Anna Bulgheroni

Lead the Nonclinical and Clinical team, collaborating closely with Regulatory Affairs, Pharmaceutical Development, and the CSO provideing integrated support for all phases of R&D. Definition of medical needs for new innovation projects and evaluation of feasibility, development timelines, and costs for new product development. Contribution to regulatory strategy across multiple regions (EU, US, CA, CH), ensuring alignment with global guidelines. Oversight of Nonclinical and Clinical activities for new submissions/approvals, ensuring adherence to quality standards, timelines, and budget control. Preparation and revision of Scientific Advice submissions to Regulatory Authorities (EU/US/CA), acting as the Nonclinical and Clinical representative in meetings. Resolution of Nonclinical and Clinical issues arising from audits, inspections, and regulatory queries across global territories. Contribution to the preparation of project updates, contingency plans, and strategic backups. Oversight of life cycle management of products, ensuring regulatory and technical documentation is up to date. Preparation/revision of scientific publications and product monographs. Nonclinical and Clinical due diligence assessments to support business development. Nonclinical and Clinical support in licensing out activities.

Collaboration on defining regulatory strategy for product development in compliance with global regulatory standards (EU, US, CA). Participation in Regulatory Authority (mainly EU/US/CA) Scientific Advice preparation (draft or review of request and briefing document) and attendance as nonclinical representative. Management of nonclinical issues coming from audits and/or from regulatory authority queries/inspections (EU, US and Rest of the World). Identification and management of necessary nonclinical studies, ensuring adherence to regulatory requirements for product submissions. Oversight of outsourced study activities, from protocol review to final study report approval. Management of budgets and development plans to ensure timely and cost-effective completion of nonclinical studies. Preparation of nonclinical regulatory documents (e.g., e-CTD Module 1.6, Module 2, Module 4). Support during licensing in and licensing out due diligence processes.

2009 – 2018 Different positions. Since 2012, Preclinical Manager (Drug and Medical Device Preclinical Project Management, Outsourcing and Regulatory Strategy) in Polichem S.A. Lugano CH (since 2016, an Almirall company) Responsible for the selection (according to the nature of the product and the regulatory strategy) and management of any in vitro/in vivo animal study aimed at assessing efficacy and safety of drugs, medical devices and cosmetics, mainly intended for topical (skin, nail, vaginal) and oral administration. Definition of the regulatory strategy throughout the full developmental program Identification of the preclinical studies needed to comply with worldwide regulatory requirements Identification of most suitable preclinical models in support of the proof of concept Selection of study sites suitable to perform the investigations Budget and developmental plan preparation and control Coordination and monitoring of the outsourced activities: from protocol revision and approval to study report revision and finalisation Management of non-clinical study documents and archiving Management and resolution of issues coming from audits and/or from regulatory authority queries/inspections (EU, US and China) Contribution to the draft, review or update of official documentation for products under development and for legacy products: e-CTD Module 2 and Module 4, Preclinical overviews, Waiver requests, Briefing Documents, Investigator’s Brochure, Investigator’s Manual, office action defence of patents, Manuscripts, Abstract/Posters Regulatory Authority (EU/US) interactions and meeting attendance (EU/US) Preclinical assessment in due diligences Preclinical support in licensing out 

Contractual Agent at the European Centre for the Validation of Alternative Methods (ECVAM) – JRC Ispra within the Marie Curie Pulmo-net project (Pathogenesis of Pulmonary Diseases) Mammalian cell culture techniques In vitro toxicity tests (MTT, XTT, LDH, ATP, NR, AlamarBlue, TEER, permeability) using mammalian cell cultures (on plastic and on membranes) Set up of air liquid interphase conditions Reconstituted models of bronchial epithelia

Associate Research Biologist in the Medical Microbiology Department in Biosearch Italia S.p.A (later Vicuron Pharmaceuticals) Microbiological basic techniques Cultivation, isolation, maintenance and identification of fungi and bacteria Techniques for evaluation of in vitro activity of antibacterial and antifungal compounds (MIC, MBC, killing curve, checkerboard) Use of automation for high throughput screening

Internal fellow at the “Istituto di Malattie dell’ Apparato Respiratorio” – IRCCS Policlinico San Matteo – Pavia Molecular biology: single step and nested PCR for Chlamydia pneumoniae and Mycobacterium tuberculosis ELISA assays Bronchoalveolar lavage processing, staining and reading of cytology smears, cytokine assay in fluid by ELISA