The pharmaceutical industry has long faced something of a perfect storm of regulatory upheaval and technological disruption. But now is different. The Inflation Reduction Act represents a unique challenge for pharma companies as the U.S. government can force them to negotiate drug prices for some Medicare drugs. And despite its name, some pundits believe the…
Strategies for tapping the cloud to scale data transformation in biopharma
Biopharma’s gradual embrace of the cloud is picking up pace. In 2022, PwC surveyed more than one hundred pharmaceutical and life sciences companies. Forty percent were already running all of their operations in the cloud; another 55% hoped to join them by late this year. The report also found that the most successful companies used…
How a data lakehouse can give you a panoramic view of your AI-enabled clinical trials
In recent years, the term “data lakehouse” has entered the lexicon of data professionals. For AI-enabled clinical trials, the lakehouse architecture promises seamless integration of diverse data streams, spanning patient health records to real-time sensor data, all processed efficiently and queried in structured formats. The lakehouse architecture aims to provide a comprehensive overview of data,…
How AI and the cloud can transform R&D workflows and fuel collaboration
The rise of cloud-based systems and AI-assisted analysis has dramatically transformed the landscape of scientific research and collaboration. One striking example is the mRNA company Moderna, which used the cloud to develop and deliver its first clinical batch of a COVID-19 vaccine candidate for phase 1 trials in a mere 42 days after the initial…
8 considerations to boost clinical trial productivity with AI while dodging hallucination hurdles
The development of new drugs is undeniably a data-intensive endeavor. Despite impressive advances in AI over the past years, researchers often continue to grapple with crushing data volumes. This hurdle is particularly apparent in clinical trials, where crucial data is often stored in machine-unfriendly formats such as PDFs, PowerPoint or HTML or other formats. This article explores…
Speed up regulatory submissions: A guide for efficiency
Drug development involves many rounds of regulatory approval and oversight, including multiple stages of regulatory submissions. In the U.S., these include the Investigational New Drug Application (IND) before clinical trials in humans, the New Drug Application (NDA) or Biologics License Application (BLA), prior to commercial sale and Annual Product Quality Reviews (APQR) to monitor ongoing…
Harnessing the untapped potential of legacy data in pharma R&D
Clinical trials for a new therapy cost a median of $41,117 per patient. Costs like this are no surprise to pharma leaders. But during an age of increasing budgetary pressures, drug developers are under pressure to do more with less money and staff. While there are no “simple” answers to this challenge, there is one strategy that offers…
5 common data management problems affecting drug discovery
Ask a pharma researcher how well they’re able to leverage their organization’s medical imaging data, and you might hear a discouraging response. While most pharma companies have massive amounts of clinical and medical imaging data, often, most of the imaging data isn’t ready for modern research processes and infrastructure. This imaging data is an untapped…