GLGi: New Drug Application Process
Time & Location
Originally Presented: October 26, 2006 12:30 PM, Palo Alto
Presenter(s):
- Evan Siegel
Adjunct Professor
THE UNIVERSITY OF QUEENSLAND
Agenda:
- Regulatory Process in Drug Development
- Investigational New Drug (IND) Application Process
- New Drug Application (NDA) and Biologic License Application (BLA) Processes
View Webcasts & Teleconferences in Healthcare
February 2, 2012
| Play RecordingTeleconference: Polish Healthcare Market (14:00 GMT / 09:00 AM EST)February 2, 2012Cancelled-Webcast: Global Obesity Epidemic - Have Different Approaches Slowed Growth? (11:00 AM EST)
January 27, 2012
| Play RecordingTeleconference: Multiple Sclerosis - Gilenya Safety and Tysabri Labels (13:15 GMT / 8:15 AM EST)January 17, 2012
| Play RecordingTeleconference: Sequenom’s Down Syndrome Test - Earlier and Less Invasive Detection (10:00 AM EST)
January 11, 2012
| Play RecordingTeleconference: China Blood Plasma Market – A Clotting Supply Chain (10:00AM HKT / CST)January 5, 2012
| Play RecordingTeleconference: China Vaccine R&D and Recent Market Update (2:00 PM HKT)December 15, 2011Teleconference: China Healthcare Reforms - 2009-2011 Review & Future Policy Outlook (4:00 PM HKT)
December 15, 2011
| Play RecordingTeleconference: Gilead Buys Pharmasset - $11 Billion Bet on the Hep C Market (1:00 PM EST)December 14, 2011Webcast: Medical Insurance Market in China - Perspectives on Foreign Participation (9:00 AM EST)
December 13, 2011
| Play RecordingTeleconference: Recap of the 53rd Annual ASH Meeting (2:30 PM EST / 11:30 AM PST)November 22, 2011
| Play RecordingTeleconference: What Does AIM-HIGH Say About Niacin? AHA Conference Review (10:30 AM EST)November 16, 2011Webcast: Medical Insurance Market in China - Perspectives on Foreign Participation (5:00 PM HKT)
November 16, 2011
| Play RecordingTeleconference: Provenge and Zytiga for Prostate Cancer - Post-CFS Review (11:00 AM EST)October 28, 2011
| Play RecordingTeleconference: Breathing Easier with PAH and COPD: Takeaways from CHEST 2011(10/28/2011)October 26, 2011Teleconference: Pharma Distribution M&A – Opportunities and Challenges (4:00 PM HKT / CST)
October 19, 2011Webcast: China's Expanding Medical Device Market (5:00 PM HKT)
October 13, 2011
| Play RecordingTeleconference: Durable Medical Equipment - Competitive Bidding Charges On (9:00 AM EDT)October 11, 2011
| Play RecordingTeleconference: German Healthcare Reforms - Pharmaceutical Reimbursement (14:00 BST / 09:00 AM EDT)October 10, 2011Teleconference: Esbriet (pirfenidone) for IPF-Launching in Europe but Stalled in the US(1:00PM EDT)
September 23, 2011
| Play RecordingTeleconference: No More Avastin for AMD at US VA Hospitals-Boon for Eylea or Lucentis?(12:00PM EDT)September 22, 2011
| Play RecordingTeleconference: Remodulin for PAH - Injected, Inhaled, and Swallowed (10:00 AM EDT)September 7, 2011Teleconference: Wound Care Market Update (14:30 BST / 9:30 AM EDT)
August 24, 2011
| Play RecordingWebcast: Trends in Outsourcing Clinical Research: CRO Industry Update (11:00 AM EDT)August 9, 2011
| Play RecordingTeleconference: Indian Pharmaceutical Market - Entry Strategies (2:30 PM IST)July 14, 2011
| Play RecordingTeleconference: Adcetris (SGN-35) for Hodgkins Lymphoma (11:00 AM EDT)July 12, 2011
| Play RecordingTeleconference: Opportunities and Challenges in a Generic World (15:00 BST / 10:00 AM EDT)June 28, 2011
| Play RecordingWebcast: The Biosimilar Drug Dilemma - Breaking Into the US Market (3:00 PM ET)May 31, 2011
| Play RecordingTeleconference: Pain, Pain, Go Away - Recap of the EULAR 2011 Congress (11:00 AM EDT)May 20, 2011
| Play RecordingWebcast: Pharmaceutical Innovation from a Socio-Economic Perspective (11:00 AM EDT)May 13, 2011
| Play RecordingWebcast: Japan's Medical Device Market - Beyond the Earthquake and Tsunami (3:30 PM HKT)May 12, 2011
| Play RecordingWebcast: Open Innovation – Best Practices and Strategies to Drive Revenue Growth (1:00 PM EDT)May 11, 2011Teleconference: China's 12th 5-Year Plan - Nationwide Pharmaceutical Champions (5:00 PM HKT)
May 5, 2011
| Play RecordingWebcast: Emerging Trends in Business Intelligence (1:00 PM EDT / 10:00 AM PDT)April 26, 2011
| Play RecordingWebcast: Japan’s Medical Device Market - Beyond the Earthquake and Tsunami (11:00 AM EDT)April 20, 2011
| Play RecordingTeleconference: New Data for Multiple Sclerosis Therapies - Review of AAN 2011 (12:15 PM EDT)April 20, 2011
| Play RecordingWebcast: CROs in China - New Development Trends in Outsourcing (11:30 AM EDT)April 18, 2011
| Play RecordingTeleconference: Cardiac Resynchronization Devices - Protecta and Promote Quadra (11:30 AM EDT)April 15, 2011
| Play RecordingTeleconference: New DME Competitive Bidding Program - Problems Already (11:00 AM EDT)April 13, 2011
| Play RecordingWebcast: Indian Nutraceutical Market - Growth and Opportunities (2:30 PM IST)April 8, 2011
| Play RecordingWebcast: Orphan Drugs - Regulatory, Clinical, and Commercialization Challenges (2:00 PM EDT)April 4, 2011
| Play RecordingTeleconference: Boceprevir and Telaprevir Approach the Finish Line - Recap of EASL (11:00 AM EDT)March 28, 2011Teleconference: Makena for Preterm Birth - Pricing Gone Too Far (11:00 AM EDT/ 8:00 AM PDT)
March 24, 2011Teleconference: Pharmaceutical Distribution in India - Changing Horizons (2:30 PM IST)
March 24, 2011
| Play RecordingWebcast: M&A - A Strategy for Focused Growth in the BioPharma Industry During Uncertain TimesMarch 22, 2011
| Play RecordingTeleconference: Yervoy for Metastatic Melanoma - Finally a Breakthrough? (11:30 AM EDT)March 21, 2011
| Play RecordingTeleconference: Mass Spectrometry and Liquid Chromatography (12:00 PM EDT/ 9:00 AM PDT)March 17, 2011
| Play RecordingWebcast: Anti-NGF Therapies for Pain - Painful Goodbye? (11:30 AM EDT)March 11, 2011
| Play RecordingWebcast: Cloud-Based Computing Solutions - Next Generation Sequencing Data Management (11:00 AM EST)March 2, 2011
| Play RecordingWebcast: Fair Market Value - Best Practices for Developing Compliance StrategiesFebruary 22, 2011
| Play RecordingTeleconference: Androgen Independent Prostate Cancer (10:00 AM EST/ 7:00 AM PST)February 16, 2011
| Play RecordingWebcast: Pharmaceutical Opportunities in India – Is it Rural? (8:00 AM EST / 13:00 GMT)February 9, 2011
| Play RecordingTeleconference: Pharmaceutical Market in Brazil (15:00 GMT / 10:00 AM EST / 1:00 PM BRST)February 7, 2011
| Play RecordingTeleconference: Personal Genome Sequencer vs. MiSeq (11:30 AM EST/ 8:30 AM PST)January 28, 2011
| Play RecordingWebcast: Foreign Corrupt Practices Act (12:00 PM EST / 9:00 AM PST)January 18, 2011
| Play RecordingWebcast: Revised Revenue Opportunity - A Case Study of the Obesity Drug Market (12:00 PM EST)December 22, 2010
| Play RecordingTeleconference: Treatments for PAH - Impact of the Thelin Recall (16:00 GMT / 11:00 AM EST)December 2, 2010Teleconference: Multiple Sclerosis - Novel Therapies Under Development (3:30 PM EST/12:30 PM PST)
November 23, 2010
| Play RecordingWebcast: Inclusion of Women in Clinical Trials (12:00 PM EST / 9:00 AM PST)November 19, 2010Teleconference: Provenge for Prostate Cancer – Coverage and Usage (11:30 AM EST/8:30 AM PST)
November 16, 2010
| Play RecordingWebcast: Hospital Chains in India - The Coming of Age (2:30 PM IST / 5:00 PM HKT)November 10, 2010
| Play RecordingWebcast: China's Healthcare Reform - Impacts on the Hospital Industry (10:00 AM HKT, GMT+8)November 4, 2010
| Play RecordingWebcast: Evaluating the Value of New Healthcare Technologies (12:00 PM EDT / 9:00 AM PDT)October 27, 2010Teleconference: Weight Loss - Lorcaserin Out (For Now), Qnexa Up at Bat (12:00 PM EDT/17:00 BST)
October 21, 2010Teleconference: A Growing Hub for CRAMS Business - India Pharma (2:30 PM IST/ 5:00 PM HKT)
October 19, 2010
| Play RecordingWebcast: Current and Future Trends in HIV Therapies (11:00 AM EDT / 8:00 AM PDT)September 16, 2010Teleconference: India Diagnostic Industry - Another Outsourcing Wave? (2:30 PM IST, GMT+5:30)
September 1, 2010Teleconference: EINSTEIN-DVT and AVERROES - European Society of Cardiology Congress (11:30 AM EDT)
August 19, 2010
| Play RecordingWebcast: Future of Medical Device Market - New Growth and Opportunities (12:00 PM EDT/9:00 AM PDT)August 5, 2010
| Play RecordingWebcast: Electronic Health Records – "Meaningful Use" Criteria and Its Impact on Health InformationJuly 29, 2010Teleconference: Health Insurance Reform - Navigating Short-and Long-Term Changes (2:00EDT/11:00PDT)
July 27, 2010
| Play RecordingWebcast: Medical Device Commercialization (1:00 PM EDT / 10:00 AM PDT)July 22, 2010Teleconference: Healthcare M&A Following Reform-What's Ahead for the Industry's Lawyers(2:00EDT)
July 13, 2010Webcast: In-Vitro Diagnostics in China - Will Growth Continue Post-Stimulus? (5:00 PM HKT, GMT+8)
June 11, 2010Teleconference: Consolidation within the HCIT Market - AllscriptsMysis/Eclipsys Story (1:00 PM EDT)
June 11, 2010Teleconference: Will Gilenia (FTY720) be the First Oral Therapy Approved for MS? (10:00 AM EDT)
May 26, 2010
| Play RecordingWebcast: Pharmaceutical and Biotechnology Manufacturing and Supply Chain Management (11:00 AM EDT)May 25, 2010
| Play RecordingWebcast: Impact of Healthcare Reforms on Australian Diagnostic Imaging (3:00 PM HKT, GMT+8)May 18, 2010
| Play RecordingWebcast: Biosimilar Biological Products Regulation (11:00 AM EDT / 16:00 BST)May 7, 2010Teleconference: Pharmaceutical Outsourcing in China - Who is the Next Target? (11:00 AM HKT, GMT+8)
April 19, 2010Teleconference: Post-Conference Review with Stefan Zeuzem, MD, PhD and Robert Gish, MD (8:30 AM EDT)
April 16, 2010Teleconference: Managed Care - New Regulations and Their Impact on the Sector (1:30 PM EDT)
April 7, 2010Teleconference: Medical Devices - New Regulations and Their Impact on the Sector (1:00 PM EDT)
March 31, 2010Teleconference: Reform Implications for Healthcare Property Sector (2:00 PM EDT / 11:00 AM PDT)
March 30, 2010
| Play RecordingWebcast: Structural Changes in the Global Pharmaceutical Market: The Role of India (5:00 PM HKT)March 17, 2010
| Play RecordingWebcast: Traditional Chinese Medicine Industry-Will the Rapid Growth Continue? (5:00 PM HKT, GMT+8)March 11, 2010
| Play RecordingWebcast: Hot Topics at Upcoming American College of Cardiology 59th Annual Session (11:00 AM EST)March 4, 2010
| Play RecordingWebcast: New Faces, New Outcomes? Inside the FDA Drug Approval Process (11:00 AM EST / 8:00 AM PST)February 24, 2010Teleconference: FDA Advisory Committee Announcement Salix Pharmaceuticals' Xifaxan (11:00 AM EST)
February 18, 2010
| Play RecordingWebcast: An Auditor's View of Pharmaceutical Manufacturing (11:00 AM EST/ 8:00 AM PST)February 12, 2010Teleconference: Lysosomal Storage Diseases – Report from LDN WORLD Symposium (11:00 AM EST)
December 6, 2009Teleconference: Analysis of ASH Plenary Session: Dabigatran Etexilate RE-COVER Study (7:30 PM EST)
November 24, 2009Teleconference: Will Reimbursement Change for NuVasive’s XLIF Procedure? (11:00 AM EST/16:00 GMT)
November 17, 2009Teleconference: Cholesterol War – Merck’s Zetia vs. Abbott’s Niaspan (10:15 AM EST / 15:15 GMT)
November 3, 2009Teleconference: Will Benlysta be the Miracle Drug for Lupus? (10:00 AM EST / 15:00 GMT)
August 5, 2009
| Play RecordingWebcast: Personalized Medicine Panel (2:00 PM EDT / 11:00 AM PDT / 19:00 BST)June 12, 2009
| Play RecordingGLG Webcast: Pharmacy Trends with Jan Berger, MD – June 12, 2009 at 2:00 PM ETMay 22, 2009
| Play RecordingGLG Webcast: Consolidation Trends - China Pharma on May 22, 2009 at 7:30AM ETAbout GLG Live Meetings
A program focused on educating business and investment professionals through seminars on current trends and core concepts in various industries. Detailed workbooks distributed at the Seminars provide educational reference materials for later review. GLG Live Meetings enable clients to increase thier own industry education by proposing new seminar topics or adding agenda terms to currently scheduled seminars.
Gerson Lehrman Group, Inc. connects communities with knowledge through two distinct, yet complementary offerings: GLG Research and G+.