Panel discussion: Outsourcing formulation development: Benefits and bottlenecks

FDD Conclave 2019 endeavoured to touch varied aspects that are relevant to FR&D scientists in the current times. Therefore, the last discussion of the third edition of the FDD Conclave 2019, focussed on another vital topic, ‘Outsourcing formulation development: Benefits and bottlenecks’. This discussion covered the various pros and cons of this practice and explored strategies to build better synergies between CROs and sponsor pharma companies. The discussion also ranged from the importance of choosing the right CRO to building a partnership based on trust to meeting deadlines and sharing the onus when it comes to errors and failures.

The panelists of this discussion were Sauri Gudlavaletti, Sr Vice President, Dr Reddy’s Laboratories; Sumedha Nadkar, Site Head and Senior Director, Perrigo Laboratories; Vijay Singh Chauhan, Thinq Pharma; and Ratnakar Mehendre, Technical Director– Chief Scientific Officer, SRS Pharma.

The moderator posed several pertinent questions to the panelists such as how to select which kind of projects should be outsourced, does it mean that pharma companies are creating their own competition, will opting for a CRO raise concerns about the pharma companies capabilities, and more to the panelists.

As they addressed these queries, the panelists said that outsourcing can help pharma companies leverage opportunities better if good synergies are built. At the same time, they also put forth their recommendation such as taking the timelines under consideration while outsourcing formulation development.

Similarly, they also advised that outsourcing a project should not be about looking for a quick-fix to a problem. And, a relationship with the CROs should be built for all the right reasons such as leveraging their capabilities for better outcomes.

Emphasis was also laid by the panelists from pharma companies on choosing the right CROs because ultimately in any special projects, they are exposing their product pipeline to a third party. They said that CROs must maintain absolute confidentiality and not disclose a client’s molecule in the market because that might mean loss of opportunity for that company.

The CROs spoke of the advantages that they bring to the table in case of formulation development projects. They also said that pharma companies need to repose their trust in them to build a good working partnership. In case of errors or failures, they opined that the onus should be shared by both parties. Thus, it was a very insightful discussion which highlighted various significant aspects of a pharma-CRO relationship and explored ways and avenues to strengthen them.