We are seeing an era of incredible progress and movement in the pharma industry when it comes to clinical trials. Sudip Parikh, SVP & managing director, Americas at DIA Global, sees two trends that will continue to have a profound impact on potentially powerful new treatments and the clinical trials that make them possible.
The first trend is technology. “When I look at the clinical landscape, the technology we are seeing is moving ahead at a fast pace,” says Parikh. “This is in both the vendor space and in the science itself. Precision medicine is a great example. I recently spoke to the CEO of CRISPR Therapeutics, who will attend our annual meeting in June. The company has raised a lot of money and is at the cusp of clinical trials for Sickle Cell. I believe the opportunity to cure Sickle Cell is now standing right in front of us.”
Also on the technology front, Parikh notes the amazing progress the industry has seen with AI, block chain, and cell and gene therapies. He believes these rapid technology advancements are now creating a new opportunity – market understanding. The marketplace seems to now be pulling these technologies into the public sphere. Parikh believes the promise and opportunity posed by these emerging technologies has led to money becoming available from investment firms to fund them. The challenge that remains for investors is being able to separate the hype from the meaningful science.
“There are small companies with large market caps and technologies that will, over time, make it to market,” says Parikh. “I think over the remainder of 2018 we will see a lot of investment taking place. I believe large pharma companies will get involved as well, as companies jockey to buy or invest in small biotech companies or attempt to create their own R&D platforms in precision medicine. We are also seeing new companies in the digital space promoting technologies like AI and block chain. These technologies will change the way companies perform R&D.”
Regulators Keep Pace With Trends
The second trend impacting trials is regulators. Parikh states we are now seeing the most proactive group of regulators the industry has ever seen. When it comes to AI and block chain, he notes regulators from around the world are really trying to understand how the technologies might be used to improve the drug development and regulatory processes.
“Regulators are preparing for these new technologies in a way that we have not seen in the past,” says Parikh. “In the past, regulators were often reactionary. Today the agencies see the potential of these technologies and are requesting government funds to ensure they are properly prepared for them. The FDA’s budget has the largest increase request that I have seen in a long time. A few years ago, there was talk of slashing the FDA’s budget. Today we are seeing a $400 million increase in that budget requested by the President. The agency will likely not get all of that, but it does tell us the agency is being proactive in addressing these new technologies.”
This type of proactive approach is critical to meeting the current challenges that exist in drug development. When new technologies and regulator funding do not converge at the same time, Parikh notes problems will arise. The biggest one is usually new technologies getting ahead of the regulatory practice – something that can cause delays in the drug approval process.
“Precision medicine is at the cusp of clinical trials,” adds Parikh. “Clinics, sponsor companies, CROs, and regulators all have to be prepared for that. In the past, many lessons were learned the hard way. Today, I think the regulators want to make sure we do this right. If not, we can set the industry back several years.”
Annual Meeting Will Address Trends
Parikh notes these two major trends will also manifest themselves in content presented at the 2018 DIA Annual Meeting. The kickoff Diamond session will focus on innovation in the Gottlieb era. The session will discuss activities undertaken by the new FDA commissioner, and how the agency is proactively trying to meet the evolving needs of the industry. Another Diamond session will address international regulatory convergence and bring other regulatory agencies into the conversation.
“How we engage patients continues to increase in importance,” says Parikh. “The two trends I mentioned are also having a significant impact on patients. From the point of view of the patient, the technology changes alone are having an enormous impact. For example, patients are now able to be part of a digital clinical trial, which significantly cuts down on the time commitment. Some of these technology advancements are happening even faster than we could have ever imagined.”
Finally, Parikh notes what can happen when those three trends do not meet up in the right place at the right time. That situation will be explored in an opening session on the opioid epidemic. Nora Volkow, director of the National Institute on Drug Abuse (NIDA) at the National Institutes of Health, will deliver the keynote address. Volkow will discuss the potential for public/private partnerships to deal with the opioid crisis that exists today and create new medicines for the future of pain management.
“Her presentation will be an invitation to industry partners to work with the federal government and regulatory agencies to come up with real solutions to the problems we face,” says Parikh.
DIA’s 2018 Annual Meeting will be held at the Boston Convention & Exhibition Center from June 24-28, 2018.