Webinar: Dose Selection Using Preclinical PK Modelling and in Vivo Studies

Sponsored by: Catalent Pharma Solutions

Focused on:

  • In Vivo
  • P B P K
  • Chemical Entities

Date: 28 November

Days to go: 5

Time: 4PM London/11AM New York

Integrating PK modelling and in vivo studies for improved formulation and dosage form development

The main goal of formulation and dosage form development is to modify the pharmacokinetics of drugs to improve efficacy and safety. This goal is achieved through various means such as improving solubility and bioavailability and targeting drug release at a specific rate or at a specific site in the gut. This webinar will introduce the audience to pre-clinical tools used in the industry to study pharmacokinetics and how they are used to guide the development of new chemical entities (NCEs).

In silico physiological based pharmacokinetic (PBPK) modelling is the gold standard for predicting the absorption, metabolism, distribution, and elimination (ADME) properties for NCEs. With minimal in vitro data, PBPK modelling can reveal likely ADME challenges that can be addressed prior to in vivo studies, thereby saving time and costs. The addition of high quality in vivo data allows even better predictions by PBPK models. The webinar will also present the benefits of characterizing animals to improve translation to human and how non-invasive imaging approaches can provide valuable insights and add value to PBPK predictive models.

Presented by

Alan F. Parr, Pharm.D., PhD,

Consultant, BioCeutics, LLC

Dr. Parr has worked in the field of Pharmaceutical Sciences for 33 years. This time period covers work done while in graduate schools and post-doc (work with many pharmaceutical companies in which I employed novel methods to radiolabel pharmaceutical dosage forms and drug delivery systems for scintigraphic imaging studies. I was responsible for designing and executing pharmacokinetic studies that were designed to better understand the in vivo behavior of dosage forms and what formulation and GI factors affected the oral bioavailability of drugs) and well as working in large pharma (Glaxo, GlaxoWellcome and GlaxoSmithKline).

Dr. Parr’s roles in big pharma including included formulation scientist, formulation manager, and Director of Biopharmaceutics and responsibilities ranged from development of formulations from the early development phase all the way through to the scale up of commercial size batches for the marketplace. Specific activities during this time period included physical property characterization, formulation screening, formulation development, manufacture of clinical supplies, transfer of product to production and overall project management.

He was intimately involved with the creation, review and submission of regulatory documents to the US Food and Drug Administration, including Investigational New Drug (IND) applications, New Drug Applications (NDA) and Marketing Authorization Applications (MAA), as well as foreign filings. Since June of 2015 Dr. Parr as served as consultant to numerous small pharmaceutical companies and has serve as principle investor for 2 NIH grants where his primary responsibility was to file an IND for an NCE that was being developed. Dr. Parr earned his Pharm.D. degree from the University of Nebraska College of Pharmacy and his Ph.D. from the University of Kentucky College of Pharmacy.

Jan Neelissen, PhD,

Scientific Adviser to Catalent Pharma Solutions, Science and Technology

Dr. Jan Neelissen began his pharmaceutical career at Astra Pain Control in 1995, with in vitro testing of new topical local anesthetics. After that he has held roles as DMPK Project Leader, Associate Director in vitro DMPK and Associate Director modelling and simulation at AstraZeneca R&D.

During these years he has been part of the delivery of 7 clinical drug candidates, co-authored 15 publications and 2 patents. He joined Catalent Pharma Solutions as Scientific Adviser in February 2017.

Key Learning Objectives

  • List common pharmacokinetic challenges faced by new chemical entities
  • Explain the insights provided by in silico PBPK modelling
  • Understand ADME deficiencies that can be improved through formulation and dosage form
  • Appreciate the value provided by imaging tools during pre-clinical in vivo studies

Audience

  • CEO
  • President
  • Director of Preclinical Development
  • VP of Preclinical Development
  • Drug Development
  • CMC
  • Manufacturing
  • Analytical Development
  • Formulation Development
  • Formulations
  • Director of Quality Assurance
  • VP of Quality Assurance
  • Regulatory Technical Section Manager
  • Team Leader
  • Formulation Development Scientist
  • Consultant for Drug Development