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At the the 2026 SCbio Life + Sciences annual conference in February 2026, I found myself disappointed by one of the presentations—not by the panelists themselves, but by the realization that a) I was unaware of the issue they discussed, and b) we're still grappling with it in this age of modern science.
The three panelists (Alyson J. McGregor MD, Christine Dagousset , and John R. Stille PhD) examined how women's health has been largely overlooked by both biotech.
A must read!
Quality Risk Management (QRM) under ICH Q9 is intended to be more than compliance documentation — it is designed to enable scientific, patient‑centric decision‑making throughout product development and lifecycle management.
Yet in practice, risk assessments are often misapplied, treated as a hoop to jump through rather than a tool that proactively shapes strategy.
f you're still running your preclinical pathology workflows on glass slides, you're not alone—but you may be leaving significant value on the table.
Digital pathology has moved well beyond the early-adopter phase. What was once a "nice to have" technology has become a strategic imperative for pharmaceutical companies, CROs, and consultancies facing compressed timelines, globalized expertise networks, and mounting pressure to deliver faster, better results.
Imagine discovering your lead immunotherapy candidate will fail—not during Phase II trials after hundreds of millions invested, but six months earlier using multi-organ chip technology. That's exactly what happened to one pharmaceutical company in 2024, saving them $180 million and allowing them to redirect resources to more promising candidates.¹
This isn't an isolated success story. It's part of a fundamental transformation that's reshaping how we develop medicines.
Last week we published an article that discussed the unique and evolving stability challenges facing modern biologics, balancing multiple variables in our approach to stability, storage and supply chain concerns around stability, and navigating the global stability landscape.
This week we will focus on risk-based stability strategies, emerging technologies and future directions, making the business case for a sound stability strategy, lessons learned from others who did not plan stability from t
When it comes to biologics, stability isn't just a regulatory checkbox that you tick off before filing your IND or BLA—it's the foundation upon which your entire product's quality, safety, and efficacy rests. Unlike small molecules that can often withstand significant environmental stress, biologics are complex, fragile macromolecules. These sophisticated proteins can lose their therapeutic activity, form dangerous aggregates, or trigger unwanted immune responses when they degrade.
On October 10, 2025, AstraZeneca became the second major pharmaceutical manufacturer to announce a landmark agreement with the Trump administration aimed at lowering prescription drug costs for American patients. At a White House event, AstraZeneca CEO Pascal Soriot joined President Trump to confirm the company voluntarily met all requests set out in the President's July 31st letter, agreeing to measures that will enable American patients to access medicines at prices equalized with those avail
Drug development is a high-stakes endeavor where precision, timing, and scientific rigor determine success. Every molecule’s journey from bench to bedside is marked by thousands of decisions—some large, others subtle—that collectively shape whether it reaches patients or ends in costly failure.
Amid the complexity of toxicology reports, manufacturing changes, and regulatory reviews, one discipline often determines whether a program advances smoothly or stalls: preclinical pathology.
A must read!
In drug development, the journey from the lab bench to first-in-human trials is filled with challenges — scientific, regulatory, and strategic. One factor often overlooked? Experienced preclinical pathologists.
From detecting subtle early toxicity signals to building a coherent safety narrative for regulators, the right pathology expertise can be the difference between a smooth IND submission and costly delays.
Read how NexusBio Partners can reduce the risk of IND rejection!
A recent FDA analysis revealed that 74% of Complete Response Letters cite CMC deficiencies. Yet many biotech teams struggle to keep Chemistry, Manufacturing, and Controls at the forefront of their compliance strategy.
The numbers tell a sobering story: the average cost to bring a drug to market ranges from $1.3 billion to $2.6 billion USD (varies based on study), with timelines stretching 10-15 years...but NexusBio Partners can help you reduce the risk of CMC failure.
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Small Players, Big Potential: Winning in the Biosimilar Market!
NexusBio Partners can support small biotech companies face the unique challenges in biosimilar development. We recommend several strategies that can help level the playing field with the big pharma players in the industry.
Read how and why this is important.
Development Strategies for Small Biotechs
NexusBio Partners can support small biotech companies face the unique challenges in biosimilar development. We recommend several strategies that can help level the playing field with the big pharma players in the industry.
Read how and why this is important.
What are biosimilars and why do they matter to the small biotech?
The biosimilar market represents one of the most promising opportunities in biotechnology today. As patents for blockbuster biologics continue to expire (and 2025 is considered a patent cliff due to the high number of biologic patents expiring this year), the global biosimilar market is projected to reach unprecedented heights, creating opportunities for small biotechs.
Most pharmacology reports, while technically sound, remain strategically quiet.
Is your pharmacology story designed to accelerate the next decision — or just survive it?
The Real Problem Isn’t Missing Data
Programs don’t stall because they lack data.
They stall when data is shaped only to meet study endpoints — not the real-world inflection points that determine momentum: regulatory conversations, clinical pivots, or investor timing.
Although this article focuses on SCbio, your state or region likely has a similar organization dedicated to supporting the biotech industry in your area.
That said, the benefits offered and the cost of membership in these groups can vary significantly, so it’s worth researching your options before committing to one—or several. Keep in mind that you're not limited to your local organization; joining groups in other states, such as SCbio in South Carolina, can broaden your access to funding.
NexusBio Partners understands that joining an industry association and economic development organization specifically focused on building, advancing, and growing the life sciences industry (like SCbio for South Carolina) is a strategic imperative, not just a nice-to-have, for companies of all sizes, but especially for startups and small to mid-sized firms who are looking to grow.
In the relentlessly innovative world of biotech and drug development, staying at the forefront isn't just an advantage – it's a necessity. While daily lab work and strategic planning are crucial, the true pulse of the industry often beats loudest at its premier conferences. For professionals at all stages, from burgeoning startups to established pharmaceutical giants, attending these specialized gatherings offers a unique confluence of knowledge, networking, and strategic foresight.
So as noted in a previous article ("AI Replacing Tox Studies @FDA?"), regulatory agencies around the world are looking for ways to improve safety, reduce drug development costs, and speed the overall project lead time.
This article briefly discusses the state of AI in the EU EMA.
I continue to ask, are we heading in the right direction?
While we accept and support that there is a growing trend to reduce or eliminate animal studies for humane reasons, we must acknowledge that we cannot do so if it puts our patients in harm's way. So how do we get there safely, gaining the benefits of AI while not losing the breadth of information gained from animal toxicology studies?
Are we heading in the right direction?
The global landscape of drug development is intricate, relying on complex international supply chains, significant investment, and intricate regulatory pathways. Introducing tariffs, a tax on imported goods, into this delicate ecosystem could have far-reaching and potentially detrimental consequences for the discovery, production, and accessibility of life-saving medicines.
How do we prepare?
In the highly competitive pharmaceutical industry, small companies face a unique set of challenges when developing new drugs. While these organizations often drive the majority of innovation and bring fresh approaches to treating diseases, they must navigate a complex landscape with limited resources.
Can small biotechs overcome these hurdles?
NexusBio Partners believes the paradigm of drug discovery is shifting.
The next breakthrough may not originate in a lab, but from AI's ability, with the right data feeding into the large language model (LLM), to predict with unprecedented precision. While AI begins to transform drug development, it is incumbent upon drug developers to ensure its credibility and safety within the highly regulated pharmaceutical industry.
What do you think?
The biotechnology industry operates at the nexus of cutting-edge science, intricate regulatory frameworks, and rapidly shifting market dynamics. While innovation is the lifeblood of biotech, a company's success—whether it’s a startup developing a groundbreaking therapy or a large firm streamlining its operations—hinges on strategic decision-making.
Join the discussion on why consultants often make perfect short term sense and sometimes are a key part of a solid long term strategy.
Proper accounting and robust business processes are at least as critical, and perhaps even more critical for biotech startups and small biotech companies than for Fortune 500s.
Read why in this brief article!
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Imagine a world where the delicate balance between medical innovation and public trust hangs by a thread. Now, place Robert F. Kennedy Jr. at the helm of the U.S. Department of Health and Human Services (HHS), where his leadership could have profound consequences, either guiding the US health system toward potentially better, but uncharted, waters or exacerbating existing and harmful divisions.
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The BIOSECURE Act, passed by the US House in late 2024, has yet to be considered by the Senate. This leaves the bill's future uncertain and raises questions about its potential impact on the US pharmaceutical industry, particularly for startup, small, and emerging biotech companies.
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