Welcome to the Biosimilars Clinical Studies & Analytical Similarity Summit—Boston

With patents for dozens of biologic drugs expected to expire within the next five years, the value of bringing biosimilar alternatives to the market has never been clearer for drug manufacturers. In the United States, the FDA has created an abbreviated licensure pathway for biosimilars, but many pharmaceutical companies and biotech firms struggle in understanding how-to:

  • Provide the pre-clinical and clinical data needed to demonstrate similarity
  • The speed and complexity of advancing a biosimilar drug development project
  • Design comprehensive clinical trials needed to prove safety and efficacy in humans

It’s because of this that we’re bringing you the Biosimilars Clinical Studies & Analytical Similarity Summit. This March, we’ll be providing key insights from thought leaders into the biggest challenges in the analytical and clinical phases of biosimilar drug development, from responding to additional regulatory challenges, demonstrating the quality attributes needed to prove interchangeability, and successfully moving through the third phase of clinical trials.

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Analytical/Pre-Clinical

 

Engineering quality attributes in your biosimilar to demonstrate chemical characterization.

 

Proving product comparability at the In Vivo and In Vitro testing stages.

 

Managing the additional bioanalytical data required by the FDA in the pre-clinical phase.

Clinical

 

Designing effective clinical trial protocols that move your product from Phase I to Phase III.

 

Optimizing your operations for managing different clinical trial sites.

 

Demonstrating effective parameters for safety, purity, effectiveness and potency to the FDA.

The summit’s key presentations include such sessions as:

Pre-Clinical/Analytical:

 

Managing the functional assay testing for quality attributes that regulators value

 

Best practices for navigating the abbreviated licensure pathway for interchangeability

 

Leveraging the FDA’s “Totality of Evidence” Methodology for Using Reference Products

Clinical Phases I-III

 

Developing effective Three-Way PK-Bridging Studies for Global IND Strategy

 

Effective Clinical Trial Monitoring to Prepare for Post-Marketing Pharmacoviligance

 

Streamlining the Process for First-in-Human Clinical Trials of Biosimilar Products


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