Current position and relevant professional experience:
l an a seasoned regulatory affairs professional, with 25 years of experience in pharmaceutical drug development. I have worked across a variety of therapeutic areas, in diverse business and cultural settings. In 2016, I set up my own consultancy. I am focused on delivering agile regulatory expertise for my customers.
Throughout my career I have held leadership roles providing global strategic regulatory advice, ensuring regulatory affairs was a key stakeholder and enabler of company strategy and vision. I have worked on both small molecules and biologics, as well as borderline drug-device and digital therapeutic technology.
I am also a Trustee and Board member of aPODD Foundation, a non-profit which focuses on accelerating paediatric oncology drug development. In addition to my duties as a member of the aPODD Board, I advise on regulatory strategy. We utilise AI and machine learning in the advancement of our goals. Such innovative approaches are immensely relevant to the advancement of our industry, and as regulatory professionals we need to invest in the development of this skillset.
Current or previous involvement in TOPRA activities:
I have been a member of TOPRA since the days of BIRA and ESRA. In the early 2000's, while I lived and worked in Italy, I was involved in the update of ESRA's digital framework. Recently, I've had the opportunity to participate in the delivery of TOPRA trainings on a couple of occasions: on the topic of paediatric development in 2016 and on clinical trials in 2017. I have signed up to the recently launched initiative to shape the professional development strategy for 2020–2025, which is something I am very much looking forward to contributing to.
Personal statement:
We do what we do for our patients. I feel strongly about patient engagement in the healthcare ecosystem. This has driven me to become a Board member for aPODD Foundation, a non-profit. Digital technologies also increasingly shape our environment. Addressing such influences will ensure TOPRA is fit for the future.
Having lived and worked across Europe, I champion diversity and multiculturalism. I don't shy away from a challenge.
With 25 years in the industry, including Board-level experience, a passion for regulatory strategy and a desire to contribute, I'd be honoured to be considered for a TOPRA Board Director position.
Nomination information
Proposer: Niamh Lawler Turner: Seconders: Elizabeth Madichie, Shaila Choi