• When choosing the lead compound for a drug delivery technology development programme its critical to take a measured commercial approach! #
• RT @reuters: UPDATE 1-AstraZeneca agrees drug discovery tie-up with MRC http://bit.ly/cROBBE #
• @andrew_ellis yeah ace film loved it, loved it loved it. in reply to andrew_ellis #
• The MHRA will give a regulatory advice meeting without charge if the situation justifies it! This can add clarity to a project! #

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• Its my birthday today so the office is closed, but I have masses of updated info for you tomorrow! #
• MHRA meetings can go quickly when you have the proposed plan well defined and justified, it makes you investor ready! #

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• Business plans need a clean structure that tells a story! #
• Conventional wisdom is not always correct! Once again a great result at the drug regulators that flies in the face of conventional wisdom. #

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• Wow the new site is realy driving traffic and loads of people are signing up for our regulatory watch service – ha…http://www.damienbove.com #
• The boundary between traditional science and new-wave science in healthcare is shrinking and weakening. #

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• ICHM3 consultancy services, new page launched! Check it out to access our world class pre-clinical expertise! #

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• The smallest detail of your development plan needs to support any orphan indication claims! #
• The best way to understand a process is to go through it, be that orphan, pediatric or herbal registration! #

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• When undertaking large projects with consultants its to fire and forget, you need to engage for the optimal result, its collaboration! #
• MHRA are turning meeting requests around quickly at the moment! So its a good idea to have the documentation ready before making a request #

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• Selling healthcare technologies into the NHS takes more than sales skills, it takes knowledge! We can help, US companies come to europe! #
• Whilst its tempting to try and squeeze tons of efficacy data from a first in man study it does require careful management. #

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• Expert panels are a hugely cost effective way of getting lots of high quality advice in drug development! Or due diligence! #
• Test #
• Expert opinions are massively valuable and an expert panel is a great cost effective way of accessing them, #
• Test #
• For many orphan indications there is a lack of reliable prevalence data, so conclusions can only be drawn from limited data, its confidence #

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• Consultancy outcomes should be consistent with the terms of insurance! Ask to see insurance certs when buying services! #
• Regulatory advice, sometimes its a few short questions, but it can be a huge answer! #
• Lots of new training opportunities will be comming out in next few months! Keep those eyes peeled to our newsletter! #

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• Business planning for healthcare technologies is all about telling a story! #

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• When you have to guess, and educated guess carries much more weight than an uneducated one! #
• Don't underestimate the beauty of electronic document submission! Just printed and posted an FDA orphan application, heavy!!! #
• I just updated my Squidoo page: First In Man Clinical Trials Regulations course http://tinyurl.com/yfp8l5o #
• Regulation of first in man clinical trails course open for bookings! Still only £500, http://www.damienbove.com/course #

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• Some projects require a huge amount of work to develop a scope! This requires a professional and flexable approach! #
• Contemplation is as powerful as action! However like all powerful flavours it needs to be used in careful moderation! #
• When you biomarker is a hormone or steroid you realy need to understand its circadian rhythm, measuring at the wrong time can ruin your data #
• an FDA orphan application, realy taxes a tree! But this weighty document will add value to you IP! #

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• A comprahensive training package for those involved in healthcare technology commercialisation will be launched soon watch this space #
• When thinking about medical devices marketing is so much more important than with drugs! Route to market needs to be in you development plan #
• New business support website to be launched soon! Helping consultants profit maximise! #

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• Choice of regulator for scientific advice is not as simple as it looks! Agencies that approve you CTA might not do you marketing license! #
• Flexibility is key when dealing with regulators! #

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• Licensing can be simple when you proposition is simple and the technology is a fit with current activites, without that its challenging #
• Keeping ontop of admin can be damed demanding but all too esential, its like taking time to learn new things! #
• Herbal medicines are a very important part of the medicine cabinet! Our experts can get yours to market with minimal fuss and expense! #
• Framework programmes require some signigicant investment of time and experise in order to acheive success! You need the right team! #

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• Whilst a methodical process is esential, sometimes asking an expert for a gut feel can slash months of time and expense from a project! #
• Opportunities come along that give you a chance to share your expertise with a huge number of people! Take them and run with it. #
• New FDA non clinical guidlines! Video review available later today! Go to http://www.damienbove.com and click on reports! #
• Development can take longer than expected, discovery more so than development, but don't make the error or not having a plan! #

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• You can know more about clinical trial design then any man alive! But until you speak to the clinical staff and gage feasibilty, its nothing #
• If the villigers are going around burning houses with an X on the door! Don't paint an X on you door, or even a Y, it looks too like a X #

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• I'v been writing an FDA orphan application all day! Just a minor point to clear up and submit! #

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• When it comes to venture capital companies, they stipulate a method of contact but in all honesty get on the phone! #
• Data exclusivity is an important element of IP associated with drug development, easpecialy when re-purposing a generic drug. #
• Attention to detail is absolutley essential when compiling a regulatory document. Confusion needs to be avoided at all costs! #

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