Harvard Catalyst Profiles

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Neal Indu Muni, M.D.

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Neal I. Muni, MD, MSPH, is the Founder and Managing Director of RTK Group, LLC, a biopharmaceutical advisory and investment practice focused on supporting clinical-stage therapeutics from development to commercialization.

Prior to founding RTK Group, Dr. Muni served for over 20 years in senior roles across the entire life sciences value chain, most recently serving as the CEO of Azurity Pharmaceuticals (formerly CutisPharma). In his role, Dr. Muni led two successful private equity transactions, including a recapitalization with Ampersand Capital Partners and successful company sale and exit to Novaquest Capital Management. During his tenure, Dr. Muni led the transformation of CutisPharma from pharmacy distribution into a fully-integrated specialty pharma, leading the acquisition of Silvergate Pharmaceuticals as well as overseeing the FDA approval and launch of two pipeline drugs, FIRVANQ® for clostridium dificile colitis and Katerzia® for pediatric hypertension.

Prior to CutisPharma, Dr. Muni served as the Head of New Product Planning and Corporate Strategy at Sunovion Pharmaceuticals, leading portfolio strategy and supporting corporate M&A and licensing. Prior to that, Dr. Muni was an engagement manager at the healthcare investment bank Leerink Swann (now SVB Leerink). Prior to Leerink, he was a Medical Officer in the Division of Cardiovascular Devices at the FDA, serving as the lead medical reviewer for drug-eluting intracoronary stents.

Over the past 20 years, Dr. Muni has maintained staff appointments at Harvard Medical School and its teaching hospitals, including Brigham and Women’s Hospital, Dana Farber Cancer Institute, and Faulkner Hospital. Dr. Muni is currently appointed as a Visiting Scholar at the Wyss Institute at Harvard University, mentoring project teams and collaborating on technology development, partnering, and company formation. Dr. Muni completed his residency in Internal Medicine at the Brigham and is appointed as Associate Physician on the hospitalist service, supervising medical residents and students. Dr. Muni received his MD as well as Master of Science in Public Health (biostatistics) from the Tulane University School of Medicine, and a BA in Business Economics and B.Sc. in Biochemistry from Brown University.

Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Faculty can login to make corrections and additions.
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  1. Leidy NK, Beusterien K, Sullivan E, Richner R, Muni NI. Integrating the patient's perspective into device evaluation trials. Value Health. 2006 Nov-Dec; 9(6):394-401. PMID: 17076870.
    Citations: 4     Fields:    Translation:HumansPHPublic Health
  2. Ho C, Jensen D, Lacy F, Muni N, Reilly S, Mallis E. Use of standards in the review of medical devices. J Electrocardiol. 2005 Oct; 38(4 Suppl):171-4. PMID: 16226095.
    Citations:    Fields:    Translation:HumansPHPublic Health
  3. Muni NI, Califf RM, Foy JR, Boam AB, Zuckerman BD, Kuntz RE. Coronary drug-eluting stent development: issues in trial design. Am Heart J. 2005 Mar; 149(3):415-33. PMID: 15864230.
    Citations: 2     Fields:    Translation:HumansAnimals
  4. Zuckerman BD, Muni NI. Cardiovascular device development: an FDA perspective. Am J Ther. 2005 Mar-Apr; 12(2):176-8. PMID: 15767836.
    Citations:    Fields:    Translation:HumansPHPublic Health
  5. Muni NI, Gross TP, Boam AB, Wang S, Zuckerman BD. Challenges in regulating breakthrough medical devices. Food Drug Law J. 2005; 60(2):137-42. PMID: 16097092.
    Citations:    Fields:    Translation:HumansPHPublic Health
  6. Muni NI, Gross TP. Problems with drug-eluting coronary stents--the FDA perspective. N Engl J Med. 2004 Oct 14; 351(16):1593-5. PMID: 15483274.
    Citations: 8     Fields:    Translation:HumansPHPublic Health
  7. Muni NI, Ho C, Mallis E. Regulatory issues for computerized electrocardiographic devices. J Electrocardiol. 2004; 37 Suppl:74-7. PMID: 15534806.
    Citations:    Fields:    Translation:HumansPHPublic Health
  8. Beech D, Pontius A, Muni N, Long WP. Familial adenomatous polyposis: a case report and review of the literature. J Natl Med Assoc. 2001 Jun; 93(6):208-13. PMID: 11446392.
    Citations: 3     Fields:    Translation:Humans
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Funded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number UL1TR002541.