Legal & Regulatory

Traceability

Trade & Brand Protection

Brand & Product Security

Business and Finance

Containers & Shippers

Devices

Software

Cold Chain

Commercial Channels

Artificial Intelligence

Digitalization

Real World Data

Data & Technology

Manufacturing & Packaging

Supply Chain

Logistics & Transportation

Commercialization

Pricing

Trade & Channel

Market Access

Opinion

Adherence

HUB Services

Patient Assistance Programs

Patient Support

News

Pharma Pulse

Academy

Publications

Partner Perspectives

Webcasts

Resources

Conferences

Conference Coverage

Conference Listing

Events

Videos

Podcasts

Editorial Podcasts

Subscribe

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

About Us

Advertise

Editorial

Contact Us

Do Not Sell My Personal Information

Privacy Policy

Terms and Conditions

Pharmaceutical Commerce

Instagram

Facebook

LinkedIn

Threads

Soundcloud

Spotlight

Digital Editions

Security

Asembia AXS25 Summit 

Topics

Data and Technology

Legal and Regulatory

Supply Chain Logistics

1rem

Authors

Steve Gransden, Executive Vice President of Strategy and Solutions for KnipperHealth has spent nearly 25 years in the pharmaceutical/biotech industry. Steve has a very diverse leadership background spanning IT, Operations, Sales and Marketing, Strategic Planning, and Solutions Development. He has worked with countless brands over multiple decades, developing state of the art platforms and, at times re-engineering processes to create more streamlined and efficient solutions. Steve is a subject matter expert in Pharmacy Services across both commercial and non-commercial business.

Launching a new therapy with a direct-to-patient cash model

By combining online with traditional direct-marketing media, manufacturers can accelerate sampling programs even in the face of restricted physician access

Multi-Channel Marketing Carries Sampling Programs Forward

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

Sponsored

In the rapidly evolving landscape of healthcare, Pharma Patient Assistance Programs (PAP) have been a lifeline for many patients seeking access to essential medications. These programs aim to help those who may not be able to afford their prescriptions, ensuring that financial constraints do not become barriers to necessary treatment. However, traditional PAPs have faced numerous challenges, from administrative inefficiencies to delays in service delivery, often resulting in patient dissatisfaction and suboptimal care outcomes.

KnippeRx, an innovator dedicated to transforming Pharma PAPs with cutting-edge solutions tackles these enduring problems. By utilizing advanced technology and a patient-focused strategy, KnippeRx has reimagined the operation of these assistance programs, providing a smooth, efficient, and effective experience for healthcare providers and patients alike. This article will delve into the solutions that are reshaping the industry, highlighting their key features, practical applications, and the future of PAPs.

KnippeRx leads the way in innovation within Pharma PAPs, approaching industry challenges with a fresh outlook. Traditional programs often grapple with cumbersome manual tasks, resulting in backlogs and delays that can impede patient care. KnippeRx’s strategy emphasizes streamlining these processes through state-of-the-art technology aimed at optimizing operations while upholding a strong commitment to patient-centered service.

One major challenge addressed is the inefficiency in enrollment and dispensing processes. By implementing the "KnippeRx Cares Technology Ecosystem," KnippeRx has developed a comprehensive end-to-end solution that simplifies patient experiences. This ecosystem utilizes automation, AI, and data analytics to ensure timely and precise service delivery, significantly decreasing turnaround times and operational costs while enhancing patient satisfaction.

These solutions also aim to improve data transparency, a vital aspect of maintaining trust and reliability in patient assistance programs. By employing KADABRA

, KnippeRx's proprietary real-time data and analytics platform, healthcare providers can access accurate, up-to-date information, enhancing decision-making and optimizing patient care strategies.



Key Features and Benefits of Knipper's Solutions

KnippeRx’s innovative approach is characterized by several essential features that distinguish it from traditional Pharma PAPs. These elements are designed to provide direct benefits to both patients and healthcare providers, ensuring a smooth and efficient experience for all parties involved.




At it’s core is a sophisticated technology infrastructure that streamlines every facet of the patient assistance process. Features such as automated online patient enrollment, electronic benefits and income verification, and AI integration exemplify how KnippeRx utilizes technology to improve service delivery. These advancements reduce manual intervention and errors while empowering patients to take greater control over their healthcare journeys.




Dedication to a patient-centered approach is reflected in the efforts to enhance the overall patient experience. By minimizing enrollment processing times and focusing on the patient journey, KnippeRx ensures that patients receive timely care. The use of comprehensive eligibility tools and advanced communication technologies further boosts accessibility, simplifying the process for patients to access needed services.




Transparency and accuracy in data are crucial for effective patient assistance programs. KnippeRx’s KADABRATM platform offers PAP Sponsors real-time insights into program data, facilitating informed decision-making and improved care outcomes. This extensive analytics capability also fosters better communication among all stakeholders, encouraging a collaborative approach to healthcare delivery.




KnippeRx’s innovative solutions are not just transforming current PAPs, but also paving the way for the future of patient assistance programs. As the healthcare landscape continues to evolve, integrating advanced technologies and patient-centric strategies will be essential in meeting the increasing demands of both patients and providers.

Looking ahead, additional advancements will further redefine the future of Pharma PAPs. Ongoing development in AI and machine learning technologies will facilitate even more personalized and proactive patient care, allowing providers to anticipate needs and tailor services accordingly. Moreover, the growing adoption of online platforms for both patients and healthcare providers will enhance accessibility, granting patients greater flexibility and convenience in managing their healthcare.

KnippeRx's commitment to innovation positions it as a leader in this evolving landscape, prepared to address tomorrow's challenges with cutting-edge solutions that prioritize patient needs and optimize healthcare delivery.

To learn more about KnippeRx’s Patient Assistant Programs, please visit 

 or contact KnippeRx at 848-373-7052 / access@knipper.com.


Revolutionizing Pharma Patient Assistance Programs, KnippeRx Leads the Future of Patient Care

In today’s healthcare landscape, groundbreaking treatments such as cell and gene therapies, mRNA vaccines, and GLP-1 drugs are transforming patient care. At the same time, essential medications remain vital for treating a wide range of conditions. Ensuring these treatments reach patients safely and efficiently is crucial—and can be accomplished by modernizing, future-proofing, and securing the healthcare supply chain.

We envision the supply chain of the future as an interconnected network of both physical and digital assets, not merely a series of transactions. Modernizing our supply chain is key for enhancing efficiency, visibility, and infrastructure. In recent years, we have embraced digital enablement to optimize our operations by integrating artificial intelligence and machine learning across our healthcare ecosystem. This has allowed us to optimize logistics, including transportation routes and delivery schedules, thereby reducing costs and improving efficiency; in our newest distribution center, we’ve automated 90% of the fulfillment processes. The goal is to ensure that our supply chain remains efficient and adaptable to future challenges.

In the ever-changing pharmaceutical landscape, the advancement of medical treatments, including drugs for rare diseases and specialty therapies, offers great promise and hope. It’s vital that our supply chain provide these crucial therapies safely and efficiently.

Specialty therapies often require specific conditions, such as temperature control and light protection, necessitating robust infrastructure and meticulous management. Additionally, many new medicines have shorter shelf lives, requiring precise inventory management to prevent stockouts and expirations, so in order to meet this growing demand, we encourage stakeholders to consider expanding cold chain storage, infrastructure, and quality controls. Overall, our efforts have resulted in nearly double-digit growth in cold chain lines year-over-year.

The commitment to those we serve drives us to uphold stringent safety and security standards, maintaining a rigorous chain of custody from manufacturer to patient. The Drug Supply Chain Security Act (DSCSA) is designed to protect US consumers by securing the supply chain against counterfeit, contaminated, or harmful drugs through electronic traceability mandates. Over the past decade, we have actively engaged in industry readiness for DSCSA serialization compliance, and we continue to advance our preparedness as we near the May 27 compliance deadline for wholesale distributors.

The industry has developed and implemented various track-and-trace technologies to comply with the DSCSA and to enhance the security and integrity of the pharmaceutical supply chain. These technologies include serialization, which assigns unique identifiers to prescription drug packages, and real-time tracking, allowing continuous monitoring of product location and status. 

Together, these innovations provide comprehensive visibility and control, safeguarding against counterfeit drugs and maintaining product integrity.

Ammie McAsey is SVP of Customer Distribution Experience at McKesson.

Ensuring that essential treatments reach patients safely and efficiently is an increasing imperative in today's pharma landscape.

Strategies to Modernize, Future-Proof, and Secure the Healthcare Supply Chain

Day 1 of Informa’s Access USA conference from Philadelphia—featuring Patient Assistance & Access Programs (PAP) and Hub and Specialty Models East—was kicked off by Tommy Bramley, Cencora’s SVP of global consulting services.

Titled “State of the Industry—The Evolving Landscape of Healthcare Coverage and Access in 2025,”

 the goal of the Access USA general session was to explore the dynamics impacting healthcare coverage and access this year, with an emphasis on industry-defining issues.

Bramley led off the session with the thought-provoking question of what most concerns attendees in terms of maximizing patient outcomes. The audience felt that the following:

After establishing where stakeholders’ priorities lie, he alluded to three main challenges that lie ahead concerning uncertainty: US federal and state policy priorities; unintended consequences of the Inflation Reduction Act (IRA); and payer economics.

When it comes to pharmaceuticals, the current Trump administration’s priorities are still being developed. Little has been released from Project 2025 regarding pharmaceutical changes Bramley noted, but IRA negotiations for 2027 are continuing. Pharmacy benefit manager (PBM) legislation is also under discussion by Congress.

There are various initiatives that could possibly affect PAPs. Regarding Medicaid, there is an interest in reduced Medicaid spending by $2.3 trillion over 10 years, with the chance to lower Medicaid expansion funding. These—along with other factors—could decrease enrollment and place pressure on PAPs.

Back during the Biden administration, coverage was proposed for anti-obesity meds under Part D and Medicaid. If this were to be finalized, Medicare Part D and Medicaid beneficiaries would have GLP-1s covered, but the projected costs to both federal and state governments would be $15 billion. Just for additional perspective, obesity costs the United States $480 billion in direct costs, and $1.24 trillion in indirect costs.

“This starts to point out the challenges with our healthcare system and willingness to pay, versus ability to pay, and certainly our ability to deal with chronic diseases. So yes, we want to address these direct costs,” Bramley stated.

In order to address those indirect costs, there are currently 11 state prescription drug affordability boards that exist to control cost at local or state level.

Patients have expressed relief related to the $2000 out-of-pocket (OOP) cap, and come 2026, it’s believed that during the initial coverage phase, plans will cover 65% of coverage, followed by the patient at 25%, followed by either the manufacturer or government covering the remaining 10% over the plan year. In the catastrophic phase, the plan would cover 60%, manufacturer 20%, and either the government covering negotiated or applicable drugs at 40% or 20%.

Meanwhile, the IRA introduces 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. It’s currently a work in progress—being in its first year, there is no ability to enroll at point of sale at this moment. In the long-term however, Bramley explained that it could help improve Rx drug affordability, while increasing patient adherence. The intention is to achieve price smoothing, which involves stabilizing prices and reducing price fluctuations, often by averaging prices over time or across different periods.

Patients are also worried concerning changes to current Part D plans, such as premium increases or other restrictions. As it stands now, the future of standalone prescription drug plans is uncertain.

There are also concerns about access to next year’s negotiated products—although plans are required to cover negotiated drugs, there aren’t mandates regarding coverage methods.

Last year, the Big 3 PBMs reportedly excluded 1,453 unique Rx medicines from their formularies, representing a 1,233 rise from 2014. And from 2014-2025, the number of meds that were excluded by one or more PBMs rose by an average of 38% per year.

The problem lies with affordability. Even when a prescription is filled, 90% of Rxs cost under $20, but 1% cost more than $125. For about one-third of brand-name commercial prescriptions across the top 10 therapy areas and for 63% of obesity Rxs, patients use copay cards.

For the aforementioned 1% of higher costs, this is where copay accumulators, copay maximizers, and alternative funding programs come into play, which will be explored more in-depth throughout the conference.

1. Bramley T. State of the Industry—The Evolving Landscape of Healthcare Coverage and Access in 2025. March 18, 2025. Access USA (general session). Philadelphia.

The conference’s opening session highlights the sector’s current landscape of healthcare coverage and access. 

Latest Conference Coverage

Access USA 2025: This Year’s State of the Industry

Out-of-Pocket Costs Rare Disease

Charitable donations have long been a vital lifeline for patients struggling to afford life-saving medications, particularly those with chronic and rare diseases. Over the past few decades, various assistance programs—including nonprofit safety nets, third-party organizations, and manufacturer-sponsored free drug initiatives—have emerged to bridge the gap between medical advancements and patient affordability. However, despite these efforts, high out-of-pocket costs still prevent many individuals from accessing essential treatments. In an interview with 

, Jonathan James, CEO of Hope Charities, shares insights on reducing barriers to care and improving patient access.

PC: Can you provide insights into the real-world out-of-pocket costs patients face, particularly in high-cost therapeutic areas?

’ll share a personal story. I was born with hemophilia, and managing hemophilia is costly, especially when considering life expectancy. As long as I can maintain access to my medications, my life expectancy is relatively in line with the general population. The big problem is that if I lose access to this medication at any point, it becomes a massive hurdle.

Many people with bleeding disorders today spend around $1 million annually. That cost has increased over time, but not exponentially—rather, it has risen incrementally year over year. There’s a strong focus on rare disease groups like hemophilia because they require high-cost medications. One of the biggest challenges we face is that keeping supplemental insurance is often more difficult than even developing the medication needed to treat the condition itself.

Thanks to medical advancements, people with hemophilia are now living longer and healthier lives. In the past, many were unable to work and were completely dependent on disability benefits, often confined to wheelchairs. Today, we have a thriving community of individuals who can live fully productive lives, attend college, and enter highly skilled professions. However, if they lose access to their medication, everything changes.

The challenge is that these individuals are now at risk of becoming vulnerable again—potentially returning to wheelchairs and being unable to work. This raises an important question: Is it better for someone to be a productive, taxpaying citizen who supports their family and contributes to the economy, or should they be forced into a situation where they are entirely dependent on social services?

We believe productivity is the better path, and out of that belief comes our drive, passion, and determination to do everything we can. This includes helping cover out-of-pocket expenses to ensure continued access to care.

Charitable donations have played a crucial role in helping patients access life-saving medications, particularly those with chronic and rare diseases who face significant financial barriers. Over the past 25-30 years, various assistance programs—including nonprofit safety nets, third-party organizations, and manufacturer-sponsored free drug programs—have emerged to support patients struggling with the rising costs of healthcare. However, despite these efforts, many individuals still face challenges in affording their treatments, with high out-of-pocket costs often preventing them from receiving necessary care.

For conditions like hemophilia, where annual treatment costs can exceed $1 million, losing access to medication can mean a drastic decline in quality of life, forcing patients to rely on disability or face severe health complications. While charitable programs provide critical relief, they also struggle with sustainability due to funding shortages and limited public awareness. Many organizations must balance the need to educate patients about available assistance while ensuring they have enough resources to support those in need.

Healthcare policies such as the Inflation Reduction Act and Medicaid redeterminations have also influenced access to care, sometimes alleviating costs for certain populations while creating new challenges for others. While high-cost medications often receive the most scrutiny, hospitalization and inpatient care account for a much larger portion of healthcare spending. Expanding financial assistance for prescription medications could help reduce hospital admissions and lower overall healthcare costs.

Looking forward, there is a need for more sustainable models of charitable giving and financial aid to ensure that patients can consistently access the treatments they need. Policy reforms, expanded subsidies, and a greater focus on preventative care may help create a more equitable healthcare system while reducing the financial strain on both patients and assistance programs.

Jonathan James, CEO, Hope Charities, discusses the critical importance of maintaining access to life-saving medications for patients with rare diseases to lead productive lives. 

Steve Gransden, Knipper Health

Articles

Latest Updated Articles