• 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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• Preperation is the key to success, without it you will feel disjointed! #
• USA FDA has some very truncated regulatory pathways for common otc products! #
• Change of route can impact on a develpoment programme to the extent to which PK/PD is impacted! #
• Working on a business plan for a client, so many data inputs required! #
• When is a device not a device, when its an advanced therapy medical technology! #
• We provide a drug regulatory watch service for free sign up at our website http://www.damienbove.com #

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• Preperation is the key to success, without it you will feel disjointed! #
• USA FDA has some very truncated regulatory pathways for common otc products! #
• Change of route can impact on a develpoment programme to the extent to which PK/PD is impacted! #
• Working on a business plan for a client, so many data inputs required! #
• When is a device not a device, when its an advanced therapy medical technology! #
• We provide a drug regulatory watch service for free sign up at our website http://www.damienbove.com #

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• MHRA product registration documentation, is very much a case be case affair, but case by case is what we do. #
• Having a network of consultants reduces costs for clients who don't have an underutilised infrastcucture to maintain. #

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• What training to tech transfer and commercialisation officers get and is it adequate? A question we intend to ask, and build our product to! #
• Investments can be a big numbers game, sometimes a fit can be difficult, then you have to try and try and try. 180 vc firms on my list #

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• Indication selection don't just look at mechanuism of action, think about you usp too! #
• Knowing how to get information out of the regulators can often be a simple case of asking for it. #
• Technical files for devices rely heavily on the classification, this needs to be established on a case by case basis. #
• Sometimes with market research the data requires such a small amount of interpritation clients just don't need you to provide it! #

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• Market access issues are central to indication selction and central to market access is an understanding of the treatment pathways #
• Wow the drug/biotech regulations change so quickley. Go to damienbove.com for our free regulatory watch service. #
• Desk research in medical technologies from 350per day. Markets, deals, suppliers, liturature, people, companies, or anything you want #
• We won a yorkshire forward award for excellence in mentoring new start up businesses. A great reflection on our work #

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• DILI the FDA liver tox regulations take a pragmatic stance on liver tox. If your going to save your product you need our expert review #

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• Orphan drug designations and stratifications, require demonstartion of plausibility in the target group, but also positive elimination! #
• Sme stauts with the EMEA attracts a 90% discount on scientific advice fees. #
• Ethis in phase 1 clinical research white paper launched on http://www.damienbove.com/medqp/ #

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• Data is so important when getting regulatory advice and a broad bredth of data is best #
• Health economic modeling requires good data' poor data makes the task meaningless! #
• Orphan drug awards can be retracted at 6 years if your doing very well. #

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• I have been off the grid with phone failure fortunatly everything is backed up. The lesson is reinforced. #
• When seaking venture capital investment for a biotch or pharma project selecting the right partners to approach is critical to success #

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