Webinar: Improve Your Phase I Success Rate: Fast Early Technology Screening for Poorly Bioavailable Molecules

Sponsored by: Catalent Pharma Solutions

Focused on:

  • Bioavailable Molecules
  • Early Technology Screening

Date: 25 January

88

Time: 11am New York / 4pm London / 5pm Paris

During the pre-clinical stage of drug development, getting to the desired quality target product profile can be challenging, specifically considering the bioavailability/solubility issues, limited API availability and the speed of execution.

There is a tendency in the industry to start with a simple formulation like powder in a bottle and switch over to another formulation once more data is available – this lets the drug developers to stay with the in-house formulation early on and the option to partner with an expert on a specific technology later. However, this linear approach increases the risk of burning time and resources especially with the increasing number of poorly soluble molecules.

It is, increasingly, essential to examine and rank multiple delivery options in parallel, to collect data about the relative dose capability, PK enhancement and manufacturability in order to select drug candidates to advance to clinical Phase 1. This parallel screening strategy de-risks the early drug development and increases the success rate for later stages as compared with the linear model where the predicable failures from iterative approach make the drug development process longer and costlier.

This webinar will provide an overview of a parallel formulation feasibility assessment approach that is designed to reveal the most suitable pathway to enhance bioavailability and accelerate development.

In just 12 weeks, prototypes of selected formulations are available for animal PK studies.


  • Know your molecule (ASSESS). Insights from experts on designing an efficient dosage form selection scenario based upon molecular, chemical, and physical properties

  • Complex molecules require a sophisticated toolkit (ENHANCE). How to select a delivery technology that will accelerate development, optimize exposure and enable dose-escalation

  • Optimize your molecule’s potential (DELIVER). Why applying the right technologies early in the process can optimize the therapeutic profile beyond exposure.


Register for the webinar to learn the strategies for parallel drug development approach and get insights from case studies.



Presented by

Stephen Tindal,

Director of Science & Technology, USA, Catalent Pharma Solutions

Stephen Tindal has nearly 30 years of experience in solving formulation challenges. He has worked on multiple pharmaceutical products and is a leading expert on bioavailability enhancement techniques.

At Catalent he has held multiple positions in process development, formulation, R&D and operations and is currently the lead expert on parallel screening platform for early stage drug development in the North America region.

He specializes in solving complex bioavailability and analytical challenges (such as investigations for OOS Dissolution or related substances).

He is a part of Catalent’s science and technology team and is based at the company headquarters in Somerset, New Jersey. Mr. Tindal holds a bachelors degree in chemistry and analytical science from Loughborough University, UK.

David Elder, Ph.D.,

Principal Consultant at David P Elder Consultancy; Former Director of CMC Due Diligence at GSK

Dr. Elder has nearly 40 years of service within the pharmaceutical industry, with Sterling, Syntex and for the last 23 years with GSK. He is now an independent CMC consultant and has broad based experience in impurities and their control, excipients, biopharmaceutics, drug product and analytical method development.

Dr. Elder obtained his PhD in crystallography from the University of Edinburgh. Dr. Elder is a visiting professor at King’s College, London. He is a member of the British Pharmacopoeia. He is the chairman of JPAG (Joint Pharmaceutical Analysis Group) and a member of the Analytical Division Council of the Royal Society of Chemistry.

He is a member of the Editorial Advisory Board for the Journal of Pharmaceutical Sciences. He has published nearly 100 papers in international journals and has given 13 webinars and over 115 presentations at international symposia.

He has co-edited one book on the Analytical Characterisation and Separation of Oligonucleotides and their Impurities (with George Okafo and Mike Webb) and is compiling a second on the ICH Quality Guidelines (with Andy Teasdale, AZ).

Nathan Barksdale,

Scientists, Catalent

Nathan Barksdale is an expert on early stage development technologies for preclinical through phase II dosage form development and cGMP manufacturing. Mr. Barksdale has over 10 years of experience in the pharmaceutical development and manufacturing industry working with small molecules & peptides.

He has an extensive background in preclinical through clinical drug development and cGMP manufacturing. He possesses a strong knowledge base in oral formulation development and manufacturing, complex process trains, and highly-potent & cytotoxic compounds. Nathan received his bachelor of science in pharmacological chemistry from the University of California, San Diego.

Key Learning Objectives

  • Understand the classification of poorly bioavailable compounds using the Developability Classification System
  • Understand how a structured, high throughput and parallel screening approach can expedite preclinical development
  • Learn various scenarios were enabling technologies such as lipid based formulation, solid dispersion and particle size engineering can be applied
  • *Latest* Learn how Catalent’s acquisition of Micron Technologies and Pharmatek can bring new technologies and new “fast to phase 1 capabilities” into the Catalent offering

Audience

  • Formulation Scientist
  • Head of Development
  • Head of Pharmaceutical Technology
  • Director Formulation
  • Director CMC
  • VP Pharmaceutical R&D
  • Director Formulation Development
  • Head of Product Development