Big-Data in der personenbezogenen Medikamentenentwicklung​

As an interim CIO, keynote speaker and book author, I have experienced first-hand the transformative power of big data in personalized medicine. This article highlights the latest developments and unique aspects of big data in personalized medicine development.

Multiomics integration: the key to holistic patient analysis

Big data in personalized drug development enables the integration of various “omics” data:

  • Genomics (genetic information)
  • Proteomics (protein expression)
  • Metabolomics (metabolic products)
  • Transcriptomics (RNA expression)

This integration, also known as “multi-omics”, provides a comprehensive picture of a patient’s biological processes. According to a study in the Journal of Personalized Medicine, multi-omics integration can improve the accuracy of disease predictions by up to 25%.

Digital twins in drug development

One fascinating approach is the creation of digital twins of patients. These virtual representations are based on big data analyses and enable:

  1. Simulation of treatment effects
  2. Prediction of side effects
  3. Optimization of dosages

Research at ETH Zurich shows that digital twins can reduce the development time of new drugs by up to 30%.

Federated learning for data protection-compliant analyses

Federated learning is a new approach in big data analysis that makes it possible to train models without storing sensitive patient data centrally. Instead, only the model updates are shared. This addresses many data protection concerns in personalized medicine.

A study by Google Health and several university hospitals showed that Federated Learning was able to improve the predictive accuracy of breast cancer screenings by 5.7% without patient data having to leave the respective hospitals.

Real-World Evidence (RWE) in drug development

Big data enables the use of real-world evidence – data from daily clinical practice – for drug development. This includes:

  • Electronic health records
  • Insurance claims
  • Patient reports

The FDA has recently published guidelines on the use of RWE in regulatory decisions, which underlines the importance of this approach.

Adaptive clinical trials through big data analyses

Big data is revolutionizing the design of clinical trials. Adaptive trial designs that adjust based on interim results are made possible by real-time big data analysis. This can:

  • Shorten the duration of your studies
  • Increase efficiency
  • Improving patient safety

An analysis by Pfizer showed that adaptive study designs can shorten the development time of new drugs by up to two years.

Precise patient stratification through big data

Big data analyses enable ever finer stratification of patient groups. This goes far beyond traditional demographic factors and takes them into account:

  • Genetic profiles
  • Biomarkers
  • Lifestyle factors
  • Environmental influences

A study in the New England Journal of Medicine showed that precise stratification can increase the response rate to certain cancer therapies by up to 30%.

Predicting drug interactions through big data

The analysis of large data sets enables the prediction of drug interactions on a previously impossible scale. A team at Stanford University developed an AI model that analyzed over 4.6 million potential drug interactions and identified previously unknown interactions.

Continuous manufacturing and big data

Big data is driving the transition to continuous manufacturing in the pharmaceutical industry. This method enables:

  • Higher production efficiency
  • Improved quality control
  • Faster adaptation to changes in demand

According to a study by MIT, continuous manufacturing can reduce production costs by up to 40% and shorten the time-to-market of new drugs by months.

Outlook and conclusion

The integration of big data into personalized medicine development is still in its infancy. Future developments are likely to include:

  • Quantum computing for even more complex analyses
  • Integration of data from smart home devices for a more comprehensive health picture
  • AI-controlled autonomous research laboratories

As interim CIO, I see it as critical to build flexible and scalable infrastructures that can keep pace with these developments. The future of personalized medicine will largely depend on our ability to use and integrate big data effectively.

Sources

  1. https://www.bmbf.de/SharedDocs/Bekanntmachungen/DE/2025/01/2025-01-10-bekanntmachung-personalisierte-medizin.html
  2. https://pmc.ncbi.nlm.nih.gov/articles/PMC10743267/
  3. https://fastercapital.com/de/inhalt/Klinische-Studien–Neue-Trends-bei-klinischen-Studien–Was-Sie-wissen-muessen.html
  4. https://www.gesundheitsforschung-bmbf.de/de/integration-von-multi-omics-daten-12170.php
  5. https://www.heise.de/news/Studie-Googles-KI-bei-Brustkrebserkennung-besser-als-Aerzte-4626531.html
  6. http://www.mwv-berlin.de/buecher-bestellen-2016/images/product_images/leseproben_images/9783954664122_Leseprobe.pdf
  7. https://pmc.ncbi.nlm.nih.gov/articles/PMC11166753/
  8. https://www.researchgate.net/publication/371451990_Federated_Learning_in_Healthcare_Industry_Mammography_Case_Study
  9. Image: ChatGPT
Dr. Claus Michael Sattler

P.O. Box 1142
28833 Weyhe
Germany

Phone: 0049 174 6031377

E-Mail: cms@sattlerinterim.com

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