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Formulating the Future: Accelerating Oral Drug Development & Manufacturing

Schedule a Meeting with Catalent in London

Date: January 19, 2023
Time: 9:00-13:30 hrs
Location: Royal Society of Chemistry, Burlington House, Piccadilly, London, United Kingdom

Event in collaboration with One Nucleus

One Nucleus logo

 

 

 

 

 

 

Fours different pills on a tableYou are invited to join Catalent’s exclusive workshop and networking event at Royal Society of Chemistry’s historic London residence, The Burlington House.
This event brings together experts in formulation and manufacturing sciences to discuss such challenges and offer solutions related to improving bioavailability, application of different pharmaceutical technologies for dosage form designs, optimizing manufacturing and scaling supply, and accelerating progression to clinic and on to market success.

AGENDA

 

9:00 am – Registration and Networking Breakfast

9:30 am – Welcome and Introductions by Tony Jones, CEO, One Nucleus

Tony Jones, Ph.D
CEO, One Nucleus

 

 

9:40 am – 10:10 am – Sustaining Accelerated Product Development

 

David Elder's headshot

David Elder, Ph.D
Principal Consultant, David P Elder Consultancy

 

 

 

Key learning points:

  • Ways of accelerating product development and innovative approaches to the development and approval of drug products
  • The continuum of product development, post-pandemic

 

10:10 am – 10:40 am – The Developability Classification System (DCS) as a Valuable Framework for Developing an Oral Formulation

 

James Butler, Ph.D
GlaxoSmithKline Research & Development, Ware, United Kingdom.

 

 

Key learning points:

  • To demonstrate how the effective use of the DCS and related concepts at an early stage is a key to successful formulation development, especially in case complex class II/IV compounds
  • To highlight the current state of knowledge, discuss challenges to achieve a general consensus among pharmaceutical scientists.
  • Real- time industrial applications of the DCS system

10:40 am – 11:00 am – Coffee Break

11:00 am – 11:30 am – Small-Molecule Manufacturing Options for Expedited Programs 

 

Stephen Tindal's headshot

Stephen Tindal
Director, Science & Technology, Catalent

 

 

 

A small molecule that has been selected for evaluation as a potential human drug is first evaluated in a phase 1 study where it’s safety is demonstrated. To be successful in bringing oral small molecules through to proof of concept, small companies must navigate a path through a bewildering process of data collection, being smart about which studies are performed and which ones are not, in order to collect a minimal, yet most impactful data set that enables the molecule to progress before running out of funding. In this presentation, we will present Catalent’s scientific advisory role, and show how Catalent can support small companies with expedited, flexible solutions for formulation and manufacturing using elements of quality by design, manufacturing on demand and adaptive clinical trials.  Phase appropriate, and not “quick and dirty”.

 

11:30 am – 12:00 pm – The Manufacturing Classification System (MCS) to Facilitate the Selection of Manufacturing Technology

 

Kendal G. Pitt, Ph.D 
Pharmaceutical Consultant, Honorary Professor, Leicester School of Pharmacy, De Montfort University.

 

 

 

Key learning points:

  • Understanding the correlation of API properties to the manufacturing process
  • How the MSC framework can be used for risk-assessing the development of a compound and its interactions with a manufacturing route?
  • Can the MSC help simplify scale-up activities into the commercial manufacturing?

12:00 pm -12:30 pm – Panel Discussion: Transforming Formulation & Manufacturing of Oral Solid Dosage Medicine.

12:30 pm – 1:30 pm – Networking Lunch & Meet the Experts

 

ABOUT THE VENUE

 

The Burlington House is located in London’s Piccadilly and is a five-minute walk from Green Park London Underground station. It was originally a private Neo-Palladian mansion owned by the Earls of Burlington and was expanded in the mid-19th century after being purchased by the British government. Today, the Royal Academy and five learned societies occupy much of the building.