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).

Nazma Rosado, President & Principal at Transformative Consulting, Inc. has over 25 years of experience in the Biopharma industry and has worked on phases I-IV with experience in all aspects of study management including study start-up, conduct and close- out. She has worked in Data Management, Clinical Operations, Regulatory Affairs and Quality Assurance, Project Management, Process Optimization, Learning & Development, Change Management, and, Organizational Design & Development for major and mid-sized pharmaceutical and small biotech companies, as well as for a contract research organization (CRO), and consulting companies. She has worked in a highly regulated industry and understands compliance needs. Nazma has focused on the Organizational Leadership and Development aspects of the companies she has worked for, and has been instrumental in designing and implementing solutions to better the workplace for staff and management. She works with senior leaders to help change behaviors that shape the company’s culture and increase employee engagement. Nazma has a passion for people and a strong desire to make the workplace more diverse, engaging, and productive by choice. Nazma has a B.A. in Neuroscience and a B.A. in Psychology from Colgate University and a M.A. in Organizational Leadership from Gonzaga University. She has 33 credits towards her Master in Public Health at the University of Connecticut. In addition to her traditional education, Nazma has earned many professional certifications including the following: Project Management Professional (PMP), Six Sigma Green Belt (6σ), Certified Professional in Learning & Performance (CPLP) and Certified Manager of Quality/ Organizational Excellence (CMQ/OE). She holds many certifications in Change Management as well including AMPG and Prosci certifications.