Tag Archive
The following is a list of all entries tagged with drug development:
Twitter Weekly Updates for 2010-02-07
Filed in Uncategorized, February 7, 2010, 2:20 pmWhilst 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! [...]
Twitter Weekly Updates for 2010-01-31
Filed in Uncategorized, January 31, 2010, 2:20 pmYou 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 [...]
Twitter Weekly Updates for 2010-01-24
Filed in Uncategorized, January 24, 2010, 2:20 pmI'v been writing an FDA orphan application all day! Just a minor point to clear up and submit! # Powered by Twitter Tools
Twitter Weekly Updates for 2010-01-17
Filed in Uncategorized, January 17, 2010, 2:20 pmWhen 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 [...]
Twitter Weekly Updates for 2010-01-10
Filed in Uncategorized, January 10, 2010, 1:20 pmPreperation 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 [...]
Twitter Weekly Updates for 2010-01-10
Filed in Uncategorized, , 1:20 pmPreperation 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 [...]
Twitter Weekly Updates for 2009-12-27
Filed in Uncategorized, December 27, 2009, 2:20 pmMHRA 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. # Powered by Twitter Tools
Twitter Weekly Updates for 2009-12-13
Filed in Uncategorized, December 13, 2009, 2:20 pmWhat 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 # Powered [...]
Twitter Weekly Updates for 2009-12-06
Filed in Uncategorized, December 6, 2009, 2:20 pmIndication 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. [...]
Twitter Weekly Updates for 2009-11-29
Filed in Uncategorized, November 29, 2009, 2:20 pmMarket 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 [...]
Twitter Weekly Updates for 2009-11-22
Filed in Uncategorized, November 22, 2009, 2:20 pmDILI the FDA liver tox regulations take a pragmatic stance on liver tox. If your going to save your product you need our expert review # Powered by Twitter Tools
Twitter Weekly Updates for 2009-11-15
Filed in Uncategorized, November 15, 2009, 2:20 pmOrphan 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/ # Powered by Twitter Tools
Twitter Weekly Updates for 2009-11-08
Filed in Uncategorized, November 8, 2009, 2:20 pmData 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. # Powered by Twitter Tools
Twitter Weekly Updates for 2009-11-01
Filed in Uncategorized, November 1, 2009, 2:20 pmI 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 # Powered by Twitter Tools
Twitter Weekly Updates for 2009-10-25
Filed in Uncategorized, October 25, 2009, 2:20 pmPresenting a business plan is more than the science! And more than market sizes! Its alllll about dynamics! Its just so important! # Powered by Twitter Tools
Twitter Weekly Updates for 2009-10-18
Filed in Uncategorized, October 18, 2009, 3:20 pmContracting out specific project elements to independent experts means we can offer a full service with high expertise in all areas! # Orphan presentations should include all that an orphan application contains! Emea and FDA combined applications! # Indication selection needs be be inclusive and broad if it is to make sense! # Ideas only [...]
Twitter Weekly Updates for 2009-10-11
Filed in Uncategorized, October 11, 2009, 3:20 pmBusiness opportunities present themselves frequentley. You have to be open to them! # Powered by Twitter Tools
Twitter Weekly Updates for 2009-10-04
Filed in Uncategorized, October 4, 2009, 3:20 pmRT @tweetmeme Sanders Says: Saving the World at Work http://bit.ly/16XLOC # Sometimes licensing is a big numbers game! Lots of companies to find the one! The key is persistence! # Powered by Twitter Tools
Twitter Weekly Updates for 2009-09-20
Filed in Uncategorized, September 20, 2009, 3:20 pmWhen building a berifing book! Put all the info in then cut it down! Its a matter of balance! Ease of reading vs completness of data! # Check Out This Free SEO Software http://www.undergroundtraininglab.com/959/tgspv2/ # Powered by Twitter Tools
Twitter Weekly Updates for 2009-09-13
Filed in Uncategorized, September 13, 2009, 3:20 pmNews should be presented in the appropriate formatt! Headline, summary, detail. Its what the public want! # Powered by Twitter Tools
Entries