The Field That Keeps Raising Its Own Evidence Bar.
Regulatory strategy for diabetes, obesity, MASH, and rare endocrine disease — where the endpoint has climbed all the way to liver histology.
Metabolic Disease Kept Raising the Standard for Proof.
For years a diabetes drug was approved on hemoglobin A1c. Then the rosiglitazone era added a cardiovascular safety requirement. Then obesity moved from a cosmetic claim to a disease with a hard weight endpoint — and the incretins proved that weight loss could carry cardiovascular benefit. Now MASH is approvable on liver histology. The bar has moved four times in one generation.
Each shift changed the trial you have to run, the safety database you have to build, and the claim you can make. We build metabolic programs for where the bar is going, not where it was — across the Division of Diabetes, Lipid Disorders, and Obesity and its neighbors.
Metabolic disease is lifelong — so the long-term safety database matters as much as the metabolic effect itself.
Four Endpoints, Four Eras — and You Have to Know Which One You're In.
The metabolic evidence bar has climbed steadily. Where your program sits on this ladder decides the size of the trial, the surrogate debate, and the strength of the claim.
Glycemic Control
Hemoglobin A1c — the accepted glycemic surrogate that has approved diabetes drugs for decades.
Body Weight
Percent weight loss turned obesity from a cosmetic claim into a disease indication with a hard endpoint.
Cardiovascular Outcomes
CVOTs proved metabolic agents could reduce MACE — and made the CV outcome a competitive advantage.
Liver Histology
MASH approvals rest on biopsy-defined fibrosis and resolution — the newest and highest metabolic bar.
One Division, Very Different Programs.
Metabolic disease spans a validated-surrogate indication and a biopsy-endpoint frontier — with rare endocrine disorders that borrow from orphan-drug flexibility.
Diabetes
Type 2 and Type 1, where A1c is the accepted surrogate but cardiovascular and renal outcomes increasingly define the differentiated claim.
Obesity
Now a disease indication with a hard weight endpoint — and, since SELECT, a cardiovascular-benefit story that reshaped the category.
MASH / NASH
Metabolic liver disease, where the first approval came on histologic surrogates and non-invasive markers are the next frontier.
Rare Endocrine Disease
Acromegaly, Cushing's, congenital adrenal hyperplasia — small populations where natural history and orphan-drug flexibility apply.
Thyroid Disorders
Hypo- and hyperthyroidism and thyroid eye disease, blending endocrine surrogates with functional and quality-of-life endpoints.
Bone & Osteoporosis
Where bone mineral density is a surrogate but fracture reduction is the outcome — and long-term safety defines the label.
The first MASH approval rested on a liver biopsy — and the field is racing to replace it with non-invasive markers.
MASH Made the Liver Biopsy a Regulatory Endpoint — for Now.
The first approved MASH therapy cleared the bar on histology: improvement in fibrosis without worsening of steatohepatitis, or resolution without worsening of fibrosis, read from paired liver biopsies. It is a demanding, invasive, high-variability endpoint — and it opened accelerated approval to a huge metabolic population.
The next wave depends on qualifying non-invasive markers — imaging and blood-based — to replace or supplement biopsy. We build the histology-endpoint program the division expects today, while positioning the biomarker strategy that will define the confirmatory and the next indication.
A Metabolic Blockbuster Is a Chronic-Safety Commitment at Population Scale.
When tens of millions of people may take a drug for years, the safety database, the class warnings, and the outcomes evidence are the program — not a footnote to the efficacy story.
signals — from the thyroid C-cell warning to gastrointestinal and pancreatic questions — follow the incretin class and shape every label in it.
The rosiglitazone legacy means metabolic programs still have to answer the cardiovascular question, even as the 2020 guidance eased the mandate.
of chronic users make post-marketing safety, real-world evidence, and outcomes data central to the lifecycle, not optional add-ons.
Six Failure Modes We Are Brought In to Prevent.
Usually the program was built for the last era's bar, not this one's.
Designing to A1c alone
Bringing a diabetes program that proves glycemic control but ignored the cardiovascular, renal, or weight story that now defines a competitive label.
An obesity trial without the CV plan
Treating weight loss as the finish line when cardiovascular benefit is what differentiates and what payers increasingly demand.
Underestimating the MASH biopsy
Powering a histology endpoint without accounting for reader variability, placebo response, and the paired-biopsy logistics that sink MASH trials.
Class safety surfaced late
Failing to design for the incretin class warnings and cardiovascular-safety expectations the division brings to every metabolic file.
A biomarker asked to replace biopsy too soon
Leaning on non-invasive MASH markers before they are qualified for the regulatory purpose the program depends on.
No population-scale safety story
A blockbuster-scale program without the pharmacovigilance and real-world evidence plan that chronic, mass-market use requires.
Metabolic Regulatory Leadership That Builds for the Next Endpoint.
Our metabolic leads have taken diabetes, obesity, and MASH programs through A1c, weight, cardiovascular, and histology endpoints — and managed the class-safety machinery that defines the field.
"In metabolic disease the endpoint keeps moving up. The programs that win are built for where the bar is heading — the next endpoint, the next safety question — not where it just was."
The discipline we bring across diabetes, obesity, MASH, and rare endocrine disease.
Developing a Metabolic Therapy? Build for the Endpoint the Bar Is Moving Toward.
Bring senior metabolic regulatory leadership in early — while the endpoint, safety, and outcomes strategy are still yours to shape.
Senior-led. Embedded in your team. No junior hand-offs.