Principal Consultant

Adriana has over thirty years of successful regulatory experience on global and regional projects in the biopharmaceutical, biotechnology, pharmaceutical and generic/biosimilar medicine industries. She has worked with the FDA, TGA, EMA, Medsafe and other Agencies. Adriana has built expertise over the entire drug development process from research and preclinical through clinical development, product licensure, commercialisation and life-cycle management for prescription medicines. As an experienced Consultant, Adriana has also provided executive regulatory advice for input into the decision-making process for executives and company boards. Adriana is passionate about working collaboratively with our clients to successfully progress prescription medicines through complex regulatory pathways that result in regulatory approvals. Adriana personally provides 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 and collaborated intimately with both Agencies and other stakeholders throughout all registration phases, which facilitated 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.
• Assessment and presentation on a strategy for utilising the FDA 505 (b)(2) NDA pathway to register a pharmaceutical product for a cancer therapy that informed the decision-making process of a company board.
• Leadership and achievement of TGA and Medsafe marketing approvals for medicines spanning diverse therapeutic classes based on dossiers originating in the United States, Europe or the United Kingdom, which 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 of numerous Regulatory Agency meetings and negotiating with the FDA, TGA and Medsafe. Achieved agreement on strategies and processes for development programs and regulatory submissions that led to regulatory approvals.
• Designed and prepared a 6-part, tailored training program covering Australia and New Zealand therapeutic legislation, TGA and Medsafe regulatory pathways, CTD Module 1, Module 3 and Quality Overall Summary and delivered to a 25-participant team across six sessions at a major biopharmaceutical company.

Colleagues have noted that Adriana's strengths include:

• A highly focused approach to work and achievement of goals.
• A global and strategic outlook with 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.
• Builder of collaborative and long-term relationships.
• Being transparent, flexible and professional.

When not consulting, Adriana's other passions include spending time with family and friends, travelling the world and experiencing different cultures, cooking and enjoying a variety of cuisines, enjoying the arts, architecture and interior design, painting and hiking. Adriana is also passionate about mentoring individuals new to the industry.