01Human observational study
What a proteomic aging clock can tell us
A 204-protein clock, developed using 45,441 UK Biobank participants, was associated with future disease and mortality risk and evaluated in Chinese and Finnish cohorts.
01 / FROM LOTTERY TO NAVIGATION
SCIENCE.
WITH
DIRECTION.
We have never moved faster.
Let’s get better at knowing where to go.
Ideas, evidence and connections for a more human-relevant future in life sciences.
HUMAN BIOLOGY. BETTER DECISIONS.IT’S A MATTER
OF DIRECTION.
OF DIRECTION.
AN INDEPENDENT PROJECT BY ERIC MERLESCROLL TO EXPLORE
02 / THE IDEA
More speed.
Or a better
direction?
The next leap in life sciences should not be measured only in how much we do. It should be measured in how much earlier we know what to do next.
Connect human-relevant models, meaningful measurements and AI to a decision. Then test it. Learn from it. Change course.
Read the manifestoTHE DIRECTION INSTRUMENTDRAG TO ROTATE ↗
A conceptual navigation object. Not a biological model or a prediction of success.
03 / CONNECT THE DISCIPLINES
Different fields.
The same question.
What evidence would help us make a better decision, earlier?
01
Human-relevant models
Ask human biology earlier.
02
Proteomics & biomarkers
Measure what matters.
03
Healthy longevity
Understand the trajectory.
04
Skin & dermal science
Build evidence behind the claim.
Therapeutics at the center. Wider applications in view.Imagery is illustrative, not experimental data.
04 / THE EVIDENCE LIBRARY
Not just interesting.
Worth understanding.
02Draft guidance
A validation framework for human-relevant methods
FDA’s March 2026 draft guidance sets out general scientific considerations for validating New Approach Methodologies in drug development and regulatory submissions.
03Test guideline
Skin science offers a practical example of fit-for-purpose NAMs
OECD Test Guideline 439 describes reconstructed human epidermis methods for identifying skin irritation hazards in a defined testing context.
Every note separates the finding, the interpretation and what remains unknown.
Boston-inspired concept artworkCOMING UP IN THE CLUSTERAll events
NOV2
NOV4
Happy Hour and Networking Hosted by Amgen
HBA Boston-Cambridge Metro
NOV18
BVS and BioMed Realty's Biotech Community Event, Cambridge
BVS Connection and BioMed Realty
Find a meeting. Save a place in your plans. Meet the people asking your questions.
An initial source-linked collection, not comprehensive coverage. The expanded source review is dated October 8, 2026; details may change at the organizer.06 / SIGNALS
What’s worth
paying attention to.
Resource to use / Source date not stated
From model output to decision-ready evidence
FDA’s M15 resource center brings together templates and examples for assessing model-informed evidence.
Regulatory development / Jun 1, 2026
Model-informed development has a final ICH framework
FDA issued its final ICH M15 guidance in June 2026.
Draft guidance / Mar 1, 2026
For NAMs, validation is the central question
FDA’s draft NAM guidance outlines general considerations for validation and reporting.
THE QUESTION BEHIND EVERYTHING
WHAT WOULD
HELP US KNOW
EARLIER?
Earlier that an idea is promising.
Earlier that it’s time to change direction.