Independent Non-Executive Director & Senior Advisor - biotech, microbiome and cardio-metabolic medicine

Prof. Dr. med.
Hans-Juergen Woerle

Turning scientific conviction into regulatory and commercial outcomes.

Current engagements, 2026

DiogenX SAS
NodThera
Three FDA firsts 8 global diabetes launches >50 diligences Galenus-Preis 2022

Twenty years advising the boards and CEOs that built Jardiance®, Vowst® and Palforzia® - now open to selective NED and advisory mandates. View track record →

About

What I bring
to a board seat

Dr. Woerle is a physician-scientist and independent director who advises biotech boards and CEOs on the scientific, clinical and regulatory decisions that determine enterprise value - what to in-license, what to kill, how to design a trial that wins the label, and how to defend it at the FDA.

Over two decades he has sat on both sides of the decision: as Global VP Medicine for Cardio-Renal-Metabolism at Boehringer Ingelheim (medical architect of Jardiance® and Trajenta®; EMPA-REG OUTCOME, the first CV-mortality label in diabetes; Galenus-Preis 2022), and as Chief Scientific & Medical Officer of Nestlé Health Science (>50 diligences; R&D integration of Aimmune / Palforzia®; scientific co-lead of the Nestlé-Seres collaboration through to the first FDA-approved oral microbiome therapy, Vowst®).

His current focus is selective: partnering with a small number of clinical- and pre-clinical-stage biotechs where a senior scientific and regulatory voice materially shifts the trajectory of the asset.

His career began in nursing - which is still where the guiding principle comes from: patient-relevant innovation is also the best commercial strategy. It is the lens that turned a glucose trial into a mortality trial, and that pushed the NHSc microbiome portfolio toward a regulated therapy rather than a nutrition claim.

Track Record

From conviction to outcome

Current Engagements

Selected Milestones

2018 - 2026

Nestlé Health Science - CSMO

Scaled R&D. Closed the deals. Shipped two FDA firsts.

  • Took a consumer-goods division to a pharma-grade R&D organisation - multi-billion-dollar evidence-based portfolio.
  • R&D lead on the Aimmune integration - Palforzia®, the first FDA-approved oral peanut desensitisation.
  • Scientific co-lead of the Nestlé-Seres collaboration - Vowst®, the first FDA-approved oral microbiome therapy.
  • Ran >50 due diligences; led or shaped the Aimmune, Zenpep®, Vowst®, Enterome and Codexis transactions.
  • Oversight Committee, Nestlé Health Science - Flagship Pioneering R&D and venture-creation partnership. Steered scientific evaluation, innovation strategy and start-up generation.
2007 - 2017

Boehringer Ingelheim - Global VP Medicine, CRM

Changed how the industry designs diabetes trials.

  • Medical architect of Jardiance® (empagliflozin) and Trajenta® (linagliptin); inventor on core patents.
  • Designed EMPA-REG OUTCOME - the first trial to demonstrate CV-mortality reduction in type 2 diabetes. Galenus-Preis 2022.
  • Led and defended the FDA Advisory Committee submission that won the first-ever CV-mortality claim for a diabetes medicine.
  • Eight global diabetes launches across US, EU, Japan and China.
  • Founding Steering Committee member, Boehringer Ingelheim - Eli Lilly diabetes alliance (>USD 10 billion). Guided joint development strategy, portfolio governance and long-term value creation across the largest diabetes alliance of its generation.
1988 - 2007

Academic & Clinical Foundation

Research Fellow, Rochester (Gerich lab) - LMU & TU Munich - Registered Nurse, LMU Munich

  • Early mechanistic work on renal gluconeogenesis and hepatic insulin resistance - scientific groundwork for the SGLT2 inhibitor class.
  • Foundational work on GLP-1 and Amylin.
  • Habilitation LMU 2008; board-certified Internal Medicine and Endocrinology.
  • Four years of bedside nursing before medical school - origin of the patient-relevant-innovation principle.

Recent Board Experience

  • Seres Therapeutics (NASDAQ: MCRB) - NED, Science & Clinical Development Committee. 2025 - 2026. Oversight of Vowst®.
  • Enterome Pharmaceuticals, Paris - NED. 2020 - 2025. Immunomodulatory oncology and inflammation.
  • Aimmune / NHSc UK R&D - NED. 2023 - 2025.
  • Cerecin Pharmaceuticals - NED. 2020 - 2025. Ketone-based brain health.

Expertise

What moves for your company

Clinical outcome-trial strategy that wins labels

CVOT and renal/HF outcome-trial design that turned Jardiance® into a cardio-renal-metabolic franchise. The test applied to every trial: will the result change how patients live - and therefore what the label, the payer and the market will pay for?

FDA Advisory Committee defence

Three FDA firsts under scientific leadership: first CV-mortality label in diabetes (Jardiance®), first oral microbiome therapy (Vowst®), first oral peanut desensitisation (Palforzia®). Prepared and defended the Jardiance AdCom personally.

In-licensing, M&A and scientific due diligence

Ran >50 diligences at NHSc - including the decisions behind the Aimmune, Zenpep® and Vowst® deals and the Enterome and Codexis collaborations. First-principles mechanistic and clinical assessment, investor-grade.

Board governance at inflection points

The scientific and regulatory voice on investor-driven boards: pipeline re-prioritisation, endpoint selection, partnering and exit readiness. Current engagements at clinical-stage (NodThera) and pre-clinical (DiogenX) - with experience spanning microbiome, incretin, NLRP3 and beta-cell biology.

Services

How to engage

01

Board Governance

Non-Executive Director and Scientific Committee chairmanship for clinical- and pre-clinical-stage biotechs. A balancing scientific and regulatory voice at the table at inflection points - partnering, M&A and exit readiness included.

02

Strategic Advisory to CEOs & R&D Heads

On-demand counsel to senior leaders navigating complex R&D and commercial bets: pipeline shaping, asset evaluation, KOL and payer narrative design, FDA AdCom preparation and leadership-team build-out.

03

Clinical Programme & Regulatory Design

Trial design, endpoint strategy and evidence generation that wins a differentiated label. FDA, EMA, PMDA; historic label expansions (CV-mortality); G-BA / IQWiG benefit assessments.

04

Scientific Due Diligence

First-principles mechanistic and clinical assessment of therapeutic programmes for investors, licensors and boards. The same lens applied to >50 NHSc diligences.

Contact

Enquire about
a mandate

Whether you are assembling a board, evaluating an asset or need a senior scientific voice in the room for a milestone inflection.

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NED commitments 1-2 days / month each. Senior Advisor engagements by agreed scope.

Endorsements

"A rare combination of medical and business judgement, integrity, and a distinctive talent for developing others. He has left a lasting mark on NHSc and decisively strengthened its reputation as a leader in evidence-based nutrition and medical innovation."

Greg Behar, CEO Nestlé Health Science

"A unique combination of scientific rigour, strategic vision and the proven ability to bridge academia, clinical medicine and global industry. My highest recommendation for any senior leadership role in academia, industry or public health."