Why Multinational Clinical Trials are Key to Bringing Novel Therapies to Patients

Originally published by BioPharmaDive Small and mid-sized biotech companies face unique challenges when bringing novel therapies to market. While many large pharmaceutical companies have the knowledge and in-house talent to clear regulatory hurdles and conduct efficient clinical trials, smaller companies often do not. That’s why small and mid-sized biotechs need to THINK BIG when working to […]

Defining the Regulatory Roadmap for Product Success

Originally published by BioPharmaDive Small and mid-sized biotech companies face unique challenges when bringing novel therapies to market. While many large pharmaceutical companies have the knowledge and in-house talent to clear regulatory hurdles and conduct efficient clinical trials, smaller companies often do not. That’s why small and mid-sized biotechs need to THINK BIG when working […]

Spotlight on oncology drug development and its future

Originally published by Pharmavoice.com Of the nearly 7,000 clinical programs reported in 2022, 43% are in oncology – signaling the tremendous need for and promise of new cancer treatments.  Jessica Lee is the vice president of regulatory strategy and head of cell and gene therapy at the specialized Clinical Research Organization (CRO) leader, Allucent. Here she discusses how […]

Focusing on smaller biotechs to have a big impact on society

Originally published by PharmaVoice.com Marcus Delatte spent over 10 years as a senior pharmacology and toxicology reviewer with the U.S. Food and Drug Administration (FDA). Today, he leverages his expertise to help small and mid-sized biotech companies develop scientific, technical and regulatory strategies at the specialized Clinical Research Organization (CRO) leader, Allucent. Here he discusses how and […]

Big passion for small biotech and its potential to address complex diseases

Originally published by Biopharmadive.com Teresa Nunes is responsible for overseeing the activities of the medical affairs and pharmacovigilance teams at the specialized Clinical Research Organization (CRO) leader, Allucent. Here she discusses what drives her passion for helping small and mid-sized biotechnology companies bring new therapies to light for patients around the world – and why she’s […]

When it comes to small populations, biotechs need to think big

Originally published by Biopharmadive.com The challenges biotechnology companies face in developing new medicines are increasingly dynamic and complex—particularly in rare disease clinical research, where patient populations for some conditions may be less than 25 people worldwide. Now, more than ever, companies need to have the right expertise in place to remain competitive and meet the […]

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 […]