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

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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)

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ASPR: Resilient People. Healthy Communities. A Nation Prepared.

Novartis CIADM

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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

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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

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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

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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