Innovations

“The future is here it is just not evenly distributed"
—William Gibson

"Hello, Serenity."

2025: Serenity AI: The Foundational Biological Human State Machine

Serenity, the world’s first AI biological state machine, transcends current limitations by predicting individual health trajectories and simulating personalized interventions. Built upon individualized, interactive DigitalMe models derived from the most comprehensive multi-omic profiling ever conducted, Serenity provides actionable, personalized insights into health, disease, and aging.1.

"Boil The Ocean."

2017: DigitalMe: First Nationwide Longitudinal Multi-Omic Human Study

Created DigitalMe, analyzing 2,700 participants with WGS DNA, RNA, protein, metabolites, lipids, toxins, antibodies, cytokines, labs, comprehensive well-being, symptoms, function, diseases, and intervention phenotyping2. This first nationwide longitudinal multi-omic study established standards for at-home clinical research and revealed novel biomarkers3. Now continuing under Alden Scientific to advance precision medicine.

"Nature Is the Pharmacy."

2013: First-in-Class Bacterial Therapeutic

Founded AOBiome to develop naturally occurring soil bacteria as alternatives to steroids, antibiotics, and biologics for skin conditions4. Combined biotechnology innovation with cost-effective virtual trials, including the world's first virtual FDA Phase II trial for acne5. Successfully demonstrated efficacy in a pivotal Phase IIb study with significant dose-response (P<0.01) in eczema and itch6.

"Faster, Better, Cheaper."

2009: AI & Matched Control Virtual Clinical Trials

Invented AI-matched control algorithms that proved lithium's ineffectiveness in ALS 18 months before three large randomized trials7, 8—at one-tenth the cost. Independently monitored pharmaceutical trials with real-time efficacy predictions9, providing actionable evidence when treatments were harmful. These methods were later applied in the world's first virtual FDA pivotal trial (AOBiome Phase IIb) and are being adopted by industry and regulators.10.

"The Patients Are the Platform."

2006: Pioneered Internet-Based Patient Research

Created PatientsLikeMe, enabling 750,000 patients with 1,800 different diseases to share their experiences and outcomes11. This research platform advanced dozens of drugs and hundreds of discoveries, influencing trial design, safety monitoring, and regulatory decisions across multiple therapeutic areas. Developed "Thrive," a cross-disease measurement instrument for patient self-management12.

Key accomplishments include gathering novel insights into off-label drug use, documenting over 500,000 adverse events, and conducting the largest-ever sleep and disease study on 75,000 patients13. Data shared on PatientsLikeMe improved millions of lives.

"Fishing Expeditions Catch Fish."

2005: First Longitudinal Mammalian State Biology Study

Completed the first longitudinal mammalian state (RNA) biology study and developed a novel vector representation of disease progression14. This work led to Tegoprubart15, which has completed a positive Phase IIa human trial16 after being licensed to Eledon Pharmaceuticals. ALS TDI continues developing new therapies from this approach, demonstrating that scaled, unbiased state biology discovery outperforms traditional academic research in producing effective targets and biomarkers.

"To Err Is Human, To Persist Is Diabolical."

2002: Test Everything, Challenged Replicability, Created the Standard

Built the most extensive disease mouse testing program (10,000+ SOD1 mice) to find treatments for my brother Stephen17. Revealed that the majority of 90 published ALS mouse studies contained serious statistical flaws that undermined their significance18. Established new standards19 for sex, sibling, weight balancing, and gene counting that contributed significantly to addressing the broader replication crisis20.

2001: First ALS Stem Cell Transplant

"Do not Try, Do."

Designed, developed, funded, and completed the first human stem cell transplant trial for ALS by paralleling efficacy, safety, manufacturing, and regulatory processes—in 18 months versus the typical 5 years21. y, safety, manufacturing, and regulatory processes—in 18 months versus the typical 5 years[21]. Pioneered patient participation and the right to try and generated the first evidence for the safety of ALS stem cell delivery that continues to inform and enable patients. 22.

Moving Forward

These innovations represent my commitment to transforming healthcare through patient-centered approaches, rigorous science, and innovative technology. At Alden Scientific, we continue this mission by developing next-generation tools that empower individuals with actionable insights about their health while advancing our collective understanding of human biology.

References

  1. Alden Scientific – Serenity AI.

  2. PatientsLikeMe Builds Multi-Omic Longitudinal Program to Track Biology of Disease and Wellness. GenomeWeb.

  3. Okun S, Wicks P. DigitalMe: A Journey Toward Personalized Health and Thriving. JMIR Res Protoc. 2018;7(7):e162.

  4. Julia Scott, My No-Soap, No-Shampoo, Bacteria-Rich Hygiene Experiment, The New York Times Magazine, 2014.

  5. AOBiome Therapeutics Reports Positive Efficacy Results from Phase 2b Clinical Trial of Ammonia-Oxidizing Bacteria (AOB) for the Treatment of Acne Vulgaris. AOBiome Press Release, 2018.

  6. Lio et al., Topical application of ammonia-oxidizing bacteria for treatment of atopic dermatitis: a randomized clinical trial, EClinicalMedicine, 2023.

  7. Heywood J. The big idea my brother inspired, TEDMED, 2010.

  8. Wicks et al., Accelerated clinical discovery using self-reported patient data collected online and a patient-matching algorithm, Nature Biotechnology, 2011.

  9. Wicks et al., Subjects no more: What happens when trial participants realize they hold the power, BMJ, 2014.

  10. Science 37 and AOBiome Complete Industry-First Virtual Clinical Trial Through Metasite™ Decentralized Operating Model. BioSpace, 2017.

  11. Wicks P et al., The power of social networking in medicine, Nature Biotechnology, 2010.

  12. Wicks, P., McCaffrey, S., Goodwin, K., ..., Heywood, J.A. (2018, August). Thrive Core Items - A Modular Health-Related Quality of Life Instrument for Electronic Assessment and Treatment Monitoring: Online Development and Psychometric Validation. Journal of Medical Internet Research, 20(11), e11231. 

  13. Winkelman JW et al., New approach for analyzing self-reporting of insomnia symptoms reveals high rate of comorbid insomnia across a wide spectrum of chronic diseases, J Clin Sleep Med, 2015.

  14. Lincecum JM, Vieira FG, Wang MZ, et al. From transcriptome analysis to therapeutic anti-CD40L treatment in the SOD1 model of amyotrophic lateral sclerosis, Nat Genet., 2010;42(5):392-9.

  15. Perrin S, Ladha S, et al. Safety and tolerability of tegoprubart in patients with amyotrophic lateral sclerosis: A Phase 2A clinical trial, PLOS Medicine, 2023.

  16. Paneyko D, Wong PC, Likhite S, et al. Tegoprubart in the Treatment of Amyotrophic Lateral Sclerosis, Brain Sciences, 2023.

  17. Scott S, Kranz JE, Cole J, et al. Design, power, and interpretation of studies in the standard murine model of ALS, ALS and Frontotemporal Degeneration, 2008.

  18. Schnabel J. Neuroscience: Standard model, Nature, 2008;454:682-685.

  19. Perrin S. Preclinical research: Make mouse studies work. Nature, 2014.

  20. Ludolph AC, Bendotti C, Blaugrund E, et al. Guidelines for preclinical animal research in ALS/MND: A consensus meeting, Amyotrophic Lateral Sclerosis, 2010.

  21. Janson CG, Ramesh TM, During MJ, Leone P, Heywood J. Human intrathecal transplantation of peripheral blood stem cells in amyotrophic lateral sclerosis. J Hematother Stem Cell Res. 2001;10(6):913–915.

  22. Heywood J, Sharma M. Getting Stem Cell Patients On the Grid, Nature Biotechnology, 2017.