Kristin Brooks, Contract Pharma10.16.19
Among the many industry changes over the years, regulatory efforts and data analytics have had a major impact on drug development and clinical research this past decade. Regulatory Breakthrough Therapy and Orphan Drug designations, and new and increasingly innovative ways to collect and evaluate data have both advanced and alleviated some of the road blocks in getting drugs to market. The challenges rare diseases present, and the growing regulatory evidence needed for drug approval, have necessitated change in clinical research. For example, Real World Evidence (RWE) and virtual trials have become important tools to evaluate safety and efficacy, particularly in an age where more personalized therapeutics for smaller patient populations have prevailed. Additionally, small and virtual biopharma have become more numerous, and with their unique needs, have a greater reliance on CROs. These and other industry developments have pharma and biopharma seeking out more advanced and comprehensive services across the drug development continuum.
Richard Staub, President of Research & Development Solutions global business unit at IQVIA, discusses how CRO services have evolved over the years and what we can expect for the future of drug development. –KB
Contract Pharma: What were some of the major pharma/biopharma industry changes in the past 20 years that have greatly impacted contract service providers?
Richard Staub: The initial launch of the CRO industry was all about building therapeutic expertise, expanding global footprint, and developing operational capabilities to become viable R&D partners with our clients. That paradigm shifted with the big data era and the ability to apply data and analytics to program development and better inform our decisions and the strategies we develop for sponsors. These data and analytics capabilities have enabled us to deliver faster and smarter clinical trial site identification, more informed patient recruitment, and better study execution and in turn help save time and money for trial sponsors.
While we continue to expand and refine our data and advanced analytics capabilities, the industry still has room for progress in incorporating these advances into drug development.
CP: What are some of the changes you anticipate for the future of the industry and CRO services?
RS: As we look to the future, the next area of opportunity is using our technologies to scale automation and drive further efficiencies and quality into the clinical development operational model, thus enhancing the more traditional services, such as clinical monitoring and all other aspects of operational delivery. We are moving rapidly into a digitally enabled era that is focused on interoperability within the ecosystem that combines therapeutic expertise with end-to-end technology to power solutions for clients.
The intersection of technology, data scientists and healthcare is going to have a profound effect on the industry. We are already witnessing the impact that big data and mobile health are having in transforming healthcare. Along with personalized and precision medicines, we see the use of apps and wearable technologies that help patients monitor symptoms and manage their diseases. Virtual trials are making it possible to bring trials to patients, reducing geographical constraints and reliance on trial sites to find participants. Artificial intelligence is driving significant clinical trial efficiencies and better decision-making. Embedded intelligence is also helping us protect patient safety and ensure the quality of the clinical trial data being collected.
Emerging biopharma is also going to continue to accelerate research. EBPs now account for over 70 percent of the development pipeline, up from over 60 percent 10 years ago. The growth of this segment requires CROs to adapt their business models to meet the specific needs of these customers.
It is also likely that we will see more innovation from emerging markets, such as China. While the industry is still dominated by the U.S. and Europe, other emerging markets could be much more competitive in the future.
CP: What are some of the major regulatory changes that have impacted the industry in the past 20 years?
RS: The 21st Century Cures Act was a significant regulatory change that provided the framework to accelerate the development of new therapies, reduce the barriers for the next generation of therapies, and expand the use of real-world evidence to supplement conventional clinical trial data. These changes paved the way for new treatments to enter the market. The legislation also provides funding for projects such as the Precision Medicine Initiative which seeks to identify genetic and lifestyle factors that could be used to better predict who will develop certain diseases.
Another significant regulation is the Food and Drug Administration Safety and Innovation Act, which gave the FDA a new and powerful expedited drug development tool, known as the "breakthrough therapy" designation. This designation helps the FDA assist drug developers to expedite the development and review of new drugs with preliminary clinical evidence that indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.
The FDA has also provided guidance on adaptive designs and master protocols to make drug development more efficient and less costly. By modernizing the approach to clinical trials, the hope is these adaptive designs can provide answers faster than traditional trials and improve patient access to new medicines.
Richard Staub is president of the Research & Development Solutions global business unit at IQVIA, where he leads the world’s largest contract research organization (CRO). Richard also serves as chair of the Research & Development Solutions Executive Committee. Previously, Richard was president of Novella Clinical, a Quintiles company, a specialty clinical research organization acquired by Quintiles in 2013, and the leader of QuintilesIMS’s Global Functional Resourcing business. Joining Novella in 2004, he served as both president and CEO from 2008-13. Under his leadership, Novella became a distinctively agile, results-oriented CRO in the highly complex and fast-growing areas of specialty pharma and medical technology. Prior to joining Novella, he was senior vice president of global business development for one of the world’s largest CROs.
Richard Staub, President of Research & Development Solutions global business unit at IQVIA, discusses how CRO services have evolved over the years and what we can expect for the future of drug development. –KB
Contract Pharma: What were some of the major pharma/biopharma industry changes in the past 20 years that have greatly impacted contract service providers?
Richard Staub: The initial launch of the CRO industry was all about building therapeutic expertise, expanding global footprint, and developing operational capabilities to become viable R&D partners with our clients. That paradigm shifted with the big data era and the ability to apply data and analytics to program development and better inform our decisions and the strategies we develop for sponsors. These data and analytics capabilities have enabled us to deliver faster and smarter clinical trial site identification, more informed patient recruitment, and better study execution and in turn help save time and money for trial sponsors.
While we continue to expand and refine our data and advanced analytics capabilities, the industry still has room for progress in incorporating these advances into drug development.
CP: What are some of the changes you anticipate for the future of the industry and CRO services?
RS: As we look to the future, the next area of opportunity is using our technologies to scale automation and drive further efficiencies and quality into the clinical development operational model, thus enhancing the more traditional services, such as clinical monitoring and all other aspects of operational delivery. We are moving rapidly into a digitally enabled era that is focused on interoperability within the ecosystem that combines therapeutic expertise with end-to-end technology to power solutions for clients.
The intersection of technology, data scientists and healthcare is going to have a profound effect on the industry. We are already witnessing the impact that big data and mobile health are having in transforming healthcare. Along with personalized and precision medicines, we see the use of apps and wearable technologies that help patients monitor symptoms and manage their diseases. Virtual trials are making it possible to bring trials to patients, reducing geographical constraints and reliance on trial sites to find participants. Artificial intelligence is driving significant clinical trial efficiencies and better decision-making. Embedded intelligence is also helping us protect patient safety and ensure the quality of the clinical trial data being collected.
Emerging biopharma is also going to continue to accelerate research. EBPs now account for over 70 percent of the development pipeline, up from over 60 percent 10 years ago. The growth of this segment requires CROs to adapt their business models to meet the specific needs of these customers.
It is also likely that we will see more innovation from emerging markets, such as China. While the industry is still dominated by the U.S. and Europe, other emerging markets could be much more competitive in the future.
CP: What are some of the major regulatory changes that have impacted the industry in the past 20 years?
RS: The 21st Century Cures Act was a significant regulatory change that provided the framework to accelerate the development of new therapies, reduce the barriers for the next generation of therapies, and expand the use of real-world evidence to supplement conventional clinical trial data. These changes paved the way for new treatments to enter the market. The legislation also provides funding for projects such as the Precision Medicine Initiative which seeks to identify genetic and lifestyle factors that could be used to better predict who will develop certain diseases.
Another significant regulation is the Food and Drug Administration Safety and Innovation Act, which gave the FDA a new and powerful expedited drug development tool, known as the "breakthrough therapy" designation. This designation helps the FDA assist drug developers to expedite the development and review of new drugs with preliminary clinical evidence that indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.
The FDA has also provided guidance on adaptive designs and master protocols to make drug development more efficient and less costly. By modernizing the approach to clinical trials, the hope is these adaptive designs can provide answers faster than traditional trials and improve patient access to new medicines.
