Holistic Approach to Innovation in the Life Sciences

2024/10/10: By Subbu Viswanathan, CPO

Over the past decade, software has been revolutionizing industries across the globe. Today, artificial intelligence (AI) is taking the reins, driving unprecedented advancements and transforming the way we live and work. However, the life sciences and healthcare sectors have been slower to adopt these technological innovations. The reality is that there is no way out but to jump in or risk being left behind by competitors.

The Promise of AI in R&D

In the realm of research and development (R&D), AI is already making significant strides (TxGNN, Alphafold etc.). Leveraging AI for identifying new therapies is one of the most exciting developments in recent years. This innovation is expanding the radius at the top of the drug development funnel (See figures), allowing for a greater volume of potential therapies to be discovered. However, the challenge lies in the subsequent stages of drug development, clinical operations, and submissions, which form the narrow shank of the funnel.

Expanding the Drug Development Funnel

To ensure that the incredible volume of input at the top of the funnel can be processed efficiently, we need meaningful innovation to expand the girth of the shank. This will enable life-saving therapies to emerge faster from the other end of the funnel. Even if we manage to increase the overall radius across the funnel, we still face a significant gating function: regulatory agencies.

Navigating Regulatory Challenges

The bottleneck created by regulatory agencies can lead to a logjam of therapies waiting for approval. So, even if we storm the gates of the agency, if the agency is straddled with the same operational drag (see High Speed/Low Drag) we have built more lanes into the city, but the city still has narrow streets. To overcome this, innovation must be thought through across multiple lenses without compromising quality, efficacy, and compliance. It’s not enough to have groundbreaking ideas on AI or innovation; we must also consider how to operationalize these ideas within a GxP framework, taking into account Annex 11 and Part 11 considerations.

From Concept to Production

Translating a cool Python script on a Jupyter notebook into something meaningful in a production setting is no small feat. This is where the expertise of software platform and enterprise software builders (like this guy) and a holistic perspective come into play. At GxSpeed, we understand that innovation requires more than just technology. It demands a comprehensive approach that encompasses operations, people, processes, compliance, and regulations.

A Mission of Innovation

I am excited to bring our multi decade experience in the life sciences industry to tackle these complex problems. Our mission at GxSpeed is to drive innovation in a way that ensures the rapid development and delivery of life-saving therapies. By embracing a holistic approach, we aim to fulfill this mission and make a meaningful impact on the future of healthcare. I don’t claim to have all the answers, so here is a call for help.  Won’t you (technologists, life science industry practitioners, scientists, compliance/regulatory practitioners, data scientists, process innovators etc.) join us and help achieve this mission?  Drop me a line and let us chat.