Navigating Regulatory Strategies for Cellular & Gene Therapies

While any drug development program can face regulatory hurdles, developing cellular and gene therapies often presents unique challenges. Small and midsize biotech and pharma companies developing cellular and gene therapies should begin to understand critical nuances for successful regulatory meetings and submissions and how they impact strategic decisions during the product development lifecycle. At the […]

Roadmap To Marketing Authorisation in Europe: Taking All the Right Turns

Approval of your Marketing Authorisation Application (MAA) is the final hurdle to pharmaceutical product launch in Europe. Adequate and timely navigation of this roadmap is essential to achieve a successful review by the EMA. Navigation of the drug development pathways towards MAA approval starts much earlier than you may know till date and is essential […]

Webinar | Pharmacogenomics and Pediatric Drug Development: When Are Children Not Little Adults and Why?

This webinar covers an introduction of the intersection of ontogeny and pharmacogenomics as it relates to differences in drug biotransformation and pharmacokinetics in pediatrics. At the end of this webinar, attendees should have a better understanding of: The concept of “developmental trajectory” in the context of drug biotransformation How ontogeny and pharmacogenomics contribute to variability […]

Next Generation Strategies for Orphan Drug Development

Original Air Date:  Monday, October 19, 2020 Time:  10:00 AM EDT/4:00 PM CET The past decade has witnessed a remarkable surge in rare disease research leading to an impressive pipeline of promising investigational products. Novel approaches, including genomics, data mining and computational repurposing of drugs will continue to fuel discovery and consequent clinical development of medicines. In […]

The Challenges of Cancer Immunotherapy Development and Ensuring Durability of Response

Original Air Date:  Wednesday, September 2, 2020 Time:  10:00 AM EDT/4:00 PM CET Although cancer immunotherapy has entered the treatment mainstream and holds the potential for long-term durable responses, only a minority of patients currently respond to these treatments. The translation of preclinical findings to human cancer has been limiting and preclinical researchers are being challenged […]

The Value of Orphan Drug Designation in your Drug Development Program

Original Air Date:  Tuesday, July 28, 2020 Time:  11:00 AM EST/4:00 PM London As a drug developer you may wonder if you have a portfolio product or development candidate that qualifies as an orphan drug and thus provides options unique to orphan drug development. There are approximately 7000 known rare diseases and more expected to be […]

Future Proofing Inflammatory Bowel Disease Diagnosis & Clinical Trials

Original Air Date:  Tuesday, June 23, 2020 Time:  12:00 PM EST Inflammatory Bowel Disease (IBD) encompasses a cluster of disorders that cause chronic inflammation of the gastrointestinal tract. Crohn’s Disease (CD) and Ulcerative Colitis (UC) are the most common forms of this prototypically complex disorder that presents multiple diagnostic and therapeutic challenges. The advent of machine learning, […]

Advancing Cancer Vaccines to Move to the Forefront of Immunotherapy

Original Air Date: Thursday, May 28 2020 Time:  10am EST / 7am PST Duration:  1 Hour Immunotherapy has revolutionized cancer treatment by using a patient’s own immune system to target and eradicate tumor cells. Therapeutic tumor vaccines, as one avenue in this emerging landscape, are designed to elicit antigen-specific antitumor immune responses. Our expanding knowledge of immuno-oncology, […]

Maintaining Momentum: Applying Recent Regulatory Guidance in the Midst of the Coronavirus

Original Air Date:  Thursday, April 30, 2020 Time:  10am EST / 7am PST Duration:  1 Hour The importance of clinical research is in the forefront around the world with COVID-19 as companies race to develop vaccines and antivirals to address the disease. Regulatory agency guidance has presented the industry with a unique opportunity to shift the direction of […]