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ADVANCES & NEW FRONTIERS IN STERILE MANUFACTURING TECHNOLOGY

17th & 18th April 2020, Mumbai, India

Approaches to Regulating Innovation

Nina S. Cauchon , Director Regulatory Affairs CMC Amgen Inc

Approaches to Regulating Innovation:  Industry Perspective on CMC Challenges and Opportunities


In the second decade of the 21st century, the pace of innovation in the pharmaceutical industry has accelerated tremendously.  Advances in science, engineering, and information technology will continue to be the drivers for future evolutionary and disruptive enhancements in the medical field.  Ongoing efforts to enhance drug product quality and reliability of drug supply chains include continuous manufacturing and sophisticated analytical methodologies.  Transformative efforts in biology are resulting in an explosion of novel modalities and therapies entering the clinic, with the biotechnology revolution well under way.   This talk will present an overview of the landscape for innovative modalities and emerging technologies in the field of human therapeutics, and the regulatory CMC challenges associated with their product development and approval.


Gap Analysis:


In the future, the rapid rise of emerging technologies and novel modalities will necessitate the equally swift evolution of efficient and harmonized regulatory frameworks to ensure global patient access while still safeguarding the expected standards for quality, safety, and efficacy.  While incredible medical progress has been made, and some of these scientific discoveries are truly trailblazing in nature, these advances also add to the current escalation of development costs for new medicines.  Timeliness and efficiency in the global regulatory environment could in turn make it more cost-effective to encourage the progress of further scientific innovation in the development of medicines for the treatment of grievous illness.


Nina S. Cauchon, PhD, has worked at Amgen Inc. in Thousand Oaks, CA, since 1998 and is a Director in Regulatory Affairs – CMC leading Advocacy and External Engagement outreach.   She has been a Global Regulatory CMC Lead for early phase to commercial programs, including both small molecules and biologics, and prior to that she was a director leading Analytical Development within Pharmaceutics/Process Development.  She holds a PhD in Medicinal Chemistry from the School of Pharmacy at Purdue University, and a RAC certification from RAPS. 

She is the current chair of the AAPS CMC Community, and has been a member of its steering committee (which organizes the annual FDA-Industry CMC Regulatory Exchange Forum) for the past 8 years. She is active on the ISPE Expedited Regulatory Pathways workstream in PQLI.  She is also active in other external organizations and organizing committees including CASSS, PQRI, BIO, and PhRMA, and is the PhRMA Deputy Topic Lead on the ICH Expert Working Group for ICH Q14/ICH Q2(R2) – Analytical Procedure Development/Validation. 

Her areas of interest are: regulatory CMC challenges for innovative modalities and emerging technologies, CMC aspects of expedited review pathways, regulatory harmonization, and science and risk-based approaches to regulations. 

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