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39


as the PK discussion group and more latterly with the Bioanalytical Zone website launched mid March 2011, there is nothing like getting people together to be open and frank about their problems.


Do you find that company bioanalysts are still prepared to openly discuss the problems they are facing and compare notes with bioanalysts from competitor companies?


As discussed above, this does take place more on an informal basis while the number of formal problem-exposing talks has diminished. However, it may be that because of the diversity and the need to cover so many areas, less emphasis on discussing common problems is inevitable.


Do you expect that cuts in Drug Discovery in the UK will strongly affect the total amount of drug bioanalysis being carried out here or will it simply mean that different people are carrying out the bioanalysis?


Whoever carries out bioanalysis means there will be a demand for information exchange. The demise of the number of major innovators from about 30 companies in the seventies to a handful now does not mean there will be fewer drugs or less bioanalysis taking place. Pharma (currently) is moving to the virtual model while many smaller companies are being spawned as big Pharma downsizes and in some cases universities are developing capabilities in this area. So yes the number of Bioanalysts will not decline but come from a broader range of backgrounds and interests. I believe the audiences are now more eclectic than ever, be it on age, status and analytical expertise.


The major threat to any scientific meeting is if target audience dwindles because drug development in its entirety is off shored and the West becomes an owner of the IP only i.e. target id and design of the drug molecule and a marketing / sales operation – many companies are trending towards this model, some overtly others more subtly.


I hope the Pharma industry in the West does not go the way the manufacturing industry has gone – but that is another discussion.


The Forum is a great opportunity to cross fertilize ideas – share experiences and above all to develop knowledge in a wide range of developing technologies to measure an even wider range of therapeutic molecules.


Perhaps one of the most engaging talks was that presented by Robin Thorpe (NIBSC) who engaged the audience for over an hour on the Tegenero story. While not a classical PK story it certainly threw more light on the understanding of the mechanism of action of these type of drugs and certainly there is a good reason for broadening the scope of talks and the range of attendees from pure regulatory bioanalysis though to clinical chemists and


maybe forensic sciences - indeed in the first few Reid Fora this was the case.


What will be the major themes of this year's Reid meeting? What do you anticipate might be the highlights?


I would like to feel that we are keeping abreast of the “usual” but also looking at the opportunities (and limitations) of enabling technologies in the Discovery arena and the developing MIST (metabolites in safety toxicology) issues – was it ever an issue or did the industry turn it into one, and last but not least – Dried Blood Spots – what are the financial benefits (pivotal) and improvements in Quality (fit for purpose) we can always add a decimal point to our data but to what benefit.


We have provided plenty of opportunity to discuss these issues and will be reporting back in the Special Edition of Bioanalysis dedicated to Eric Reid’s memory.


Going beyond 2011, is there a future vision for the Reid Forum?


These are my personal views and as it will be my last Forum I can be a little more candid in my aspirations for the Forum.


Of late the industry has come to embrace the CRO fraternity, in larger number, an issue not lost on the Forum. It is important that the Forum does not descend into 10 CROs “seeking” business from 3 (2) major Pharma. I think the Forum exhibition sessions are something we have developed over the last few years giving exhibitors and delegates opportunity to discuss issues in depth. We continue to hold the price of the forum by moving from wine and silver service at lunch (for those that can remember) to Formica self service lunch while still maintaining the nature of the social sessions.


I believe the Forum needs to keep in touch with its constituency on a more regular basis and maybe link up with other groups such as the EBF could make this possible, developing a more professional approach to the organization (increased cost) of the meeting – however maintaining the essence of a meeting designed by analysts for analysts is essentially the way forward BUT can the time be found to do this?


Sounds like an all-consuming activity – do you have any time for other interests?


These include hill walking, gardening, antique and modern glass collecting as well as belatedly jogging, much against my logical sensibilities, except for the theoretical belief that fitness equal good health – last but not least travelling to visit the family diaspora now spread around the world.


Many thanks for your time, Howard. We wish you well with the Reid Forum (www.chromsoc.com).


There is much more to Howard Hill than being a leading light in the Reid Forum Syndicate. He joined HLS in 1999 as Director of Pharmaceutical Analytical Services and more recently as Group Director of Pharmaceutical Development. He has held a number of positions as Director / Head of Bioanalytical / Metabolism / Pharmaceutical Analysis in a variety of Contract Laboratories including IPHAR (Germany, Spain), BIOS (UK), BioResearch and Phoenix in Canada, Hazleton and Covance in the UK. Prior to his career in Contract Research he worked for Wellcome Laboratories, where he was a Post Doctoral Research Associate at the University of London, Middlesex Hospital Medical School and a Senior Analyst with Hoechst in the UK. He has authored over 200 papers, presentations and posters and co-edited the series "Methodological Surveys in Bioanalysis of Drugs" with Drs Reid and Wilson. He is past Chairman of the Joint Pharmaceutical Analysis Group of the Royal Society of Chemistry and the Royal Pharmaceutical Society (GB). He has a BSc and PhD (1971) in Biochemistry from the University of Wales and is a member of the Royal Society of Chemistry and American Association of Pharmaceutical Scientists. (Bio-details from Bioanalysis; Howard Hill is a Senior Editor of Bioanalysis, a journal of the Future Science Group)


RELATED READING


The rise of the biologic Gill, V


Chemistry World, January 2008


FDA takes tough line on biologic drug Crow, JM Chemistry World, April 2008


Bioanalysis of biotherapeutics at a crossroad Ezan, E


Bioanalysis, March 2011, Vol. 3, No. 5, Pages 469-471.


Specificity of bioanalytical methods for pharmacokinetic support of biological macromolecular therapeutics is important Findlay, JWA Bioanalysis, March 2011, Vol. 3, No. 6, Pages 567-569.


Ligand-binding assays: old challenges, new solutions Oldfield, P


Bioanalysis, March 2011, Vol. 3, No. 6, Pages 571-573.


Characterization of protein therapeutics by mass spectrometry: recent developments and future directions Chen, GD; Warrack, BM; Goodenough, AK, et al. Drug Discovery Today, 2011. Vol. 16 Issue: 1-2 Pages: 58-64


Intact protein analysis in the biopharmaceutical field Staub, A; Guillarme, D; Schappler, J, et al. J. Pharm. Biomed. Anal., 2011. Volume: 55 Issue: 4 Pages: 810-822


Process analytical technology (PAT) for biopharmaceuticals Author(s): Glassey, J; Gernaey, KV; Clemens, C, et al. Biotechnology Journal, 2011. Volume: 6 Issue: 4 Pages: 369-377


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