Independent consultants we have met over the last years...

 

We are pleased to give you here the contact details of independent consultants we have met while supporting various projects.

If you are interested by their skills and expertises, feel free to use their contact details and directly get in touch with them...

Rod Baker

Rod Baker

A pharmaceutical and regulatory consultant having significant experience in both biotech and pharma companies. Specialist knowledge and experience in CMC with particular expertise in characterisation of drug substances, pre-formulation and formulation, assay development, clinical trials manufacture and supply, packaging, scale up and process development, gap analyses on CMC regulatory packages and compilation of regulatory submissions. I have been involved in projects from late stage research through all stages of clinical development to registration and have worked with a wide range of dosage types.
In addition I have significant experience of selecting and managing contract research organisations for outsourced work and negotiating contracts with such organisations.

Contact

rod@bioedge.co.uk
www.bioedge.co.uk


Denis Carniato

Denis Carniato

Denis Carniato is currently president and founder of DC2A Consulting, a provider of drug discovery & medicinal chemistry consulting services to pharma and start-up biotech.
As a medicinal chemist with over 25 years of experience in drug discovery and development in the pharmaceutical industry, Denis Carniato hold several positions as head of combinatorial and/or medicinal chemistry groups at Roussel-Uclaf , Hoechst-Marion-Roussel , Theramex and Merck-Serono.  As research project leader he has contributed to put several drug candidates into pre-clinical and clinical development in the fields of endocrinology, bone diseases and diabetes. Then he became director of chemistry at Cytomics pharmaceuticals, a biotech specialized in oncology. Denis Carniato is inventor or co-inventor of 40 patents and publications.

Contact

d.carniato@orange.fr

Jeff Duke

Jeff Duke

Jeff Duke, M.Sc, C.Chem, C.Sci, FRSC is Managing Director of Grove Lodge Consulting Ltd, supporting the pharmaceutical industry with Chemistry, Manufacturing & Controls (CMC) expertise. Major areas include Analytical Chemistry, General Chemistry, Manufacturing and Controls, product support and strategy development, Quality by Design, both as a product development strategy and as a trainer providing training to clients across Europe. Managing large global Departments and Projects particularly outsourced projects including those outsourced into Asian CRO/CMO’s

Jeff worked at Pfizer Global R&D for over 20 years, most recently as head of the Materials Science & Oral Products group in both the US & the UK. Prior to this Jeff worked as Head of Strategy & Co-ordination for Pharmaceutical Sciences Asia Business Development Group. Prior to this, Jeff headed the European Pharmaceutical Sciences Analytical R&D group with departments in the UK and Freiburg, Germany.

Contact

Mobile: +44 7890 074900

Email:jeff@grovelodgeconsulting.com

Web:  www.grovelodgeconsulting.com

Sonia Escaich

Sonia Escaich

Sonia Escaich holds a PhD in Human biology from Lyon I University of Science.
She has 18 years of experience in the R&D divisions of pharmaceutical companies: Sandoz in Vienna, Systemix in Palo Alto and Aventis in France. She directed research projects for vaccine and drug discovery in the field of microbiology. She then became a cofounder of Mutabilis and served as CSO and CEO of the biotech company. With her business background, she then founded ESE conseil.

ESE conseil provides scientific expertise for drug discovery projects in the field of antiviral, antibacterial and gene therapy.
ESE conseil is specialized in the set-up of research and innovation projects in biotechnology, and help to establish the development strategy, the development and business plans; and assistance in the search of financing partners.

Contact
Sonia.escaich@free.fr

Josiane Lemut

Josiane Lemut

Josiane Lemut is a CMC expert acting as a consultant, more specialised in the development of ophthalmic and parenteral drug delivery systems.

She is a pharmacist with a biopharmaceutical background (graduated from Pharmacy University of Clermont Ferrand).

J Lemut has a good knowledge of the start up environment and constraints.

She has a strong experience in the formulations of drug delivery systems, the management of CMC activities including CMO identification, management of operational activities (preformulation, hit to lead selection, formulation , analytic, scale up), clinical supply, regulatory documents writing, CMC gap analysis, due diligence.

She held various positions at Dow Corning, Smithkline Beecham, Flamel Technologies, Fournier, Lilly, Auris and Fovea / Sanofi during the 23 years of her career.

During the latest experiences in start up companies: Fovea/ Sanofi (ophthalmic field) and Auris (auricular field) her missions included the role of CMC expert including the management of the drug synthesis, formulation, analytical, batches manufacture, clinical supply and dossier writing activities. She coordinated also all the subcontracting activities for the CMC part.

Earlier at Lilly she had the responsibility of process validation management on a sterile plant including technological transfer, process validation and troubleshooting activities.

For six years, she acted as preformulation / formulation manager at Fournier: management of the NCE projects from phase 1 to phase 3, lead selection, and development of new drug delivery systems more specifically microemulsions formulations.

She was head of formulation at Flamel technologies; she built the pharmaceutical development group and coordinated the projects with multidisciplinary experts and international companies for the Micropump technology.

Previously she was in charge of the pharmaceutical development at Smithkline Beecham: coordination of the galenic and analytical activities, development of tablets, capsules, sachet, and troubleshooting management.

She begun at Dow Corning in charge within the DDS department of the development of new drug delivery system based on silicone technology: gastroretentive formulations, sublingual systems, microspheres, dermal gels.


Contact
jlemut@cmcexpert.fr

Olivier LOGET

Olivier LOGET

Pharma consultancy (early pre-clin to clin dev) specifically in Safety, Tox, Pharmaco, Opht, ADME/PK & Reg Affairs. Providing expert assessment for due dil (DD) vet drugs cosmetics agrochemicals & chemicals too. 

> 60 y combined international exp team of highly qualified pharma consultants fluent in 3 languages providing scientific advice & training to identify best approach to move projects quickly through dev & onto commercial market. With experience working in Biotech, Pharma & CRO uniquely qualified to offer complete outsourcing management services for critical studies & product dev. Extensive exp in DD (> 100): expert assessment of in/out-licensing & creating gap analysis for determination of project value. Working closely with clients to help manage key objectives & make appropriate assessment of regulatory hurdles taking into consideration international regulatory landscape evolving requirements. Either in house studies or monitor outsourced studies.


Contact details:

 e-mail address: olivier.loget@capeval-pharma.com

Phone number: +33 612 13 29 72

Web site: www.capeval-pharma.com

Patrick Page

Patrick Page

International experience in drug discovery research and drug development in the Pharmaceutical/Biotechnology sectors with particular strengths in identifying, evaluating and integrating pharma projects from discovery to phase 2 clinical PoC. Patrick led multiple projects in companies such as Astrazeneca, Merck-Serono and was co-founder, General Manager, CSO/CDO of the Swiss biotech, Genkyotex. Patrick founded Huperion an independent drug discovery, preclinical development and early clinical development consulting company that delivers an integrated approach to projects based on unique expertise in the followings area:
- Preclinical research & Drug discovery services: Design and Execution of discovery & Medchem strategy for Hit Finding, H2L and Lead Optimization.
- Preclinical Development services: Defining most appropriated phase 1 enabling regulatory package and execution of related strategy & tasks.
- Project leadership and management services: A wide range of service is provided according to your project needs.
- Drug discovery and development strategy: Strategic planning, Target Product Profile development, risk analysis & contingency plans, prioritization of project portfolio.
- Due diligence and support services: Technology assessment and evaluation for prospective investment, compound evaluation for CD progression without contamination risk to the client.
- Study Regulatory compliance and authoring of non-clinical sections for regulatory submissions: review and writing of non-clinical and CMC sections for regulatory submission.

 

Contact

Email : patrick.page@huperion.com

Tel: +33 6 46800559


François Roman

François Roman

François J. Roman founded FRconsulting in October 2007 in Belgium and in France in 2010. In October 2009, he cofounded AMYLGEN, and sits in its Scientific Advisory Board. Previously, François J. Roman served as the VP R&D at Euroscreen, Belgium from 2004.

For more than 25 years, F.J. Roman has been involved in many Drug Discovery programs and has managed various projects in a broad range of therapeutic areas including metabolic, CNS, gastrointestinal, pulmonary and inflammatory diseases in several organizations in the Pharmaceutical Industry (Pfizer, Parke-Davies, Laboratoires Servier, Jouveinal Laboratoire . F.J. Roman holds a Ph.D. in Biochemistry from the University of Paris VI, France and has more than 40 publications and 35 patents.

Contact
froman@orange.fr

Mike Williams

Mike Williams

Dr Mike Williams has 35 years of Pfizer experience culminating in his 2003 appointment as Executive Director of the 117 strong Sandwich Chemical R&D group. Mike has broad experience of drug development from the Med. Chem. interface,where he had a pivotal role in cutting time/cost to reach early development milestones, through to regulatory registration. As well as his extensive experience with > 50 early drug candidates, Mike played a key role in the late development, and filing of such agents as Viagra, Zoloft and Relpax. His special responsibilities have included early outsourcing initiatives, technology adoption, and the evaluation of licensing opportunities.

Since leaving Pfizer in 2007 Mike has worked as an independent CMC consultant. He carries out due diligence evaluations, and has been co-editing and writing 3 books on the pharmaceutical industry published in 2010 (Wiley-VCH), 2011 (RSC) and 2012 (Wiley). Throughout 3Q 2009 he evaluated all CMC aspects of the Wyeth small molecule candidate portfolio for Pfizer, ahead of the merger. Recent clients include catalyst and technology (flow chemistry) companies, and he is currently a CMC consultant for Convergence Pharmaceuticals (Cambridge), and the DNDi (Geneva).

Contact
mike_t_williams2007@yahoo.co.uk
Tel: 01304 373993
Mobile:   07923 967104