Peter Pedro Caetano

Peter Caetano is instrumental in delivering new medicines to market by using his pharma/biotech regulatory affairs expertise in drug selection, development, registration, reimbursement and post-approval compliance. His 15 years' experience in global regulatory science, strategy and leadership includes selection of novel biological candidates through internal and external innovation (due-diligence); CMC, nonclinical and clinical drug development by managing CTAs, INDs, PIP, PSP, parallel Scientific-HTA advice; registration by leading eCTD BLAs and MAAs; post-approval variations, licenses, inspections. This in multiple therapeutic and geographic areas. At Ipsen Dr. Caetano is based in Oxfordshire, UK, representing the company at the Association of the British Pharmaceutical Industry, but with worldwide responsibilities including direct management of EU, US, Chinese and Japanese regulatory activities. Previously, he was based in Buckinghamshire (Allergan), US (P&G in Ohio and Genzyme Sanofi in Boston), and Latin America (Genzyme-Brazil, Argentina, Chile). Dr. Caetano's regulatory contributions and advice have top depth and breadth because he combines mastery of ICH, FDA, EMA, PMDA, and global regulations/precedents (including work for EU agency INFARMED) with a strong command of business and patient needs. Besides regulatory roles, he worked for 2 years in Pharmaceutical Sales & Marketing in hospitals affiliated with the medical schools of Harvard, Brown and Boston universities. For another 2 years he was a pharmacist in hospital, community and manufacturing plant settings. He has been a university professor and lecturer at medical, pharmacy and dentistry schools. Regarding clinical and scientific education, Peter holds a PhD/MS in Pharmaceutics (Pharmacology) from Michigan, an MPH focused in pharmacoepidemiology from Harvard, two PharmDs from Ohio State & Lisbon. He has certifications from DIA, RAPS, LSHTM, and is about to finish a Regulatory MSc at TOPRA to master trends such as ATMPs, patient-focused drug development, real world data. In business education he concluded a Post-Graduate Diploma at Oxford, in Strategy and Finance (Valuation of cell and gene therapies). And has a double MBA from ESSEC (France-Singapore) and Mannheim (Germany), plus an AA from Cincinnati. Peter communicates with native excellency in English and Portuguese, and is conversant on Spanish and French. He is an extrovert with many personal interests that serve as bridge to connect to others. He is a leader with a proven ability to aggregate and motivate diverse teams.