Christopher Cole

This video clips offers topline findings from our survey of nearly 90 bio/pharma professionals on the impacts of Trump-era tariffs and trade policy.

Tariffs & Trade Policy: Results of a Bio/Pharma Peer Survey

Spanning the first two weeks of August 2025, 

® conducted a survey on the impacts of Trump-era tariffs and trade policies on the organizations at which you and your peers in the bio/pharmaceutical industry work. Responses reveal that most perceive tariffs as a major influence on their operations and supply chains, with nearly half reporting significant effects and another large segment anticipating moderate impacts. In navigating these challenges, companies are actively adapting their strategies, primarily by increasing investment in trade compliance and diversifying supply bases, to mitigate risks rather than relying on a single approach, such as reshoring.

This video clip summarizes our key findings. 

Click here to access our full, extensive results

*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.


 Welcome to the explainer. If you're in the bio slash pharma industry, you really don't need me to tell you that tariffs and trade policy have been a bit of a roller coaster lately, but how are companies actually handling it all? Well, we're about to jump into a new survey to see exactly what your peers are thinking and doing.

So here's our game plan. We're gonna start with just how big this disruption really is. Then we'll look at the strategic playbook companies are using to adapt. We'll hear directly from your peers about their biggest hurdles, and finally, we'll see what the industry is actually asking for to make things better.

Alright, first up, tariffs as a major disruption. Let's really dig into the scale of this challenge. Let's just start with the headline number, the one that tells you pretty much everything you need to know. 86.2%. That's how many of your peers are saying that tariffs are gonna have a moderate to significant impact on their supply chain.

So, yeah, this isn't some minor headache, right? This is a huge sector-wide issue, and when you break that number down, the story gets even clearer. Just look at this, almost half, nearly 50% are preparing for a significant effects. That tells you that for a lot of companies, probably just like yours, tariff policy isn't just noise in the background.

It's now a primary driver of their operational strategy. So where is this pressure actually being felt the most? Is it just one specific area? Not even close. You can see things like equipment procurement and API sourcing are definitely feeling the heat. But look at that massive 72% pointing to finished product trade.

The impact is being felt all the way across the value chain from getting raw materials right through to the final product, leaving the warehouse. So with this kind of widespread disruption, you have to wonder what are companies actually doing about it. Let's take a look at their strategic playbook.

While for the long haul, the main play seems to be a defensive one. You've got almost half of companies doubling down on trade compliance, basically just trying to navigate these incredibly complex rules, and close to 40% are working to diversify their supplier base, which is a classic move to hedge against risk.

Now, in the immediate short term, things are a little different. It's more of a mixed bag of tactics. You see this blended approach of trying to get regulatory relief through exclusions. Shifting sourcing to countries that aren't tariffed, and for a decent chunk actually investing in domestic manufacturing.

So what's the big takeaway here? It's that there's no single magic bullet. Your pairs are building out this really flexible blended playbook. It's part compliance, part diversification, and part targeted investment, all designed to manage this ongoing uncertainty. But you know, numbers and charts, they only tell half the story.

What does all this disruption actually feel like for the people on the ground day in and day out? The survey's, open-ended responses. They really paint a picture. The first major theme that comes through loud and clear is the direct hit to the wallet. We're talking rising costs and finding it harder to compete in a global market.

It's a straight shot to the bottom line. The second theme, it's the sheer exhaustion. It's trying to plan for the long term. When you're dealing with constant policy, whiplash, the ground is always shifting beneath your feet, and that makes strategic planning almost impossible. And this one, wow. This is a story where that uncertainty turns into a real, tangible and super expensive failure.

A $2 million loss and six weeks of loss production, all because a last minute policy change forced a risky supply chain decision. So given all these challenges, what does the industry actually expect from the future? And maybe more importantly, how prepared do they feel for whatever is coming next?

There's a really strong consensus here. 70% of your peers believe that future administrations will probably soften tariffs, but not get rid of them completely. It really suggests that everyone is settling in for this being the new normal. But here's the catch. Even with that expectation, there's a clear confidence gap.

The vast majority feel they're only partially prepared. That leaves a pretty significant chunk of the industry, nearly one in five, admitting they're just not ready for future policy shifts, leaving them vulnerable. And what's really fascinating is that there's a lot of skepticism that tariffs are even the right tool for the job.

Most of your peers see them as a pretty weak or insufficient policy lever. If the goal is actually to encourage reshoring manufacturing. Okay, so if tariffs aren't the answer, what is. Well, your peers were very, very clear about the kinds of policy changes that would actually help them out. All the responses really boil down to two main ideas.

First, give us policies that make it easier to innovate and do r and d. And second, for goodness sake, create a trade environment that is stable, predictable, and doesn't rely so heavily on tariffs. And this translates into some pretty specific asks. Things like getting rid of tariffs on critical materials like APIs, making customs more efficient.

Protecting intellectual property and making sure that big investments in r and D are actually rewarded long-term. You know, this one response really just ties it all together perfectly. It's a call for a coherent strategy that combines stability with real incentives for domestic innovation. That's what the industry is asking for.

That really leaves us with the final crucial question. This survey shows a clear disconnect between the policy tools being used and what the industry actually needs. It leaves the path forward pretty uncertain, and makes you wonder, will future policy reflect the playbook of the past, or will it finally adapt to the needs of the future?



Videos

Silver Spring, MD, USA - June 25, 2022: Closeup of the FDA sign seen at its headquarters campus in Silver Spring, Maryland. FDA is a federal agency of the Department of Health and Human Services | Image Credit: © Tada Images - stock.adobe.com

A recent FDA inspection has identified significant quality concerns at a Novo Nordisk pharmaceutical manufacturing plant in Bloomington, Indiana (1). The site, which was acquired in late 2024 through Novo Nordisk’s purchase of Catalent facilities (2), received an FDA Form 483 following findings of contamination and unresolved equipment problems.

Inspectors documented cases of “atypical extrinsic particles,” including cat and human hair in vial stoppers, along with pest infestations in classified areas (3). These observations were made between late June and mid-July 2025.

Unresolved contamination complaints and equipment failures

The plant, which produces therapies for Regeneron and Scholar Rock, has faced recurring complaints of contamination dating back several years. According to the FDA’s inspection report obtained by 

, “Your investigation failed to determine a root cause for the contamination, assess the potential impact to the rest of the lot, or evaluate whether similar issues may have occurred in upstream batches” (4).

The report noted that the company’s review “was limited to a one-year time frame, and no complaints were assessed. Although components were considered a potential root cause, no corrective or preventative actions were taken to address this.” The agency added that since then, “approximately 20 additional deviations related to hair contamination during 100% manual visual inspection have occurred,” along with 14 deviations uncovered through a gap analysis.

Client concerns extend back to June 2022, when reports of “foreign matter” and “particles” were raised (1). In 2024 and 2025, roughly 10 work orders were logged for “recurrent leaks and other failures” in a key system, with some repairs delayed for extended periods.

Acquisition expanded US fill-finish capacity

The Bloomington facility became part of Novo Nordisk’s network in December 2024, when Novo Holdings completed its $16.5 billion purchase of Catalent’s operations (3). At the time, company leadership emphasized the importance of adding US fill-finish capacity to strengthen its supply chain for diabetes and obesity treatments.

“We are very pleased with the agreement to acquire the three Catalent manufacturing sites which will enable us to serve significantly more people living with diabetes and obesity in the future,” said Lars Fruergaard Jorgensen, president and CEO of Novo Nordisk, in the acquisition announcement (3). “The acquisition complements the significant investments we are already doing in active pharmaceutical ingredients facilities, and the sites will provide strategic flexibility to our existing supply network.”

Broader workforce shifts in gene therapy manufacturing

Separately, Catalent recently announced it will reduce its workforce by 350 employees at its Baltimore gene therapy site, citing changes in customer demand (5). “Our gene therapy business continues to see strong growth and we look forward to working on behalf of customers to deliver novel therapies for patients with genetic diseases/disorders,” a company spokesperson told Endpoints News. “It is never easy to see talented colleagues leave Catalent and we remain committed to providing them transition support as they manage this change.”




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Articles

The FDA inspection of a Novo Nordisk plant in Bloomington, Indiana, revealed significant quality issues, including contamination and equipment failures. Acquired in 2024 from Catalent, the facility faced unresolved contamination complaints, with inspectors finding atypical particles like hair in vial stoppers and pest infestations. Despite previous contamination reports, corrective actions were lacking. Novo Nordisk's acquisition aimed to enhance US fill-finish capacity for diabetes and obesity treatments. Concurrently, Catalent announced workforce reductions at its Baltimore gene therapy site due to shifting customer demand.

FDA cites Indiana drug plant for contamination, pest issues, and unresolved equipment failures, raising concerns over pharma manufacturing quality.

FDA 483 Cites Contamination and Safety Issues at Novo Plant

The US-EU pharma tariff cap has been finalized at 15%, impacting manufacturing, supply chain, and quality and promoting domestic production and resilience.

Understanding the Operational Impacts of the 15% US-EU Pharma Tariff Cap 

The recent finalization of a trade deal between the White House and the European Union, which sets a 15% cap on pharmaceutical imports, carries significant implications for pharmaceutical technology, manufacturing, and supply chain strategies (1). This development, contrasting sharply with earlier proposals that threatened tariffs as high as 250% (2), shifts the landscape for bio/pharma professionals focused on drug development, manufacturing, outsourcing, and quality systems.

Supply Chain Vulnerabilities and Manufacturing Cost Structures

The impact of tariffs on the pharmaceutical supply chain is highly dependent on where in the chain they are applied (3). While tariffs on APIs are expected to have a minimal impact on the total cost of a finished drug due to APIs contributing relatively little to overall costs, tariffs on finished pharmaceuticals or key components could significantly raise manufacturing expenses (2). Such components as bottle plugs, closures, molded parts, and glass represent a substantial portion of overall manufacturing costs. This highlights the critical need for agile, precise, and efficient quality control methods, as well as robust supply chain resilience, to preserve product integrity and meet timelines, especially for life-saving treatments (2,4).

Strategic Manufacturing and Onshoring Initiatives

The discussion around tariffs also underscores the argument for domestic pharmaceutical manufacturing (2). Experts note that a direct impact throughout the supply chain from tariffs could prompt a re-evaluation of manufacturing locations. This aligns with growing interest in onshoring, where shifting drug manufacturing to domestic Contract Development and Manufacturing Organizations (CDMOs) can lead to improved quality, reduced rework, and enhanced long-term efficiency (5,6). Companies like AbbVie are already investing in US API manufacturing, with a commitment of $195 million in its North Chicago plant as part of a larger $10 billion capital investment for expanding US innovation and manufacturing capacity (7,8). Such investments support the idea that while much of the research and development is conducted in the United States, greater domestic production capacity could mitigate risks associated with international trade fluctuations (2,7,8).

Emphasizing Innovation and Quality Systems

These trade dynamics reinforce the importance of early formulation planning, novel platforms, and tailored approaches to secure long-term intellectual property protection against generics (9,10). Furthermore, collaborative innovation in CDMOs, focusing on early engagement, IP strategy, and advanced formulation, is crucial for redefining partnerships in bio/pharmaceutical development (11,12). Maintaining high-quality systems, including environmental audits and waste reduction, also plays a role in enhancing supply chain security and reshaping priorities in pharmaceutical manufacturing (13,14). As the industry navigates these trade agreements, the emphasis on robust manufacturing processes, resilient supply chains, and adherence to stringent quality control will be paramount for delivering treatments effectively (4).

Joint Statement on a United States-European Union Framework on an Agreement on Reciprocal, Fair, and Balanced Trade

Trump: Tariffs Could Potentially Hit 250%. 

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Bio/Pharma's Tariff Response: Key Insights from Industry Survey Results

Trump-era tariffs have been all over the news of late, which led us to speak with international trade expert Jason Waite, of Alston & Bird, in late July. Jason had so much to say, we cut the interview into three parts. Check out 

 for some great insights. We also spoke with Dave Miller, PhD, at AustionPx about 

the impact of these tariffs on reshoring and the associated unepexcted benefits

. We also asked experts who we interviewed as part of the BIO 2025 conference in Boston about 

lasting impacts of recent changes in US government policy

. But we wanted to hear from you, our readers, too!

Spanning the first two weeks of August 2025, 

Tariffs most strongly affect finished product trade but also disrupt earlier supply chain stages and regulatory processes, pushing firms to pursue a balance between reshoring, supply chain flexibility, and regulatory mitigation tactics. Looking ahead, respondents expect future administrations to moderate but not eliminate tariffs, prompting ongoing uncertainty that most organizations address through partial readiness and evolving trade strategies. Broadly, rising costs, supply chain strain, and policy uncertainty emerge as key challenges, while respondents emphasize the need for policies that strengthen innovation incentives and create stable, predictable trade environments supporting supply chain resilience and fair drug pricing. These insights underline a theme of pragmatic adaptation amid complexity and evolving policy landscapes.

Read on the delve into the findings from each of the nine survey questions.

1. To what extent will Trump-era tariffs affect your organization's operations or supply chain?

Nearly half of respondents (49.4%) report that tariffs will significantly affect their operations or supply chain, with another 36.8% seeing moderate effects, showing that Trump-era tariffs are broadly perceived as a major driver of operational decisions (

). A smaller portion are unsure (5.7%) or report only slight/no impact (8%), highlighting uncertainty in how tariffs affect different organizations and tying to the need for companies to adapt their strategies—through diversification, compliance, or reshoring—to manage potential disruptions. Essentially, tariffs are a major concern for most (indeed, only 1.1% said their company isn’t impacted at all), and companies are navigating uncertainty through strategic adjustments.

 Responses to “To what extent will Trump-era tariffs affect your organization's operations or supply chain?”

2. How will Trump-era trade policies influence your company's long-term supply chain strategy?

The nearly one-half (48.3%) of respondents who said their organization plans to increase investment in trade compliance was the largest single response, showing that companies are focused on ensuring they can navigate tariffs, customs rules, and regulatory complexities without disruptions (

). Still, almost two-fifths (37.9%) say their company plans to diversify their supplier base, indicating that companies are hedging against geopolitical risk and trade uncertainty by spreading sourcing across multiple countries or suppliers. A much smaller, but notable, segment (6.9%) is moving production closer to home to reduce reliance on global supply chains exposed to tariffs. Only a tiny fraction (2.3%) feel the policies don’t affect their company.

 Responses to “How will Trump-era trade policies influence your company's long-term supply chain strategy?”

3. Which areas of your organization have been or will be most impacted by Trump administration tariffs or trade restrictions?

Respondents were directed to choose all potential responses that applied, so the total percentage does not equal 100. That said, finished product trade is clearly the biggest pressure point, with 72% identifying finished product imports/exports as the most impacted area, showing that tariffs and restrictions are hitting organizations most directly at the market-facing end of the value chain, where pricing, competitiveness, and global sales are affected (

). Approximately one-fifth cited API sourcing (22%) and raw materials (21%), highlighting vulnerabilities earlier in the manufacturing process, with another 23% noting equipment procurement as impacted, showing tariffs also disrupt capital investment and infrastructure. Secondary but meaningful impacts on innovation and regulation were seen, with 13% flagging R&D and 15% noting regulatory timelines as being impacted, suggesting that trade policies also slow development pipelines and approval processes. Only 4% selecting “no significant impact” as their response underscores how broadly tariffs and trade restrictions are felt across the sector.

 Responses to “Which areas of your organization have been or will be most impacted by Trump administration tariffs or trade restrictions?” Respondents could choose more than one response.

4. Will your organization take any of the following steps in response to tariffs?

While it should be noted that respondents were instructed to pick all responses that apply, their responses suggest that most organizations are not standing still, with only 4% saying theirs is taking no specific action and the vast majority planning proactive responses like shifting sourcing, investing in domestic manufacturing, or applying for exclusions (

).

The 33% who said their company plans to invest in US manufacturing indicates that the tariffs are nudging some companies toward reshoring, though not universally. Still, nearly one-third expect their organization to apply for exclusions, showing that many are trying to reduce exposure through regulatory channels rather than restructuring operations entirely. A practical strategy to reduce costs without fulling committing to US-based production was seen among the roughly 26% who indicated their company plans to shift sourcing to non-tariffed countries. These three responses point to a clear trend: organizations are balancing domestic reshoring with 

rather than relying on one single strategy.

Thankfully for these companies and the patients they ultimately serve, less than one-quarter said they plan to absorb costs (17%) or pass them to customers (5%), suggesting they see active operational adjustments as more sustainable than simply eating the costs or raising prices.

 Responses to “Will your organization take any of the following steps in response to tariffs?” Respondents could choose more than one response.

5. Do you expect future US administrations to maintain or roll back these types of tariffs affecting pharma/biopharma trade?

With only 4.6% saying they are unsure, responses indicate that most respondents feel confident in making a prediction (

). Among those making a prediction, a strong majority (70.1%) believing future US presidential administrations will dial back tariffs but not eliminate them, reflecting a view that tariffs are unlikely to disappear entirely but may be softened or targeted more narrowly. Overall, results suggest expectations of a more measured, pragmatic trade policy approach in bio/pharma, rather than extremes.

 Responses to “Do you expect future US administrations to maintain or roll back these types of tariffs affecting pharma/biopharma trade?”

6. How prepared is your organization to manage ongoing or future trade policy shifts?

Most organizations are in a middle ground, having taken steps to manage trade policy shifts but lacking full confidence (

). Indeed, the majority believe they have some systems or strategies in place but still see gaps in their readiness. Only a small fraction (13%) feel completely ready, while a notable minority remain exposed to risk; nearly 17% say they lack sufficient preparation, suggesting a meaningful segment remains vulnerable to disruption from tariff or policy changes.

 Responses to “How prepared is your organization to manage ongoing or future trade policy shifts?”

7. Do you believe that the Trump administration's tariffs will be effective in encouraging the reshoring of bio/pharmaceutical manufacturing to the US?

Most respondents think tariffs may have some

effect on reshoring, but confidence in them as a strong or sufficient policy tool is low (

). Many see them as only a partial lever, with other measures likely needed to meaningfully shift biopharma manufacturing back to the US.

 Responses to “Do you believe that the Trump administration's tariffs will be effective in encouraging the reshoring of bio/pharmaceutical manufacturing to the US?”

8. What has been your organization's biggest challenge related to tariffs or trade policy since 2018? (open-ended question)

Two clear themes emerged from the response to this question. First, rising costs and supply chain strain. Tariffs are driving up input costs, destabilizing supply chains, and eroding competitiveness. The second theme is policy uncertainty and planning disruption. Constant policy shifts create uncertainty, making it difficult for companies to plan investments, production, and market strategies.

Select responses (lightly edited for clarity) include:

“Since 2018, the biggest challenge our organization has faced in terms of tariffs or trade policies is the significant increase in costs and the decline in market competitiveness caused by the continuous adjustment of tariffs.”

“Compliance and Administrative Burdens Navigating tariff exclusions, customs procedures, and rules of origin (e.g., under USMCA) required additional legal and logistical resources.”

“Seeming non-targeted tariffs across sectors whether they are worth re-shoring or not. The focus appears to be on how best to throw off negotiation opponent but not on what one needs to get.”

“There are few API sources in the US, and these can't be realized for years, if not decades. Pharma has no choice but to pay the increased prices, and pass that to the patient. Forcing [pharmacy benefit managers (PBMs)] to absorb more costs, or highly regulating them, could solve the patient-cost problem.A steady policy would help most of all, without the manipulating and grand-standing that only wastes more money than it will ever save. Generic industries will be put out of business by the demand for cheap products by the PBMs.”

“Selling drug products to other countries.”

“The cost of consumables has gone up significantly and their availability is becoming reduced or scarce.”

“Taking the US-China trade disputes as an example, in 2018, the Trump administration imposed a 25% tariff on Chinese home appliances, which led to a rise in the cost of our exported products such as refrigerators and washing machines to the United States. This made our products lose their price competitiveness in the US market, and our market share was squeezed by South Korean brands such as LG and Samsung. Moreover, the continuous escalation of trade frictions has brought great uncertainty to our business operations. We have to constantly adjust our procurement, production, and sales strategies to adapt to the changes in tariff policies, which has increased our management costs and operational risks. At the same time, the complexity and volatility of trade policies have also affected our long-term planning and investment decisions, making it difficult for us to formulate stable business development strategies.”

“We lost two significant orders for process equipment for Chinese and Irish pharmaceutical manufacturers due to the uncertainty of tariffs, roughly 1/3 of our annual revenue target.”

“To avoid tariff barriers or geopolitical risks, enterprises are forced to adjust their supply chains (such as ‘nearshoring’ and ‘friendly offshore contracting’). However, during the reconfiguration process, they encounter problems such as high investment costs, long production capacity transfer cycles, and great difficulty in adapting to new markets. As a result, the efficiency and cost pressures increase significantly in the short term.”

“Uncertainty in Trade Policy Frequent shifts in tariff exemptions, renewal of the Generalized System of Preferences (GSP), and negotiations (e.g., USMCA, Phase 1 China deal) created planning difficulties. Companies hesitated on long-term investments due to unpredictable trade environments.”

“Changing landscape makes it difficult to plan. We cannot adjust if the rates are changing between countries as well as the rates.”

“Balancing cost control with regulatory compliance while maintaining product quality. Tariffs forced us to either absorb costs (hurting margins) or find new suppliers (risking quality). In 2020, a last-minute tariff hike on Chinese APIs made us switch to a European supplier—their product failed our third-party tests twice. We lost 6 weeks of production and $2M in rework costs. Navigating these trade policy whiplash moments, where speed clashes with quality, has been our biggest nightmare.”

“Frequent adjustments to tariff rates and tax collection scopes make it difficult for enterprises to formulate long-term supply chain plans. Cost accounting, order fulfillment, and market layout all experience significant fluctuations.”

“We originally planned to expand overseas production bases to meet international market demand. However, due to sudden adjustments in trade policies, we may face issues such as restricted imports of raw materials and hindered exports of products. This makes it difficult to advance the preliminary plans and increases operational risks and costs.”

“I’m in the business of therapy outsourcing from Europe. For new therapies that weren’t invented here, it upsets the economic modeling and market access plans that took years to develop and refine. Changing these around to conform with an unpredictable trade policy is going to be expensive in time and money.”

“There are several challenges. 1. the uncertainty; 2. it is retroactive to orders already in the pipe; 3. reduces margin; 4. increases cost to our customers so they have to stop orders and go get more funding.”

“The sharp price increases from 2020-2024 have acclimated us well to any tariff impact.”

9. What policy changes would most benefit your company and the broader bio/pharma industry? (open-ended question)

Among the two strong themes that emerged from the responses to this question was strengthening innovation and R&D incentives. Many called for policies that make it easier and more rewarding to develop new drugs. In short, respondents want polices that reduce barriers to innovation and ensure companies can recoup R&D investments.

The other strong theme was trade, supply chain, and pricing reform, particularly making the supply chain more resilient and the market more transparent. Respondents want predictable, tariff-light trade policies that stabilize costs while protecting supply chains and ensuring fair drug pricing.

Select responses (lightly edited for clarity) include:

“Trade and supply chain resilience, elimination of tariffs on critical inputs (e.g., APIs, single-use bioprocessing materials) and streamlined customs processes for temperature-sensitive shipments.Policies to diversify API production (e.g., incentives for US/EU manufacturing while avoiding overreliance on any single region). Pricing and reimbursement reform, greater transparency in PBM (pharmacy benefit manager) pricing models and value-based payment frameworks for innovative therapies. International reference pricing safeguards to avoid disproportionate cost pressures.”

“Giving play to the role of industrial funds: policies that strengthen investment and financing support, such as giving play to the role of biopharmaceutical industry mother funds, equity investment funds, and innovation transformation funds, can provide sufficient funds for enterprise R&D, production, and expansion, and help enterprises grow and develop.”

“Simplifying the procedures for international multi-center clinical trials: This can help domestic innovative drugs accelerate their ‘going global’ process, enable enterprises to carry out R&D and clinical work according to international high - standards, improve the ‘gold content’ of innovation, and open up a broader market outside China.”

“1. Streamline drug approval and regulatory processes. Accelerate FDA reviews for breakthrough therapies while maintaining safety standards. Harmonize global regulations (e.g., mutual recognition agreements with EU, UK, Japan) to reduce redundant clinical trials. Modernize manufacturing standards (e.g., adopt continuous manufacturing, AI-driven quality control). 2. Reform intellectual property (IP) protections. Extend patent exclusivity for novel biologics (beyond 12 years) to incentivize high-risk R&D.Prevent premature generic/biologic competition by closing loopholes (e.g., ‘skinny labeling,’ patent evergreening concerns).Strengthen trade secret protections in international markets (e.g., China, where IP theft remains a risk). 3. Tax and R&D incentives. Permanent R&D tax credits (instead of periodic renewals) to support long-term innovation. Repeal or delay drug pricing provisions in the Inflation Reduction Act (IRA) that could discourage investment in small-molecule drugs (e.g., Medicare price negotiations after 9 years vs. 13 for biologics). Expand R&D grants for rare diseases, antimicrobial resistance (AMR), and next-gen therapies (e.g., gene editing, mRNA).4. Trade and supply chain policies. Eliminate tariffs on critical pharma inputs (e.g., APIs, specialty chemicals) to reduce production costs. Diversify API supply chains via incentives for US/allied production (e.g., India, EU) to reduce reliance on China. Expedite customs clearance for temperature-sensitive biologics to prevent spoilage.”

“Shortening the review and approval cycle: Policies that compress the review time for drug supplementary applications, drug clinical trial applications, and medical device reviews, such as implementing national registration review and approval reform pilots, can enable products to be launched on the market faster, shortening the time for R&D investment to be converted into commercial returns.”

“Require quality and the ability to supply to be the main drivers behind formulary/PBM choices. Cost has been, and continues to be, the driving factor behind which products are covered. Better yet, make health insurance carriers and PBMs be non-profit, and pay reasonable salaries, not bloated salaries/bonuses based on how much money they can make at the patient's expense.”

“Strengthening the construction of clinical resources: policies to increase the number of research-type beds and build shared research-type wards can provide more clinical resources for drug R&D, accelerate the progress of clinical trials, and improve the efficiency of R&D.”

“The policies that nurture R&D would be most beneficial. Exclusive pricing for R&D establishments would be very good.”

“Formulation of the innovative drug catalog: It is clearly proposed to formulate a catalog of innovative drugs, which lays the foundation for the full-chain industrial policies of innovative drugs and helps establish a diversified and multi-level drug price formation mechanism. The R&D of innovative drugs is the core competitiveness of biopharmaceutical enterprises. The formulation of the innovative drug catalog will provide a basis for the full-chain industrial policies such as pricing, payment, and sales of innovative drugs, accelerate the clinical application of innovative drugs, improve accessibility, and bring more market opportunities for enterprises.”

“Target on small molecule development.”

“Return free trade and stop the tariff nonsense. This is a global economy.”

“Clearly apply medical insurance data to research and development practices, and encourage commercial insurance funds to participate in innovation investment.”

“We need more longer-term plans. We also need to make better decisions regarding what we tariff and the amounts. Also, we need to maintain our technology and not lose it to other countries.”

“First, a clear, long-term tariff exemption framework for critical biopharma inputs and APIs, specialized raw materials. Constantly renegotiating exclusions wastes time and money. Second, tax incentives for domestic biomanufacturing R&D—help us build the ecosystem needed to reshore without crippling costs. And finally, a unified federal-state trade policy for biopharma—right now, state tax breaks clash with federal tariffs, creating chaos. These three changes would stabilize costs, spur innovation, and make the US a viable biopharma manufacturing hub again.”

“A tighter compliance regimen to reduce cheating, particularly on IP security, [current good manufacturing practice] compliance matters for companies abroad, and a clearer long-term path for trade policy that keeps prices static. Since most therapy components are unlikely to be manufactured in the US competitively, Trump policies have no long-term durability in controlling drug pricing, particularly on chemical drugs.”

“Removing tariffs for R&D products. Increase R&D funding by the government.”

“Any policy change that reduces approval time for biosimilars would help.A revisit of the BPCIA, particularly expanding allowances for abbreviated pathways would help us.”

The survey findings underscore that Trump-era tariffs are profoundly reshaping the bio/pharmaceutical landscape, creating significant cost increases and supply chain vulnerabilities, particularly in finished product trade and critical input sourcing. In response, companies are not merely absorbing costs but proactively investing in trade compliance and diversifying global supply chains, often balancing reshoring efforts with a focus on flexibility and regulatory exclusions. Despite these adaptations, the industry continues to grapple with pervasive policy uncertainty and administrative complexities, which hinder long-term planning and investment. Looking ahead, the bio/pharma sector largely anticipates a moderation, but not elimination, of tariffs and recognizes a general state of "middle ground" preparedness for future trade shifts. Ultimately, the industry's call to action is clear: it seeks stable, tariff-light trade policies that foster supply chain resilience and fair drug pricing, coupled with robust government support to strengthen innovation and R&D incentives, including extended patent protections and streamlined approval processes, to ensure continued development of vital therapies.

The Trump-era tariffs have significantly impacted the bio/pharmaceutical industry, influencing operations, supply chains, and long-term strategies. Companies are adapting by investing in trade compliance and diversifying supply bases to mitigate risks. Tariffs primarily affect finished product trade but also disrupt earlier supply chain stages and regulatory processes. Future administrations are expected to moderate but not eliminate tariffs, maintaining uncertainty. Rising costs, supply chain strain, and policy uncertainty are key challenges. The industry seeks stable trade policies, innovation incentives, and streamlined regulatory processes to support resilience and fair drug pricing.

Survey responses indicate that bio/pharma faces tariff-driven rising costs and supply strain, with firms aiming to boost compliance and diversification and seeking stable trade and R&D support.

Dave Miller, PhD, explains how early formulation planning, novel platforms, and tailored approaches secure long-term protection against generics.



In this final part of our 5-part interview series on the current CDMO landscape, Dave Miller, PhD, chief scientific officer at AustinPx, discusses the growing importance of intellectual property (IP) strategy in formulation development, emphasizing how it has become inseparable from solving traditional drug delivery challenges. Miller, who brings both sponsor and CDMO perspectives to the table, highlights how IP considerations must be built into the earliest stages of formulation planning, particularly as many compounds entering the market are already late in their patent lifecycles.

As Miller explains, “It’s not just about solving the drug delivery problems but also generating additional IP to protect the asset beyond loss of exclusivity.” For clients developing molecules with patents close to expiration, composition-of-matter IP tied to the drug product itself is increasingly relied upon as a way to extend protection. By designing tailored formulations that address issues such as bioavailability, stability, and manufacturability, companies can often create unique, patentable compositions that simultaneously meet therapeutic and commercial needs.

Miller also underscores the role of proprietary platforms in providing what he calls “perpetual protection against generic competition.” Even when generics attempt to work around a formulation, they often lack access to the specialized processing technologies required to replicate the performance of the innovator product. This technological barrier, he notes, can provide a lasting competitive edge beyond traditional regulatory exclusivity.

Ultimately, Miller frames the role of a CDMO not as a transactional service provider, but as a true development partner. From the earliest design of a formulation through to commercialization, the goal is to deliver therapeutic benefit while ensuring long-term protection of the asset.

Check out previous parts of the interview series with Miller:

Part 1 - Collaborative Innovation in CDMOs: Dave Miller, PhD, on Early Engagement, IP Strategy, and Advanced Formulation

Part 2 - The Importance for CDMOs of Partnering With a Sponsor’s Mindset

Part 3 - Onshoring’s Unexpected Benefits: Quality, Efficiency, and Supply Chain Resilience

Part 4 - Sustainability Becomes Essential: Green Manufacturing and Supply Chain Resilience in Bio/Pharma

Dr. Miller brings over two decades of pharmaceutical development experience and has spent his career investigating ways to improve the bioavailability of poorly soluble molecules. As CSO of AustinPx, Dr. Miller leads the pharmaceutics and analytical development teams and oversees the application of the KinetiSol Technology. Prior to his current position, Dr. Miller served as Vice President of Research and Development at DisperSol Technologies and Senior Principal Scientist at Hoffmann-La Roche. Dr. Miller specializes in formulation and processing technologies for improving oral bioavailability of insoluble small molecules. He has applied his expertise toward advancing numerous drug candidates through all stages of development from early discovery to line extension. Dr. Miller is a co-inventor of the pharmaceutical applications of the KinetiSol technology and continues to be a key innovative driver for application and expansion of the platform. He has published over 40 research articles in peer-reviewed journals, authored 8 book chapters, and is co-editor of the First, Second, and Third Editions of the textbook, Formulating Poorly Water-Soluble Drugs. He is a co-inventor on numerous granted and pending patents worldwide. Dr. Miller holds a BS in Chemical Engineering and a PhD in Pharmaceutics from the University of Texas at Austin.

We deal with a lot of clients that have IP in the forefront as they're developing the delivery system for their molecule. So now the IP strategy is part of the formulation strategy. It's not just about solving the drug delivery problems but also generating additional IP to protect the asset beyond loss of exclusivity. And some of the clients that come to us have molecules that have been in clinical development for a long time. And, and so by the time they reach market, the IP protecting the molecule itself will be near expired.

So then we really rely on the drug product composition of matter IP to protect the asset beyond loss of regulatory exclusivity. So we do a lot of front end evaluation of the formulation development plan with IP in mind. But as I said, it's not about developing a formulation just to achieve IP.

When you develop a tailored formulation development program and a tailored composition specific to the issues of that molecule, and you do it right and you do it well, you solve the bioavailability, stability, manufacturability issues simultaneously. A natural side effect of that is the composition that you've generated specific to that molecule is novel. It's unique, it's patentable. And so IP is attainable when you take that approach, but also even without the IP, when you are using novel platforms like we have that aren't accessible to generics, even if they could formulate around, they still don't have the underlying processing tools to create that composition, to generate those performance metrics. Without access to our platforms they have generics that can't copy the performance of the product. They might be able to circumvent the formulation, but they can't achieve the same performance metrics. So that ultimately ends up being what I like to call perpetual protection against generic competition.

As long as the generic can't access the tool that makes it possible, that could never duplicate your product, and that's very attractive for a number of our clients for which drug product IP is essential to the development. Again, it's not just about, as a CDMO, transactional services, providing the pills on time for the clinical study. It's about co-development, starting at the front end with the full development pathway in mind, all the way to the commercial future of the molecule. And IP is right there at the forefront of those early considerations. So, that's the approach we take. And, again, being a sponsor ourselves, whenever we initiated a new program, especially when you're working on 505(b)(2) molecules, developing the formulation that not only checks the boxes in terms of providing therapeutic benefit and then meeting sort of the standard criteria of stability manufacturability, but also, once we prove the therapeutic benefit in the clinic, are we going to have a duration of exclusivity that allows the investors to recoup their investment?

Those were the key requirements when we started developing our own products. And so we just naturally bring that to the table that we can design a delivery system that provides more than just meeting the standard requirements of a dosage form, but also providing IP that could protect the asset for, you know, a decade after loss of exclusivity. So, it's becoming critical to a large majority of our clients and programs.

Dave Miller, PhD, explains how environmental audits, waste reduction, and supply chain security are reshaping priorities in pharmaceutical manufacturing.



In part 4 of our 5-part interview series on the current CDMO landscape, Dave Miller, PhD, chief scientific officer at AustinPx, discusses the growing centrality of sustainability in pharmaceutical manufacturing, noting how it has shifted from a peripheral concern to a core industry requirement. He observes that over the past five years, eliminating harmful solvents, reducing carbon footprints, and strengthening supply chain resilience have moved from “nice-to-have” benefits to mandatory criteria for many large pharmaceutical companies. “The conversation on sustainability… has changed dramatically,” Miller says, pointing to evolving client expectations and more rigorous environmental audits.

He explains that sustainability now factors into multiple aspects of drug product development, from the choice of manufacturing processes to the selection of raw materials and excipients with lower environmental impact. Clients increasingly examine how CDMOs handle waste streams, ensure responsible disposal of pharmaceutical byproducts, and minimize reliance on energy-intensive inputs. Miller notes that these environmental measures are not just regulatory or ethical requirements but also a competitive differentiator, especially for domestic CDMOs whose practices are transparent and verifiable compared with some overseas operations.

The shift toward sustainability is also linked to supply chain security. By reducing dependency on certain inputs and adopting greener, more efficient manufacturing processes, companies can mitigate risk while meeting environmental goals. For Miller, this convergence of operational resilience and environmental responsibility marks a significant transformation in the way the industry defines quality and long-term value.

And be on the lookout for part 5 to drop on Monday, August 18!

Yeah, that's a good question, and it's taken on some different nuances for us. What's near and dear is our KinetiSol technology. Its origins are in the plastics recycling space. So, as the history of the technology, I was a graduate student at the University of Texas, my co-inventor, Chris Brough, was an industrial engineer, developing a novel plastics recycling technology. He'd actually already developed it and was commercializing it at the point when I met him and recognized the value in that technology for creating novel pharmaceutical compositions, but also in doing so as a side effect, it was like, if we could utilize this platform, as opposed to traditional platforms like spray drying in pharmaceutics, we could eliminate a lot of solvent waste. So, the origins of the technology were already in recycling and trying to conduct manufacturing and improve in a more environmentally friendly way, to improve the environment.

It was sort of a green approach when we started back in 2007, but when we brought it over into the pharmaceutical industry, and one of the key advantages aside from the compositions we could create was we're eliminating solvents… this is gonna be great. All these chlorinated solvents that are being used to create these formulations, all these toxic solvents, the energy that goes into evaporating and recovering solvents, we're eliminating all of that.

And we thought that back in 2007, up until for several years thereafter, we thought that was a disadvantage. But when we would talk to large pharma partners, it's a nice to have, right? It's ultimately, we need the product, but if in turn you can also eliminate solvents and it's more environmentally friendly, that's a small cherry on top.

But that conversation has changed dramatically in the last five years, where eliminating solvents and being more environmentally friendly and reducing carbon footprint and shoring up the supply chain by eliminating some, some key inputs to the manufacturing process that you no longer need to consider, that's become extremely important now.

So, the conversation’s changed. From when we started to where we are now, that sustainability requirement has not just a check checkbox; now, it's mandatory. A lot of our large pharma clients that have historically used organic solvents in their drug product manufacturing, particularly to enable molecules, are now actively pursuing greener options.

And we just find ourselves in the right place at the right time. So, starting with our KinetiSol technology, we are seeing sustainability as being key. And, also, our clients audit us to ensure that we're good global citizens and that we handle our waste streams appropriately. We have all the environmental measures in place to ensure that, you know, we're not dumping pharmaceutical waste into bodies of water nearby, and I think that's another differentiator in the CDMO space for domestic versus, say, Eastern markets. You're never really exactly sure, what their sustainability practices are, but for us, it's part of the audit process now is seeing how we handle our waste streams. So, yeah, the conversation on sustainability with respect to environmental friendliness has changed dramatically.

And I think we were always there at the start. Our focus was to move a green technology to the forefront. And then sustainability has also sort of shifted into, as I touched on before, shoring up the supply chain, making sure that the inputs to your manufacturing process are also green, sustainable, and again, with processes like our KinetiSol, you can eliminate things like organic solvents, the need for purified nitrogen, , utilizing excipients that don't require the same sort of energy consumption and the carbon footprint to create. I think it's really important. Like I said, we've seen a sea change in sentiment with respect to green technology from when we started to today, and it's becoming an area where we are ahead of the competition in terms of winning new business. When they look at our approach to green manufacturing and recognize we've been here all along, ringing that bell, and it's more than just a cherry on top now. It's essential. It's a foundation.