By James Perhach, Director of Clinical Development & Research on May 9, 2017 2:27:50 PM
The development planning process of a biopharma candidate, balancing scientific strategy with corporate needs is imperative to success. Therefore, biopharma teams need to integrate all development components to lead the candidate product to a marketed product. Here is our insight on how and why to build a fully integrated product development plan.
How to Make Sure Your Development Plan Is "Fully Integrated"
All representatives of development from preclinical, clinical, regulatory, commercial, financial/ budget, analytics, and manufacturing should participate in developing an integrated plan. This allows each member to be aware of each stakeholder’s needs/wants and to ensure that the data obtained maximizes the potential of the future product.
The commercial representative needs to identify their considerations for the desired patient population, preferred route of administration and estimated length of treatment. This target perspective of the potential end use allows for the determination of the required duration of administration and the preferred route of administration.
Things To Be Considered
This integrated plan outlines the profile of initial studies in man to assess the efficacy of the candidate as well as initial signs of any safety concern in man. This also permits a focused characterization of the disposition of the candidate product in the species selected for the preclinical safety evaluation. Clinical groups can consider the preliminary design of the efficacy studies and the desired number of patient exposures to satisfy the regulatory authority in the targeted regions of the world where marketing is planned.
Even with positive efficacy data to continue development, certain aspects of the candidate’s human profile might change the commercial appeal of the candidate. What alterations to the desired clinical profile could be acceptable to continue the project? Could the commercial interests accept somewhat less efficacy but an improved overall safety profile relative to an existing competitor? Or can an adverse event be recognized as a potential commercial opportunity? Analytics, if possible, should be utilized to properly characterize the probability of success.
Why This Strategy Works Well for Scientific and Commercial Objectives
Integration of all contributors from the very beginning of a development program allows for rapid adjustment of a program's requirements. A fully committed team is especially critical for defining the go/no go criteria recommendation to the unit’s management, integration optimizes the development teams not having any surprises and allows all team members to manage the expectations of their respective management.
Integration of all ‘stakeholders” in the development from the beginning allows the creation of various development scenarios. An integrated team is best suited to reach a decision to recommend abandoning the project to permit the capital allocated to this project to be made available for other programs.