5th Annual Global Regulatory Affairs CMC Conference

October 29-30, 2019 | Philadelphia, PA

Sheraton Philadelphia University City Hotel

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DAY ONE | TUESDAY, OCTOBER 29

8:00 REGISTRATION & WELCOME COFFEE

8:50 CHAIRPERSON’S OPENING REMARKS
Shawn Roach, PhD, RAC, Consultant II-Regulatory CMC
HALLORAN CONSULTING GROUP

9:00 ICH Q12: FROM VISION TO IMPLEMENTATION

  • Provide an overview of the ICH Q12 vision and tools to enable continuous improvement
  • Discuss the keys to successful implementation of the ICH Q12 vision
  • Following the comment period on the draft guideline, provide a summary of industry’s feedback, highlighting perceived gaps in the guidance
  • Present a case study in implementing ICH Q12 for a program currently in the FDA Established Conditions Pilot Program

Lindsey Gorka, Manager, Regulatory CMC Strategy, PFIZER

 

9:45 ANCILLARY MATERIALS REQUIRED FOR THE DEVELOPMENT OF CELL THERAPY PRODUCTS

Jiwen Zhang, VP, Regulatory Affairs
PASSAGE BIO

 

10:30 COFFEE AND NETWORKING BREAK

 

11:00 CHANGE CONTROL: REGULATORY SYSTEMS AND STRATEGIES TO MANAGE PHARMACEUTICAL PRODUCT CHANGES AND THE GLOBAL SUPPLY CHAIN
Throughout the lifecycle of a product, organizations will make a variety of changes to either suppliers, packaging, or the formulation of a drug. CMC executives must manage the implications to the supply chain from post-approval changes to pharmaceutical products that require regulatory approval. With global regulators requiring different levels of evidentiary support and varying approval timelines, it is a challenge to ensure the appropriate product is being distributed compliantly to each region. This case study presentation will demonstrate the importance of understanding global health authority expectations and processes to maintain product supply to the patients we serve.

Donnie Pulliam, Manager, Global Regulatory Affairs-CMC
BIOGEN

 

11:45 UPSCALING CMC OPERATIONS FOR EXPANSION INTO GLOBAL MARKETS
Expanding the commercial viability and success of a drug hinges largely on the ability to market the product on a global scale and in a variety of regional markets. As an organization looks to launch a product into new countries, CMC executives must prepare for the additional regulatory and quality requirements that will accompany that expansion. From data such as stability and comparability protocols through to additional ancillary documentation by employing stringent and proactive preparation strategies CMC teams will be able to launch products into new markets with little risk to supply disruption.

  • Harmonizing current regulatory documents for local use
  • Preparing change control tracking for multiple regions
  • Analyze country by country regulatory expectations

Marlene Markle, Associate Director, Regulatory CMC
BRAEBURN PHARMACEUTICALS

 

12:30 LUNCHEON FOR ALL PARTICIPANTS

 

1:30 – 3:00 STRATEGIES TO PROVIDE COMPREHENSIVE CMC DATA FOR EXPEDITED APPROVAL PRODUCTS
Many pharmaceutical organizations strive to obtain expedited pathway designations for new products as this allows for quicker approval timelines and fast market launches; however, this can also greatly impact the clinical development processes. While accelerated pathways offer a variety of potential benefits for manufacturers, there a great strain placed on CMC and developmental teams as operational and submission timelines are severely condensed. The data compiled, analyzed and reported during CMC operations is vital to showcasing product safety and efficacy; therefore CMC executives are continually exploring avenues to streamline CMC processes that will not diminish the quality of CMC outcomes.

  • Effect of expedited pathways on operational deadlines
  • Streamlining processes to align with expedited timelines
  • Lessons learned from expedited CMC data submissions

1:30 CASE STUDY ONE: Karin Pihel, Director CMC, RA
ENZYVANT THERAPEUTICS

2:00 CASE STUDY TWO: Mallika Singh, Senior Director, CMC Project Management
INCYTE CORPORATION

EXPEDITED PRODUCT APPROVAL APPLICATIONS PANEL DISCUSSION
PANELIST:
Jason Birri, HALLORAN CONSULTING GROUP

Karin Pihel, ENZYVANT THERAPEUTICS

Mallika Singhm, INCYTE CORPORATION

 

3:00 COFFEE AND NETWORKING BREAK

 

3:30 SMALL GROUP DISCUSSION: BEST PRACTICES IN REGULATORY AFFAIRS CMC BY THERAPEUTIC AREA
Facilitated discussions will provide participants with an opportunity to delve into unique CMC challenges associated with specific therapeutic and treatment areas where product approvals and post-market reporting are proving difficult, ensuring knowledge is gathered on regions of most concern.

GROUP ONE: CELL AND GENE THERAPY
Yemin Xu, REGENERON

GROUP TWO: BIOLOGICS
Naveen Pathak, SHIRE

GROUP THREE: RARE DISEASE
Jack Greene, SYNSPIRA THERAPEUTICS

 

4:15 CHINA: MANAGING GLOBAL FILING CONTROL STRATEGIES
As the regulatory landscape in China continues its evolution in regards to mitigating global submission filing, a multitude of issues and concerns still remain among CMC regulators. Historical hurdles, such as – in-country testing requirements, lengthy and unpredictable approval timelines and unclear technical requirements have notoriously made it difficult to file and enter China with an investigational product. Although China appears to be adopting ICH approaches and practices on various CMC topics, it remains unclear where the CFDA will trend over the next five years, which continues to be perplexing among CMC regulators.

  • Priority review vs standard review
  • Change of control strategies and methods
    • Multiple changes in stage one
    • Update on CMC-specific regulations
  • Multiple versions of drug product
  • Back-dating expiry to shorten shelf-life

Melissa Mertzman, Director, Dossier Development & Operations
JANSSEN RESEARCH & DEVELOPMENT, LLC

 

5:00 END OF DAY ONE CONFERENCE

2019 Global Regulatory Affairs CMC Presenter List

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We hope to see you at the conference!

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