Image Description: Chemist Lee Geismar, who was part of the team that reviewed the new drug application for thalidomide in the early 1960s, is shown some years later poring over several volumes of another application. Image Source: https://www.fda.gov/
Delivering new therapeutics to patients is no easy or simple task. It requires multiple steps, coordination of numerous different disciplines and years of research, development, testing, and multiple regulatory steps. While the process begins in the laboratory, a crucial step to bringing new therapeutics to market is testing these candidates in humans. To do this, companies must submit and receive approval from the Food and Drug Administration (FDA) for an Investigational New Drug Application(IND) — the first arduous regulatory hurdle in a long, resource-intensive journey.
One of the main challenges in IND submissions is the requirement for extensive documentation and coordination amongst multiple disciplines and departments. The submission includes detailed information on the target therapeutic’s chemical composition, proposed clinical trial design, manufacturing information, and the safety and efficacy data from preclinical studies. Think of 100s of thousands of documents from multiple different departments which need to be reviewed, analyzed, and summarized — a process, which is labor-intensive, costly, and can be prone to errors. And a process we believe will be vastly improved with advanced technology, which is why we co-led with Innovation Endeavors, the Seed financing for Weave Bio, a generative AI company which is tackling this problem; a problem that impacts every single therapeutics company, regardless of size, stage, modality, or disease area.
Weave has created the first digital platform, AutoIND, which uses generative AI, specifically Large Language Models (LLM), and knowledge graphs to manage and organize IND studies, draft sections, create tables, streamline and automate reviews, update drafted documents whenever the source files change, link and track every statement to specific sentences in the source files, and facilitate collaboration among colleagues. While conventional IND preparation processes can take more than a year, AutoIND produces a first draft of an IND in a single day and can reduce the overall time it takes to produce a final IND submission by well over 50%, returning capacity to regulatory teams, lowering costs, and ultimately decreasing the time it takes to deliver new therapies to patients. For an industry which submits approximately 1,500 INDs annually, AutoIND has the potential to transform the regulatory process.
This is particularly urgent today. The industry is at a critical crossroads, facing both unprecedented challenges and opportunities. Since 2000, R&D spending has exceeded $3.4 trillion. The average cost per successful New Molecular Entity (NME) has increased from $800 million in 2000 to $3.1 billion in 2022. In addition, the industry is grappling with a “patent cliff” challenge — the expiration of drug patents and the flood of generic alternatives — which is estimated to threaten more than $200 billion in annual revenue by 2030.
The Inflation Reduction Act (IRA) has further intensified these challenges with reforms, which impose pricing caps and penalties on drugs whose costs exceed inflation metrics. These pressures, coupled with the persistent unmet needs of patients — diseases such as Alzheimer’s, Parkinson’s, and countless others remain without cures, underscore the urgency to bring new therapeutics to market quicker.
Magnetic’s founding investment thesis was that technology will impact every part of the healthcare ecosystem, and our seed investment in Weave extends our investment in the sector beyond drug discovery, clinical trials and manufacturing, to regulatory and processes.
Healthcare is incredibly complex and technology start-ups looking to solve problems in this complex sector require multidisciplinary teams. Weave was co-founded by Magnetic’s Venture Partner, Umut Eser (AI/ML expert) and Ari Caroline the broader senior team Brandon Rice (CPO), and Lindsay Mateo (CCO).
Weave’s solution is poised to deliver unmatched value to pharma and biotech companies, significantly cut costs, and rapidly accelerate the delivery of groundbreaking drugs to patients. This is just the starting point for Weave. We believe Weave’s technology has the potential to improve the entire regulatory cycle and move beyond regulatory to other process-heavy areas in healthcare, such as asset life cycle management. We know change is on the horizon and we are excited to continue to work with Innovation Endeavors and the Weave team to help realize the profound potential of Weave’s important technology.
Christine Aylward
Founder & Managing Partner