Personalized medicine growth hindered by outmoded drug development paradigm

Regulatory NewsRegulatory News | 11 July 2022 |  By 

Kenneth Getz, executive director Tufts CSDD

There has been explosive growth in the number of applications and approvals for personalized medicines, yet the current drug development paradigm is not optimizing the development of these treatments, asserted Kenneth Getz, the executive director of the Tufts Center for the Study of Drug Development (CSDD).
Getz told Regulatory Focus in a 7 July interview that over the past 20 years, there has been unprecedented growth in the number of personalized development therapies approvals, including treatments for oncology and immunology, yet this growth has not translated into modern drug development operating models.
“We have yet to see any improvements in our success rate and in our drug development cycle times” for personalized medicines and other drugs, said Getz. “In fact, studies show that studies are taking longer, and [patient] retention and recruitment rates are the lowest they have ever been in our history.”
Getz also addressed the current state of personalized medicines at the June Drug Information Association (DIA) meeting in Chicago. Getz told the meeting that research conducted by CSDD and other groups “indicates that drug development failure rates are the highest they have ever been.”
“The average overall duration of a development program and a clinical trial by individual phase is not getting faster. They are all taking longer, and the durations are less predictable now than they were ten years ago. Recruitment and retention rates are at their lowest in our history, particularly in oncology and rare diseases, two dominant segments in our R&D pipeline,” he added.
At the same time, the number of personalized medicines in development has experienced dramatic growth. Such medicines represented 23% of all drugs in development 2013, to 51% in 2017 to 64 percent in 2021. The percentage of all approved new molecular entities (NMEs) classified as personalized medicines was 9% in 2013, to 26% in 2016 to 39% in 2021. Drugs that rely on biomarkers and genetic data are classified as personalized medicine.
“Nearly all drugs in research and development for cancer related diseases and 60% of drugs in development for other diseases now rely on genetic information and biomarkers, and almost 40% of all approvals are now part of the class of personalized medicine,” said Getz.
These medicines, said Getz, have “delivered remarkable treatments to patients, most notably in oncology and immunology and our pipeline has many more to come.”
Getz said the growing adoption of digital technologies and data analytics are “enabling the collection and the faster access to much higher volumes of scientific and operating data that can be interrogated and shared to which rich insights can be drawn and applied.”
Staid R&D model not accommodating personalized medicines
Yet these developments are not accommodated by optimal drug development models. The average number of data points collected per clinical trials is 3.4 million, a fourfold increased form the data points collected over the past ten years, said Getz.
In addition, patient eligibility criteria are becoming more stringent, and the number of endpoints “has tripled in our Phase 3 programs.”
Getz added, “We are also “observing higher levels of inefficiency and performance volatility than ever before … we cannot continue using 20th century drug development operating models cultures and mindset to optimize the value of 21st century solutions. Our research supports that notion.”
More interaction, collaborations would help
Getz told Focus that one of the lessons learned from the COVID-19 pandemic is that drug development hurdles can be addressed if regulators work more collaboratively with industry in bringing products to market. Also, the industry’s use of shared platform approaches also helps to reduce the complexity of drug development.
Also, he noted that shared data and development risks, and the involvement and engagement of the community and clinical care community enables the rapid deployment of deployment of vaccines worldwide.
Getz said that it is all these elements coming together that helped to bring COVID-19 vaccines market expeditiously. “The pandemic opened our eyes to what can be managed … it is how we do things in concert with each other, the pandemic really opened our eyes to things that needed to be managed simultaneously.”


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