Comparability & Biosimilarity

Ensuring Regulatory Compliance and Commercialization Success

March 23-24, 2017 |Hyatt Regency | Bethesda, MD


Due to a protein molecule’s structural complexity, it is often challenging to preserve the molecule’s bioactivity, potency and stability throughout its lifecycle from development to scale up to storage and delivery. Regulators demand scientifically tested data to ascertain that the product is consistent and comparable between batches, between process and site changes, and between new and old analytical methods. This is compounded if you work with biosimilars, which requires proof of highly similar or finger-print similarity in terms of safety, efficacy and potency between your molecule and the originator’s in order to demonstrate biosimilarity.

The 3rd Annual Comparability and Biosimilarity conference delves into the regulatory requirements and guidelines, the analytical strategies and techniques, as well as mathematical modeling and statistical data that can help to establish analytical comparability and biosimilarity. We invite scientists with experience in the following areas to share their expertise through case study presentations on:

COMPARABILITY

  • Regulatory opinions on analytical characterization for comparability
    • How to determine that 2 batches are comparable according to regulator’s requirements?
    • What is the benchmark/standard?
  • How to demonstrate comparability
    • In early stages with low number of slots and little data
    • Under compressed deadlines with a product having breakthrough therapeutic designation?
    • Between a batch in animals and a batch in humans
    • Higher order structure and conformational stability analysis
  • Stage-wise process changes
    • Comparability during clinical and post-approval stages
    • How to justify the difference is still within acceptable range
    • How to set acceptance criteria?
    • How to handle excursions that happen?

BIOSIMILARITY

  • Regulatory perspective on degree of similarity between innovator and biosimilar
    • Implication of physical differences and how they are viewed by the regulators
    • How to establish biosimilarity with difference carbohydrates, different amino acid sequence etc?
    • How close does the match have to be?
    • What kind of analytical data is needed to prove similarity, and reduce size of phase III clinical trials?
    • What does highly similar or fingerprint similarity mean?
  • Case Studies on Establishing Analytical Similarity
    • How do you select the methods?
    • How do you select the lots – how to have a good representative of innovator and biosimilar lots
    • How to use statistical analysis to determine and conclude biosimilarity
  • Orthogonal methods
    • The need for “highest possible” resolution versus “good enough” resolution
    • Assessing the same parameters using different approaches/principles
    • Fingerprinting methods – MS or NMR?
    • HDX-MS for higher order structure analysis
  • Statistical demonstration of biosimilarity

If you would like to submit a proposal to give a presentation at this meeting, please click here.

The deadline for submission is August 26, 2016

All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academia. Additionally, vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

For more details on the conference, please contact:
Mimi Langley
Senior Conference Director
Cambridge Healthtech Institute
Phone: 781.972.5439
Email: mlangley@healthtech.com

For partnering and sponsorship information, please contact:
Jason Gerardi (Companies A-K)
Manager, Business Development
Cambridge Healthtech Institute
T: 781.972.5452
E: jgerardi@healthtech.com

Carol Dinerstein (Companies L-Z)
Director, Business Development
Cambridge Healthtech Institute
T: 781.972.5471
E: dinerstein@healthtech.com

Register Today!

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“Great talks from academia/university personnel with reviews of the literature.”
- Professor, University of Manitoba

“Very intimate setting; insightful presentations. A great way to get perspective of the field!”
- Scientist, Janssen