3 min read
Over the past two decades, the FDA has steadily increased the number of guidance documents it publishes each year. The agency issued about 101 guidance documents annually from 2005–2010, rising to 173 per year between 2011–2019, and more than 190 in FY...
2 min read
Clinical Impact, Technology Innovation, and Emerging Advances in Cell and Vaccine-Based Oncology
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Historically, oncology drug development followed a straightforward principle: identify the highest dose patients could tolerate without unacceptable side effects, then use that dose in subsequent trials and clinical practice. This maximum tolerated dose...
3 min read
The decision to partner with a Clinical Research Organization (CRO) is never taken lightly—especially in oncology. With high complexity, accelerated timelines, and evolving regulatory expectations, the stakes in oncology drug development are uniquely...
3 min read
The development of innovative oncology therapies has evolved dramatically, moving beyond traditional chemotherapies to include immunotherapies, targeted agents, radiotherapies, and cell and gene therapies. As these new modalities emerge, the limitations...
2 min read
Discussion with Erin Mathias, Sr. Director, Global Biostatistics
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Discussion with Gabriela Rosu, MD, Sr. Director, Global Medical Affairs
1 min read
Clinical trials require meticulous planning and strategic guidance for success. In this case study, Veristat's expertise was instrumental in transforming a clinical-stage biotech company's maiden Phase I trial for an immuno-oncology antibody.
Initially...
1 min read
Learn how Veristat’s multidisciplinary team was able to work with the sponsor to solve challenges across numerous areas of this full-service phase II cancer trial. Collaborative efforts led to the sponsor decided not to close the Phase II study upon the...
1 min read
Project Optimus is an initiative from the FDA Oncology Center of Excellence led by Drs. Mirat Shah and Atik Rahman.The goal of the initiative is to educate, innovate, and collaborate with the oncology community- including companies, academia,...