Contributed Commentary by Henry Levy

October 16, 2018 | In September, Veeva Systems hosted the 2018 Veeva R&D Summit. Innovators such as Eli Lilly and Company and TESARO discussed streamlining regulatory information management processes on a global scale, while Bristol-Myers Squibb shared its enterprise-wide journey of modernizing quality management.

Modernizing product development and improving clinical trials is especially critical to support breakthrough innovations such as gene therapy. Bluebird bio, a growing and influential biotechnology company driving gene therapy innovation, spoke about the opportunity to develop treatments by understanding what drives diseases, like sickle cell, at the genetic level.

“Gene therapy has shown tremendous promise, but now what’s really changed is the science. We’re finally starting to understand how we can interact with and affect genes to not only alleviate symptoms, but actually fix a disease,” said Nick Leschly, CEO of bluebird bio. “At bluebird, we’re inspired by the chance to look a patient in the eye and say, ‘We have something that can literally transform your life.”

Here are four of my key takeaways from the event across clinical, regulatory, and quality.

1) There is a significant opportunity to connect workflows across research and development.

It takes an average of 10-12 years to develop and bring a drug to market at an average cost of $2.6 billion, the same amount of time it took over a decade ago at twice the cost. One reason is that siloes still exist across key functions. To bring products to market faster, both large pharmaceutical and specialty biotech companies are working to connect disparate business processes and systems.

“When I arrived at Foamix, I was given a great opportunity to build foundational technology that interoperates with other parts of the business, with systems that will talk to each other throughout the process,” said Bonnie Pappacena, vice president of quality at Foamix, a specialty pharmaceutical company that develops topical dermatology drugs. “We now have the beginnings of a unified technology environment across R&D.”

TESARO, a biopharmaceutical company specializing in oncology, shared its process of modernizing operations. “We never had a central place for data and information,” said Rich Fredericks, director of regulatory information management and presenter at the Veeva event. “Now, we’ve learned the importance of having a central repository and a single source of truth across all areas. This has dramatically improved and streamlined everything at the company.”

2) More organizations are unifying clinical trial processes for faster study execution.

Improving collaboration between partners and streamlining clinical trial processes like study startup were major issues discussed at the event.

In a panel discussion, IACT Health, Janssen, and Syneos Health addressed the importance of achieving greater collaboration with contract research organizations (CROs) and investigator sites. Dr. Jeff Kingsley, founder and CEO of IACT Health, a clinical research firm with 200 trials happening concurrently, noted that a lack of transparency is a major challenge.

“Sponsors, CROs, sites, and technology vendors fail to share a lot of important information because it’s proprietary, but I think it’s worth sharing,” said Kingsley. “If I know precisely what you care about, if I see what you’re tracking, I can adjust my behavior in real time. We need to focus on creating a common language to drive transparency across our processes.”

Incyte, a Delaware-based oncology company, also outlined its initiative to improve study startup processes to speed cycle times in clinical.

“Without any technology, study startup was a very manual process, and we couldn’t track everything,” explained Jennifer Heckman, senior director of clinical trial logistics at Incyte. “Our biggest goal was to establish a single source of truth to share information easily while in a secure and validated environment.”

3) Transforming RIM processes enables companies to support globalization.

Many organizations implement new regulatory systems and processes individually, by product, or by region. Lilly, however, took an innovative approach with a single-phase deployment and discussed this during the Veeva event.

Lilly first implemented an end-to-end process for chemistry, manufacturing, and controls (CMC) post-approval changes, working with partners like manufacturing sites to improve the consistency of global processes.

“While we started with CMC, we wanted to make sure that the process would work for every submission type moving forward,” said Paula Hudson, global implementation lead for RIM systems and processes at Lilly. “We focused on our future state: one global, harmonized process across submission types that incorporates best practices in the industry.”

The company plans to develop a workflow to react quickly to health authority questions and commitments. “It takes about 4-6 hours to update regulatory commitments for a product,” said Hudson. “A single system with a globally consistent process will allow us to update commitments faster so we can use that time to push more submissions through the cycle.”

4) A growing number of companies are modernizing quality management across the enterprise.

Industry leaders like Sysmex, Alkermes, Ultragenyx, Upsher-Smith, Gilead, and Bristol-Myers Squibb showcased how they are changing quality management at their organizations. For example, Bristol-Myers Squibb harmonized quality management systems processes across change control, corrective action/preventative action (CAPA), deviations and complaints, audits, and notifications to management.

“Our goal is to move from 21 quality processes across the company to only six harmonized processes,” said Priya Durvasula, PhD, Head, IT Partner, Global Quality, at Bristol-Myers Squibb. “Embarking on this journey in multiple waves will allow us to achieve our vision of an integrated quality management system (QMS).”

Of course, we had a few announcements of our own. This year, Veeva Vault Training was announced to help bring together training with quality goals to improve critical metrics. And during his keynote speech, Veeva founder and CEO Peter Gassner announced Veeva Vault CDMS, a new application to our clinical suite that combines coding, EDC, data cleaning, and reporting.

Henry Levy is the general manager of Vault CDMS at Veeva Systems. Levy has overall responsibility for the Veeva Vault CDMS product and making Veeva the market leader for data collection and cleaning for clinical trials. Levy has spent 25 years transforming how the $1.7 trillion life sciences industry improves patient health. He also represents Veeva as president of Align Biopharma and Align Clinical CRO, two industry standards groups dedicated to improving how healthcare providers engage life sciences companies, as well as making it easier for sponsors and CROs to work together during clinical trials, respectively. Levy serves on the board of Alliance for Clinical Research Excellence and Safety. He can be reached at henry.levy@veeva.com.