The Benefits of Digitizing Operations in the Biotech Industry

In this episode, Matt Neal, Senior Director of Regulatory Affairs Operations at Atara Biotherapeutics, talks about his work introducing innovations to evolve the regulatory operations and submissions space. Matt improved knowledge management and information management at a company, by leading Atara’s transition towards a digital cloud-based database ecosystem that’s accessible and cross-functional. 

He explains why these changes can be challenging within the life sciences and why getting leaders to bring new data-centric technologies like AI and natural language processing is crucial for operations to be upgraded. Unfortunately, the industry finds itself behind others, and developing good ideas is still a very slow process, but Matt believes that communication with the patient community, bringing company information to an accessible platform, and standardizing the language in work environments can accelerate the innovation process in life sciences.

Tune in to learn how Matt Neal is getting rid of the waste in Life Sciences to improve the industry!

Summary:

The Life Sciences Industry is ready to face communication, regulation, and innovation challenges.

About Matt Neal:

Matt Neal joined Atara Biotherapeutics in 2019 as the Head of Regulatory Operations. Prior to that, Matt was the Head of Product Management for the InSight Suite of Regulatory Information Management Solutions at Parexel, Inc., and partnered with Microsoft. Before joining PAREXEL, Matt was a Director of Regulatory & Safety Operations at Amgen, Inc. (2003-2016) and was one of the pioneering members of the Regulatory Submissions Department for GlaxoSmithKline (1996-2003). Matt has been publishing and submitting electronic dossiers to the FDA since 1996 and submitted the very first fully electronic NDA for GSK in 1999.

Things You’ll Learn:

• An orphan drug is a medication used for a disease that only very few people have. These deserve as much attention in research as other medications.
• Atara Biotherapeutics recently got approval for the first-ever allogeneic T-cell therapy that can create T cells from donor cells rather than from the individual the T cells are for.
• Life Sciences standards for data storage and manipulation standpoint are far behind other industries.
• The IDMP (Identification of Medical Products) is a data standard for storing information about medical products as it relates to patient safety and drug manufacturing.
• A Regulatory Affairs Operations department has to deal with health authorities and share information with them about the operations behind medical products.
• Medical products take from 10 to 15 years to get through development to a health authority’s approval.
• A digital lab notebook allows data stored inside a company’s database with easy access for a long time.

Resources:

• Connect with and follow Matt Neal on LinkedIn.
• Follow the Atara Biotherapeutics on LinkedIn.
• Explore the Atara Biotherapeutics Website!
• Connect with and follow co-host Kerri Anderson on LinkedIn.
• Connect with and follow co-host Samantha Black on LinkedIn.