Scientific Update Consultancy Success Stories
Major pharmaceutical company (USA)
For the last 10 years, Scientific Update has consulted for the Process R&D department of a major US pharmaceutical company. All the current process R&D projects are reviewed at each visit (2-3 visits per year) and recommendations on future actions are provided in a written report. This advice ranges from sourcing issues, synthetic route choice, chemical development, safety and environmental, polymorphism issues, scale up and new technologies, as well as organisational and personnel issues. The company has found this extremely valuable.
Small independent, well established pharmaceutical company (Europe)
For the past 5 years current chemical development projects have been discussed over 2-4 visits per year, but in addition some training is involved and one or two talks are prepared for each visit. The first talk is always on "Highlights from the current literature of organic chemistry" (which is useful to both process chemists and medicinal chemists). The second talk is on a topic of particular interest, specified by the client. Talks over the last two years have included,
- Polymorphism and Crystallisation
- Automation and New Technologies
- Catalytic Oxidation
- Catalytic Reduction
- Resolution Methods including Large Scale Chromatography/SMB
- Filtration and Drying from a Production View
- Phase Transfer Catalysis
- GMP Regulatory Issues
- Biocatalysis
Small emerging pharmaceutical (biotech) company (UK)
This company has drug discovery, a small chemical process R&D department, but no pilot plant and production.
Consultancy discussions focussed on strategic development issues, for example quantities of bulk active required for various stages of a development program, how Process R&D may be able to significantly accelerate overall project timelines, API costing estimates and their strategic context for the candidate management team (including considerations of how to influence in a multi-disciplinary environment), and outsourcing. There were also discussions about the specifics of the process chemistry, tips and tricks. Further e-mail interactions followed.
Small emerging pharmaceutical company (N. America)
This company has drug discovery, a small process R&D dept with 20L glassware, but no pilot plant and production. Most toxicology and clinical supplies were outsourced, but processes were partly developed in-house.
Consultancy involved detailed review of all chemistry twice a year, with written reports detailing follow up actions. Further telephone and email discussions followed. In addition advice on outsource partners and liaison with those partners has been undertaken.
Small emerging biotech company (Australia)
We have found a European outsource partner to manufacture a key intermediate and liaise with both parties. We have provided realistic estimates of manufacturing costs for a new drug which encouraged the company to continue with development. Consultancy is via email and phone with only occasional face-to-face contact.
Virtual pharmaceutical development company
The services for virtual pharma are effectively acting as their "chemistry department", i.e. performing all the functions such as project management, outsourcing, drug supply to deadlines, cost control, etc. that would normally be provided in-house. Our extensive knowledge of chemical and pharmaceutical development, the wide range of outsource providers, cost control and how to meet aggressive timelines/deadlines means that we have contributed greatly to the success of projects.
We have been actively involved with two projects for virtual pharma which have gone from discovery to launch, and with several others where the drug was developed to a position where it could be successfully licensed to a major pharmaceutical company.
Key steps in the project management services and consultancy we offer are shown below,
- Assist with choice of outsource partner
- Audit them for GMP and other issues
- Monitor the cost of the project to make sure the client is not being overcharged
- Monitor the chemistry to make sure it is carried out efficiently, timely and to regulatory standards
- Suggest ways in which chemical development work could improve the manufacture, then outsource any development work and monitor progress
- Monitor potential scale up issues which may affect the success of the project
- Ensure timely delivery of kilogram quantities of drug substance of appropriate quality
- Monitor analytical methods to ensure that all impurities are being evaluated
- Ensure that synthetic samples of all key impurities are provided (if necessary by contracting out)
- Address salt form and polymorphism issues early in the lifetime of the drug substance
- Liaise with other consultants/companies involved in drug formulation and secondary manufacture
- Write the chemistry section of the regulatory package or Drug Master File, or assist outsource provider in this task
- Advise on development, scale up, analytical, regulatory issues
- Look after client's interests when monitoring outsource projects.
We have also found that for a virtual pharma company with little or no chemistry staff, the outsource partner/collaborator benefits greatly from our presence on the project, both with our problem solving knowledge, but also our ability to understand the outsource provider's problems, or acting as an independent arbiter when conflict between the partners is an issue.
Generic API manufacturer (N. America)
Advice on devising cost-effective synthetic routes, development and optimisation, scale up etc has been provided. In addition, visits to this company also include lectures on topics of interest including highlights from current literature of value to process chemists.
Outsource Providers
Scientific Update consultants sit on the scientific advisory boards for a number of companies involved in contract process R&D and custom chemical manufacture.
Technology Providers
Scientific Update consultants sit on advisory boards for software and equipment manufacturers.
Flavour-Fragrance Company
For many years Scientific Update consultants have worked with a flavour-fragrance company advising on current projects, new technology, as well as providing continuing education for their scientists.
Specialty Chemical Company
Scientific Update consultants have advised on projects as diverse as fluorochemistry, chemicals for electronics, coatings and other polymers.
Device Manufacture using Polymers
Advice on scale up of processes for the manufacture of speciality polymers was provided.
Government Organisations
Scientific Update has advised UK, Swedish and South African government organisations on industry-academic interactions, collaborations and research funding and has managed collaborative programmes (eg. The UK LINK Asymmetric Synthesis scheme encompassing more than 70 projects).
Expert Witness
Scientific Update consultants have been involved as an expert witness in trials in USA, UK, Holland, Denmark and Finland in cases involving process chemistry, crystallisation and polymorphism and related issues.