Inside the 2026 BioMaP-Consortium Meeting: Key Takeaways on Pharmaceutical Reshoring and Supply Chain Security

On February 25–26, 2026, Global Key Solutions attended the BioMaP-Consortium General Membership Meeting in Arlington, VA, the premier gathering for organizations working to strengthen domestic biopharmaceutical manufacturing in the United States. Organized by ATI (Advanced Technology International) in partnership with BARDA and ASPR, the two-day event brought together government leaders, contract manufacturers, pharmaceutical innovators, and congressional staff to address the urgent challenge of reducing America's dependence on foreign drug supply chains.

GKS was one of 14 organizations selected to present a research poster at the meeting. Our poster, "The Foreign Inspection Gap: Regulatory Data Intelligence for Global GMP Oversight," presented findings from our ongoing research on FDA foreign inspection trends from 2014–2024. For full details on our poster and key findings, see our original press release.

The following is a two-day recap of the meeting notes as attended by George Kwiecinski.

What is the BioMaP-Consortium?

The Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP) is a public-private partnership established in 2023 by the Biomedical Advanced Research and Development Authority (BARDA) under the Administration for Strategic Preparedness and Response (ASPR). Managed by ATI (Advanced Technology International) through an Other Transaction Authority (OTA) agreement, the consortium brings together over 160 member organizations across the drug and vaccine manufacturing supply chain, including raw material suppliers, innovative manufacturing technology developers, and fill-finish service providers.

The consortium's mission: create fast and flexible partnerships with the commercial biopharmaceutical industry to ensure the United States can manufacture biologics (such as vaccines) at the speed and scale necessary during a public health emergency. With the potential for $20 billion of funding over the next 10 years, BioMaP represents one of the most significant investments in domestic pharmaceutical manufacturing capacity in U.S. history.

BioMaP operates across three Technical Key Domain Areas: (1) industrial base expansion of the biomanufacturing supply chain, (2) biomanufacturing capacity expansion and reservation, and (3) advanced biomanufacturing technologies.

Meeting Agenda

---

Day 1: Setting the Stage

IBMSC Keynote: APIs as a National Security Priority

The meeting opened with a keynote from Joe Hamel, Senior Advisor for Enabling Innovations and Technology at the Interagency Board for Medical Supply Chain (IBMSC) within ASPR. Hamel, a veteran of more than two decades in national health security operations, set the tone for the entire conference:

Hamel outlined the current state of APIs supplying the U.S. market:

• A large majority of API facilities are located overseas
• Supply is geographically concentrated in a handful of countries and regions
• Origin transparency is limited for many products; buyers often cannot trace Key Starting Materials (KSMs)
• This reliance on foreign suppliers leaves the entire medical supply chain vulnerable to geopolitical instability, shipping delays, pandemics, and natural disasters

The IBMSC team, led by Deputy Assistant Secretary Arlene Joyner and Acting Deputy Director Wayland Coker, presented their five strategic pillars: Domestic Manufacturing Resilience, Supply Chain Visibility and Security, Surge Readiness and Responsiveness, Strategic Public-Private Collaboration, and Innovation and Sustainability.

A key policy anchor for the discussion was Executive Order 14336, "Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve," issued in August 2025. Through this order, ASPR has been tasked with establishing pharmaceutical independence for the United States through multiple public-private partnerships.

ASPR's Current Priorities

ASPR leadership also outlined their current PCI (Pharmaceutical and Chemical Innovation) priorities, including:

• Onshoring MCM candidates for Viral Hemorrhagic Fevers (VHFs), including tech transfer to domestic CDMOs
• Advanced Manufacturing Capability Improvement, focusing on FDA-aligned smart manufacturing concepts
• Leveraging Industrial Base Expansion (IBx) Investments, finalizing construction with industry partners to expand domestic capacity
• Extended Reality (XR) Training for the biomanufacturing workforce, evaluating XR-based onboarding for entry-level technicians

---

Day 1: BARDA's Mission

Dr. Chris Hutchinson, BARDA CBRN Division

Dr. Chris Hutchinson presented on BARDA's Division of Chemical, Biological, Radiological, and Nuclear (CBRN) countermeasures. BARDA's mission: develop and make available FDA-approved medical countermeasures in times of national need.

For BioMaP consortium members, flexible technology, agility, and sustainability were identified as the most critical capabilities. Hutchinson emphasized:

• BARDA supports validated manufacturing and post-market commitments
• The next threat is unknown, which is why agile and flexible manufacturing abilities are essential
• Partnerships with product sponsors are the foundation of surge readiness

Dr. Christine Oshansky, Pandemic Influenza Preparedness

Dr. Christine Oshansky from BARDA's Influenza and Emerging Infectious Disease Division (IEIDD) delivered one of the most operationally detailed presentations of the meeting.

"Our mission is to prepare for and respond to pandemics."

— Dr. Christine Oshansky, BARDA IEIDD

Key operational details included:

• If the U.S. needed 660 million doses (two per person), the current fill-finish capacity would be the primary bottleneck, not bulk drug substance production
• BARDA is actively seeking CMOs willing to assume the risk of fill-finish manufacturing prior to product release, a forward-thinking concept for pandemic surge readiness
• Public-private partnerships with vaccine manufacturers including CSL Seqirus, Sanofi, and GSK support the National Pre-pandemic Influenza Vaccine Stockpile (NPIVS)
• Strategic goals include room-temperature distribution, self-administration capabilities, and therapeutics covering the full spectrum of pandemic disease

Oshansky also noted that her team spends significant time on regulatory readiness, maintaining datasets for safety and immunogenicity across diverse influenza subtypes (H2Nx, H5Nx, H7Nx, and others). This aligns with CDC's pandemic influenza planning guidance and the broader national strategy for pandemic preparedness.

---

Day 1: BARDA Ventures, IBMSC Investments, and Program Updates

BARDA Ventures and the SMART Antiviral Prize

The meeting featured a look at BARDA Ventures, the agency's investment arm designed to accelerate promising technologies. Among the highlights:

• Antheia, a biosynthetic API company producing active pharmaceutical ingredients through engineered yeast, reducing dependence on traditional chemical synthesis supply chains
• The SMART Antiviral Prize, a challenge-based initiative driving innovation in antiviral development

EQUIP-A-Pharma

One of the most forward-looking programs discussed was EQUIP-A-Pharma, focused on creating in-process data as drugs are produced, enabling real-time commissioning and qualification. The program claims an 80% reduction in time for stability studies, a breakthrough for speeding drug submissions. Mark Cuban Cost Plus Drugs was also mentioned in the context of domestic drug pricing and access.

DEKA Saline on Demand (Project CASPIAN)

A standout example of agile manufacturing: DEKA Research's saline-on-demand system (Project CASPIAN), producing IV saline from saltwater on-site. This is what agile pharmaceutical manufacturing looks like in practice.

Digital Stockpile & Manufacturing Response Network (DS-MRN)

ASPR introduced the DS-MRN, a secure digital infrastructure and network of cross-industry manufacturers ready to produce medical products during disruptions. When fully implemented, the DS-MRN will:

• Stabilize patient access to critical medical products through unexpected disruptions
• Leverage American manufacturing to support disaster response and public health emergencies
• Augment response assets with digital infrastructure for pre-positioning virtual designs
• Impact resilience at a national scale by thwarting counterfeiters and surging manufacturing capacity

---

Day 1: Task Orders and Member Presentations

Task Orders: The BioMaP Work Program

The afternoon featured detailed reviews of multiple active task orders across the BioMaP consortium. These task orders, issued under the OTA agreement between BARDA and ATI, cover drug substance production, sterilization, diagnostics, workforce development, and supply chain management:

• Task Order 2: Production of drug substances and drug products, with awards to companies like the API Innovation Center and Christina Smolke's distributed manufacturing program based in Athens, GA. Charlie Lyon, VP of the API Innovation Center, presented alongside SOCMA (Society of Chemical Manufacturers and Affiliates) members.

• Task Order 3: Sterilization capacity for vaccines and therapeutics, featuring Meissner (Jon Day) and their work on cobalt-60 sterilization infrastructure.

• Task Order 6: Increasing domestic manufacturing capacity of the diagnostic pipeline.

• Task Order 10: Domestic capability building, including antibody manufacturing.

• Task Order 12: Vendor Managed Inventory (VMI) for APIs used in medical countermeasure finished dose form drug products. Key capabilities include real-time inventory management systems and the ability to rapidly convert APIs to finished drug products within 30 days of notice.

• Task Order 13: Continuation of supply chain management and oversight work.

Joseph Hamel presented Task Orders 12 and 13, emphasizing the need for "real-time inventory management systems" and the ability to rapidly convert manufacturing capacity during a flare-up.

Member Presentations

The poster session and networking brought together a wide range of innovative companies:

• Continuus Pharmaceuticals (Bayan Takizawa), continuous manufacturing
• SteriTek (Larry Nicholes), sterilization services
• Wheeler Bio, antibody manufacturing
• Sentio BioSciences, quality-focused biotech

The session also included a presentation on UV-C robotics for cleanroom disinfection by PSC Biotech, now in use by Genentech, AstraZeneca, and Novo Nordisk.

---

GKS Poster: The Foreign Inspection Gap

Between Day 1 and Day 2, our poster was on display alongside 13 other organizations. Our research on the widening gap between foreign drug imports and FDA inspection capacity generated strong interest from attendees working on supply chain visibility and regulatory oversight.

---

Day 2: Manufacturing Readiness Panel

Day 2 opened with a panel moderated by Dr. Kerrie DeMarco (Senior Vice President, Strategic Analysis) featuring:

• Kevin Webb, COO & President, API Innovation Center
• Dr. Gabriela Grasa Mannino, Senior Director, US Pharmacopeia (USP)
• Robert Huffman, Director, BARDA
• John Brewer, Manager, IBMSC

Brewer challenged the room on the reality of domestic preparedness:

The panel discussed the importance of diversifying investments across multiple manufacturing sites to "keep them warm," maintaining operational readiness without over-concentrating risk in any single facility or company. But investment requires confidence, and Webb put it plainly:

Webb's point struck at the heart of the reshoring challenge: companies cannot invest in domestic API and KSM manufacturing without reliable, long-term demand signals from the government. He credited universities and the need for a robust training pipeline as essential complements to capital investment.

Additional Day 2 attendees included Michael Edmonton, Director of Strategic Sourcing at Walmart, and representatives from Cascade Bio.

---

Day 2: Congressional Staff Panel

The congressional staff panel featured Ted Yoho, former U.S. Congressman and member of the House Agriculture Committee, alongside Julie Oxer from ASPR legislative affairs and Taylor (congressional staffer).

Yoho brought a national security lens to the conversation, highlighting the intersection of pharmaceutical manufacturing, military readiness, and food security. He pointed to a critical vulnerability: the U.S. military's drug supply chain is estimated to be 72–88% dependent on foreign sources, primarily China and India. Yoho emphasized that antimicrobial resistance is poised to become one of the largest causes of death globally by 2050, and urged attendees to engage directly with their members of Congress on these issues. He also raised foot-and-mouth disease preparedness for cattle and food security as a parallel national security concern.

Key takeaways from the panel:

• The IBMSC office is appropriated with $10 million annually and oversees 109 stockpiled countermeasures
• ASPR offers classified briefings for members of Congress on pharmaceutical supply chain threats
• Engaging Congress effectively requires focusing on the cost-benefit of domestic manufacturing and bringing products directly to members, especially new members who participate in "Freshman 101" briefings

---

Day 2: Drug Delivery Innovation Panel

The afternoon featured a panel moderated by Justin Yang (Executive Liaison, BioMaP-Consortium) with presentations from:

Kindeva Drug Delivery

Katrina Spencer, Director at Kindeva Drug Delivery, presented on advanced drug delivery platforms and contract manufacturing capabilities.

PharmaJet

Dan Mallon, Senior Vice President at PharmaJet, showcased their needle-free injection technology, a significant innovation for mass vaccination campaigns and pandemic response scenarios.

ApiJect Systems

Philip Tull, Vice President at ApiJect Systems, delivered a compelling presentation on the economics of generic drug packaging. For generics, API is not the cost bottleneck; it's the packaging. ApiJect's Blow-Fill-Seal (BFS) technology can replace glass vials and syringes, dramatically reducing packaging costs and foreign dependency.

Wacker Biotech

Liz Allen from Wacker Biotech presented on their biopharmaceutical CDMO capabilities.

---

Key Themes and Takeaways

After two days of presentations, panels, and networking, several themes emerged as central to the BioMaP mission:

1. APIs and KSMs are a national security issue, not just a supply chain problem. The framing has shifted. From IBMSC to Congress, pharmaceutical reshoring is being discussed alongside defense preparedness and military readiness.

2. Fill-finish is the bottleneck. The U.S. can produce bulk drug substance, but converting it into finished dosage forms at pandemic scale remains the critical constraint. Companies like ApiJect and PharmaJet are working to solve this.

3. Manufacturers need demand certainty to invest. Government must provide long-term procurement signals if domestic manufacturers are going to build and maintain capacity. Without it, reshoring remains aspirational.

4. Data and digital infrastructure are essential. Programs like the DS-MRN and VMI systems under Task Orders 12 and 13 reflect a growing recognition that visibility, traceability, and real-time data are foundational to supply chain resilience, a mission directly aligned with KeyPedia.

5. Regulatory readiness must keep pace. BARDA, ASPR, and their partners are investing in regulatory science, continuous manufacturing, and real-time process data to accelerate product approval without sacrificing quality.

---

GKS at BioMaP: Our Research in Context

Our poster presentation, "The Foreign Inspection Gap: Regulatory Data Intelligence for Global GMP Oversight," was directly relevant to the themes discussed throughout both days. Our key findings include:

• 23 fewer inspections for every additional $1 billion of drug imports (2014–2019)
• China inspection intensity down 82% (101.8 → 18.3 per billion USD)
• Foreign facilities showed observation rates 1.3–1.8x higher than the U.S. baseline (49.3%)

These data points reinforce what speakers across the meeting emphasized: the gap between the volume of foreign pharmaceutical manufacturing and the regulatory oversight it receives is a measurable and growing risk.

For full details, access to the poster, and the complete meeting agenda, visit our original press release.

Related Research:

• Preprint: The Foreign Inspection Gap: FDA GMP Oversight of U.S. Drug Imports, 2014–2024, Research Square, 2025
• Published: An Analysis of FDA Warning Letter Citations from 2019–2023, J. Pharm. Innov. 19, 78 (2024)

---

Companies and Organizations Featured

The BioMaP-Consortium brings together a diverse ecosystem of companies and government agencies. Organizations featured at the 2026 General Membership Meeting include:

Organization	Role
API Innovation Center	KSM/API domestic manufacturing
ApiJect Systems	Blow-Fill-Seal drug delivery
Antheia	Biosynthetic API production
Arranta Bio (now Recipharm Advanced Bio)	Biomanufacturing CDMO
Cascade Bio	Biomanufacturing
CMC Pharma	Pharmaceutical manufacturing
Continuus Pharmaceuticals	Continuous manufacturing
DEKA Research	Agile manufacturing (saline on demand)
General Therapeutics	Pharmaceutical development
KBI Biopharma	Biopharmaceutical CDMO
Kindeva Drug Delivery	Drug delivery and CDMO
Mark Cuban Cost Plus Drugs	Affordable generic drugs
Meissner	Filtration and sterilization
PharmaJet	Needle-free injection systems
PSC Biotech	Cleanroom and quality consulting
SOCMA	Chemical manufacturers association
SteriTek	Sterilization services
US Pharmacopeia (USP)	Standards and supply chain data
Wacker Biotech	Biopharmaceutical CDMO
Wheeler Bio	Antibody manufacturing

---

What's Next

The BioMaP-Consortium continues to drive the mission of strengthening domestic biopharmaceutical manufacturing. For organizations working on API production, supply chain visibility, regulatory compliance, or manufacturing technology, this meeting demonstrated that the public-private partnership model is active and expanding.

For more information, questions, or to discuss our research, reach us at hello@globalkeysolutions.net.

---

Global Key Solutions is a regulatory data intelligence company building KeyPedia, a platform that transforms FDA enforcement, inspection, and compliance data into actionable insights for the pharmaceutical industry.