The Changing Paradigm of Regulatory Submissions: Embracing Automation, Gen AI, and Innovation for Faster Approvals
This informative webinar is aimed to be forward-looking, discuss the potential promises of emerging technological tools in expediting and radically changing submission preparation, pinpoint potential challenges and brainstorm resolutions. The current landscape of regulatory submissions is weighed down by the sheer volume of documentation required, complex guidelines and repetitive information across documents. It also involves the painstaking, cumbersome writing styles […]
Podcast: Artificial Intelligence, GCP Compliance, & Inspection Readiness in Clinical Trials
AI is increasingly being integrated across various industries, demonstrating its versatility and potential. In the biotech sector, it is important to consider how the use of AI might impact integral factors such as GCP compliance and inspection readiness. The incorporation of AI in the clinical trial process brings about a transformative influence on GCP compliance […]
Evolving Advisory Committee Processes: Key Updates From ODAC
By Nadine Bouchard (VP, Regulatory Affairs, Head of Program Management) and Lisa Sanders, PhD (Sr. Director, Regulatory Affairs) Background To help in their decision-making, the US Food and Drug Administration (FDA) sometimes makes use of an Advisory Committee, as defined in various regulations. An Advisory Committee provides independent expert advice and makes non-binding recommendations to […]
Strengthen Your Regulatory Submissions Through Strategic Storyboarding
By Young-Sil (Anna) Yim, Senior Director, Regulatory Affairs at Allucent Introduction A successful marketing authorization application is expected to convey the complete story of the drug in a clear, harmonized, and strategic manner. The process is rarely easy, as the authoring process requires distilling the full product development journey, starting from early activities including CMC […]
Navigating Regulatory Challenges: A Collaborative Journey to FDA Approval
Case Study Zachary Swan, PhD (Director, Regulatory Affairs) Background and Challenge Allucent was approached by a commercial-stage biopharmaceutical company focused on infectious diseases to provide writing and strategy support for their unique and complex New Drug Application (NDA) with multiple indications. The company faced a significant challenge when the FDA’s assessment deemed their initial studies in […]
Pre-IND Meeting Guide: Benefits & How to Prepare
Regulatory guidelines allow for formal meetings between the FDA and sponsors or applicants to discuss the development and review of an investigational new drug (IND) application for drugs or biologic products. This meeting, known as a pre-IND meeting, is intended to address specific questions related to the initial US clinical study (also known as a first-in-human […]
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 […]
FDA Orphan Drug Designation for Rare Diseases
An estimated 30 million people in the United States are afflicted with rare (orphan) diseases or conditions; however, the availability of novel treatments for these diseases and conditions has been historically low compared to conditions with a higher prevalence. This is mostly due to the financial risks of recouping the costs of drug development. In […]
CAR T-Cell Therapy Challenges to Development & Approval
Chimeric antigen receptor T-cell (CAR T) therapy is a revolutionary immunotherapy that uses cells from the patient’s immune system to fight certain kinds of cancer. The first two FDA approved CAR T therapies, Yescarta™ and Kymriah™, were both approved in 2017. Former FDA Commissioner, Scott Gottlieb, noted the significance of these approvals in his October […]
What is a 505(b)(2)?
The 505(b)(2) New Drug Application (NDA) is a streamlined NDA process in which the applicant relies upon one or more investigations conducted by someone other than the applicant and for which the applicant has not obtained right of reference. In other words, the 505(b)(2) pathway enables investigators and/or manufacturers to apply for approval without having […]