Accelerating innovation in a regulated world searching for solutions

A New Beginning: Accelerating Innovation in a Regulated World

 

The Need for Speed: Accelerating Innovation in a Regulated World Searching for Solutions

Never has the pursuit of innovation been so urgent, especially in the Life Sciences, Healthcare, Energy and Resources, and Public Services sectors.

Pharmaceutical firms are rushing to develop vaccines and drugs to protect us from COVID-19, manufacturers are striving to reimagine their supply chains and keep their plants operational despite new constraints, energy firms are innovating towards a zero carbon future, and technology firms are finding new ways of helping organizations and people go about their daily lives.

“It’s very clear that our quality of life is going to be driven by innovation. However, innovation tends to spread less rapidly in these regulated industries, and we don’t have the luxury of time,” stated Seema Mehra, Vice President & Business Head, Energy & Resources, Tata Consultancy Services (TCS).

This insight set the stage for the panel of distinguished leaders from business and academia Seema moderated as part of the sixth edition of the 2020 TCS Innovation Forum. Entitled, “Accelerating Innovation in a Regulated World, the panel provided insights on how their firms are innovating both because of – and in spite of – the coronavirus crisis.

A changing regulatory landscape

Chris Lee, Vice President of Global Regulatory Affairs Operations & Quality Management at pharmaceuticals firm Merck, spoke about how the search for a COVID-19 vaccine and drugs has sparked industrywide changes.

“I’ve never seen as much collaboration between not only industry but also academia and public health officials. Everyone is really coming together to address the pandemic in, hopefully, a short timeframe,” he said.

Medical research and drug development are rigorously regulated, and progress can sometimes be slow, but Chris highlighted how regulators have already responded quickly.

Stressing that clinical trials are still essential to meet regulatory requirements, Chris added, “Desperate times require desperate measures, and most of the major regulatory authorities have issued guidance around drug development for COVID-19 vaccines and therapies.”

Keeping the show on the road

The need to treat existing health conditions does not disappear just because we have a new pandemic. At the same time as working to find a coronavirus vaccine, it has been equally important to keep drugs moving around the world, to address problems like diabetes that millions of people suffer from. This too has demanded an innovative mindset.

For Karen Harris, Vice President & Information Officer – Manufacturing and Quality at drug firm Eli Lilly, the pandemic has led to leveraging technology to protect supply chains.

“We have recently invested in several solutions to increase end-to-end visibility across our supply chain. We’ve invested in several new next-generation tools to help production planning and scheduling more effectively and efficiently in our manufacturing facilities. And we’ve also invested in many data and analytics solutions that provide information and insights to our supply chain analysts and planners. These technologies have enabled rapid decision-making to ensure we get our important medicines to patients around the world,” she explained.

The panel also noted that the crisis has led to a much greater uptake of technology. For example, telehealth for cardiovascular care has really taken off in the US, moving from hardly 5% of appointments pre-COVID to more than 90% today in several areas.

And for Petra Zijlstra, Chief Information Officer at global chemicals supplier Shell Chemicals, the crisis led to rapid innovation for managing safety in both the building and maintenance of chemical plants.

“Shell has a zero-tolerance policy that prioritizes the physical care of our workers. With COVID-19, it was imperative for management to proactively embrace social distancing and employ a strategy to ensure the safety of employees in our plants around the world,” stated Petra.

Ongoing evaluation and testing

The panel also discussed how these innovations are captured and implemented.

For Chris, there is a need to stress-test collaboration platforms to ensure that the necessary level of interaction can take place internally and externally.

“If you think about the World Health Organisation, you can just imagine the tsunami of content that has to be reviewed and the level of collaboration you’ll need. And that’s not only in the research and development space, but also how we better connect with our regulators and the public health ecosystem,” added Chris.

At Eli Lilly, teams have created a cross-functional governance structure to funnel digital innovations and decide which ones will be adopted or piloted.

“Once the proof of concept has been established, there are many other factors to consider.

Is the technology ready to implement and then ultimately to scale? Is the use case and the value there? Does it drive significant compliance? Does it improve safety? Or does it drive efficiencies from a productivity perspective? These questions will all need to be tackled before the suggested innovation moves further down the funnel,” Karen explained.

In the panel’s view, capabilities such as remote patient monitoring for diabetes or wearable technologies for heart conditions can help scale virtual healthcare globally. A greater use of AI in such clinical scenarios will need high level of accuracy. So far, AI is used more as a supplementary enhancement in workflows like improving the quality and scalability of image and Xray diagnosis.

As well as this product-focused innovation, Petra acknowledged the need to be innovative when it comes to management and HR practices, helping guide people through a stressful time.

“We can’t deny there is a crisis. As a leader, you must bring a calmness into the team and give them confidence to do the job. Leaders must also listen to their teams, ensuring employees feel safe at work and at home and letting them know they can speak with their manager, friends or colleagues to reduce stress,” she said.

Vision and Purpose

There can be no doubt that the COVID crisis – despite all the suffering it has caused – has also acted as a catalyst for innovation.

For many industries, this innovation relies on the speed of regulation, and a new era of collaboration is underway to help the two move forward in tandem.

Seema closed the panel offering, “All organizations need to adapt to the changing environment, but those organizations which have a very strong purpose would always find innovations to build resilience into their fabric.”