Rudy Padua, Ph.D. is bringing 16 years of medical device industry experience to his new role as director of clinical affairs at St. Teresa Medical, Inc. in St. Paul, Minnesota. He comes to St. Teresa from Brad Lutonix, where he served as clinical trial manager and managed global investigational device exemption and post-market clinical trials.
Rudy Padua, Ph.D.: New Director of Clinical Affairs at St. Teresa Medical
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“We are pleased to welcome Rudy to St. Teresa as we move forward this fall with human clinical trials for ORTHOCLOT in the UK. He will play a central role in the development and execution of our clinical plan and human trial procedures in Europe, ” said Phil Messina, co-founder and CEO of St. Teresa Medical, in the August 28, 2014 news release.
According to the news release, Dr. Padua has experience with everything from early-stage research and development projects focused on the development of next-generation biologics/medical device products to the conduct and management of pre-clinical studies and pre- and post-market clinical studies.
Dr. Padua joins the company as St. Teresa Medical is working on its late-stage fibrin sealant platform technology called ORTHOCLOT. As indicated in the news release, it is “the only rapidly dissolvable and absorbable fibrin sealant that will be available in the European Union during early 2015 and in the United States in 2016.”
Dr. Padua told OTW, “From my past experience, I have found that having a good solid relationship with both our clinical research organization (CRO) partner and participating clinical sites is crucial to the success of a clinical trial. Continuous oversight of CRO activities will ensure that clinical study-related tasks are executed on time and within budget. At the same time, good consistent communication with clinical site investigators and research coordinators to address their concerns or to just provide acknowledgement of their great efforts in enrolling subjects for the study can go a long way in ensuring that enrollment objectives are met.”
Asked about how he will proceed, he stated, “My first duty was to completely understand the company’s product (ORTHOCLOT), the only fibrin sealant indicated for cancellous bone bleeding, once approved, and to begin developing the relationship with our CRO. Since then, we developed a scientifically sound clinical study protocol and have solidified our EU clinical trial sites and primary investigators. We are well on our way to enrolling our first patient this fall.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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