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International Clinical Trials
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Although we don’t yet know if COVID-19 will be a seasonal disease, it may recycle with other respiratory pathogens in the winter respiratory season. With that said, Phase I and II studies can be executed at any time, although off season is typically preferred so as not to confound the data with natural disease acquisition. Phase III randomised, controlled efficacy studies of vaccines aimed at preventing lab-confirmed respiratory diseases are typically conducted with the season in mind and make for an intense time for sponsors, CROs, and sites. Regardless of the phase, a potential vaccine for a pandemic respiratory virus must contend with:
An Aggressive Calendar
With a pandemic such as COVID-19, time is of the essence as the virus claims lives, overwhelms the healthcare system, upends daily life, and destabilises the global economy. These studies must be made a priority, starting with ensuring sites are ready to go when the vaccine is available. There is generally no ‘wiggle room’ in the schedule.
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About the author
Cindy Dukes has over 40 years of diversified clinical experience, including 34 years of clinical research focused in infectious diseases, vaccines, oncology, women’s health, and rare diseases. At ICON, she is the therapeutic expert for vaccines and leads ICON’s Vaccine Centre of Excellence. She also provides strategic management and oversight for studies across a number of therapeutic areas, including pivotal Phase III trials that have supported the approval of 14 vaccines as well as numerous drugs in other therapeutic areas.
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News and Press Releases |
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Nemera joins IPAC-RS as an Associate Member
Nemera is excited to announce that it has become an Associate
Member of the International Pharmaceutical Aerosol Consortium on
Regulation & Science (IPAC-RS). Nemera’s decision to join IPAC-RS is
part of its commitment to advance science and innovation.
Nemera
is committed to enhancing better patient outcomes by seeking innovative
solutions and contributing actively to discussions about the future of
drug delivery devices. Its membership in IPAC-RS will facilitate this
important commitment.
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Digital Transformation of the Cold Chain
Sensitech EMEA
The Life Sciences cold chain is a seamless and interconnected global network of people, equipment, data and processes that helps to ensure the safety and integrity of our medicines and vaccines. Cold chain logistics spending totaled $13 billion in 2017, an investment designed to protect some $283 billion in Life Sciences cold chain products, growing at 19% annually.1 Sensitech Inc., a part of UTC Climate, Controls & Security, a unit of United Technology Corp., has played an essential part in the Life Sciences cold chain since 1990, providing a comprehensive set of solutions for manufacturers of biologics, prescription pharmaceuticals, clinical trial materials, and over-the-counter drugs. These solutions help to ensure product quality, patient safety, and regulatory compliance while helping to prevent theft and optimizing cold chain performance.
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