Blogs

R&A blog content

  • We need faster endpoints for targeted cancer drugs, and there is one

    We need faster endpoints for targeted cancer drugs, and there is one

    As a former regulator, Jorge shares his perspectives for the need of more faster endpoints to measure how targeted cancer drugs can benefit patients. He believes it can be created by combining two...

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  • Three ways to improve your chances that insurers will pay for a new CGT

    Three ways to improve your chances that insurers will pay for a new CGT

    When developing cell and gene therapies (CGTs), drug companies face significant hurdles. One of which is getting insurance companies to pay for these treatments that can potentially cure patients...

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  • The Parexel Podcast | Episode 15: Pandemic preparedness: Investing in the future of infectious disease vaccine development

    The Parexel Podcast | Episode 15: Pandemic preparedness: Investing in the future of infectious disease vaccine development

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  • How market exclusivities can affect your development program

    How market exclusivities can affect your development program

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  • Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

    Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

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  • The Evolving Cell and Gene Therapy (CGT) Sector in China

    The Evolving Cell and Gene Therapy (CGT) Sector in China

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  • Hong Kong Exchange: Nurturing China’s Biotech Valley

    Hong Kong Exchange: Nurturing China’s Biotech Valley

    About the Authors Daniel Huang is an Analyst based in the Hong Kong...

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  • The Move Toward Global Standards: Navigating New EAEU Guidelines

    The Move Toward Global Standards: Navigating New EAEU Guidelines

    As the pandemic clearly revealed, there is an urgent need for a more cohesive, coordinated approach to streamline global regulatory guidelines to ensure patients have faster access to new and...

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  • The Special Approval Pathway (SAP) for COVID-19 related products in China

    The Special Approval Pathway (SAP) for COVID-19 related products in China

    The regulatory pathway for COVID-19 drugs in China is governed by the Special Approval Program (SAP) which was introduced by National Medical Product Administration (NMPA) in 2005.  SAP is...

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  • NMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020

    NMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020

    Conducting clinical trials during the COVID-19 pandemic has produced many challenges globally. The initiation, conduct, implementation and completion of a trial during this time requires special...

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  • Top 10 Myths About Working with the FDA for an Oncology Drug Approval

    Top 10 Myths About Working with the FDA for an Oncology Drug Approval

    Among biotech companies, a primary concern is how to establish a clinical strategy for scientific and commercial success at the earliest stage. In that respect, regulatory considerations figure...

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  • GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”

    GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”

    As global regulatory agencies are preparing to return to on-site inspections1, industry needs to be ready. With the continued threat of COVID-19, the way inspections will be performed and hosted...

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  • Making a Seamless Transition to Virtual Meetings with Health Authorities: Best Practices and Recommendations

    Making a Seamless Transition to Virtual Meetings with Health Authorities: Best Practices and Recommendations

    Chances are, you are reading this article in your home office, or perhaps in a corner of the dining room – but probably not in your normal workspace. Just as most of us have had to adjust to...

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  • FDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19

    FDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19

    Global manufacturers and regulators are facing new challenges during the SARS-CoV-2 pandemic to maintain supply chains, and avoid shortages, of drugs, biologics and medical devices.  Numerous...

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  • Using risk assessment decision tree models to maintain safety and data validity in clinical trials during COVID-19

    Using risk assessment decision tree models to maintain safety and data validity in clinical trials during COVID-19

    During the COVID-19 pandemic, challenges to the conduct of clinical trials may arise, e.g. due to travel restrictions or quarantines, interruptions to supply chains, or when site personnel or...

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  • Putting the Pandemic in Plain Language

    Putting the Pandemic in Plain Language

    The COVID-19 pandemic has brought many negative feelings to the forefront of our everyday lives, including anxiety, fear and social division, but what if we explored the new positive relationships...

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  • SARS-CoV-2 Landscape of Repurposed Drug Trials and Key Lessons for the Future

    SARS-CoV-2 Landscape of Repurposed Drug Trials and Key Lessons for the Future

    About the Authors Saakshi Chadha, PhD is a Senior Analyst in the Health...

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  • Critical considerations for re-starting clinical trials in countries recovering after the COVID-19 pandemic

    Critical considerations for re-starting clinical trials in countries recovering after the COVID-19 pandemic

    The COVID-19 pandemic led to a variety of risk-based adjustments to clinical trial conduct. Mitigation measures had to be taken based on a risk assessment by sponsors and investigators in which...

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  • Managing Continuity in Clinical Trials in the COVID-19 environment:  The Decentralized Option and Regulatory Flexibility

    Managing Continuity in Clinical Trials in the COVID-19 environment: The Decentralized Option and Regulatory Flexibility

    Introduction/Situation COVID-19 has created a number of challenges in managing clinical trials for acute, chronic, life-threatening, and rare diseases. Due to the pandemic, as many as 90% of...

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  • Vendor Audits and cGMPs

    Vendor Audits and cGMPs

    Industries are taking ongoing actions in their response efforts to COVID-19 and this includes being prepared for Regulatory Authority CGMP requirements which include Vendor Audits. FDA through...

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