By Allison Proffitt

December 3, 2019 | “All the solutions which are developed are, of course, made with end users in mind. Therefore, we touch base with the different pharma companies, life science companies to really see what are their needs and then start developing it.”

When Hilde Vanaken describes Tata Consultancy Services’ development processes, she isn’t just repeating the company line. She’s been on the other side of that development process.

Vanaken spent 26 years of her career in pharma, the last 15 with Janssen. She was one of the founders of Janssen’s innovation department that—in collaboration with TCS—developed iStep, a clinical trials platform that won the pair at 2019 European Innovation Award at SCOPE Europe. Janssen was adamant that the intellectual property associated with iStep transfer out of Janssen hands to TCS so it could be developed and marketed across pharma. Vanaken left too, joining Tata Consultancy Services as Senior Industry Advisor Life Sciences & Healthcare.

Tata team accepts their European Innovation Award at SCOPE Europe in September 2019. (L to R) Sanjay Patil – Engagement Manager; TCS Life Sciences and Healthcare; Narayanan R – Chief Architect & Head, TCS CCT Platform; Sudhanshu Saxena – Business Analyst, TCS Life Sciences and Healthcare; Rachna Malik – Global Head, TCS ADD Platforms; Allison Proffitt – Editorial Director, Clinical Research News; Hilde Vanaken – Sr. Industry Advisor, TCS Life Sciences and Healthcare

“It’s not such a traditional move, going after 26 years on a pharma side going to a technology company,” Vanaken admits. But after the collaboration with TCS on iStep, she realized that there was a fit for her at TCS: “What I absolutely like doing is [envisioning] those big, complex programs, and bringing them to reality through partnerships.”

Connected Clinical Trials—TCS’s commercial version of the solution developed with Janssen—is part of the Advanced Drug Development, a comprehensive suite of GxP compliant platforms aimed at digital transformation of clinical development. The foundations of the ADD suite, Vanaken says, are partnerships, like the one with Janssen, AI and machine learning, and flexibility.

“ADD is about using digital technologies, novel technologies, to translate any type of clinical trial data—whether it’s from clinical data, CC data, medical data, regulatory data—it doesn’t matter—translating this data into easily understandable novel insights,” she explains.

ADD has tools for optimized study planning and accelerated study setup, voice recognition modules for advanced data collection, data processing automation, tools for data engagement: mobile apps and patient engagement dashboards with easy-to-understand screens, and safety and regulatory solutions. “They really have offerings at all levels: clinical, medical, safety, supply,” she says.

Cross-Pharma Solutions

The platforms that are part of ADD are designed to harness digital technologies like automation, AI, and IoT to bring disruption in clinical research and integrate key features of TCS intellectual property assets with commercial-off-the-shelf offerings. ADD is working on several new solutions built on cross-pharma conversations, Vanaken explains. Two example she’s excited about: a regulatory solution and a safety tool.

“Everybody receives questions from [regulatory] health authorities on their study, but we don’t have any insight. It’s very difficult; there’s no system available to really see if we’ve already answered those questions,” she explains. “Health authorities often ask similar questions across compounds, across studies.”

TCS did a “cross-pharma exploration” to see what regulatory tools could address those challenges, Vanaken says, and is working on building automated regulatory responses. The responses will be created by an AI/machine learning system, taking into account previous questions and answers.

In the safety domain, TCS is working on automated patient safety reports gathering publicly available safety data, mined with AI/ML, from structured and unstructured data sources. Those data—collected in one database—can create novel insights, she says.

The third core element of the ADD platform—flexibility—comes into play in how the ADD platforms and modules are accessed by users. “It’s always developed so you can choose what you want,” Vanaken says. “It might be for a phase 4 study [you’re] only interested in personalized notifications for patients. So you only take that component,” she says as an example.

Vanaken expects the TCS model—working in partnership with pharma to identify needs, delivering AI-driven solutions in a flexible manner—to result quickly in new products. Many pharma will choose to add one or two tools at a time, but Vanaken reports that a few pharma companies have already requested details from TCS on reorganizing their full structure to create a unified platform that can enable new kinds of work.

“You can move from the traditional way of working to more preventive research, more predictive research, novel insights which we never had before,” she says of the benefits. “That’s a big shift in implementing these kinds of novel technology which will be brought forward by ADD.”