Founder and CEO, Bruder Consulting & Venture Group, New York
Dr. Scott Bruder was invited by Dr. Johnny Huard to speak at the Fifth Annual Vail Scientific Summit (VSS), Presented by Canon Medical. Dr. Bruder has worked closely with the Food and Drug Administration (FDA) and one of his functions at the VSS was to help the attendees learn ways to navigate their new drugs, biologics and combination products through the FDA approval process.
What does your company do and how is it related to working with the FDA?
“Over the last five years, I’ve built a boutique consulting group in the area of tissue repair and regeneration, and we help small, medium and large companies navigate the product development pathway. We help them strategize and prepare all sorts of documents required during the FDA approval process, and eventually, establish commercial relationships so that they can achieve the kind of clinical and commercial success that they desire.”
What have you found to be your biggest challenge in dealing with matters that concern the FDA?
“I have found through the last 25 years of developing products that there is a lack of appreciation and true understanding of what it takes to navigate the whole pathway. As a motivated innovator and veteran of the product development pathway, I would like to help people take their ideas and their inventions through the laboratory and into patients in a timelier manner. One of the most effective kinds of guidance that we are able to provide our client partners is helping companies plan ahead for the long journey now, so that they don’t need to do work that should have been done earlier in the process.”
What does it take to achieve success in navigating the process to FDA approval?
“You have to approach this with an open mind, and you need patience, tenacity, perseverance and diligence in every step along the way. It is a multifaceted effort and requires the integrated participation of scientists, clinicians, regulators, businesspeople, as well as reimbursement experts. This conference (Vail Scientific Summit) drew me here because there is a mixture of entrepreneurs, scientists and others involved in clinical research.”
What are some of the misconceptions that people have regarding the workings of the FDA?
“Far too many people see the FDA as the enemy, as the barrier that prevents them from getting their products cleared and approved. My philosophy is that the FDA and its personnel need to be regarded as partners in the process. The sooner you approach them as partners, the sooner you may see success in the approval process.”
Why did you choose to attend this Vail Scientific Summit? Besides the opportunity to share your thoughts on the FDA, is there a particular speaker or topic that drew you to attend?
“I have not been to this Summit before. I’ve seen it advertised for several years, and I’ve known Johnny (Dr. Huard) for a long time and have great respect for him, as well as for Dr. Philippon. When Johnny called me and said that he needed to address the issue of product development, the FDA and what it means to the scientist and the clinician, I jumped at the opportunity. I knew there would be a very high-level group of scientists, an interesting mix of physicians and others, who would bring new ideas to the table. I’m delighted to have been included as faculty and look forward to future meetings.”
For further information or other inquiries about The Steadman Clinic or Steadman Philippon Research Institute, contact Lynda Sampson, Vice President of External Affairs (firstname.lastname@example.org).