The first panel discussion on Day 2 at FDD Conclave 2018 addressed the significance and need for integrated project management in formulation development and drug delivery. A distinguished panel comprising Subhadra Ummeda Group Head – Business Analytics Novartis Hyderabad; Dr Shirish Kulkarni, Sr VP-R&D, Sun Pharma; Sandhya Shenoy, AVP- R&D, FDC; Dr Sumedha Nadkar, Site Head and Senior Director, Perrigo Labs India participated in this discussion which was moderated by Dr Amit Biswas, Executive Vice President-Integrated Product Development, DRL.
The discussion ranged from on horizontally and vertically integrated management for global product development, functional excellence in integrated project management to speed to the market, optimum resource utilisation and the role of data analytics in integrated project management.
Dr Biswas commenced the discussion by expounding on the need to integrate project management in product development and the steps involved in doing so. He briefed the audience that integrated project management is a set of processes to ensure that all projects are managed properly. Project management in developing a product begins right from inception to commercialisation. He also said that one of the important aspects of integrated project management is taking the right decisions at the right time to help companies develop the product on time and help patients.
Shenoy highlighted that cost and time are pivotal factors of product development and elaborated how project management helps in managing these aspects. According to her, there are two factors for success: commitment to management and willingness of the team.
She also advocated the need for collaborative and cross-functional methods of working for effective product development to minimise and avoid errors. She also anticipated that once we start working in this manner each person feels accountable and responsible for executing the project. She also shared her learnings of working in collaboration, not only during the development of a product but also in the post development process. She also advised that having a plan is essential but sticking to the plan is challenging and hence the working conditions should be conducive to enable it.
Nadkar emphasised on how co-locating the entire project and its operations is not always necessary in product development. She cited successful examples of effective product development. She also stressed that understanding and good communication skills is a must for any project manager of any product development process.
Expressing views in an individual capacity, Kulkarni said, in India project development is still at a nascent stage. He also said that often project managers do not receive the due they deserve and pointed out that if anything goes wrong then the project manager is held responsible but in the case of success it is a considered a team effort. The audience also seemed to agree with this viewpoint. Sharing his experience in the US, he elaborated on the work culture and functioning mechanisms over there. He explained how each project had a hierarchy and were done in a more systematic manner. He also pointed out the need for trained manpower in product development. Citing an example, he explained the important role played by a product manager when it came to regulatory filing and ensuring that the product reaches the market on time.
He also mentioned that qualifications is important but not mandatory. More than education, he laid stress on the grasp of a subject and learning skills. He pointed out that a project manager needs to understand different tools of projects management in product development.
Highlighting the importance of data analytics in project management, Ummeda informed that it enables the Indian pharma industry to collect data across many projects. Reminiscing about her DRL days, she shared how they used to have knowledge system management, and how it was beneficial in collecting data from previous chemical reactions, pre formulation compatibility studies etc. She also informed that this data played a crucial role in fast track the projects.
She pointed out that today there is a wealth of data is accumulated in Big Pharma companies which help in fast tracking the product development process. Ummeda also mentioned the relevance of data analytics in clinical trials conducted by these companies.
The panelists also shared their views in developing effective project management strategies for product development. They also interacted with the audience to resolve their queries on this subject.