Issuu on Google+

ReportLinker

Find Industry reports, Company profiles and Market Statistics

>> Get this Report Now by email!

Hot Topics: Obesity ' The US FDA and cardiovascular risk analysis: the AdComm Cometh Published on July 2011

Report Summary Introduction Datamonitor proposes that the guidelines for developing obesity therapeutics are going to be overhauled in 2012, with major repercussions for developers. Trial requirements are likely to intensify substantially, the prospect of which has already pushed one developer to suspend US development until clear regulatory pathways are established. Features and benefits * Profile of key areas of regulatory stance on diabetes drug cardiovascular safety, and their relevance to future obesity scenarios * Examination of alternative scenarios where diabetes precedents may be less relevant * Identification of issues requiring longer term consideration, and likely interim fixes * Clinical and commercial considerations for the implementation of new guidelines, and respective ramifications Highlights Evolution of cardiovascular risk analysis in diabetes should provide useful blueprints for seismic shifts in obesity risk assessment. Cardiovascular risk assessment requirements will directly impact study populations, trial size and duration of study, while the very purpose of obesity therapies may ultimately be revisited and redefined. The FDA is likely to provide companies mid-regulatory review with a degree of flexibility. Datamonitor believes that this may not improve their candidates' long term prospects, but might explain their eagerness to resubmit their new drug applications beyond obvious and conventional commercial competitiveness. Diabetes will not provide all the answers for obesity risk/benefit analysis, but it does provide a starting point. Likely frameworks will dramatically increase future development costs, but by the same token, these standards provide a far clearer picture of acceptable risk benefit profiles ' capable of attracting developers in the longer term. Your key questions answered * A unique Datamonitor view of the regulatory landscape in obesity, providing in depth background for a much talked-about market sector * Independent, objective analysis of a topic traditionally dominated by invested stakeholders. * Pan-disease contextualisation, providing pragmatic assessments and realistic scenarios.

Table of Content Executive Summary Strategic scoping and focus Datamonitor key findings

Hot Topics: Obesity ' The US FDA and cardiovascular risk analysis: the AdComm Cometh (From Issuu)

Page 1/4


ReportLinker

Find Industry reports, Company profiles and Market Statistics

>> Get this Report Now by email! Related reports OVERVIEW Catalyst Summary OBESITY, DIABETES, CARDIOVASCULAR RISK, AND THE US FDA Obesity and type 2 diabetes cardiovascular safety: compare and contrast Enhancing identification of safety signals prior to approval Demonstrating cardiovascular benefit versus ruling out unacceptable risk Realistic thresholds for unacceptable risk Suitable primary endpoints for cardiovascular risk Size and duration for long-term cardiovascular trials Suitable trial populations Comparators and controls Intent to treat versus per protocol analysis Concurrent management of other cardiovascular risk factors Risk rule-out requirement in the absence of signals from previous trials, and pre- or post-approval setting Applicability to currently marketed products Implementation considerations Aspects of timing Handling of products at different stages of development Future challenges in diabetes and considerations for obesity BIBLIOGRAPHY Journal papers Websites Institution reporting and presentations Datamonitor reports APPENDIX Report methodology

Hot Topics: Obesity ' The US FDA and cardiovascular risk analysis: the AdComm Cometh (From Issuu)

Page 2/4


Find Industry reports, Company profiles and Market Statistics

ReportLinker

>> Get this Report Now by email! Fax Order Form To place an order via fax simply print this form, fill in the information below and fax the completed form to: ƒ ƒ

Europe, Middle East and Africa : + 33 4 37 37 15 56 Asia, Oceania and America : + 1 (805) 617 17 93

If you have any questions please visit http://www.reportlinker.com/notify/contact

Order Information Please verify that the product information is correct and select the format(s) you require. Hot Topics: Obesity ' The US FDA and cardiovascular risk analysis: the AdComm Cometh

Product Formats Please select the product formats and the quantity you require. 1 User License--USD 3 800.00

Quantity: _____

Corporate License--USD 9 500.00

Quantity: _____

Contact Information Please enter all the information below in BLOCK CAPITALS

Title:

Mr

Mrs

Dr

Miss

Ms

Prof

First Name:

_____________________________ Last Name: __________________________________

Email Address:

__________________________________________________________________________

Job Title:

__________________________________________________________________________

Organization:

__________________________________________________________________________

Address:

__________________________________________________________________________

City:

__________________________________________________________________________

Postal / Zip Code:

__________________________________________________________________________

Country:

__________________________________________________________________________

Phone Number:

__________________________________________________________________________

Fax Number:

__________________________________________________________________________

Hot Topics: Obesity ' The US FDA and cardiovascular risk analysis: the AdComm Cometh (From Issuu)

Page 3/4


Find Industry reports, Company profiles and Market Statistics

ReportLinker

>> Get this Report Now by email! Payment Information Please indicate the payment method, you would like to use by selecting the appropriate box.

Payment by credit card

Card Number: ______________________________________________

Expiry Date

__________ / _________

CVV Number _____________________

Card Type (ex: Visa, Amex…) _________________________________

Payment by wire transfer

Crédit Mutuel RIB : 10278 07314 00020257701 89 BIC : CMCIFR2A IBAN : FR76 1027 8073 1400 0202 5770 189

Payment by check

UBIQUICK SAS 16 rue Grenette – 69002 LYON, FRANCE

Customer signature:

 

Please note that by ordering from Reportlinker you are agreeing to our Terms and Conditions at http://www.reportlinker.com/index/terms

Please fax this form to: Europe, Middle East and Africa : + 33 4 37 37 15 56

ƒ ƒ

Asia, Oceania and America : + 1 (805) 617 17 93

Hot Topics: Obesity ' The US FDA and cardiovascular risk analysis: the AdComm Cometh (From Issuu)

Page 4/4


Hot Topics: Obesity The US FDA and cardiovascular risk analysis: the AdComm Cometh