Personal: Born on September 8th 1959, Milano, Italy.
Education: Doctor in Chemistry 1985. Università' degli Studi di Milano,Italy. Final grade: 110/110. Thesis: “Total Synthesis of the Antibiotic 32'287 Conocandin).” Mentor Prof. Carlo Scolastico.
1986-1987 Degree from the "Chemical and Analytical Methodologies in Advanced Organic Chemistry A.Quilico", Politecnico di Milano, Italy.
Research Associate (1989-1990) in the laboratories of Prof. Stephen Hanessian, at the University of Montreal"
Montedison International Operations Management Programme 2001 Insead, Fointanebleau, France.
Affiliations: American Chemical Society, Italian Chemical Society, GIC, Italian Peptide Society, European Peptide Society, Fellow of the Royal Society of Chemistry
Scientific activity:
One Book: “From Bench to Market. The Evolution of Chemical Synthesis from Discovery to Industrial Production.”; Oxford University Press: Oxford, 2000.
Publications: 141; patents/patents applications 110
Experience:
- The industrial experience accumulated in 32 years, in large (Pharmacia; BMS, Fresenius Kabi), medium size (Sigma-tau & Antibioticos) and small (Dipharma-Indena) companies, ranges from drug discovery (medicinal chemistry) to Process R&D (Chemical, Analytical Fermentation and Formulation Development). Drug Discovery was mainly focused on oncology, CNS and rare diseases. Drug development was focused on the identification of efficient and sustainable synthesis of APIs as well as innovative formulation techniques. Nutraceutical products and functional food were also part of the area of expertise.
- In Farmitalia Carlo Erba (Pharmacia) I reached the position of Senior Scientist leading a Process Development Laboratory, defining industrial process of New Chemical Entities (NCEs). I started in 1992 the CombiChem Lab for Drug Discovery.
- Joining BMS I took the position of Process R&D Manager (26 head count, lab and pilot plant) with the responsibility like the definition of new processes, technology transfers, and process validation. I support the Legal Office of BMS in several litigations.
- Moving to Secifarma/Dipharma I took the responsibility of all the technical department of the company R&D (14), QC (24) and QA (5). Several syntheses of generic products based on hazardous reactions have been developed.
- Later in Antibioticos I became responsible of R&D [85 in Italy (Milan and Turin) and 35 Spain (Leon)] with chemical and biological development laboratories and pilot plants. The expertise covered a wide range of technologies like mutagenesis, genetic engineering, recombinant proteins development & production, enzymatic & organometallic catalysis, photochemistry and classical organic chemistry. The focus was the development of pharmaceutical green chemistry processes. In addition, between 1999 and 2002 I had also the responsibility of the Corporate Quality Compliance structure of Antibioticos managing almost 100 people in Quality Control, Quality Assurance and Regulatory Affairs.
- I moved in 2006 to Sigma-Tau as Director of Medicinal Chemistry, Chemical & Analytical Development (54 HC) coordinating the discovery and development of NCE in the fields of CNS, anticancer, cardiovascular, metabolic and rare disease as well as malaria. I was developing technologies internally managing the outsourcing activities for drug substances (API) and drug products (formulations) for clinical trials supply and patent protection. Later I took the position of Corporate R&D Preclinical Development Director and Medicinal Chemistry Director. The Preclinical Development comprises Toxicology, General Pharmacology, PK/PD (pharmacokinetic/pharmacodynamics modelling), Analytical/Chemical and Pharmaceutical Development and Medicinal Chemistry. I was the Chemical Manufacturing and Control (CMC) project leader of the Sigma-tau malaria program managing the relationship with Malaria Medicine Venture and other no-profit organizations.
- Moving to Indena as R&D Director, I was managing 35 people covering drug discovery & development. The main areas of interest were chemistry, biology, formulation, toxicology, clinical trials & regulatory affairs in the pharma and nutraceutical segments.
- In Fresenius-kabi I took the position of Senior Vice President of API (Chemical and Analytical Development as well as Regulatory Affairs). I coordinate a multicultural team of over 180 people in India, The Netherlands, Austria, Italy and USA. The area of interest is the development and launch of generic antibacterial and oncology products.
Achievements and Interests:
- New approaches to the synthesis of fine chemicals based on organometallic and enzymatic catalysis.
- Development of new methodologies and a mechanistic model (Cabri-Hayashi model) for the regioselective arylation of unsaturated systems catalysed by palladium complexes.
- Synthesis of several class pharmaceutical products for clinical trials and for the market: CNS Diltiazem, Pentoxyfilline, Tramadol, Bupropion, ergoline derivative: Cabergoline, Pergolide;anticancer Doxorubicin, Epirubicin, Daunomycin, Idarubicin, and new anthracyclines; Taxoids; Camptotechins; NIBs; platinums. Antibiotics:carbapenems, penems, II-IV generation cephalosporins, penicillin betalactamase combinatios, Daptomycin. Steroids derivatives AD,ADD, Estrogens, Progestins, Istaroxime; antiviral Acyclovir, Zidovudine; immunosuppressant, Tacrolimus, Sirolimus and Micofenolic acid; food additives by fermentation: b-Carotene, Lutein, Astaxantin and Lycopene; others: Gemfibrozil, Nabumetone, Thimidine, Lipoic acid, Ivermectin, Ethanbutol, (R)‑(‑)‑Carnitine Chloride, Gypsy Moth Sex Pheromone, benzofuran derivatives (ADR851 analogues), Benzyl-acylclouridine FCE 25913. Recombinant proteins: hGH, FCSF, EPO, β-interferon1a; heparinoids. Artesunate for severe malaria. Polipeptides: Degarelix; Carfilzomib; Octeotride; Liraglutide.
- Pharmaceutical Green Chemistry.
- Drug Discovery areas. CNS: 5HT6; 5HT7; A2a; A2a/MAOb; Oncology: Topo I inhib.; HDACi; HSP90i; Heparanase; PI3K; PARP. Metabolism: CPT1. Rare disease: Hutchinson-Gilford Progeria Syndrome; Waldenstrom Macrogrobulinemia.
- Analytical Development: nanotechnologies for protein analysis.
- Formulation: modified release formulations, solid dispersion formulation technologies, sterile products and complex formulations (supramolecular assembly).
- Development of new nutraceutical products and combinations for the Italian and US market for supportive care, pain and sugar management applications.
MOLECULE BROUGHT TO THE CLINIC:
- CMC Project Leader for the Eurartesim® registration for the treatment of uncomplicated malaria Malaria at the EMA and WHO. Product approved.
- Gimatecan Phase I/II (Oncology; oral; Topo I inhibitor)
- Namitecan Phase I/II (Oncology; iv; Topo I inh)
- Adarotene Phase I (Oncology; oral; retinoid)
- ST1535 Phase I (Parkinson; oral; A2A/MAO-B)
- Roneparstat Phase I/II (Oncology; iv; Heparanase inh)
- Rostafuroxin Phase I/II (Hypertension; iv; ouabain antagonist)
- Istaroxime Phase I/II (Hearth Failure; oral; inhibition of Na+/K+ ATPase)
- Samital Phase II (Oral mucositis)
- several bioequivalence studies in the generic field
Awards:
1993 Federchimica Prize for achievements in anthracyclines chemistry.
1995 Ciamician Medal (SCI) for achievements in organometallic catalysis.
1996 Bristol-Myers Squibb President Award.
2013 Price for the industrial application of Organic Chemistry by the Organic Chemistry Division of the Italian Chemical Society.
2022. Enrico Faggi Catalysis Award
Reviewer Journal of Organic Chemistry, Tetrahedron Letters, Organometallics, Organic Process Research & Development, Journal of Medicinal Chemistry, Green Chemistry, Organic Letters, Synlett and ACS Medicinal Chemistry Letters.
