This is our story of co-creating a solution with a leading bio-technology company
As we know ...
A successful drug approval process involves various stages, including discovery and development, pre-clinical research, clinical research (phases 1-3) and an incubation period, which can sometimes last 15 years or longer. The probability of failure in phases 1-3 is high due to reasons such as poor enrollment, faulty trial designs, and lack of efficacy and safety. This has significant bearing on the development cost of novel drugs. Pharmaceutical companies are continuously exploring new ways to evolve the drug development process. This entails tailoring treatment to specific patient groups, shortening the development cycle and lowering drug development costs.
The challenge for a bio-technology company was ...
It had to understand the industry precedent as well as the regulatory scenario for a potential fast-to-market clinical drug development strategy, while analyzing competitors’ development plans in hematological malignancies. An early decision had to be taken to determine the future clinical study design for two drugs that were in different phases of development.
Here’s what we co-created as a solution…
WNS conducted an in-depth analysis of syndicated data sources and global clinical trial repositories to provide actionable insights for the bio-technology company. The key steps included:
-
Analyzing past regulatory approvals (full, conditional and accelerated) by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). There was specific focus on the European Union’s Conditional Market Approval (CMA) and post-marketing obligations
-
Analyzing competitors’ strategies in phases 1-3, and offering actionable insights to shorten the company’s traditional drug development path
-
Analyzing a specific drug class — Mechanism of Action (MoA) to assess its pharmacological effect and Target Product Profile (TPP) to gauge aspects such as efficacy and safety
The outcomes from the process of co-creation are…
The analysis and insights generated enabled the bio-technology company to:
-
Take a quick decision on the clinical development plan for one of the drugs and build a fast-to-market strategy
-
Channelize human and financial resources for appropriate programs where the probability of getting approvals was high
-
De-prioritize the drug that was in the early stage of pre-clinical research, enabling potential savings of ~USD 700 Million