Appointment brings extensive regulatory experience as lead asset ETD001 progresses through Phase 2 clinical trial for treatment of cystic fibrosis
Brighton, UK, 11 September 2024: Enterprise Therapeutics Ltd (Enterprise), a biopharmaceutical company dedicated to the discovery and development of novel therapies to improve the lives of those suffering from respiratory disease, today announced the appointment of Annabella Amatulli as Head of Regulatory Affairs.
In this newly created role, Annabella will be responsible for driving the Company’s regulatory strategy and working in close collaboration with clinical, medical, patient engagement, and market access teams. The primary focus of her role will be to support the ongoing Phase 2 clinical trial of lead asset ETD001, a novel long acting ENaC blocker which offers the potential to treat people with cystic fibrosis (CF) not currently benefitting from CFTR modulator therapies1. Annabella will also define the regulatory pathways for Enterprise’s pipeline of other novel low molecular weight compounds which also have first-in-class and best-in-class potential.
Annabella has more than 14 years’ experience working in pharmaceutical companies, with a focus on regulatory affairs. Prior to joining Enterprise, she was Head of Global Regulatory Sciences at Alfasigma, where she contributed to the growth of the company and the regulatory strategy for all products, across varying phases of development. Annabella has an extensive range of regulatory experience throughout Europe, the US and in other regions of the world. She has led interactions with health authorities including EMA, FDA, MHRA and NMPA to obtain Orphan Drug Designation, Fast Track and Breakthrough approvals for numerous candidates, negotiated Paediatric Investigation Plans, set up a global early access programme, and obtained global approval for a rare disease therapeutic.
Prior to Alfasigma, Annabella held various senior regulatory positions in both SMEs and large pharmas, including Chief Regulatory Officer at Napo Therapeutics and Global Regulatory Affairs Biotech & Development Director at Dompè Farmaceutici, as well as roles within Janssen-Cilag (J&J), Schering-Plough, and Mylan. As a member of the Pharma Trade Association, she led the regulatory workstream dedicated to advanced therapies (ATMPs). Annabella is also one of the founders of the Milan chapter of the Healthcare Businesswomen’s Association and is currently Regional Chair of the Southern Europe Region.
Dr John Ford, CEO, Enterprise Therapeutics, said: “We welcome Annabella as Head of Regulatory Affairs. Her broad experience in managing regulatory teams and liaising with health authorities will be hugely beneficial as we continue to progress our respiratory therapeutics programmes. Annabella’s expertise will prove especially valuable as we transition through Phase 2 clinical trials for our lead asset ETD001, moving closer to providing a novel treatment for all people with CF, including those with the highest unmet medical need.”
Annabella Amatulli, Head of Regulatory Affairs, Enterprise Therapeutics, added: “I am delighted to join Enterprise at such a pivotal time. The work that the Company is doing has the potential to vastly improve the lives of people with respiratory diseases. I look forward to working with the leadership team to help drive the continued development of the pipeline.”
For more information about Enterprise Therapeutics, visit www.enterprisetherapeutics.com
