Accelerating Development in Infectious Disease and Vaccine Clinical Trials
Infectious disease and vaccine research are unique in its ability to have widespread impact on public health. Working Together to Accelerate Clinical Development for Drugs, Vaccines, Diagnostics, and Devices. At BBMCT, each and every one of us within our Infectious Disease business unit is devoted to advancing this important work. An unparalleled combination of therapeutic depth and capabilities make us a valuable partner for infectious disease and vaccine research.
BBMCT has a highly-experienced infectious disease team, including medical, regulatory, operational, and laboratory experts who have extensive experience designing and conducting infectious disease clinical trials. Our team is actively working with the global regulatory authorities and Sponsors responding to the COVID-19 situation.
- A broad range of expertise in bacteriology, virology, mycology, and associated diseases and syndromes
- Work in both preventative and therapeutic vaccines, including for common diseases like influenza, respiratory syncytial virus and S. pneumoniae, as well as emerging threats like Ebola virus, Zika virus and COVID-19 (coronavirus)
- A proven record of success in all forms of regulated anti-infective and immunologic agents, including drugs, biologics and devices
- A comprehensive set of services covering Phase I-IV at a global level, including full Phase I study capabilities for first-in-human and immunogenicity studies, in a wide range of patient populations
- Regulatory engagement for planning and study start-up worldwide, supported by dedicated regulatory intelligence and country-specific regulatory specialists
- Expertise navigating the nuanced requirements and aggressive timelines set forth by government agencies
Our work includes projects targeting:
- Complex hospitalized infections targeting gram-negative pathogens (e.g., complicated urinary tract infections, healthcare and ventilator-associated pneumonias)
- Predominantly gram-positive infections (e.g., bacteremia and endocarditis, acute bacterial skin infections, osteomyelitis and C. difficile infections, both acute and recurrent with microbiome replacement)
- Invasive fungal infections (e.g., aspergillosis, candidemia)
- In addition, we have established pathways for HIV and hepatitis clinical development, and have conducted studies in challenging respiratory syncytial virus and other respiratory infections.
If you are developing treatments for COVID-19 and need assistance, BBMCT is well-equipped to assist:
- Speed: Our proven flat operating model and our multi-disciplined approach are designed for efficiency. We are well-equipped to move quickly and have taken steps to accelerate contracting and site-startup
- Site and investigator relationships: We are able to leverage strong relationships to quickly assess feasibility, accelerate enrollment and move trials forward
- Regulatory engagement: Knowledgeable in the changing regulatory landscape at local, regional, and global levels. Our team can provide regulatory support and strategy
- Remote monitoring tools and technology: Our processes and technology platforms enable remote monitoring and fast data acquisition. We support both sites and patients with portals for accessing and recording data that is easily accessible. We can support alternative methods for safety assessment, including phone contacts and virtual visits
- Critically ill patients: We have extensive experience in acute care settings with critically ill patients, spanning pediatric to geriatric patients
- Advanced therapies: Extensive experience working with Sponsors to overcome development challenges and accelerate cutting-edge technologies including cell and gene therapies
- Testing: BBMCT’s central laboratories continue to expand testing capabilities for SARS-CoV-2. To learn more about how we can support COVID-19 trials and our testing capabilities
Excellent NanoDegree Program for those in the healthcare and pharma background. It helps a lot when you refer to research papers which include a clinical trial aspect.
Good, didactic material. I liked the discussion part because it allowed us to reflect upon the things we’ve just learned and apply them to our backgrounds.
The knowledge you’ll learn and obtain in this NanoDegree is rich and very helpful. Please spend time watching the videos and reviewing the materials carefully.