5th Annual Global Regulatory Affairs CMC Conference

October 29-30, 2019 | Philadelphia, PA

Sheraton Philadelphia University City Hotel

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DAY TWO | WEDNESDAY, OCTOBER 30

8:30 REGISTRATION & WELCOME COFFEE

8:50 CHAIRPERSON’S OPENING REMARKS
Jason Birri, Associate Principal Consultant
HALLORAN CONSULTING GROUP

9:00- 10:30 APPROVAL APPLICATION MODULE: OVERCOMING CHALLENGES ASSOCIATED WITH SPECIFIC APPROVAL AVENUES
As innovation within the pharmaceutical industry continues to expand into new treatment areas and products become more complex, the data requirements and challenges associated with standard approval applications concurrently grow. Each type of product regulatory application comes with individual challenges for the regulatory affairs CMC team and continued exploration of regulatory and operational trends is vital for securing timely approval. Through multiple case study presentations, attendees will be able to garner insight into methods from ensuring comprehensive submission dossiers are compiled and submitted to the FDA.

9:00 CASE STUDY ONE: BIOLOGICS LICENSE APPLICATION (BLA)
Shelley Toth, Senior Specialist, RA
EMERGENT BIOSOLUTIONS

9:45 CASE STUDY TWO: INVESTIGATIONAL NEW DRUG APPLICATION (IND)
Jane Xiang, Director, Regulatory Affairs CMC
TAKEDA

 

10:30 COFFEE AND NETWORKING BREAK

 

11:00-12:30 INTRICACIES OF ENSURING QUALITY AND COMPLIANT STARTING MATERIALS IN DRUG DEVELOPMENT
While the source and quality of a product’s active pharmaceutical ingredient (API) is often the primary focus of regulatory documentation, ensuring the safety and efficacy of a therapy’s starting material through a variety of different protocols is a vital responsibility during the developmental and postmarket phases. A critical strategy for CMC teams to utilize while documenting the rationale for starting material selection and inclusion is the employment of comprehensive quality management processes when securing starting material suppliers. Through the exploration of both small molecule and biological products, CMC executives will be better equipped to meet acceptance and justification levels regarding starting materials.

  • Determination of appropriate dosing levels
  • Securing compliant supplier for starting materials
  • Outlining justifications for starting material selection

11:00 Case Study One: Small Molecule Drugs
A.R. Matura, Associate Director, Global Regulatory Affairs Pharmaceuticals
BOEHRINGER-INGELHEIM

11:45 Case Study Two: Cell Therapy Products
Mauricio Umaña, Director, Global Regulatory Affairs
AVROBIO

 

12:30 LUNCHEON FOR ALL PARTICIPANTS

 

1:30 STRATEGIES FOR COMPREHENSIVE CMC SUBMISSION PROCESS FOR COMBINATION PRODUCTS

  • Harmonization of drug and device regulatory requirements
  • Navigating FDA’s Request for Designation process
  • Methods for completing Formal Risk Analysis
  • Assessing the need for the human factor studies
  • Global regulatory expectations in critical markets

Angela Turner, Senior Manager, Regulatory Affairs CMC
BAUSCH HEALTH

 

2:15 REGULATORY AND OPERATIONAL CONSIDERATIONS FOR PEDIATRIC FORMULATION DEVELOPMENT
Healthcare providers and regulators have placed increasing importance on the inclusion of more pediatric focused formulations for new and current products on the markets and this has ushered in strong regulatory requirements regarding pediatric product safety, product usability and the reduction of dosing risk. As the regulatory requirements become more complex the industry has seen a rise in applicable tools to assist manufacturers in the re-formulation and development of child safe product variations; however, CMC teams must remain current on the data and justifications that must be submitted for regulatory approval of new treatments.

  • Regulatory expectations for pediatric formulations
    • The Best Pharmaceutical for Children’s Act
    • Pediatric Research Equity Act
  • Considerations during pediatric formulation
    • Taste
    • Dosing
    • Delivery method
  • Explore applicability for a pediatric waiver

Daniel Petrillo, Senior Manager, CMC Regulatory Affairs
TAIHO ONCOLOGY

 

3:00 COFFEE AND NETWORKING BREAK

 

3:10 ALIGNING CMC OPERATIONS WITH PATENT STRATEGY TO INCREASE PRODUCT LIFECYCLE

John Serio, Partner
BURNS LEVINSON

 

3:55 METHODS FOR MEETING STABILITY EXPECTATIONS DURING EARLY STAGE PRODUCT DEVELOPMENT
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.
Lingling Rogers, Director, Regulatory Affairs CMC
ARENA PHARMACEUTICALS

 

4:40  END OF CONFERENCE

2019 Global Regulatory Affairs CMC Presenter List

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We hope to see you at the conference!

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