Rajesh B. Shukla, PHD

 

Rajesh Shukla is the Acting Vice President at Castle Creek Pharmaceuticals. Rajesh is a performance-driven innovation leader in entrepreneurial and established pharmaceutical companies with extensive experience in drug and drug/device combination R&D, institutional stewardship, and fostering strategic alliances with global corporate, academic, regulatory, and defense entities.

 

He brings depth in scientific, engineering, clinical, medical and regulatory management of large and complex clinical development programs with academic clinical centers, alliance partners, HHS and DoD/MoD agencies.

Rajesh is experienced in early and late phase clinical trial design, initiation and enrollment in Orphan and non-Orphan disease areas.  He has obtained more than $100MM in extramural clinical development funding for Oncology, CNS, Infectious Diseases and respiratory diseases from NIH, NIST, BARDA and DoD. His Intellectual Property (IP) strategy depth spans pre-LOE and post-LOE including API and formulation design for injectables, topicals and solid dosage forms. For drug/device combination products he brings post-LOE IP expertise for injectables, auto-injection and inhaler drug/device combination products.

Prior to joining Castle Creek Pharmaceuticals, Rajesh headed early through NDA stage clinical development programs in Immunology, Infectious Diseases, Epilepsy, Oncology, Endocrinology, Asthma and Anaphylaxis clinical programs at Pfizer, Bristol-Myers Squibb, Teva, Acorda Therapeutics, and, most recently Motif Biosciences where he led rapid completion of two Phase 3 trials in skin and skin-structure infections. During his tenure at Pfizer, Rajesh led advances in the treatment of acute immune system diseases and epilepsies.

Rajesh’s R&D career began after completing postdoctoral tenure at Yale University. As an Easton, Pennsylvania native, he completed bachelor’s degree in Biochemistry from Lehigh University and his PhD from Carnegie-Mellon University.