The introduction of vaccines against Measles, Mumps, Rubella (MMR), and Varicella (the “V” in MMRV vaccines) led to a drop in the incidence of these diseases by 89% (Varicella) and 99% (MMR). These effective vaccines are a core component in most pediatric immunization programs across the world. Hence, every time a new pediatric vaccine is added to the existing immunization schedule, clinical evidence must be provided that the newcomer does not adversely influence the immunogenic response to the MMRV-licensed vaccines. These required non-inferiority studies when vaccines are co-administered (known as concomitant vaccine testing) come with their own challenges.
The NIH defines precision medicine as “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person1.” In cancer patients, we can rephrase the definition to “through detailed understanding of a cancer’s biology, providing the right drug, for the right patient, at the right time.”
In order to identify the correct drug, biomarkers are used to identify patients that can be treated with the appropriate therapy for their cancer. The FDA defines biomarkers as “a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions2.” Great strides have been made in the discovery and validation of biomarkers in drug development. Continue reading
Advancing vaccine and novel immunotherapeutic development requires focused, specialized expertise. If you are looking to reveal more efficiencies in your vaccine and novel immunotherapeutic testing strategy, consider these three best practices:
1. Apply resources specifically tailored to your development
As you advance your vaccine or novel immunotherapeutic, it’s crucial to match solutions to your needs so you make the most of your efforts. Our dedicated vaccine and novel immunotherapeutic experts offer a consultative approach to determine exactly how to meet your requirements and accelerate your program. Co-located under the same roof, our scientists and study managers assign you a single point of contact to help simplify communications and decision-making so you can concentrate on the next steps. Continue reading
Like my colleagues at Covance, my work ultimately contributes to improving healthcare and patients’ lives. Our efforts to accelerate fresh approaches towards effective treatments became deeply personal in 2007 when my oldest sister, Vicki, was diagnosed with advanced Triple Negative Breast Cancer (TNBC).
From her initial diagnosis, my sister was full of vitality and enjoyed a high quality of life due in part to several of the novel treatments that Covance had helped develop. She even participated in a long-term clinical trial involving an angiogenesis-inhibitor, in addition to traditional chemotherapy, during her early treatment.
Vicki became a student of her diagnosis, reading countless journal articles on the rapid advances in scientific understanding. When her health took a sharp decline, she asked for my support in helping her gain access to a new trial focused on the immune system. She wanted to do whatever she could to help others find a better treatment, or even a cure, for TNBC. Ultimately, she was too weak to make the journey to participate in a cutting-edge clinical trial. Vicki died on October 1st, 2013.