barda core service overview 2013 barda industry day · 2013. 11. 29. · the centers will also...
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ASPR: Resilient People. Healthy Communities. A Nation Prepared.
United States Department of
Health & Human Services Office of the Assistant Secretary for Preparedness and Response
BARDA Core Service Overview 2013 BARDA Industry Day
Centers for Innovation in
Advance Development & Manufacturing (CIADM)
Fill and Finish Manufacturing Network
(FFMN) Tom Warf
Director, MFE November 13, 2013
ASPR: Resilient People. Healthy Communities. A Nation Prepared.
Centers for Innovation in
Advanced Development & Manufacturing
Fill Finish Mfg. Network
Nonclinical Network
Clinical Studies Network
Strategic Innovations
Portfolio
ADS Modeling
Hub
Regulatory & Quality Affairs
2009
2012
2013
2010
2014 TBD
2006
The CIADMs and FFMN are BARDA Core Services
1
Support Analytical
testing
Scale-up manufacturing
Manufacturing process optimization
Provide regulatory and quality expertise and
analytical and process validation support
Produce clinical investigational lots,
engineering lots, and commercial scale lots for stockpiling or response
Support Surge Pandemic Influenza Manufacturing
ASPR: Resilient People. Healthy Communities. A Nation Prepared.
CIADM: Capabilities
2
These public-private partnerships will provide advanced development and manufacturing capabilities as core service assistance to medical countermeasure developers for CBRN threats to augment national health security on a cost-effective, reliable and sustainable basis.
The Centers will also contribute to U.S. emergency preparedness by providing vaccine and biological product manufacturing surge capacity for pandemic influenza and other public health events.
ASPR: Resilient People. Healthy Communities. A Nation Prepared. 3
• Pandemic influenza surge inventory (50M doses/center)• CBRN Medical Countermeasures• Regulatory support• Analytical development• Clinical trial and commercial scale lots• Live virus vaccines• 23 core services
CIADM Capabilities
Clinical and Commercial Lot Manufacturing
Technology Transfer Pandemic Surge
inventory
Analytical development; Lab Services
CIADMs
NIH
DoD
BARDA Existing CBRN
Contractors
New CBRN Innovators
Pandemic Influenza
Mfgs
Universities FD) (W
) Technical
Staff (WFD
ASPR: Resilient People. Healthy Communities. A Nation Prepared. 4
CIADM Stakeholders
• CIADM will provide core services andpandemic surge capability bycoordinating with:
• Pandemic influenza vaccine manufacturers• Universities• MCM developers and manufacturers
• CIADM supports:• Pandemic influenza vaccine manufacturing
• Development and response• NIH• DoD• BARDA existing CBRN MCM contractors• Emerging infectious diseases
ASPR: Resilient People. Healthy Communities. A Nation Prepared.
Centers for Innovation in Advanced Development & Manufacturing (CIADM)
5
ASPR: Resilient People. Healthy Communities. A Nation Prepared.
Novartis CIADM
6
ASPR: Resilient People. Healthy Communities. A Nation Prepared.
Novartis CIADM
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• Detailed design nearing completion
• NVD internal capital approved
• Long lead-time procurement in process • Tech Services Building groundbreaking – Oct 2013
ASPR: Resilient People. Healthy Communities. A Nation Prepared.
TAMUS CIADM
8
ASPR: Resilient People. Healthy Communities. A Nation Prepared.
Texas A&M University System
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CORE SERVICES ─ ‘Development Services’
• Most are currently available in the NCTM ─ ‘Manufacturing Services’ phase-in/ ramp-up as capacity is brought
online • 4Q2013 – Adjuvant Facility Retrofitted [Marietta, PA] & Ready for Service • 2Q2015 – NCTM Core Retrofitted [College Station, TX] & Ready for Service • 4Q2015 – Live Virus Vaccine Pilot Facility [Bryan, TX] Ready for Service • 1Q2018 – Pandemic Influenza Facility [Bryan, TX] Ready for Production
─ ‘Workforce Training Capabilities’ are ready by 3Q2014
ASPR: Resilient People. Healthy Communities. A Nation Prepared.
NCTM Flexibility Mobile Bioprocessing Units
10
ASPR: Resilient People. Healthy Communities. A Nation Prepared.
Emergent CIADM
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ASPR: Resilient People. Healthy Communities. A Nation Prepared.
Emergent CIADM
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• VaxInnate signed as influenza candidate December 2012 • Conceptual design in progress for new Area 3
Manufacturing Suite, QC labs and Warehouse at the Baltimore facility
• Proof of Concept studies in progress at the Gaithersburg Development Lab for converting the VaxInnate process from traditional stainless steel reactors to disposables
ASPR: Resilient People. Healthy Communities. A Nation Prepared.
• Complete Core Services capabilities • Establish Workforce Development • Complete Construction/Renovations • Establish Pandemic Surge
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CIADM Trajectory for the Future
Core Services; Workforce Development
Facilities – construction complete
Pandemic Surge Capacity available
Additional products being developed
through the CIADM.
Support Emerging influenza-focused or
CBRN pharmaceuticcompanies whdo not have fil
finish capabilities already in-
house
Support FDA remediation of drug shortage
situations
uce clinical tigational lots, neering lots, commercial cale lots
Prodinvesengiand
s
Support SurgePandemic Influenza
Manufacturing
al o l
ASPR: Resilient People. Healthy Communities. A Nation Prepared.
Fill and Finish Manufacturing Network: Capabilities
14
Establishes a network of existing facilities that are pre-qualified and under contract to fill and finish vaccine for U.S. Government-contracted vaccine manufacturers in a public health emergency.
ASPR: Resilient People. Healthy Communities. A Nation Prepared. 15
Fill and Finish expertise in the following: • Pandemic Influenza Surge Inventory (16M – 50M doses per Contract) • CBRN Medical Countermeasures • Regulatory Support • Analytical Development • Clinical Trial and Commercial Scale lots • Labeling & Packaging • Storage and Distribution • Lyophilization
FFMN Capabilities
Clinical and Commercial Lot Manufacturing
Technology Transfer Pandemic Surge
inventory
Analytical development; Lab Services
ASPR: Resilient People. Healthy Communities. A Nation Prepared. 16
FFMN Stakeholders
FFMN
FDA
New CBRN MCM
Innovators
Pandemic Influenza
Mfg(s) Existing BARDA CBRN
Contractors
DoD
NIH
• FFMN will provide filling and finishing capabilities by coordinating with:
• Pandemic influenza vaccine manufacturers • Contract Manufacturing Organizations (Bulk
CBRN MCMs)
• FFMN supports:
• Pandemic influenza vaccine manufacturers • FDA (drug shortage) • Existing BARDA CBRN contractors • New CBRN MCM innovators • DoD • NIH
ASPR: Resilient People. Healthy Communities. A Nation Prepared.
FFMN Contractors
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Offeror Potential Influenza Vaccine Candidate
Cook Pharmica GSK *
JHP CSL Biotherapies *
DSM Novartis *
Nanotherapeutics partnered with Baxter Pharmaceutical Solutions (BPS)
Protein Sciences Corp (PSC) or Baxter Healthcare or
Other * BARDA Stockpile Contract company
Awarded Contracts on Sep 27, 2013 !!!
ASPR: Resilient People. Healthy Communities. A Nation Prepared. 18
Fill and Finish Manufactur Network ing
Network
Fill and Finish Manufacturing Network
ASPR: Resilient People. Healthy Communities. A Nation Prepared.
Fill and Finish Manufacturing Network
ASPR: Resilient People. Healthy Communities. A Nation Prepared.
• Confirm Pandemic Influenza Partner • Tech Transfer Pandemic Candidate • Establish Pandemic Surge Capacity
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FFMN Trajectory for the Future
Pandemic Influenza Partner
Establish Pandemic Surge Capacity
Tech Transfer Pandemic Candidate
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