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This serialization system represents a business imperative that yields significant competitive advantages.

Serialization 2.0: Why It’s Time to Upgrade, and What’s at Stake

Tasked with the delivery of two ultra-sensitive gene therapies to Japan – treatments targeting vision loss that required continuous -80°C temperature control and dry ice replenishment throughout an 80-hour transit – Marken activated a customized, precision-driven supply chain strategy. Navigating one of the world’s most complex regulatory landscapes for advanced therapies, success depended on flawless execution, specialized handling protocols, and seamless cross-functional collaboration.
So how did Marken overcome these high-stakes challenges – ensuring the integrity of these transformative therapeutics while exceeding client expectations? Read the full case study to find out.  


Marken’s Precision Logistics Expedites Delivery of Critical Gene Therapies to Japan

When a South Korean patient needed a life-changing gene therapy, Marken orchestrated an international distribution strategy under the strictest regulatory and temperature specifications. With precise temperature-control required at -80°C with dry ice, Marken’s teams navigated weekend scheduling, specialized package handling and final-mile complexities to ensure the vital treatment remained on schedule with white glove service from pick up to final mile delivery. Discover how Marken made it happen. 

Marken’s Precision Logistics Accelerate Life-Changing Therapy Delivery to Patient in South Korea

Informa’s Access USA conference from Philadelphia continued with its first panel discussion of the conference. Amy Niles, chief mission officer of the PAN Foundation—a national charitable foundation and healthcare advocacy group—was joined by Bill Allen, a patient and family advisory council member with PAN Foundation; Susan Neff, aging services supervisor and SHIP/MIPPA with the Pennsylvania Department of Aging; and Dan Sherman, founder and president of the NaVectis Group, and a financial navigator for Lacks Cancer Care.

Titled “Moving the Needle on Awareness of the Medicare Part D Reforms,”

 its name does a wonderful job of foreshadowing potential coverage points. The premise of the session dates back to fall of last year, when the PAN Foundation conducted a national poll expressing that 87% of Medicare beneficiaries had not seen, read, or heard any sort of information concerning about the Medicare Part D reforms that took effect Jan. 1, 2025. Since that time, this year, PAN decided to once again release a poll with Medicare beneficiaries as a way to measure the value of educational outreach, so this session provided a deeper dive into these efforts.

Specifically, PAN Foundation wanted to understand the awareness and knowledge levels of Medicare beneficiaries both before and after CMS conducted its outreach in advance of the Medicare Part D cap—which ensures that individuals with Medicare Part D plans will not pay more than $2,000 in out-of-pocket costs for covered prescription drugs within a year—and the Medicare Prescription Payment Plan (M3P).

There were two waves of research, including:

 Research conducted in June 2024 with 1,006 adults on Medicare/Medicare Advantage

 Research conducted in January 2025 with 1,001 adults on Medicare/Medicare Advantage

After analyzing both waves, these only represent a sliver of the findings, but the awareness of both reforms increased by 27% from June 2024 to January 2025, while awareness among all the surveyed groups (people with chronic conditions, people with disabilities, those eligible for the Low-Income Subsidy, white Medicare beneficiaries, and Medicare beneficiaries of color) also rose. Further, 66% of Medicare beneficiaries want to learn more about these reforms.

Beneficiaries are no more or less likely to believe the Part D reform or the M3P would be personally helpful to them.

Regarding Part D findings, over 1 in 3 Medicare beneficiaries (35%) reported unaided awareness of the cap, an increase from 1 in 10 (11%) in Wave 1. When aided (having a description of what the reform entails), nearly 7 in 10 (69%) realized they’ve heard of it, an increase from 40% in Wave 1, while 37% are at least somewhat familiar, up from 14% in Wave 1.

“I think the Part D cap is particularly helpful for the individuals with rare diseases, chronic diseases,” said Niles. “They're used to spending thousands and thousands of dollars out of pocket, and now, that has come down to $2,000. It's going to be very beneficial for that individual. Tommy [Bramley] also talked about the peace of mind that it gives people. That is true. You never know when you may be diagnosed with a chronic disease or a rare disease, and having that peace of mind is very helpful.”

In terms of the Medicare Prescription Plan (M3P), which allows one to spread OOP prescription drug costs over the course of a year as opposed to paying them all at once at the pharmacy, there continues to be a lack of understanding—2 in 5 beneficiaries still don’t under the plan well. And arguably even more shocking—1% of the people polled by PAN have opted into the payment plan to date.

When asked about his experience with opting into M3P and as an individual Niles that could benefit from the Part D cap, benefit, Allen—who’s been living with prostate cancer since 2004—described his experiences from a patient perspective.

“Well, the first thing that you encounter is that being retired and then having to have access to medications is very expensive for my disease. The most typical thing was you get inundated with a lot of papers at the beginning of the October enrollment period,” he explained. You're getting your annual notice of change from Medicare. You're getting information from agencies to pick a supplemental or advantage plan—there're a lot of steps. There's a lot of salesmanship going on at this time when you're trying to make a decision.

“… I'm on Medicare with an insurer supplement. My wife is on Medicare with another insurer. I got a letter in the mail. She got a conversation from a physician's assistant in the doctor's office. She felt like, 'I don't know what this means.' I got a five-page letter, and I'm trying to read through and make a decision, do I opt in or opt out. We never thought to communicate together because we thought this only applies to my plan. And when I asked her about it, she said, ‘I had no idea what it meant.’ … So that's a lack of communication just in a household. Can you imagine what the communication is in mass?

Niles then posed the question to the panel: if you had the opportunity to speak to Congress or to speak with CMS, today or tomorrow, what recommendations and changes would you like to see, either with the Medicare reforms or the Medicare Part D design in general?

“We wish that they could change the name from Medicare Prescription Payment Plan to ‘Option’ instead of ‘Plan’ because the word plan also is used for stand-alones for Medicare Advantage and Medigap. … And I wholly agree with what Tommy presented earlier about the stand-alone plans,” Neff commented. “We hope that CMS can bolster them because there are still people who want to have Medigap with a stand-alone. They don't want to go to Medicare Advantage, we're seeing. We only have 14 left, and we see the prices of those plans—with their premiums being very, very high, so we hope that CMS takes some action to bolster those stand-alone plans.”

As for Sherman, it all comes down to education.

“Let's just be honest here, insurance companies are not excited about this program … There is no meat behind the requirement for the Part D enrollee to actually reimburse the insurance company,” he pointed out. “The only thing that can happen is that they'll kick them out of the prescription payment plan. I think I read somewhere that they're predicting at least a 30% loss in this, that they're not going to get reimbursed … I know providers might not like to hear what I'm going to say, but I would like that there actually is a requirement that providers need to provide education about this, at a certain threshold. It can't be for every single prescription, but for me, to be as proactive as possible is what's going to be the most beneficial.”

1. Niles A, Allen B, Neff S, Sherman D. Moving the Needle on Awareness of the Medicare Part D Reforms. March 18, 2025. Access USA (general session). Philadelphia.

The conference’s first panel offers insight on the current state of awareness among beneficiaries of the Part D cap and Medicare Prescription Payment Plan via the PAN Foundation’s latest research.

Latest Conference Coverage

Access USA 2025: Spreading Awareness of Medicare Part D Reforms 

It’s no secret that for years, critics have commented about the prices for medication in the United States being exorbitantly high. In response to this issue, President Donald Trump yesterday unveiled a new executive order (EO)—"Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients”

—meant to provide an equal playing field by having drug companies match the lower prices they pay for pharmaceuticals in developed countries.

The president believes that that the order could help decrease drug prices by 30% to 80%.

Similar to tariffs in which Trump felt that the United States was not treated fairly when it came to be taxed on certain imports, the EO notes that Americans “unwittingly sponsor” drug manufacturers and other nations.

“The United States has less than five percent of the world’s population and yet funds around three quarters of global pharmaceutical profits,” explained the executive order. “This egregious imbalance is orchestrated through a purposeful scheme in which drug manufacturers deeply discount their products to access foreign markets, and subsidize that decrease through enormously high prices in the United States.

“ … Drug manufacturers, rather than seeking to equalize evident price discrimination, agree to other countries’ demands for low prices, and simultaneously fight against the ability for public and private payers in the United States to negotiate the best prices for patients. The inflated prices in the United States fuel global innovation while foreign health systems get a free ride. This abuse of Americans’ generosity, who deserve low-cost pharmaceuticals on the same terms as other developed nations, must end. Americans will no longer be forced to pay almost three times more for the exact same medicines, often made in the exact same factories. As the largest purchaser of pharmaceuticals, Americans should get the best deal.”

Although drugmakers’ cooperation is voluntary, if changes aren’t seen within 30 days, government programs such as Medicare and Medicaid will work to enable—as 

 describes—DTC purchasing programs for pharma companies to sell medications at most-favored-nation prices. There are also possible tariff implications and action by FDA that could be taken along the avenue of revoking approvals if companies refuse to comply.

 The US market—per Trump—is also considering imports from other nations.

Ways to decrease healthcare costs are encouraged, but industry organizations—including the Healthcare Distribution Alliance (HDA)—are concerned about the pharma supply chain’s lasting future.

“As a sector saving the healthcare system approximately $63 billion annually, HDA and the nation’s pharmaceutical distributors share the Trump administration’s desire to reduce the cost of healthcare for all Americans. However, we are deeply concerned that the MFN approach—including the broadly referenced direct-to-consumer and importation provisions—could negatively impact access for providers and patients, as well as the long-term stability of the supply chain,” commented the organization in a formal statement.

“ … While we have significant concerns about the EO as currently proposed, HDA and all of our members are committed to working with the White House to review and consider policies that lower out-of-pocket costs for American patients while improving access to quality care, supporting innovation, and maintaining a strong and resilient supply chain.”

1. Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients. The White House. May 12, 2025. Accessed May 13, 2025. 

https://www.whitehouse.gov/presidential-actions/2025/05/delivering-most-favored-nation-prescription-drug-pricing-to-american-patients/

2. Lupkin S. Trump signs an order to reduce drug prices, but it's unclear how it would work. NPR. May 12, 2025. Accessed May 13, 2025. 

https://www.npr.org/sections/shots-health-news/2025/05/12/nx-s1-5395625/trump-lower-drug-prices

3. Hollan M. President Trump Announces Most-Favored-Nation Policy for Pharma Prices. 

https://www.pharmaceuticalcommerce.com/view/president-trump-announces-most-favored-nation-policy-for-pharma-prices

4. Hollan M. White House Unveils Pharma Most-Favored-Nation Executive Order. 

https://www.pharmexec.com/view/white-house-most-favored-nation-executive-order

5. HDA Statement on “Most-Favored-Nation” Executive Order. HDA. May 12, 2025. Accessed May 13, 2025. 

https://hda.org/newsroom/2025/hda-statement-on-most-favored-nation%E2%80%9D-executive-order/

Trump anticipates that the executive order will help lower drug prices by 30% to 80%.

White House Introduces Most Favored Nation EO

SK pharmteco, a contract development and manufacturing organization (CDMO), has opened a new, 300,000 square-foot current good manufacturing practice (CGMP) plasmid suite at its plant in King of Prussia, PA.

The project demonstrates the company’s interest in a scalable supply of high-quality plasmids, which are critical in the development cell and gene therapies (CGTs). Plasmids are considered the building blocks for viral vector manufacturing and therapies that treat patients with unmet medical needs.

SK pharmteco’s announcement comes at a time when the CGT field faces obstacles pertaining to reimbursement in the United States. High upfront costs of these therapies can range anywhere from $500,000 to $3.5 million, which creates a challenge for patient access.

“This new cGMP plasmid suite in King of Prussia represents a solid investment in our capabilities and our commitment to the cell and gene therapy sector,” said Joerg Ahlgrimm, SK pharmteco’s CEO. “We understand the vital role that high-quality plasmids play in developing these transformative medicines, and this expansion will enable us to serve our clients better and ultimately contribute to bringing these therapies to patients in need.”

The facility will provide a variety of services, such as process development and plasmid manufacturing. There will not only be four suites working to manufacture three distinct plasmid grades, but two independent aseptic fill-finish operations. It is also expected to provide integrated CDMO and contract analytical testing services, along with an in-house cGMP cell line.

In other plasmid news, the CDMO has also unveiled Plasmid-IQ Design, its branded plasmid engineering platform.

 It intends to enhance genetic constructs and significantly improve their production efficiency and performance.

“Plasmid design is a cornerstone of modern biological research, and optimizing its structure is critical to achieving research and manufacturing goals efficiently,” noted John Lee, global head of cell and gene therapy. “Plasmid-IQ Design addresses often overlooked challenges in plasmid engineering and offers tailored solutions that enhance stability, scalability, and performance. Our collaborative approach leverages deeply nuanced biology while also tailoring that biology to the unique needs of our advanced therapy customers.”

1. SK pharmteco Opens New CGMP Plasmid Suite in King of Prussia, Strengthening Commitment to Cell and Gene Therapy Innovation. SK pharmteco. May 1, 2025. Accessed May 7, 2025. 

https://www.skpharmteco.com/news-insights/press-release/sk-pharmteco-opens-new-cgmp-plasmid-suite-in-king-of-prussia-strengthening-commitment-to-cell-and-gene-therapy-innovation/

2. SK pharmteco Launches Plasmid-IQ™ Design, a Proprietary Plasmid Engineering Platform to Revolutionize Genetic Construct Design. SK pharmteco. May 7, 2025. Accessed May 7, 2025. 

https://www.skpharmteco.com/news-insights/press-release/sk-pharmteco-launches-plasmid-iq-design-a-proprietary-plasmid-engineering-platform-to-revolutionize-genetic-construct-design/

The move bolsters the CDMO’s commitment to cell and gene therapy by incorporating advanced manufacturing and fill-finish capabilities.

SK Pharmteco Debuts New cGMP Plasmid Suite 

Video interview with Omar Hafez about IPAY 2028 and what it means for the industry

From Uncertainty to Opportunity: Navigating IPAY 2028

Omar Hafez, SVP of Market Access at Avalere Health, discusses the upcoming changes tied to the Initial Price Applicability Year (IPAY) 2028—the first year Medicare will include medical benefit drugs in its price negotiations. There are significant implications for therapeutic areas like oncology, immunology, and neurology, and this new pricing model could affect provider reimbursement and patient access. Hafez offers strategic insights for pharmaceutical manufacturers on how to prepare, including understanding the importance of real-world evidence and global pricing strategies.

How the 2028 Medicare drug price negotiations will reshape market access, provider reimbursement, and patient care

Pavel Dimitrov

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