The pharmaceutical industry in 2024 is shaped by notable legal and regulatory developments that transpired in 2023. The Supreme Court, in a pivotal move, addressed the standard for enablement in the context of antibody genus claims and refrained from overturning Federal Circuit decisions related to written description and induced infringement concerning skinny labels. Simultaneously, the current administration unveiled new regulatory objectives impacting the pharmaceutical sector. These include announcements regarding the integration of artificial intelligence (AI) in drug development, coupled with joint efforts from the White House and the Federal Trade Commission to curtail prescription drug costs. This involves challenging the propriety of patents listed in the FDA Orange Book and leveraging “march-in” rights under the Bayh-Dole Act.

AI Integration and Regulatory Objectives

In response to these developments, the FDA introduced initiatives on artificial intelligence and machine learning in drug development. The agency issued discussion papers as part of its communication strategy with stakeholders, aiming to explore considerations for the use of AI/ML in developing drugs and biologic products. While lacking specific policy proposals, these papers underscore the FDA’s acknowledgment of the pivotal role AI/ML will play in drug development. Furthermore, the FDA expressed its commitment to adopting a flexible risk-based regulatory framework that fosters innovation with AI while ensuring patient safety.

Executive Order on AI and Intellectual Property

President Biden’s executive order on artificial intelligence in October 2023 outlined broad initiatives aimed at enhancing safety and security in the rapidly evolving AI space. This includes directives to the US Patent and Trademark Office (USPTO) director to provide guidance on inventorship in AI use and address other considerations at the intersection of AI and intellectual property within specified timeframes. Consequently, the industry anticipates requested guidance in February and July, providing stakeholders with an opportunity to review and comment, actively contributing to the shaping of USPTO regulations involving AI.

Federal Initiatives on Drug Costs

In parallel, federal agencies focused on reducing drug costs in 2023. The Federal Trade Commission, in September, announced objectives to combat improper Orange Book listings, which it views as barriers to generic drug manufacturers entering the pharmaceutical market. Subsequently, the FTC challenged over 100 patents through an FDA regulatory process in November 2023, alleging improper listing in the Orange Book. Responding to this, Senator Elizabeth Warren and Representative Pramila Jayapal urged targeted companies to address the allegations and voluntarily delist challenged Orange Book patents. As the industry awaits outcomes, the FTC is contemplating next steps for companies ignoring warning letters.

Policy Objectives and the Bayh-Dole Act

December 2023 brought new policy objectives from the Biden Administration, aiming to reduce prescription drug prices, partly through the utilization of the Bayh-Dole Act. This legislation allows certain entities to retain title and commercialize patents resulting from federally funded research, subject to specific criteria. Simultaneously, the National Institute of Standards and Technology (NIST) released a draft inter-agency framework for “march-in” rights, allowing agencies to consider price and terms in determining whether to license patents from federally funded research.

Conclusion

Judicial interpretations of the conditions for patentability in 2023 influenced the composition of pharmaceutical patent claims. Moreover, many governmental and regulatory initiatives focused on AI advancements and attempted to lower prescription costs. It is recommended that interested parties keep an eye on proposed rules in both areas and communicate with relevant authorities to actively influence laws that affect the pharmaceutical sector.

The U.S. FDA revised its position on the use of electronic systems, records, and signatures in clinical studies in 2023 and released guidelines for the planning and execution of Decentralized Clinical Trials (DCTs). In addition to developing guidelines, the FDA set up a broad framework that included internal mechanisms for evaluating decentralized and virtual trials, workshops, demonstration projects, stakeholder participation, and a dedicated website.

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What are Clinical Trials?

Clinical trials are research studies performed on humans to evaluate a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker), is safe and effective in people.

These studies play an instrumental role in healthcare by establishing the effectiveness of treatments, identifying potential side effects, and contributing to the development of medical guidelines and policy.

The Phases of Clinical Trials

Clinical trials progress through four key stages:

• Phase I: Typically involving a small group of healthy volunteers, this phase assesses the safety, dosage, and side effects of a new treatment.
• Phase II: This phase tests the treatment on a larger group of people who have the condition or disease the treatment is designed to treat, providing further data on safety and effectiveness.
• Phase III: This phase involves randomized and blind testing in several hundred to several thousand patients. This large-scale testing, which can last several years, provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions.
• Phase IV: Also known as Post Marketing Surveillance Trial, this phase occurs after the FDA approves the use of the drug. It monitors the drug’s effectiveness and impact on patient’s quality of life and compares it to other common treatments.

The Role of Clinical Trials

Clinical trials are instrumental in the development of new drugs, therapies, devices, and other forms of treatment. products. By performing rigorous testing through various phases of clinical trials, we can ensure that these new products are not only effective but also safe for use. The feedback and data collected during these trials help refine and improve the product, leading to a version that meets stringent healthcare standards and provides the maximum benefit to patients.

Examples of Clinical Trials

Clinical trials are research studies conducted with human participants to evaluate the safety and efficacy of new medical treatments, interventions, or drugs. Here are a few examples of clinical trials across different medical fields:

Cancer Treatment Trial:

Title: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> or = 4 cm) – IIIA Non-Small Cell Lung Cancer (NSCLC)

Objective: To determine if adding the drug bevacizumab to standard chemotherapy improves outcomes in patients with surgically removed non-small cell lung cancer.

Source: https://pubmed.ncbi.nlm.nih.gov/29129443/

Vaccine Trial:

Title: A Phase 3 Study to Evaluate the Efficacy and Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants

Objective: To assess the efficacy and safety of a new monoclonal antibody (MEDI8897) for preventing respiratory syncytial virus (RSV) in infants.

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2110275

Cardiovascular Disease Prevention Trial:

Title: The Heart Outcomes Prevention Evaluation 4 (HOPE-4) Study

Objective: To evaluate the impact of a community-based intervention program aimed at improving cardiovascular health by addressing lifestyle factors (diet, physical activity) and managing hypertension.

Source: https://pubmed.ncbi.nlm.nih.gov/30015069/

 Alzheimer’s Disease Trial:

Title: A Phase 3 Study of Efficacy, Safety, and Tolerability of Aducanumab (BIIB037) in Early Alzheimer’s Disease

Objective: To assess the effectiveness, safety, and tolerability of an investigational drug (aducanumab) in slowing the progression of early-stage Alzheimer’s disease.

Source: https://clinicaltrials.gov/study/NCT02484547

Diabetes Management Trial:

Title: A Study to Evaluate the Efficacy and Safety of ITCA 650 in Patients With Type 2 Diabetes and Cardiovascular Disease

Objective: To assess the efficacy and safety of ITCA 650, a subcutaneous delivery system for exenatide (a diabetes medication), in patients with type 2 diabetes and cardiovascular disease.

Source: https://pubmed.ncbi.nlm.nih.gov/29242349/

 These examples showcase the diversity of clinical trials, ranging from cancer research and infectious disease prevention to cardiovascular health and chronic disease management. Each trial is designed to answer specific research questions and contribute valuable insights to medical science.

Participating in Clinical Trials

Participation in clinical trials is voluntary and can provide participants with access to the latest treatments before they’re widely available. However, it’s important that potential participants fully understand what participation involves.

Before enrolling, make sure to:

• Understand the purpose of the trial.
• Know which tests and treatments are part of the trial.
• Understand potential risks and benefits.
• Know your rights as a participant, including the right to leave the trial at any time.
• To find ongoing clinical trials that you might qualify for, visit clinicaltrials.gov, a database of privately and publicly funded clinical studies conducted around the world.

In Conclusion

Clinical trials are indeed the cornerstone of medical advancements, providing the framework for developing and refining treatments that can save or improve lives. By understanding their process and importance, we hope to inspire trust and participation in these vital studies, which could lead to the next big breakthrough in healthcare.

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This blog post is for informational purposes only and should not be used as a substitute for professional medical advice.

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Understanding these gaps and effectively implementing new approaches are critical challenges the industry must address while adhering to regulatory requirements.

This webinar will provide valuable insights into:

• The FDA’s Decentralized Clinical Trials (DCT), Digital Health technologies for Remote Data Acquisition & ICH E6 (R3) draft guidance recommendations
• Opportunities presented by the guidance
• Challenges in implementation and gaps in the guidance
• Ways organizations can move forward implementing new approaches under the guidance

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The US Food and Drug Administration (FDA) has released a draft guidance document on decentralized clinical trials (DCTs) for drugs, biological products, and medical devices. This guidance outlines the FDA’s recommendations for designing, executing, and evaluating these trials and provides guidance on ensuring patient safety and the accuracy of the data generated. Additionally, it includes information on how sponsors of these types of trials can use emerging technologies and remote monitoring methods to conduct the trials while still ensuring the safety of patients and the accuracy of the results.

The post White Paper – FDA Draft Guidance Summary Decentralized Clinical Trials for Drugs, Biological Products, and Devices appeared first on Astrix.