Research Institute for 

Pharmacy & Biochemistry

cs-CZen-GB
22 August 2019
Lecturer profile

Dr. Dionigio Franchi

Up to December 2010 Dr. Franchi was the Director and Site Lead of the Pharmaceutical Development Department in the R&D of GlaxoSmithKline, Verona, Italy. He has more than 25 years experience in the R&D Verona of GSK, a highly productive and dynamic division, with a solid track record of projects delivery from candidate selection to filing and launch. During 2000-2010 he provided integrated knowledge and data for progressing compounds to the following milestones: 39 Commit to Candidate; 28 FTIH; 22 First Phase II dose; 13 PoC Decisions; 2 NDA/MAA Submissions.

Dr. Franchi has proven technical knowledge and leadership in the pharmaceutical industry, including development and registration of new chemical entities and experience across a range of pharmaceutical dosage forms (tablets, suspensions, injectables).

He possesses consolidated experience in:

  • Operating under a variety of quality systems: Company Standard Operating Procedures; GLP and GMP compliance; GLP authorized testing facilities; controlled drug substances authorization; API manufacturing GMP authorization; drug product manufacturing license;
  • Preparing regulatory inspections, e.g., GMP manufacturing licenses and pre approval inspections;
  • Preparing Chemistry Manufacturing Controls (CMC) sections of regulatory documents (IB, IMPD, IND, NDA, MAA) and addressing regulatory questions.

Dr. Franchi has also special expertise in such areas as biopharmaceutics, understanding of causes of attrition and “in silico” and “in-vitro/in-vivo” predictions.

In 2011 he was a consultant of APTUIT Srl., Verona, Italy. At present he is a consultant at Nickel Technology Poznan, Poland, acts as an external professor at the University of Pavia, Istituto Universitario di Studi Superiori (IUSS), and as a visiting professor at the universities of Bologna, Firenze, Milano, Siena and Athens.