The SCIO Trial Process Innovation is Critical for Precision Medicine

Partnership with Trial Process Innovation Specialists (BBCR Consulting) is critical to accelerate and significantly reduce costs for Precision Medicine.

Biotechnology today has become an integral part of the national and international economy and thus a critical component of economic competitiveness. Among the various fields that make use of biotechnology processes, medical biotechnology has been one of the most beneficial and controversial. It has already generated superlative discoveries to improve the lifespan and quality of human life. Although this is a high-growth sector, moving a promising research discovery to market is a complex and costly undertaking. Despite the sector’s growth, most of the 1,500 U.S. biotech firms do not make money.

Challenges

One of the major challenges facing this industry is the rising costs of clinical trials. Most experts agree that the cost in the drug and device industry — the cost of clinical trials in particular — is rising significantly. According to an FDA report (FDA critical path initiative-link), “The investment required for one successful commercial launch of a medicinal product increased more than 55% in less than a decade, due in large part to the monies required to take a drug from the laboratory and carry it through the standard phases (1-3) of clinical study”.

A key part of the problem is the rising costs of clinical trials for both drug and device. It is therefore crucial to ensure that trial process is conducted more efficiently and cost-effectively requiring the adoption of the SCIO concept which involves the development of a strategy at the time of IND or IDE submission.

Declining pharmaceutical industry productivity is well recognized by drug developers, regulatory authorities and patient groups. For more than a decade, there has been a steady downturn in the submission of major drug and biologic product applications to the FDA. It is therefore crucial to ensure that the clinical trial attrition is  reduced.

The Future

To address these challenges, Big-Picture Thinkers, both within and outside the industry, are involved in the re-examination of every stage of drug development in an effort to foster fast innovation. MIT’s New Drug Development Paradigms (Center for Biomedical research MIT-Link) and Children’s Hospital Informatics Program’s new forecasting models to reduce drug costs are some of the latest developments towards that goal.

With high costs associated with the later phase of development, developing Clinical Proof of Concept in early stages is becoming extremely important. Obtaining this evidence allows companies to focus efforts and expenses on the most promising compounds and to abandon drug candidates before such investment is wasted. However, in the pharmaceutical industry, achieving the clinical proof of concept milestone typically takes 3-4 years and $15M to $40M. BBCR’s focus is to create experimental design and reach proof of concept in timeframes of about 2.5 years and reduce costs up to 30%.

The economic crisis of 2008 has amplified the importance of managing expenses closely and making decisions when the time is right. However, cutting research costs across the board in a recession is not smart. Instead, companies should use the SCIO trial process  to be competitive globally. Companies must rely on consulting expertise and network for their success. Based in Massachusetts, BBCR, LLC addresses innovation in clinical development to emerging companies. BBCR operates on the fundamental principle that strategy and study design are keys for the success of drug and device development.

Please help us to communicate this crucial needed change and provide us with your opinion:

1. Do you believe that clinical protocol is a crucial step for the success of the trial?

2. Do you agree that a thoughtful clinical protocol and trial design would facilitate patient recruitment and data interpretation?

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