SFJ Philosophy

SFJ’s decision-making process aims at enhancing the probability of clinical and regulatory success and maximizing the future value of the asset. Decisions are made in collaboration with the sponsor. A few examples:


  • Study A – Within the first 9 months of the study, sponsor’s plan was well behind enrollment timelines. SFJ rapidly intervened with additional funding and a plan to increase site numbers. The study ultimately finished 3 months ahead of schedule.
  • Study B – SFJ dramatically revised inclusion criteria and resized the sponsor’s trial significantly. These changes ensured focus on the appropriate patients and enhanced likelihood of clinical success. A parallel trial by the sponsor in a different indication failed, while SFJ’s trial led to the drug’s approval.
  • Study C – SFJ refined patient inclusion criteria and reclassified endpoint sequence. Trial success was credited in part to these changes.

Case Study:

Vizimpro Co-Development With Pfizer

In 2012, SFJ began a partnership with Pfizer for the funding, design, and execution of a 452-patient global Phase 3 trial of dacomitinib (Vizimpro), a first line therapy for EGFR-mutated non small cell lung cancer. Upon the success of the trial, this once-daily oral medication received regulatory approvals globally between December 2018 and May 2019.

Process Highlights For This Global Registration Trial:

  • SFJ and Pfizer agreed basic study design parameters
  • SFJ assembled a world-class team of KOL’s as its Scientific Advisory Committee, with representation from Hong Kong, China, Japan, Europe and the US
  • SFJ’s team led the protocol-drafting effort, with regular alignment meetings with Pfizer peers

Results: Several Success-Enhancing Design Changes

  • Inclusion criteria adjustments
  • Exclusion criteria adjustments
  • Significant increase in the number of subjects to enhance trial powering
  • Operational excellence and efficiency:

SFJ Value-Add

Within 9 months of the Co-Development Agreement closing, SFJ:

  • Drafted the protocol and all study documents.
  • Completed all required regulatory meetings.
  • Selected a CRO
  • Secured the comparator drug supply

SFJ Accelerated Recruitment Around The Globe:

Efficiency From Database Lock To NDA

SFJ- Pharmaceuticals Efficiency-from-Database-Lock-to-NDA