Christopher Cole

Denis Beckford Vera, head of Radiopharmacology, Champion Oncology explains how patient-derived xenografts improve drug biodistribution studies and first-in-human dose accuracy.

Why PDX Models Improve Radiopharmaceutical Biodistribution Studies

Denis Beckford Vera, Head of Radiopharmacology, Champion Oncology, makes a case for incorporating patient-derived xenografts (PDXs) into the early stages of radiopharmaceutical development. He argues that doing so leads to more accurate, clinically relevant results and fewer costly setbacks down the line.

At the core of Vera's argument is the value of biodistribution studies conducted in PDX models rather than traditional immortalized cell lines. PDX tumors more faithfully replicate the architecture, vascularity, and receptor density of real patient tumors. They give researchers a far truer picture of how a radiopharmaceutical will actually behave in the body. Vera explains, "If you start early in the development using these patient-derived xenografts to evaluate the biodistribution of your radiopharmaceutical, even to choose lead compounds, you're going to have the real assessment of how your radiopharmaceutical is behaving."

One of the distinctive advantages of radiopharmaceuticals, is their inherent visibility. Researchers can directly observe where a compound travels and how it accumulates, making biodistribution an especially powerful tool for optimization. This real-time insight can streamline the path from preclinical research to first-in-human trials.

A major concern he raises is the tendency to overestimate first-in-human doses when relying on conventional cell line models, which often exhibit artificially high and homogeneous receptor expression. PDX models, by contrast, capture the heterogeneity seen across and within patients. Vera explains, "If you, from the beginning, use clinically relevant, preclinical models like patient-derived xenografts, you will have a real understanding of how much this drug is going to the tumor, and then that will directly impact the first-in-human dose estimation."

Ultimately, Vera's message is one of efficiency and precision, building on clinically relevant models from the outset reduces the likelihood of having to return for costly re-optimization later in development.

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

I'm Denis Beckford Vera. I am the head of radiopharmacology at Champion Oncology. This is very related to clinical translation. So if you start early in the development using these patient-derived xenografts to evaluate the biodistribution of your radiopharmaceutical, even to choose lead compounds, you're going to have the real assessment of how your radiopharmaceutical is behaving. Moving from biodistribution, I think biodistribution should be the first type of assessment that you do preclinically in these, clinically relevant models, to understand where target engagement, for instance, in the tumor. How this tumor heterogeneity, and how this, tumor architecture, that mimics the patient's tumor, can really affect the biodistribution of the radiopharmaceutical, which is very tied to vascularity, for example. It is different in immortalized cell lines than in real patient samples. The receptor density and how the receptors distribute between the tumor and between, different patients and the lesions between the same patient as well. So you're going to get an idea of how this can really distribute. More importantly, you can really save time because with radiopharmaceuticals, you have something that you don't have with other modalities. You can see, you can see your real molecule. So if you are able to see where it goes and how it behave where it goes. So then you can optimize the process for later efficacy studies in this same tumor model. Even further, if there is a biologically relevant species, you can also identify off-target toxicity as well doing biodistribution studies, which is very important, very relevant to, to these types of treatments. From the beginning, you are evaluating your compound in clinically relevant models. You later don't have to come back and do optimization, what happens many times. So this is what happens, when you use biodistribution to assess a first-in-human studies and to estimate first-in-human doses. So many times, this dose is overestimated, based on these regular cell line-derived xenografts. We have high receptor expression, in many cases, has more homogeneous receptor expression. And then you're saying, you are getting a wrong understanding on how much your drug is really accumulating in those tumors. So if you, from the beginning, use clinically relevant, preclinical models like patient-derived xenografts, you will have a real understanding of how much this drug is going to the tumor, and then that will directly impact the first-in-human dose estimation. So you will not have to go back and do, or you will have the probability that you will have to go back and do so much optimization to improve in human doses and things like that, will be less likely, than if you went right.

Videos

Denis Beckford Vera, head of Radiopharmacology, Champion Oncology, discusses PDX models preserving tumor architecture and heterogeneity, yielding clinically relevant data for more accurate radiopharmaceutical translation.

Improving Clinical Translation of Radiopharmaceuticals Using PDX Models

Denis Beckford Vera, head of Radiopharmacology, Champion Oncology, discusses the critical role of patient-derived xenograft (PDX) models in advancing radiopharmaceutical development. PDX models are created by implanting fragments of a patient's actual tumor into immunocompromised mice, a process that preserves the tumor’s original architecture, molecular characteristics, and inherent heterogeneity.

Vera emphasizes that traditional, simplified cell lines often fail to capture the complexity of human cancer, which can lead to biased data and an overestimation of drug uptake. To ensure accurate clinical translation, researchers must utilize models that mimic real-world conditions rather than relying on oversimplified systems.

Vera further explores the importance of biodistribution studies, which are fundamental to developing radiopharmaceuticals. By utilizing a larger cohort of PDX models, researchers can account for heterogeneity between different patients. This approach provides a much clearer picture of how a lead compound will behave in a human clinical setting.

As Vera explains, "The more that you involve this patient-derived xenograft, the biggest the cohort or the biggest the number of patient-derived xenograft that you use, even within one disease, is going to give you way better and more information on how your compound will really behave in a real scenario or in the clinic." Ultimately, the interview underscores that the power of PDX models lies in their ability to provide the biologically relevant data necessary for successful clinical translation.

I'm Denis Beckford Vera I am the head of radiopharmacology at Champion Oncology. Patient-derived xenograft model are created by implanting, fragments of real patient's tumor into immunocompromised mice. What is very relevant of this model is that this approach research preserves much of the tumor's original architecture, heterogeneity, and molecular characteristics, which it is very important when you are translating targeted drugs, and in this case, targeted radiopharmaceuticals. Because, as we know, cancer and these diseases are very heterogeneous. And, most of the time, we really use very simplified, tumor models or cell lines that really don't express the real architecture of patient samples. Therefore, using patient-derived xenograft can really mimic what may later, later happen in the clinic, if you are assessing your radiopharmaceutical of your, lead compounds, in patient-derived xenograft. Let's say, rather than mentioning specific examples, I'm going to say in general, when patient-derived xenograft can really, change the development plan or the clinical translation, and again is similar. So if you have, cell lines that have very homogeneous receptor expression, for instance. So you may overestimate your drug uptake or your drug behavior in preclinical models. While if you have patient-derived xenograft, and I like to repeat that because it's very important that it keeps the architecture, the receptor heterogeneity expression, and as well a molecular characteristic of patient samples. Between patients and within a patient, if these samples are taken from the same patient or from different patients, you are really, getting the behavior of the drug that you really need in the, in the clinic. Basically, if you are oversimplifying your model, your animal model, you are basically lying to yourself. So you don't have the opportunity to really see which, the real behavior you sample. More importantly, the patient history. The patient history in those tumors. If you are already targeting a specific disease, you are going to be able to see if a standard of care of other drugs have not been working for that particular tumor or for that particular set of patient populations. So this is gonna be very powerful in translating your radiopharmaceutical, for example. So biodistribution studies are key to developing radiopharmaceuticals. And this is because with radiopharmaceuticals, you have the ability to see. You can treat what you see, and you can see what you treat. So biodistribution studies are probably one of the main components of, developing radiopharmaceuticals. And then we go back to the model. If you are developing, your radiopharmaceutical doing biodistribution, which biodistribution is tied to biology. So if you are oversimplifying your biology, again, you're lying to yourself. You are not really getting the real outcome. You are biasing the outcome. Whether if you use preclinical model with real clinical samples or clinically relevant, animal models, you are really getting the data that you need. The more that you involve this patient-derived xenograft, the biggest the cohort or the biggest the number of patient-derived xenograft that you use, even within one disease, is going to give you way better and more information on how your compound will really behave in a real scenario or in the clinic. You can not only evaluate the heterogeneity of this disease between patients, but also within the patient, if these samples have been taken from the same patient, but from different part of the disease or different part of the patient as well. So it's gonna be very powerful because it is all related to biology.

This week’s coverage on PharmTech.com highlights a pharmaceutical industry in rapid transition.

PharmTech Weekly Roundup - February 27, 2026

Welcome back to the PharmTech Weekly Roundup! The content team at 

 was busy again this week, and I’ve got a lot to share in just a few minutes, so be sure to check out the full articles and interviews on PharmTech.com.

Several key themes emerged this week: regulatory modernization at the FDA, a strategic pivot toward long-term CDMO partnerships, and the increasing use of AI and process patents as competitive moats. From the race for early-stage trial speed between the US and China to innovations in multi-dose delivery for high-demand obesity therapies (that’s right, the GLP-1s), I’m highlight the most critical messages for manufacturing and development professionals.

In response to FDA commissioner Marty Makary saying late last week that the US risks ceding leadership in early-stage drug development to China because of avoidable regulatory and operational delays in initiating clinical trials, 

Brian Scanlan, managing partner at Freedom Bioscience Partners told us

 that to remain globally competitive, the US must address regulatory bottlenecks in early-phase trial execution while CDMOs adopt AI-driven process development to narrow China's speed advantage.

Yet another big development in the booming area of GLP-1s dropped on Monday when 

Eli Lilly launched the multi-dose KwikPen for Zepbound

, which could alleviate supply chain bottlenecks by reducing device component consumption and streamlining refrigerated distribution with its four doses that cover a full month.

Ask the Expert series, Siegfried Schmitt of Parexel International explained

 that updated regulatory guidelines from the European Commission and the FDA underscore that robust data governance remains the essential foundation for quality as manufacturing systems become increasingly digitalized.

GSK’s agreement to acquire 35pharma for $950 million

, announced on Wednesday, targets the pulmonary hypertension market with a selective molecule designed to mitigate bleeding risks and provide secondary metabolic benefits.

How Innovation Is Reshaping Outsourced Development and Manufacturing

,” from our Bio/Pharma Outsourcing Innovation eBook, Katie Edgar of KBI Biopharma says success in modern outsourced development is increasingly defined by "decision quality," with integrated CDMO models using multivariate analytics to evaluate scale-up feasibility and risks earlier in the lifecycle.

, announced on Thursday, concentrates investment into high-growth specialty therapeutics for immunocompromised patients and is a component of a broader strategy to transition toward a more capital-efficient structure by prioritizing high-growth pharmaceutical sectors.

The FDA introduced a significant regulatory shift with the 

release of draft guidance for the Plausible Mechanism Framework

, which is meant to streamlines approvals for individualized therapies by allowing biological evidence and master protocols to replace traditional randomized controlled trials.

Andrew Mitchell of BioVectra told us that the CDMO sector is experiencing a "boom" in new modalities

 like antibody-drug conjugates, RNA, and cell and gene therapies, creating a critical need for staff to upskill in IT and digital data analysis.

In another Bio/Pharma Outsourcing Innovation eBook article, 

that as drug pipelines become more injectable-heavy, biopharma companies are transitioning toward long-term, trust-based CDMO partnerships to de-risk development and ensure supply resilience.

Outsourcing Innovation eBook, our very own Susan Haigney explains

 that outsourced formulation services are shifting toward integrated full-service models to better manage the complexity of high-potency molecules and poorly soluble compounds.

first of new monthly series called Pharma Market Insights from Felix Gonzalez at FounderNest

, he writes that manufacturing and formulation patents, particularly in polymorph engineering and continuous flow, have become core strategic tools for extending market exclusivity and durability.

Nathan Edwards and Michael Bianco of Arya Consulting Partners are back with 

part 4 of their 4-part article series on rare diseases

. They say the economic advantages of rare disease development—including faster enrollment and regulatory flexibility—are driving biopharma buyers to engage in earlier Phase II transactions.

Continuing with the rare disease theme (Rare Disease Day is Feb 28), 

Elisabeth Gardiner of Tevard Biosciences explains in a video interview

 that research into ultra-rare conditions continues to yield critical genetic insights that lead to broad-spectrum therapeutic breakthroughs for the general population, such as PCSK9 inhibitors.

This week’s coverage on PharmTech.com highlights an industry in rapid transition. Whether it is adopting agentic AI for asset management or navigating the geopolitical shifts in clinical sourcing, the most successful organizations are those prioritizing technical discipline and strategic collaboration.

This week’s coverage on PharmTech.com highlights a pharmaceutical industry in rapid transition. 

Univar Solutions News -  Created with Canva

Univar Solutions LLC announced on February 24, 2026 that its Ingredients + Specialties from Univar Solutions division has been appointed as the distributor for Ingredion Pharma Solutions, creating an exclusive distribution channel for pharmaceutical starches within the United States and Canada.

 This agreement integrates a specialized portfolio of functional excipients into an extensive distribution network to assist manufacturers in streamlining their supply chains. This transition provides a centralized source for critical materials, such as wet granulation binders, fillers, and lubricants. By centralizing procurement, development teams can reduce vendor complexity while gaining access to a broader range of high-quality ingredients.

"We are thrilled to enhance our product range while deepening our partnership with Ingredion," said Aaron Lee, global senior vice president of Health & Nutrition for Univar Solutions.

 "Through this agreement, we will expand access to pharmaceutical starches and other functional excipients in the United States and Canada, helping our pharmaceutical and nutraceutical customers address formulation challenges and grow their businesses. This partnership truly underscores our commitment connecting customers to high-quality ingredients and customized market solutions, and we are optimistic that the collaboration will help enhance tableting, softgel, and encapsulation applications."

How does this consolidation of supply impact product development?

The collaboration is intended to move beyond simple ingredient delivery by offering technical sales support and deep market knowledge to solve complex formulation hurdles.

 By leveraging facilities that adhere to current good manufacturing practices and providing regulatory assistance, the arrangement helps development teams navigate compliance requirements while maintaining product quality. This level of technical support is vital for professionals tasked with optimizing the stability and efficiency of modern delivery systems. By combining science and innovation with a leading portfolio of specialties, this partnership seeks to find the solutions needed to safely improve lives and communities.

What specific technical solutions are now accessible through this arrangement?

Manufacturers now have expanded access to a variety of specialized excipients, including gelatin replacements for vegetarian softgel designs and emulsions for encapsulation, according to the release from Univar Solutions.

 This includes specific starch-based products like UNI-PURE F, UNI-PURE FL, UNI-PURE GA, and UNI-PURE WG-220, which are engineered to improve formulation performance and overcome technical challenges. The availability of these materials through a single partner allows development teams to focus on ingredient innovation and the creation of high-value products.

"We are excited to expand our partnership with Ingredients + Specialties from Univar Solutions in the pharmaceutical starches, mannitol, and specialty excipients product space," said Joe Rogus, pharma senior sales manager – United States and Canada for Ingredion.

 "They are a world-class organization with an excellent track record in delivering high-value specialty products and services to pharmaceutical markets. We're confident that this collaboration will drive ingredient innovation and deliver exceptional value to our customers."

Integrating these resources allows for more creative approaches to tablet and capsule manufacturing by combining logistical strength with specialized chemical expertise. This strategic alignment ensures that developers have the necessary tools to improve the safety and effectiveness of their pharmaceutical products in a rapidly evolving market.

What other partnership has Univar Solutions made recently?

Earlier this month, the subsidiary Univar Solutions B.V. announced the expansion of its ingredient portfolio through an exclusive glycolic acid distribution agreement with the CABB Group in select European, Middle Eastern, and African markets.

 At the time, Nick Powell, CEO of Ingredients + Specialties from Univar Solutions said, "We are delighted to announce our partnership with the CABB Group in beauty and personal care and home care and industrial cleaning in EMEA, focusing jointly on efficacy and performance for customers and end consumers," said Nick Powell, CEO of Ingredients + Specialties from Univar Solutions. "This strategic alliance enhances our ability to deliver quality, innovative ingredients, and we are confident that together we can deliver greater value by offering glycolic acid solutions that meet the increasing demand for multi-purpose consumer products in the region."

Univar Solutions Selected as Ingredion Pharma Solutions Distributor in United States and Canada

Univar Solutions Expands Ingredient Portfolio with Exclusive Glycolic Acid Distribution Agreement in EMEA

Articles

Univar Solutions’ Ingredients + Specialties unit has been appointed exclusive US/Canada distributor for Ingredion Pharma Solutions’ pharmaceutical starches, consolidating access to functional excipients for drug and nutraceutical manufacturers. The model centralizes procurement of key materials used as binders, fillers, and lubricants while pairing distribution scale with technical sales, regulatory support, and cGMP-aligned supply. Expanded access includes starch-based UNI-PURE grades and additional solutions such as vegetarian softgel gelatin replacements and encapsulation emulsions, aiming to reduce vendor complexity and accelerate formulation problem-solving.

Univar Solutions' Ingredients + Specialties division has been appointed as the distributor for Ingredion Pharma Solutions, creating an exclusive distribution channel for pharmaceutical starches within the United States and Canada.

Univar Solutions Selected as Exclusive US and Canada Distributor for Ingredion Pharmaceutical Starches

Late last week, FDA Commissioner Marty Makary said the United States risks ceding leadership in early-stage drug development to China because of avoidable regulatory and operational delays in initiating clinical trials.

 In a televised interview, Makary identified hospital contracting, institutional review board processes, and Investigational New Drug application review timelines as key bottlenecks that may be slowing first-in-human and early-phase studies in the US.

We connected with Brian Scanlan, managing partner at Freedom Bioscience Partners and life sciences partner at Edgewater Capital Partners—who will present at Interphex in April on whether China’s surge in biotech innovation will upend global CMDO demand

—to get his perspective on, and good practical advice on what to do with, the development.

PharmTech: How do you expect China’s growing lead in early‑stage trials to reshape capital allocation and M&A priorities in the pharma services sector over the next 3–5 years?

Scanlan: China’s growth in both clinical trials and new therapeutic innovation has sent alarm bells through the pharma services world, the investor community, and within our own federal government. The US is now playing defense, which has prompted the BIOSECURE act,

 tariffs, and executive orders. I think geopolitics will ultimately be the major force that governs how this plays out—where the regional balance of therapeutic innovation and pharma services infrastructure will ultimately land. Generally speaking, capital flows will favor speed, but directed by geopolitics.With that in mind, over the next 3-5 years, pharma service M&A priorities could shift back to early-stage, tech-enabled, services businesses (a welcome site after 3-4 years of tepid demand). However, this will only happen in conjunction with a cooperative regulatory environment that enables streamlined approval pathways as well. Much of this is already starting to happen.

How should US and European development and manufacturing leaders balance the apparent speed and scale advantages in China with rising geopolitical, regulatory, and data‑security risks?

The US and EU are really a tale of two cities. The US is moving much more rapidly to enact regulatory streamlining; both FDA streamlining reforms, and removal of barriers so big infrastructure projects can be fast-tracked. In the EU, there has been a lot of talk, but thus far, very little action.

Separately, there is an entire ecosystem of both small and large CDMOs that are getting significant traction in the introduction of real AI/ML models into their process development workflows, and a lot of the “AI noise” is starting to subside. I have seen some very compelling data out of several CDMOs that are reducing process development times,developing novel chemistries and formulations in a fraction of time it took just a year ago.Examples of this are Lonza,

 Over the next 3-5 years, actual implementation of functional/validated AI process development models will be the key to bridging the divide between China and the western CDMOs. It’s all about speed now.

Where do you see the biggest operational gaps in Western CDMOs and biotechs that must be closed to stay competitive with Chinese earlydevelopment capabilities?

Regulatory agility followed closely by cycle time reduction (ie productivity enhancement).

For a mid‑size pharma or services company that can’t simply ‘follow the herd’ into China, what practical playbook would you recommend to remain globally competitive in early development and manufacturing?

For the smaller players, specialization trumps scale, and they match up very well with the emerging biotech community in terms of culture. My advice to these companies is to “stay in your swim lane” and own that specialization, which includes tools to unlock speed and efficiency in process development, manufacturing, and continuous improvement. Small-/mid-sized pharma service companies also play a vital role to provide key capability/service advantages within their regions versus the large and mega pharma services counterparts.



CNBC. FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals. February 18, 2026. 

https://www.cnbc.com/amp/2026/02/18/fda-chief-warns-us-is-losing-ground-to-china-in-early-drug-trials.html

Biotech Whiplash: Will China’s Surge in Biotech Innovation Upend Global CDMO Demand?

Excelsior Sciences Raises $95 Million to Speed Small Molecule Drug Development Using AI

Beyond the $12M: Revolutionizing Drug Formulation Development at Persist AI

FDA leadership is warning that avoidable US trial start-up friction—contracting, IRBs, and IND review timelines—could hand China a durable advantage in first-in-human and early-phase development. Investor attention is shifting accordingly, with geopolitics increasingly dictating capital flows, supply-chain decisions, and services M&A. In the West, FDA-led streamlining and faster infrastructure enablement may contrast with slower EU execution. Closing the speed gap is expected to depend on regulatory agility plus validated AI/ML embedded in CDMO process development to compress cycle times.

In response to Marty Makary warning the US may lose the early‑stage drug development lead to China, Brian Scanlan says speed, AI‑driven CDMOs, and focused specialization are now critical.

Can the US Catch Up? Brian Scanlan on FDA Delays, China’s Edge, and the Race for Early Stage Speed

This week, we highlight big news from Roche, BMS, GSK, J&J, and Lilly, as well as well as key insights from industry experts.

PharmTech Weekly Roundup - February 20, 2026

This week, we’re seeing a strategic shift toward advanced modalities like cell therapies and targeted protein degradation, alongside a structural pivot to rare disease assets to stabilize portfolios against those looming patent cliffs everyone’s talking about, as well as global R&D competition.

Ask the Expert series, regular hosts, Susan Schniepp or Nelson Labs and Siefried Schmitt of Parexel

 highlight that while orphan drug pathways offer financial incentives and expedited timelines, manufacturers must adapt to the complexities of small-batch production and the need for more agile, high-level quality systems.

, which met its primary endpoint of showing superior complete remission in primary membranous nephropathy, marking a major expansion of this molecule into autoimmune kidney disease.

BMS announced that FDA had accepted the New Drug Application for iberdomide

, a first-in-class CELMoD agent for relapsed/refractory multiple myeloma. In a new, transformative approach meant to significantly accelerate the regulatory pathway, the NDA for iberdomide is utilizing minimal residual disease negativity as a primary endpoint.

. On Tuesday, The European Commission approved the company’s depemokimab, brand name Exdensur, the first and only ultra-long-acting biologic in the EU to treat respiratory disease which has an only twice-yearly dosing schedule. GSK also announced new effective data for its RSV vaccine, including reduced hospitalizations in adults aged 60 or older and reduced major adverse cardiovascular events in the same population during RSV-related hospitalization.

investing over $1 billion in a new next-generation cell therapy facility outside of Philadelphia 

to localize production, ensure supply chain resilience for oncology and neurology pipelines, and create 500 specialized biomanufacturing jobs.

Eli Lilly announced it had struck a strategic licensing deal with CSL regarding the IL-6 monoclonal antibody clazakizumab

. Under the agreement, CSL gets an upfront payment of $100 million and remains eligible for future clinical, regulatory, and commercial milestones, as well as royalties on global net sales, while Lilly will be responsible for exploring development, global regulatory approval, and distribution of the treatment to patients with end-stage kidney disease.

In part three of a four-part article series on rare diseases

, Nathan Edwards and Michael Bianco, both of Arya Consulting Partners, examine how revenue concentration and accelerating patent cliffs undermine the traditional blockbuster model, whereas orphan drugs offer a structurally different strategy for stabilizing biopharma portfolios through more durable, predictable, and risk-adjusted long-term value creation. Be sure to check out all 4 parts.

 warning issued from FDA Commissioner Marty Makary

, who said in a TV interview that the US is losing ground to China in early-stage drug development, calling for urgent regulatory reforms to streamline IND applications and trial contracting to maintain Western leadership in R&D speed. The comments suggest that development teams will need to balance the leveraging of speed and capacity of China’s developers with US scrutiny on clinical data provenance, trial diversity, and biosecurity.