2011 Program Co-Chairs

Boro Dropulic, PhD
President and
Chief Scientific Officer
Lentigen Corporation
Paul W. Shabram
Vice President
of Operations
PaxVax
Mark Plavsic, DVM, PhD
Senior Director,
Corporate Microbiological
& Viral Safety
Genzyme Corporation
TOPICS:
» Storage » Formulation
» Transportation (Cold Chain) » Patient Delivery
» Plasmid and Vector Development » Characterization
» Cell Expansion and Yield Optimization » Purification
» Feeding, Harvest, and Washing Strategies  

2011 Program Schedule

  Sunday, April 3, 2011

4:00 pm–7:00 pm Welcome Reception (Half Moone)

  Monday, April 4, 2011

7:00 am–8:00 am Registration and Continental Breakfast (Nauticus, 3rd Floor)

8:00 am–8:30 am Meeting Overview (Nauticus, 3rd Floor) & Exhibit Setup (Half Moone)

8:30 am–10:00 am Plenary – Contaminant Detection and Prevention (Nauticus, 3rd Floor)
& Exhibit Setup (Half Moone)

10:00 am–10:30 am Morning Break (Half Moone)

10:30 am–11:15 am Harald Petry, PhD Enhanced Novel MicroRNA AAV Gene Therapy In Vivo
Director Research and Development
Amsterdam Molecular Therapeutics (AMT)

11:15 am–12:00 pm J. Michael Hatfield, PhD Recent Regulatory Guidance and Testing for Oncolytic Viruses
Senior Fellow
Atticus BioConsulting

12:00 pm–1:30 pm Lunch (Half Moone) and Poster Presentations from 1:00 pm-1:30 pm (Half Moone)

1:30 pm–2:15 pm Ricardo Jimenez Surviving a QP Audit for Clinical Phase
Viral-Based Therapeutics
Head of Quality Compliance
Lonza Houston

2:15 pm–3:00 pm Richard O. Snyder, PhD Recombinant AAV Vectors: Persistence
In Vivo and Clinical Product Release
Director of Biotherapeutic Programs
Center of Excellence for Regenerative Health Biotechnology, University of Florida

3:00 pm–3:30 pm Afternoon Break (Half Moone)

3:30 pm–4:15 pm Arifa S. Khan, PhD Regulatory Perspective on Safety of Viral-Vectored Vaccines
Section Chief
FDA CBER

4:15 pm–5:00 pm Boro Dropulic, PhD Lentiviral Vector Gene Delivery Into T Cells and Stem Cells
President and Chief Scientific Officer
Lentigen Corporation

5:00 pm–5:45 pm Keynote Address – US Government Strategies for Medical Countermeasures
and Pandemic Influenza Vaccines
(Half Moone)
Robin A. Robinson, PhD
Director & Deputy Assistant Secretary
BARDA/ASPR/HHS

5:45 pm–8:00 pm Pirates of Hampton Roads Reception (Half Moone)

  Tuesday, April 5, 2011

7:30 am–8:30 am Continental Breakfast (Half Moone)

8:30 am–9:15 am Stuart Melville Platform Solutions for Vaccine Development and Production
Senior Purification Development, Scientist
Eden Biodesign, Ltd.

9:15 am–10:00 am Joshua C. Grieger, PhD Scalable Production of rAAV Using Transient
Transfection of Suspension HEK293 Cells
Research Associate
UNC Gene Therapy Center

10:00 am–10:30 am Morning Break (Half Moone)

10:30 am–12:00 pm Technology Workshops (Half Moone)

12:00 pm–1:30 pm Lunch (Half Moone) and Poster Presentations from 1:00 pm-1:30 pm (Half Moone)
plus Baculovirus Reference Material Meeting (By Invitation)

1:30 pm–5:00 pm Special Sessions on Flexible Facilities and Systems,
plus Presentations in the Baculovirus Expression Track.
(Half Moone)

6:00 pm–9:00 pm Jazz Banquet at Scotty Quixx

  Wednesday, April 6, 2011

7:30 am–8:30 am Continental Breakfast (Half Moone)

8:30 am–9:15 am Simon G. Godwin Analytical Approaches to Determining Critical Process Controls
Associate Director of Gene Therapy Development
Genzyme Corporation

9:15 am–10:00 am Paul W. Shabram Novel Adenovirus Vector Vaccine Development Platform
Vice President of Operations
PaxVax

10:00 am–10:30 am Morning Break (Half Moone)

10:30 am–11:15 am Sridhar Pennathur, PhD The Challenges Faced in Testing Live Virus Vaccines for Adventitious Agents
Senior Director, Corporate Quality Control
MedImmune, LLC.

11:15 am–12:00 pm Sherri Spear Liquid Formulation Development of Adenovirus Type 2
Technology Development
Genzyme Corporation

12:00 pm–1:30 pm Lunch (Half Moone) and Poster Presentations from 1:00 pm-1:30 pm (Half Moone)

1:30 pm–2:15 pm J. Fraser Wright, PhD Recombinant Adeno-Associated Virus Manufacturing for
Human Clinical Trials: An Overview of Chemistry,
Manufacturing, and Controls Established at CHoP
Scientific Director, Clinical Vector Core
The Children's Hospital of Philadelphia (CHoP)

2:15 pm–3:00 pm Barbara A. Thorne, PhD Applying ICH Q5A Guidelines for
Viral Clearance Studies to AAV Vectors
Process Development Consultant

3:00 pm–3:30 pm Afternoon Break (Half Moone)

3:30 pm–5:00 pm Plenary – Contamination Detection and Prevention – Discussion and Wrap-Up
(Nauticus, 3rd Floor)
& Exhibit Teardown (Half Moone)