Go to Client Portal
NAMSA
Jack Risdahl

Jack Risdahl, DVM, PhD

Principal Strategy Consultant, Preclinical

Reserve your Consultation with our Experts

Contact Us

expertise areas:

FDA, Preclinical, Product Development

Dr. Jack Risdahl has over 30 years of experience in medical product development and testing. Dr. Risdahl has both Doctor of Veterinary Medicine (DVM) and Doctor of Philosophy (Ph.D.) degrees, and began his career in academia at the Medical and Veterinary Schools at the University of Minnesota. Following, he served in a Global Director role at Baxter while also holding a faculty position at the Mayo Clinic.

Prior to joining NAMSA in 2012 through acquisition, Dr. Risdahl was an entrepreneur, co-owner and managing partner of the Integra Group. While at NAMSA, Jack was the Director of Preclinical and Functional Studies with global oversite before joining the Global Strategy Consulting Group in 2017. His expertise in preclinical studies and safety evaluations allows him to work with innovative medical device companies looking to accelerate the development of their technology, and to also address regulatory agency expectations and responses to those studies. As a former entrepreneur, he is also able to understand and assist in product development strategies for accelerating product development testing that meet specific business goals. He has a broad experience across the medical device spectrum of products for devices, biologics and combination products including but not limited to regenerative medicine, cell therapy and transplantation, neurostimulation and cardiovascular devices. 

CORE COMPETENCIES

  • Oversees and performs preclinical studies and safety evaluations for medical devices, biological drugs and combination products for worldwide regulatory submissions
  • Evaluates and prepares business and scientific analysis for new product testing plans necessary for medical product development
  • Assists in the development, design and execution of medical product testing plans for a wide range of medical devices from concept to final product
  • Performs and oversees pathology evaluations for wide range of studies and regularly consults with study pathologists
  • Serves as expert in the area of preclinical model development and applications for medical products
  • Supports multiple U.S. Food and Drug Administration (FDA) pre-submission meetings to assist in answering preclinical study design questions
  • Acts as expert in the areas of preclinical study design for regulatory submission for multiple device and combination product types, including but not limited to: regenerative medicine, cell therapy and transplantation, neurostimulation and cardiovascular devices
  • Serves as an experienced leader for medical device testing plan development, covering both efficacy and safety testing as required by regulatory agencies
  • Former managing partner of a preclinical testing business which was responsible for the design and build of facilities, programs for preclinical testing and evaluation of medical devices, and marketing and business operations
  • Responsible for the implementation and application of standards and guidelines to meet the requirements for U.S. FDA Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) device and tissue regulations. Dr. Risdahl has designed and developed several animal testing facilities, implemented programs and obtained American Association for Accreditation of Laboratory Animal Care (AAALAC) certifications for these operations. 

RECENT PROJECTS 

  • Oversight of Notified Body non-conformance of animal studies related to recent MDR changes: successful outcome with acceptance of response
  • Management of FDA acceptance of animal testing plans for numerous U.S. FDA pre-submission meetings: response and follow-up to FDA deficiencies with successful outcomes to avoid re-testing requirements
  • Worked with numerous companies to assist in developing product development testing plans to successfully meet investor, company board, regulatory and marketing goals

PUBLICATIONS

Book Chapters

  • Risdahl, J.; Peterson, P.; and Molitor, T. Opiates Infection and Immunity.  In: Drugs of Abuse and Immune Function. Ed. H. Friedman, CRC Press, P1-42.  1996.
  • Risdahl, J.; Huether, M; Gustafson, K; Molitor, T. Morphine Alteration of Histamine Release in vivo.  The Brain-Immune Axis and Substance Abuse.  B. Sharp, T. Eisenstein, J. Madden, and H. Friedman, Plenum Press, 14 pgs, in press.  1995.
  • Schoolov, Y; Pampushsh, M; Risdahl, J.; Molitor, T; Murthaugh, M. Effect of Chronic Morphine Treatment on Immune Responses to Keyhole Limpet Hemocyanin (KLH) in Swine.  The Brain-Immune Axis and Substance Abuse.  B. Sharp, T. Eisenstein, J. Madden, and H. Friedman, Plenum Press, 9 pgs, in press.  1994.

 

Journals/Proceedings

  • Roberts WW; Teofilovic D, Jahnke, RC, Patri J, Risdahl JM, Bertolina JA. Histotripsy of the Prostate Using a Comercial System in a Canine Model.  Journal of Urology 2014 Mar; 191(3):860-865
  • Floyd, TC, Rothwell, SW, Martin, R, Risdahl J, Olson, CE. A Salmon Thrombin-Fibrinogen Dressing Controls Hemorrhage in a Swine Model Compared to Standard Kaolin-Coated Gauze.  J Special Operations Medicine 2012 12(1): 48-54
  • Floyd, TC, Rothwell, SW, Martin, R, Risdahl J, Olson, CE, Rose N. Salmon Thrombin-Fibrinogen Dressing Allows Greater Survival and Preserves Distal Blood Flow Compared to Standard Kaolin Gauze in Coagulopathic Swine with a Standardized Lethal Femoral Artery Injury.  J Special Operations Medicine 2012 12(2):16-26
  • McGregor CG, Davies WR, Oi K, Teotia SS, Schirmer JM, Risdahl JM, Tazelaar HD, Kremers WK, Walker RC, Byrne GW, Logan JS. Cardiac Xenotransplantation: Recent Preclinical Progress with 3-Month Median Survival. Journal of Thoracic Cardiovascular Surgery 2005 Sep; 130(3):844-51
  • Teotia SS, Walker RC, Schirmer JM, Tazelaar HD, Michaels MG, Risdahl JM, Byrne GW, Logan JS, McGregor CG. Prevention, Detection, and Management of Early Bacterial and Fungal Infections in a Preclinical Cardiac Xenotransplantation Model that Achieves Prolonged Survival.  Xenotransplantation. 2005 Mar; 12(2):127-33
  • McGregor CG, Teotia SS, Byrne GW, Michaels MG, Risdahl JM, Schirmer JM, Tazelaar HD, Walker RC, Logan JS. Cardiac Xenotransplantation: Progress toward the Clinic. Transplantation. 2004 Dec 15; 78(11):1569-75
  • Guedes MI, Risdahl JM, Wiseman B, Molitor TW. Reactivation of Porcine Cytomegalovirus through Allogeneic Stimulation. Journal of Clinical Microbiology. 2004 Apr; 42 (4):1756-8
  • McGregor CG, Franz RP, Olson LJ, Tazelaar HD, Branzoli SE, Ugurlu MM, Teotia SS, Schirmer JM, Wiseman BS, Risdahl JM, Byrne GW, Logan JS.  100 Day Cardiac Xenograft Survival in Procine-to-Primate Model.  Journal of Heart Lung Transplant. Jan 2002; 21 (1): 122 –  IN PRESS.
  • J Risdahl, S Edgerton, C Adams, M. Martin, B. Wiseman. Establishing a Designated Pathogen Free Swine Colony for Xenotransplantation.  Proceedings of the 17th IPVS Congress, Ames, Iowa, USA.  Volume 2. 2002.
  • Guedes, M; Ma, S; Risdahl, J; Wiseman, B; Rossow, K; Molitor, T. Porcine Cytomegalovirus Infection in Swine Fetuses Inoculated at Different Ages.  Proceedings of the 17th IPVS Congress, Ames, Iowa, USA.  Volume 2. 2002.
  • Rodriquez NA, Cooper DM, Risdahl JM. Antinociceptive Activity and Clinical Experience with Swine.  Contemporary Top Laboratory Animal Science.  2001 May 40(3): 17-20.
  • Slack J, Risdahl JM, Valberg SJ, Murphy, MJ, Schram BR, Lunn DP. Effects of Dexamethasone on Development of Immunoglobulin G Subclass Responses following Vaccination of Horses.  American Journal of Veterinary Research.  Dec 2000; 61(12):  1530-3.
  • Risdahl, J.; Khanna, K.; Peterson P.; Molitor, T. Opiates and Infection.  Journal of Neuroimmunology  83: 4-18.
  • Bolin CA, Whipple DL, Khanna KV, Risdahl JM, Peterson PK, Molitor TW. Infection of Swine with Mycobacterium bovis as a Model of Human Tuberculosis.  Journal of Infectious Disease.  Dec; 176(6) 1559-66.
  • Risdahl JM, Huether MJ, Gustafson KV, Molitor TW. Morphine Alteration of Histamine Release in vivo.  Advances in Experimental Medicine and Biology.  373: 161-8. 1995.
  • Risdahl, J.; Peterson, P.; Chao, C.; Pijoan, C.; Molitor, T. Effects of Morphine Dependence upon the Pathogenesis of Swine Herpes Virus Infection.  Journal of Infectious Disease. 167:1281-1287. 1993.
  • Leitner, G; Risdahl,J.; Schwandt, L; Peterson, P; Molitor, T. Pathogenesis of Escherichia coli in Pigs under Acute Cocaine Exposure.  Advances in Bioscience. 86: 467-472.
  • Risdahl, J.; Chao, C.; Murtaugh, M.; Peterson, P.; Molitor, T. Acute and chronic morphine administration to swine.  Pharmacology, Biochemistry, and Behavior. 43: 799-806. 1992
  • Molitor, T.; Morilla, A.; Risdahl, J.; Chao C.; Murtaugh, M.; Peterson. Chronic Morphine Administration Impairs Cell Mediated Immune Responses in Swine.  Journal of Pharmacology and Experimental Therapeutics.  260:581-586. 1992
  • Risdahl, J.; Morilla, A.; Chao, C., Murtaugh, M.; Peterson, P.; Molitor, T. Immunosuppressive Effects of Morphine in Swine.  The Pharmacologist ; 33:3. 1991

 

Published Abstracts

  • HD Tazelaar, RP Frantz, LJ Olson, RC Walker, SS Teotia, JM Risdahl, GW Byrne, JS Logan, CG McGregor. Cardiac pathology in procine to primate heterotopic xenografts (xg) functioning for >60 days.  Accepted for presentation at: The International Society for Heart and Lung Transplantation 22nd Annual Meeting and Scientific Sessions.  Vienna, Austria, April 9-12, 2003.
  • HD Tazelaar, RP Frantz, LJ Olson, RC Walker, SS Teotia, JM Risdahl, GW Byrne, JS Logan, CG McGregor. Autopsy pathology (AP) in primate recipients of heterotopic xenografts (xg) functioning for >60 days.  Accepted for presentation at: The International Society for Heart and Lung Transplantation 22nd Annual Meeting and Scientific Sessions.  Vienna, Austria, April 9-12, 2003.
  • C; Frantz.R; Olson, L; Tazelaar, H; Branzoli, S; Ugurlu, M; Teotia, S; Schirmer, J; Wiseman, B; Risdahl, J; Byrne, G; Logan, J. 2002.  Prolonged Cardiac Xenograft Survival in Transgenic Porcine-to-Primate Model.  Proceedings for the 28th Annual Meeting of the Western Thoracic Surgical Association.  Big Sky, Montana , June 19-22, 2002.
  • Risdahl, J; Edgerton, S; Adams, C; Martin, M; Wiseman, B.   Establishing a Designated Pathogen-free Swine Colony for Xenotransplantation Organ Production.  Xenotransplantation, Vol 8, Supplement 1, August 2001, Page 123.
  • Huether, M.; Molitor, T.; Risdahl, J.   A Method for the in vivo Quantitation of Leukocyte Chemotaxis in Swine.  Fourth International Veterinary Immunology Symposium.  July 16-21, Davis, CA.
  • Huether, M.; Risdahl, J; Molitor, T.    Lipopolysaccharide Induced Cytokine Expression in Swine.  Fourth International Veterinary Immunology Symposium.  July 16-21 Davis, CA.
  • Bolin, C.; Gustafson, K.; Risdahl, J.; Molitor, T.  1995.  A Swine Model of Tuberculosis.  International Tuberculosis Symposium, Washington D.C.
  • Risdahl, J.; Huether, M; Gustafson, K; Molitor, T.   Morphine Alteration of Histamine Release in vivo.  Second Annual Symposium on the Brain – Immune Axis and Substance Abuse, West Palm Beach, Florida, June 16-18.
  • Risdahl, J.; Choi, C; Huether, M; Gustafson, K; Molitor, T.   Morphine Mediated Alteration of Herpes Pneumonia Pathogenesis.  Second Annual Symposium on the Brain – Immune Axis and Substance Abuse, West Palm Beach, Florida, June 16-18.
  • Schoolov, Y; Pampushsh, M; Risdahl, J.; Molitor, T; Murthaugh, M;   Effect of Chronic Morphine Treatment on Immune Responses to Keyhole Limpet Hemocyanin (KLH) in Swine.  Second Annual Symposium on the Brain-Immune Axis and Substance Abuse, West Palm Beach, Florida, June 16-18.
  • Risdahl, J.; Lokensgard, J.; Huether, M; Peterson, P.; Molitor, T.   Morphine induces Transcription of Latent Herpes Virus.  Substance Abuse and Brain Immune Axis Satellite of CPDD meeting, Toronto, Ontario, June 17-18.
  • Risdahl, J.; Huether, M.; Peterson, P.; Molitor, T.    Morphine Suppresses Antigen Specific Delayed Type Hypersensitivity.  Substance Abuse and Brain Immune Axis Satellite of CPDD meeting, Toronto, Ontario, June 17-18.
  • Leitner, G.; Risdahl, J.; Peterson, P, Molitor, T.   Pathogenesis of Esherichia coli under Acute Cocaine Exposure.  The Second International Conference on Alcohol, Drugs of Abuse, and Immunomodulation (AIDS).  Sept. 9-12, Tucson, Arizona.
  • Leitner, G; Choi, C; Risdahl, J; Murtaugh, M; Collins, J; Molitor, T.   Modulation of host Immune Responses by SIRS virus.  Proceedings of the Third International Veterinary Immunology Symposium.  Budapest, Hungary, August 17-20.
  • Risdahl, J.; Peterson, P.; Molitor, T:   Chronic Morphine Alters Herpes Virus Pathogenesis in Swine.  Abstracts of the Second International Symposium on Drugs of Abuse, Immunity and AIDS.  University of South Florida, June 1-3.
  • Molitor T.; Leitner, G.; Choi, C., Risdahl, J.; Murtaugh, M.; Collins, J.   Modulation of Host Immune Responses by SIRS Virus.  Third International Veterinary Immunology Symposium.  Vet. Immunology and Immunopathology.  Supplement to vol. 35.  Feb.
  • Molitor T.; Leitner, G.; Choi, C., Risdahl, J.; Rossow, K., Collins, J.   Does SIRS Virus Cause Immunosuppression?  Abstracts from the International Symposium on Swine Infertility and Respiratory Syndrome. University of Minnesota, May 17-19.
  • Risdahl, J.; Chao, C.; Murtaugh, M.; Peterson, P., Molitor, T.   A Swine Model for the Evaluation of Immune Responses during Chronic Morphine Administration.  Abstracts Presented at Research Perspectives in Psychoneuroimmunology III, Columbus, Ohio, Sept. 12-14.
  • Risdahl, J.; Chao, C.; Murtaugh, M.; Peterson, P., Molitor, T.   Chronic Morphine Exposure Increases Severity of Herpes Virus-induced Diseases in Swine.  Abstracts Presented at Research Perspectives in Psychoneuroimmunology III, Columbus, Ohio, Sept. 12-14.
  • Risdahl, J.; Chao, C.; Murtaugh, M.; Peterson, P.; Molitor,T.   Acute and Chronic Morphine Administration to Swine.  Abstracts from Conference of Research Workers in Animal Disease, P51, 71.
  • Risdahl, J.; Chao, C.; Murtaugh, M.; Peterson, P.; Molitor,T.   Immunosuppressive effects of Chronic Morphine in Swine. American Association of Swine Practioners 22nd Annual Meeting, March.
  • Risdahl, J.; Maheswaran S.; Ames, T.   Purification of Pasteurella haemolytica Leukotoxin.  Abstracts from Conference of Research workers in Animal Disease, 298, 54.
  • Ames, T.; Risdahl, J.; Maheswaran, S.   Pasteurella haemolytica Leukotoxin Induced Lung Pathology in Calves.  Abstracts from Conference of Research workers in Animal Disease, 84, 23.