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Thursday
August 9
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Friday
August 10
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| 8:30-8:40 |
Welcome and Introductions
Mike Kurilla, NIAID
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Recap of Day 1 and Goals for Day 2
Jane Knisely and Rose Aurigemma, NIAID
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| 8:40-8:45 |
Overview of Key Bottlenecks in the Development of Therapeutics for Infectious Diseases
Speakers:
John Powers, NIAID (20 minutes)
Mike Dudley, Rempex (20 minutes)
Q & A (10 minutes)
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8:45-9:00
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Concurrent Breakout Sessions |
Breakout Session 1
A. Critical Path for the Development of Small Molecules
Leader: David Shlaes (Anti-Infectives Consulting), Mike Dudley (Rempex Pharma)
B. Critical Path for the Development of Biopharmaceuticals
Leader: Steve Projan (MedImmune)
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| 9:00-9:15 |
| 9:15-9:30 |
| 9:30-9:45 |
Bottleneck #1: Early Translational Research: Beginning with the End in Mind
Framing the issue (5 minutes)
Moderator: Rich Whitley (University of Alabama)
Case Study (15 minutes)
Speakers: Urban Ramstedt (Unither)
Discussion (10 minutes)
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Breakout Session 2
A. Developing Drugs for Special Populations/Limited Use
Leader: Jim McKerrow (UCSF)
B. Common Mistakes in IND Submissions
Leader: Jon Mirsalis (SRI), Amy Ellis (FDA)
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| 9:45-10:00 |
| 10:00-10:15 |
Bottleneck #2: Lead Identification and Optimization
Framing the issue (5 minutes)
Moderator: David Pompliano (BioLeap)
Case Study (15 minutes)
Speakers: Mark Suto (Southern Research)
Discussion (10 minutes)
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| 10:15-10:30 |
Morning Break
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| 10:30-10:45 |
Morning Break
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Breakout Session 3
A. Challenges in Antimicrobial Drug Discovery
Leader: Lynn Silver (LL Silver Consulting)
B. Hand Off to Pharma – What are They Looking For in a Product Package?
Leader: David Shlaes (Anti‐Infective Consulting)
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| 10:45-11:00 |
Bottleneck #3: Toxicology and Pharmacology
Framing the issue (5 minutes)
Moderator: George Drusano (Univeristy of Florida)
Case Study 1 ‐ Tox (15 minutes)
Speaker: Jon Mirsalis (SRI)
Case Study 2 ‐ Pharm (15 minutes)
Janet Leeds (SIGA)
Discussion (10 minutes)
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| 11:00-11:15 |
| 11:15-11:30 |
Breakout Reports and Open Discussion
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| 11:30-11:45 |
Bottleneck #4: Non‐Clinical Efficacy
Framing the issue (5 minutes)
Moderator: Jim McKerrow (UCSF)
Case Study 1 (15 minutes)
Speaker: David Andes (Univeristy of Wisconsin)
Discussion (10 minutes)
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| 11:45-12:00 |
| 12:00-12:15 |
Lunch
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| 12:15-12:30 |
| 12:30-12:45 |
Adjourn Day 2
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| 12:45-1:00 |
| 1:00-1:45 |
Bottleneck #5: Chemistry, Manufacturing and Controls
Framing the issue (5 minutes)
Moderator: Helen Parish (SRI)
Case Study 1 – Small Molecule (15 minutes)
Speaker: Marina Protopopova (Sequella)
Case Study 2 – Biopharmaceutical (15 minutes)
Speaker: Steve Giardina (SAIC)
Discussion (10 minutes)
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| 1:45-2:15 |
Bottleneck #6: Clinical Development
Framing the issue (5 minutes)
Moderator: Nkechi Azie (Astellas)
Case Study – (15 minutes)
Speaker: Prabha Fernandes (Cempra)
Discussion (10 minutes)
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| 2:15-2:45 |
Open Discussion: Other Bottlenecks?
Rich Whitley (University of Alabama)
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| 2:45-3:00 |
Afternoon Break
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| 3:00-4:00 |
Panel Discussion: Resources for Overcoming Bottlenecks in Drug Development
Moderator: Rose Aurigemma (NIAID)
Panelists:
NIAID: Michael Schaefer
FDA: Dave Roeder
NCATS: David Maloney
DoD: Paula Bryant
Gates foundation: Richard Elliot
BARDA: Melissa Stundick
Venture Capitalist: Chris Earl
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| 4:00-5:30 |
Poster Session and Networking
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| 5:30 |
Adjourn Day 1
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