ABOUT
The client is an emerging biotechnology company focused on developing and commercializing patient-friendly compounds to treat psychiatric and neurological disorders. The company is developing breakthrough non-hallucinogenic psychedelic derivatives with the therapeutic potential to treat a wide range of mental health and neurological conditions that have a high unmet need.
CHALLENGE
The client had a biologics program (based on a cytokine) and was in the process of setting up the manufacturing process at a facility in the UK. The client began experiencing problems and found the consultants they had hired very challenging to work with. The client determined they needed a new manufacturing consultant with expertise in biologics. As a small virtual company, the client also needed a consultant with experience in the CMC (Chemistry, Manufacturing and Controls) process since it did not have a full-time CMC expert in-house.
SOLUTION
The client chose to partner with Syner-G because of its excellent reputation and breadth of experience in biologics. Syner-G helps its clients design and implement science and risk-based, phase-appropriate solutions to expeditiously advance drugs during development. Syner-G’s CMC 360 and Regulatory Affairs business units operate in an integrated fashion to ensure full compliance with scientific standards and regulatory requirements.
RESULTS
From day one of the partnership, Syner-G’s experts became an integrated part of the client’s team. According to the client’s chief operating officer (COO), “The Syner-G team had our best interest at heart – even down to budget challenges.” He continues, “They were able to help us get the best deal with the manufacturers, and they provided deep guidance on what development paths were risky and not as fruitful.” In addition to CMC management, Syner-G gave the client access to its team of quality assurance experts.
“We originally inherited a drug development program that was set on a particular research and development path,” says the COO. “Syner-G helped us realize that it wasn’t the best path for us and then collaborated with us to choose a more appropriate drug development path.” That new path ultimately generated an IP for the client.
Syner-G also helped with a small molecule product the client was having trouble with. “Syner-G had the agility and depth of knowledge to provide a small molecule expert to the team as well,” says the COO. “We didn’t have to go out and find another consult to manage the challenges.” The COO says that Syner-G was a “one-stop shop” for them, and they were able to generate an IP for that product as well.
The COO explains that what he appreciates most about the partnership with Syner-G is the openness and integrity of the relationship and that they can trust the team will always give honest and direct feedback. “You can really rely on their expertise and honesty, and I am confident that they will find the solution to whatever problem or challenge we are faced with.”