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The pre-filled syringes industry is growing at an exponential rate. With increasing demand for self-administration, a rise in biologics, large-volume delivery and the delayed EU MDR at the forefront of the field, SMi’s 13th annual event will bring you the key insights you need to grow and enhance your pre-filled syringes portfolio and discover what the future holds for the PFS and combination products industry.

 

 

The Workshop will give an overview of the landscape of long acting injectable technologies, addressing the key barriers facing development in industry and discussing strategies in overcoming hurdles in sustained-release delivery. Delegates will engage in an interactive case study review to explore the best approaches and strategies for long acting injectable development and optimal delivery. Further discussion will delve into the future potential for long-acting injectables
 

 

  • Assess the current landscape for fragile molecule formulations and delivery 
  • Explore real world examples through injectable device case studies 
  • Discuss considerations and strategies for successful long-acting injectable delivery
  • Gain insight into the future landscape of long acting injectables
  • Drug-delivery developers 
  • Medical Device Engineers 
  • Primary Packaging material designers 
  • Secondary packagers 
  • Smart device developers 
  • Training device developers 
  • Device-safety solution providers 
  • Drug developers 

Previous attendees include:
 

Advanz Pharma; Aspen Pharma; AstraZeneca; Bayer AG; Bayer Pharma; Beckton Dickinson (BD); Becton Dickinson (BD); Becton Dikinson; Boehringer Ingelheim; Boehringer Ingelheim GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; BSI Group; CCIT SA; Covestro Deutschland AG; Credence MedSystems, Inc.; Doublee Bond Pharmaceutical; Drug Discovery Support; Emergo by UL; Eveon; Fruh Verpackungstechnik AG; Gerresheimer Buende GmbH; GSK; Harro Hofliger; Harro Hofliger Packaging Systems Ltd; Haughton Design Ltd; HK Packaging Consulting GmbH; IPP; Ipsen; IPSEN Pharmsciences; Johnson & Johnson; Mallinckrodt; MHRA; Mitsubishi Gas Chemical Company, Inc; Mitsui Chemicals Inc.; Nelson Labs NV; Nemera; Novartis A G; Novo Nordisk; Novo Nordisk A / S; Owen Mumford; Pall Europe Ltd; Panasonic Healthcare Co., Ltd.; Pfizer; Pfizer Ltd UK; Pfizer R&D Ltd; Pfizer UK Limited; PHC Corporation; Regeneron Pharmaceutical Inc; Roche; SCHOTT Pharmaceutical Systems; SCHOTT Pharmceutical Systems; SI02 Medical Products ; Swiss Fillow AU; Teva Pharmaceuticals; Transcoject GmbH; UCB Celltech; W.L. Gore & Associates, Inc.; West Pharmaceutical Services; Ypsomed; Zeon Europe GmbH; ZwickRoell GmbH & Co. KG; ZwickRoell Ltd;
 

Workshop programme

13:00 Registration & Coffee

13:30 Opening Remarks

Joel Richard

Joel Richard, Chief Development Officer, MedinCell
View Bio

Rene Holm

Rene Holm, Head & Scientific Director, Janssen
View Bio

13:40 An overview of technologies for long acting injectables

  • Current successful technologies in industry
  • What are the limitations and barriers facing development?
  • Competitive advantages of injectable in situ forming implant technologies
  • How do we select compounds for long acting injectables?

     

  • Joel Richard

    Joel Richard, Chief Development Officer, MedinCell
    View Bio

    Rene Holm

    Rene Holm, Head & Scientific Director, Janssen
    View Bio

    14:40 Formulations of fragile molecules

  • Current landscape for delivery of fragile molecules
  • Specific formulation challenges for peptides and proteins
  • Overcoming hurdles in fragile molecule sustained-release delivery
  • Joel Richard

    Joel Richard, Chief Development Officer, MedinCell
    View Bio

    Rene Holm

    Rene Holm, Head & Scientific Director, Janssen
    View Bio

    15:10 Afternoon Tea

    15:30 Case Study Introduction

    Joel Richard

    Joel Richard, Chief Development Officer, MedinCell
    View Bio

  • Delegates will be presented with a case study overview of the BEPO® long acting injectable 
  • Recent progress of BEPO®
  • Challenges in development of the long acting injectables and considerations in formulation development
  • 16:10 Interactive Case Study Review

  • Delegates will be tasked to assess and discuss:
  • Best approaches for development
  • Strategies to overcome formulation challenges
  • Brainstorm improvements for optimal delivery
  • Discussion of lessons learned from the exercise
  • Future potential for long acting injectables
  • Joel Richard

    Joel Richard, Chief Development Officer, MedinCell
    View Bio

    Rene Holm

    Rene Holm, Head & Scientific Director, Janssen
    View Bio

    16:50 Closing Remarks

    Joel Richard

    Joel Richard, Chief Development Officer, MedinCell
    View Bio

    Rene Holm

    Rene Holm, Head & Scientific Director, Janssen
    View Bio

    17:00 End of Workshop

    +

    FEATURED SPEAKERS

    Joel Richard

    Joel Richard

    Chief Development Officer, MedinCell
    Rene Holm

    Rene Holm

    Head & Scientific Director, Janssen

    Joel Richard

    Chief Development Officer, MedinCell
    Joel Richard

    Dr Joël Richard is currently Chief Development Officer and Executive Committee Member at MedinCell (Montpellier, France). He is leading all the development activities of the company, based on the proprietary technology BEPO® for Long-Acting Injectables. (LAIs). These activities comprise formulation and process development, device development, analytical development, process transfer and scale-up, non-clinical development, manufacturing and supply of clinical batches, regulatory affairs and clinical development operations, quality and regulatory compliance. Dr Richard has more than 30 years of experience in chemistry and (bio)pharmaceutical R&D, including several global senior leadership positions in various Biotech and Pharma companies, such as Ipsen (France), Serono (Italy), MerckSerono (Germany), Ethypharm (France). Dr Richard has focused his research activity on new formulation technologies and innovative drug delivery systems (microspheres, nanosystems, self-assembling gels), especially for injectable peptide and protein formulations. He has graduated from Ecole Normale Supérieure (Cachan, France), and got a PhD in Materials Science (Paris VI, France), and the “Habilitation à Diriger les Recherches” in Chemistry (Bordeaux I, France). He also had an entrepreneurial experience, co-funding Mainelab (France) with Pr Jean-Pierre Benoit, a drug delivery company specialized in developing solvent-free processes for protein delivery systems. He has published 70 peer-reviewed scientific papers, 8 book chapters and 2 review editorials in various fields (colloids and interfaces, drug delivery, supercritical fluids, protein formulations, sustained-release formulations…). He is the author of 140 international communications and 55 patent families. He has also been serving as an APGI Board Member for 3 years and is a Member of the Controlled Release Society (CRS).

    Rene Holm

    Head & Scientific Director, Janssen
    Rene Holm

    René Holm received his pharmaceutical training at the Royal Danish School of Pharmacy, now the school of pharmacy at University of Copenhagen, Denmark, in 1998 and his PhD in biopharmaceutics from the same institution in 2002. Dr. Holm joined Lundbeck in 2001 and changed to Janssen in 2016. Dr. Holm has worked within pharmaceutical development, formulations for non-clinical testing in drug discovery, physical chemistry and material science covering both small and large molecules and is now responsible for the functional unit ensuring development of all non-solid formulations for Janssens small molecule value stream.

    Dr. Holm is (co-) author of more than 185 original articles in peer-reviewed journals and patents in the field of biopharmaceutics, preformulation, formulation and physical pharmacy and is a honorary professor in physical chemistry at the Department of Science and Environment, University of Roskilde, Denmark.
     

    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

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

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

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

     

    HOTEL BOOKING FORM

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    WHAT IS CPD?

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

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

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

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

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

    CPD AND PROFESSIONAL INSTITUTES

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

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

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

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

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

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

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

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

    As a formal provider of CPD certified activities, 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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