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| home > white papers > Data Technology as a Catalyst for Growth in the Life Sciences - AIGENPULSE |
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 WHITE PAPERS |
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AIGENPULSE
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Data Technology as a Catalyst for Growth in the Life Sciences
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The life sciences industry is changing at a rapid pace. The need to develop the next blockbuster is pushing current technologies and methodologies to the limit. Scientific advancement over the last decades was embossed with giant leaps in knowledge, however, the new reality is that smaller incremental gains need to be carved out with ever increasing investments. In order to survive, progress and prosper in this new reality, a holistic approach to getting the most of research data is crucial. In fact, it will likely be the difference of being in existence in 5-10 years or not. For those bold enough to step into an area they are unfamiliar with, huge rewards are waiting.
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News and Press Releases |
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MedPharm announce expansion of partnership with Palvella Therapeutics in developing a new treatment for the debilitating rare disease, pachyonychia congenita
MedPharm Ltd have announced the expansion of their partnership with Palvella Therapeutics, Inc., a Philadelphia-based biopharmaceutical company focused on developing and commercialising therapies for debilitating, rare genetic diseases. To date, MedPharm has employed its world-renowned specialist formulation expertise to support Palvella’s development of a novel, high-strength rapamycin topical formulation for application to the skin (PTX 022) as a disease-modifying treatment for pachyonychia congenita (PC). Most recently, MedPharm has made arrangements to manufacture the clinical (IMP) batches for use in Palvella’s upcoming Phase 2/3 clinical study.
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White Papers |
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Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials
Perceptive Informatics
Standardized assessment criteria are becoming increasingly important in obtaining valid outcomes in oncology clinical trials. While standardized criteria encourage a more uniform approach to assessing clinical trial data, they are often subject to the interpretation of the user. These differences in interpretation, while seemingly minor, can have a major impact on assessments. The most commonly used standardized criteria for lymphoma have been no exception. Differences such as minimum new lesion size, lymph node normalization size requirements, inclusion of extranodal lesions and assessment of organomegaly can have a profound effect on overall response. Additionally, heightened scrutiny of the assessment criteria used in a given protocol can lead to questions about a drug’s efficacy if not applied correctly according to regulators’ interpretation.
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Industry Events |
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SCOPE Europe – Summit for Clinical Ops Executives Europe
17-18 September 2019, Barcelona, Spain
Building on the success of its long-running US-based counterpart, Summit for Clinical
Trials Operations Executives Europe (SCOPE Europe) is a two-day event serving clinical
innovation leaders, clin ops execs, functional heads, category managers, and those
responsible for the planning and management of clinical trials in Europe and the Rest of
the World. The event will feature opening and closing plenary keynote sessions, five
conference tracks, interactive breakout discussion groups, and networking.
It is an opportunity for leaders from large, mid-sized, and small pharma, specialty
pharma, biotech, vendor companies, and academic research centers to come together to
share best practices and discuss the new era of analytics-driven and patient-centric
trials.
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