myBIO 2013 - Tagged with Drug Discovery And Development Track

And Now for Something Completely Different: How Will Pharma Access External Early-Stage Innovation?

9:00 AM - 10:15 AM on Tuesday, Apr 23, 2013

161 (see all)
Iain Dukes (see all)

Location Building: S401A
Track Drug Discovery and Development Track

Description: Pharma faces hard realities: the FDA yearly approves enough “new molecular entities” to maintain a robust industry, mergers and acquisitions are shrinking the field of Big Pharma and large biotechs, and...

Broad-Spectrum Antivirals: The “New” Holy Grail

3:45 PM - 5:00 PM on Tuesday, Apr 23, 2013

42 (see all)
Timothy Rodell (see all)

Location Building: S401A
Track Drug Discovery and Development Track

Description: Antibiotics gave us powerful weapons against bacterial infections. But viruses, with their interdependence on the cell and talent for mutation, have eluded similar clinical success. The goal is a new generation...

Clinical Trials Modernization: Confronting Challenges to Study Start-Up - Avoid Delays, Improve Efficiency, Mitigate Risk

9:00 AM - 10:15 AM on Wednesday, Apr 24, 2013

60 (see all)
Paul Hastings (see all)

Location Building: S401A
Track Drug Discovery and Development Track

Description: Conducting a modern clinical trial requires coordination of a large and diverse group of stakeholders – including patients, clinical investigators, physicians, regulators, and the research sponsors. Studies have suggested that barriers...

Clinical Trials Modernization: The Promises and Challenges of Risk-Based Approaches to Monitoring

10:30 AM - 11:30 AM on Wednesday, Apr 24, 2013

37 (see all)
James Dixon (see all)

Location Building: S401A
Track Drug Discovery and Development Track

Description: Monitoring the progress of clinical investigations typically involves frequent visits to each study site. However, general guidelines for Good Clinical Practice (GCP), FDA regulation, and International Conference on Harmonization (ICH) guideline...

Clinical Trials Modernization: Tools for Developing the Clinical Trials of the Future

2:30 PM - 3:30 PM on Wednesday, Apr 24, 2013

Location Building: S401A
Track Drug Discovery and Development Track

Description: A variety of private-public partnerships focused on regulatory science are dedicated to new drug development tools (DDTs)—biomarkers, aids for patient-reported outcomes, novel clinical trial designs, new statistical approaches for analyzing clinical...

Open Innovation: Transforming the Model of Biopharmaceutical R&D

2:30 PM - 3:30 PM on Tuesday, Apr 23, 2013

Location Building: S401BCD
Track Drug Discovery and Development Track

Description: Pharmaceutical companies are exploring new strategies and alliance models to address the industry’s innovation gap. One approach is ”open innovation”—defined as “a paradigm that assumes that firms can and should use...

Opportunities and Challenges in Developing Innovative Stem Cell Therapies

3:45 PM - 5:00 PM on Monday, Apr 22, 2013

86 (see all)
Barry Berkowitz (see all)

Location Building: S401A
Track Drug Discovery and Development Track

Description: Stem cell-based therapies are rapidly emerging as a promising new class of treatment for a wide range of diseases. Few have been marketed and some have reached clinical trials with many...

Physiology First: Back to the Future in Drug Discovery

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

111 (see all)
John Mendlein, Ph.D. (see all)

Location Building: S401A
Track Drug Discovery and Development Track

Description: Targeted therapies have dominated drug discovery for the past 10–15 years. As industry roll-ups and other issues squeeze innovation to a trickle, new approaches achieve new priority. The earliest drug discovery...

Russia’s Drug Development Outlook

10:30 AM - 11:30 AM on Tuesday, Apr 23, 2013

Location Building: S401 A
Track Drug Discovery and Development Track

Description: Historically Russia has not been associated with a leading role in drug discovery and development. However, the situation is changing now. The Russian government has created initiatives that are showing the...