Webinar:

De-Risk Your Early Phase Programs - Assess Molecule Developability and Select the Best Candidate Formulations for in Vivo Studies

Sponsored by: Catalent

Focused on:

  • Drug Development
  • Biotech

Date: 28 February

55

Time: 4PM London/11AM New York

Early stages of drug development programs are designed to be lean and fast paced. The diminishing return on investment facing the pharmaceutical industry applies additional downward pressure even at the early stages to select the best molecules to advance into the clinic phases as quickly and efficiently as possible. Larger pharmaceutical companies have the resources and expertise to screen dozens of molecules in late stage preclinical studies and allow for attrition for molecules. Small biotech companies lack the resources, API quantities, and expertise to allow for such attrition and only a few molecules may anchor an entire program. In either case, scientists need to implement strategies to fully characterize and assess molecule developability, enhance the solid state chemistry of API, and apply necessary solubility enhancing technologies.

Lipid based drug delivery systems (LBDDS) are the most studied and understood bioavailability enhancing solutions and have been used to deliver more than 60 new drug molecules to the global market. The versatility and range of LBDDS are customizable to meet the demands of increasingly poorly soluble drug candidates. In addition to addressing a molecule's physicochemical characteristics, LBDDS screening is fast, simple in the preclinical setting, and its scalability is relatively straightforward.

Presented by

Sudhakar Garad,

Global Head of Chemical and Pharmaceutical Profiling - Novartis Institutes for BioMedical Research

Sudhakar Garad received his Ph.D. from the Bombay College of Pharmacy, University of Mumbai, India in 1998 in Pharmaceutical Drug Delivery Technology with Dr, M.S Nagarsenker. Soon after completion of his Ph.D., he worked with Pfizer, India for less than a year in clinical research. Taking into consideration his excellent credentials during his Ph.D, he was selected as a post doctoral fellow at the University of Connecticut to understand micro-environmental properties above dissolving surface of the polymers.

After his post doctoral fellowship, he worked with Vertex pharmaceutical for a period of three years as Senior Investigator in formulation development group. After Vertex he joined Novartis as a Group Head. He worked with Novartis for 9 years and joined as a Director of formulation development at Cubist Pharmaceuticals/Merck for 2.5 years. Currently Sudhakar is working as a Global head of Chemical and Pharmaceutical profiling and Disease Area Head (New Indications) at Novartis. His primary role is collaborate with research colleagues and build the right biopharmaceutical properties into new chemical entities, if not enable them via solubility/dissolution enhancement technologies to expedite molecules into tox and clinical studies.

He is also responsible for enabling research, clinical and commercial molecules via novel delivery technologies (Brain targeting, permeability enhancement, TI improvement etc). He has many publications, book chapters and patents. In last 20 years of his career he has taken more than 200 new chemical entities in clinical studies across dozen disease areas ( CVM, Oncology, ATI, MS, Respiratory, NS, GI, Antibacterial, Tropical diseases, HCV etc), via oral, parenteral, inhalation and transdermal route of administration.

Derek Bush,

Sr. Manager, Product Development - Catalent Pharma Solutions

Derek is currently responsible for managing a team of pre-formulation and formulation scientists in Pharma Development of new pharmaceutical products (INDs, ANDAs, NDAs, pre-IND animal PK) developed in soft gelatin capsules at Catalent Pharma Solutions in St. Petersburg, FL.

He has been with Catalent for approximately 5 years working primarily in the design and development of lipid-based formulations, pre-formulation method development, formulation development incorporating QbD principles, clinical batch manufacturing, CMC documentation preparation/review, process scale-up, and DOE studies.

Prior to joining Catalent, Derek worked in softgel formulation development at Banner Pharmacaps conducting research and development and new product development for soft gelatin capsules and gelatin enrobed tablets. He received his Doctorate degree in biophysical chemistry from Duke University and completed a postdoctoral industrial fellowship through the North Carolina Biotechnology Center.

Key Learning Objectives

  • Understand the importance of preformulation characterization to improve small molecule drug developability
  • Learn how LBDDS can be used for preclinical formulation screening
  • Understand the advantages of using LBDDS to overcome physicochemical and biopharmaceutical challenges
  • Learn how to select the best drug candidate and drug formulation for animal studies.

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