Herman Lelie, Ph.D., is the founder of Constitution Laboratories and an alumnus of MIT and UCLA, holding a doctorate in Biochemistry and Molecular Biology. With a robust career in healthcare start-ups, he possesses comprehensive experience from translational laboratory research to FDA product clearance. Dr. Lelie’s work is characterized by a passion for innovation and a commitment to advancing medical technologies. His leadership and vision have been pivotal in bringing cutting-edge healthcare solutions to market, benefiting thousands of patients worldwide
Can you provide us with an overview of what Constitution Labs does and who you serve?
Constitution Labs is a full-service CRO that provides contract R&D for drug discovery, drug development, and CMC (chemistry, manufacturing, and controls). We also provide analytical testing services for a range of products in industries including cosmetics, OTC drugs, and consumer products that need routine product testing and Certificates of Analysis (COAs). We maintain a full-service laboratory with state-of-the-art instrumentation, facilities, and a team of MIT and UCLA-trained Ph.D. scientists with decades of experience in pharmaceutical industry R&D.
On the CRO side, our clients are mostly early-stage biotech and pharma companies developing new products – who don’t want to make large investments of time and money into developing a new lab, purchasing equipment, and hiring talent. For early-stage biotech companies, R&D execution is critical in getting their first products to the market given the complex and lengthy regulatory process. Getting it done right can make or break many of these companies. Many of the larger CROs are not able to effectively serve these customers’ specific needs.
Scientific challenges are our passion and as a small CRO, we can take a deep dive with our clients to truly understand their challenges and provide creative and thorough solutions. We keep a low overhead, making our services more affordable without sacrificing quality. Currently, we are serving as the R&D arm of multiple companies targeting a variety of diseases from cancer to inflammatory diseases.
What is the mission of Constitution Laboratories? What are your technological focus areas?
Our mission is to help advance healthcare solutions by providing a platform for emerging technologies to rapidly develop products. This is achieved by leveraging our technical expertise, facilities, and experience. We have multiple focuses including formulation development, preclinical target discovery, in vitro evaluation of therapeutic efficacy/toxicity of drugs, analytical assay development and validation, stability studies, metabolite analysis, and GLP bioanalytical testing. We have established a biobank of over 150 cell lines that are authenticated by Short tandem repeat (STR) analysis and free of contamination by mycoplasma as assessed by periodic testing. This biobank can be used for characterizing therapeutic potential and researching mechanism-of-action. Between our in-house analytical, molecular biology, and chemistry laboratories and external partnerships, we cover a lot of ground.
As a contract research and analytical testing provider, why do you believe researchers and clients outsource these services? What are the challenges you find that companies and clients have in outsourcing?
Drug development and drug discovery are highly complex product development challenges and warrants expertise across a wide range of scientific disciplines. Building a team that matches these credentials to solve the scientific challenges involved in developing a new drug for even just one disease area can take years and is very costly. Working with a CRO that already has the right team of scientists, instrumentation, and protocols in place can save significant capital and time. The main challenge I believe companies and clients have in outsourcing is the need for guidance to best align with their development needs. Far too much effort is wasted on studies and experimentation that are not relevant or are tangential to the real needs of the client. This makes outsourcing very risky if you pick the wrong partner. It takes a lot of discussion and cross-functional coordination between the scientist, quality/regulatory, and management to provide the best value to clients. At Constitution Labs, we are highly committed to customer service and focused on our clients’ urgent needs. We are driven by our love for solving and executing complex scientific challenges in the lab. This is how we like to stand out.
What benefits, apart from speed, flexibility, cost reduction, etc. do companies and clients gain by outsourcing?
The phrase, “no man is an island” can extend to “no company is an island.” It can take a village and more. You need an international network of collaborators to drive success in biotechnology. Collaboration is key because biotech requires multi-disciplinary expertise. No single person or company can cover everything needed to succeed in this industry and the only way to stay afloat is to extend your network. Outsourcing is the solution here. Even the process of quoting is a major learning experience for not only companies but also for the CROs themselves. We find that even clients with in-house expertise to accomplish a project can benefit more by contracting the services, like an extension of their team.
How is Constitution Labs unique in what it has to offer its clients? It seems like rapidly changing technology is shaping a lot of industries, how do you feel about that and what changes, if any, are you making to keep up?
Constitution Labs is unique in the CRO space because we are innovative, lean, and agile. We bring deep technical expertise to every scientific problem we take on. We are Ph.D. scientists and researchers who treat every client’s research project as if it were our own. When it comes to research and lab work, we are genuinely passionate about the science and enjoy leveraging our experience to truly dissect the problem. We then develop an efficient and creative experimental plan to generate impactful results and solutions. We treat every client and project as unique to make sure we don’t miss anything or just take a standard one-size-fits-all approach that many CROs take.
We started Constitution Labs in October 2020. While many industries struggled to stay afloat, we saw tremendous opportunities in biotechnology and the analytical testing sphere. In a matter of months, an industry known for historically moving very slowly flipped like a switch with countless companies pivoting their focus toward COVID-19. Things just got faster. The FDA review process was accelerated, R&D divisions became hyper-focused, novel technologies thrived – and within months, several vaccines and treatments were approved. Achieving these successes required a lot of flexibility, and that allowed start-ups like ours to thrive. Starting during the pandemic has allowed Constitution Labs to develop a more modular workflow that embraces innovations. As technology quickly evolves and artificial intelligence helps streamline services, smaller companies like ours adopt more quickly and can pass the benefits to the client.
Sponsored by Constitution Laboratories LLC.
