In Industry Insights, members of ASPET’s Industry Science Committee discuss the intersection of pharmacology and industry, private sector highlights, and how the industry and membership can support each other.
Drug Development: Perspectives on an Evolving Landscape
By Marcus S. Delatte, PhD
ISC Member
The evolution of the drug development landscape is a complex process that ASPET and other organizations can impact in different ways to help ensure positive outcomes for patients seeking safe and effective treatments for health issues. ASPET is composed of academic and industry scientists that represent various disciplines including pharmacology, toxicology, clinical pharmacology, and chemistry. These disciplines serve on teams that create and develop potential therapeutic products for clinical use and marketing approval via regulatory agencies (e.g., Food and Drug Administration, United States; and European Medicines Agency, European Union). ASPET scientists have the relevant expertise to understand how various factors, such as emerging public health crises and advancing technology, drive drug development and what actions are needed to impact this process to ensure patient access to safe and effective therapeutic products.
Public health crises create an urgency to develop safe and effective medications to treat conditions that include CNS, heart, and infectious diseases. This urgency may be related to the increased incidence and severity levels of diseases, as well as the lack of safe and effective treatments. Such urgency occurred during the COVID-19 pandemic and resulted in Operation Warp Speed, which supported the unprecedented rapid development of multiple mRNA vaccines (e.g., Comirnaty and Spikevax). These vaccines helped to reduce the infection rates, severity, and deaths related to the virus. Vaccines and other products typically rely on findings collected by academic scientists and used by companies to create products intended to address public health crises.
Technological advances such as artificial intelligence (AI) and new alternative methods (NAMs) drive the changes in drug development by increasing efficiencies in different aspects of programs, while decreasing timelines and the use of various resources. AI tools are employed to analyze large and complicated datasets, write regulatory documents, design efficiencies in protocols, and many other tasks. These tools are intended to complete tasks faster than humans, to provide alternative perspectives on strategies, and to fit customers’ needs under different contexts. NAMs represent various assays intended to reduce/replace and complement animal testing, while helping to decrease drug development costs and timelines. Data from NAMS can be collected in a quick and efficient manner, used to de-risk products, and leveraged to inform traditional approaches to assess and manage product-related risks. Together, these tools rapidly drive drug development and provide many benefits related to the use of each.
Scientists and organizations involved in drug development significantly impact the fast-evolving drug development landscape through education, technology adoption, and partnerships. Adopting technologies such as AI and NAMs has helped better understand mechanisms of drug effectiveness and toxicity; however, the limitations of each must be put in proper context when leveraging findings to inform risk assessment and management plans for products and engaging regulatory agencies. Efforts to adopt new technologies and educate regulators create opportunities to form partnerships between scientists, companies developing therapeutics, regulatory agencies, and other stakeholders such as patient advocacy groups and organizations such as ASPET. Agencies such as the FDA face technical knowledge gaps due to rapidly advancing technology, which impacts the technical and regulatory decisions made on drug development programs. Partnerships between scientists, the private sector, scientific organizations and regulatory agencies create opportunities to educate agency staff across emerging scientific and regulatory topics, as well as in strategies to successfully engage external stakeholders seeking support to develop therapeutic products. These partnerships may further help increase the awareness around the needs of patients and their families, the influence of external stakeholders, and the overlap in the priorities amongst these groups.
ASPET has launched efforts to support empowering its academic and industry scientists through the formation of the Industry Science Committee. This committee guides efforts to organize and create Thought Leadership content related to drug development; promotes the mentioned content via mechanisms that include infographics, webinars, and symposiums; as well as uses this content to educate its membership and external stakeholders. These efforts by ASPET demonstrate its commitment to positively impacting the drug development process. Together, ASPET and its partners can impact the evolving drug development landscape to help ensure that safe and effective drugs are developed for different patient populations, and with advanced technologies that help reduce the time and cost of product development.
