Our Expertise

Nick Lowther holds both a BSc (1st Class Hons) and a PhD in Chemistry from the University of London (Kings College).  He has authored or co-authored 18 scientific publications and 5 patent applications and has over 34 years experience in the pharmaceutical industry.

 

Nick has particular expertise in developability assessment, active ingredient characterisation, physical form selection, pre-formulation, analytical development, early drug substance route/process development and early formulation development.  He has many years experience of working at the discovery/development interface in both line management and project leadership roles. 

 

Nick spent over 17 years in various technical R&D positions of increasing scope/responsibilities within big Pharma, in particular with Novartis (previously Ciba) based in Horsham, UK and Basel, Switzerland.  During his time with Novartis, Nick made a significant contribution to technical R&D activities in support of many development candidates, especially in the Oncology, Cardiovascular Diseases, Anti-viral, Dermatology and Respiratory Diseases therapeutic areas.  In the latter phase of his career with Novartis, Nick spent in excess of 5 years as technical representative, responsible for all drug substance and product activities, on a cross-functional team dedicated to managing all early development activities (lead optimisation to Proof-of-Concept) for the Novartis Respiratory/Dermatology franchise.  He is fully conversant with elaboration of early development project strategies and concomitant supportive technical strategies to expedite compound selection and evaluation to proof-of-concept.  As well as oral and topical dosage forms for many early phase products, Nick also has experience with the inhaled route of administration, having taken several inhalation candidates from compound selection into Ph 1/2a as either DPI or pMDI dosage forms.  

 

After leaving Novartis in 2003, Nick joined Fulcrum Pharma Developments, a 'virtual development' company in the service sector offering development services for client's assets.  Nick was the CMC lead on many ‘powder to proof-of-concept’ projects for clients both in the EU and in Japan, and acted as cross-functional project leader on 2 projects.  As well as project management deliverables, Nick directed technical development activities via appropriate selection and management of suppliers of both drug substance (characterisation, physical form selection, analytical development, synthesis route development, stability testing, and scale-up and manufacture of non-GMP and GMP batches) and drug product (formulation and analytical development, stability testing, manufacture of technical and GMP batches, clinical packaging, labelling and distribution) services.  Nick also worked with several clients as a technical consultant in the field of drug substance and drug product development (various dosage form types).  He contributed CMC sections to several IMPDs.  Nick also conducted technical due diligence on in-licensing and out-licensing opportunities for several clients.  He also compiled detailed technical evaluation/data summary reports for clients. 
 
Since becoming an independent consultant in 2009, Nick has worked with numerous UK, EU, Swiss, Asian, US and Australian-based clients on development projects in various therapeutic areas.  Nick has worked closely with drug substance and drug product CDMOs to progress client's assets through clinical development.  Nick as acted as consultant CMC manager for several small Pharma companies, in particular Xention Ltd from 2011-2016.  Nick has provided support to in- and out-licensing opportunities for various clients.  In  particular, he was part of the Dezima Pharma team which successfully out-licensed a significant cardio-vascular asset to big Pharma in 2015.   
 
Nick is very familiar with the challenges needed to be addressed in the early phases of pharma projects, in small companies as well as large, and the approaches needed to deliver and meet budget and timelines. 
 
Nick is well networked with an array of technical contract manufacturers/service providers who would be well placed to support your project.

 

Areas Of Expertise

 

  • Technical and cross-functional project management
  • Candidate selection and developability assessment
    • Many years experience working at the Discovery/Development interface
  • Elaboration and execution of early ‘candidate selection to first-time-in-man’ project strategies
  • API characterisation
  • Physical form selection/polymorphism studies/salt selection
  • Pre-formulation
  • Management of early dosage form design/development
    • Oral (e.g. tablets, capsules, lipid microemulsions, solid dispersions)
      • approaches for poorly soluble drugs
      • controlled release
    • Topical (solutions, semi-solids)
    • Inhaled (DPIs, pMDIs, solutions for nebulisation)
    • Analytical development
    • Manufacture of Clinical Trial Supplies
  • Management of API development (small molecules)
    • Route development
    • Process development/scale-up
    • Analytical development
    • cGMP manufacturing
  • Identification/selection of technical service suppliers (CROs/CMOs)
  • Management of outsourced services
  • Due diligence assessment of technologies and products
 
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