John Avellanet

DOI:https://doi.org/10.5912/jcb267


Abstract:

For the biotechnology executive looking to cut a deal with a pharmaceutical company, it is not the type of new molecule that matters, but the quality of the records and data that back up the new biotechnology drug's efficacy that matters. Executives unprepared for pharma's due diligence weaken their own negotiating hand. This paper presents three key aspects to research data quality that any prospective pharma due diligence will examine. Recommendations within the paper stress the elements of a biotechnology preparation strategy that will not only serve to prove the biotechnology's scientific quality, but will also give the biotechnology company an edge over others competing for a slice of the pharma pie.

Keywords:intellectual property ,pharmaceutical negotiation ,FDA ,data quality ,record integrity ,licensing ,en ,