Boogie on down to BIO

  • by: |
  • 03/29/2013

Join me, Jim DiBiasi (Partner, 3D Communications), Tony Russo (Chairman and CEO Russo Partners), Howard Yuwen (Executive Director, Regulatory Affairs, Alexixon, and moderator David Schull (President, Russo Partners) for a must attend panel discussion:

Thriving, Not Just Surviving: FDA Advisory Committee Meetings

2:30 PM - 3:30 PM on Monday, Apr 22, 2013

Location Building: N426A

Description

For many biotech executives, the term "FDA advisory committee meeting" evokes feelings of fear, even among those with historical experience. Instead of tackling Advisory Committee (Ad Com) hearings as times of opportunity in which their companies can thrive, too many executives are focused on survival. Yet, the fate of their drugs in development can rest heavily on the decisions the FDA's outside advisors. In this dialogue, biopharma executives and industry experts review lessons learned from past experiences, as well as what best practices participants can apply to get ready for and succeed in the advisory committee environment. 

Learning Objectives:

  • Discuss the integration needed for medical/regulatory affairs for Ad Com success
  • Identify necessary and beneficial steps to prepare your company for Ad Com interaction
  • Examine lessons learned from a recent case study

Ability Level: Advanced

Learning Objectives:

  • Discuss the integration needed for medical/regulatory affairs for Ad Com success
  • Identify necessary and beneficial steps to prepare your company for Ad Com interaction
  • Examine lessons learned from a recent case study
CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog