Tim Wright, CEO of MiMedx, a biopharmaceutical company developing, manufacturing, and marketing regenerative biologics utilizing human placental allografts for multiple sectors of healthcare, is the subject of an upcoming feature in Life Science Leader. During his interview for the article in our September issue, Wright talked about why it is every executive’s job to think “down the road a bit.” Prior to accepting his job as CEO, while doing his due diligence of the company, Wright looked at the potential application of MiMedx products and learned more about amniotic membranes and their use for regenerative healing. During this process he thought, “We need to elevate the standard of care for patients suffering from advanced or chronic wounds.” To do this he believes you need to start with a focus on the science. “We have to clearly explain the mechanism of action of what MiMedx tissue does and convey that to the physicians treating patients. We also need to explain the development of health economics rationale that supports the use of these products.” But, if you have a good molecule mechanistically, that is structurally flexible (e.g., Merck’s Keytruda), you have the potential to leverage the basic product technology into other indications. “That’s exactly what MiMedx had started to do in the musculoskeletal area by filing three INDs.” However, this requires working very close with the FDA. Historically, MiMedx amniotic tissue products were regulated under Section 361 of the Public Health Service (PHS) Act. But the way Wright sees it, if MiMedx is able to reformulate its products (i.e., take what is essentially a sheet of skin and reformulate so it can be injected to treat other ailments) and have them clinically proven safe and effective, the MiMedx products of the future will need to be regulated by CBER as a “drug, device, or biological product” under the Food, Drug, and Cosmetic Act (FDCA) and Section 351 of the PHS Act, which is a higher standard. “If we’re going to continue to be leaders in placental science, we will have to work even more closely with the FDA and build out our capabilities in R&D. Because while there is a tremendous amount of growth opportunity just in advanced wound care, the next big wave of growth for MiMedx revolves around applying placental science to other indications and forms of delivery.”
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