2026 INTERPHEX CONFERENCE SUBMISSIONS ARE NOW OPEN
August 28, 2025
Call for Programming Submissions Opens
October 3, 2025
Call for Programming Closes
November 13, 2025
Submitters Notified
January 15, 2026
Conference Schedule Announced
February 5, 2026
Speaker Information Due
Timeline is subject to change.
The 2026 INTERPHEX Conference submissions are now open! This program is designed to provide critical insights into some of the leading trends and topics shaping the pharmaceutical and biotechnology industries. It offers an enriched and immersive experience, equipping attendees with essential resources to help grow their careers.
We were also excited to have the return of the Learning Lab - an enclosed, private education space reserved for Full Conference badge holders. This area provides an enhanced experience with tons of amazing features including: Conference Program, Career Center, Access to Conference Presentations and much more!
2026 TRACKS AND THEMES
- TRACK 1
- TRACK 2
Track 1: Advanced Manufacturing Innovation: Driving Process Excellence and Manufacturing Breakthroughs for Small Molecules and Biologics
Keywords: Advanced Manufacturing, AI, Efficiency, Continuous Improvement, Risk Management, QbD, Smart Packaging, Sustainability
This track explores how the pharmaceutical industry is undergoing a fundamental transformation where advanced digital technologies, cost-effective production strategies, and sustainable innovation converge to redefine manufacturing excellence. Sessions should offer actionable strategies for building resilient, efficient operations that leverage smart technologies, lean manufacturing, and next-generation packaging solutions to serve the greater mission of improving global health.
Advanced Manufacturing: Where New Technologies and Digital Intelligence Meet Process Excellence
Keywords: AI, Machine Learning, Robotics, Digital Twin, Pharma 4.0, Automation, Continuous Manufacturing, QbD, PAT, Real-Time Release Testing, Predictive Analytics, New Therapeutic Modalities, Enzymatic Processing, Injectable GLP1 Delivery, Digital Quality Systems, Decentralized Manufacturing, Externalized CM Models
This theme examines the technological advancements redefining pharmaceutical and biologics manufacturing through engineering innovation and data-driven process control. Discussion should cover the implementation of continuous manufacturing, 3D printing for personalized drug delivery systems, and distributed manufacturing networks. Topics include how AI, machine learning (ML), digital twins, and robotics transform manufacturing by modeling complex systems, predicting critical quality attributes, detecting real-time deviations, and supporting automated decision-making and execution.
Advanced control strategies, including Process Analytical Technology (PAT) and Real-time Release Testing (RTRT), are explored within Quality by Design (QbD) frameworks to ensure consistent product quality and regulatory compliance. The theme also highlights the role of enzymatic and biocatalytic processes in improving efficiency and selectivity for both small molecules and biologics. Digital quality systems to manage quality, compliance across CDMOs, and CMC accelerated development timelines are addressed as integral components of modern manufacturing excellence.
Cost-Effective Pharmaceutical Manufacturing for Global Drug Accessibility
Keywords: Cost-Effectiveness, Efficiency, Lean Manufacturing, Facility Design Optimization, Supply Chain, Innovation, Quality, Global Access, Dosage Reduction, Logistical Challenges, Global Cooperation, Environment Sustainability
Rising healthcare costs put pressure on manufacturers and patients alike, making cost-effective pharmaceutical production a critical priority. This theme provides strategies to streamline operations, reduce waste, optimize supply chains, and adopt smart technologies that lower production costs without compromising quality or compliance. Lean manufacturing, digital transformation, and strategic partnerships are highlighted as practical approaches to improve efficiency, scalability, and operational excellence.
Strategic facility design emerges as another foundational approach, where early-stage design decisions significantly impact cost of goods through optimized space utilization, energy-efficient systems, and integrated process layouts. Cost-effective production reduces drug prices, while optimized delivery and logistics—such as minimizing cold chain dependencies and establishing robust distribution networks—ensure medicines reach even remote or underserved regions. Collaboration with local healthcare providers, governments, and non-profits further enhances global reach.
This theme focuses on actionable insights that balance operational efficiency with regulatory requirements, driving measurable savings, and ultimately enhancing patient outcomes and global health impact.
Operational Excellence and Smart Packaging: Advancing Sustainable and Patient-Centric Manufacturing
Keywords: Risk Management, Manufacturing, Operations, Efficiency, Compliance, Resilience, Supply Chain, Continuous Improvement, Digital Health Integration, Connected Packaging, Adherence Packaging, Anti-Counterfeiting, Circular Economy, Drug-Device Design, Sustained Delivery Systems
Pharmaceutical manufacturing technologies converge to deliver safer, more efficient, and patient-centric medicines. This theme covers how risk-based approaches, such as FMEA and risk ranking, can be embedded into manufacturing and packaging operations to drive compliance, efficiency, resilience, and continuous improvement.
At the same time, packaging and delivery systems are evolving from passive drug containers to active enablers of drug administration and patient engagement. Sessions examine how innovations like smart packaging with embedded sensors, IoT-enabled adherence monitoring, NFC-based anti-counterfeiting, and time–temperature indicators strengthen both product integrity and patient safety. Additional attention is given to drug-device combination products, particularly for parenteral therapies, where delivery systems such as autoinjectors, wearable pumps, and long-acting implants play a critical role in sustained release and dose accuracy. These integrated systems require coordinated design, manufacturing, and regulatory strategies to ensure performance and patient compliance.
Sustainability is also at the forefront, with recyclable materials, water-soluble films, and 3D-printed components advancing environmental responsibility without compromising functionality. By integrating risk management with next-generation packaging and drug-device solutions, organizations can align regulatory expectations with business value, reducing costs, improving operational excellence, and enhancing global access. Sessions show how continuous improvement, digital integration, and sustainable design can transform manufacturing and packaging into strategic assets for long-term success.
Track 2: Global Regulatory and Compliance Excellence and Supply Sustainability for Medicine Access
Keywords: Regulatory, Compliance, Global, Reshoring, Annex 1, Technology Transfer, Contamination Control Strategy
This track focuses on aligning regulatory compliance and drug quality with supply chain sustainability to drive innovation and global medicine access. Sessions cover risk-managed alignment of global regulations, compliance, and innovations for better access to medicines, reshoring of US manufacturing operations, and innovations driving EU Annex 1 compliance for sterile manufacturing. Attendees gain practical insights into the challenges and opportunities for regulatory compliance as it pertains to globalization and medicine access, onshoring of pharma manufacturing to the United States, and the latest expectations in sterile manufacturing originating from EU Annex I.
Future-Ready Pharma: Aligning Global Regulations, Compliance, and Innovation to Medicine Access
Keywords: Regulatory Agility, Quality Excellence, Supply Chain Resilience, Risk Management, Operational Impact, Digital Innovation, AI-Driven Transformation, Global Access
The pharmaceutical industry faces a rapidly evolving regulatory, compliance, and operational environment. FDA enforcement has intensified, with rising global inspections and warning letters nearly tripling since 2022. Persistent quality challenges remain under scrutiny, demanding more robust remediation and compliance strategies. At the same time, companies must navigate complex post-approval CMC changes across global markets, where harmonization of regulatory submissions and approval of changes is increasingly critical to accelerate patient access to medicines.
Ensuring supply chain resilience requires effective supplier audits that go beyond compliance, strengthening partnerships and reducing operational risks. Meanwhile, challenges continue for adapting to a growing global manufacturing base, expanding inspection focus, and addressing recalls/import alerts with proactive risk management.
Innovation is also reshaping the quality/CMC landscape. AI and automation are already improving efficiency, enabling predictive quality control, and automating CMC and regulatory CMC activities while also supporting data integrity. When applied strategically, these tools offer an opportunity to enhance quality and regulatory compliance while improving affordability and access.
This theme integrates regulatory and compliance trends, supplier oversight, AI/ML adoption, and global access strategies, enabling organizations to achieve compliance, resilience, and innovation in a highly competitive and regulated environment.
Reshoring the Medicine Cabinet: Enabling Compliant and Resilient Domestic Pharmaceutical Manufacturing
Keywords: Supply Chain Resilience and Visibility, Pharmaceutical Sovereignty, Technology Transfer, PreCheck Program, Cost of Goods, Highly Potent API Containment, Sustainability, Infrastructure, Skilled Workforce, IP Control, U.S. Domestic Manufacturing
As the U.S. pharmaceutical industry shifts from offshore to domestic production, manufacturers face complex process transfer challenges and significant operational hurdles. Key obstacles include high costs, limited domestic infrastructure, dependence on foreign APIs, regulatory complexities, and skilled workforce shortages. This theme shares both successful onshoring initiatives and lessons learned, with a focus on technology transfer strategies, timeline management, and cost modeling that aligns capital investment with long-term operational efficiency. Sessions also examine the FDA’s newly announced PreCheck program, which aims to streamline regulatory oversight and accelerate domestic production readiness. Topics include containment strategies for highly potent active pharmaceutical ingredients (HPAPIs), sustainability in localized manufacturing, and infrastructure planning for scalable operations. Proven methodologies for executing domestic manufacturing transitions in a cost-effective manner without compromising product quality, compliance, or performance should also be highlighted.
Sterile Manufacturing: Innovations Driving Annex 1 Compliance and Beyond
Keywords: Contamination Control Strategy, Closed Processing Systems, Quality RiskManagement, Combination Products, Human Factor Engineering, Robotic Aseptic Filling, Rapid Microbial Methods, Single-Use Technologies, Real-Time Environmental Monitoring, HPAPI Handling, Sustainability
This theme delves into the latest advancements in sterile manufacturing that are redefining contamination control, process robustness, and regulatory compliance in the era of the revised EU GMP Annex 1. With heightened expectations for aseptic processing, this theme shows how the industry is adopting cutting-edge technologies to ensure sterility assurance through science- and risk-based approaches. Topics include the implementation of closed, automated systems such as robotic filling isolators and single-use technologies that minimize human intervention in Grade A environments. The integration of rapid microbial methods, in-line particle monitoring, and real-time environmental data analytics are covered as key enablers of proactive quality control. Presentations also address the critical role of a formal Contamination Control Strategy (CCS), and how digital tools support data integrity and continuous process verification. Case studies illustrate practical applications of advanced sterilization methods, process simulation improvements, quality risk management (QRM), and facility design aligned with modern aseptic standards. Additionally, the theme explores containment strategies for sterile handling of highly potent compounds and the role of sustainability in sterile manufacturing operations.
Keywords: Advanced Manufacturing, AI, Efficiency, Continuous Improvement, Risk Management, QbD, Smart Packaging, Sustainability
This track explores how the pharmaceutical industry is undergoing a fundamental transformation where advanced digital technologies, cost-effective production strategies, and sustainable innovation converge to redefine manufacturing excellence. Sessions should offer actionable strategies for building resilient, efficient operations that leverage smart technologies, lean manufacturing, and next-generation packaging solutions to serve the greater mission of improving global health.
Advanced Manufacturing: Where New Technologies and Digital Intelligence Meet Process Excellence
Keywords: AI, Machine Learning, Robotics, Digital Twin, Pharma 4.0, Automation, Continuous Manufacturing, QbD, PAT, Real-Time Release Testing, Predictive Analytics, New Therapeutic Modalities, Enzymatic Processing, Injectable GLP1 Delivery, Digital Quality Systems, Decentralized Manufacturing, Externalized CM Models
This theme examines the technological advancements redefining pharmaceutical and biologics manufacturing through engineering innovation and data-driven process control. Discussion should cover the implementation of continuous manufacturing, 3D printing for personalized drug delivery systems, and distributed manufacturing networks. Topics include how AI, machine learning (ML), digital twins, and robotics transform manufacturing by modeling complex systems, predicting critical quality attributes, detecting real-time deviations, and supporting automated decision-making and execution.
Advanced control strategies, including Process Analytical Technology (PAT) and Real-time Release Testing (RTRT), are explored within Quality by Design (QbD) frameworks to ensure consistent product quality and regulatory compliance. The theme also highlights the role of enzymatic and biocatalytic processes in improving efficiency and selectivity for both small molecules and biologics. Digital quality systems to manage quality, compliance across CDMOs, and CMC accelerated development timelines are addressed as integral components of modern manufacturing excellence.
Cost-Effective Pharmaceutical Manufacturing for Global Drug Accessibility
Keywords: Cost-Effectiveness, Efficiency, Lean Manufacturing, Facility Design Optimization, Supply Chain, Innovation, Quality, Global Access, Dosage Reduction, Logistical Challenges, Global Cooperation, Environment Sustainability
Rising healthcare costs put pressure on manufacturers and patients alike, making cost-effective pharmaceutical production a critical priority. This theme provides strategies to streamline operations, reduce waste, optimize supply chains, and adopt smart technologies that lower production costs without compromising quality or compliance. Lean manufacturing, digital transformation, and strategic partnerships are highlighted as practical approaches to improve efficiency, scalability, and operational excellence.
Strategic facility design emerges as another foundational approach, where early-stage design decisions significantly impact cost of goods through optimized space utilization, energy-efficient systems, and integrated process layouts. Cost-effective production reduces drug prices, while optimized delivery and logistics—such as minimizing cold chain dependencies and establishing robust distribution networks—ensure medicines reach even remote or underserved regions. Collaboration with local healthcare providers, governments, and non-profits further enhances global reach.
This theme focuses on actionable insights that balance operational efficiency with regulatory requirements, driving measurable savings, and ultimately enhancing patient outcomes and global health impact.
Operational Excellence and Smart Packaging: Advancing Sustainable and Patient-Centric Manufacturing
Keywords: Risk Management, Manufacturing, Operations, Efficiency, Compliance, Resilience, Supply Chain, Continuous Improvement, Digital Health Integration, Connected Packaging, Adherence Packaging, Anti-Counterfeiting, Circular Economy, Drug-Device Design, Sustained Delivery Systems
Pharmaceutical manufacturing technologies converge to deliver safer, more efficient, and patient-centric medicines. This theme covers how risk-based approaches, such as FMEA and risk ranking, can be embedded into manufacturing and packaging operations to drive compliance, efficiency, resilience, and continuous improvement.
At the same time, packaging and delivery systems are evolving from passive drug containers to active enablers of drug administration and patient engagement. Sessions examine how innovations like smart packaging with embedded sensors, IoT-enabled adherence monitoring, NFC-based anti-counterfeiting, and time–temperature indicators strengthen both product integrity and patient safety. Additional attention is given to drug-device combination products, particularly for parenteral therapies, where delivery systems such as autoinjectors, wearable pumps, and long-acting implants play a critical role in sustained release and dose accuracy. These integrated systems require coordinated design, manufacturing, and regulatory strategies to ensure performance and patient compliance.
Sustainability is also at the forefront, with recyclable materials, water-soluble films, and 3D-printed components advancing environmental responsibility without compromising functionality. By integrating risk management with next-generation packaging and drug-device solutions, organizations can align regulatory expectations with business value, reducing costs, improving operational excellence, and enhancing global access. Sessions show how continuous improvement, digital integration, and sustainable design can transform manufacturing and packaging into strategic assets for long-term success.
Keywords: Regulatory, Compliance, Global, Reshoring, Annex 1, Technology Transfer, Contamination Control Strategy
This track focuses on aligning regulatory compliance and drug quality with supply chain sustainability to drive innovation and global medicine access. Sessions cover risk-managed alignment of global regulations, compliance, and innovations for better access to medicines, reshoring of US manufacturing operations, and innovations driving EU Annex 1 compliance for sterile manufacturing. Attendees gain practical insights into the challenges and opportunities for regulatory compliance as it pertains to globalization and medicine access, onshoring of pharma manufacturing to the United States, and the latest expectations in sterile manufacturing originating from EU Annex I.
Future-Ready Pharma: Aligning Global Regulations, Compliance, and Innovation to Medicine Access
Keywords: Regulatory Agility, Quality Excellence, Supply Chain Resilience, Risk Management, Operational Impact, Digital Innovation, AI-Driven Transformation, Global Access
The pharmaceutical industry faces a rapidly evolving regulatory, compliance, and operational environment. FDA enforcement has intensified, with rising global inspections and warning letters nearly tripling since 2022. Persistent quality challenges remain under scrutiny, demanding more robust remediation and compliance strategies. At the same time, companies must navigate complex post-approval CMC changes across global markets, where harmonization of regulatory submissions and approval of changes is increasingly critical to accelerate patient access to medicines.
Ensuring supply chain resilience requires effective supplier audits that go beyond compliance, strengthening partnerships and reducing operational risks. Meanwhile, challenges continue for adapting to a growing global manufacturing base, expanding inspection focus, and addressing recalls/import alerts with proactive risk management.
Innovation is also reshaping the quality/CMC landscape. AI and automation are already improving efficiency, enabling predictive quality control, and automating CMC and regulatory CMC activities while also supporting data integrity. When applied strategically, these tools offer an opportunity to enhance quality and regulatory compliance while improving affordability and access.
This theme integrates regulatory and compliance trends, supplier oversight, AI/ML adoption, and global access strategies, enabling organizations to achieve compliance, resilience, and innovation in a highly competitive and regulated environment.
Reshoring the Medicine Cabinet: Enabling Compliant and Resilient Domestic Pharmaceutical Manufacturing
Keywords: Supply Chain Resilience and Visibility, Pharmaceutical Sovereignty, Technology Transfer, PreCheck Program, Cost of Goods, Highly Potent API Containment, Sustainability, Infrastructure, Skilled Workforce, IP Control, U.S. Domestic Manufacturing
As the U.S. pharmaceutical industry shifts from offshore to domestic production, manufacturers face complex process transfer challenges and significant operational hurdles. Key obstacles include high costs, limited domestic infrastructure, dependence on foreign APIs, regulatory complexities, and skilled workforce shortages. This theme shares both successful onshoring initiatives and lessons learned, with a focus on technology transfer strategies, timeline management, and cost modeling that aligns capital investment with long-term operational efficiency. Sessions also examine the FDA’s newly announced PreCheck program, which aims to streamline regulatory oversight and accelerate domestic production readiness. Topics include containment strategies for highly potent active pharmaceutical ingredients (HPAPIs), sustainability in localized manufacturing, and infrastructure planning for scalable operations. Proven methodologies for executing domestic manufacturing transitions in a cost-effective manner without compromising product quality, compliance, or performance should also be highlighted.
Sterile Manufacturing: Innovations Driving Annex 1 Compliance and Beyond
Keywords: Contamination Control Strategy, Closed Processing Systems, Quality RiskManagement, Combination Products, Human Factor Engineering, Robotic Aseptic Filling, Rapid Microbial Methods, Single-Use Technologies, Real-Time Environmental Monitoring, HPAPI Handling, Sustainability
This theme delves into the latest advancements in sterile manufacturing that are redefining contamination control, process robustness, and regulatory compliance in the era of the revised EU GMP Annex 1. With heightened expectations for aseptic processing, this theme shows how the industry is adopting cutting-edge technologies to ensure sterility assurance through science- and risk-based approaches. Topics include the implementation of closed, automated systems such as robotic filling isolators and single-use technologies that minimize human intervention in Grade A environments. The integration of rapid microbial methods, in-line particle monitoring, and real-time environmental data analytics are covered as key enablers of proactive quality control. Presentations also address the critical role of a formal Contamination Control Strategy (CCS), and how digital tools support data integrity and continuous process verification. Case studies illustrate practical applications of advanced sterilization methods, process simulation improvements, quality risk management (QRM), and facility design aligned with modern aseptic standards. Additionally, the theme explores containment strategies for sterile handling of highly potent compounds and the role of sustainability in sterile manufacturing operations.
2026 CONFERENCE FORMAT
QUICK FIRES
A 10-minute presentation that is followed by 3 minutes of Q&A on the latest scientific topics. New research, insights, and ideas are especially appropriate for this program
KEYNOTE
A 60-minute session in which a prominent scientist frames the issues being explored in the day’s track themes.
PANEL DISCUSSION
A 45-minute session built around a themed topic. Ideal for cutting-edge research and new ideas.
SCIENTIFIC PROGRAMMING ADVISORY COMMITTEE
The INTERPHEX Scientific Programming Advisory Committee is made up of top-notch industry experts that will help select our conference sessions and continuously share their extensive knowledge with us so that we can put on the best event in April!
2025 RECAP
2025 BY THE NUMBERS
85+ CURATED SESSIONS
161 GLOBAL SPEAKERS
