BioFabConsulting provides a range of regulatory, preclinical study design, early phase commercialization consulting as one of many benefits available to ARMI | BioFabUSA members. The expertise available from BioFabConsulting reflects the diverse interests and needs of BioFabUSA heterogenous membership. These efforts are headed by both Dr. Richard McFarland, PhD, MD (Chief Regulatory Officer) and Dr. Becky Robinson-Zeigler, PhD (Deputy Chief Regulatory Officer). Their expertise spans across the spectrum of review, policy, jurisdiction, and types of medical products relevant to tissue engineering and regenerative medicine applications, and the knowledge-base does not stop there.
With more than 20 years combined experience at the FDA, it does not come as a surprise to many that their expertise is not siloed in biologics product development, but also medical device, drug, and combination product development. Since BioFabConsulting’s launch at the end of May, the services, available exclusively to members, have made a significant impact on those who have taken advantage of them.
One of the first ARMI members to get involved was Dr. Lisa Larkin of the Skeletal Tissue Engineering Laboratory (STEL). STEL is an academic spinout of the premier research laboratory for regenerative medicine at the University of Michigan at Ann Arbor. Through reverse-engineering of primary bone marrow stromal cells and adipose stem cells, STEL has developed exciting and innovative methods for the fabrication of cell-derived three-dimensional musculoskeletal tissues, tendons, bones and ligaments for widespread applications in tissue engineering and regenerative medicine.
Dr. Larkin, who has been incredibly active in the ARMI | BioFabUSA Community, initially expressed interest in BioFabConsulting and took advantage of the free one-on-one meeting time available at the 2018 Spring Summit. Drs. McFarland and Robinson-Zeigler worked with Dr. Larkin in the beginning to understand the needs of STEL and set the scope of the work to be done by BioFabConsulting. Additional time was then utilized that allowed the two to provide insight on what is needed to move Dr. Larkin’s product to the next stage of the developmental process.
Dr. Robinson-Zeigler stated that a majority of their time in the beginning was spent, “…putting to bed some of the misconceptions about product development in the tissue engineering space. A lot of what Dr. Larkin though was true was able to be discounted. Based on our extensive FDA experience, we were able to tell her exactly what is possible and needed to get her product through the regulatory process.” She continued to state that Dr. Larkin is not the first to experience something like this, but instead that these misconceptions are common, especially within small academic spinouts.
Dr. Larkin was overwhelmingly positive when asked about her experience with BioFabConsulting stating that, “… in the regenerative medicine space, where the FDA doesn’t necessarily know how to regulate what we’re creating, you get a lot of people out there that say they have the expertise to actually help you get through the FDA, but when you actually sit down and talk to them, they really have no idea how the FDA is going to regulate it. To have these two people sitting in front of you that know what the pitfalls are, that know exactly what the FDA is looking for, and can very quickly say, ‘That is not going to work and this is what you need to know about in the future’ is invaluable.”
Dr. McFarland and Dr. Robinson-Zeigler both agreed that Dr. Larkin coming to them early in the developmental process was invaluable. While the process of getting something through the FDA is challenging regardless of the stage, becoming involved in the regulatory and preclinical process earlier is of great benefit. Dr. McFarland further emphasized this point by stating, “Coming to use early will optimize the time that is spent on the ‘need to know’ data and minimizing the time that is spent on the ‘nice to know’ data. If you do that, it is generally cheaper and faster.”
The positive outcomes that Dr. Larkin has experienced are largely due to not only their expertise, but the passion that the two have for regulatory and preclinical work. Dr. McFarland stated, “It is really satisfying for us to be able to this work because we know with all of our history at the FDA, we have seen people with good ideas that didn’t have the benefit of getting their product in the later stages of the developmental process. It is really satisfying to help someone get there by providing them the complete package.”