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Setting standards -- three essential starting points

by Amy DuRoss | April 23, 2019

Welcome to the Vineti blog! This is our first post, and we’re looking forward to sharing insights, perspectives and company updates here.

Today, we’re at Meeting on the Med with the Alliance for Regenerative Medicine, and hearing updates from more than 50 advanced therapy companies. These progress reports represent just some of what’s emerging in cell and gene therapy to benefit patients. According to ARM, there are more than 1,000 advanced therapy clinical trials underway, with the potential to enroll more than 59,000 patients.

How do we make all of this amazing transformative science work on behalf of all these patients? We take these personalized therapies -- and we standardize and simplify.

Standardizing a product process that is so unique to each patient may sound counter-intuitive. But it’s not only possible -- it’s essential. How else we will put personalized therapies in the hands of all who need them? We need to bring standardized, industrial rigor to these deeply individual therapeutics.

At Vineti, we talk with our clients and partners about standardization in one form or another every day. Here are just three of the areas where I think standards matter most right now.

  1. Healthcare Provider experience: To operate personalized therapies at scale and make them a part of mainstream medicine, we must provide simple, intuitive, consistent, standardized experiences for Healthcare Providers. Here’s a look at just one example of Vineti’s approach, which we routinely hear is the best in the industry.

  1. Data collection that protects patient safety: When each drug product is a personalized “batch of one,” or has been manufactured to match a specific patient’s biology, that therapy must reach only its intended patient. Regulators in the United States and Europe have said clearly that adequate systems to gather data and provide traceability are a must-have.

  1. In-process labeling: To keep a personalized therapy linked to its intended patient, labeling takes on new importance -- and complexity. How do you keep the patient identifiers clear, while also protecting privacy? How do you handle the “number jumble” -- drug manufacturer ID numbers, medical center ID numbers, patient identifying numbers -- and keep things standardized and understandable for everyone involved in handling that therapy? For a few tips on labeling, see my colleague and Vineti co-founder Heidi Hagen’s blog post here.  

In some of these areas, our industry has existing standards from traditional off-the-shelf areas to use as a starting point. In others, we need to build from the ground up. Vineti is proud to support the critical work of the Standards Coordinating Body, created specifically to help advance standards for advanced therapies.

I’m thoroughly enjoying talking to leaders in our field about standards here at Meeting on the Med. And I’d also like to hear from you! What do you see as the areas of greatest need in standards to keep our industry moving and growing over the next five years? Please send us a message. Thank you! 

Amy DuRoss is the CEO and Co-founder of Vineti. If you’d like to learn more about how Vineti’s Personalized Therapy Management (PTM) platform can help you solve your advanced therapy supply chain and workflow challenges, please contact us.

 

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