matrices, Control Algorithms, Containment Guides and Confidence

  • Importance of control matrices and algorithms
  • Current status of containment guides
  • Methods of optimizing confidence towards worker safety
  • Future of containment designs
  • Dr Thomas Adam

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

    14:40 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

     

     

  • 15:20 Afternoon Tea

    15:50 Development and manufacture of HPAPI drug products through the clinical phases from molecule to market

    David OConnell

    David OConnell, Director Scientific Affairs, PCI Pharma Services
    View Bio

  • How HPAPIs can be developed into suitable drug dosage forms
  • Strategies to adhere to the highest quality standards
  • Complexities at each stage of the development cycle from FiM studies to global supply
     
  • 16:30 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
  • 17:10 Design and Innovation of a New Compound Facility

    Dr Jack Brown

    Dr Jack Brown, Senior Research Fellow, Boehringer Ingelheim Pharmaceuticals, Inc.
    View Bio

  • 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
  • 17:50 Chair's closing remarks

     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 The Challenges Verifying Containment Performance of a HPAPI OSD Facility

    Mr Nigel Saunders

    Mr Nigel Saunders, SME Containment, GSK
    View Bio

    · A real life example of the challenges containment testing presents
    · Strategies used to verify containment performance.
    · The successes, learnings and rewards

     

    12:20 Networking Lunch

    13:20 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

    14:00 Respiratory APIs: Peculiarities of Development and Formulation

    Dr Enrico Bettetini

    Dr Enrico Bettetini, Senior Advisor Associate , Oriento SA
    View Bio

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

    14:40 Panel Discussion: CMO Outsourcing Options and Selection Methodologies

  • Criteria for CMO selection
  • Confidentiality
  •  EHS compliance
  •  Efficiency at every step
  • Dr Ildiko Ziegler

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

    Dr Jack Brown

    Dr Jack Brown, Senior Research Fellow, Boehringer Ingelheim Pharmaceuticals, Inc.
    View Bio

    17:00 Chair's closing remarks

     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.

    David OConnell

    Director Scientific Affairs, PCI Pharma Services
    David OConnell

    David O’Connell is the Director of Scientific Affairs at PCI Pharma Services, an integrated full service provider expertly delivering a seamless transition from development to commercialization. After graduating from Glasgow Caledonian University with a Bachelor of Science degree in applied bioscience David spent seven years as a Supervisory Scientist working for Aptuit in Edinburgh before moving to Penn Pharma as Head of Formulation Development in 2009. Here he played a vital part in the design of the potent Contained Manufacturing Facility (CMF), which won the ISPE Facility of the Year award for Facility Integration (2014). In 2013 David took on the role of Director, Pharmaceutical Development at the PCI site in Tredegar and in 2017 became PCIs Director of Scientific Affairs.

    Dr Enrico Bettetini

    Senior Advisor Associate , Oriento SA
    Dr Enrico Bettetini

    Enrico Bettetini is cofounder of a contract GLP laboratory, Senior Advisor Associate at Oriento SA and freelance pharma consultant. He has previously 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 physically engineered powders. He developed micronized steroids, even as sterile suspension, or LABA/LAMA molecules mainly for dry powder inhalers (DPI) and controlled dosage drugs with TEVA's and Third Parties' Pharma.

    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 Research Fellow, Boehringer Ingelheim Pharmaceuticals, Inc.
    Dr Jack Brown

    Senior Research Fellow; Chemical Development, Boehringer Ingelheim
    Pharmaceuticals, Inc. 7/18- present. responsible for the scale-up of process,
    from laboratory into the kilo lab to the pilot plant. Safe execution of
    processes in the kilo lab and pilot plant. Oversee process safety for Chemical
    Development.

    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
     

    Dr. Andrew Kyle

    R&D Senior Chemist, SK Biotek
    Dr. Andrew Kyle

    Andrew Kyle is a Senior Chemist within the R&D group at SK biotek in Swords, Dublin. His main focus is in HPAPI products, supporting process development and optimisation to facilitate the technical transfer of scalable synthetic routes to the manufacturing plant. Andrew holds a DPhil degree in Organic Chemistry from the University of Oxford and has previously held the position of Chemistry Team Leader at Abzena, gaining extensive expertise in early stage antibody drug-conjugate design and development.

     

     


     

    Fabio Zenobi

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

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

    Mike Perry

    Director, Pharmadagio Limited
    Mike Perry

    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

    Qualified as a Mechanical and Electrical Engineer, after an early career specialising in mechanical handling and high-speed filling and packaging equipment Nigel joined GlaxoSmithKline 25 years ago working in primary API manufacturing. Responsible for project managing the installation of API manufacturing plant specialising in containment system. 10 years ago, Nigel transferred into a central role in Engineering & EHS. He is the Global Subject Matter Expert on containment system and materials handling for the Pharma, Consumer Health and Biopharm Supply Chains and works closely with R&D on technical transfer of HPAPI’s into GSK manufacturing and CMO’s.

    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

    PhD, MScTox, ERT, Lonza
    Ms Ester Lovsin Barle

    Ester Lovsin Barle, DVM, MSc, PhD, MScTox is the Head of Corporate Toxicology at the at Lonza and responsible for Health topics at the Corporate Lonza EHS. Previously she has been the Head of Health Hazard Assessment in Novartis Global HSE & BCM. Her responsibilities include scientific development and cross-organizational implementation of health based exposure limits (HBEL), compiling global policy on occupational toxicology and patient safety related process in support of manufacturing in Lonza globally, as well as global implementation of safe handling of chemicals. She is leading the Lonza Global biosafety network. She received her PhD in veterinary sciences from University of Ljubljana, Slovenia and a second masters degree in toxicology and risk assessment from Medical University in Vienna.
    Dr. Lovsin Barle is author/co-author of over 60 publications including peer-reviewed articles and book chapters. She is a member of several pharma industry and toxicological associations and boards and has served as the president of the Slovenian Society of toxicology. She lectures at several universities.

     

    Sponsors and Exhibitors

    Supporting Media Partners

    Supporters

    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

    Interview with Dr Ulrich Ruemenapp from Bayer Pharma

    Download

    Interview with Ildikó Ziegler Gedeon Richter

    Download

    HPAPI 2019 Attendees

    Download

    2019 HPAPI Chair Letter

    Download

    Interview with Ester Lovsin Barle from Lonza

    Download

    Waste Management for Highly Potent APIs

    Download

    Antibody-Drug Conjugates

    Download

    The Manufacturing of Oncological Products by a CDMO

    Download

    Interview with Peter Marshall, AstraZeneca

    Download

    HPAPI Work Shop Programme 15th May

    Download

    HPAPI 2019 Speaker Line-Up

    Download

    HPAPI 2019 Conference Brochure

    Download

    HPAPI 2019 Programme

    Download

    HPAPI Past Attendees

    Download

    HPAPI Info Graphic 2019

    Download

    Sponsors and Exhibitors


    BSP Pharmaceuticals

    Sponsors and Exhibitors
    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


    Dec Group

    Sponsors and Exhibitors
    http://

    Leading global provider of powder handling and process containment technologies, Dec Group provides efficient high containment solutions from milligrams to tons and from concept to completion.


    MINAKEM

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

    Minakem is a fully integrated CDMO for HPAPIs and ADC drug-linkers thanks to a dedicated site (FDA approved) having more than 40 years’ experience in HPAPIs, state-of-the-art containment systems, capability to handle broad range of chemistry and technologies including preparative-HPLC from grams to hundreds of kg per batch (GMP).


    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.


    SK Biotek

    Sponsors and Exhibitors
    http://www.skbiotek.ie

    SK biotek and AMPAC Fine Chemicals a team to be reckoned with… SK Biotek (SKBT) and AMPAC Fine Chemicals (AFC) are wholly owned subsidiaries of the South Korean conglomerate SK, a global leader in energy, chemicals and information technology. The partnership between the companies, established in 2018, creates substantial market synergies in the API CDMO space by combining highly complementary assets and expertise of these companies, enabling us to provide the highest quality services to our customers. SKBT has two sites in Korea, an R&D/Manufacturing facility in Daejeon and a large scale manufacturing site in Sejong and a further site in Swords, Co. Dublin, Ireland, which specializes in the supply of clinical and commercial API. The state of the art facility in Swords has been manufacturing API and Intermediates for >50 years. As leaders in operational excellence and continuous improvement and boasting exceptional technical capabilities, Swords Campus provides a strong offering to our customers through scale-up, launch and secure commercial supply of NCEs. Within the general Campus capabilities, we offer access to world-class potent handling capability (down to low nanogram per cubic meter levels) and have a strong material science group on Campus. Our plants in Korea offer cost effective supply of late phase and commercial pharmaceutical API and Intermediates. Our scientists and engineers are leading exponents of continuous manufacturing methodologies (tubular and fixed bed reactions) and have successfully developed processes from low kilograms through to 10s of tonnes. Continuous Flow Processing can offer many advantages over traditional batch processing. It is not just greener, highly efficient and often cost effective, it also provides access to low and high temperature, hazardous, high-pressure and catalytic reactions. AMPAC Fine Chemicals (AFC) became part of the SK family in the mid-2018, expanding the manufacturing footprint to the US. AFC is a custom manufacturer of APIs and Intermediates; we have been solving problems for customers through technology and innovation to reliably deliver quality products for >75 years. With integrated facilities in California, Texas, and Virginia specializing in process development, scale-up, and cGMP compliant production from kilograms to multi-ton quantities, we have developed capabilities that support a wide range of processes and technologies. We are the leading exponent of Simulated Moving Bed technology (SMB) and offer this powerful technology from lab, through pilot to large commercial scale. We have a proven track record in successfully developing processes involving highly energetic chemistry and now offer supply capability for Controlled Substances from our DEA approved facility in Virginia. As part of the SK Family, AMPAC and SK biotek in combination is able to provide our customers a broader portfolio of offerings. With a strong technology toolbox supporting Continuous Processing, highly energetic chemistries, SMB and HPAPI and access to over 1000m³ of global capacity, spread across three continents, we have the capability and capacity to support all your API and Intermediate needs across the full lifecycle. As an SK customer, we commit to work with you and your product as if it were our own; after all, we have been doing it for decades, producing many of the world’s most recognized drugs.


    Solo Containment

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

    Trusted by major players in HP API & ADC development, Solo bring high performance containment solutions in innovative single use packages. Solo’s solutions include toxin-linker compounding as well as NCE molecule development isolators and now extend to Grade A aseptic fill/finish isolators – all supported by validation documentation and containment performance testing.

    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.

    Media Partners


    PharmaVOICE

    Supporters
    http://www.pharmavoice.com

    PharmaVOICE magazine, and its supporting VIEW publications, provide commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE's more than 41,000 U.S.-based subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers.

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

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

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

     

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    WHAT IS CPD?

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

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

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

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

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

    CPD AND PROFESSIONAL INSTITUTES

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

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

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

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

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

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

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

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

    As a formal provider of CPD certified activities, 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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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
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