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The biopharma industry has had major paradigm shifts in recent years for the development and commercialization of established and emerging categories of therapeutics. Today’s webinar will provide a perspective on these major trends and challenges and discuss key capabilities needed for next generation CMC development including:  

  • Phase-appropriate CMC development approaches e.g. Quality by Design (QbD) approaches to improve product quality and accelerate time to market
  • Integrated CMC development strategies e.g. drug-device combination products
  • Product Lifecycle Management e.g. data for process characterization & development and managing product variations
  • Oversight & Risk Management process to improve the efficiency and effectiveness of CMC development with external CMC partners  

Learn more about our Speaker(s):


Editorial Content from:

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V Glozman Business (2017)

 

 

 



Vitaly Glozman
PwC USA
Partner


Vitaly is a principal with PwC's Advisory services. He is a leader in PwC Management Consulting team focused on the pharmaceuticals and life sciences industry. He has more than 21 years of experience and a proven track record of success in strategy development, acquisition integration, supply chain and procurement management, product development, and technologies. His experience spans global health / NGO, biopharmaceutical, specialty, medical device and equipment, and healthcare provider companies.

  Snehal pic - Casual

Snehal Srikrishna
PwC USA
Director

Snehal is a Director with PwC's Advisory services for the Pharma & Life Sciences industry. He leads engagements with biopharma companies to improve operational excellence by streamlining their operating models globally, and developing internal capabilities for companies to achieve the next level of performance. He has more than 13 years of experience in developed and emerging markets and a proven track record of success in designing CMC operating models, integration and transformation of R&D functions including CMC, and implementing next generation product development enabled by digital / technologies. His experience spans global health / NGO, biopharmaceutical, specialty, generics, and medical device companies.

 

 

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