Susan Haigney

In a 2026 industry outlook interview, Raj Puri explains balancing speed with the financial and regulatory risks of accelerated drug launches via alignment.

Navigating the Complex Risks of Accelerated Pharmaceutical Launches

Raj Puri, chief commercial officer at Argonaut Manufacturing, explores the complex balance between speed and risk in pharmaceutical product launches. Puri explains that while getting a product to market quickly is vital for patient access and commercial survival, compressed timelines introduce significant regulatory and financial hurdles. He notes that, "As a biotech or pharma company, getting product to market as quickly as possible is critical”.

One of the primary challenges discussed is the "gamble" of mass production. Puri highlights that accelerated timelines often force companies to decide whether to manufacture commercial-scale products before receiving indicative guidance from regulatory agencies. He explains, "The compressed review timeline actually forces the biotech and pharma companies into taking a bit of a gamble, and that decision really is, do you start mass production before you have indicative regulatory feedback?". This financial risk is compounded by the need to negotiate proactively with agencies for allowances, such as submitting manufacturing data on a rolling basis.

Puri also shares a personal case study involving a life-saving biologic where the Phase 3 study was discontinued early due to "overwhelming efficacy". While a positive outcome, this created a gap in patient access during the submission window and led to clinical utilization challenges. Because the study ended early, the resulting regulatory label required ICU clinicians to use unfamiliar clinical trial tools, necessitating a massive educational effort.

Finally, the interview addresses the global implications of accelerated launches. Different requirements from the FDA, EMA, and Japanese Health Authorities often force companies to prioritize one jurisdiction over others. Puri concludes that while compressed timelines are highly desirable, they necessitate robust contingency strategies and a deep, collaborative relationship with regulatory bodies to ensure alignment on all requirements.

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.

Good morning. My name is Raj Puri. I'm the Chief Commercial Officer at Argonaut manufacturing. Argonaut is a contract manufacturing company based in Carlsbad, California. We have two separate divisions within the company. One division is focused on the production of life science and diagnostic products, and then the second division is focused on aseptic filling of drug product. So again, pleasure to be here today.

As a biotech or pharma company, getting product to market as quickly as possible is critical. Both from a patient access perspective, you want to save or improve lives of many patients as possible, as quickly as possible, but also from a commercial perspective, we basically burn cash until we get to market. So, from a commercial perspective, getting there as quickly as possible is obviously desirable. It can have significant challenges, these compressed timelines, and I've gone through them, personally, myself, from a regulatory perspective, what you can often see is that you're able to negotiate proactively with the agencies allowances regarding the data required on submission. And so again, you have to work very closely with the agency to determine what allowances will be made. But for example, in your PPQ package, which is essentially the manufacturing data that's provided on your submission, you may have the opportunity to reduce the amount of data provided and provided on a rolling basis, rather than everything has to go in at once on the submission date. So again, it takes close coordination with the regulatory body to negotiate those allowances.



From a commercial risk perspective, the compressed review timeline actually forces the biotech and pharma companies into taking a bit of a gamble, and that decision really is, do you start mass production before you have indicative regulatory feedback? So typically, let's say you have a year review timeline. After six months, you probably have some guidance whether or not your clinical package is acceptable or not. You then can say, after six months, everything looks good, we're going to pull the trigger. There's some risk here. But, clinical data looks pretty good. We're going to make the decision to manufacture and have product ready for launch. When you have a compressed timeline, you can't actually make that decision. You may actually have to make a decision on actual submission before you have any indicative guidance about whether or not you're going to make product to be ready for commercial launch. So there's a significant financial risk associated with making that decision at the time of submission versus when you have some indicative guidance from the agency. Personally, early in my career, I was part of a team at one of the big pharma companies responsible for setting regulatory strategy for a lifesaving biologic. The phase three study was actually discontinued due to overwhelming efficacy, which again, was a fantastic outcome. We were very, very excited the product was saving lives, and it became not ethical now to treat patients with a placebo when we knew that the active was extremely effective.

So we're very excited, but it did create some significant challenges for us on the back end. So, one of those challenges was actually a patient access issue. We discontinued study due to overwhelming efficacy, and it took us probably six to eight months to actually make a submission to the regulatory agency. You have to compile all the data, do the analysis, and then you have a review time on top of that. We did not have a scalable program in place where we continue to have availability for patients to access this product. So that was a major challenge from a patient access perspective, in that window between study discontinuation and commercial approval. And then from a clinical utilization perspective, we also had a challenge in that, because the study was discontinued early, we had a much smaller patient population than we had anticipated. What ended up happening was that the regulatory agencies then integrated into our label, the use of a clinical trial severity score.

What that meant is that you now had, commercially, you had clinicians that weren't involved in clinical trials were being asked to use a tool that they never used before. And so from a commercial perspective, we're now trying to educate the ICU doctors and nurses on how to actually assess patients effectively using this tool. And it's something they'd never done before. And so that also created a major challenge for us, again, somewhat precipitated by the compressed timeline. At the end of the day, the compressed outlines, while extremely desirable, they really do force companies to have a very robust contingency strategy developed prior to submission, and really forces them to work very closely with the regulatory agencies to make sure that they have alignment regarding requirements. It also may have the unintended effect of forcing companies to prioritize certain jurisdictions over others. Because, what the FDA may require might be quite different than what the EMA require, which may be different than what the Japanese Health Authority requires. And so now you have to say, Okay, which of these are the priority market? Because frankly, we can only really meet one. And so that's another peripheral outcome of going through a compressed review timeline.

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In a 2026 industry outlook interview, Raj Puri discusses how the tariffs hinder US pharma investment but drive demand for geographically segregated supply chains.

Balancing Unpredictable Tariffs with Geographically Segregated Supply Chains

In this interview, Raj Puri, chief commercial officer at Argonaut Manufacturing, discusses the complex challenges and shifting strategies within the U.S. pharmaceutical supply chain. Argonaut, a contract manufacturing organization based in Carlsbad, California, operates specialized divisions for life science diagnostics and aseptic drug product filling. Puri identifies the unexpected 2025 White House tariffs on equipment and consumables as a significant disruption for mid-sized companies attempting to expand domestic infrastructure.

Puri highlights the financial strain these policies impose, noting that Argonaut itself was hit with a seven-figure tariff on critical equipment during the final phase of a three-year investment plan. This volatility complicates long-term planning for the industry. "The tariffs have a chilling effect on companies trying to make investments into US-based pharma manufacturing facilities is simply due to their unpredictable nature," Puri explains. However, he also observes a "positive" side effect, the tariffs have driven increased interest in U.S.-based CDMOs as firms seek proactive strategies to manage their COGS.

Beyond immediate trade policy, the Puri elaborates on the broader necessity of supply chain redundancy in the wake of COVID-19 and ongoing geopolitical shake ups. Puri notes a qualitative trend where biotech and pharmaceutical companies are no longer satisfied with simply having multiple sites under one provider. Instead, they are prioritizing geographical and economic segregation to mitigate risks. Regarding this strategic shift, Puri states: "They want completely economically and geographically segregated manufacturing sites".

Ultimately, the interview underscores a critical transition period for the industry. While tariffs present a unique hurdle that hinders domestic investment, they are simultaneously accelerating a movement toward more resilient, diversified, and U.S.-centered manufacturing models.

Good morning. My name is Raj Purdy. I'm the Chief Commercial Officer at Argonaut manufacturing. Argonaut is a contract manufacturing company based in Carlsbad, California. We have two separate divisions within the company. One division is focused on the production of life science and diagnostic products, and then the second division is focused on aseptic filling of drug product. So again, pleasure to be here today.

In my opinion, the biggest and most unwelcome surprise of 2025 was the implementation of tariffs by the White House, like many other industries, pharma industry was negatively impacted by the Tariffs applied to the acquisition of new equipment and critical consumables from non-US manufacturers. Very specifically for Argonaut, we are in the final stages of implementing a three year investment plan to build a new drug product manufacturing site in Carlsbad, California. And with all the latest and greatest equipment, unexpectedly, we got hit with a seven figure tariff on one of the key pieces of equipment, which again, for a mid-sized company, is a significant challenge.

The tariffs have a chilling effect on companies trying to make investments into US-based pharma manufacturing facilities is simply due to their unpredictable nature. On the positive side though, I would say that the Tariffs applied to pharmaceutical products not made in the US have created additional interest in US based CDMOs as a potential strategy to keep down cogs. So I get I think it's being done somewhat proactively, as we don't have a lot of details on how products made by CDMOs will be treated from a tariff perspective, but we certainly are seeing increased interest as a result.

In my opinion, the issue of tariffs geopolitical shocks and global supply disruptions underscore what we already know about the importance of having redundancy and pharmaceutical supply chains, and I think covid taught us, taught that lesson as well in 2020.

While I don't have a lot of quantitative data, qualitatively, my experience has been that biotech and pharma companies are actively looking to establish secondary commercial manufacturing sites, which are both geographically and economically segregated from their primary. So we've seen that organizations are not necessarily looking to work with the same CDMO, even if they have multiple geographical sites, because if there is an issue with that organization, they're now in a difficult position. They want completely economically and geographically segregated manufacturing sites.

Nerve cell with blue background attacked by red antibodies - 3D illustration of autoimmune disease | Image Source: ©peterschreiber.media -stock.adobe.com

, a biotech company that develops programmable T cell target immune medicines, announced on Jan. 29, 2026 that it is collaborating with Eli Lilly and Company to develop tolerizing therapies that restore immune homeostasis for autoimmune diseases (1). As part of the agreement, Repertoire will receive an upfront payment of $85 million with up to an additional $1.84 billion for development and commercial milestones and tiered royalties on net sales.

Collaboration activities will be led by Repertoire until a candidate is nominated. Repertoire’s T cell receptor (TCR)-epitope discovery platform, DECODE, will be used to discover and develop the tolerizing therapy candidates. Lilly will then lead clinical development, manufacturing, regulatory affairs, and commercialization of the therapy.

“This collaboration further expands Repertoire’s partnered pipeline of tolerizing therapies and affords us the opportunity to translate the unique discoveries produced by our DECODE platform into potentially paradigm shifting new medicines for autoimmune patients by addressing the root cause of the immune dysregulation and resetting their immune system to a healthier state,” Torben Straight Nissen, PhD, chairman and CEO of Repertoire and executive partner at Flagship Pioneering, said in a press release (1). “Lilly’s established leadership in immunology and commitment to advancing novel, potentially transformative medicines to patients with clear unmet needs give us great hope for the impact our innovation can have in the hands of such an exceptional partner.”

Repertoire was founded in 2019 by Flagship Pioneering. The company’s DECODE platform reveals the entire immune synapse to provide understanding of the interactions between TCRs and their cognate antigenic epitopes. The company translates these discoveries into T cell-targeted therapies for the treatment of cancer and autoimmune diseases.

What other companies are collaborating with Flagship Pioneering and Repertoire?

In December 2025, Flagship Pioneering announced a research program in collaboration with Pfizer, in which Repertoire will identify and optimize TCR bispecifics for metastatic prostate cancer (2). Flagship’s in-house drug discovery and development unit, Pioneering Medicines, is leading the partnership with Pfizer and will drive the exploration process to discover potential drug development programs.

“Repertoire’s DECODE platform uniquely maps the entire immune synapse, presenting enormous uncharted potential to discover new antigens capable of activating the immune system to fight cancer, and when coupled with Repertoire’s immune medicine engineering technologies and capabilities, places us in a strong position to generate targeted medicines to engage them,” Nissen said in a press release at the time (2). “Guided by Pfizer’s drug development expertise in oncology, we will apply our platform to uncover new potential T-cell targeted medicines.”

“This research program with Repertoire demonstrates both the continued momentum in our strategic alliance with Pfizer and the breadth of novel modalities our Flagship companies offer as a supply chain of potential therapeutic innovation,” said Paul Biondi, Flagship Pioneering managing partner, in the press release (2). “We have now collaborated on eight programs across multiple modalities and five therapeutic areas in our shared commitment with Pfizer to co-create a pipeline of novel candidates that have a potential to become differentiated medicines with greater precision, speed, and scale for the patients who need them most.”

TCR bispecifics are a potential immunotherapy that may be able to overcome barriers associated with disease progression. The research program aims to identify and develop an early optimized TCR bispecific that can control the disease reduce toxicity, according to the company.

Repertoire Immune Medicines. Repertoire Immune Medicines Announces Strategic Collaboration with Lilly to Develop Tolerizing Therapies for Autoimmune Diseases. Press Release. Jan. 29, 2026.

Flagship Pioneering. Flagship Pioneering and Repertoire Immune Medicines Announce Agreement to Identify T Cell-Targeted Immune Medicines for Prostate Cancer Under Strategic Partnership with Pfizer. Press Release. Dec. 22, 2025.

Articles

Repertoire Immune Medicines has partnered with Eli Lilly to develop tolerizing therapies for autoimmune diseases, leveraging Repertoire's DECODE platform for T cell receptor-epitope discovery. The collaboration involves an upfront payment of $85 million to Repertoire, with potential additional payments up to $1.84 billion. Repertoire will lead initial discovery efforts, while Lilly will handle clinical development and commercialization. Additionally, Repertoire is collaborating with Pfizer to identify TCR bispecifics for metastatic prostate cancer, highlighting the potential of their DECODE platform in both autoimmune and oncology applications.

Repertoire’s T cell receptor-epitope discovery platform will be used to develop tolerizing therapy development candidates with Eli Lilly and Company.  

Repertoire Immune Medicines and Lilly Collaborate on Treatments for Autoimmune Diseases

International day of Women and Girls in science is observed every year on February 11, The day recognizes the critical role women and girls play in science and technology. 3D Rendering | Image Credit: ©Waseem Ali Khan -stock.adobe.com

International Day of Women and Girls in Science

 (1). This day focuses on the gender gap in science, technology, engineering, and mathematics (STEM) fields and emphasizes the need to close gender gaps in STEM through supporting girls in targeted programs and promoting actions and policies surrounding inclusion.

In recognition of the International Day of Women and Girls in Science, 

will be interviewing industry experts on the innovations and successes women have achieved in the pharmaceutical industry. We will also be highlighting some recent news about notable CEOs, scientists, and innovators impacting the industry and improving patients’ lives.

The following are some of the women we will be highlighting in the weeks to come:

Jennifer Levin Carter, MD, MPH, MBA is Founder & CEO of Medzown. Dr. Carter is a globally recognized leader in precision medicine, with a proven track record of building transformative companies at the intersection of data, technology, and patient care. Dr. Carter will be discussing lessons she’s learned from founding her own company in the biotech field. Watch Part One of our interview with Dr. Carter now, in which she discusses the differences between personalized medicine and precision medicine. Check back in February for more with Dr. Carter.


https://www.pharmtech.com/view/personalized-medicine-vs-precision-medicine

Elisabeth Gardiner, CSO of Tevard Biosciences

to explain how transfer RNA is impacting the development of gene therapies for diseases with unmet needs. In an upcoming interview, Elisabeth will discuss how women working in STEM fields uniquely contribute to areas such as rare disease treatment development.


https://www.pharmtech.com/view/gene-therapy-rare-diseases-and-transfer-rna

 to talk about her work as director of Clinical Research at 

, which is an early-phase oncology clinical trial unit located within General Hospital San Pedro in Logroño in northern Spain. Check back on February 11 to watch the interview.

, CEO of IMUNON, which is advancing a novel non-viral, DNA-based immunotherapy for women with advanced ovarian cancer and experts from Symbiosis, Quotients Sciences, and more.

 on February 11 for all of our coverage of the International Day of Women and Girls in Science.

UN. International Day of Women and Girls in Science, 11 February. UN.org. 

https://www.un.org/en/observances/women-and-girls-in-science-day

The International Day of Women and Girls in Science, observed on February 11, highlights the gender gap in STEM fields and promotes inclusion. PharmTech will feature interviews with industry experts, showcasing the achievements of women in the pharmaceutical industry. Notable figures include Jennifer Levin Carter, a leader in precision medicine; Elisabeth Gardiner, who discusses transfer RNA in gene therapies; and María de Miguel, who leads oncology clinical trials. The coverage aims to celebrate women's contributions to science and inspire future generations to pursue STEM careers.

Visit PharmTech.com for upcoming coverage of the International Day of Women and Girls in Science on February 11.

Innovations from Women in STEM 

Laine Mello Industry Outlook | Created with Canva

Laine Mello, director of Marketing at Ecolab for its bioprocessing business, shares her insights on the digital transformation of the pharmaceutical sector, the shift from batch to continuous processing, and the economic drivers shaping the industry’s future into 2026.

PharmTech: How is AI reshaping the drug discovery and manufacturing landscape?

 We are seeing AI fundamentally change the drug discovery timeline. Researchers are now able to design new molecules in weeks rather than months, which is an incredible shift that helps identify promising candidates with precision that wasn't possible even two years ago. This acceleration has massive implications for how quickly therapies can reach patients. On the manufacturing side, the impact is just as significant. Predictive maintenance tools are now catching equipment issues before they cause batch failures, and real-time analytics are allowing for much faster quality decisions. Digital monitoring is even making continuous processing more viable by removing the uncertainty that previously made manufacturers hesitant to move away from batch production.

What primary hurdles prevent companies from full adoption?

Adoption isn't always straightforward because regulatory frameworks are still catching up. There is an understandable need for transparency in how AI makes critical decisions, especially when patient safety is involved. Many facilities are struggling to integrate cutting-edge digital tools with legacy systems that might be 10-15 years old. We also have to address data governance and cybersecurity; these are not solved problems yet, and they cannot be afterthoughts when you are dealing with sensitive manufacturing data.

What benefits does continuous manufacturing offer over traditional methods?

It’s been a game-changer, we’ve seen facilities cut production cycles by 30%-40% while actually improving consistency. Shifting away from batch processing isn't just about increasing speed, it fundamentally changes how quality control and scale-up work. Once a facility can run continuously, it opens the door to optimizing operations in ways that simply weren’t possible before.

How is the industry responding to increasing margin pressures and the need for better process economics?

The industry is responding to margin pressure by investing heavily in next-gen therapies, such as biologics and advanced modalities that offer clinical benefits that generic competitors cannot easily replicate. This shift creates a demand for sophisticated purification solutions. For example, high-capacity chromatography resins are helping manufacturers maximize yield and recovery. These advanced resins enable intensified processing, which translates directly into cost savings and faster throughput. For biologic manufacturers dealing with complex molecules, these improvements in purification efficiency can be the difference between a commercially viable process and one that struggles economically.

What digital technology and sustainability shifts did you see in 2025?

In 2025, digital technology stopped being a "nice to have". Companies that had been piloting AI or the IoT for years suddenly found themselves racing to implement these tools across R&D and manufacturing to avoid falling behind the competition. At the same time, sustainability moved beyond simple compliance to become a genuine competitive differentiator. Companies are discovering that reducing water and energy consumption isn't just good for the planet, it improves their bottom line and makes their operations more resilient.

What will be the defining priorities for bioprocessing in 2026?

The reduction of the cost of goods will be the defining priority in 2026. Pricing pressures are intensifying, particularly for complex biologics. Manufacturers need to squeeze more productivity out of every single process step. We expect continuous and intensified bioprocessing to move from being innovative to becoming a standard practice, utilizing modular facilities and multi-column chromatography to deliver flexibility without sacrificing efficiency. We are also focused on solving technical challenges like stability and aggregation for high-concentration biologics and mRNA platforms that push the limits of current manufacturing.

How is the relationship between pharmaceutical companies and their suppliers changing?

We are seeing a shift where pharma companies are no longer looking for transactional relationships. Instead, they expect suppliers to act as strategic partners. This involves co-creating solutions, sharing technical expertise, and collaborating on process innovations. Using collaborations and acquisitions to access new technologies quickly is becoming essential for staying agile in a market where competitive advantages can erode very quickly.

The pharmaceutical sector is undergoing a digital transformation, with AI significantly accelerating drug discovery and enhancing manufacturing processes. Continuous manufacturing is replacing traditional batch methods, offering improved efficiency and quality control. However, regulatory challenges and legacy systems hinder full digital adoption. Economic pressures are driving investment in advanced therapies and purification solutions. By 2025, digital technology and sustainability became crucial competitive factors. In 2026, reducing costs and enhancing bioprocessing efficiency will be priorities, with a shift towards strategic partnerships between pharmaceutical companies and suppliers to foster innovation and agility.

Laine Mello, director of Marketin, Ecolab, details how AI, continuous manufacturing, and Pharma 4.0 drive bioprocessing efficiency and cost savings.

How Digitalization Is Transforming Pharmaceutical Manufacturing Processes

Raj Puri Industry Outlook | Created with Canva

In a rapidly shifting pharmaceutical environment, the role of CDMOs has become increasingly complex. 

, oversees operation of two distinct divisions: one for life science and diagnostic products and another for aseptic drug product filling. In this interview, Puri discusses the economic, regulatory, and human factors shaping the industry's future.

PharmTech: In an industry often defined by high-tech equipment, how does a CDMO set itself apart from other firms?

 While anyone with sufficient capital can build a state-of-the-art facility, the only long-term sustainable advantage we have as a CDMO is our staff. Our executive team prioritizes getting and keeping the "right people on the bus.” As a midsize organization, we offer a dynamic environment where staff can work across various functional areas. This cross-training, where an operations professional understands the demands of Quality Assurance and vice-versa, creates an organization that truly understands the floor-level challenges of manufacturing. Our team’s intellectual curiosity drives us to adopt the latest technologies and techniques to remain on the cutting edge.

How are tariffs and massive manufacturing investments affecting the industry?

 has been the biggest and most unwelcome surprise of 2025, particularly those applied to equipment and consumables from non-US manufacturers. For Argonaut, which is completing a three-year investment plan for a new site, we were hit with a seven-figure tariff on a key piece of equipment. These costs have a chilling effect on investments because they make ROI calculations for multi-million dollar projects incredibly difficult.

We are also seeing north of $370 billion in announced investments for US manufacturing. If realized, this massive influx will likely extend construction timelines and increase costs significantly, disrupting the typical supply and demand curve. Simultaneously, if the government forces down pharmaceutical pricing, companies will be desperate to reduce their COGS. This creates an operational tightrope for CDMOs, we must find ways to lower costs while the FDA maintains its high expectations for product safety and manufacturing robustness.

How has the global climate changed how pharma companies view supply chains?

Geopolitical shocks and the lessons of COVID-19 have underscored the vital importance of redundancy. We are seeing a shift where biotech and pharma companies are looking to establish secondary manufacturing sites that are both geographically and economically segregated from their primary sites.

There is significant pressure to get products to market faster. What are the risks and rewards of compressed timelines?

Speed is critical for patient access and commercial viability. However, compressed timelines force companies to take a financial gamble, often requiring them to start mass production at the time of submission before receiving any indicative guidance from regulatory agencies.

I’ve seen cases where a Phase 3 study was discontinued early due to overwhelming efficacy. While this is a fantastic outcome for patients, it created a 6-8 month gap for data analysis and submission, leading to patient access issues before commercial approval. It also resulted in a smaller data set, leading to regulatory labels that required clinicians to use unfamiliar clinical trial severity scores. Ultimately, these compressed timelines require a robust contingency strategy and close coordination with regulatory bodies to negotiate allowances like rolling data submissions. They may even force companies to prioritize one jurisdiction, such as the FDA, over others due to differing requirements.

In the evolving pharmaceutical landscape, CDMOs face increasing complexity due to economic, regulatory, and human factors. The key differentiator for CDMOs is their workforce, emphasizing cross-functional training and intellectual curiosity. Tariffs and substantial US manufacturing investments impact ROI calculations and operational costs, challenging CDMOs to balance cost reduction with regulatory compliance. Geopolitical events and COVID-19 have highlighted the need for supply chain redundancy. Compressed timelines, while beneficial for patient access, pose financial risks and require strategic planning and regulatory coordination to manage potential data and approval challenges.

Raj Puri, CCO, Argonaut Manufactoring, provides key insight on navigating tariffs, supply redundancy, and the risks of compressed timelines.