David Coughlan Email & Phone Number

Dublin, Ie

Oxford, Gb

A biotechnology company headquartered in Oxford, UK developing first in class RNA therapies for chronic liver disease. Responsible for establishing early asset strategy and subsequent execution from late biology validation / development candidate nomination through IND-enabling activities and early clinical studies, integrating scientific rationale, non-clinical/clinical development, CMC, regulatory and early commercial input.

Leopardstown, Dublin, Ie

A clinical stage biotechnology company developing novel assets in cardiometabolic, hepatic, hematological and related indications. Strategic and operational responsibility for all non-clinical activities from discovery phase biology through non-clinical IND enabling development to CMC supply oversight for clinical studies, leading a high performing team and managing key global stakeholder relationships and negotiations.• Established a portfolio of pharmaceutical assets and indications underpinned by major preclinical research and clinical, commercial and regulatory considerations.• Led scientific discussions with leading global regulatory bodies (FDA, EMA, BfARM, MHRA) resulting in successful fast track and orphan drug designations for key pharmaceutical assets, as well as agreement on abridged non-clinical plans.• Oversaw the multi-disciplinary development of assets through Phase 2, including scientific publication of data in high impact journals. • Led asset presentations and relationship building with pharma, investors and other stakeholders at global healthcare and scientific conferences.• Led evaluation of numerous assets from academia and biotech at various stages of development, including subsequent in-licensing of a novel oncology asset.

Leopardstown, Dublin 18, Ie

A clinical-stage biotechnology company developing novel assets in immune-mediated inflammatory diseases with a focus on dermatology (AD, acne) and respiratory (COPD/IPF). Responsible for establishing from company start-up all pharmaceutical and clinical development operations, leading biology validation while building and leading a team, establishing a network of key opinion leaders (KOL) and consultants and developing and executing early clinical development plans. • Led the company operational start up, establishing operating model while building clinical/non-clinical operations teams.• Established, with commercial input, portfolio of commercially attractive pharma assets. • Drove the biology validation on lead compounds and subsequent successful filing of several new INDs, moving from candidate selection to first trials within 12 months.• Led the design, clinical execution and close out of key Phase 1 and Phase 2 clinical trials.• Presented clinical data at global scientific conferences• Completed numerous patent grants and publications.• Led repositioning of non-core assets into non-pharma space and successful out-licensing to a US commercial company (Nuvothera Inc).

Leopardstown, Dublin 18, Ie

Dublin, Dublin, Ie

An oral drug delivery technology company with internal development assets in osteoporosis, oncology and thrombosis and co-development programs with leading pharma companies.• Directed the collaboration and managed key relationships with Novo Nordisk A/S leading to technology licensing deals for oral insulin and GLP-1 portfolios.

Dublin, Dublin, Ie

Dublin, Dublin, Ie

Dublin, Ie

Guest lecturer to undergraduate pharmacy students and pharmaceutical technicians

Part Time Community Pharmacy Locum

Dublin 2, Ie

Phd, Pharmaceutics

Dip Qi, Postgraduate Diploma In Quality Improvement

Dip Fm, Postgraduate Diploma In Financial Management

Bsc(Pharm), Pharmacy