Consultancy

• Chemical route design and selection.
• Biocatalysis/Industrial biotechnology (IB)– training, scale-up, regulatory issues, understanding the supply base.
• Economic cost benefit analysis of hybrid chemical-IB routes
• Process understanding and troubleshooting
• Green chemistry and sustainable chemical manufacturing
• Green chemistry tools and training
• Solvent selection & use
• Setting up and managing research consortia, grant funding, especially Innovate UK and EU Innovative Medicines Initiative funding.

Expertise

• Over 25 years’ experience working as a scientist and leader in chemical development and manufacture of clinical and commercial drug substance
• Expertise in the Discovery interface, Preclinical and Phase1/Phase II development, supporting the progression of new candidate drugs from discovery into development
• Drug substance project strategy development and integration with drug product, safety and clinical planning
• Extensive experience of outsourcing drug substance development and manufacture
• Authoring and reviewing regulatory submissions from Phase I to marketing submissions

• Drug Discovery
• Medicinal and Synthetic Chemistry
• Biomarkers and Pharmacokinetic / Pharmacodynamic (PK/PD) Relationships
• Pain and Inflammation
• Mechanisms of Drug Metabolism
• Toxicology / Safety Risk Mitigation /  Drug Induced Liver Injury
• Due Diligence

• Continuous Flow Chemistry
• Microreaction Technology
• Synthesis of Active Pharmaceutical Ingredients

• Characterisation of orphan proteases, design of universal substrate libraries.                                                                                                                                        Amour, A., Bird, M., Chaudry, L., Deadman, J., Hayes, D., Kay, C. (2004) ‘General considerations for proteolytic cascades’. Biochem. Trans., 15 (32), 15.
• Solid phase methodologies, linkers, single bead characterization.                                                                                                                                                                Williams, G. M., Carr, R. A. E., Congreve, M. S., Kay, C., McKeown, S. J., Murray, P. J.; Scicinski, J. J.; Watson, S. P. (2000) ‘Analysis of solid-phase reactions: Product identification and quantification by use of UV-chromophore-containing dual linker analytical constructs’. Angew. Chem., Int. Ed., 39, 18, 3293.
• Lead discovery, GPCR.

Vittorio Farina studied organic chemistry at the University of Pisa, where he received his BS/MS degree. He studied further at the University of Alberta in Edmonton (Canada), where he received a PhD under Prof. Derrick L. J. Clive. After a postdoctoral stay at Cornell University with Prof. John McMurry, in 1983 he accepted a position in the Chemical Development department at Bristol-Myers in Syracuse (New York, USA). In 1987, he moved to the anticancer research department of Bristol-Myers in Wallingford, Connecticut.

In 1993, he left Bristol-Myers Squibb, joined Boehringer Ingelheim in Ridgefield, Connecticut, where he led the process development department for over a decade. In 2006, he moved back to Europe, accepting a position of Senior Director in the Chemical Development group of Janssen Pharmaceutica in Beerse, Belgium. In 2019, after over three decades of activities developing chemical processes toward Active Pharmaceutical Ingredients, he founded Farinachem Consulting GmbH. The consulting company is based in the Frankfurt area (Germany).

Dr. Farina has authored ca. 120 peer-reviewed publications, several books and book chapters and is the inventor of over 20 patents. He is on the advisory board of Advanced Synthesis and Catalysis and Organic Reactions, as well as on the board of the Ischia Advanced School of Organic Chemistry and the International Symposium of Homogeneous Catalysis. He has also chaired several conferences and symposia, i.a., the 2012 Gordon Research Conference on Stereochemistry in Newport, Rhode Island.

Among his other activities, he is a co-founder of ISPROCHEM, an international school of process development being held yearly on the banks of Lake Garda in Gargnano, Italy. Dr. Farina’s activities involve consulting on process development issues and teaching.

• Support for API development & manufacturing projects
• Route selection and process R&D
• Second generation process development
• Process optimisation and troubleshooting
• Development of external partnering strategy
• Selection of process R&D and manufacturing partners
• Initiation & oversight of API outsourcing activity
• Establishing technology partnerships

• Coupling reactions – palladium catalysis, copper catalysis
• Sulfur dioxide and carbon monoxide in catalysis
• Rhodium catalysed C-C bond formation
• Hydroacylation

• Consulting and training in Design of Experiments (DoE)
• Principal component analysis (PCA)
• Process development
• Homogeneous and heterogeneous catalysis
• Metal removal and metal recovery

• Legal services including patent litigation with synthetic backup
• Identification and synthesis of pharmaceutical and agrochemical impurities
• Alkaloid chemistry and synthesis
• Photochemistry
• Innovative heterocyclic chemistry
• Transition metal mediated cascade sequences and cyclisations
• Route design for multi step synthesis

Philip J. Parsons started his independent research career at the University of Southampton in 1979, after completing Post-Doctoral studies with Professor G Stork at Columbia University. While at the University of Southampton, he co-founded Cookson Chemicals Ltd., now Tocris Bioscience a brand of Bio-Techne, which won the Queen’s Award for Industry for International Trade in 2002. In 1990, he was appointed Professor and Head of Organic Chemistry at the University of Reading. He later moved to the University of Sussex in 1995 where he was appointed Dean of the School of Chemistry, Physics, and Environmental Science. Recently, he was appointed Professor and Senior Reseach Investigator and now Professor at Imperial College London; he has recently founded Pareon Chemicals Ltd.

• Chemical development
• Vendor selection, engagement and management
• Problem solving
• Assistance with Strategy and Management of Drug Development Programs
• Technical and Regulatory Documentation
• Regulatory/QA

• Helping you connect the dots in pharmaceutical chemical development; from concept to commercial
• Preclinical: Phase appropriate route scouting, solid form selection, crystallisation, salt screening, safety and initial scale-up.
• Clinical: Selection of starting materials, equipment selection. Process design and safety, including crystallisations and specifications based on QbD principles.
• Commercial: Tech transfers, Process validation, supplier qualification and regulatory filings.
• Supply Chain: Sourcing and qualifying supplier of raw materials and intermediates. Contract Research (CRO) and CDMO partners. Equipment and Technology suppliers.
• Regulatory: Preparations of dossiers for various regulatory authorities e.g. IND, NDA, DMF, ASMF. Nitrosamine risk assessments.
• Chemical technology development: Understand, Solve, Develop, Launch.