Case Study: Bispecific Antibodies

Project Background

Client

• The client is a biotech firm, with presence in Germany and the US, focused on the development and commercialization of biotherapeutics at a global level.
• One of the core focus areas of the company has been the development of bispecific antibodies using its proprietary technology.
• With a strong backing from investors, the client was looking to progress its molecules into pivotal clinical trials and, therefore, required an in-depth analysis on the current state of clinical trials. It approached us to get comprehensive details on the research landscape and evaluation of clinical trial designs of competitors’ bispecific antibodies.

Objective

• To build a comprehensive pipeline of clinical and preclinical / discovery stage bispecific antibodies using publicly available databases such as clinicaltrials.gov, International Clinical Trials Registry Platform and websites of active players in this area.
• To gather the details for every clinical trial covering details of the manufacturer / sponsor, target antigen, underlying technology, targeted indications, trial status, trial results (if completed) and prepare a dashboard to present detailed insights.
• To recommend clinical trial evaluation parameters based upon the detailed information captured on other ongoing / completed clinical trials.

Project Approach

Project Outcome

Deliverable

• An Excel database of around 100 clinical trials covering extensive details on the following parameters: Phase of Development, Target Antigen, Technology, Indication, Sponsors, Trial Title, Trial Objective, Trial Status, Start Date, End Date, Enrolment, Age Group, Inclusion Criteria, Exclusion Criteria, Study Design, Primary Endpoint, Secondary Endpoint, Treatment Arms, Route of Administration, Locations, Trial Results.
• A PowerPoint dashboard with graphical data analysis highlighting key insights and takeaways from the clinical trial landscape; the overall project was delivered in a short turnaround time of seven days.

Outcome

• The head of the client R&D team utilized the clinical trial tracker to improve study parameters for his team’s planned clinical trials of their lead bispecific antibody.
• The final report also provided the entire R&D unit an in-depth and accurate view of the active / completed trials which were covered during the study.
• The discussion and the outcome reflected the early growth stage of the industry. The compiled trial results provided an indicative guidance in terms of existing gaps across the bispecific antibodies research landscape globally. This allowed the client to reallocate research budget in order to focus on a wider array of trials.