Medical and Regulatory Affairs

Clinical Research: Phase 1 - Phase 4

PharmaLive | Advancing Gene Therapy Development: Key Regulatory and Clinical Trial Considerations

Insights into the human genome have created myriad therapeutic opportunities for previously untreatable diseases. Gene therapy offers promise for addressing unmet medical needs across therapeutic areas and even the potential for curing certain genetically based conditions. As research tools and technology become more sophisticated, gene therapy development is accelerating at an unprecedented pace. According to...

Your Guide to 8 New & Revised Concepts to the IVDR

If you develop or manufacture in-vitro diagnostic products, you know the May 2022 roll-out date for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) is just around the corner. But what, exactly, does that mean? In this infographic, we highlight eight new and revised concepts presented to the IVDR.

FAQs: In Vitro Diagnostic Medical Device Regulation

On May 26, 2017, the EU Regulation 2017/746 of the European Parliament and the Council on in vitro diagnostic medical devices (IVDR) became active under the EU Regulation on Medical Devices (MDR). Recertification by May 26, 2022, became required for all previously approved products. The IVDR will replace the EU’s current Directive on in vitro...

Ten Tips for Establishing the Clinical Utility of Molecular Diagnostics: Stepping Stones to Precision Medicine

Introduction The strongest foundation for successful widespread marketing of any diagnostic is evidence of clinical utility. Clinical validation – determining a test’s ability to diagnose a health condition or predict risk of clinical outcomes – may fail to convince physicians and especially healthcare payers to accept a new diagnostic. Failure to gain payer acceptance may...

8 New Elements of the IVDR — and How to Change Your Approach

If you develop or manufacture in-vitro diagnostic products, you know the May 2022 roll-out date for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) is just around the corner. But what, exactly, does that mean? Many of our sponsors have been approaching us with questions, such as: What aspects of the IVDR apply...

Premier Insight 278: A Decade-Long Partnership Culminates in FDA Approval

Background Psychiatric conditions are complex, chronic, often debilitating diseases, and there remains a persistent need for novel medications with proven efficacy and safety. Many of the established antipsychotic agents are highly effective but are associated with significant side effects that may negatively impact adherence and patients’ experiences with treatment. Thus, recent research has focused on...

IVDR Survival Guide: Know the 4 Main Challenges and How to Overcome Them

March 23, 2022 | 10:00 AM EST / 7:00 AM PST / 3:00 PM GMT With the positive aim of increasing patient safety, the In Vitro Diagnostic Regulation (IVDR) has fundamentally changed the way in vitro diagnostics (IVD) are regulated in the EU. The depth of expectations for review and documentation have increased substantially. As...

The Key to Streamlining Regulatory Approval for IVDs

Regulatory approval is the final hurdle sponsors face when launching an in vitro diagnostic (IVD). After spending many years and millions of dollars on development, it can prove frustrating when the finish is in sight, but there are barriers to success. Fortunately, many of those barriers can easily be avoided. In more than 30 years...

Opportunities Beyond Hope: Immuno-Oncology Drug Development

Introduction Over the past decade, immuno-oncology (IO) has become one of the most promising and fastest-growing areas of cancer research and drug development. Present-day advances in immuno-oncology can be attributed to an explosion of research in this area in recent years, leading to a paradigm shift in the understanding of cancer. Until the late 1990s...

Addressing the Challenges and Opportunities in Gynecologic Cancer Research

Despite the impact on women’s health worldwide, significant unmet needs exist in the diagnosis and treatment of gynecologic cancers. Located in the female reproductive system, many have a reputation for being “silent,” as they are often detected in later stages when treatment options are limited. However, the recent introduction of novel medicines — targeted therapies...