Agile Transformation of Pharma R and D

Organizations of widely different sectors and business innovations are already transformed themselves as an agile business process. But the R and D sectors of Biotechnology and Pharmaceutical organizations still untouched and they are still working in their old ways.

The reasons cloud be the research and scientific approach remain result driven and traditional. If the result of one stage is satisfactory then only scientists can proceed for the next step. It is a fact that many clinical research or trial groups are working without much coordination. They strictly follow the scientific process, protocols to take the decisions. And the reporting is done in a month to show the progress to the key decision-makers. In reality, they are losing 30% of the time and productivity- and most importantly there is no window to quickly iterate the method of testing for such an expensive process like drug development.

The reason behind the spread ability of agile transformation across the industry verticals like software, finance, manufacturing and other public sectors due to its flexible approach of delivery in multiple contexts. According to the market leaders, the definition of agile is the “ability to quickly reconfigure strategies, structure, process, people and technologies toward value-creating and value protecting opportunities.” Fail early and fail often is not the accomplishment to be agile. When the development of the product is agile that means, that product is expected to be successful, monitoring the progress and getting feedback from the customer rapidly.

Challenges of Agile transformation, that pharma companies are facing are:

1. The pharma industry is not only research driven, but it also has lots of complex layers that are beyond the company’s control. Like a huge investment of sponsors for drug or device development, lots of compliance and regulatory rules and high rates of failure.
2. The scientists are sometimes rigid and sequential from moving the traditional way to an agile model until the benefits starts to materialize.
3. Due to intense competition for a critical project like oncology, transformation is difficult because any distraction or delay in the project can lead to a huge loss.
4. Due to the involvement of different stakeholders, it is difficult for pharma R and D to transform smoothly into Agile methodology.

Despite these risks, the drug development process needs to change. Longer drug development cycle, high rate of failure, rapid change in regulation and standards, demands of new medicine are creating immense pressure on the industry to move pipeline faster and cost-effective outcomes.

Strategic Approach Towards Agile transformation:

1. Creating a core group, who have a line of sight on most of the running projects, so that they can make the decision quickly.
2. Flexibility to change the protocol where the trial is in progress. Researchers can take small proof of the value of the research data for analysis and can decide whether to continue with the current procedure or to refine the protocol.
3. Centralized database for all the stakeholders to talk in the same language and can make informed decisions focusing on the deliverables and strategy.
4. Implementation of new technology like blockchain and AI can ease to take the decision and can save a considerable amount of money and time.

Implementing Agile transformation will help the companies to prioritize the important product features, help in the development process with rapid customer review which is truly needed for enabling a product time to market. To capture these values, pharma companies should plan their transformation thoughtfully and take the advantages to successful agile transformation.

References:

1. https://hbr.org/2019/11/why-science-driven-companies-should-use-agile
2. https://www.bcg.com/en-in/publications/2019/agile-work-wonders-pharma.aspx
3. http://www.copyright.com/blog/rd-strategy-structure-decision-shift/
4. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/r-and-d-in-the-age-of-agile
5. https://www.mckinsey.com/business-functions/organization/our-insights/agile-the-new-active-ingredient-in-pharma-development
6. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/designing-an-agile-transformation-in-pharma-r-and-d?cid=other-eml-alt-mip-mck&hlkid=2e41ea9b4c5e4d26a67d6d7854672d4f&hctky=11501080&hdpid=892bd186-56fd-4b19-beba-e00f1c9ef709
7. https://www.pharmavoice.com/article/2019-06-research/