Helping Translate Life Sciences into Products

Kinexum has become one of Catalyst’s “go to” consultant firms for due diligence support, particularly for regulatory, clinical and CMC-related assessments. Kinexum’s team of experts work seamlessly, as an extension of our own team, to provide comprehensive evaluations and strategic insights. Project plans are well-organized and executed with consistently high quality and timely delivery, often under very tight timelines. The team’s collective expertise is far-reaching, and without exception, each individual is genuinely engaged and professional. We view the Kinexum team as a valued partner and a pleasure with whom to work. 

We partnered with Kinexum seeking expertise on how to approach the FDA with our IND strategy for our combination drug-device product. We were very pleased with the guidance, direction, and preparation of submission materials, which resulted in an extremely collaborative pre-IND meeting with the Agency. We particularly appreciated the speed with which the Kinexum team converted our pre-IND meeting, which took place around Thanksgiving, through the year end holidays, to an IND filing in the first week of the New Year, that enabled us to start our tightly scheduled clinical trial.

When our Korean pharmaceutical company, Dong-A ST, was planning to place multiple development candidates in a US listed company to be the largest shareholder and strategic partner, our banker recommended we retain Kinexum to prepare detailed regulatory, clinical and product development plans for fundraising and further development in the US. Kinexum’s work product supported a successful transaction and fundraising, and a couple years later, now the US affiliate returned to Kinexum for an update of such plans in light of a significant change in the market. We are very pleased with the quality, speed and responsiveness of Kinexum’s work, and believe the disciplined scenario planning, timelines and budgets for clinical development of the sort Kinexum generates would be valuable to many companies, including Korean life science companies. Dong-A ST Research Center calls the Kinexum report as the Bible and still refers and cross-checks the pathway suggested by Kinexum. Something that everyone should have.

Over the years, we have had the pleasure of working with Kinexum on various projects involving product development, clinical program design, and FDA interactions. Kinexum’s team of consultants is highly skilled and knowledgeable, consistently providing valuable insights and expertise. Whenever we have questions related to FDA processes, Kinexum responds promptly and professionally, delivering effective solutions. Their support has been instrumental in the success of our collaborative efforts. Kinexum is a reliable and professional partner, and we appreciate their commitment to helping us achieve our goals. We look forward to continuing our successful collaboration with them.

Kinexum has been wonderful to work with! Being new to drug development, the team successfully guided us to FDA approval of our IND even (and especially) when faced with external challenges. Kinexum brings a unique expertise in metabolic diseases and diabetes to the table that seems unparalleled in this industry and the team is a true pleasure to work with. In fact, members are not only highly professional, they have also become close colleagues and friends. I have to give a particular shout out to Michael Zemel and Jo Van Betsbrugge who are just so knowledgeable and from whom I personally learned so much during the process. Now, I am very much looking forward to continuing to work with Kinexum as we move along our drug development journey.