4th Annual Global Pharmaceutical Regulatory Affairs CMC Conference

October 29-30, 2018 | Philadelphia, PA

Doubletree by Hilton Hotel Philadelphia Airport

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DAY TWO | TUESDAY, OCTOBER 30

8:30 REGISTRATION & WELCOME COFFEE

9:00 REGULATORY CONSIDERATIONS FOR DRUG SUBSTANCE STARTING MATERIALS

  • Development of rationale for starting material decisions
  • Review guidance and standards for starting materials
    • ICH Q7
    • ICH Q11
  • Specification and acceptance criteria of materials
  • Regulatory requirement global variations
  • Building justifications for starting materials decisions

Bette Monot-Chase, PhD, Director CMC & Quality, ASKELPION

 

9:45 SMALL GROUP DISCUSSIONS: OPTIMIZING CMC ANALYTICAL METHODOLOGIES
As pharmaceutical and biotechnology therapies increase in chemical complexity, the study of the products chemistry, reactions and efficacy are requiring equally sophisticated and in-depth analysis. In addition to being utilized internally for product safety evidentiary support, many executives are experiencing an escalation of regulatory interest in analysis’ data outcomes. As a variety of different analytical methodologies are used throughout the products lifecycle, these small group discussion will allow for attendees delve deep into the specificities associate with different analytical processes in order to ensure streamlined and optimized internal analyses.

Table One: Trace Drug Substance & Drug Product Impurities
Daniel Petrillo, Senior Manager, CMC Regulatory Affairs, TAIHO ONCOLOGY

Table Two: Criticality Analysis

Table Three: Extractable/Leachable analysis

 

10:30 COFFEE AND NETWORKING BREAK

 

11:00 DETECTION AND CONTROL STRATEGIES FOR GENOTOXIC IMPURITIES
The control of genotoxic impurities (GI) or potential genotoxic impurities (PGI) is not only crucial for ensuring compliance regulatory standing, but is vital to ensure the product does not cause harm to the patient. As GIs are extremely reactive and have the potential to interact and damage DNA, the employment of effective detection strategies for genotoxic impurities is essential. As regulations surround impurity levels are increasingly more rigorous, CMC executives must explore optimal methods for the identification, analysis and control of GIs in new products to avoid potential clinical hold during the development phase.

  • Regulatory guidelines impact GI control
  • Analysis methodologies specific for PGIs and GIs
  • Control solutions following GI identification

Steve Meyerhoffer, CMC Regulatory Affairs – Development Projects, GLAXOSMITHKLINE

 

11:45 LUNCHEON FOR ALL SPEAKERS, SPONSORS AND ATTENDEES

 

1:15 BIOSIMILAR CMC REGULATORY COMPLIANCE STRATEGIES
According to Deloitte, there are currently more than 700 biosimilar products that have been approved or are in development worldwide, and analysts expect the market to reach an estimated $25-$35 billion by 2020. As the healthcare industry sees a continued increase in the development of biosimilar therapies, regulatory agencies are concurrently working to strengthen and clarify requirements and evidentiary data expectations for CMC submission dossiers. As CMC is the first and one of the most crucial components in the establishment of a products biosimilarity to an originator biological product, CMC executives must have a comprehensive understanding of current regulatory standards and guidelines in global markets.

  • Impact of biosimilar product characteristics on regulatory expectations
  • Differences between regulations for biosimilars vs. non-biologic therapies
  • Highlighting biosimilarity compliance considerations
  • Global expectations for biosimilar product CMC packages

Neil Di Spirito, Member of the Firm, EPSTEIN BECKER GREEN

 

2:00 SMALL GROUP DISCUSSIONS: BEST PRACTICES IN TOOLS AND TECHNOLOGY USE WITHIN CMC OPERATIONS
Throughout the lifecycle of a product, CMC teams are challenged with a plethora of different responsibilities ranging from analytical tasks, submission document authoring and data change control processes which offers opportunities to employ a variety of technologies and software to streamline operations. While software and technologies offer potential for greatly optimized processes and only through lessons learned can executives truly implement these efficiencies. These facilitated discussions will provide attendees the opportunity to delve into real world examples and best practices regarding CMC focused technologies.

  • REGULATORY INFORMATION MANAGEMENT:
    Lisa Little-Tranter, CMC Regulatory Scientist, ELI LILLY AND COMPANY
  • TRACKING APPROVAL SOFTWARE:
    Alex Smith, Director, Regulatory Sciences, HOGAN LOVELLS
  • CMC SUBMISSION AUTHORING:
    Yolanda Caringal, Director, BRISTOL-MYERS SQUIBB

 

2:45 OPTIMIZING THE DEVELOPMENT OF RISK-BASED STABILITY STUDIES & REPORTS
Stability studies are critical during the regulatory approval process for new products, as they measure the stability of a therapy through a variety of different environmental factors, and data acquired from these studies result in safe shelf life estimations, necessary storage parameters, and other product safety parameters. Lack of clarity surrounding current expectations, the absence of harmonized guidelines in emerging markets and uncertainty of how to integrate these reports with recently developed technologies are examples of the plethora of challenges that can impact the approval process. It is imperative for a streamlined approval process that CMC executives have an understanding of how to decode stability studies and how to utilize the data from these studies in the most efficient manner.

Cheryl Collier, Sr. Drug Stability Manager, B.BRAUN MEDICAL

 

3:30 CLOSING REMARKS AND COFERENCE CONCLUSION

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