Robert Feltz, Director of Analytical and Formulation Services, Sharp Clinical
Rising clinical trial complexity
Clinical trial supply management is used across the entire life cycle of investigational drug products in clinical trials and encompasses a wide range of activities. Forecasting and planning, procurement, manufacturing, packaging, labeling, storage, distribution, and tracking must all be managed to ensure clinical trial supply, presenting a considerable challenge for drug developers.
Clinical trials are becoming more challenging in line with the increased complexity of investigational drugs that focus on personalized medicine, smaller patient populations and rarer indications.
This complexity is further compounded by the fact that multiple stakeholders are typically involved in clinical trials, including drug sponsors, contract research organizations (CROs), clinical sites and manufacturers. Effective clinical trial supply management with coordination and communication is critical to ensure the right quantity of the investigational drug is delivered to the right location at the right time, ensuring trial success and participant safety.
Recently, new trends have driven the increased complexity of clinical trials, making clinical trial supply management more difficult:
1. Changing regulations
Adhering to regulatory requirements ensures the safety of patients by protecting against risks such as contamination and misadministration. Regulatory requirements are constantly evolving, with new models for trial administration in different clinical settings. Although changing regulations are designed to ensure continued patient safety, keeping up can be a challenge for drug developers.
For example, the new regulatory framework set out by the Medicines and Healthcare Products Regulatory Agency (MHRA) in 2023 is the biggest overhaul in UK clinical trial regulation in over 20 years.1 Similarly, the FDA announced updated recommendations for good clinical practices in 2023, to modernize clinical trials.2 The changing regulatory landscape is more complex for drug developers looking to run parallel trials across multiple countries, requiring an awareness of global regulatory regimes.
2. Accelerated drug development
The changing regulatory landscape comes at a time when demand for accelerated drug development is increasing. Drug developers are under pressure to progress candidates through clinical trials more rapidly. Accelerating commercialization gives developers an edge over their competitors, enabling them to return on financial investments sooner and minimize the impact of disease by delivering therapies to patients sooner. However, product efficacy and safety must be maintained with accelerated timelines.
Developers can use technology to streamline timelines, especially if they are working with a new molecule or formulation. Advanced analytical instruments have improved sensitivity, selectivity, and efficiency, providing developers with rapid data generation and accelerated decision-making. Staying informed and adapting to continued technological advancements allows analytical, research and development teams to remain competitive and accelerate drug development.
3. The rise of AI-driven drug discovery
Drug discovery and development is expensive and time-consuming, with only 10% of candidates successfully progressing through to commercialization.3 However, with the rise of artificial intelligence (AI) and machine learning (ML), drug discovery and development is changing. By enhancing predictive modeling, accelerating the screening process, and enabling the integration of data sources like genomics, proteomics, and clinical data, AI and ML are revolutionizing drug discovery and simplifying development.4
The global AI in drug discovery market size was valued at $1.1 billion in 2022 and is anticipated to grow at a compound annual growth rate (CAGR) of 29.6% between 2023 and 2024.5 Increased AI-driven drug discovery is likely to lead to an influx of novel drug substances.
The cost of this revolution will be an influx of AI-enabled drugs and a set of new challenges for developers. Verifying the safety, purity, and efficacy of every new compound is a considerable undertaking that requires analytical due diligence. However, by leveraging advanced technologies, techniques, and strategies, developers can take advantage of the AI revolution to launch therapies quicker than their competitors.
4. The impact of digital transformation
Digital transformation is reshaping R&D, marketing and supply chain management, driven by AI and AI analytics and the demand for more efficient and effective healthcare delivery. Robust privacy and security frameworks are an essential part of this and can help to harness the potential of AI. Impulsive digital investing without having the appropriate infrastructure in place can lead to project failure and financial loss. To benefit from analytical data management systems, developers should always focus on process improvement when integrating technologies. By addressing patient data privacy, training employees to transition from legacy systems and ensuring regulatory compliance, developers can overcome infrastructure challenges and achieve successful digital transformation.
It is expected that budgets in the pharmaceutical industry will decrease, leading to an increase in outsourcing. Digital drug companies in particular will rely more heavily on CDMOs. To navigate a landscape characterized by reduced budgets, the pharmaceutical industry must identify and solve existing workforce gaps and critical skills, particularly in CDMOs and other outsourcing organizations.
All-in de-risking strategies
Effective outsourcing strategies enable drug developers to navigate the challenges stemming from emerging trends and de-risk their clinical trial supply. Partners with an integrated range of logistical and administrative support services can improve transparency, reliability, auditability, and flexibility.
With an all-in provision including comparator sourcing, manufacturing, analytical release testing, primary and secondary packaging, cold chain storage, qualified person release, and robust distribution to multi-site clinical trials or even direct-to-patient, outsourcing partners can provide greater security and auditability of compound handling. A centralized approach also reduces the number of point failures in the supply chain, leading to less disruption and more rigorous and better-documented adherence to regulations.
Outsourcing partners offering analytical testing, formulation development, and manufacturing services on the same site provide real-time monitoring, control and rapid adjustments to help ensure consistent product quality. On-site analytical services can also reduce turnaround times, streamlining process development, scale-up, and routine quality control. The additional benefits of all-in outsourcing include improved confidentiality, faster decision-making and collaboration and cost efficiency.
Looking ahead, by prioritizing risk-mitigation strategies and optimizing clinical trial supply management, drug developers can successfully navigate the substantial industry transformations and continued challenges.
Robert Feltz, director of analytical and formulation services, Sharp Clinical
References
- https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-regulation
- https://www.fda.gov/news-events/press-announcements/fda-announces-additional-steps-modernize-clinical-trials
- Mullard A. Parsing clinical success rates. Nat Rev Drug Discov. 2016 Jun 30;15(7):447.
- Niazi SK. The Coming of Age of AI/ML in Drug Discovery, Development, Clinical Testing, and Manufacturing: The FDA Perspectives. Drug Des Devel Ther. 2023 Sep 6;17:2691-2725. doi: 10.2147/DDDT.S424991. PMID: 37701048; PMCID: PMC10493153.
- https://www.grandviewresearch.com/industry-analysis/artificial-intelligence-drug-discovery-market
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- Source: https://www.appliedclinicaltrialsonline.com/view/trends-impacting-clinical-trial-supply-management