Adriana has over 25 years of regulatory experience on global and regional projects in the biopharmaceutical, biotechnology, pharmaceutical and generic medicine industries with a consistent record of delivering superior results. She has worked with the FDA, the TGA, the EMA, Medsafe and others. Adriana has demonstrated expertise over the entire drug development process from research and preclinical through clinical development, product licensure, commercialisation and life-cycle management for vaccines, biological, biotechnology, pharmaceutical and generic medicines.

Adriana’s passion is to work collaboratively with our client’s team to successfully progress medicines through complex global or regional regulatory pathways that result in regulatory approvals. Adriana will personally provide all consulting services.

Adriana’s notable career highlights include:

  • Being the Australia and New Zealand regulatory lead for a United States developed novel COVID-19 vaccine through the 2020/21 pandemic challenged environment. Led the TGA and Medsafe rolling submissions that enabled TGA and Medsafe approval of the COVID-19 vaccine for use in Australia and New Zealand for immunisation of individuals during the COVID-19 public health emergency.
  • Leadership of the regulatory team that prepared and submitted the first Biologics License Application to the FDA for CSL in Australia. FDA licensure was achieved in six months following the accelerated review, for streamlined product launch and vaccine supply in the United States.
  • Project management and leadership of a large cross functional team for a complex and time challenged clinical program for the 2009 influenza pandemic. Timely FDA and TGA approvals were achieved that enabled conduct of clinical studies in Australia and the United States. The program met the urgent public health need for influenza pandemic vaccine.
  • Achievement of TGA and Medsafe marketing approvals for medicines spanning diverse therapeutic classes that led to new product launches and product supply in Australia and New Zealand, and added to company's commercial product portfolio and the bottom line.
  • Chairing meetings and negotiated with the FDA, TGA and Medsafe. Achieved agreement on strategies and processes for development programs and regulatory submissions that led to regulatory approvals

Colleagues have noted that Adriana’s strengths include:

  • A highly focused approach to work and achievement of goals.
  • A global and strategic mindset, and strong business acumen.
  • Being a thought leader of strategies and project plans, and enlister of others on clearly defined pathways and milestones that lead to successful outcomes.
  • A mindset of continuous improvement.
  • Outstanding oral and written communication skills, and a builder of collaborative and long-term relationships.
  • Strong Project Management capabilities.

These are the foundation to her success in achieving global and regional regulatory approvals that lead to clinical trials, product licenses and launches, and optimal life-cycle management.

When not consulting, Adriana’s other passions include travelling the world, experiencing different cultures, appreciating interior design and architecture, enjoying the arts in their diverse forms, taking pleasure in cooking and enjoying a variety of cuisines, hiking and rejuvenating in nature, spending time with family and friends.

Adriana Stefancic
Principal Consultant: Adriana Stefancic