Biosimilars: Preparing For Opportunities And Challenges.

Barry Rosenblatt

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$349


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Description of the topic:

This session with explore the complexities surrounding the development of a biosimilar molecule.  It is intended for anyone who may be involved in the oversite and participation in the development, manufacturing and distribution of a potential biosimilar product.  Upon completion of this session the attendee will have a greater understanding of the process and what is required for a higher probability of success. 

Background:

Biosimilars have been touted as a major key towards controlling spiraling prices for biopharmaceuticals.  The path towards development and commercialization of Biosimilars has not been as clear-cut as many companies assumed.  Differences in global regulatory expectations, as well as the complexities of development and costs have led to slower penetration in markets dominated by originator molecules.  

Why should you attend?

The decision making process behind the choice of developing a novel biologic vs a follow-on or Biosimilar is complex and requires an understanding of the differences and similarities between each path.  It is easy to assume that since a predecessor has performed much of the groundwork, the biosimilar route is the more expeditious one, resulting in a quicker and less expensive path to approval.  This presentation will explore many of the complexities involved in the process, including the various regulatory definitions, the technical hurdles, and the economic considerations. 

Topics to be covered include:

  • Introduction: Why Do it?
  • Defining a "biosimilar"
  • Identical (interchangeable) vs Similar vs "Biobetter" vs Follow-on biologic
  • Interchangeability
  • US vs. ROW regulatory guidance's

o   FDA

o   EU

o   ROW (India, Korea, etc.)

  • The comparability exercise
  • Choice of reference material
  • Analytics
  • Trend towards complexity–Insulin to mAbs
  •  CMC
  • Pre-clinical considerations
  • Clinical issues-Immunogenicity
  • Economic

o   Pricing vs. COGs

Who will benefit:

This course will be beneficial to anyone working in biosimilar development that needs an understanding of the current and expected regulatory landscape.  Personnel in regulatory affairs, R&D, quality, and compliance will find this course particularly useful.

  •  Process development scientists.
  • Project managers. 
  • Regulatory. Key decision makers.  
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Barry Rosenblatt , President, SME Biotech Consulting

Subject matter expert in the chemistry and manufacturing  controls (CMC) of biotheraputics with a proven 30+ year track record in biotechnology and the pharmaceutical industry.  Developed, transferred and validated purification processes and assays for multiple new molecular entities through all stages of drug development, including licensure.  Currently serving as a consultant to the industry as President/sole proprietor of SME Biotech Consulting.  Proven presenter who has served as instructor, presenter, as well as Chairperson for conferences and courses.  Previously served as associate director of Process Development for Centocor/JNJ (18 years) and 8 years as head of Analytics, Process Evaluation, Contract Manufacturing, and Sterile Services at Charles River Laboratories, Malvern PA..  Academic credentials include a Ph.D. in Cell Biology/Immunology from the Albert Einstein College of Medicine, Bronx, NY


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