Howard has over 25 years experience in the biopharma industry with cross-functional leadership roles in clinical development, regulatory, safety risk-management, and external innovation. He has over two decades experiences with hands-on conduct/oversight of diverse IND submissions, data standards, clinical operations, planning and managing early and late-stage/pivotal protocols, NDA/BLA fillings which succeeded to achieve multi-regional commercialization for pediatric and adult indications. His recent consulting work includes training about modern R&D including novel immune-oncology combinations; regulatory science, updated FDA & ICH Guidances, Quality by Design; clinical due diligence & public-private partnerships; and benefit-risk strategies. Howard has extensive due-diligence/in-licensing experience within the biotech community. As part of his work in external innovation, he served as Industry Representative to the FDA Oncology Drugs Advisory Committee (ODAC) and he has been selected to advise patient advocacy groups and multiple committees at the National Cancer Institute, FDA, BIO Clinical Committee, and both the International Conference on Harmonization and NCI Expert Working Groups to modernize guidelines for clinical protocols. His publications include diverse topics in cancer sciences, applications of external data, and chapters in major textbooks about Cancer Medicine. Howard has a passion for teamwork and a strong desire to optimize productivity, organizational culture, quality evidence and participant safety from clinical trials. Howard has BA and MA from Brandeis Univ. and MD from Univ. Illinois. He is board-certified oncologist-hematologist trained at Massachusetts General Hospital and Dana Farber Cancer Institute, and published laboratory-clinical research as Assistant Professor at Harvard Medical School. He earned professional awards for Team Leadership by Pfizer & Takeda, and is certified in updated GCP - ICH E6(R2).