Drug Digest: Outsourcing Partnerships Fuel Global Biopharma Discovery and Scale-Up

*Full transcript available below.

Outsourcing is driving biopharma efficiency and scale, including in the drug discovery area and early phase development. Forming strategic partnerships helps integrate specialized workflows, linking advanced therapy formulation and manufacturing to de-risk clinical progression. External contract research organization and contract development and manufacturing organization expertise are helping to accelerate complex modalities (e.g., cell and gene therapy, RNA, next-gen biologics, etc.) via optimized process development and integrated antibody discovery platforms. This episode of PharmTech Drug Digest will explore how this critical leveraging of partnership expertise speeds drug candidates from discovery to first-in-human clinical trials and beyond.

Interview featuring

Daniel Delubac, PhD, CEO, iOrganBio

Dr. Delubac is a technical leader with a strong track record in building transformational laboratory products and techbio platforms across AI, software, robotics, and process engineering. He has built some of the most impactful healthcare products in non-invasive prenatal testing at Counsyl, liquid biopsy at Guardant Health, early cancer detection at Freenome, patient-derived models of cancer at Xilis, and the first AI-agentic synthetic chemistry platform at Chemify. Dr. Delubac trained as an applied physicist, then earned a PhD in Biomedical Engineering from Carnegie Mellon University. At iOrganBio, he is rethinking cell-based products from an engineering and data-driven perspective and building the next generation, AI-enabled infrastructure designed to manufacture the exact same cells we have in our body—that will model biology in vitro accurately, restore degraded bodily function, cure disease, and power population-scale, affordable, holistic, regenerative medicine.

Sponsors

This episode of Drug Digest is sponsored by:

• Quotient Sciences
• Piramal Pharma Solutions

About Drug Digest

Drug Digest is a tech talk video series with the Pharmaceutical Technology® editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

Upcoming episodes

• March/April 2026: Quality and Regulations
• May 2026: Small Molecule Manufacturing
• June/July 2026: Large Molecule Manufacturing
• August/September 2026: Formulation and Development for Small Molecules

Transcript

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

Patrick Lavery

MJH, pharmaceutical technology presents drug digest, a tech talk with the pharmaceutical technology editors all about emerging opportunities, obstacles and advances in the pharmaceutical, biopharmaceutical and biotech industries. Join us as we discuss with industry experts the research, development, formulation, analysis, upstream and downstream, processing, manufacturing, supply chain and packaging, as well as business strategies and regulatory issues.

Feliza Mirasol

Hello everyone, and welcome to the drug digest video series. I'm the Pharm tech group science editor feliza mirasol In this episode, I'll explore how that critical leveraging of partnership expertise speeds drug candidates from discovery to first in human clinical trials and beyond. But before we get into it, here's a few words from our sponsors. This episode of drug digest is sponsored by quotient sciences and piramal pharma solutions. Quotient sciences is a global CR DMO with integrated drug product development, manufacturing and clinical testing capabilities in the US and UK, leveraging its translational pharmaceutics platform to accelerate clinical programs and time to market while maintaining rigorous quality and control. Piramal pharma Solutions is a global cdmo and part of piramal pharma Ltd, providing end to end drug development and manufacturing services across the product life cycle through an integrated network of facilities in North America, Europe and Asia. Now we'll take a closer look at how strategic outsourcing is transforming the biopharmaceutical landscape by driving unprecedented efficiency across drug discovery and early phase development by forming strategic partnerships. Companies are integrating specialized workflows that link Advanced Therapy formulation directly to manufacturing effectively de risking the path to clinical progression. This collaborative approach leverages external expertise to accelerate complex modalities such as cell and gene therapies and RNA using optimized process development and integrated discovery platforms to discuss how these critical partnerships speed drug candidates from the lab to first in human clinical trials. I am joined today by Dr Daniel duluback, the CEO of I organ bio, a US based biotech firm, Daniel, why don't you go ahead and introduce yourself and give our audience some background into your expertise and industry experience.

Speaker 1

Thank you. Felisa. I'm Daniel dillabeck, currently the Chief Executive Officer of I organ bio. My background has been heavily on the engineering side of a PhD in Biomedical Engineering from Carnegie Mellon. I've been a technologist at Council, garden, health and freedom on the diagnostic side. I've most recently built the technology platform at chemify before founding co founding I organ bio with professors Sri Bing Shan and shelling.

Feliza Mirasol

Shen, Now, Daniel, I'd like to kick off the conversation by asking you, How do strategic outsourcing partnerships improve biopharma efficiency and scale?

Speaker 1

Yeah, I think this is a great question in the context of drug discovery and drug development, and later, the breadth of expertise, a the set of quasi independent challenges that have very little technical or operational overlap that needs to be tackled are extremely broad, Right? So as an example, being exceptional at sample, sourcing, model creation, drug design and running clinical trial at the same time is not a correlated outcome a they are independent function and independent capabilities that needs to be developed. So a well thought out strategic outsourcing strategy or approach is one that can enable access to the very best technologies, the most appropriate capabilities to advance a particular program, and so many of those programs also have different dependencies, right? So building a small molecule drug versus a biology versus a cell therapy actually depends on a different set of technology. So being able to strategically select within the market. Place the most appropriate technologies, which themselves are independently scalable, right? So running one clinical trial versus 10 clinical trial shares the same expertise, and so we can reach scalable subsystems, if you will, within the overall ecosystem to build a very streamlined and scalable infrastructure for the entire industry, and thus sponsors right drug discovery company can then select the right partners and concatenate them to create very efficient programs for drug discovery.

Feliza Mirasol

Now, in what ways do partnerships reduce risks during early clinical development.

Speaker 1

I think one way to think about risk reduction in early drug development, and at least the way I think of it, is minimizing the likelihood that the drug fails in clinical trials and does not become a successful compound in the clinic, or modality in the in the clinic. And so any investment that moves the needle towards increasing the likelihood that the drug is successful ends up becoming a good a good investment. And so similarly to my answer a little bit earlier, having access to the most advanced, the most powerful technologies to select the right compound to advance through ind in human trials, is when it's to be thought of very carefully throughout those programs. And so strategic outsourcing is the natural way to do this, specifically in how the ecosystem is built. Right through strategic outsourcing, the access to proprietary IP is really what is being discussed right and so accessing the right technology through outsourcing to increase the likelihood of success is, I think, that the primary way to achieve this and how the ecosystem can help. Another way to think about risk in more economic terms is, of course, the cost of approaching inhuman trial, and part of the cost is, of course, weighted by time, right, how long it takes to get there. And so engineering relationship that can move fast, right, and concatenating all of the partners and as a sponsor, ensuring that all those partners work efficiently together to advance a program is, I think, something that we can tack on to risk reduction, cost reduction and more rapid advancement of compounds in the ecosystem.

Feliza Mirasol

And how does external expertise accelerate development for advanced and next gen therapies?

Speaker 1

I think this is a nice follow up question in advanced modalities, right boundary modalities that are the cusp of what we've done before and where we still need technology development to establish optimality in our collective ecosystem level ability to advanced compound the dependency on the right technology increases right, and particularly in the context of startups, right, where most of the disruptive innovation is happening on the emerging technologies that are dedicated to improving our capabilities for advanced and next gen therapies becomes even more reliant. There is, of course, more risk for those right. This is not just technology risk, but, you know, efficacy, safety regulatory, etc, etc. So the combinatorial of all those components, we're very aware, for example, in ex vivo cell therapy, is that manufacturing itself is is a risk that needs to be overcome throughout the development process to propose to the market, to patients and a safe, effective and affordable therapy that will have strong impact on the marketplace. So I'll refer back to this question, but with a heightened emphasis, sorry to my answer to your previous question, but with a heightened emphasis of accessing through partnerships, the most appropriate, the most valuable technology, the one that have either demonstrated or a high likelihood of impacting a drug development process for the better and selecting those from the marketplace on a program per program basis is, of course, for advanced modality, a riskier value proposition, if you will, but one that I think is is most appropriate the likelihood that the. A single organization, no matter how big can crack independently, in particular, in high innovation areas, everything that needs to be done for successfully delivering a drug to the market is lower and less efficient, as a matter of fact, in terms of overall capital allocation than relying on independent companies that are solving each one of those problems independently of one another. And that priory is not obvious which company is going to be or which technology, which the company is built on, is going to be the best position to solve a particular problem. So from a sponsor perspective, being able to assess all those technology, test those technology through pilots, before putting in on the critical programs and what have you, creates an overall system level efficiency that large companies and drug development company can leverage when it best suits their own internal capabilities as a complement to what they can do without without partners.

Feliza Mirasol

So now let's go back for a minute about your comment on sponsors looking for partnerships that meet their technology needs. How do these sponsors or drug developers or what have you evaluate and decide or select on which company best fits their needs? How does that process work?

Speaker 1

Yeah, great question. So I think this is a problem driven and priority driven process, a as a sponsor, as a drug developer, as a big pharma, as a program manager. One knows the end to end process, and typically, one has experiences from previous programs as to what went well and what did not, and what a priori right from a first principle scientific perspective, are the key risks of a particular program. And so going back to your question about risk mitigation and de risking, it is thinking ahead as to what problems, what challenges, what risk will be part of this program, and working with the market to assess the technologies that could have an impact on that risk and then narrowing to the one that will most likely decrease that risk and help the sponsor overcome those challenges. And so it becomes what typically the external innovation arm of pharma company focus on the technology that allow them to overcome some very well understood and characterized challenge that those organization face,

Feliza Mirasol

and why are integrated workflows between partners critical for drug discovery success

Speaker 1

in this potentially envision setup right and one that myself and some people that I know across the industry think is optimal, the concatenation of experts in very specific steps within the drug discovery process is The best way to a cross drug discovery, then the interface of companies working on the same program becomes critical, right, and the upstream and downstream integration of both physical components, models, drugs, biologics, what have you right that needs to go from partner to partner, but just as importantly, of data right, and the compilation of everything that has been learned along the way into one FDA submission, for example, to use a canonical milestone in The process, but generally speaking, making sure that there's no loss of know how no loss of information throughout the entire process becomes critical, right? And thinking of this as integration is, I think, the right question to ask, right or the right problem statement to optimize the relationship between partners. And I think this is really where the sponsors role becomes prominent as they select the right partners to work together. So one can envision a centralized model where everything flows through the sponsor run gets allocated to different partner, which is a very effective model, the more distributed version to this. Sorry, off this approach is to get the partners to work with one another directly. I don't think this is prominent in the space and specifically for IP reasons. It may not realize. Eyes, but for overall system efficiency, for ecosystem fluidity of both material and data, this is a model that might be worth exploring, for for for sponsors

Feliza Mirasol

and of course, how do strategic partnerships help Biotherapeutics reach first in human trials faster.

Speaker 1

Thanks for this question, and thanks for this last statement as a corollary to your previous question, right? The drug discovery process is well established as a series of milestones that needs to be reached towards drug selection, to ind, to, you know, phase 123, trials, etc, etc, right? So we have a good understanding of all the milestone that the drug needs to go through. And so do strategic partnership allow us to move faster? I would say, if one considers the cost and time to develop the technologies that enhance the selection process, design and selection process of the right drugs and running the trials, and running those trial faster, I think so, right? We were making the interface between all the players a little less smooth, right? It takes time to, for example, put in place a contract to exchange information, etc, etc. So one could make the arguments that running a program fully internally would go faster. But of course, that comes at the expense of accessing the right technology. With that said, those technologies within each one of the buckets that need to come together for a successful program. Each one of those could move faster. So I think there's a bit of trade off here, and the impact of programs on, sorry, of outsourcing, on the speed of a particular program, and so would have to do maybe a little bit of one off assessments to answer this, but I think a well thought out and a well oiled machine to run those trials could get the best of both worlds right, making sure all the contracting is in place, making sure that the various strategic partners are well embedded within a pre established process, we could approximate the overall speed of an internally run program. I think there's through strategic partnership, also the opportunity for arbitrage to actually go much faster. And I think nothing here would be more apparent than the example of running clinical trials internationally for American based company were relying on strategic partners for particular blocks of the development, again, specifically clinical trials, their opportunity to shave off years in the overall process, if one continued to only leverage the historical way of approaching drug discovery.

Feliza Mirasol

Now, Daniel, what are your thoughts on how AI and digital technologies are accelerating drug discovery?

Speaker 1

I think there are two elements that I'd like to bring to the table as my answer one is the ultimate realization of AI in drug discovery. Don't know how long it's going to take, how many years or decades, but by the time our AI predictive system are as accurate as they will inevitably become throughout the process, we can envision quasi immediate drug discovery processes. Right we measure the right biomarkers for a patient, we leverage our understanding of biology again through AI and drug design again through AI. Those were both expertises. They're too advanced, too complex for the human mind together, independently, but not for AI, right? So by the time we have reached that level of optimality, slash, quasi perfection, in the predictive capabilities of AI for human health and perturbation of human health through external compounds or biologics or cell therapies, we technically will be able to go from diagnosis to treatment on a personalized basis, quasi immediately, by designing the drug fully computationally, knowing that it's going to be safe and effective computationally and deliver this to the patient. So the promise is there. It's inevitable that is going to happen, but it's going to be hard, and it's going to take the whole ecosystem working together to move the entire field in that direction. Now, the process together is going to be long. Where are we today? But we're. Seeing last year and this year a major inflection point in the deployment of AI technologies throughout the drug discovery process, from more efficient clinical trials to primarily the drug design aspect and part of the drug discovery process, but we see the introduction of AI in almost every single node that makes the entire process of drug discovery, from designing and manufacturing cell therapies to designing and manufacturing non animal models for drug discovery, to computational assessments of drug safety, to computational assessment of drug efficacy, etc, etc. And so it's having, today already an enormous impact, and it is likely that we have passed the threshold of AI being AI, sorry, value, additive, value, accurate throughout the entire process for every component. So we don't have generalizable AI that can solve the entirety of the drug discovery process, but we are seeing a lot of localized AI that are having very meaningful, very impactful, very measurable improvements on each one of the steps that make the end to end drug discovery process and development,

Feliza Mirasol

I'm afraid that's all the time we have. Thank you, Daniel for your deep insights into the outsourcing and partnership landscape in today's modern and complex biopharma environment. Thank you to our audience for watching And a huge thank you to our sponsors, quotient sciences and piramal pharma solutions for supporting today's episode. You can catch all the Pharm tech drug digest videos@www.pharmtech.com Until next time, have a great day.

Patrick Lavery

Did you enjoy this episode? If you did, please share this video with colleagues who you think would enjoy the content. Thank you to our editors and experts for sharing their insight. Thank you as well to our sponsors for sponsoring this episode. If you want to stay in touch with pharmaceutical technology team, subscribe to this podcast as well as to our E newsletters. When you sign up for our newsletters, you will be updated about future episodes of drug digest. Receive our magazines and more. Thanks to everyone for joining us for this episode of drug digest. We will see you next time you.