Attending Biotech and Pharma
Speaker Profiles
Mario Rottländer, Head of Department, Medicinal Chemistry and Support,
H Lundbeck A/S
Mario Rottländer is Head of Department Medicinal Chemistry and Support with H Lundbeck A/S, an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological disorders. He graduated in chemistry at the University of Manchester, Institute of Science and Technology (UMIST) and at the Marburg University in Germany. He received his PhD in 1999 from the Marburg University for his pioneering work about applications of highly functionalised organometallic reagents in combinatorial chemistry and solid phase synthesis in the group of Professor Paul Knochel. In 1999 he joined the CNS company Lundbeck in Copenhagen, Denmark, as a research scientist. Since then he contributed to the pipeline of drug candidates in numerous projects within the areas of depression, Alzheimer’s disease, Parkinson’s disease, psychoses, and epilepsia. In 2006, he was appointed Head of Department of Early Lead Generation. His current responsibilities and main interests include outsourcing and drug discovery technologies with focus on lead identification.
Dr J Paul Madeley, Managing Director,
Synth-Isis Ltd
Paul Madeley began his career with Boots Pharmaceuticals in 1977. Later, following his PhD studies, he worked as a development chemist with Courtaulds and then Abbott Laboratories. Since 1995 he has worked in the virtual pharmaceutical arena, first with British Biotech and then with OSI Pharmaceuticals, where he was Senior Director of Chemical Operations, with responsibility for outsourcing, technology transfer, chemical development, scale-up and validation. He has also managed analytical and pharmaceutical development functions at various times.
Dr Madeley has worked on over sixty API programmes, covering more than three hundred synthetic process steps. He set up Synth-Isis Ltd in 2004 to provide consultancy services to virtual pharmaceutical and biotechnology companies around the world; this covers everything from candidate selection to process validation and commercial production.
We have compiled the chemistry sections of several regulatory submission dossiers and have actively participated in due diligence discussions with potential licensing partners and investors on behalf of clients.
The Company has an extensive network of service providers and consultants who can offer assistance in virtually any aspect of drug development.
Contact:
Dr Paul Madeley
Managing Director
Synth-Isis Ltd
Office: +44 (0)1865 321208
Mobile: +44 (0)7921 061384
Email: pmadeley@synthisis.com
www.synthisis.com
Dr Roland Collicott, Senior Consultant,
ChalPharm Consulting
Heading up the ChalPharm Consultancy, Dr Roland Collicott provides assistance to the pharmaceutical industry in the areas of chiral analysis, polymorphic characterisation, stability studies, chemical analysis in a GMP environment, specifications and all aspects of international CMC documentation. He also runs training courses to cover many areas of analytical chemistry, particularly in chromatography, chiral and polymorphic analysis. He has served as an expert witness and consulted in trials in Canada, UK and Germany.
Before founding the ChalPharm Consultancy in 2005, Roland was Analytical Section manager at OSI Pharmaceuticals responsible for delivering validated analytical chemistry methods and CMC documentation for OSIs regulatory submissions. In this role, he was responsible for collating and interpreting data from a wide range of analytical techniques, acquired in-house or at contract, for the characterisation of new compounds. There he also gained valuable international experience, working closely with regulatory and clinical groups as well as manufacturing and analytical contractors in Asia, Europe and the US.
Roland began his career in physical chemistry at Glaxo Group Research and originally specialised in chromatography, introducing the use of chiral HPLC columns to resolve enantiomers. He gained a PhD from his research into novel silicon-based chiral derivatisation reagents for HPLC, GC and NMR analysis. In 1998 he joined British Biotech, where he became involved in many other areas of analytical chemistry including polymorphism in pharmaceutical products. As Group Leader, he managed British Biotech’s QC procedures, stability testing and the analytical development of its NCEs.
Contact:
Dr Roland Collicott
ChalPharm Pharmaceutical Consultancy
Office: +44 (0)1753 885997
Mobile: +44 (0)7909 681661
Email: rcollicott@chalpharm.com
www.chalpharm.com
Prof Karrar Khan, Consultant,
Independent Consultant
Professor Karrar A Khan,
Professor Khan has over 35 years experience of drug discovery, pharmaceutical development, registration and managing pharmaceutical scientists. His experience includes 20 years as Head of Pharmaceutical Development for Boots Pharmaceuticals and Knoll and two years as Director for OSI where he managed their pharmaceutical development, analytical operations and DMPK. Professor Khan has also held various product development and management positions with Abbott Laboratories, and Beecham Pharmaceuticals. In these roles, he developed medicines for several therapeutic areas including antibiotics, anti depressant, anti inflammatory, anti obesity, psychosis, cardiovascular, pain, cancer, Parkinson disease, diabetes and skin. Professor Khan developed and contributed to the launch of two once a day controlled release dosage forms. His expertise ranged from development for FIM ,phase 1 to phase 3- 4 and significant experience of bringing prescription and OTC products to market on a world wide bases (contributed to the registration and launch of over 60 pharmaceutical products).
He is a Qualified person under the EC quality assurance requirements. He now works as pharmaceutical development consultant.
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Professor Khan has authored or co-authored more than 40 scientific publications and is an inventor of several development patents. He has been an invited speaker at many national and international conferences.
Professor Karrar A Khan
Contact Details
176 Melton Road West Bridgford Nottingham NG2 6FJ
Telephone +44 115 914 6758
karrar.k@ntlworld.com
Mr Neil Graham, Managing Director,
Enpharma Ltd
Neil Graham is the Managing Director of Enpharma Ltd, a development consultancy that provides a managed portal to an extensive network of experienced experts throughout the international pharmaceutical industry.
Neil Graham has worked in positions in Regulatory Affairs and Compliance in the pharmaceutical industry for over 20 years. After initially training as a Patent Agent he moved into Regulatory Affairs with Roussel Laboratories and then moved to British Biotech. He subsequently joined Shire Pharmaceuticals Group plc as Director of Regulatory Affairs.
He launched Enpharma Ltd in early 2000 and has since provided pharmaceutical development services in Regulatory Affairs, Documentation services, CTD and eCTD publishing and technical due diligence to a wide range of biotech and pharma companies.
Irene Gow, Dir of Scientific Affairs,
Nexus Oncology
Irene is an immunologist by training. During her 16 years in the pharmaceutical industry she worked with several biotech companies before joining Nexus Oncology as Director of Scientific Affairs. Irene started her career as a CRA, then moved to project management and eventually led a successful clinical operations group. She has been involved in many clinical development programmes, including taking a product from Phase 1 to a successful NDA/MAA. Her particular areas of expertise are early phase oncology and orphan drug development. At Nexus, Irene is responsible for consultancy and feasibility projects, as well as providing support for their clinical projects and training programme.
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