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Better use of available data can add rigor to analyzing managed-markets contracts, thereby allocating rebates / discounts more effectively

A Data-Driven Approach to Contract Performance Monitoring and Analysis

The management of lung cancer brain metastases has seen significant advancements, with a focus on personalized treatment strategies. The integration of targeted therapies and immunotherapies has improved patient outcomes, offering more effective and less invasive options compared to traditional methods. Stereotactic radiosurgery and whole-brain radiation therapy remain crucial, but their roles are evolving with the advent of novel systemic therapies. Multidisciplinary approaches are essential for optimizing treatment plans, considering factors such as genetic mutations, patient performance status, and overall prognosis. Continuous research and clinical trials are vital for further progress in this field.

This whitepaper presents a structured analysis of prior authorization outcomes for RA treatments requiring medical benefit coverage. It examines real-world access barriers from the perspective of payer decision patterns, documentation requirements, site of care, and plan type. Unlike claims-based studies or survey-based research, this analysis draws from actual prior authorization cases, providing a direct window into the real-world challenges faced by prescribers and patients alike.

New Data Reveals What’s Behind Delays and Denials in RA Care

The management of lung cancer brain metastases has seen significant advancements, with a focus on personalized treatment strategies. The integration of targeted therapies and immunotherapies has improved patient outcomes, offering more effective and less invasive options compared to traditional methods. Stereotactic radiosurgery and whole-brain radiation therapy remain crucial, but their roles are evolving with the advent of novel systemic therapies. Multidisciplinary approaches are essential for optimizing treatment plans, considering factors such as genetic mutations, patient performance status, and potential side effects. Ongoing research continues to refine these strategies, aiming for improved survival and quality of life.

Case study on how one mature/late stage biopharmaceutical brand leveraged SamaCare’s insights and intervention platform to decrease administrative related discontinuations of their drug and maintain market share during a biosimilar release. 

How One Brand Protected Market Share Amid Biosimilar Pressure

The management of lung cancer brain metastases has seen significant advancements, with a focus on personalized treatment strategies. The integration of targeted therapies and immunotherapies has improved patient outcomes, offering more effective and less invasive options compared to traditional methods. Stereotactic radiosurgery and whole-brain radiation therapy remain crucial, but their roles are evolving with the advent of novel systemic treatments. Multidisciplinary approaches are essential for optimizing care, emphasizing the importance of collaboration among oncologists, radiologists, and neurosurgeons to tailor interventions based on individual patient profiles and tumor characteristics.

Case study on how a neuro biologic brand leveraged SamaCare’s insights and interventions platform to decrease patient access friction and improve patient starts. 

How One Neuro Brand Cut Through Prior Auth Barriers

 has reported that Catalent, a global contract development and manufacturing organization (CDMO), is downsizing. The CDMO cites an “unexpected shift in demand from a large customer,” and will be laying off 350 employees from its Baltimore gene therapy plant.

Although the client is currently unknown, Sarepta Therapeutics, a genetic medicine company, is based at that location.

“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 Catalent spokesperson told 

. “It is never easy to see talented colleagues leave Catalent and we remain committed to providing them transition support as they manage this change.”

Novo Nordisk completes $16.5 billion Catalent acquisition

Catalent’s ownership changed hands last year, after Novo Holdings, Novo Nordisk’s parent company, agreed to acquire the CDMO in a $16.5 billion deal.

The deal officially closed in December 2024.

Per the transaction, Novo Nordisk purchased three manufacturing sites that Novo Holdings acquired from Catalent. Novo Nordisk paid out a combined $11 billion to its parent company for the three plants.

Novo Nordisk president and CEO Lars Fruergaard Jorgensen commented at the time of the annoucement that, “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. 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.”

These sites house fill-finish processes and will contribute to the increased supply of Wegovy.

Rising role of CDMOs and outsourced manufacturing

The news comes at a point when the industry—particularly pharma manufacturing—has been gaining momentum, especially due to the role of CDMOs and contract manufacturing organizations (CMOs).

“The pharmaceutical manufacturing market has been undergoing significant growth since 2015 and is divided between and CMOs,” noted Bruce Phelan, a senior partner with Blue Fin Group, in an interview with 

 “There has been a significant shift of pharmaceutical manufacturers core competencies, especially in manufacturing expertise and increased sophistication of complex products, and an increased reliance on CDMOs and CMOs for capacity and expertise, inclusive of API manufacturing as well as finished goods manufacturing.

“As such, small and large pharmaceutical companies have increased their outsourcing to their drug manufacturing CDMO or CMOs partners because they need access to manufacturing capacity or technological manufacturing capabilities beyond what they have within their in-house manufacturing capabilities and capacities and to mitigate potential risk of under supply or low yield. The global need for manufacturing capacity and technical expertise has significantly accelerated over the past seven to eight years and furthermore during the pandemic … Purchasing and vertically integrating a CDMO or CMO into pharmaceutical manufacturers supply chain is worth considering dependent upon the need for increased/excess supply of the finished goods (product), specific manufacturing requirements, the need for excess or increased capacity based on commercial product forecasting, and to manage downside risks of the lack of outsourced manufacturing capacity or the trained personnel to operate sophisticated manufacturing processes.”

FDA setbacks highlight manufacturing challenges

However, the potential for CDMO and CMO growth aside, the FDA had issued a second complete response letter (CRL) to Regeneron’s odronextamab, based on issues with one of the aforementioned third-party manufacturing sites that had been purchased by Novo.

Regeneron’s Biologics License Application (BLA) is seeking the approval of odronextamab for the treatment of relapsed/refractory (R/R) follicular lymphoma (FL) and for R/R diffuse large B-cell lymphoma (DLBCL) following two or more prior lines of systemic therapy.

1. Brown A. Catalent Lays Off 350 Workers Over Change on Demand From a ‘Large Customer.’ 

. August 20, 2025. Accessed August 20, 2025. 

https://endpoints.news/catalent-lays-off-350-workers-over-change-in-demand-from-a-large-customer/

2. Hollan M. Novo Nordisk’s Parent Company to Acquire Catalent To Boost Supply of Wegovy. 

. February 5, 2024. Accessed August 20, 2025. 

https://www.catalent.com/catalent-news/novo-holdings-completes-acquisition-of-catalent/

3. Novo Holdings Completes Acquisition of Catalent. Catalent. December 18, 2024. Accessed August 20, 2025. 

4. Hollan M. What Novo Nordisk’s Purchase of Catalent Means for the Industry. 

. February 14, 2024. Accessed August 20, 2025. 

https://www.pharmexec.com/view/novo-nordisk-purchase-catalent-means-industry

5. James D. Regeneron Faces FDA Setbacks with CRL for Odronextamab, Delays on Eylea HD BLA Amid Third-Party Manufacturing Issues. 

. August 1, 2025. Accessed August 20, 2025. 

https://www.pharmexec.com/view/regeneron-fda-crl-odronextamab-eylea

Catalent is downsizing due to an unexpected demand shift from a major client, resulting in 350 layoffs at its Baltimore gene therapy plant. Novo Nordisk recently acquired Catalent in a $16.5 billion deal, enhancing its manufacturing capabilities for diabetes and obesity treatments. The pharmaceutical industry is increasingly relying on CDMOs and CMOs for manufacturing expertise and capacity. Despite growth potential, challenges persist, as evidenced by FDA setbacks for Regeneron's odronextamab, linked to issues at a Novo-acquired manufacturing site.

The CDMO will be cutting 350 jobs at its Baltimore gene therapy site after a major client’s demand shift, less than a year after Novo Holdings’ $16.5 billion acquisition.

Catalent to Lay Off 350 Workers at Baltimore Gene Therapy Plant 

 the White House and European Union today revealed a framework for a deal centered around “reciprocal, fair, and balanced trade” that is expected to get into effect Sept. 1 of this year. Although the agreement covers all imported goods coming from the EU, pharmaceuticals fall under a distinct set of regulations.

The United States will be applying the higher of either the most-favored nation (MFN) tariff rate or a duty of 15%, so basically, tariffs will not be higher than the aforementioned 15%. This includes generic pharmaceuticals, their ingredients, and chemical precursors, stemming from President Trump previous July announcement from President Trump reaching a formal trade agreement with the EU in which a maximum 15% levy would be imposed on “most” EU exports, including autos and their parts; semiconductors; and pharmaceuticals.

 The EU will also be investing $600 billion in the US and purchasing $750 billion worth of US energy exports through the year 2028.

Shifting tariff proposals earlier this year

The development comes amid the multitude of changes that have transpired over the course of six months beginning in early February, when President Trump announced that the US planned to approve a tariff of 25% or higher on pharmaceuticals.

 That number then skyrocketed to as high as 250%—a new high—which Trump had revealed in an interview with CNBC’s “Squawk Box.”

Potential impact on the pharma supply chain

, Dave Malenfant, a healthcare supply chain expert, discusses the potential impact of a proposed 250% tariff on pharmaceutical imports, emphasizing that the effect depends heavily on where in the supply chain the tariff is applied. If imposed on active pharmaceutical ingredients (APIs), the impact would be minimal, as APIs contribute relatively little to the total cost of a finished drug and adjustments could be made through negotiation.

However, if applied to finished pharmaceuticals or key components—such as bottle plugs, closures, molded parts, and glass—the cost implications could be significant, since these materials represent a substantial portion of overall manufacturing costs.

“It depends where the tariff is applied. If you're talking about the active pharmaceutical ingredients, they'll have very minimal impact, as you get into the royalties and all that,” he explained. “When you look at the cost of a pharmaceutical product, a lot of the cost is not in the active ingredient, as much as the components to package it in the processing. If we are buying a finished pharmaceutical and it's got a 250% tariff on it, and the proposed regulation says that there will not be a duty drawback, because right now, on a lot of pharmaceuticals, you have duty drawback, which means you pay duty upfront, and then you can go and apply to the government and draw back.

"What that does is it will have a direct impact throughout the entire supply chain, but at the same time, it's telling the US, why aren't we making these pharmaceuticals in the United States? Most of the research and development has been done in the United States, but then we export it out to cheaper countries to make the product, and they import it back in, such as Singapore—I’m not going to talk about India, because India is a unique situation—or other countries, and then we import it back in trying to distribute it within the United States. … I think if we're going to sell in United States, I firmly believe that we should make it in United States.

1. Hollan M. White House and European Union Announce Long-Awaited Details on Pharma Tariffs. 

. August 21, 2025. Accessed August 21, 2025. 

https://www.pharmexec.com/view/white-house-european-union-details-pharma-tariffs

2. Saraceno N. As Trump Pharma Tariff Deadline Looms, Here's How the Sector Got Here. 

. July 31, 2025. Accessed August 21, 2025. 

https://www.pharmaceuticalcommerce.com/view/trump-pharma-tariff-deadline-looms-how-sector-got-here

3. Saraceno N. Trump: Tariffs Could Potentially Hit 250%. 

. August 7, 2025. Accessed August 21, 2025. 

https://www.pharmaceuticalcommerce.com/view/trump-tariffs-could-potentially-hit-250

The new framework, set to take effect Sept. 1, limits tariffs on pharmaceutical imports to 15% but follows months of shifting proposals, including threats of tariffs as high as 250%.

White House and EU Finalize Trade Deal With 15% Cap on Pharma Tariffs

As personalized medicine moves from innovation to mainstream, the burden of precision delivery falls on third-party logistics providers (3PLs) and carriers. These therapies are not one-size-fits-all—they are custom-built treatments based on an individual’s genetic makeup, lifestyle, and environment. The goal is maximum efficacy through highly tailored care.

What was once a standardized approach to medication is now an individualized therapy, and that transformation demands a delivery system as specialized as the treatment itself. Every shipment must arrive intact, temperature-controlled and on time because with personalized medicine, even minor lapses can compromise patient outcomes.

Unlike traditional medications, personalized therapies can't be quickly replaced if a shipment fails. Reproducing a customized treatment takes time—a delay that can be critical for patients often battling serious illnesses. For them, a missed dose isn't just inconvenient; it can mean a setback in treatment or a missed window for optimal effectiveness.

With the drug delivery industry continuing to grow, forward-thinking carriers are strengthening their chain of custody and increasingly adopting tools like predictive analytics, temperature-controlled packaging, and real-time tracking to keep shipments safe enough to withstand long-distance travel.

Below are some areas for providers and logistics companies delivering personalized medicines to consider.

Law aims to protect the integrity of medication

Protecting the integrity of medications, especially personalized ones, requires in-depth knowledge of industry legislation.

The Drug Supply Chain Security Act (DSCSA), enacted by the FDA regulation in 2013, was designed to safeguard the US pharmaceutical supply chain from counterfeit, contaminated, stolen, or otherwise harmful drugs. It helps protect patients from receiving incorrect or injurious drugs, enhances the security of our nation’s drug supply, and enables a more seamless flow of data between supply chain partners.

While this regulation applies to all prescription drugs, its importance is amplified when it comes to personalized medicine. Every product must be traceable, from manufacturer to pharmacy, using serial numbers and detailed documentation. Carriers must not only understand this legislation but actively ensure their systems and partners align with it to avoid breaches that could compromise patient safety.

Yet not all stakeholders fully comply, and I have experienced gaps in execution firsthand.

Challenges in home delivery of personalized medicines

A decade ago, a family member of mine asked that an injectable drug be delivered to her home. However, the driver left her mediation in the mailbox like it was a bill or a magazine, even though it was temperature-sensitive and should have been brought to the door. Medications like this one can become ineffective or unsafe if left in extreme heat or cold.

Although those delivering pharmaceuticals are better trained today, 3PL providers must ensure drivers are properly instructed so that they don’t drop custom-engineered treatments and dash. Major carriers have the necessary infrastructure to move medications within and between metropolitan areas, but it gets trickier and costlier when the carrier must deliver pharmaceuticals to rural areas and only has the time to make a handful of stops.

In this scenario, the company might outsource the delivery to an independent contractor. If so, the smaller delivery service must understand the importance of correctly delivering temperature-sensitive medications. Otherwise, the driver could place the delivery on the front porch, out in the elements, or in the mailbox like what happened with my family member.

And while all medications should arrive intact and on time, the stakes are especially high when the treatment is personalized and tailored to an individual’s specific health needs.

To prevent missteps like these, carriers should:

Review and reinforce contracts with third-party delivery partners.

Ensure all drivers are trained in handling temperature-sensitive treatments.

Conduct routine audits to maintain compliance and quality standards.

Tracking technology provides real-time visibility

Today’s packaging and tracking technologies give consumers real-time visibility into their deliveries, a major leap from the static updates of five to 10 years ago. Mobile apps, GPS tracking, and instant notifications now offer moment-by-moment insights into a package’s journey, while smart sensors monitor conditions like temperature along with shock and humidity, which are critical for sensitive items like personalized medicines.

Beyond just tracking location, modern systems also predict potential delays and proactively communicate changes, building greater trust and confidence. In a world where speed, safety, and convenience drive consumer loyalty, real-time transparency is an expectation rather than a luxury.

In addition to enhancing transparency, these technologies are crucial for protecting the integrity of sensitive shipments, especially personalized medications that demand controlled temperatures and careful handling.

Many medications require strict temperature control to maintain their effectiveness, potency, and safety. Proper packaging plays a crucial role in ensuring that these medications remain stable during storage and transportation. This might include passive cooling systems like insulated boxes with gel packs or dry ice, or it could even include active systems like refrigerated shipping containers that maintain temperature control. Other options exist—think smart packaging that contains temperature sensors and GPS tracking for real-time monitoring.

Medications that include vaccines, biologics, and insulin often become ineffective or unsafe when exposed to temperatures that are too hot or too cold. This is because fluctuations in temperature can cause chemical or structural changes that render them ineffective. Insulin, for example, must be stored between 36°F and 46°F because exposing it to heat or freezing can cause it to lose its potency, making it less effective for blood sugar control in diabetes patients.

To mitigate risks, carriers are increasingly using predictive analytics to anticipate and adapt to disruptions. Whether it’s a snowstorm or extreme heat, these tools help reroute deliveries and preserve medication integrity.

Ensure quality of care every step of the way

As medicine becomes more individualized, the expectations placed on the delivery infrastructure rise as well. Logistics providers are no longer just moving packages—they are delivering highly sensitive and patient-specific therapies that often represent a critical part of someone’s care plan.

Meeting this challenge means investing in better training, more advanced technology and stronger partnerships throughout the supply chain. It requires a culture of accountability and precision at every touchpoint.

Personalized medicine is redefining healthcare. To fully realize its potential, the systems that deliver it must be equally modern, responsive and reliable.

Tim McClatchy is Vice President of Life Sciences at Kenco.

The shift towards personalized medicine necessitates a specialized delivery system, placing significant responsibility on third-party logistics providers and carriers. These custom-built treatments require precise handling, as any lapse can compromise patient outcomes. The Drug Supply Chain Security Act emphasizes the importance of traceability and compliance, especially for personalized therapies. Advanced tracking technologies and predictive analytics are crucial for maintaining the integrity of sensitive shipments. As medicine becomes more individualized, logistics providers must invest in training, technology, and partnerships to ensure reliable delivery of patient-specific therapies.

As this medical approach continues to become more widely adopted, the industry must adapt to help provide precise, compliant, temperature-controlled delivery of highly individualized treatments.

Carlos Moreira, IMS Health Managed Markets Service

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