Parexel Blog

Parexel Blog

  • Biosimilars in China

    Biosimilars in China

    In February 2019, National Drug Regulators in China approved the country’s first ever biosimilar product referencing Rituxan, a monoclonal antibody[1].  This biosimilar product, HLX01...

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  • Rescuing Product Approvals from Data Integrity Issues

    Rescuing Product Approvals from Data Integrity Issues

    The pharmaceutical industry is inundated with a plethora of communications about data integrity.  Most of those are focused on the downside – operational snags, negative inspection findings,...

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  • Reimagining the Global Value Dossier - Part 4

    Reimagining the Global Value Dossier - Part 4

    Health Technology Assessment (HTA) agencies are increasingly demanding the inclusion of patient-relevant data in submission dossiers. It is evident that there is an effort to ensure...

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  • Commercializing Gene and Cellular Therapy

    Commercializing Gene and Cellular Therapy

    Gene and cellular therapy manufacturing requires strict control in current Good Manufacturing Practice (cGMP) facilities.  Designing a facility or finding a contract manufacturer to meet the...

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  • Impact of MDR, Article 117 medicinal products with an integral medical device

    Impact of MDR, Article 117 medicinal products with an integral medical device

    The medical devices regulation (MDR) and in-vitro diagnostics regulation (IVDR) replace the three current Directives (93/42/EEC, 98/79/EC and 90/385/EEC) for medical devices. The Regulations...

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  • Critical CGMP Compliance Risks Go Beyond The CEO and The Park Doctrine

    Critical CGMP Compliance Risks Go Beyond The CEO and The Park Doctrine

    If you work in the pharmaceutical industry or follow the industry news, you’ve likely heard the phrases “Park doctrine” or “responsible corporate officer (RCO) doctrine” mentioned when the...

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  • Capturing the patient voice in market access communications

    Capturing the patient voice in market access communications

    Patients have unique perspectives on their conditions that, when incorporated into value communications, can provide an authenticity and salience which would otherwise be lacking. Who knows...

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  • The Ins and Outs of Incorporating Patient Centricity in Drug Development

    The Ins and Outs of Incorporating Patient Centricity in Drug Development

    This article was original published in Pharmaceutical Executive Magazine. The cost of drug R&D doubled between 2003 and 2016, according to The Innovation...

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  • New Post-Market Surveillance Requirements (PMS) for all Medical Device Manufacturers

    New Post-Market Surveillance Requirements (PMS) for all Medical Device Manufacturers

    With a three (3) year transition period, the European Medical Device Regulation (MDR) replaces the current Medical Device Directives from May 26, 2020 on. Article 120, however, allows legal...

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  • Tips from FDA – Put Design of Experiments to Use in Drug Applications

    Tips from FDA – Put Design of Experiments to Use in Drug Applications

    One of the benefits to having worked at FDA was the opportunity to gain exposure to how a wide variety of manufacturers perform product development and manufacturing and how they present...

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  • Addressing drug development challenges that are unique to patients with rare diseases

    Addressing drug development challenges that are unique to patients with rare diseases

    Zizi Imatorbhebhe, MBA MS PMP® Senior Director Integrated Solutions, and Kemi Olugemo, MD Senior Medical Director, Global Therapeutic Head CNS share their insights on tackling hurdles to...

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  • Parexel & SCRS - Aligning Sites with Patient Needs to Increase Engagement

    Parexel & SCRS - Aligning Sites with Patient Needs to Increase Engagement

    In clinical development, patient engagement is critical to success. However, when we talk about patient engagement, we can’t overlook the important role that investigative sites play in this...

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  • Criticality of Institutional Biosafety Committee for Clinical Studies of Cell and Gene Therapy Products

    Criticality of Institutional Biosafety Committee for Clinical Studies of Cell and Gene Therapy Products

    Conducting clinical trials for innovative gene therapy products that include viral vector-based products and gene-modified cells is not entirely straightforward.  Operationally, there are...

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  • What you need to know about FDA’s NEW draft Drug Master Files Guidance for Industry

    What you need to know about FDA’s NEW draft Drug Master Files Guidance for Industry

    Drug Master Files (DMFs) may be submitted to the FDA to provide confidential and often proprietary information regarding facilities, processes, or components used in the manufacturing,...

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  • Further Limits on The Use of Guidance for Enforcement – How Will FDA React?

    Further Limits on The Use of Guidance for Enforcement – How Will FDA React?

    On October 9, 2019, the President signed two executive orders that address how the federal government develops guidance and limits the use of guidance in civil administrative enforcement...

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  • The Evolving Role of Medical Affairs

    The Evolving Role of Medical Affairs

    The role of Medical Affairs professionals is evolving at a rapid rate.  In addition to providing scientific support, Medical Affairs now has much greater strategic importance by providing...

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  • Developing a better Global Value Dossier

    Developing a better Global Value Dossier

    The global value dossier (GVD) has become a standard tool throughout the life sciences industry for supporting product launch and local health technology assessment (HTA) submissions.  There...

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  • Regulatory Update: Patient Engagement in Drug Development

    Regulatory Update: Patient Engagement in Drug Development

    This month, the FDA released a draft of its second patient-focused drug development (PFDD) guidance document, detailing best practices for understanding patient experiences and the related...

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  • Can FDA Disperse the Perfect Storm Forming Around Poor Pharmaceutical Quality?

    Can FDA Disperse the Perfect Storm Forming Around Poor Pharmaceutical Quality?

    Certain areas of the global biopharmaceutical market continue to struggle with poor product quality, which has impacted the U.S. market and its patients.  This is a result of a perfect storm...

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  • What FDA Considers When Assessing Microorganisms in Non-Sterile Drug Products

    What FDA Considers When Assessing Microorganisms in Non-Sterile Drug Products

    The presence of microorganisms in sterile drug products is of paramount concern to patient safety.  However, it may be less obvious why concern for the presence of microorganisms in...

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