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Written By
Sharmain Zain
(Marketing Lead)
3 Ways Early Validation Changes Product Outcomes
Bringing a new product to market is always a gamble — and the odds are rarely in your favor. In pharmaceuticals, only 7.9% of candidates entering Phase I trials ever reach approval (BIO/Informa), with the median cost of development estimated at around $1 billion (JAMA; RAND). Failures at the final stage are devastating:
- Pfizer’s torcetrapib collapsed in Phase III after more than $800 million invested, erasing $20 billion in shareholder value overnight (Wired).
- In 2025, Sanofi’s amlitelimab missed its Phase III endpoints, wiping 9% off the company’s market value in a single day (Reuters).
The same unforgiving dynamics play out beyond pharma.
In 2010, Kellogg’s was forced to pull immunity claims from Rice Krispies boxes after U.S. regulators judged the evidence inadequate — a reminder that weak validation can undermine consumer trust and trigger costly course corrections
In animal nutrition, a water-delivered prebiotic tested in 9 million broiler chickens only proved commercially viable because early trials showed consistent survival and performance gains — generating return ratios as high as 1:2.50 to 1:4.17 (Frontiers in Veterinary Science).
Across all sectors — whether drug candidates, functional foods, or feed additives — the pattern is the same: late-stage failure is costly, avoidable, and usually caused by weak early validation in human- or animal-relevant systems.
That’s why companies turn to platforms like ProDigest’s SHIME®, Colon-on-a-plate®, and Upper GIT SHIME®. Take Marinova, for example: using SHIME®, they confirmed the fermentation of fucoidan polysaccharides and the production of immune-relevant metabolites — evidence that strengthened their global positioning in the immune health space.
1. Prevent Late-Stage Failures by Testing Earlier
The most painful failures happen late, when expectations are high and investments are sunk. Nearly 50% of Phase III trial failures are due to lack of efficacy (Nature Reviews Drug Discovery), making attrition one of the biggest drivers of wasted R&D.
Amylyx’s ALS drug Relyvrio is a stark reminder. Approved in 2022 and celebrated as a breakthrough, it was withdrawn just two years later after its confirmatory trial showed no clinical benefit. The collapse didn’t just wipe revenue forecasts — it left patients, payers, and regulators questioning how such a drug had advanced without stronger validation (STAT News).
In nutrition, POM Wonderful spent more than $35 million on pomegranate-related medical research—funding over 100 studies across 44 institutions—only to have U.S. regulators rule its disease-prevention claims misleading, forcing marketing changes, wasting investment, and damaging consumer trust (U.S. Court of Appeals opinion, ftc.gov).
Animal feed products face the same risk. Several enzyme supplements designed to improve poultry feed efficiency were ultimately shelved after large-scale field testing revealed inconsistent benefits compared with cheaper, established alternatives (Poultry Science Journal).
The takeaway: Weaknesses overlooked in early studies don’t disappear — they re-emerge later, when the cost of failure is highest. Rigorous validation helps prevent advancing the wrong candidates, protecting both investment and credibility.
2. Accelerate Development with Actionable Readouts
Validation isn’t only about avoiding failure — it’s about moving faster with the right candidates. Models with strong in vitro–in vivo correlation (IVIVC) can shorten development timelines by 6–12 months (IQ Consortium) by eliminating the wrong lead compounds earlier in development.
ProDigest’s work demonstrates this in action. Colon-on-a-plate® has shown strong alignment between ex vivo and in vivo outcomes, from SCFA production and microbiota shifts to immune modulation and barrier integrity. In one case, results from NUTRIOSE® testing matched clinical data across microbial composition, metabolite output, and host response — proof that high-throughput screening can deliver signals that truly translate. SHIME® extends this further, offering long-term insights into microbial adaptation, metabolite production, and host interactions, with more than 150 peer-reviewed publications validating its outcomes against human data.
Success in bringing new products to market often depends on how quickly teams can move from concept to testing and, ultimately, to launch. That kind of speed is rarely accidental — it comes from investing in validation early. Moderna’s rapid development of its COVID-19 vaccine was enabled by years of early validation of its mRNA platform, allowing the company to move from sequence identification to clinical trials in just 63 days (NEJM). That readiness shaved years off a traditional development cycle.
In functional foods, mechanistic data can accelerate product positioning. A clinical study on a prebiotic galacto-oligosaccharide (GOS) showed significant bifidogenic effects within weeks, validating the mechanism before larger trials and enabling faster commercial rollout.
In animal nutrition, early readouts also guide faster adoption. Studies of yeast-based additives have shown measurable improvements in rumen fermentation and feed efficiency before farm-scale rollout, de-risking commercial introduction (National Library of Medicine).
The takeaway: Early validation doesn’t slow development — it accelerates it. Actionable data helps companies prioritize winners, refine formulations, and move to market faster with confidence.
3. Build Regulatory & Market Confidence from Day One
Strong claims need strong science. Regulators expect mechanistic evidence, investors want de-risked pipelines, and consumers demand proof before they buy in. The FDA’s IVIVC guidance underscores the importance of bridging laboratory results to clinical outcomes.
Pharma has seen what happens when that bridge is missing. Crenezumab, an Alzheimer’s antibody, consumed over a decade of R&D investment but was discontinued in Phase III after showing no measurable clinical benefit . Without convincing mechanistic evidence early, its multi-billion-dollar late-stage program was always a high-risk gamble.
In nutrition, the European Food Safety Authority (EFSA) has historically taken a strict stance on probiotic and prebiotic claims. During the first wave of evaluations under the EU Health Claims Regulation, fewer than 1 in 5 submissions were approved, with most rejected for lacking robust mechanistic evidence.
To succeed, companies increasingly rely on validated in vitro data to build stronger dossiers. A good example is Marinova, which used the SHIME® model to study fucoidan polysaccharides. The results showed consistent fermentation patterns and the production of immune-relevant metabolites — evidence that strengthened Marinova’s immune health positioning and global evidence package.
Animal feed dossiers are held to the same standards. EFSA evaluations increasingly require mechanistic evidence of safety and efficacy — including microbiome endpoints — before additives can be authorized for use (EFSA Journal).
The takeaway:
Proof moves markets. Early mechanistic validation doesn’t just cut risk — it builds the case regulators can’t ignore, investors rally behind, and end-users choose in the real world.
Too often, proof arrives at the end — when changes are expensive, delays are inevitable, and failure carries the highest price. Bringing validation forward flips that equation. It turns uncertainty into direction, setbacks into adjustments, and promising ideas into products with staying power.
This is where ProDigest makes the difference. With the broadest portfolio of validated gut models — from high-throughput systems like Colon-on-a-plate®, to long-term simulations with SHIME®, to integrated co-culture platforms that capture host interactions — we help pharma, food, and feed innovators generate mechanistic insights that actually translate.
By investing in validation at the start, companies strengthen every stage that follows — from lab bench to market.
