Optimizing Your Clinical Development Plan: Strategies for Biotech Success
By Sugato De (VP, Regulatory Strategy, Head of Medtech), Josh Taylor (Sr. Director, Regulatory Affairs), Lisa R. Sanders (Sr. Director, Regulatory Affairs), John McIntyre (Director, Clinical Strategy) Critical Importance of the Clinical Development Plan Imagine you walk onto a plot of land and decide it is the perfect place to build your next home. You […]
Patient-Centric Approach To Accelerating Clinical Trials
In an interview with Life Sciences Review, Anita Nelsen, senior vice president, clinical trial operations, Allucent, provides a general outlook on the current clinical trial landscape and highlights the value of a patient-centric approach. Click below to read the full article. Read here
How to Overcome Challenges in Combination Immunotherapy Clinical Trials
Immunotherapy has quickly become a major focus in the world of cancer research and treatment. In recent years, there has been a surge in the number of biotech companies conducting clinical trials for combination immunotherapies. What are Combination Immunotherapies? The combination immunotherapy approach involves the use of two or more different types of immunotherapies in […]
Long-Term Follow-Up for CGT Trials: Best Practices to Operationalize
By Desmond Cabrera, Project Director, Cell and Gene Therapy With today’s cutting-edge technology, we are on the cusp of developing truly magnificent therapies using cell and gene science. However, as with any new therapy, we must always consider the patient first. Guidelines to Ensure Patient Safety As far back as 2001, as new cell and […]
The Role of Statisticians in Study Design and Why to Engage them Early
By Melanie Buitendyk, Director, Biostatistical Consulting A Sponsor has a promising therapy and is in the process of planning their clinical development strategy. Key components of this planning include regulatory and corporate objectives, go-no-go decisions, and on a study level, includes study design, study objectives, and endpoints. Well-planned, well-designed, and well-written protocols are essential in […]
Benefits of Bayesian Dose Escalation Designs for Oncology Studies
As acceptance of flexible trial designs continues to advance, many sponsors are increasingly exploring alternate methods for dose escalation to support identification of a maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) in open-label Early Phase or First in Human studies. Bayesian dose escalation designs have also coincided with advances in oncology therapy […]
A Snapshot of Gap Analysis
When building a successful regulatory strategy, it is critical to keep the end objectives in mind and design a process that is tailored to your specific product. Planning for regulatory requirements can help you avoid non-compliant practices from the very beginning, but how do you make sure your strategy is comprehensive? The answer may be […]
The Essential Role of the CMC Expert in Drug Development
The Chemistry, Manufacturing, and Controls (CMC) expert plays a critical role in the drug development process, supporting sponsors in their ultimate goal of marketing authorization approvals to bring life-changing products to the patients who need them. CMC applies to the entire drug product development lifecycle, beginning during drug candidate selection and continuing through post-approval and […]
Mind the Gap: The Importance of Gap Analysis in Securing Regulatory Approval
Significant pressure to achieve regulatory approval to start generating return on investment can affect any sponsor, but it is of the greatest importance to small biopharma companies without existing marketed products. Biopharma companies may have conducted successful research and put in the work to warrant approval and market access, but to an uninitiated sponsor bridging […]
Anticipating Obstacles to Approval Before Your Early Phase Oncology Study: Four Critical Areas to Consider
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have rigorous processes for reviewing applications for new drugs for marketing. By working with an experienced partner who can focus on the approval process from preclinical studies up to pivotal clinical investigations for you, the development is more likely to proceed along […]