Life Sciences 2024ward
scientist pointing to graphics of scientific icons
Predictions for the Life Sciences 2024: Regulatory Science
Isaac R. Rodriguez-Chavez
4Biosolutions Consulting
T

he landscape of the life sciences will continue to evolve in 2024, propelled by technological advancements, research breakthroughs, and regulatory adaptations. As we stand in front of 2024, exploring the imminent trends in regulatory affairs, FDA policies, and clinical research becomes paramount. This article aims to illuminate unfolding regulatory developments in drugs, biologics, and medical devices, and their potential impact on clinical trial participant care, regulatory affairs professionals, and public health. By appraising the current landscape of medical product development, it endeavors to present a comprehensive view of the path ahead.

New Regulatory Dynamics Reshaping the Regulatory Affairs Profession in 2024

The life sciences field will rapidly evolve and present both challenges and opportunities for regulatory affairs professionals in 2024. Key factors that will continue shaping the landscape include advancements in technology, research, and regulatory frameworks. As clinical research continues to globalize, regulatory affairs professionals will increasingly need to possess expertise in both domestic and international regulations. This will demand more targeted training to effectively navigate complex international regulatory frameworks.

Antimicrobial resistance, budget constraints, and other issues that impacted the biotechnology and pharmaceutical industries in 2023 will necessitate innovative regulatory approaches to meet evolving industry needs in 2024. Meanwhile, advancements in digital technology that will continue in 2024 promise to spur greater innovation in regulatory science and expand the regulatory framework to operationalize these technologies in clinical research. The increase in precision medicine, real-world evidence, adaptive trials, decentralized trials, participant-centric approaches, and digital integration ecosystems will require regulatory affairs specialists to master both national and international policies and standards. In 2024, demand for professionals versed in global regulatory dynamics will intensify given expanding markets and the imperative for multicountry product approvals.
Discussions around implementation of regulatory reliance approaches for market authorization, lifecycle management, and GMP certification for pharmaceuticals and medical devices will continue to be the greatest regulatory trend in Latin America in 2024. New reliance regulations are expected to be approved in different jurisdictions; since this is a new approach for many regulators and applicants, the main challenge will be their application. We can also expect that electronic labeling will become a reality in 2024 with potential benefits for patients, healthcare professionals, and other stakeholders in the region. We will also observe growing interest and conversations regarding the potential use of AI to support healthcare, including regulatory activities. — Anonymous.
The necessity of matching accelerating technological transformation and acquiring comprehensive global regulatory knowledge will mandate agile shifts in skills and knowledge for professionals in 2024’s complex and unharmonized global regulatory landscape. As the emphasis on leveraging preventative care for trial participants grows, these experts will be pivotal in enabling the development and approval of pioneering, safe, and effective new therapies. Their role in facilitating compliance and navigating complex regulatory terrain will remain essential in 2024.

FDA Policies and Regulatory Affairs in 2024

Regulatory developments in 2024 will be guided by events in medical product development:

  1. Streamlined Drug Approval: Envisage the FDA increasingly accepting regulatory submissions that contain innovative methods such as adaptive clinical trials, decentralized clinical trials, and real-world evidence mixed with trial participant centricity to expedite the novel medical product approval process, ultimately providing quicker access to groundbreaking therapies for people with unmet medical needs.
  2. Biologics Oversight Amplification: FDA guidance documents expected in 2024 will clarify the regulatory framework for biologics, ensuring the safety and efficacy of intricate therapies such as gene- and cell-based products.
  3. Strengthening Medical Device Regulations: It is also reasonable to expect FDA to propose new guidance documents to address burgeoning technologies and enhance the safety and efficacy of digitally enhanced medical devices, particularly in connection with cybersecurity, artificial intelligence, machine learning, and digital health applications, in 2024.
Progressing negotiations on the EU General Pharmaceutical legislation is crucial to the long-term future of innovation in Europe. These are high-stakes negotiations to ensure that the legislation encourages future investment, innovation, and global competitiveness in the EU. This must be achieved in tandem with the overall aims of the revision to the legislation, including a future-proofed regulatory framework, more equitable access to affordable medicines, and mitigating shortages, amongst others. The June 2024 elections for the European Parliament are likely to impact the timelines and future negotiating positions on the legislation. 2024 will no doubt be an interesting and pivotal year for the progression of the legislation. — Elizabeth Short and Julie O’Brien, Pfizer.

Trends in Clinical Research

Innovation in modern clinical trial designs will continue flourishing in 2024 by expanded adoption of:

  1. Participant-Centric Trial Approaches: Industry’s heightened focus on engaging and including participants in clinical trials will employ technology for remote monitoring, decentralized clinical trials (DCTs), and patient-reported outcomes (PROs), fostering inclusivity, diversity, equity, and accessibility in research.
  1. Real-World Evidence from DCTs, Data Integration, and Adaptive Trials: As regulators and sponsors increasingly adopt real-world evidence and innovative trial designs, advancing digital health technologies will fuel expanded use of real-world data from sources such as electronic health records, claims data, and wearable devices. Real-world evidence will complement traditional trials by providing invaluable insights into treatment effectiveness, safety signals, patient outcomes, and health equity across diverse trial participant populations in real-world settings. DCTs will also gain incremental momentum in 2024, meeting participants where they are through telehealth and remote monitoring, and continue to boost inclusivity, diversity, equity, access, retention, convenience, and data quality. Adaptive trial designs, allowing midcourse modifications based on accumulating data, will also continue to progress. As gatekeepers and guideposts steering product development, regulators will play a key role in incorporating real-world evidence and enabling novel trial designs to improve efficiency, generalizability, and participant-centricity of the evidence-generation process. 2024 will continue to reveal the full promise of innovation through data integration.
With the advent and growth of new health solutions, pharmacovigilance (PV) systems and regulations in Latin America will continue to evolve towards more harmonization, convergence, and reliance, including more detailed requirements for medical devices (e.g., SaMD [software as a medical device] and advanced therapy medicinal products [ATMPs]). Publication of the revised ICH Guideline E2D (expected in early 2024) in this context should influence the management of post-approval safety data in Latin America. We can also expect PV systems in the region to continue to evolve towards patient-centric risk management by including patients and caregivers in the process and demanding greater collaboration between industry, academia, regulators, and patient advocacy groups. — Anonymous.

Developments in Drugs, Biologics, and Medical Devices

We can also anticipate an evolution of medical products development in 2024.

For Drugs:

  1. Precision Medicine: The convergence of genomics and personalized medicine will drive increased drug repurposing and targeted therapies, revolutionizing treatment paradigms.
  2. Accelerated Approval Pathways: FDA’s commitment to Breakthrough Therapy and Fast Track designations and similar expedited pathways will prioritize innovative treatments for severe or life-threatening conditions.
  3. Increased Advancements in Digital Health and Novel Endpoints: Growing integration of wearable devices, mobile apps, novel endpoints, artificial intelligence, and machine learning will improve optimization of clinical trials and evidence generation and expedite drug development and monitoring.

For Biologics:

  1. Trailblazing Biologics and Gene Therapies: Clear FDA guidance will catalyze the development and approval of biologics in 2024, paving the way for revolutionary treatments in rare genetic diseases and cancer.
  2. Biosimilars’ Expanding Domain: Market growth for biosimilars, backed by FDA clarity and guidance, will foster innovation and accessibility.
  3. Innovating Manufacturing Processes: FDA’s drive toward innovative manufacturing methods will ensure high-quality biologics, cost reduction, and supply chain resilience (along with increased manufacturing facility inspections) in 2024.

For Medical Devices:

  1. Increased Innovations in Digital Health: The amalgamation of medical devices and progress in novel digital health technologies will engender novel solutions for diagnosis, monitoring, and treatment, progressively transforming both clinical research and healthcare delivery.
  2. Regulatory Focus on Digital Health: It is reasonable to expect FDA to continue establishing guidelines for software as a medical device, artificial intelligence, and machine learning, prioritizing safety and efficacy.
  3. Cybersecurity Imperatives: With heightened device connectivity, expect FDA to safeguard trial participant privacy and device integrity through fortified cybersecurity regulations.
  4. Evolution of Imaging Technologies: Advancements in three-dimensional printing, augmented reality, and machine learning in imaging will reshape diagnostics and treatment guided by FDA regulatory support.

The landscape of 2024 foretells a progressive paradigm shift in the life sciences industry. Our drive towards accelerated approvals, innovative therapies, and improved trial participant outcomes will be transformative and will enhance public health and well-being.

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