Regulatory Challenges in Combination Therapies: Key Stats and How Consulting Firms Can Help

Discover the top 5 alarming statistics about regulatory hurdles in combination therapies. Learn how biotech and pharmaceutical consulting firms help navigate the complex regulatory landscape. 

Combination therapy submissions can overcome regulatory hurdles on first pass only 10% of the time 

The most jarring figure when it comes to combination therapies is that only 10% of submissions succeed through the regulatory approval process on their first try. That low rate speaks to the complicated nature of regulatory requirements and the level of scrutiny these therapies face. The FDA, EMA, and similar regulatory agencies need all data showing the safety and efficacy of each ingredient in the drug and the combination of those ingredient drugs. 

There are several reasons responsible for the low approval rate.

First, combination therapies typically utilize novel and mechanistically uncharacterized drug-drug interactions. It requires extensive pre-clinical and clinical testing which may take long and is expensive. Finally, the inclusion of active agents makes the combination costly, and regulatory agencies need strong data to prove benefit over existing therapy with a positive benefit risk ratio. 

Biotech and pharma consulting firms are vital in increasing these approval percentages. These firms can support a company perform the design of well-crafted clinical trials, the preparation of detailed submission dossiers, and all the necessary communications with the regulatory authorities because of the knowledge carried out by their post-approval drug submission practice and their global exposure. 

Only 80% of the Biotech Companies Complete the Regulatory Pathway without consulting help 

However, navigating the regulatory pathways for combination therapies is not an easy task and fewer than 20% of biotech firms navigate their path without consulting assistance. That statistic serves to underscore the need for deep knowledge and experience in regulatory affairs that most small biotech companies simply do not have. 

The regulatory requirements for combination therapies are complex and multidimensional. Submission should include detailed information on pharmacokinetic, pharmacodynamic and safety profiles of the individual drugs in a combination, as well as possible interactions. They also need to show that the combination therapy offers a meaningful clinical advantage over other treatments. 

How Consulting Firms Can Help Prevent Trial Delays

Consulting firms that specialize in biotech, pharmaceuticals, and the life sciences provide insights to help companies navigate these difficult waters. They also offer strategic advice on submitting regulatory documents, assist in designing development studies and guide teams in preparing the lengthy compilation of documents needed for approval. Through collaboration with these firms, biotech companies can maximize their odds of navigating and obtaining regulatory approval successfully. 

Response to Regulatory Issues by Combination Therapy Consulting Firms:

Nearly 60% Consulting Firms See Increased Client Inquiries regarding combination therapy. 

At least one-third of pharmaceutical consulting firms have seen regulatory-related client queries about combination therapies jump significantly in the past five years. This increase is a testament to the prevalence and interest in combination therapies on the part of both patients and physicians, as well as the awareness of the need for new regulatory pathways. Because of this, they raise questions the pharmaceutical consulting firms would be able to help companies answer, resulting in a much clearer game plan for the company that is developing combination therapies. These include regulatory strategy development, clinical trial design, and regulatory submissions assistance. Understanding the challenges posed by various instructions, consulting firms use their knowledge to guide the entity through the procedure, minimizing chances of delays, and improving approval prospects. 

In addition, client inquiries emphasize the need to adapt to changing regulatory guidelines. Combination therapy requirements are continuously changing among regulatory agencies, and consulting firms must stay updated on the requirements to advise their clients accurately and in a timely manner. 

More than 1 in 4 Combination Therapies Delayed for months by Failure to Meet Regulatory Requirements 

Clinical trials are an integral part of the drug development pipeline, and almost one-third of combination therapy studies experience a hold due to failure to comply with regulatory practices which can cost more, take longer to develop and have a negative impact on the market. 

Clinical trials are complex, lengthy procedures that can face regulatory compliance problems at different phases. For instance, the companies might face issues with getting approval from regulatory agencies to begin a trial or keeping regulatory compliance through a trial. Also a trial can be stopped because of concerns about safety when an unexpected adverse event occurs and regulatory agencies step in. 

This is where pharma consulting firms and biopharma consulting firms come into the picture to help avoid these possible risks. They assist with the design of trials to meet regulatory requirements, with the preparation of regulatory submissions and with maintaining compliance during the trial. Consulting firms minimize the risk of delays that can occur when companies are struck with compliance issues by addressing these matters upfront. 

Despite Industry Consensus of the Benefits of Combination Therapy, over 40% of life science consulting firms characterize regulatory uncertainty as greatest barrier to successful development 

Per McKinsey, regulatory ambiguity remains a major deterrent to developing combination therapies, with >40% of life science consulting firms indicating it as the primary hurdle to combination therapy development. This uncertainty has arisen for several reasons including changing regulatory guidance, variability in regulatory expectations from region-to-region, and the abstract nature of combination therapies. 

The regulatory landscape for combination therapies continues to evolve based on new scientific developments and clinical data. These developments could also lead to several regulatory agencies revising their guidelines and requirements, leading to further uncertainty for developers of combination therapies. Another issue is that, global regulatory requirements can differ considerably from one area to another and thus complicate the approval process for businesses approaching multiple markets. 

Conclusion

While development of combination therapies leads to better treatment of an involved disease, the regulation of said therapies proves to be a challenging landscape. Admittedly, these frightening numbers point to the complexity and the militant nature of regulatory requirements for combination therapies. As this article highlights, Only 10% of submissions are approved on the first attempt, fewer than 20% of biotech firms with regulatory pathways undertaken by themselves get approved, and nearly 30% of clinical trials are delayed by compliance violations. Which shows the need for specialized consulting firms. 

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