Standardizing Operations to Meet Global Sustainability and Resilience Goals

In an interview regarding the presentation “Beyond Traditional Markets: The Strategic Importance of Emerging Pharma Trends and CDMO Innovation” at CPHI Europe 2025, held Oct 28-30 in Frankfurt, Germany, panelist J.D. Mowery, president, Bora Pharmaceuticals, offers insights into critical trends shaping the biopharmaceutical industry, drawing on his 25 years in the sector. The discussion focused on evolving supply chains, regulatory needs, macroeconomic forces, and the accelerating integration, but also the operational hurdles, of artificial intelligence (AI), the necessity of establishing global standards for sustainability, and the need to increase trust in outsourcing partnerships.

PharmTech: How is the sector reimagining supply chains to protect against rising tariffs, geopolitical shocks, and global disruptions?

J.D. Mowery: When considering the CDMO sector, the biopharma industry, and geopolitical concerns like tariffs, we are seeing a pivot toward localized supply chains. Many organizations are looking to execute clinical trials and conduct as much work as possible within the region where they operate.

At Bora, we have the advantage of executing this strategy on a global scale across our different regions. For instance, our sites in Mississauga and Maple Grove have commonality, allowing us to serve the APAC region there or conduct a tech transfer to handle services within the US region. These pressures—similar to how people reacted to COVID and constraints on crossing borders—are expected to remain in place for at least the next three to five years.

What role should regulatory harmonization play in ensuring timely access to critical medicines during cross-border disruptions?

Regulatory support is crucial during constraints like tariffs or border shipping issues. As an industry, we already understand the value of reciprocity among different regulatory agencies and the importance of having common standards so that treatments and therapies are treated equally within a given country.

The more regulatory bodies work together to achieve common standards and recognize one another's work, the greater the benefits. This cooperation results in cost savings for countries, cuts down on factors like greenhouse emissions (by reducing travel), and ensures that local regulators, especially where language barriers exist, are better equipped to perform proper facility assessments. Reciprocity was always important, but current disruptions further exemplify why it is essential.

How can public–private partnerships be structured to not only address immediate shortages but also incentivize long-term resilience in pharmaceutical supply chains?

The economic conditions of the last few years, sometimes referred to as the "biotech freeze" or "pharma freeze," have shifted the landscape. Several years ago, capital could often be raised with less robust data, sometimes based more on an idea or philosophy. Now, much more robust data is necessary to secure capital and allow clinical trials to progress.

This requirement for robust data is viewed as a positive development because the resulting products and therapies are stronger and more data-founded. This ecosystem now allows the public and private sectors to focus on the right therapies and ensure they reach commercialization. Ultimately, the patient benefits because they can have greater faith in the outcomes derived from clinical trials. While competition for market share remains relevant, there is also an opportunity for entities to focus on their core strengths.

Where do you see the greatest potential for innovation that could safeguard medicine security without significantly increasing costs?

The greatest potential for innovation lies with AI. AI is being globalized faster than electricity or the internet. If the correct AI system is implemented, it offers "almost passive knowledge" that can be continuously fed data. AI can be leveraged across all areas, including supply chain management, sales and marketing, operational efficiencies, and drug discovery. AI's ability to process, analyze, and synthesize data into a useful format allows decisions to be made in a fraction of the time, requiring fewer man hours than previously needed.

For instance, AI can be used for something as simple as authoring a Biologics License Application. It can distill the information accumulated during process validation and PPQ development to create a regulatory dossier much faster. This speed leads to cost reduction and allows products to flow through and gain approval more quickly. We view AI not as a threat of job displacement, but as an opportunity to amplify our employees' capabilities by providing a strong tool to leverage their deep expertise. I believe this is the biggest innovation opportunity we will see in my lifetime.

What barriers exist to wider adoption of AI in bio/pharma?

A major challenge is that many organizations do not fully appreciate how dispersed or disparate their systems and data are until they begin the implementation journey. Significant effort—or inertia—is required upfront to consolidate and cleanse the data before it can be leveraged to get the full benefits of AI. Companies often realize they are further away from starting than anticipated once they assess their systems.

This difficulty can make it challenging for organizations to defend the investment, as they are often looking for the ROI as quickly as possible. This situation is comparable to the introduction of electronic batch records: converting poor paper records to a digital format simply results in a poor digital format. Therefore, companies must undertake the "housekeeping and cleanup" to establish a solid foundation, focusing on data cleansing, data hygiene, and creating a good, solid data lake before they can fully realize the benefits of AI.

How can industry and governments simultaneously improve resilience and meet environmental targets?
Implementing set global standards is crucial. Operating facilities, supply chains, and shipping all impact the environment, and if everyone measures themselves against a single set of goals, it will be very important for progress.

Standardization simplifies the process for the biopharma sector when choosing CDMO partners, ensuring they operate against the same environmental criteria used in the biopharma companies' own facilities. Whether applying standards across innovators and CDMOs or across different countries and regions, this harmonization allows everyone to be "on the same sheet of music" regarding environmental impact and sustainability. When people measure using multiple scales, initiatives, and methodologies, it becomes very difficult to compare and contrast performance.

Achieving standardization is a heavy task, requiring deliberate effort. It involves getting people aligned and understanding the value of harmonization. Just like regulatory bodies striving for reciprocity, the process requires identifying the "right bar," selecting the best practices from the best actors, and creating one primary set of standards that most entities are comfortable working with.

Talk about your CPHI Frankfurt presentation.

The presentation will be an opportunity to discuss how we can better serve the sector. Other industries, like the automotive and computer industries, are much more mature when it comes to outsourcing compared to biopharma. From a cost perspective, the biopharma industry should be outsourcing more, allowing CDMOs to distribute overhead costs across multiple customers and SKUs, rather than companies building facilities to manufacture only one or two drugs.

The primary reason this hasn't happened is that the CDMO sector is still working to gain the trust of the biopharma industry. At Bora, we focus on building this trust by maintaining an extremely strong "on time in full" performance, with most of our sites exceeding 95%. Biopharma companies rely on this trust to ensure they have their product when needed for commercial distribution or clinical trials. Gaining this trust will be a key point during the presentation.