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NASEM-Led Study for FDA is Helping Drive Industry/Regulator Agenda on Innovation Needs

August 29, 2022

An FDA-commissioned study carried out through the National Academies of Sciences, Engineering, and Medicine (NASEM) is helping drive the industry/regulator agenda on advancing innovation in pharmaceutical manufacturing.

PART I: The NASEM Study and FDA Reflections

PART II: Existing Mechanisms to Enable Innovation

PART III: Challenges and Opportunities

PART IV: The Path Forward

Pandemic Experience Showcases the Potential for Faster Innovation, More Collaboration, and Workplace and Operations Modernization

June 23, 2022

The potential for faster innovation, and the power of collaboration and workplace and operations modernization are emerging into high relief as the assessment of the pandemic experience continues to deepen.

Among recent venues where industry and regulators have come together to explore these themes was the February ISPE Facilities of the Future Conference. Focused on the dialogue that took place there, the IPQ story that follows is divided into three parts:

PART I: The Evolving Landscape of Pharmaceutical Operations

PART II: Government-Industry Collaboration in This and Future Pandemics

PART III: Reducing the Cost of Vaccine Manufacturing for Broader LMIC Access

Progress in Addressing Impurity Challenges in Focus at USP’s 2022 Peptide/Oligo Workshop

May 10, 2022

The progress in understanding and addressing the challenges of impurities was a key focal point of this year’s USP Therapeutic Peptides and Oligonucleotides Workshop, held virtually on February 28, March 2 and March 4, 2022.

PART I: US and European Regulator Perspective on the CMC Challenges of Oligonucleotides

PART II: USP Standards Development Efforts for Peptides and Oligos

PART III: Peptide and Oligo Analytical, Manufacturing and Raw Material Considerations

Pandemic Experience and Supply-Chain Risk Management Expectations Increase Attention on Excipient GMP Third-Party Auditing

May 1, 2022

The pandemic experience and the increasing expectations of regulators regarding supply chain visibility and risk-management are driving forces for incorporating more third-party auditing of excipient suppliers into user quality management systems.

Janet Woodcock and Jeff Baker will Continue to Play Key Manufacturing Innovation Roles in New FDA and NIIMBL Positions

February 28, 2022

In her new role as FDA’s Principal Deputy Commissioner, Janet Woodcock will be able to continue her strong contribution to the effort in the US and around the world to make drug and biologic regulatory processes as supportive as possible of manufacturing innovation.

FDA’s KASA and Related PQ/CMC Initiatives on Improving CMC Data Structuring and Sharing Will Help Support ICH M4Q Revision

February 17, 2022

FDA’s Knowledge-aided Assessment and Structured Application (KASA) and related Product Quality/CMC (PQ/CMC) initiatives have been laying some important conceptual and information technology (IT) groundwork for the ICH effort now underway to revise its M4Q guideline on the quality component of the Common Technical Document (CTD).

Part I: The Advancing Knowledge-aided Assessment Component of KASA

Part II: Bringing Biologics into the KASA System

Part III: The Progress of FDA’s PQ/CMC Initiative

Part IV: The Goals of Accumulus Synergy in CMC Data IT and Regulatory Communication

Part V: The Drivers for Revising ICH M4Q and Evolving the CMC Regulatory Process

Key GMP Focal Points in Europe Include Guidance Revisions, New Vet Regulations, and Adaptive Assessment/Inspection Approaches

January 12, 2022

Key focal points in the European GMP arena include revisions to guidance, new veterinary medicine regulations, and adapting assessment/inspection processes to enable manufacturing through the COVID pandemic, foster international collaboration, and address point-of-care manufacturing.

Part I: Update on EMA GMP-related Activities

Part II: MHRA Innovation Pathway and Proposal for Point-of-Care Regulatory Framework

Part III: Insights from Europe and ICMRA Regarding Onsite Inspection Alternatives

USP and Ph. Eur. Initiatives in the Biologics Arena Continue to Bear Fruit; FDA Joins the Pharmacopeias in Upgrading Particulate Guidance

December 28, 2021

The emerging biotech product modalities and their complex analytical challenges and needs have led USP and the European Pharmacopoeia to adapt their standard-setting approaches and work collaboratively with stakeholders internationally in setting and pursuing priorities.

Part I: Update on USP’s Evolving Role and Current Initiatives In the Biologics Arena

Part II: European Pharmacopoeia and FDA Join USP in Focusing on Particulate Control

COVID Vaccine Industry Project Leaders Are Sharing Insights on How the Daunting CMC Challenges Were Addressed

November 18, 2021

The leaders of industry’s major COVID vaccine efforts have been sharing their insights at recent conferences on: ● how their companies managed to address the daunting development, manufacturing, and supply chain challenges involved in delivering a vaccine in unprecedented speed during a pandemic, and ● the lessons that can be garnered from that experience in moving forward.

Part I: Implementing the Pfizer/BioNTech mRNA Vaccine Development Plan

Part II: New Digitalized Facility as Springboard for Moderna’s mRNA Vaccine

Part III: Oxford University/AZ Partnership for Global Adenovirus Vaccine Access

Part IV: J&J’s Experience in Handling the Supply Chain Challenges

Part V: Novavax’s Approach to Assuring Comparability for its Protein-based Vaccine

Part VI: Inter-Company Panels at DIA and ISPE Meetings on Vaccine Experience

Biomanufacturer Raw Material Control on Regulatory Front Burner as Analytical Power and Formulation Challenges Intensify

September 9, 2021

A more powerful analytical toolbox is allowing industry and regulators to better understand how biotech product manufacturers can improve the control strategies for the raw materials they are using. However, there are still significant knowledge and control gaps, and experts from industry, regulatory agencies, and pharmacopeias are actively sharing insights on how best to fill them.

Part I: Biotech Regulator Vantage Point on Raw Material Control

Part II: The Added Challenges of Materials Management for CGTs

Part III: Biomanufacturer Use and Control of Polysorbates

Manufacturing, Impurities, and Characterization Methods Are Key Regulatory Focal Points for Peptides and Oligonucleotides

August 9, 2021

The manufacturing process, the control of impurities – in the starting materials, the API and the drug product – and the analytical methods for characterization are focal points for regulators during CMC reviews of both synthetic peptide and oligonucleotide (oligo) therapeutics.

Part I: Recent CMC/Regulatory Challenges of Oligonucleotide Drugs

Part II: Comparability Challenges in Crossing Over to Generics

Part III: Comparing Peptide and Oligonucleotide CMC Issues

Part IV: Starting Material Specifications for Oligonucleotides

A Confluence of Forces Is Now Spurring Combination Product Regulatory Reform in Europe

July 2, 2021

A confluence of forces is intensifying the pressure on and opening pathways to the reform of drug/device combination product regulation in Europe, with legislative changes and strategic priority needs at issue.

Part I: EU Pharma Strategy Roadmap, Comments from Industry, and Related Agency Strategies

Part II: Culture/Structure/Process Change and Global Alignment

Part III: HPRA CEO Lorraine Nolan on HPRA and EMA Strategy

Part IV: EMA’s Zaïde Frias and NB/Industry Perspectives on EU Regulatory Transformation

Pandemic Urgencies Highlight Constraints in Manufacturing Change Regulatory Paradigm and Where Adjustments Are Needed

May 11, 2021

The pressing need during the COVID-19 pandemic to accelerate product development and rapidly accommodate the shifting manufacturing and distribution demands has shed strong light on the constraints in the existing quality regulatory framework and the pathways to reducing them.

Part I: Industry Quality Leaders on the Global PAC Regulatory Problem and Solutions

Part II: Evolving the Quality Regulatory Paradigm at the Global Level

Regulators Are Exploring with Industry How to Strengthen Quality Risk Management Practices, with Revision of ICH Q9 a Key Focal Point

April 29, 2021

Regulators and industry are sitting down together to mine their experience and map out some clearer directions and expectations about what is needed to empower quality risk management (QRM) in improving the pharmaceutical quality system (PQS) and the industry/regulatory communication process at the review and inspection levels.

 

Part I: ICH Q9 Revision Lead O’Donnell on the Evolution of QRM

Part II: FDA’s Rick Friedman on Advancing Aseptic Processing through QRM

Part III: Industry/Academia Thought Leaders on the Evolving QRM/KM Relationship

Regulators Share Pandemic’s CMC Impact at CASSS Japan Forum; Guidance Output Continues Apace in Q1 2021

April 1, 2021

This four-part story explores the significant impact of the pandemic during 2020-2021 on the CMC review processes for vaccines and biotherapeutics at FDA, EMA and Japan’s PMDA in their efforts to support accelerated product development and review, while assuring that quality standards are met and the ongoing non-COVID-related workload addressed.

 

Part I: EMA Perspective

Part II: FDA CBER Perspective

Part III: FDA CDER Perspective

Part IV: Panel Discussion Among US, Europe, and Japan Regulators

Academia/Industry Collaboration Intensifies on Addressing the Pressing Needs in Biopharma Workforce Development

March 18, 2021

Academia and industry are collaborating more intensely on addressing the pressing needs in biopharma workforce development, in recognition of the challenges of keeping pace with the rapidly evolving process and product technologies and the cross-functional understanding and skills needed to support them.

Part I: NIIMBL’s Engagement with Academia on Workforce Development Needs

Part II: ISPE Workforce of the Future Traction at UMBC and UC Davis

Part III: Keck Institute’s Behrens on Biopharma Talent Needs and KGI/Industry Partnering

Part IV: Xavier’s Phillips on Sharable Quality and Regulatory Science Curriculum

Part V: CASSS Panel on Opening Up Biopharma Career Pathways

Part VI: European and Global Workforce Development Collaborations

Latest Improvements in FDA’s Inactive Ingredient Database Include Change Log and Use of Maximum Daily Exposure

February 9, 2021

FDA’s latest efforts to improve the functionality of its Inactive Ingredient Database (IID) include a quarterly log to track changes in the records and the use of the term “maximum daily exposure” (MDE) in lieu of “maximum potency.”

Recent Technology and Partnership Advances Made Possible Precision and Speed of Vaccine Response to Pandemic, NIAID’s Graham Stresses at CASSS WCBP Conference

February 2, 2021

The precision and speed of COVID-19 vaccine development was made possible by recent R&D advancements and a strengthened network of public-private partnerships, NIH National Institute for Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VCR) Deputy Director Barney Graham affirmed in his keynote presentation at the opening session of the CASSS Well-Characterized Biotechnology Products (WCBP) conference in late January.

Pandemic Intensifies USP’s Focus on Supply Chain Vulnerabilities and Vaccine Development

January 28, 2021

Improving understanding of supply chain vulnerabilities and providing support for vaccine development and delivery are two focal points of the USP effort to help address the pressing challenges that the COVID-19 pandemic has brought to the fore regarding the availability of quality medicines.

Pandemic Spurs Deepening of Pharmacopoeia/Regulator/Industry Communication Channels

December 23, 2020

The pandemic is prompting all of those involved in medicine production, regulation, and standards-setting to take a hard look at their operations for how they can be: ● adapted to continue being productive and address the pandemic exigencies, as well as ● potentially improved on a longer-term basis. It is also significantly deepening communication and cooperation channels.

Part I: EDQM Pandemic Actions Continue Apace in Fall 2020

Part II: Pharmacopeia, Regulator and Industry Expert Panel Explores Pandemic and Nitrosamine Communications

Part III: Second Panel Focuses on Pandemic Organizational Impacts and Key Learnings

Part IV: EDQM and Ph. Eur. Evolution Addressed by Leaders Keitel and Vielle

COVID Vaccine Global Distribution Challenges Explored by Bio Supply Management Alliance (BSMA) Panel of European Experts

December 3, 2020

A panel of leading experts, assembled virtually for the 2020 Bio Supply Management Alliance (BSMA) Europe symposium on November 12, seized on the analogy of a Formula One race pitstop in assessing the expertise, cooperation, and timing that will be needed for successfully delivering COVID-19 vaccinations.

Pandemic Stresses Increase FDA Attention on Risk Management Plans for Drug Shortage Prevention and Mitigation

November 15, 2020

The stresses of the COVID pandemic on the drug supply chain have thrown a spotlight on the importance of risk management plans (RMPs) in preventing and addressing drug shortages.

USP’s Global Efforts to Strengthen Standards and Accelerate Innovation for Biologics Include ICH Engagement

November 9, 2020

Direct engagement in the ICH guideline development and revision process is helping USP prioritize its related compendial standard setting, revision, and harmonization efforts, and, in turn, enriching ICH awareness of the pharmacopeial standards and approaches that can help inform its guidelines.

CBER Director Marks Traverses the Complex COVID-19 Vaccine/Therapy Regulatory Landscape at FDLI’s Annual Conference

October 13, 2020

At the 2020 annual conference of the Washington, D.C.-based Food and Drug Law Institute (FDLI), held virtually on October 6-8, Center for Biologics Evaluation and Research (CBER) Director Peter Marks provided valuable insights on the difficult terrain that the regulators at CBER have to navigate to reach their goal of making effective vaccines and therapeutics for COVID-19 available as efficiently as possible.

Stronger Unapproved Stem-Cell Enforcement Accompanies FDA Center for Biologics’ Cell and Gene Therapy Advancement Efforts

September 14, 2020

Over the last few years, FDA has ramped up its efforts to protect the public from unapproved and potentially dangerous stem cell products, while striving to create a regulatory framework and approach that is as supportive as possible for the advancement of the entire cell and gene therapy (CGT) field.