Dr. Mukesh Kumar, Ph.D. RAC, DABRM

Dr. Mukesh Kumar is an accomplished serial entrepreneur, senior executive, author, thought leader, public speaker, and advisor to management teams and BODs with more than 18 years of across healthcare industry success. He is the founder of Akan Biosciences and FDAMap, two Maryland-origin companies.

His latest company, Akan Biosciences, is developing state-of-the-art regenerative and reparative cell therapies, where he serves as the Chairman of the Board. Akan Biosciences is one of the only companies in the world to get FDA approval for INDs for use of non-expanded native SVF for osteoarthritis. Akan Bio also launched allograft HCT/P products in 2021 at more than 200 clinics nationwide with contracts to be the preferred allograft product for more than 5000 clinics in the US alone by 2022. In addition, Akan Bio is developing products for the treatment of autism and Crohn’s disease.

Another of his companies, FDAMap, has worked with more than 1100 companies or all sizes over the last 6 years including several Fortune 100 and Fortune 500 pharmaceutical, biotech, medical devices and digital health, and healthcare companies. He is one of world’s top experts in US regulatory affairs, compliance, clinical trials, and smart product development strategies. His clients are in more than 50 countries in the Americas, Europe, Asia, Africa, and Australia. He has been pivotal in the development of more than 100 medicinal and diagnostic products with more than 200 clinical trials, thousands of submissions to the US FDA, European Medicines Agency, and regulators in about 34 countries. His approach of disruptive product development is based on using novel, smart, out-of-the-box regulatory approaches that expedite patient access while reducing development cost.

Mukesh sits on the Board of several small and medium size companies developing innovative products prominent among which are Vivacelle Bio, Inc. of Kansas, ResQ Pharma, Inc, of Illinois, Kibow Pharmaceuticals, Inc. of Pennsylvania, Amarex Biosciences, Pvt Ltd of New Delhi, India, and Pepfactor, Inc. of Sydney, Australia.

In addition to running companies, Mukesh is an accomplished author and thought leader in healthcare related topics having written numerous articles in peer-reviewed journals and other professional publications. His weekly blog, FDA Puran, is subscribed by over 100,000 readers globally, and he has authored more than 800 blogs on US and worldwide healthcare regulations. Mukesh loves to teach and mentor upcoming talent. He created a Certificate in Clinical Project Management at the Montgomery College, Maryland, where he trained 100s of budding clinical research professionals over 8 years. He is currently a Professor (Adjunct), Regulatory Sciences, at the School of Medicine, George Washington University, Washington DC, and the lead trainer for FDAMap where he delivers about 50 lectures every year on various topics related to product development and entrepreneurship to students at all levels. He has trained more than 10,000 students over the last 20 years and personally mentored more than 100 budding scientists, developers, regulators, entrepreneurs, and policy wonks most of who have developed into successful professionals and his life-long network of experts.

Dr. Kumar is a PhD in Biochemistry, a certified regulatory professional by the Regulatory Affairs Professionals Society, USA, a certified clinical trialist by The Bloomberg School of Public Health, John Hopkins University, a Diplomate of the American Board of Regenerative Medicine, a compliance inspector, and a certifier.