In biopharmaceutical development, finding the right talent can make or break a company's progress. This was the challenge facing Medipost, a Korean biotech firm developing a groundbreaking biologic for cartilage regeneration using cord blood stem cells, as they established their US operations.
In our latest client spotlight, we had the pleasure of speaking with Adrian Orr, Vice President of Clinical Development at Medipost, to shed light on how strategic staffing and consulting support have been critical for enabling growth and progress.
Read our staff augmentation guide for more about how we use full-time consultants to extend or augment your internal team with one or several skilled life science professionals. Our resources hit the ground running to immediately add value to your company through a contingent staffing model ideally suited for hiring needs that require full-time external support but don't justify hiring a permanent FTE at the moment.
Background
When Adrian joined Medipost two years ago, he faced a significant challenge: establishing the presence of an established overseas biotech company in the US. Founded in 2012, Medipost has built a successful cord blood banking business in Korea, specializing in umbilical cord stem cells. Their innovative biologic product, CARTISTEM®, developed to help regrow knee cartilage, had been advancing in Korea since 2012. Now, they needed to build out their entire US operation to pursue FDA approval.
The challenge: building US operations from scratch
Starting from zero, Medipost established its initial US presence in Cambridge, Massachusetts, setting up in one of the CIC buildings in Kendall Square. The founding US team consisted of just three people: Adrian, the CEO, and the COO.
Their mission was ambitious: establish complete US operations, including:
Manufacturing operations in Canada
Regulatory framework
Quality systems
Clinical trial infrastructure
A core team of experienced professionals
"Finding the right staff and contractors was our biggest challenge," Adrian explains. "Before we contacted The FDA Group, we had nobody on the ground here, just myself. We were reaching out to other agencies to try and find people. While there are many people who have worked in clinical development, it's difficult to find individuals with the right experience—people you can truly rely on."
The solution: specialized strategic staffing support
After evaluating several staffing and consulting firms, Medipost partnered with us to build out its team. Why us? Our thorough vetting process and deep understanding of our candidates' capabilities—something that has become increasingly hard to find with search and staffing firms as generalist recruiters flood the industry and put the work back on their clients.
"We had reached out to different hiring companies, different contractors," Adrian notes. "When we saw the people that The FDA Group identified and how well they knew them, it made a difference. We're looking for candidates that, when we interview them, they actually match what we're looking for. We're not just being thrown people just because they're available. The FDA Group vets them very carefully, and they end up being a very good match for us."
The results to date
Over the past two years, the partnership has led to several successful placements and achievements:
Key hires:
One of our top RA/QA consultants who has served as a Quality consultant for almost two years.
Another consultant who was initially brought on as a contractor and was later converted to a full-time employee, continuing to excel in his role with Medipost.
Major milestones:
Successful establishment of manufacturing capabilities in Canada.
Significant progress through FDA regulatory processes:
Three years of collaborative work with both The FDA Group and the FDA.
Approaching finalization of clinical trial design with the FDA.
Development of relationships with multiple clinical sites across the US and Canada.
Advanced preparation for their first US clinical trial, scheduled to launch late next year.
Regulatory progress:
Much of Medipost's success has come through its careful navigation of the regulatory landscape. "For three years, we've been working with The FDA Group, but also with FDA itself to go through our regulatory approvals," Adrian explains. "We're coming close. We hope to finalize the design with them, and we've been working with many sites in the US and Canada, including with some of the staff we've been working with at The FDA Group to get our study off the ground."
Looking ahead
Medipost continues to expand its operations, with plans for additional hiring and growth. They're maintaining their partnership with us as they prepare for their upcoming clinical trial launch and continue to build their US presence.
"We've got other posts coming up," Adrian shares. "We're expanding, and we're looking for new people. The interesting thing is we've been able to move ahead with the people we've brought on through The FDA Group."
Key takeaways for other firms
For other clinical development leaders building teams, Adrian offers this valuable insight: "You've got to find the right team for yourself, and because you can't do everything yourself, you need to reach out and find vendors that you trust. There are a lot of companies out there that you could pick and choose from, but it's really about getting people to understand what you really want."
He also emphasizes the importance of long-term thinking: "You really don't have time for hiring and hiring people that are not going to work out. What you're looking for is really finding a company that can help you identify people you really need who are going to work out for you in the long term. That really helps—finding somebody, settling them in, getting them experience in your product and your trials, and taking it from there, rather than constantly trying to hire people that will not stay with you long-term."
"[The FDA Group'] focuses immediately on what we need, and we just get that done, rather than constantly just trying to interview various people and hoping they work," Adrian notes. "The people that you did send work out pretty well. We hired one of them, we actually went on to convert that person, and the other person is working really well for us now. For the long term, that's been very helpful for us."
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How Medipost is Accelerating US Clinical Trials for a Cartilage Regeneration Therapy with Strategic Staffing Support