Expert in Pharmaceutical Development, CMC, Project Management, Intellectual Property
Expert ID: 724481 United Kingdom
Prior to that he was responsible for Technical Services, then New Product Development at Colorcon, where his responsibilities included development and technical support for a range of modified release systems, including HPMC matrices, insoluble coatings and enteric coatings for tablets and pellets.
In these roles he developed both modified release systems and modified release formulations incorporating customers' APIs.
He has in-depth knowledge of the competitive landscape for oral modified release systems, covering technical, commercial and intellectual property aspects of the market.
Expert has developed modified release products throughout his career. Most recently he led the development of proprietary oral modified release systems at Phoqus Pharmaceuticals. These included zero-order, increasing-rate, pulsatile, delayed-release, chronotherapeutic and fast-release formulations. Prior to that he was responsible for Technical Services, then New Product Development at Colorcon, where his responsibilities included development and technical support for a range of modified release systems, including HPMC matrices, insoluble coatings and enteric coatings for tablets and pellets. In these roles he developed both modified release systems and modified release formulations incorporating customers' APIs. He has in-depth knowledge of the competitive landscape for oral modified release systems, covering technical, commercial and intellectual property aspects of the market.
Expert has managed corporate intellectual property portfolios in pharmaceuticals and drug delivery for over 10 years. He has detailed knowledge of the background IP for oral drug delivery, pharmaceutical coatings and electrostatic powder deposition. He has developed and managed most aspects of IP strategy, including selection of attorneys, when and where to file, cost reduction, competitor monitoring, prior art searching, patents, trademarks and registered designs
Expert has over 20 years pharmaceutical development experience, comprising 2 years at Wyeth (UK) formulating solid dosage forms; seven years at SK&F/SmithKline Beecham developing tablets, capsules, oral liquids, injectables, creams, ointments and a rectal foam; four years at Colorcon developing coating systems and controlled release formulations and just under nine years at Phoqus developing controlled release and fast dissolve formulations at Phoqus. These products varied between NCE, generic and OTC. His experience covers all phases of product development, from salt selection, through preformulation, formulation, clinical supply, scale-up and through to commercial manufacture. From 1988 onwards, expert has been increasingly responsible for drafting some or all of the cmc regulatory dossiers (IND, CTA, NDA, and MAA) for these various products and interacting with regulatory authorities. In his current role, Expert usually coordinates outsourced development activities on behalf of pharmaceutical companies and advises on product development issues.
Expert has a wide knowledge of pharmaceutical processes and equipment based on his hands-on experience of developing products and processes over many years. During his time with Colorcon and Phoqus, he was involved in and responsible for the design and construction of new manufacturing equipment for electrostatic coating at laboratory and pilot scale. His process development, scale-up and trouble-shooting experience takes in all of the key pharmaceutical unit operations for secondary manufacturing and this experience is underpinned by his professional qualifications as a pharmacist and chemical engineer.
Having learned the Big Pharma approach to project management at SmithKline, serving on numerous project teams and undergoing formal training in project management, expert was responsible for programme management of a portfolio of development projects at Colorcon and worked with an external consultant there to design and implement a new global product development and project management process. As VP Technical Development at Phoqus, he devised and implemented the project management system there and was responsible for programme management for internal technology and product development as well as management of their portfolio of customer projects through individual project managers. In his current role, he manages projects and outsourced activities for pharmaceutical ab biotech companies.
Expert was formerly Head of Technical Service and Product Development with Colorcon in the UK. He lectured on numerous training courses organized by Colorcon and continues to lecture on the subject of coating on behalf of other organizations
Expert has formulated hard capsules during early part of career (Wyeth and SmithKline Beecham) and continues to do so as a consultant on
behalf of clients. Expert has also gained significant expertise in softgel capsule formulation and manufacture, including cross-linking mechanisms
|Year: 1985||Degree: PhD||Subject: Powder Technology||Institution: London School of Pharmacy|
|Year: 1981||Degree: B.Pharm||Subject: Pharmacy||Institution: London School of Pharmacy|
|Years: 2007 to Present||Employer: Undisclosed||Title: Owner||Department:||Responsibilities: Consulting in areas of expertise and management of business|
|Years: 2008 to 2010||Employer: Neuropharm Limited||Title: VP, Pharmaceutical Development and Manufacturing||Department:||Responsibilities: Member of the senior management team of this AIM-listed pharmaceutical company. Was responsible for cmc, pharmaceutical development, manufacturing, reporting to CEO.|
|Years: 1998 to 2007||Employer: Phoqus Pharmaceuticals||Title: Vice-President, Technical Development||Department:||Responsibilities: Member of the senior management team of this AIM-listed drug delivery company. Primary line responsibilities were for technology development, product development, project management and intellectual property management, reporting to CEO and Board on these areas. Additional roles in the development of marketing materials, direct selling to customers and business development. Was intimately involved in four rounds of VC financing and associated due diligence, plus AIM listing in Nov 2005 and secondary placing in 2006 raising in total £44million. Managed growth of Technical function from 5 people to 28 from 1998-2007. Managed the successful design and build of Feasibility Machine with US contractors and design of Pilot Machine through UK contractors. Managed conception of, and data generation for, Phoqus’ product and service offerings. Built patent portfolio from three families to 24 since 1998. Oversaw conduct of 19 customer projects since 2003. Co-authored more than 40 publications or presentations on electrostatic coating. Achieved Orphan drug designations for In-house products.
|Years: 1997 to 1998||Employer: Colorcon Inc||Title: Head, GTD (Europe)||Department: Global Technology Development||Responsibilities: Reported to VP, Global Research and Development. Responsibility for development of new products and line extensions, liaison with academic departments throughout Europe, management of external research collaborations, responsible for IP management, responsible for transition of University-based projects into internal projects and establishment of R&D teams to work on them (e.g. the electrostatic coating projects that later were spun out to form Phoqus). Worked with consultants to redesign the corporate R&D function. Supervised three post-doctoral and two PhD projects. Authored 7 refereed publications on film coating and excipients. Presented at numerous company-sponsored and external seminars.|
|Years: 1994 to 1996||Employer: Colorcon Limited||Title: Manager, Technical Service and Development||Department: Technical||Responsibilities: Responsible for customer service throughout Europe, Africa and the Near Middle East, involved working alongside the sales and marketing functions to deliver premium technical service functions to customers. Managed network of Technical Managers and Laboratories in UK, France, Germany, Italy and Hungary.
Redesigned the Technical Service function to improve productivity and flexibility. Reported to Technical Director.
|Years: 1987 to 1994||Employer: SmithKline&French/SmithKline Beecham||Title: Senior Section Head/Team Leader||Department: Pharmaceutical Technolgies||Responsibilities: Led product development teams for NCEs, PLE’s, compiled cmc dossiers for IND/CTEX and NDA/MAA, prepared expert reports, worked on numerous R&D project teams, was responsible for analytical and formulation work on assigned projects. Developed many products through to commercialization, including immediate and modified release tablets, liquids, injectables and topicals. Set up and managed a production unit to manufacture launch stocks of an effervescent product. Member of team working with external consultants to develop a competency-based pay and progression system.|
|Years: 1985 to 1987||Employer: Wyeth Research (UK)||Title: Section Head, Solid Dose Formulation||Department: Pharmaceutical Development||Responsibilities: Responsible for formulation work on solid dosage forms for NCE’s and generic products.|
|Associations / Societies|
|Royal Pharmaceutical Society of Great Britain;
Institution of Chemical Engineers;
|Licenses / Certifications|
|Publications and Patents Summary|
|has over 40 publications and over 20 granted and pending patents|
|Training / Seminars|
|Regular presenter on Film Coating at the Royal Pharmaceutical Society's Annual "Tableting Technology" course and Brighton University's Qualified Person Training Programme. Regular presenter at European Continuing Education College Film Coating Programme.|
|Experience of identifying and project managing suppliers of formulation, analytical, regulatory, clinical, manufacturing, engineering and intellectual property services.|
|Strong technical and commercial knowledge of oral drug delivery,modified release, film coating and excipient supply. Experience of venture capital financing and IPO.|
|Other Relevant Experience|
|Can advise on intellectual property strategy and portfolio management, including selection of service providers.|
Fields of Expertise
controlled-release drug delivery, intellectual property, pharmaceutical product development, Chemistry, Manufacturing and Controls, pharmaceutical technology, project management, tablet coating, gelatin capsule, intellectual property strategy, intellectual property management, protein drug delivery, active pharmaceutical ingredient, investigational drug procedures, abbreviated new drug application, melt extrusion tableting process, generic drug manufacturing, contract manufacturing, business management, compaction, cellulose chemistry, drug release polymer, drug product approval, bioadhesion, over-the-counter drug product development, Food and Drug Administration compliance, wet granulation, colonic drug delivery, bulk mixing, agglomeration, drug formulation, Current Good Manufacturing Practice, pharmaceutical coating material, Food and Drug Administration validation, acrylate coating material, pharmaceutical research and development, life-cycle cost, generic drug, cellulose coating material, drug degradation, roll compacting, Microsoft Project Manager, drug validation, drug clinical trial, pharmaceutical product shelf life testing, injectable pharmaceutical product, pharmaceutical capsule, tablet packaging process, tablet manufacturing, chewable tablet, pharmaceutical product formulation, pharmaceutical packaging process, licensable technology, muco-adhesive, polymer drug-delivery method, cream, pharmaceutical quality assurance, parenteral drug delivery, excipient, drug stability, effervescent tablet, tablet, inventions, drug development, pharmaceutical industry, Food and Drug Administration drug packaging regulation, cellulosic material mechanical behavior, pharmaceutical engineering, pharmaceutics, color additive regulation, drug dosage form development, drug delivery, research and development management, development process, pharmaceutical dissolution, trademark, new drug, new product development management, coating material, Food and Drug Administration regulation, drug regulation, pharmaceutical drug, gelatin, drug, transdermal drug delivery, tableting, programmable drug delivery, pharmaceutical manufacturing, pharmaceutical color additive, over-the-counter drug, oral drug delivery, nonaseptic pharmaceutical process validation, new drug application, nasal drug delivery, microencapsulation, manufacturing, liquid coating material, investigational drug, injectable drug, Good Manufacturing Practice, Good Laboratory Practice, film, edible film, dosage form, coating, cellulose, buccal drug delivery