As the Biden-Harris administration’s approved measures move closer to fruition, government agencies are now facing the challenge of putting these policies into action. With 2023 quickly approaching, the time to act is now.
By December 31st, 2025, the NIH, NASA and other agencies will have made a groundbreaking shift in the way taxpayer-funded research in biosciences is handled. Instead of being locked behind paywalls, all of this data will be made freely available to the public – freeing up valuable information to those who need it most. The work has already begun, and soon we can expect to see the fruits of this groundbreaking initiative.
Despite the shift in federal policy, biopharma publishing expert believes that it won’t have much of an effect on big pharma.
Vikram Savkar, Senior Vice President and General Manager of the Medicine Segment of the Health Learning, Research & Practice business at Wolters Kluwer, recently weighed in on the importance of understanding the implications of potential policy changes. Savkar manages research tools in biopharma, such as the New England Journal of Medicine, and believes it is essential to have a comprehensive understanding of how policy changes may affect the industry.
We all have a vested interest in the publishing space, and our focus is on improving the lives of patients. Anything that can help to speed up the process of turning research into treatments, drugs, and clinical pathways is a huge plus. We are passionate about our mission and strive to ensure that our work has a meaningful effect on patient outcomes.
Savkar delved into the intricacies of acceleration, emphasizing that it isn’t always beneficial. He clearly articulated the nuances of what makes acceleration meaningful and how to interpret it.
The long-standing paywall which has blocked access to research for so many, is finally being taken down, thanks to this new policy. For big-budget pharmas and institutes, this won’t create much of a difference, as they have never been hindered by paywalls. Nevertheless, this policy marks a significant step towards increasing access to research for all.
AI will be at the forefront of the meaningful acceleration that will come from text and data mining, according to him. He believes this will be a major driver of progress in many areas.
We are on the brink of an exciting transformation in the world of research and data science, thanks to the burgeoning field of artificial intelligence. With the policy requiring all peer-reviewed literature and data sources to be made available in a standardized format, AI-powered tools can be applied to large bodies of content to draw automated conclusions. This will open up new possibilities for researchers, and for those providing the data, and promises to be a game-changer in how we view and interact with data.
The Open Access Policy, issued by then-OSTP Director Alondra Nelson, Ph.D., faced opposition from those worried the U.S. was handing over its intellectual property to the rest of the world. However, Nelson argued that the policy would benefit the nation in the long run.
In August 2022, the White House declared that research funded by the American public should be widely accessible to researchers and the public alike. After all, this research has the potential to save lives, inform critical policy decisions, and create more equitable outcomes for all. With tens of billions of dollars invested in cutting-edge research each year, there should be no delay or barrier between the public and the returns on their investments.
Ultimately, her memo issued three key recommendations for all federal agencies, including the NIH and FDA, to help better protect public health and safety. These recommendations included: improving risk assessment and management processes; modernizing policies, systems, and practices; and strengthening collaboration and coordination across agencies. With these steps in place, the government could better safeguard the public from potential threats and ensure everyone has access to safe, effective products.
By the end of 2025, let’s ensure that all publications and data stemming from federally funded research are publicly accessible and free to use. Let’s update our public access policies to make sure that not only are these resources accessible, but that they also don’t require an embargo period. Let’s make sure that the knowledge gained from this research is shared with the public, as soon as possible.
Ensure that research and scientific integrity are upheld in public access policies by creating and implementing clear procedures. Make sure that the principles of honesty, objectivity, and accuracy are upheld throughout the process.
Coordinate with the Office of Science and Technology Policy (OSTP) to ensure the fair and equitable distribution of federally funded research results and data. Together, we can ensure that the benefits of this research are accessible to all and that the data is used to its fullest potential.
As implementation of the policy continues, Savkar’s primary concern is managing expectations. He worries that the potential issues surrounding implementation may come to fruition, but remains hopeful that with time, agencies will be able to work out the details.
“Creating false expectations can lead to sudden disappointment, which is something we want to avoid,” he said.
AI tools are paving the way for a new era of drug development, bringing with them the potential to greatly accelerate the process and bring new treatments to the market faster. But while these technologies are powerful, patients shouldn’t expect to see the fruits of their labor immediately. It’s going to take time to combine these AI tools with the appropriate policy to bring about meaningful change, but the end result will be worth the wait.
When it comes to drug development and clinical pathways, the stakes couldn’t be higher. We’re talking about the potential to make an incredible, life-altering difference in peoples’ lives – a difference between life and death. It’s a situation that requires much more than just throwing a ChatGPT at it and hoping for the best.
Despite the federal government’s standardization of data formats by December 2025, creating content will still require manual translation, he explained.
It’s time to buckle up and embark on a thrilling journey to explore the possibilities of utilizing this content. With a strict focus on editorial rigor, peer review and quality control to counter disinformation, we can look forward to a productive future in the next few years. Let’s make sure to stay vigilant and explore this exciting new space!