A Molecule’s Journey – Breaking Down Roadblocks to Commercial Success - Navigating through the important considerations necessary to successfully bring a biologic molecule to market

A Molecule’s Journey – Breaking Down Roadblocks to Commercial Success - Navigating through the important considerations necessary to successfully bring a biologic molecule to market

04/17/2018, 10:30 AM - 11:15 AM

TBD

Language:
English

When bringing a molecule from the bench to market, there are many important considerations that biopharma executives must take into account throughout the journey that will impact the success of their commercial strategy. To safeguard against development setbacks and ultimately the viability of the drug candidate, every decision made should focus on getting to the clinic as quickly as possible, but never at the expense of product quality, process efficiency, or patient safety. The key to this success is to make the right decisions at the right time. In this presentation, we will share some key considerations to help biopharmaceutical companies navigating the complexities associated with business planning, cell line development, process development, technology choices, regulatory and risk assessment. We will also cover key strategic aspects including the choice of services (CDMOs/ CMOs) providers and its impact on the commercial production strategies (insourcing vs. outsourcing). Finally we will review 2 case studies which demonstrate the importance of choosing the right service provider, because the viability of the clinical development program, and ultimately the company often rely on the capabilities, flexibility and agility of the partner along the clinical development of the molecule.

Contributors

  • Christian Cattaruzza

    Speaker

    Marketing Director - Process Solutions

    Merck KGaA

    Christian Cattaruzza is Director of Bioreliance End to End Solutions. He leads the strategy for a portfolio of services including process...

  • Shawn Smith

    Speaker

    Associate Director, Marketing E2E Americas

    MilliporeSigma

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. Understand what are the critical parameters impacting the success of a clinical development program for a biologic and which role they play. We will cover business as well as technical (Process development and technology choices), and regulatory copnsiderations in this talk. 2. Understand how the choice of services (CDMOs/ CMOs) providers will impact the overall clinical development program from early clinical up to the commercial production strategy (insourcing vs. outsourcing). 3. Learn from real examples the importance of choosing the right service provider and how flexibility and agility of the partner is important for a successful clinical development program.

Categories

  1. Track
    CMO/CDMOs: A Competitive Advantage

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