Brad Blum

Executive Profile

Over 19 years as a Life Science executive with a proven track record of achieving strategic, financial, and operational goals in small company environments across all stages of the product life cycle. Expertise in all aspects of commercial operations, strategic planning, business development, external collaborations, and organizational leadership. A hands on, energetic, and collaborative leader who builds strong relationships and effective teams in entrepreneurial environments.

Key Experience

Successful registration and launch of large molecule specialty biological drug, staffing, and leading commercial teams and sales forces, developing and executing brand and portfolio strategy ; new product evaluation and early commercial development, managing licensing and external collaborations/co-promotions; mobilizing external advocacy networks; coaching and developing individuals and teams.

Biological Drug submissions in North & South America

• Responsible for regulatory submission package/dossier approval.
  
• FDA Registration and Product Listings.
• Developed Compliance Improvement Strategies.
• NDA/ANDA/BLA (CMC) Submissions.
• Reviewed clinical reports and regulatory documents for FDA submissions.
• Worked with the clinical and regulatory groups on clinical pharmacology, SAP and clinical reports, IND annual report, and other regulatory submissions.
  

Developed and implemented marketing and distribution strategies for biologic drugs in developed and under developed countries.

Professional Experience