Background and Capabilities of our Consultants:

• Specialized knowledge in AI/ML applications customized for your clinical research and trial analysis

• Our Team is led by Dr. Kenneth A. Kern, MD, MPH, MS, MBEE, RAC, FACS, FSSO.  Dr. Kern has a background as an academic surgical oncologist, with 20-years’ experience in cancer drug development, including advanced qualifications in regulatory affairs, public health, and business enterprise from institutions including Harvard, MIT, Johns Hopkins, and UC Berkeley

• Dr. Kern has developed successfully medicinal drugs at Pfizer and AstraZeneca, with a focus on small molecule signal transduction inhibitors (especially RAS and adjacent pathways), immunotherapy and other biologics (bifunctional antibodies and ADCs), and cancer vaccines.

• This means out Team can provide time-tested, creative, and innovative solutions leading to success in novel drug development.

• Experienced across Phase 1-3 trials, including IND and NDA filings, FDA interactions, and preventing clinical holds.

• We specialize in complex regulatory filings, because we understand both clinical development from the oncology-medical aspect, and regulatory requirements from the perspective of CFR and EU Regulations and Directives.