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DNA and CRM: Gene Therapy Chain of Custody Innovation

Advisory

It may still seem like science fiction of the future, but gene therapy is here and happening right now. 

What is gene therapy?

Created to help manage or prevent diseases, gene therapy may be used to treat patients instead of synthetic drugs or multiple surgeries in the very near future. Currently, researchers are focusing on several approaches, including:

  • Replacing a mutated gene that causes disease with a healthy copy of the gene
  • Inactivating, or “knocking out,” a mutated gene that is functioning improperly
  • Introducing a new gene into the body to help fight a disease

Gene therapy has been around for over 30 years in some form or another. Originally cautioned against by Theodore Friedman and Richard Roblin back in 1972, the first successful gene therapy performed on a human occurred in 1990. There are now three FDA-approved products: two cell-based gene therapies for cancers of the blood (i.e., Kymriah and Yescarta) and one directly administered gene therapy (i.e., Luxturna) for an inherited disorder of the retina of the eye.

According to Peter Marks, M.D., Ph.D. (Director, Center for Biologics Evaluation and Research), there are still clinical trials with a focus on treatment for genetic conditions and diseases that have no cure, “such as those for the treatment of diseases ranging from hemophilia to spinal muscular atrophy. The progress and demand in this field is also evident in the more than 800 active investigational new drug applications for gene therapies on file with FDA.

With solutions created for such specialized needs and highly sensitive genetic materials, medical facilities and startups performing research and procedures need to take the utmost precautions and meet security measures.

DNA and CRM: Tracking chain of custody

The FDA has very stringent rules and regulations surrounding chain of custody. These rules become even more strict when genetic material is involved. In gene therapy, a patient’s own DNA is their treatment, so following chain of custody by knowing the location of their genetic material at all times is imperative. This is key not only in completing successful clinical trials in a very specific timeframe (the typical door-to-door transport time is 40–50 hours or less), but in adhering to strict FDA and HIPAA guidelines around personally identifiable information and genetic materials. 

“Errors along any point of the process or supply chain can be potentially devastating for patients and highly costly for clinical trial sponsors… Innovative therapies that may not only treat but potentially cure cancer and genetic diseases are promising, but if those therapies cannot be distributed to patients (or the patients cannot be brought to the therapies) they have no value,” said Sascha Sonnenberg, Vice President of Cell & Gene and CTS Services at Marken.

Tracking chain of custody can be accomplished in many ways — shipping orders, package tracking numbers, or even smart packaging that monitors and reports on location, temperature, shock, and orientation. With so many variables involved, a tailored CRM solution like Salesforce makes easy work of tracking the end-to-end journey of each patient.

Better insights and 360-degree views with Salesforce

For example, gene therapy and biotech manufacturing facilities could use a doctor-facing CRM portal that allows doctors and nurses who submit patients for therapy treatment and trials to follow along as the blood for therapy is re-engineered. Within the portal, scheduling, transportation, and procedural information can be monitored and tracked from the time the blood leaves a patient’s body to the time it is put back in. 

Salesforce provides drug manufacturers an integrated view of all patient and provider interactions. Using built-in analytics and artificial intelligence, Silverline previously built a Salesforce Org tailored to provide insights into precise whereabouts of individual treatments, along with pertinent patient, provider, and payer information for a medical startup focused on personalized medication. With proper precautions taken and chain of custody maintained, biotech companies and manufacturing facilities can quickly situate themselves as experts in the gene therapy field. But only those that set themselves up with the right tools in place for collecting, tracking, and monitoring gene therapy assets will lead the way. 

 

See how our Life Sciences experience and expertise can help bring your company into the future.

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