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Clinical Development: “A Futuristic View”

Saama is pleased to continue our Clinical Trial Excellence for Tomorrow and Beyond blog series, each installment of which will be authored by one of our six new Clinical Board of Advisor members. This week, Stephen CunninghamLinkedIn_Icon, M.D., President, SRC Pharma Consult; former Chief Scientific Officer and Head of U.S. Clinical Development, Medical Affairs and Evidence-Based Medicine, Novartis, discusses the types of clinical development challenges and opportunities big pharma will face as the 21st century progresses.

Clinical development still relies on fragmented technology infrastructure circa 1990’s. Relatively speaking, we are still in the “Industrial Age” regarding the use of technology to transform clinical drug development.

Development organizations in the Pharmaceutical industry have a strategic imperative to understand the science, the patient, and customer information and leverage this meta-data to reduce time to market whilst improving quality, managing regulatory risk and reducing cost.

One of many challenges lies in the reality that pharmaceutical companies do not understand the technology world well, and vice versa. These knowledge gaps have led to the sub-optimal adoption of potentially transformative technologies in clinical development.

In the near future, progressive pharmaceutical organizations with an imaginative, bold and well planned IT strategy will outpace the competition.

The potential opportunity to do this by implementing current and soon to be available technologies is almost unimaginable.

Advances in artificial intelligence (AI), meta-data acquisition, integrated block chain-based clinical trial management systems, and AI-based safety data analysis capabilities have enormous potential. An AI-based ability to view and interpret clinical development data, commercial intelligence, claims data, and health records will transform the value proposition of data management.

In the research world, AI-guided meta-data analysis will transform the fields of genomics and proteomics. Platform technologies will lead to medications tailored for genetic subtypes. Three-D printing will lead to individualized patient dosing regimes.

The ability to use voice-activated, AI-based interrogation of internal and external data sources, combined with crowd sourcing technology will improve trial design, reduce the number of patients required, decrease costs, improve outcomes, and reduce the time to potential peak sales of important new therapies.

Integrated clinical trial management systems based on blockchain technology will dramatically improve clinical trial management, financial management, and data protection, reducing time to approval and cost by up to 30%. Developments in tele-medicine and the future availability of micro-devices such as “lab on a chip,” vital sign monitoring and the evolution of digital biomarkers will revolutionize clinical development. Real time trial data from remote patients will flow into databases.

Artificial intelligence and next generation meta-data analytic capabilities linked to FDA systems will greatly enhance safety signal analysis and interpretation. Advanced information interpretation algorithms will collate, interpret, and report safety information. Early approvals based on Phase 2 data will be facilitated. Transparency and data sharing with FDA will further mitigate risk.

Pharmaceutical companies that understand the future gains attainable from sophisticated interpretation of internal and external meta-data facilitated by AI will reap the benefits. To achieve this, companies will need a vision, a plan, and flawless cost-conscious implementation. For such companies, “the future is here.”

Saama’s Clinical Trial Excellence for Tomorrow and Beyond blog series continues next week Scot Harper, Ph.D., President of SLH Group, a life sciences consulting company and previously CEO of Novartis Clinical Operations. Dr. Harper will address some steps life science industry clinical development executives can take to improve the productivity and performance of their clinical trials in the future.

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About Stephen Cunningham

mmDr. Stephen Cunningham is a 25 year pharmaceutical veteran who has led teams that delivered on the development, regulatory approvals and launch of numerous significant products to improve patient health. He has global experience leading cross-functional teams from Phase 1 through life cycle management in the areas of Neuroscience, Cardiovascular, Metabolism, Respiratory, Immunology, Oncology, Women’s Health, Transplant and Clinical Pharmacology.


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