Welcome to P2C Pharma
Specialist early-stage drug development consultancy support,from preclinical-to-clinic.
About P2C Pharma
P2C Pharma is a privately owned pharmaceutical consultancy
firm founded by Dr. Mark Saunders, a scientist with over 20 years of experience working in and leading various pharmaceutical contract research organisations engaged in early-stage preclinical and clinical drug development.
Working as a seamless extension of our client's own R&D team, P2C aims to provide an extra resource to help plan, execute and manage both internal and external R&D programs, including technical, intellectual property (IP) and project management support for all aspects of non-clinical and early-clinical CMC development.
Our core expertise can support you in the following areas:
- API solid-form screening and optimisation
- Pre-formulation testing and biopharmaceutics evaluation of NCEs
- Development of 'phase-appropriate' preclinical formulations for PK/Tox assessment (small molecules and biotherapeutics)
- Formulation design, drug delivery technology assessment and selection for rapid entry into clinical studies (oral, parenteral (IV, SubQ, IM, IP and IVT), inhaled and nasal dosage forms)
- Sourcing and management of external laboratory providers
Please click the link below to learn more.......
Our Core Services
From early preclinical evaluation through to First-in-Man enabling studies, we integrate into your in-house team to help you design, select and manage your outsourced activities.
CMC Health-check
Unforeseen problems in your API or drug product can set you back months and require the utilisation of unplanned budget to rectify; this can now be mitigated by using our CMC Health-check service.
A CMC Health-check is a comprehensive and non-biased technical review of the quality and robustness of the generated CMC package and can be implemented at any stage of a development program.
It is specifically designed to identify as quick as possible potential development issues both on and off the critical path which could impact the delivery of a project and ultimately the value of your lead asset.
Technical Support
With many of today's drugs exhibiting challenging biopharmaceutical properties, quickly identifying a robust and safe dose vehicle that can give sufficient exposure in vivo
is a complex and time-consuming task.
Having worked in this area for nearly 20 years, we can employ our extensive expertise to aid you and your chosen CRO with the rapid design and selection of phase-appropriate dose-vehicles to support all stages of your preclinical program.
We also assist clients to help guide technology scoping and evaluation for development of enabling oral, parenteral and inhaled formulations for rapid progression to First-In-Human studies and can work with both internal and/or external laboratory resources to plan and manage the various activities.
Project Management
If your internal resources are limited or you lack the technical expertise for specific parts of your development plan, we can work with you to provide project management support for the entire R&D program or individual functional components of the non-clinical and clinical development stages.
We work with you to help design and assess project technical briefs and associated costs, as well as plan and implement the necessary resource needs / investment timings to ensure all activities remain on the critical path.
We can also help source and manage external vendors, including preclinical research laboratories and clinical contract development and manufacturing organisations (CDMOs).
Technical Due Diligence
If you are interested in out-licensing your lead asset and need to perform an internal due diligence to identify potential development gaps, we can help. Typical activities include:
- Critical review of the up-to-date CMC-package and related files
- Identify key risks either to usability of existing drug or to future manufacturing processes
- Challenge your CMC team on key risks to try to uncover gaps or solutions
- Prepare a risk analysis assigning risk priority and risk mitigation options
- Develop a high-level plan for taking the CMC activities to the next development milestone
Dr Mark Saunders
Director and Founder at P2C Pharma
Dr. Mark Saunders is a seasoned professional with demonstrated scientific and leadership skills in the pharmaceutical industry, having spent over 20 years working in the contract research, development and manufacturing field.
After completing his degree in Biochemistry from The University of Exeter and his PhD from The London School of Pharmacy (now part of UCL), Mark was involved in the commercial set up of a University spin-out CRO, initially providing outsourced solid-state chemistry support for clients NCEs. The company quickly grew and Mark oversaw the implementation of the analytical, solid-form screening and formulation development groups, culminating in the establishment of a dedicated Phase I / II cGMP clinical manufacturing site supporting oral (solids / suspensions / liquids) and orally inhaled and nasal drug products. After the business was acquired in 2007, Mark immediately went on to found Kuecept Ltd, a niche CRO specialising in designing bespoke preclinical and early-clinical formulations for drugs that exhibit complex bioavailability barriers through solubility / DMPK liabilities. Since inception, the company's technical expertise was globally recognised by over 100 leading emerging and mid / large pharma and biotech organisations and in April 2016, Kuecept Ltd was acquired by Aptuit LLC. For the next 2 years, Mark ran the Early Formulation group and oversaw the integration of the Kuecept team into the global Aptuit business, including relocating the laboratories from London to Oxford. After 2 years Mark left to set up his own consulting business, P2C Pharma Ltd. In addition, Mark is also currently supporting the start-up company Fluid Pharma Ltd (www.fluidpharma.com) as a Strategic Advisor and is also a Director of Relevo Ltd, a technology innovator offering connected health-care solutions for respiratory therapies.
In addition to his commercial roles, Mark is also a member of the UK and US Controlled Release Societies, the UK Aerosol Society and Association of Pharmaceutical Scientists of Great Britain (APSGB), as well as serving as a member of the APS Materials Science Focus Committee. Mark has also been an author/collaborator on over 100 articles, book chapters and conference presentations and is also co-named on several patents on novel drug delivery technologies and particle engineering. In addition, Mark also co-edited 'The Essentials of Pharmaceutical Preformulation' book which was published by Wiley-Blackwell. in 2012.
Testimonials
“During the last few years it has been a pleasure to collaborate with Mark. I have also been impressed with his breath of knowledge in drug development, especially where the formulation of highly insoluble drugs is an apparent obstacle in the progression of a drug beyond pre-clinical evaluation. Both his managerial skills and hands-on experience in this field of science make him an invaluable asset in solving complex issues related to drug bioavailability..”
Patrick CamilleriDirector at Bio-Chemical Solutions
“Mark has an excellent understanding of R&D services. He is very responsive to clients' needs and pragmatic. Mark's knowledge of the pharma service industry and extensive network makes him a very valuable partner to work with. He is affable and reliable. I highly recommend him for anyone wanting an excellent service at a good value."
Philippe RoguedaDirector and co-founder at Merxin Ltd
“Mark is a natural business leader and entrepreneur who understands the market space and can shape a business to match. He has huge amounts of energy and passion for his subject and can see the business opportunity very quickly. He is a highly respected professional who can lead high level customer engagement but also thoroughly understands the industry. I always enjoy my conversations and commercial interactions with him, it’s always been a positive experience.”
Paul
OvertonBusiness & Corporate Development
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