Case Study – Takeda Pharmaceuticals

Technical Due Diligence on Drug Delivery Microsphere Technology


IMPACT was engaged by a large foreign pharmaceutical company to perform third party technical due diligence of a small drug delivery company.  Both companies are developing sustained release drug delivery platforms.  Based on encouraging feasibility study results, the large company was considering licensing technology from the smaller company, and engaging in a joint development project.  The large company sought an assurance that the data presented by the small company were valid, an assessment of the scalability of the drug delivery platform and manufacturing process, and an evaluation of the small company’s ability to manufacture aseptically under cGMP.


The timeline was very short, and the consequences of a mistake were high.  IMPACT’s fast-track technical due diligence approach was followed.  The key steps in this approach were:

  1. Provide a clear set of objectives to all parties in advance and send an advance list of questions.
  2. Perform three or more pre-visit telephone conference calls.  The calls addressed the following:  scope, relationship building, timeline establishment, and preliminary Q&A. 
  3. Perform a site visit to perform a detailed review of batch records and lab notebooks and to interview operating, scientific, QA, and regulatory staff.  The purpose of this visit was to validate the answers to the list of questions by reviewing primary records, to ask follow-on questions, and to perform a site inspection.
  4. Perform a post-visit follow-up conference call with additional questions and prepare a draft report.
  5. Provide a copy of the report to the audited party for review of potentially confidential information and to provide an opportunity for them to dispute or clarify the factual basis of findings.
  6. Submitted the final report to client.


Following this procedure, IMPACT was able to efficiently, quickly, and thoroughly assess the capabilities of the smaller company and provide a thorough report to our client within three weeks.  While the smaller company may not have agreed with all of our conclusions, they were able to ensure that we did not disclose confidential information and that our supporting facts were correct.