IQ CMC Summit

October 12, 2022
Hamilton Hotel, Washington DC


Building upon the Conventional and Collaborating on Novel and Emerging Areas in the Bio/Pharma/Medical Device Industries

The CMC Summit features plenary talks on contemporary topics and fosters an environment where members can explore collaborative topics, coordinate existing efforts, and launch new initiatives across Leadership Groups. This year, the CMC Summit features a holistic view of the IQ CMC Portfolio and examines various perspectives on novel and emerging modalities in pharmaceutical development. Attendees will have the opportunity to participate in interactive breakout sessions and explore potential areas of industry collaboration.

 Event Goals

Program

8:00 AM 
9:00 AM
9:05 AM

Breakfast 
Welcome
Overview of IQ CMC Portfolio: Leadership Group Presentations

 

  • Analytical LG
  • Biologics CMC LG
  • Drug Product LG
  • Drug Substance LG
  • Quality LG
  • Statistics LG

10:55 AM

KEYNOTE: Three Decades of Industrial Reduction to Practice to Advance Novel Drug Delivery Technologies from Benchtop to Commercial Products
Ravi Shanker (Pfizer)

11:50 AM


12:50 PM

Lunch


Development of mRNA Vaccines at Lightspeed... A Regulatory Perspective
Paul Rohlfing (Pfizer)

1:20 PM

Highlighted Working Group Presentations

  • ALG - Next Generation Capture WG
    Emerging Analytics Platforms for Collaboration
    Brian Good (Eli Lilly)
  • BioLG - Biosimilar and Comparability WG
    Comparability Approaches and Practices in Biopharmaceuticals: An Industry Perspective
    Ruth Cordoba-Rodriguez (AstraZeneca)
  • DPLG - Long-Acting Injectables WG
    Long-acting injectable (LAI) drug products – a versatile tool to deliver novel therapeutics as well as increase patient compliance
    Venkat Koganti (BMS)
  • DSLG - Co-processed API WG
    Industry and Academic Collaboration for Regulatory Engagement on Co-processed APIs
    ​Lindsey Gorka (Pfizer)

2:20 PM

What aspects of Quality are governing the development of novel and emerging areas?
Case example using continuous manufacturing

Ganapathy Mohan (Merck)

2:50 PM
3:00 PM
3:45 PM
4:00 PM
5:00 PM

Break
Breakout Sessions
Break
Debrief from Breakout Sessions
Closing Remarks