MyData-TRUST, new to NC, plans Sept. 10 data privacy summit for life sciences
A summit on data privacy and protection in the life sciences will draw up to 100 professionals to the North Carolina Biotechnology Center in Research Triangle Park (RTP) on Sept. 10 for a full day of presentations, panel discussions and networking.
More than a dozen experts will discuss recent developments in the field for an audience of data privacy, legal and compliance professionals, as well as professionals in clinical operations, data management, informatics and IT security, at pharmaceutical, biotech, medical tech and health care companies and contract research organizations (CROs).
The event, U.S. Data Privacy for Health 2024, is being organized by MyData-TRUST, a Belgium-based global data protection and privacy consulting firm that specifically serves the life sciences industry. The N.C. Life Sciences Organization (NCLifeSci) and FBFK Law, a Texas law firm, are supporting the summit.
Attendees, who can register online, will receive Continuing Privacy Education (CPE) credits that can be applied to various professional certifications.
“Privacy and data protection in 2024 is an incredibly dynamic space, and recent developments in AI (artificial intelligence) have added a new dimension of excitement and complexity,” said Avery Miles, MyData-TRUST’s deputy director for the United States. “Our program speaks to the specific needs and challenges of professionals working with privacy and data protection within life sciences, clinical trials and the healthcare space, and offers practical insights that they can take back to their organizations. A full-day conference with high-quality, narrowly tailored data privacy content dedicated exclusively to life sciences is a rare find.”
Topics to be covered at the summit include:
- Emerging data privacy regimes in the U.S. life sciences sector
- Challenges and opportunities facing global DPOs (Data Protection Officers)
- Running clinical trials in Europe: where GCP meets GDPR
- CRO GDPR code of conduct
- Data privacy for healthcare apps
- How to effectively manage a data breach
- AI in health care and clinical research
The event will also include networking sessions over lunch and after the day’s program.
Company new to North Carolina
MyData-TRUST established an East Coast office in June to expand its service offering and support its growing client base in the United States. The company chose the Research Triangle region over sites in Boston and New Jersey, Miles said.
The Research Triangle’s advantages included relative affordability, a qualified workforce, major research universities and hospitals, direct flights to major cities, and a high concentration of CROs, pharmaceutical companies and biotech startups, he said.
The company is leasing temporary space at NCBiotech’s Landing Pad, which provides office space and services to companies new to the state and is planning a move to permanent space in the Research Triangle area.
“We are so grateful to NCBiotech for the opportunity to lease space at the Landing Pad,” Miles said. “We are in the ‘heart of the action,’ so to speak, and have taken advantage of the many networking opportunities to create brand awareness and make industry contacts.
“While MyData-TRUST has been in Europe for seven years now, and we’ve had an established West Coast U.S. office in the Bay Area since 2019, we are keen to expand our U.S. operations to North Carolina and provide bi-coastal coverage for our clients. NCBiotech understands this growth mindset and has provided immense support to help us bring a successful global business model to a new market.”
The company has three employees at the new North Carolina office and is looking to fill a business development and sales position. “We will also be hiring additional operational roles in the near future,” Miles said.
Since its founding in 2017, MyData-TRUST has grown to 120 employees -- doubling since 2022 -- with offices in Belgium, France, the United Kingdom, Romania, Mexico, San Francisco and now North Carolina.
Miles, a Greensboro native and graduate of the University of North Carolina at Chapel Hill, was tapped to lead the East Coast office by the company’s founders, who knew him from his days as a data protection and privacy attorney in the CRO industry.
Miles started with Raleigh-based PRA Health Sciences (now ICON PLC), where he negotiated commercial contracts and clinical trial agreements, then held various positions during nine years with RTP-based Worldwide Clinical Trials, where he transitioned to data privacy full time.
“I left the CRO industry for a couple of years and had been working for large Fortune 500 companies in medtech and health care,” Miles said. I was excited to get back to working within a smaller organization where I could play a strategic role in growing a business. I’ve spent my entire career in life sciences and developed my own niche as a privacy professional within this space. In a lot of ways, I was custom-built for MyData-TRUST and was thrilled with the opportunity to join a team of talented, like-minded professionals from across the globe.
“I was also eager to get back to serving clients, especially in the biotech sector. It is immensely rewarding to help our clients build a privacy program, but also to be a part of a broader project or mission of bringing something meaningful into the world, like life-saving therapies.”
Filling an industry niche
Data privacy and protection in the life sciences is mostly concerned with safeguarding the personal and medical information of patients and research subjects. Such data is essential to product development and for demonstrating the safety and efficacy of drugs, therapies or medical devices to obtain regulatory approval.
“Data is the lifeblood of innovation in the life sciences industry,” Miles said. “Advances in technology and data science, fueled by AI and ML (machine learning), have meant that we can more efficiently analyze massive datasets and derive incredible insights like never before. These insights can improve healthcare, save lives and have profound positive impacts on the human experience.
“But when striving for these lofty goals, organizations must have measures in place to lawfully use the personal data they collect and safeguard the confidentiality of their patients and research subjects. As such, privacy should be considered an extension of an organization’s data-optimization strategy.”
Authorizing legitimate use of valuable patient data and protecting it from misuse or accidental or criminal breaches, is vital for a company to avoid fines, lawsuits and legal damages -- repercussions that can be “potentially existential for a startup biotech,” Miles said. Failure to comply with privacy laws and regulations can also delay clinical trials, costing companies time, money and trust.
“That’s real money and real risk to the ultimate goal of getting their study, drug or therapy approved,” Miles said. “In addition to the fines and reputational damage, you may end up with valuable data that you can’t use for your core objectives.”
As a cautionary tale, Miles cited the recent case of Enzo Biochem, a New York-based bioscience tools and diagnostics company. Enzo suffered a ransomware cyber-attack that compromised the clinical test results of more than 2.4 million patients and the Social Security numbers of 600,000 patients. The New York Attorney General subsequently fined the company $4.5 million for poor data-security practices.
Data privacy and protection is becoming a more complex challenge due to a rapidly changing and ever more stringent regulatory environment, Miles said.
“We have seen an explosion of new privacy and data protection laws both abroad and in the United States,” he said. “Compliance can be complicated, especially if you are new to privacy, in a new jurisdiction or dealing with co-regulatory frameworks such as Good Clinical Practice. If organizations want to successfully get their clinical trials up and running, and running smoothly thereafter, they need to fulfill all of these regulatory requirements.
“We are here to help organizations do just that, and we can deliver our service in a very nimble, cost-effective and tailored fashion because we are exclusively dedicated to the life sciences sector and understand the business. We have also embraced AI and technology in our privacy management solutions to increase efficiencies and reduce costs.
“We’re international so we can cover a wide range of jurisdictions, but we’re small enough that we continue to maintain our white-glove service standards for our clients. I would characterize us as a niche boutique, but the industry need is extensive. Organizations are starting to realize that privacy is not just a core value; it is a value proposition. MD-T delivers that value, and we’ve grown an entire multinational business out of it.”