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Ashanthi DeSilva’s Story: A Look Back at the First Gene Therapy Trial – TEST

In 1976, pop culture icon John Travolta starred in the made-for-television movie The Boy in the Plastic Bubble about a young man with a compromised immune system. The premise of the film is that Travolta’s character has to decide between living in isolation behind a protective bubble or dying engaged with the physical world. Hollywood...

Clinical Research: Phase 1 - Phase 4

Rethinking Data Quality Best Practices in the Era of Decentralized Clinical Trials

Pandemic-related disruptions have accelerated much-needed change in clinical operations, but this change has been accompanied by questions about data collection and data quality. In a recent survey commissioned by Oracle Health Sciences, more than 75 percent of industry respondents indicated that limitations in patients’ ability to attend on-site visits sped up their adoption of decentralized...

Clinical Research: Phase 1 - Phase 4

Premier Research to Present on Development Considerations for Advanced Therapies at LSX World Congress

DURHAM, N.C., January 25, 2021 — Premier Research, the clinical research company that delivers outcome-focused insights which support sponsors in developing life-changing therapies, will join the healthcare and life science industries’ most forward-thinking executives at the LSX World Congress virtual conference from February 1 to 5, 2021. The conference will include a presentation by Premier...

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7th Annual LSX World Congress

February 1-5, 2021

There are more challenges than ever when it comes to innovative clinical research addressing the largest areas of unmet need. These challenges demand fresh solutions backed by the strength of experience. Premier Research is proud to once again join the health care and life science industries’ most forward-thinking executives at the LSX World Congress from...

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How to Navigate Global Regulatory Frameworks & Expedited Programs for Gene Therapy Development in the U.S., EU, & Japan

As scientific knowledge, clinical experience, and acceptance of gene therapy products have evolved, so have the regulatory frameworks for ensuring the safety of these novel treatments. To date, there is no harmonized international standard for regulating gene therapy products; however, the U.S., EU, and Japan have established regulatory frameworks with subtle variations. Understanding how gene...

Clinical Research: Phase 1 - Phase 4

Choose the Right FDA Program to Expedite Your Rare Oncology Trial

Rare cancers account for 27 percent of all new cancer diagnoses in the U.S. and 22 percent of all new cancer diagnoses in the EU.1 With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. Faced with limited treatment...

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Dec. 8: Virtual Presentation – Effects of Digitization on Patients at the Center of the Clinical Study

8 December 2020 | 6:30pm CET Effects of Digitization on Patients at the Center of a Clinical Study: Regulatory Aspects, Initiatives And ExamplesPresented by Industrial Pharmaceuticals Division, German Pharmaceutical Society

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Beware of Underestimating the Value of a Pre-NDA Meeting

Drug development is a resource-intensive endeavor. Seeking input from the U.S. Food and Drug Administration throughout the journey can help optimize those resources and maximize the likelihood of regulatory approval. When preparing to submit a new drug application (NDA), a pre-NDA meeting with the FDA can be a critical step in ensuring the submission of...

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5 Tips to Avoid an IND Clinical Hold: Regulatory Guidance and Insights

A clinical hold from the U.S. Food and Drug Administration can significantly prolong the time and increase the cost of drug development, which is particularly concerning for emerging/small biotech and specialty pharma companies. In this blog, we discuss common reasons for clinical holds and provide useful tips for both avoiding and addressing them. Brief background...

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Outsourcing-Pharma.com: Holistic Approach Benefits Drug Development

Professionals focused on drug development are charged with making the most of their resources, maximizing the value of their work, and bringing effective products to market as quickly as they can without compromising quality or safety. It is a long list of responsibilities, and development professionals struggle to balance all of them. Sameena Sharif, senior...