Latest Content
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View NowEMA Guidance: Management of Clinical Trials - What it means for Patients?
A lay summary for patients participating in clinical trials
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Learn MorePutting the Pandemic in Plain Language
The COVID-19 pandemic has brought many negative feelings to the forefront of our everyday lives, including anxiety, fear and social division, but what if we explored the new positive relationships...
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Learn MoreNavigating new steps in how FDA is managing COVID-19 Products
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See Parexel's latest COVID-19 expert content
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Learn MoreCOVID-19 Impact on Rare Disease Patients and Manufacturers
About the Authors Yi Liu, PhD is a Senior Analyst in the Health...
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Learn MoreUnderstanding the COVID-19 regulatory procedures the FDA is using
A diagram that shows various procedural steps when interacting with the FDA through CTAP.
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Learn MoreHow COVID-19 is Accelerating Telemedicine Adoption in Asia Pacific
About the Authors Gary Cheng is a Vice President of Health Advances and...
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Learn MoreThe Changing Fortunes of Telemedicine in Europe – Past, Present, and Future beyond COVID-19
About Health Advances European Practice Health Advances European Practice helps clients navigate through...
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Learn MoreCOVID-19 Vaccine Development - Part 3: Late stage clinical development and field trials
Following successful completion of Phase 1 healthy subjects’ studies and animal challenge tests as discussed in Part 2, a number of strategies are possible to demonstrate vaccine efficacy. Such...
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Learn MoreCOVID-19 Vaccine Development - Part 2: Non-clinical and Early phase clinical development
Clearly, the potential for vaccines to enhance rather than protect against infection through the two mechanisms of ADE and ERD discussed in Part 1, highlights the need for studies in animal models...
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5 strategies for mitigating the impact of COVID-19 on clinical trials
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Learn MorePart Two: The Unique Impact of COVID-19 and Implications for the MSK Industry
About Health Advances and Our Musculoskeletal Practice Health Advances is a healthcare-focused strategy...
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Learn MoreThe Great Lockdown of 2020: Will the Life Sciences Emerge Unscathed?
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Learn MoreRapid Responders: How Innovative Technologies are Accelerating Development of New Vaccines
About the Authors Joseph McInnes, PhD is a Senior Analyst in the Health...
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Learn MorePerspective on Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency
In summary FDA is moving quickly to implement emergency use applications (EUAs) policy to provide flexibility to those manufacturers of face masks and respirators to meet the need of medical...
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Learn MoreBack to the future – Are you prepared to meet unprecedented demand to use old drugs for new purposes?
There has been significant momentum to begin repurposing existing drugs to find either prophylactic or acute treatments for COVID-19. These activities could result in further strains on...
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Learn MoreCOVID-19 isn’t putting FDA out of the compliance business – Be ready for inspection alternatives
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Learn MoreSolutions for sustainable supply chains in a period of global tumult
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Learn MoreRestricted pharmaceutical exports from India: Are you ready to mitigate risk of drug shortages?
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Learn MoreCAR-T: How far have we come and where are we going?
In this episode, Doug Olson, one of the first CAR-T patients treated on a clinical trial for CLL almost 10 years ago, details his experiences with this therapy in its earliest days....
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Learn MoreReflections on Cancer Drug Development Strategies with Newly-Introduced Chinese Regulations
The global cancer drug market is set to maintain strong growth over the next decade due to factors such as environmental pollution, population aging, and poor lifestyles that leave...
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