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This workshop will examine CMC development of oligonucleotide therapeutics through interactive discussions. Review the key CMC concepts for oligonucleotide therapeutics and the successes and challenges for the platforms that have already progressed to product approval. Explore the use of oligonucleotides in complex and emerging modalities and assess the next generation of manufacturing platforms. Assess oligonucleotide impurities, their guidelines and how these should be controlled and addressed through interactive discussions. Delve into the regulatory expectations by phase of development and how to plan for the end goal, and understand how this can be applied to future projects


 

  • Discuss key developments and challenges in Oligonucleotide CMC
  • Explore the use of oligonucleotides in complex and emerging modalities
  • Delve into Oligonucleotide impurities, their control and impurity guidelines
  • Develop your understanding of the regulatory expectations throughout the different phases of development
     

Executives, Directors, VPs, Heads, Principals, Managers of:

RNA Biology/Discovery
Novel Therapeutic Modalities
Innovation Technologies
Formulation and Drug Delivery
Clinical Research and Development
Cell Biology


 

Accanis Therapeutics; Advanced Cell Diagnostics – A Bio-Techne Brand; Aescap 2.0; Alnylam Pharmaceuticals UK & Ireland; AmpTec GmbH; Aseptic Technologies SA; AstraZeneca; Bachem AG; BianoGMP; BioNTech IMFS GmbH; BioNTech RNA Pharmaceuticals; Boehringer Ingelheim Pharma GmbH & Co. KG; Calithera Biosciences; CEPI - Coalition for Epimemic Prepardness Innovation; Chemgenes Corporation; Curevac Ag; Dicerna Therapeutics.; Duke University School of Medicine; Ethris GmbH; Exicure Inc.; F.Hoffmann-La Roche AG; GSK; Horizon Discovery; InteRNA Technologies BV; Intertek; Lipocalyx; MedImmune; MHRA; MiNA Therapeutics; N4 Pharma UK Limited; New England Biolabs; NHS Blood and Transplant Authority; Nitto Avecia; NOF Europe GmbH; Nouscom SRL; ProQR Therapeutics; RCSI; RCSI Royal College of Surgeons in Ireland,; RNA Medco; ROCHE; Roche Diagnostics Deutschland GmbH; Roche Innovation Center; Russell Publishing Ltd; Sanofi; Sanofi-Aventis Deutschland GmbH; Takeda Development Centre Europe Ltd.; TCR Solutions; The Italian Institute of Technology; The RNA Medicines Company; Thermo Fisher Scientific; University Medicine Mainz Hospital; University Of Portsmouth; University Of Surrey; Yuria Pharma;

Workshop programme

13:00 Registration & Coffee

13:30 Opening Remarks

Mia Kiistala

Mia Kiistala, Principal Consultant, Aurora CMC Consulting

13:40 Key CMC development milestones for oligonucleotide therapeutics –Complex and emerging modalities / manufacturing platforms

Mia Kiistala

Mia Kiistala, Principal Consultant, Aurora CMC Consulting

  • Review of key CMC concepts for oligonucleotide therapeutics
  • CMC challenges and successes for the platforms that have already progressed to product approval
  • Review of the ‘next generation’ manufacturing platforms and use of oligonucleotides in complex and emerging modalities
  • Leveraging CMC synergies between ‘legacy oligonucleotides’ and complex /emerging modalities and acknowledging the new frontiers in the CMC development path
     
  • 14:20 Addressing impurities and their control

    Mia Kiistala

    Mia Kiistala, Principal Consultant, Aurora CMC Consulting

  • ICH Impurity guidelines
  • Oligonucleotide Impurities: ID and control strategies, and Formation and fate
  • We thought the analytics for 20’mers and siRNA were complex. When you multiply the chain length by 5 – and / or conjugate the oligonucleotide, what is the multiplier for the complexity of impurity control?
  • Mass spec-based impurity method vs. orthogonal chromatography methods, or all of above?
  • Connecting Module 3 and Module 2 in demonstrating impurity control
     

     

  • 15:00 Afternoon Tea

    15:30 Attending to Regulatory expectations by phase of development

    Mia Kiistala

    Mia Kiistala, Principal Consultant, Aurora CMC Consulting

  • Planning for the end goal – NDA vs. BLA – oligonucleotide manufacturing platform
  • Pre-IND and Phase 1
  • Phase 2/3
  • Late stage, pre-marketing
     
  • 16:10 Key Takeaways and Discussion

    Mia Kiistala

    Mia Kiistala, Principal Consultant, Aurora CMC Consulting

  • Delegates will have the chance to discuss and benchmark concepts and challenges of oligonucleotide development and CMC based on learnings from first 3 sessions
  • Outlook into the future of oligonucleotide therapeutic development
     
  • 16:50 Closing Remarks

    Mia Kiistala

    Mia Kiistala, Principal Consultant, Aurora CMC Consulting

    17:00 End of Workshop

    +

    FEATURED SPEAKERS

    Mia Kiistala

    Mia Kiistala

    Principal Consultant, Aurora CMC Consulting

    Mia Kiistala

    Principal Consultant, Aurora CMC Consulting
    Mia Kiistala

    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.
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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

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

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

     

    HOTEL BOOKING FORM

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    WHAT IS CPD?

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

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

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

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

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

    CPD AND PROFESSIONAL INSTITUTES

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

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

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

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

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

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

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

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

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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