This innovative technology allows study teams to predict, optimize, and control trial timelines and costs in real-time, enabling iterative feasibility analysis and mid-study course correction. By automatically incorporating ongoing financial forecasting, Spectrum dynamically adjusts budgets based on real data, ensuring accurate modeling and efficient trial management.
Product and Service Innovations: Can you share any new products or services your company is unveiling at this year’s DIA? How do your latest innovations address current challenges in the pharmaceutical and healthcare industries?
At this year’s DIA annual meeting, Lokavant is excited to unveil its new AI feasibility solution, Spectrum. This novel technology enables study teams to predict, optimize, and control trial timelines and costs in real-time, enabling iterative feasibility analysis and mid-study course correction – critical to success in today’s hyper-complex trial environment. The solution also automatically incorporates ongoing financial forecasting without time-consuming manual intervention to accurately model budgets. With Spectrum, timeline changes dynamically drive commensurate changes in budgets – providing more granular modeling using real data, not just assumptions.
Market Trends and Challenges: What major trends do you see shaping the future of the pharmaceutical industry? What are the biggest challenges your company is currently facing, and how are you addressing them?
One major trend shaping the future of the pharmaceutical industry is the increasing emphasis on personalized medicine, which has also increased the complexity and variability in clinical trials. Today, every trial is like a rare disease trial, resulting in unique requirements and difficulties in patient recruitment and data collection. This adds to trial timelines: today it takes an average of eighteen months to recruit patients for a phase III trial, a 39% jump in trial timelines from 2008 to 2019. Additionally, today’s trials must absorb more mid-study protocol amendments – which, per trial, have increased from 2.1 to 3.3 since 2015 (a 60% jump), according to a 2022 study by Tufts Center for the Study of Drug Development.
To address these challenges, Lokavant is focusing on enhancing our data analytics capabilities and implementing continuous feasibility assessments to ensure that today’s complex trials are designed and conducted as efficiently as possible. More specifically, we have developed an AI software solution that improves feasibility analysis on the front as well as continually throughout a trial so study staff can make course corrections early and often, as needed, to keep trials on track.
Technology and Digital Transformation: How is your company incorporating digital transformation into its business model? What roles do digital health solutions and telemedicine play in your company’s offerings?
Lokavant leverages advanced technologies such as cloud computing, AI, and machine learning to improve our product and service offerings. Our methodology leverages the latest in extensible integrations and platforms to ensure the data powering our models are the most relevant and timely, providing near real-time data and insights that enhance decision-making and operational efficiency. We are also working to incorporate causal AI, a prescriptive form of artificial intelligence that offers recommendations in real-time so study teams can take proactive remedial action.
Global Expansion and Market Access: What strategies are you employing to expand your presence in global markets? How do you address market access challenges in different regions?
One of Lokavant’s earliest customers, CMIC Group – the largest Contract Research Organization (CRO) in Japan – taught us a lot about this unique part of the world. Since then, we have received an $8 million strategic investment from Mitsui & Co. Ltd. to expand across the Asia-Pacific (APAC) region. We are prioritizing this region for several reasons, including:
1) Better regulatory alignment with international standards. Several APAC countries are reforming their regulatory processes to attract more trials to the region, which can lead to more competitive timelines for trial approvals and clearer regulatory guidelines. Korea, Singapore, and Australia standout here, with Japan also seeing similar regulatory shifts.
2) Multinational trial expansion. Participant enrollment has become more difficult as clinical trials have evolved to focus more on specialized indications and sub-indications. Given their genetic diversity and substantial populations, APAC countries can support acceleration of multinational trials.
3) Growth in oncology and rare disease in APAC countries – Japan in particular – and this aligns with global research trends. These countries often have incentives for orphan drug development, which is attracting more rare disease trials. Lokavant’s new AI feasibility solution is ideal for analysis of complex trials and indications to help ensure smoother trial execution.
