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Personalized Solutions for Complex Drug Development

Parimer

Bringing a drug to market can seem daunting, often with unique hurdles, particularly for small and mid-sized companies. These challenges usually require creative solutions, such as reverse engineering drug formulations, making small batches of chemicals to test, or addressing special needs for the treatment of rare diseases.


Though there are challenges, there are ways to simplify the process of bringing a drug to market. To be successful, a company needs the right expertise, agility, and resourcefulness to navigate these complexities. Some of the ways to achieve this include working with a U.S.-based manufacturing company and creating small-batch testing.


Parimer is a U.S. based drug development company
Parimer is a U.S. based drug development company

Finding a U.S.-Based Manufacturer

Bringing a drug to market or achieving FDA compliance in the U.S. is already a complex process, and not working with a U.S.-based drug development company can make it even more challenging. There are limited drug development companies in the United States, which poses a challenge when creating or reverse-engineering drugs. Many companies send their drug development projects overseas, but this process is cumbersome, expensive, and time-consuming. “According to the FDA, 70% of active pharmaceutical ingredient (API) manufacturers are located overseas, with the majority in China and India. This reliance can lead to supply chain vulnerabilities.”


Another challenge arises when a drug manufactured overseas needs to meet U.S. compliance standards. The drug must be reverse-engineered, and its manufacturing process documented to comply with FDA regulations. As  Pharma Manufacturing Magazine "The complexity of reverse-engineering drugs for FDA compliance underscores the importance of having a U.S.-based partner who understands the regulatory landscape." 


Due to these challenges, it is crucial to identify a U.S.-based manufacturer willing and able to accommodate specialized projects. These projects require close collaboration between the development team and the manufacturer to address technical issues, identify viable manufacturing options, and maintain project momentum. However, many drug development companies are hesitant to take on small-batch testing, leaving limited options in the United States.


Parimer is a solution to these challenges. As a U.S.-based lab, Parimer can develop or reverse-engineer drugs. For example, Parimer successfully reverse-engineered a Japanese-created drug to meet U.S. compliance standards.

Parimer is capable of small-batch drug development
Parimer is capable of small-batch drug development

Small-Batch Production: A Specialized Need

Small-batch drug development involves producing minimal quantities of a drug to continue the testing process. It is not always necessary or required to produce large volumes, which can lead to waste. However, small-batch production is often essential to bring a drug to market or secure FDA approval.


This type of production presents another significant challenge in drug development. Many manufacturers are unwilling to accommodate projects with limited production volumes, which are often critical for early-stage research, testing, or specialized applications. This reluctance creates a gap in the market for small and mid-sized companies. These needs can only be met by manufacturers willing to adapt and work with smaller batch sizes. By leveraging industry expertise and connections, it is possible to overcome logistical barriers and deliver solutions that meet the specific needs of these projects.


40% of drugs fail to reach the market due to formulation challenges that could be addressed with reverse engineering and small-batch production.


Parimer is equipped to address these challenges. With its small-batch production capabilities, Parimer can:

  • Develop innovative production techniques: Exploring alternative manufacturing methods suitable for small-batch production, such as continuous manufacturing or microfluidic technologies.

  • Optimize production processes: Streamlining production to minimize waste and improve efficiency.

  • Build strong relationships with suppliers: Establishing reliable partnerships for raw materials and other essential components.

Parimer supports rare disease drug development
Parimer supports rare disease drug development

Supporting Rare Disease Drug Development

Rare diseases often require specialized drugs that are not yet available on the market. This is a critical area where personalized solutions and small-batch production intersect. These projects involve small patient populations and highly specific requirements, making them less appealing to larger pharmaceutical companies.


95% of rare diseases lack an FDA-approved treatment, highlighting the need for specialized drug development. 


Rare disease treatments often require custom formulations or small production runs to meet the needs of niche populations. These projects demand attention to detail, open communication, and a focus on creating tailored solutions. The ability to address these challenges is vital for bringing life-changing treatments to underserved communities. As McKinsey & Company states, small-batch production is no longer just a necessity for rare diseases; it’s becoming the standard for precision medicine.


Parimer has the expertise to support rare disease drug development. For example, Parimer’s scientists developed a drug to treat a rare genetic disease called PMM2-CDG (Congenital Disorder of Glycosylation Type 1a), which impacts fewer than 1,000 people worldwide. Finding a company to help create this drug was challenging due to the minimal target market, but Parimer partnered with Maggie’s Cure, LLC, to bring this project to fruition.


A Personalized Approach to Collaboration

Parimer delivers personalized solutions for drug development. In addition to being a U.S.-based manufacturer, conducting small-batch production, and supporting rare disease drugs, the team is dedicated to providing personal attention and meaningful collaboration. Unlike larger organizations, where clients can feel lost in the shuffle, Parimer focuses on building strong, communicative partnerships.


The Parimer team engages deeply with each project, offering insights and advice that go beyond the basics. They prioritize attention to detail, ensuring that every aspect of the project is handled with care and precision. This level of involvement not only helps move projects forward but also fosters trust and confidence.

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