From Discovery To Clinic: Creating A Comprehensive And Efficient Development Operation




Click this link to email Alicia at OneNucleus to complete your complimentary registration for From Discovery to Clinic: Creating a Comprehensive and Efficient Development Operation

Alicia's Email Address: alicia@onenucleus.com

Date: November 22, 2018

Time: 8:30 - 14:00

Location: Chesterford Research Park, Little Chesterford, Saffron Walden, CB10 1XL
Cambridge, UK

Building on the success of last year’s “Getting Ready for Phase 1” event, this event will delve into the challenges facing the pharmaceutical industry to achieve clinical success. The pharmaceutical industry continues to experience decreasing productivity and high levels of attrition. Inflation of molecule physicochemical properties and complexities in clinical trial protocols stand among the main reasons for these trends. The most successful companies can leverage different expertise, manage risks, and follow logical sequences of operations in an integrated manner. 

This event will focus on key considerations for transitioning a molecule from discovery through clinical studies including molecule developability assessment, phase appropriate formulation selection, integration of product development and clinical supply, and creating an appropriate clinical study design.

Time

Agenda Item

Presenter

8:30

Registration & Coffee

9:00

Introductions

 
 

9:10

Introduction to the challenges and context

  • Reasons for attrition in early and late phases
  • Trends in medicinal chemistry
  • Biopharmaceutics considerations
  • Design quality into NCEs

David Elder of David P Elder Consultancy

9:55

Assessing molecule developability using pharmacokinetic modeling

 

  • Assess developability of NCEs
  • Understand ADME deficiencies that can be improved through drug design or formulation
  • Set target PK profile and starting dose
  • DMPK modeling to guide formulation selection
  • Case studies

Jan Neelissen of Catalent

10:40

Coffee and Networking

10:55

Integrated Drug Productand Clinical Supplies

  • Selecting an optimal formulation: when advanced technologies (solubility enhancing) are required versus simplified approaches (i.e. powder-in-capsule)
  • Efficiently coordinating all components of clinical supplies: clinical manufacturing, packaging, storage and distribution (manufacture at the clinics + integrated services)

Julien Meissonnier of Catalent

11:55

Clinical

  • Overview of Phase 1 study protocol designs and goals
  • How to initiate Phase 1 study
  • Importance of pharmacokinetics, achieving max tolerated dose and establishing therapeutic index
  • Case studies

Malcolm Boyce of Hammersmith Medicines Research

12:40

Lunch and Networking

 
 

1:1 Private Consultancy Appointments

Following the meeting, all presenters and Catalent’s Science and Technology leaders will be available for private, no-obligation discussions on specific programmes and challenges.