Webinar:

The Product Development Superhighway

Sponsored by: Catalent Pharma Solutions

Focused on:

  • Cdmo
  • Supply Services
  • Early Phase Development
  • Drug Development

Date: 9 April

78

Time: 3PM London/10AM New York

Leveraging End-to-End Solutions for Market Success

Pharmaceutical and biotechnology companies value streamlined services from early-phase development to clinical supply services to commercialization. These services not only provide with improved efficiencies, such as the ease of transition from one development phase to the next, but also remove the challenges of dealing with multiple vendors when transitioning into clinical supplies and commercial availability.

Join experts for a discussion on how contracting with a single service provider can offer significant benefits to the customer through:

• Integrated expertise between the formulation development teams, the manufacturing teams, clinical supply specialists and the packaging teams

• Consistent exchange of information between the teams and retention of critical product knowledge gained over time

• Flexibility of selection of dosage form based on a wide variety of technologies

• Time and cost-saving benefits of integrated offerings and streamlined communications

Presented by

Lisa Caralli,

Director, Science & Technology

Lisa Caralli is the Science and Technology Director, Pharmaceutics at Catalent San Diego. She has over 27 years of industry experience in pharmaceutical research and development. Lisa’s area of expertise is in analytical methods and formulation development of small molecules and peptides. In her role, she works with pharmaceutical companies to identify the right development pathway for their early development drug candidates and advances in new technical offerings within Catalent. Prior to joining the San Diego site, Lisa was an Analytical Project Manager at Ionis Pharmaceuticals where she worked on the chemistry, manufacturing, and controls of antisense (oligonucleotide) drugs. Lisa joined Ionis from Amylin Pharmaceuticals where she directed their amino acid analysis core facility and performed methods development for peptide-drug candidates. She began her career at the Immune Response Corporation studying biological markers of autoimmune diseases. Lisa holds a B.S. in Biochemistry from the University of California at Davis.

Ann McMahon,

Customer Service Excellence Manager

Ann McMahon is Manager, Customer Service Excellence for Catalent’s Clinical Supplies Services business unit and has over 17 years of experience in the pharmaceutical industry. Prior to Catalent, Ann was a Manager, New Product Launch at West-Ward Pharmaceuticals and Manager, New Product Launch for Boehringer Ingelheim. Ann’s areas of expertise include project management, packaging and labelling, supply chain management, operational and supplier management, and analytical services. Ann holds a B.S. in Biology/Biochemistry from Ohio Northern University and a M.S. in Clinical Pharmacology from the Ohio State University.

Key Learning Objectives

  • Identify opportunities to streamline product development and shorten timelines
  • Explore strategies to reduce the risk of avoidable delays during product development
  • Understand how dosage form selection can shape future decisions and project trajectory
  • Understand the pros and cons of working with a single integrated provider

Audience

  • Consultant; Senior Manager
  • Clinical Supplies; Director
  • Clinical Operations; Senior Director
  • Pharmaceutical Development; Director
  • CMC; Manager
  • Procurement & Sourcing; Project Manager; Head
  • Technical Development; Senior Director
  • Product Development; Director
  • Manufacturing & Operations