Application of Single-Use Technologies in Medical Countermeasure Development & Manufacturing for Emerging Pathogens
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1 Application of Single-Use Technologies in Medical Countermeasure Development & Manufacturing for Emerging Pathogens BPSA s 7 th Annual Int l Single-Use Summit July 13, 2017 Mike Angelastro Director (acting), BARDA Division of Manufacturing, Facilities & Engineering
2 Outline BARDA 101 What, why & how is BARDA? CIADM Program Update from 2012 Adoption of single-use Q&A 2
3 Introduce Some Acronyms (ISA) U.S. Department of Health & Human Services (HHS) Assistant Secretary for Preparedness & Response (ASPR) Biomedical Advanced Research & Development Authority (BARDA) Chemical, Biological, Radiological & Nuclear Threats (CBRN) Medical Counter-measures (MCM) Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Centers for Innovation in Advanced Development & Manufacturing (CIADM) 3
4 BARDA Origins In existence since 2004 under predecessor organizations Project BioShield Act of 2004, provided funding under the Special Reserve Fund (SRF) 2005 National Strategy for Pandemic Influenza for federal agencies pandemic response Dec 2006 Pandemic & All-Hazards Preparedness Act (PAHPA), and Mar 2013 Pandemic & All-Hazards Preparedness Reauthorization Act (PAHPRA) 4
5 BARDA Mission Support the advanced development of and make available medical countermeasures (MCMs) for Chemical, Biological, Radiological & Nuclear (CBRN) threats, pandemic influenza and emerging infectious diseases by transitioning candidates from early development across the Valley of Death into advanced development to regulatory approval O Neill Building Washington, DC 5
6 ? Medical Countermeasures? BARDA develops medical countermeasures (MCMs) by forming public-privatepartnerships with biotechnology and industry partners Vaccines Therapeutics Diagnostics 6
7 BARDA Organization HHS ASPR Secretary Tom Price, MD ASPR (acting) George Korch, PhD Biomedical Advanced Research & Development Authority (BARDA) Division of Chemical, Biological, Radiological & Nuclear (CBRN) Influenza & Emerging Diseases (IED) Division Office of the Director Rick Bright, PhD Division of Quantitative Analysis (DQA) Division of Regulatory & Quality Affairs (RQA) Manufacturing, Facilities & Engineering (MFE) Division Diagnostics & Medical Devices (DMD) Division Division of Clinical Studies (DCS) 7
8 BARDA MCMs Transistions, in general (1) Early research & development efforts supported by NIH, DoD, industry, academic labs (2) Advanced research & development (ARD) supported by BARDA for HHS [CMS for DoD] Typically after completion of Phase I ARD supports the data necessary for potential use of the MCM during a declared emergency Criteria for inclusion of a product into the SNS formulary Emergency Use Authorization (EUA) (3) Project BioShield (PBS) Support late-stage development and procurement Pivotal clinical and non-clinical studies and validation of the manufacturing process Once licensed/ approved transitioned to CDC SNS for maintenance 8
9 PRODUCT PIPELINE Why BARDA? Vaccine & Drug Development: Expensive, Risky, and Lengthy PHASES Preclinical Development IND NDA/BLA Discovery Phase I Phase II Phase III Licensure Production & Delivery NIH, CDC NIH & ($11.8B) DoD Valley of Death BARDA ($540M) Project Project Bioshield/ BioShield CDC s ($5.6B) SNS MERS-COV ZIKA EBOLA % 5-17% 10-25% 18-35% 45-70% 90% PROBABILITY OF SUCCESS TO LICENSURE Licensed Product TIME PIPELINE PHASE COST 3-7 yr yr 1-2 yr yr yr 1-2 yrs $100M -130M $60-70M $70M-100M $130M-160M $190M-220M $18M-20M 9
10 Public Health Emeregency Medical Countermeasure Enterprise 10
11 Stakeholder Collaborations 11
12 BARDA Today Track record 27 products cleared, approved or licensed since products procured for the nation s SNS Our mission is evolving Emerging infectious diseases (Ebola, MERS, Zika) Combatting antibiotic resistant bacteria New initiatives in traditional domains: Blood products, influenza therapeutics and vaccines, chemical threats, diagnostics We are increasingly flexible in how we partner Traditional contracts & cooperative agreements [very few grants] Portfolio partnerships (Continuous Manufacturing w/ FDA) Partnerships centered on BARDA s core services (i.e. CIADM) Non-traditional contracting (i.e. CARB-X Contract) 12
13 BARDA Core Services RQA CSN Clinical Studies Network 2014 Regulatory & Quality Affairs ADS Analytical Decision Support FFMN Fill & Finish Manufacturing Network CIADM 2011 NSN Nonclinical Services Network Centers for Innovation in Advanced Development & Manufacturing 13
14 Centers for Innovation in Advanced Development & Manufacturing (CIADM) 14
15 HHS CIADM Core Service Network 15
16 As Envisioned Complimentary Capabilities Contracts Awarded June 2012 up to 25 years 16
17 HHS CIADM Domestic Surge Capability As Envisioned To Close Capacity Gap 3 Awards made Each delivers 50M doses if influenza vaccine within 4 months 1 st doses delivered by week 12 Capacity Gap 150M Influenza Vaccine Doses Other Use for Increased Vaccine Capacity Moderate/ Large scale biopharmaceutical manufacturing to support MCM candidates for select emerging infectious diseases 3 awards made to address capacity gap that existed with pandemic influenza response 17
18 Seqirus CIADM Holly Springs, NC First cell-based influenza vaccine manufacturing facility in the U.S. 18
19 Seqirus CIADM Holly Springs, NC Clinical Scale cgmp Fill & Finish (including lyo) Capability 19
20 TAMUS CIADM College Station, TX Mobile Clean Rooms (MCRs) 20
21 TAMUS CIADM College Station, TX National Center for Therapeutics Manufacturing (NCTM) 21
22 TAMUS CIADM College Station, TX Inside the Mobile Clean Room (MCR) 22
23 TAMUS CIADM College Station, TX Multiproduct Facility [mabs, Live Virus] 23
24 Emergent BioSolutions CIADM Baltimore, MD 24
25 Emergent BioSolutions CIADM Baltimore, MD Ribbon Cutting May ,000 sq-ft manufacturing facility purchased in 2009 by Emergent Bayview Manufacturing Facility Retrofit & construction created three fully segregated manufacturing areas, QC Labs, administrative space & (future) cgmp pilot operation Three ~9,000 sq-ft cgmp suites, each with two 2,000 Liter SUB trains Infrastructure and experience to manufacture vaccines and therapeutics 25
26 Emergent BioSolutions CIADM Baltimore, MD Facility Design Multi-product Manufacturing Live viral vaccines Cell culture Microbial Segregation Floor-to-ceiling dividing wall Segregated utilities Segregated HVAC w/ low-wall returns Segregated drains and waste flows 26
27 Emergent BioSolutions CIADM Baltimore, MD Single-use Bioreactor Platform ( L) 27
28 Emergent BioSolutions CIADM Baltimore, MD Depth filters for clarification Jacketed and un-jacketed single-use mixers range from 50 L to 1000 L 28
29 Emergent BioSolutions CIADM Baltimore, MD Pre-packed columns (up to ~50 cm) Single-use Tangential Flow Filtration (TFF) 29
30 DoD s NANO-ADM Alachua, FL NanoADM facility was built by Nanotherapeutics Inc. and is Contractor-owned, contractor-operated (COCO) enterprise DoD s JPM-MCS procured and installed specialized single-use modular pharmaceutical manufacturing equipment 30
31 Whole of Government Approach DoD NANO-ADM HHS CIADM Focused on global threats Supports 1.4M service members 18 to 55 years old Works toward a state of good health Maintains broad product portfolio to protect service members Produces small force to full force scale depending on threat Focused on threats to the homeland Supports U.S. population pediatrics to geriatric Works on the entire health continuum Maintains a vaccine-focused pandemic flu portfolio Produces relatively large scale to support the entire U.S. population. 31
32 DoD s NANO-ADM Alachua, FL A 180,000 sq ft. cgmp biologics manufacturing facility Two BSL-3 cgmp upstream/downstream/media areas 32
33 DoD s NANO-ADM Alachua, FL Facilitates S&T Supports pilot-scale through cgmp large-scale manufacturing for development and sustainment Designed for Biosafety Level 3 (BSL-3) manufacturing Utilizes single-use technologies Implements agile manufacturing strategies 33
34 Contacting BARDA Announcements Requests for Information (RFI) & Proposals (RFP) Broad Agency Announcements (BAAs) To request a Tech Watch meeting Michael.Angelastro@hhs.gov Director (acting) BARDA s Division of Manufacturing, Facilities & Engineering 34
35 BARDA Endorsements Medical CBRN Defense Consortium (MCDC) Currently recruiting collective expertise in the technology areas specifically related to the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) mission. 35
36 BARDA Endorsements Also recruiting The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) A public-private consortium dedicated to advancing biopharmaceutical manufacturing innovation 36
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