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By Amy Raymond, PhD, PMP, Executive Director, Therapeutic Strategy Lead, Rare Disease Cell and gene therapies (CGTs) include cutting-edge approaches that offer the hope of a healthier, happier, and better tomorrow for a wide range of patient populations. Operationalizing these trials requires proactive and flawless management at every stage.
State-of-the-art cryogenic freezers alongside material transfer equipment have been installed that are designed to retain the integrity of investigational advanced therapy products by minimizing their time-out-of-environment. With sites in the U.S.,
Approaches to outsourcing clinicaltrials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. Overseen by an insourced project manager. Contracts are milestone- or unit-based.
ClinicalTrials Are your clinicaltrials on track? Companies fortunate enough to have reached the clinical stage are asking this question. What has the impact of summer been on recruiting efforts and the ability to manage clinicaltrial participants? Or maybe you are nearing the clinic.
Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. The FDA’s Fast Track program is designed to facilitate the development, and expedite the review of, novel potential therapies that are designed to treat serious conditions and fill unmet medical need. NYSE: PFE) today announced the U.S.
Preclinical data support MP0420’s potential efficacy as both a prophylactic and as an acute therapy. MP0420 is designed to bind the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells. Chief Medical Officer of Molecular Partners.
Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinicalsupply and commercial launch. at the BioProcess International Theater.
About MorphoSys
MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases. The presentation as well as a replay of the webcast will also be available on MorphoSys’ website.
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Approval of amendments to PARADIGME protocol is proceeding as planned and completed in the best-recruiting countries
Designed to enlarge the eligible patient population and increase the rate of enrolment into the trial.
59 patients enrolled as of 18 November 2020.
Financial Highlights.
Molecular Partners, a global leader in the development of DARPin® therapeutics, will be responsible for the conduct of phase 1 & 2 trials that may lead to emergency use approval; Novartis will be responsible for further development, manufacturing, distribution and commercialization.
company (NASDAQ: AMZN), announced that it is working with Pfizer to create innovative, cloud-based solutions with the potential to improve how new medicines are developed, manufactured, and distributed for testing in clinicaltrials. (AWS), an Amazon.com, Inc.
In todays clinical research landscape, it is both essential and challenging to accelerate clinicaltrials. Delays in clinicaltrials can have significant financial consequences for sponsors. The challenges are compounded by increasing trial complexities.
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