Case Studies 2017-11-15T11:07:17+00:00


Labrys & Pfizer

Complete Study Rescue:

Infectious Disease International Trial Rescue at Study Midpoint

 NCGS was hired by a top tier pharmaceutical company to rescue an international pivotal infectious disease study. The study was being managed by a large publically traded CRO. To find a solution, we had to understand the issues the study, sponsor and sites were facing. NCGS formulated a plan; below summarizes the positive impact of establishing a quality team of 10 year tenured staff, the cost of not doing it right the first time and the impact on subsequent sales:

  • Study Pain points – DCFs, CRA turnover, CRA experience, payment promptness, grant funding
  • Feet on the street for discovery – Our industry is handheld and human-driven requiring delivery of human-to-human credible commitments
  • $24 Million Complete Rescue
    • Shifted 80/20 rule to 80/30, increased targeted enrollment and evaluability
    • 13 previously inactive sites enrolled 77 subjects
    • 85% sites enrolling
    • 36% increase in targeted population enrollment
    • 26% increase in evaluability (from < 40% to > 66% in critical care indication)
  • Outcome: Positive study results presented at IDSA, labeling changes underway, formularies already shifting
  • Closed enrollment two months early
    • Successful fiscal return ($1.15B annual sales = ~ $192M in two months)
  • Real Cost of Not Doing it Right The First Time
    • DCF range shifted 80% – From 75-100 DCF per subject to 8-28 DCFs per subject = Fiscal impact $300k
    • DCF Patterns defined and retraining corrected repeat patterns
    • Global study extension = Increased development costs
    • Damaged relationship with customer base and reticence to conduct future Sponsor trials
    • Delayed time to market / reduced marketable period of patent lifetime = Lost revenue
    • Successful fiscal return ($1.15B annual sales = ~ $192M in two months)
  • Fiscal Development Savings – $10,746,989.00
    • $700,000 ($350,00/mo.) saved by not having trial open x2 additional months
    • $300,000 saved by effecting a data quality shift / dramatic DCF drop
    • $3,642,500 saved in avoiding additional Subject Monitoring by positively shifting evaluability
    • 775 x $3,500 visit + $1,200 travel
    • $6,054,489 saved in site grant funds
    • Evaluability Shift from 40% to 65% dropped the overall enrollment requirement
    • 775 Additional Subject Enrollment avoided due to evaluability shift
    • MRSA 339 X $5,000 = $1,695,510
    • Non MRSA 436 x $10,000 = $4,358,979

Labrys Case Study – Small Virtual Biotech

On January 3, 2013, Labrys Biologics, a small California biotech led by then CEO Steve James, secured $31 million in a Series A venture financing, and simultaneously closed on the acquisition of an anti-CGRP humanized monoclonal antibody, LBR-101, from Pfizer, Inc.

At that time LBR-101 was phase 2 ready, and Labrys hired NCGS to run a global phase 2b trial for Chronic Migraine(CM).  After early collaborative sessions between Labrys and NCGS, the VC dominated board of directors agreed that a “sister” study testing LBR-101’s effect on High Frequency Episodic Migraine(HFEM) would be very cost effective (~two phase 2 trials for the price of 1.5) by taking advantage of the efficiencies gained by using mostly the same study sites and recruitment of very similar patient populations – many valuable patients were captured in the HFEM study that didn’t qualify for the CM trial.

Labrys was under intense pressure to advance LBR-101 quickly through the clinic because other, larger, pharmaceutical companies also had anti-CGRP targeted migraine treatments racing to market.  NCGS was able to complete enrollment for the two studies faster than even our own aggressive projections:

  • CM – 264 subjects randomized, 259 days from first subject enrolled
  • HFEM – 297 subjects randomized, 313 days from first subject enrolled

On June 3, 2014 (17 months after series A funding), Teva Pharmaceutical Industries, Ltd agreed to acquire Labrys Biologics.  The agreement included $200 million in upfront cash, as well as up to another $625 million in potential milestone payments.