Evidence generation in Europe- How valuable is the French National administrative health data (SNDS)

Watch this presentation to learn • Overview of the SNDS and the key working practices to access the database and ongoing SNDS developments • Similarities and differences between SNDS and other claims databases • Strengths and opportunities for HTAs and market access in Europe through case studies • Stakeholder perspectives: current and potential benefits to … Continued

The Wizard of Oligos: There’s no place like having a successful drug development program!

Oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases— are experiencing tremendous growth in the pharmaceutical industry. But, performing the needed PK/PD and clinical pharmacology assessments to optimize the safety and efficacy of investigational oligonucleotide candidates and gain regulatory approval can be challenging. It’s enough to make … Continued

The Promises and Pitfalls of Gene Therapy for Rare Diseases

The state of gene therapy faces much uncertainty as recent regulatory and clinical setbacks have raised questions about its promise. With only two gene therapies FDA-approved for rare diseases to date, the path to developing these medicines is still a difficult one. This presentation exploreed how the biopharma industry can overcome development challenges in the … Continued

Part 4: Best Practices for oligonucleotide therapeutic development: Q&A

In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth is oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases. Certara supported the first FDA approval of … Continued

Part 3: Oligonucleotide therapeutic development: Clinical pharmacology considerations

In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth is oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases. Certara supported the first FDA approval of … Continued

Part 2: Oligonucleotide therapeutic development: Pre-clinical and translational considerations

In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth is oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases. Certara supported the first FDA approval of … Continued

Part 1: What are oligonucleotide therapeutics, and how do they work?

In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth is oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases. Certara supported the first FDA approval of … Continued

Plan to Accelerate Your Time to Drug Submissions

There are common themes driving how quickly you can get from your last database lock (DBL) to submission of your marketing application. Speaking from first-hand experience across more than 50 marketing submissions, Synchrogenix regulatory science experts will demonstrate how, through thorough planning, you can improve and shorten your speed to drug submission. Speakers Anjana Bose, … Continued

A Drug Development Software and Services Overview with a Focus on rsNLME and Simcyp

A successful drug product must demonstrate drug substance viability, clinical viability, and economic viability. Drug developers typically use a range of software tools to help demonstrate the viability of their products in these domains. In this product theatre, Drs. Hannah Jones and Keith Nieforth will explain how Certara’s products and services can help accelerate the … Continued

Combining APIs: MPT Development & Regulatory Considerations

This third webinar in the “Let’s Talk MPTs” discussion series will provide MPT product developers and other stakeholders an overview of clinical development and regulatory considerations when developing products that combine one or more active ingredients into an MPT product. Speakers Dr. Virna Schuck, PhD is Senior Director of Clinical Pharmacology at Certara and has over 16 years … Continued

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