In our latest client spotlight, we had the pleasure of speaking with Kurt Wassenaar and Harper Thomas from Performance MedTech (PMT), a clinical data science and drug development company focused on developing a groundbreaking therapeutic for early-stage Parkinson's disease.
Their innovative approach using intravenous NAD+ therapy showcases the potential for revolutionary treatments in neurodegenerative diseases.
Background
Performance MedTech's journey began with Harper's experience in performance medicine, where he observed the benefits of NAD+ therapy in various applications. NAD+ (nicotinamide adenine dinucleotide) is a naturally occurring coenzyme critical for metabolism, but its production in our bodies declines significantly as we age.
Through extensive customer discovery, including interviews with hundreds of physicians, PMT identified a promising application for NAD+ therapy in treating Parkinson's disease. They discovered cases where patients with advanced symptoms experienced profound benefits, sometimes within hours or days of treatment.
The Challenge: Bridging Experimental Medicine and Clinical Validation
Kurt, with his background in bioinformatics, recognized a critical gap in the field: the lack of organized, HIPAA-compliant data systems to capture variables and construct clinical trials that meet FDA requirements. This gap often results in promising experimental treatments failing to translate into validated, widely accessible therapeutics.
To address this, PMT is developing a sophisticated bioinformatics system with AI components for pattern analysis coupled with a HIPAA compliance engine. This system will enable them to transform anecdotal evidence into a robust research database, facilitating FDA-viable results and guiding their clinical trial process.
The FDA Group's Role: Navigating the Regulatory Landscape
This is where we came in. As Kurt and Harper share in greater depth in the video, the regulatory process can be daunting for entrepreneurs and scientists focused on technology development and fundraising. The complexities of working through the FDA's regulatory world require specialized expertise that goes beyond their core team's capabilities.
Here’s how we addressed that with targeted consulting support:
Expertise on Demand: PMT values the ability to access a deep pool of specialized knowledge as their project evolves.
Flexibility: As the project pivoted from initially considering a 503B compounding facility to their current focus, we adapted seamlessly to their changing needs.
Time and Resource Efficiency: Our ability to quickly connect PMT with vetted experts saves them valuable time and resources in their startup phase.
Comprehensive Support: From regulatory strategy to specific technical questions, we provided end-to-end support throughout the development process — continuing to pull specific specialized experts from our network as the project progressed.
The Unique Value of Expert Regulatory Consultants
Kurt and Harper emphasized several key benefits of working with specialized consultants through this partnership model:
Risk Mitigation: Expert guidance helps avoid costly mistakes that could invalidate their efforts.
Credibility: FDA approval is crucial for gaining acceptance in the medical community, particularly among neurologists.
Efficiency: Access to experienced consultants allows the PMT team to focus on their core competencies in science and business development.
Adaptability: As startups often pivot, having access to a broad range of expertise is invaluable.
Advice for Fellow Innovators
For other companies in the life sciences space, Kurt and Harper offer this advice:
Engage with regulatory consultants early in the process. Harper emphasizes the importance of early engagement.
“What I would say is to anybody who's even considering taking a route in which they’re going to get into patient care or anything that the FDA could potentially even touch is to really to try to lock in with you guys and find out what they don't know and become aware, just because you can only do so much research on your own."
Don't underestimate the complexity of FDA regulations and the value of specialized knowledge. Harper points out the vast experience available through consultants.
"There's so much to set up; you get the generations of experience that go through your whole group and your whole pool. You cannot do that research on your own."
Invest in quality legal and regulatory support — it's money well spent. Harper stresses this point, particularly for startups.
"It's money extremely well spent. And the same goes for having an attorney. You know, do not write your own opera. Do not write your own operating agreement and term sheet to send out two investors if you haven't done it before because it'll come back and bite you later. Those are the expensive problems."
Hire the best people you can find and listen to their expertise. Kurt offers a succinct piece of advice:
"Hire the smartest, the best people you can find and listen to them."
Kurt further elaborates on the value of working with expert consultants:
"I don't know that you realize this, but finding the people that you have at your fingertips would take us forever to find and validate. So we don't have time to do that. We don't have the money to do that and we would, we would fumble around making mistakes for probably longer than we would survive without that. You provide an enormously valuable service in centralizing the resources and the expertise in one place with people like yourself who know how to get to the right people to help us with what the problems are. So, I mean, that's a really critical skill.
Looking Ahead
PMT's journey showcases the exciting potential of bridging innovative medical approaches with rigorous scientific validation. Their work not only holds promise for Parkinson's patients but may also have implications for other neurodegenerative diseases like Alzheimer's and dementia.
As they continue to develop their NAD+ therapy and navigate the clinical trial process, we remain committed to supporting their efforts every step of the way. We're excited to see the impact of their work and are honored to play a part in bringing potentially life-changing treatments to those in need.
Stay tuned for more updates on Performance MedTech's progress and other inspiring stories from our clients who are pushing the boundaries of medical innovation.
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How Performance MedTech is Leveraging Regulatory Consultants to Bring an Innovative NAD+ Therapy to Life