Articles

The evolving demands of the temperature-controlled supply chain for cell and gene therapy

As drugs have become more complex, so too has the supply chain, which must innovate to accommodate the necessary, specialized conditions for the storage and transportation of these drugs, even under extenuating circumstances. As the pharmaceutical industry shifts its attention to biologics and cell and gene therapies, the need for more advanced storage solutions has heightened considerably.

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Supporting Small and Virtual Companies for Clinical Trials

The virtual pharma business model has gradually become a popular alternative to traditional pharma. As an integrated service provider, Yourway offers the logistical support from study design to packaging needed by virtual and small companies entering into clinical trials. Yourway is a large organization that has flexible solutions embedded into our offering, and this nimbleness and agility help us to provide optimal solutions to virtual pharma companies. 

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Storage and Distribution Support for Clinical Trials Worldwide

Patient centricity has moved to the forefront of clinical trials. Direct-to-patient services provide convenience and lead to greater participation and retention, addressing two key challenges that face study sponsors. Yourway has the resources and expertise to devise tailored clinical logistics solutions for decentralized/virtual trials anywhere in the world, for even the most sensitive medications.

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Managing the Complexities of International Clinical Trials

Gulam Jaffer, President of Yourway, discusses the challenges in conducting international clinical trials and the solutions a clinical logistics partner can provide.

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Shorter Timelines to Deliver Clinical Trial Supplies

Time is of the essence in drug development and commercialization, which is why being first to the clinic and first to market is essential in the industry. According to the Tufts Center for the Study of Drug Development, the cost to bring a drug to market in 2013 was on average $2.6 billion, up from $802 million in 2003 ($1 billion in 2013 dollars).¹ Over that same period, the average approval rate for drugs entering clinical development declined from 21.5% to just 12%.

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Tracking your Project from Packaging Line to Patient

The Value of Integrated Services Supporting the delivery of clinical trial materials requires more than a logistics service provider. Clinical trials are growing in number and complexity. More trials are dispersed over many locations in different countries of the world with varying regulations impacting the operating of clinical studies and the import/export of clinical trial materials. Often, patients are located in rural/remote areas and receive their medications and treatment in the home, rather than at investigator sites. Drugs are also becoming more complex, more sensitive to environmental conditions and more expensive.

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Keys to Successful Storage, Management and Transport of Biological Materials

Biological materials are shipped from collection and production sites to other locations for analysis and/or further processing. These materials require special handling, and their storage and shipment — generally at very low temperatures — must be achieved in compliance with various local, national and international regulations. Partnering with an experienced and reliable logistics provider can ensure the successful management of biological materials, even for the most complex supply chains.

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The Patient-Centric Clinical Supply Chain for Cell and Gene Therapies

Cell and gene therapies present a new frontier in targeted, patient-centric treatments for a wide range of rare diseases that have not been well addressed by more conventional therapies. However, owing to the unique supply chains —particularly for autologous cell therapies —strict temperature controls and short viability windows of these products, delivering these therapies to patients requires new levels of agility, flexibility and innovation in the logistical management of supply.

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Integrated Clinical Packaging, Warehousing and Transport Services Supporting Pharma and Biopharma

Managing clinical trials is complex and challenging. Ensuring that the right clinical trial materials and finished pharmaceutical products reach patients at the right time and in excellent condition is just one of the intricate tasks involved. Maintaining temperature-controlled shipment of biologic samples across borders is another. Yourway offers the unique combination of highly responsive, personalized logistics support and the full gamut of integrated services, enabling clinical trials to run smoothly from start to finish.

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