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Expert in Pharmaceutical Development, CMC, Project Management, Intellectual Property
Available for your Consulting and Expert Witness Needs
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| Summary of Expertise: |
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Primary Expertise Areas:
(links show more experts in each area)
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Expertise Description: |
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controlled-release drug delivery expert |
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. |
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controlled-release drug delivery expert |
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. |
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intellectual property expert |
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 |
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pharmaceutical product development expert
Chemistry, Manufacturing and Controls expert |
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. |
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pharmaceutical technology expert |
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. |
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project management expert |
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. |
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tablet coating expert |
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 |
| Show Secondary and Basic Areas of Expertise |
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Degree |
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Subject |
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Institution |
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Honors |
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1985
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PhD
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Powder Technology
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London School of Pharmacy
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1981
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B.Pharm
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Pharmacy
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London School of Pharmacy
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Upper Second Class Honours (2(i))
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| Years |
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Employer |
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Department |
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Title |
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Responsibilities |
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2007 to
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(Undisclosed Consulting Company)
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Owner
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Consults on pharmaceutical development, CMC, clinical manufcturing and packaging, modified release formulation, intellectual property strategy and management, film coating and new technology development
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1998 to 2007
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Phoqus Pharmaceuticals
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Vice-President, Technical Development
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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.
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1997 to 1998
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Colorcon Inc
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Global Technology Development
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Head, GTD (Europe)
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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.
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1994 to 1996
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Colorcon Limited
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Technical
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Manager, Technical Service and Development
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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.
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Redesigned the Technical Service function to improve productivity and flexibility. Reported to Technical Director.
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1987 to 1994
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SmithKline&French/SmithKline Beecham
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Pharmaceutical Technolgies
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Senior Section Head/Team Leader
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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.
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1985 to 1987
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Wyeth Research (UK)
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Pharmaceutical Development
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Section Head, Solid Dose Formulation
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Responsible for formulation work on solid dosage forms for NCE's and generic products.
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Associations/Societies
Royal Pharmaceutical Society of Great Britain;
Institution of Chemical Engineers;
AAPS
UKAPS
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Licenses/Certifications
MRPharmS
MIChemE
CEng
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| Publications: |
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Publications and Patents Summary
has over 40 publications and over 20 granted and pending patents
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As a member of the Intota consultant network,
Expert is a specialist who provides technical consulting to corporate, legal and government clients. Expert provides professional consulting as a Pharmaceutical Development Consultant, CMC Consultant, Project Management Consultant, Intellectual Property Consultant. Expert may consult as an independent consultant or as a member of a consultancy, consulting company,
or consulting firm. Consultants service will be covered by a consulting contract.
Ask an expert initial screening questions and ask the experts services particulars, by simply submitting
an expert request.
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Intota experts can serve as expert witnesses or litigation consultants offering expert testimony, expert advice, litigation support,
forensic services, and related expert witness services. Expert can serve as an expert witness or litigation consultant in intellectual property (patent, trademark, trade secret, copyright),
product liability, and insurance matters. Expert may provide forensic expert witness testimony, litigation consulting services, forensic investigation,
and forensic testing if appropriate in litigation areas as a Pharmaceutical Development Expert Witness, CMC Expert Witness, Project Management Expert Witness, Intellectual Property Expert Witness.
Intota provides attorneys and legal professionals the opportunity to ask an expert initial screening questions and
ask the experts services particulars by submitting an expert request.
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| Language Skills: |
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| Foreign Language |
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Description |
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French
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Intermediate standard
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German
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Basic Standard
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Strong technical and commercial knowledge of oral drug delivery,modified release, film coating and excipient supply. Experience of venture capital financing and IPO.
Expert serves as a resource to
Intota Market Research Services
for customized marketing research in industries or areas related to
Pharmaceutical Development, CMC, Project Management, Intellectual Property.
Experts are an invaluable source of overall industry insight as well as insight into specific companies and firms for
custom business to business (b2b) and industrial market research. Intota uses analyst and
consultant resources from Guideline whose Research Directors manage the research and analysis of the qualitative
and quantitative data as well as report writing for the custom studies. The methods and tools
used by Intota market research combine the insights of technical experts and industry insiders with secondary
research to provide the custom b2b and industrial market research you need.
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| Additional Skills and Services: |
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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.
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Supplier and Vendor Location and Selection Experience of identifying and project managing suppliers of formulation, analytical, regulatory, clinical, manufacturing, engineering and intellectual property services.
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Other Skills and Services
Can advise on intellectual property strategy and portfolio management, including selection of service providers.
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Expertise
