News & Views

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News, Press Release, Views
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Category: News, Press Release, Views

Anova Announces First Patient Enrolled to Phase 1/2a Study of DB107 for the Treatment of High-Grade Gliomas

Anova has announced enrollment of the first two patients in the highly anticipated study of DB107 for the treatment of brain tumors. The Phase 1/2a clinical trial is a multicenter, open-label study designed to confirm whether treatment DB107, when added to standard-of-care (SOC), provides clinical benefit to patients with newly diagnosed high-grade gliomas (HGG) when compared to historical performance.
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Views
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Category: Views

The Value of Real World Evidence

Real World Evidence (RWE) is now routinely being used in synthesis with evidence from controlled trials, informing cost-effective modelling for technology assessments.
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Views
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Category: Views

The Real World Value of Compassionate Use

Patients with serious and/or life-threatening conditions can receive compassionate use access to promising treatments when they are not able to participate in a clinical trial and have no comparable or effective therapeutic options. The number of patients receiving access through these mechanisms remains very low.  Biopharmaceutical companies can benefit from these programs, where evidence has been successfully used to support…
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Views
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Category: Views

FDA Expanded Access Program Announcement

On December 14, 2018, the FDA floated plans in Biocentury, to launch a new program in 2019 to help more patients access unapproved therapies through Expanded Access. Chris Beardmore, CEO, Anova discussed the likely implications for FDA and other program participants.
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News, Views
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Category: News, Views

Precision Medicine and Right to Try – A Call to Action

We don’t need new regulation to form n=1 trials and offer them to patients. It is time to stop looking for changes in regulation to give us permission to pursue these activities. In short it is time to deliver on the promise of precision medicine.
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News, Views
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Category: News, Views

It’s About Time We Start Looking at Study Subjects as Individuals

It’s is about time clinical trials change their traditional focus from observing large groups of largely undifferentiated patients to the individual patient as the unit of observation. Norman Goldfarb, Editor of the First Clinical Research Journal talks with Chris Beardmore, CEO & Co-founder of Anova Enterprises about the concept of N=1 clinical trials.  To access the interview in full, click…
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News, Views
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Category: News, Views

Creating a Learning Healthcare System (Part 3): Realizing the Promise of Personalized Medicine

Today’s traditional drug development infrastructure is ill equipped to develop treatments that target the needs of individual patients.  A learning environment for molecular diagnostics and biopharmaceuticals is needed. Introducing the third in a series of Anova White Papers on Creating a Learning Healthcare System, we discuss how an approach in partnership with an omics provider could help biopharmaceutical companies find…
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News, Views
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Category: News, Views

Ancillary Service Provider Agreements in Clinical Research

I am surprised and often speak on how research sites work with local professionals to support the conduct of clinical trials.  As clinical trials have grown more complex, it is common for study sites to require to support of ancillary service providers to help them fulfil protocol requirements.  These are important relationships formed across academic medical centers, hospitals and community…
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News, Views
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Category: News, Views

Creating a Learning Healthcare System (Part 2): Accelerating Clinical Development – New Tools

Challenges facing drug development and evidence of financial decline across the biopharmaceutical industry are forcing change.  A new approach can be expected that will be capable of shortening the drug development process from 10-15 years to just a few.  The reliable generation of evidence of product efficacy and safety following first-in-man studies will be sufficient to speed development of new…
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News, Views
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Category: News, Views

Pharma’s Broken Business Model: An Industry on the Brink of Terminal Decline

Like many industries, Pharma’s business model fundamentally depends on productive innovation to create value by delivering greater customer benefits. Further, sustainable growth and value creation depend on steady R&D productivity with a positive return on investment (ROI), in order to drive future revenues that can be re-invested back into R&D. In recent years, however, it has become clear that Pharma has…

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