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HM.BioConsulting
SPOTLIGHTS

SPOTLIGHTS

News and Insights to Biotech and Innovation.
Read Key Thought Leader opinions, promotional highlights, marketing insights, and curated updates from the life sciences world, all through the lens of business development consulting.
HM.BioConsulting Consortium shares scientific advancements with commercial impact, and spotlights innovations driving growth across the biotech and pharma landscape.


Organ-on-Chip Technologies in 2026 TissUse in the Spotlight: NIH, FDA and GAO Push and the Formation of Vendor Alliances
Download PDF here: An Interview between Ganakshi Gehlot, Vignesh Viswanathan, TissUse, and Henning Mann, PhD, HM.BioConsulting TissUse Authors: Ganakshi Gehlot, Vignesh Viswanathan HM.BioConsulting Authors: Desiree Goubert, Henning Mann Over the years of Assay Development in the MPS field, we have seen fluctuating interest in combining organs in in-vitro models: liver and kidney, for example, to reproduce toxic effects. Over the past decade, organ-on-chip has evolved from
Henning Mann
5 days ago12 min read


Australia's New Approach Methodologies Advantage
HM.BioConsulting Spotlight Series ISSUE 10-1 · MAY 2026 A Strategic Intelligence Report by Henning Mann, HM.BioConsulting, Emma Aitken, Australian Trade & Investment Commission, Michael Phelan, InnovApproach Consulting Prepared by Henning Mann, PhD | Founder & Principal, HM.BioConsulting May 2026 Get the Full Article PDF EXECUTIVE SUMMARY Australia has quietly become a powerful launchpad for early-phase clinical development, and a rising hub for New Approach Meth
Henning Mann
May 2713 min read


Fixing Clinical Trial Matching - From Bottleneck to Breakthrough
A Conversation between Rebecca Clyde, PhD, Botco.ai, and Henning Mann, PhD, HM.BioConsulting Authors: Rebecca Clyde, Desiree Goubert, Henning Mann Clinical trial matching is entering a new phase where advanced AI is embedded directly into clinical workflows, enabling a meaningful shift in speed and accessibility. In a recent discussion with Rebecca Clyde, Co-founder and CEO of Botco.ai, we discussed how this approach connects patients, physicians, and trial sponsors while red
Henning Mann
Apr 269 min read


From Moon to Market: When New Approach Methodologies Cross the Threshold
A Reflection by Désirée Goubert, PhD, & Henning Mann, PhD; HM.BioConsulting Download PDF here: There is something quietly profound about the idea that human tissue models have now travelled beyond low Earth orbit, circled the moon, and returned. As a first, not as a vision or grant proposal, let alone a symbolic gesture, but indeed as working and applied biological systems designed to answer a very practical question: how does the human body respond to extreme environments?
Henning Mann
Apr 154 min read


Synergy, Not Substitution: How Organ-on-Chip and Digital NAMs Unite for Translational Impact
Christian Maass, PhD, Principal Scientist & Lead, MPSlabs, ESQLabs GmbHHenning Mann, PhD, Founder & CEO, HM.BioConsulting Download the full article: "It's cool if you can kill your tumor cells in vitro, but you don't know if you treat your patient or kill the kidney with the same dose...you need a translator, that's what computational modelling is and what we develop at MPSlabs." Executive Overview Over the past decade, Organ-on-Chip (OoC) platforms have matured into po
Henning Mann
Dec 15, 202511 min read


From Worms to Workstreams: How Ora Biomedical Is Scaling AI Driven Longevity Discovery
Mini StartUp Review & Example for Fractional BD Opportunity By Henning Mann, PhD | HM.BioConsulting3–5 minute read Download the File “Longevity research is evolving. AI and automation are accelerating drug discovery. In this space Ora Biomedical is one to watch.” From Worms to Workstreams: How Ora Biomedical Is Scaling AI‑Driven Longevity Discovery Mini StartUp Review Henning Mann, PhD, HM.BioConsulting Background: Aging as a Modifiable Endpoint Aging is the single gr
Henning Mann
Nov 18, 20256 min read


Organ-on-Chip in 2025: AIM Bio In the Spotlight After the Regulatory Push
Download the article: A conversation between Elizabeth (Lizzy) Crist, Business Development Manager & Technical Lead (USA), AIM Biotech and Henning Mann, PhD, Founder & CEO, HM.BioConsulting, former Sen. Dir. Applied Science, Nortis Inc., Executive Intro With the FDA, NIH, and GAO each advancing the shift toward human-based preclinical models , Organ-on-Chip (OoC) and broader Microphysiological Systems (MPS) technologies have been moved into the spotlight and given unprecede
Henning Mann
Nov 4, 202517 min read


Capital Discipline in 2025: How Emerging Biotechs Can Thrive in a Constrained Funding Market
Review Opinion: Henning Mann, PhD, HM.BioConsulting LLC Download PDF: The more conversations we have with clients and prospects, the more we learn how the financing climate for small and mid-size biotech companies in 2025 is tighter than it has been in years. What we hear every day is reinforced by both our own experience and what leading industry publications report: Public and private investors are increasingly cautious, forcing companies to extend runway and demonstrate tr
Henning Mann
Sep 30, 20255 min read


Why Now Is the Time for Organ-on-Chip Companies to Step Up and Lead the Human-Based Research Revolution
Henning Mann, PhD, HM.BioConsulting “Growth in this field depends on reaching the toxicologists, clinical development leads, and investment committees who have never encountered the term “context of use.” That conversation has to leave the MPS and NAM bubble.” Download PDF" 🚨 Regulator-Backed Policy Changes and Momentum In April 2025, the FDA published its Roadmap to Reducing Animal Testing in Preclinical Safety Studies, a stepwise plan to phase down reliance on animal mod
Henning Mann
Jul 22, 20258 min read


Article: Why Contract (Fractional) Business Development Is a Game Changer for Emerging Companies
Opinion, Henning Mann, PhD, HM.BioConsulting Download the full article as PDF INTRODUCTION Emerging and growth-stage companies are still operating under real financial discipline, and runways are being managed in quarters. Investors and boards are scrutinizing burn rate as closely as pipeline progress, and every senior hire now carries an opportunity cost measured against the next R&D milestone. Almost every company in this position genuinely needs commercial or business de
Henning Mann
Jul 22, 20256 min read
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