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Seminar in Cambridge, UK - Achieving POC Success - Starts in Candidate Selection

Join our complimentary seminar in Cambridge, UK

Title: Achieving Proof-of-Concept - Success Starts in Candidate Selection

How correlating your API characteristics with your drug product goals supports efficient transition from candidate selection through to Proof-of-Concept

Date / Time Location 

Tuesday 25th June

2019

Granta Centre,

Cambridge

10am – Introductions

10.30am – Seminar starts

12.00pm – Lunch

1.00pm – Close

Granta Centre, Granta Park,

Great Abington, Cambridge

CB21 6AL

Seminar overview
Many pharma companies are seeking new ways of making drug development more efficient and cost-effective. This has led to an increase in the outsourcing of development activities to contract research partners who focus solely on disciplines such as clinical testing, formulation development and manufacturing. This in turn has created a siloed approach to drug development where there is a distinct lack of communication between the multiple vendors working on a particular drug molecule. For example, the Contract Development & Manufacturing Organization (CDMO) who is making the drug product, will seldom talk to the Clinical Research Organization (CRO) who is actually designing and performing the clinical trial.

This seminar series explains the benefits of Translational Pharmaceutics, a unique approach which integrates formulation development, real-time adaptive manufacturing and clinical research. The seminar will illustrate how, by breaking down the siloes and integrating horizontally, we can operate with more flexibility in the early phases of drug development, reducing costs and shortening timelines.

Key learning objectives:

  • The importance of salt and polymorph screening and prototype selection for pre-clinical assessment
  • DCS assignment with in-vitro techniques and modelling data to drive clinical formulation technology selection
  • Choosing the appropriate dosage form for first-in-human/Phase I trials (Compounding or GMP manufacturing – how to balance cost, time and dose flexibility
  • Challenges with poorly soluble molecules in early development – what technologies can we deploy
  • Bridging to robust and scalable Phase II drug products – how to avoid losing time in development

Drug product development

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