Research & Development: Page 27

PharmaVoice Team/PharmaVoice

The Next Chapter for Real World Evidence: Validating Data with the Patient Voice

In June 2020, in accordance with the 21st Century Cures Act of 2016 and the Prescription Drug User Fee Act (PDUFA), the U.S. Food and Drug Administration (FDA) launched Project Patient Voice. This patient-focused drug development initiative facilitates systematic approaches to collecting and usin...
By Ramita Tandon • Nov. 16, 2020
PharmaVoice Team/PharmaVoice

COVID-19: Silver Linings

COVID-19 has stretched our industry to adjust to all types of new “normals," yet amid all of the disruption and loss of life, there are pockets of light that are expected to lift the life sciences and its people to new heights. Of all the industries that have been impacted across the globe, the l...
By Taren Grom • Nov. 16, 2020
Explore the Trendline➔

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Trendline

Clinical trial diversity

As pharma wises up to the fact that the current playbook for improving clinical trial diversity has yet to make a meaningful impact, the quest is on to refine that approach.
By PharmaVoice staff
PharmaVoice Team/PharmaVoice

Expanding the Spectrum of Clinical Trials

In recent years, pharma and biotech companies have become more aware of the lack of representation of certain demographics in clinical trials and its resulting ramifications. Although the participation of women in clinical trials has improved in recent years, the participation of racial and ethni...
By Carolyn Gretton • Nov. 16, 2020
PharmaVoice Team/PharmaVoice

Centering on the Patient by Decentralizing Clinical Trials

When it comes to decentralizing clinical trials, what was long a cracked door has been flung open wide by the COVID-19 pandemic. With COVID-19 sparking major upheaval in clinical trial execution, sponsors, CROs, and other supporters of drug development have been forced to adopt tools long used in...
By Carolyn Gretton • Nov. 16, 2020
PharmaVoice Team/PharmaVoice

Health Consumerism on the Rise

COVID-19 has pushed the promise of healthcare consumerism into the open, creating a space where patients have a real voice in their healthcare decisions. The healthcare consumer of the future is arriving faster than anticipated, fueled by the COVID-19 pandemic. Health consumerism, which was begin...
By Robin Robinson • Nov. 16, 2020
PharmaVoice Team/PharmaVoice

Speak Out: Making Data Central to Your CNS and Pain Trials

A Therapeutic-Area-Specific Approach to Data Capture Solutions For data capture, CNS and pain trials are demanding, with complicated eligibility criteria, extensive monitoring requirements, comprehensive data collection, and substantial demands on patients. To design a great solution, we consulte...
By Kyle Hogan • Nov. 16, 2020
PharmaVoice Team/PharmaVoice

Upfront

Takeda’s Innovators in Science Award Takeda Pharmaceuticals and the New York Academy of Sciences are drawing attention to the urgent needs of patients worldwide affected by an estimated 7,000 rare diseases. The 2020 Innovators in Science Award recognizes scientists from around the globe for their...
By PharmaVoice Team • Oct. 1, 2020
PharmaVoice Team/PharmaVoice

HealthTech

Organ-on-a-Chip Transforms Drug Development Trend Watch: Healthtech Applications Run the Gamut from Chip Technology to EHRs, to Electronic Skin and Clinical Trials Draper’s Ex Vivo Immuno-oncology Dynamic Environment for Tumor biopsies (EVIDENT) is a microfluidic platform that maintains tumor fra...
By PharmaVoice Team • Oct. 1, 2020
PharmaVoice Team/PharmaVoice

Case Study: Leveraging AI for Meaningful Clinical Trials

Clinical trial sponsors seeking to develop new drugs and therapies face unique challenges, particularly when it comes to understanding patient dosing and response to therapy. This aspect can be difficult, as patients often: Do not take their medicine regularly, or at all Take creative measures to...
By Rich Christie • Oct. 1, 2020
PharmaVoice Team/PharmaVoice

AI and Drug Discovery

Discovering and bringing new drugs to market is notoriously slow and costly for a reason. Science moves slowly because of the incredibly complex nature of human biology and the difficulty of sluggish recruitment of clinical trials. And in spite of greater investments in R&D by pharmaceutical ...
By Claire Bonaci • Oct. 1, 2020
PharmaVoice Team/PharmaVoice

The Accessibility of AI: Innovation at Your Fingertips

The availability of datasets keeps growing exponentially. With this we are witnessing an escalation of available new life-altering systems. Some of these tools are highly autonomous and can perform functions with little to no human intervention. Self-driving cars, rockets that land upright on dro...
By Max Divak • Oct. 1, 2020
PharmaVoice Team/PharmaVoice

Site Unseen? Virtual and Hybrid Trials the Way of the Future

Decentralized trials create new opportunities for reaching more patients and safeguarding them during a pandemic, but what do they mean for sites? The clinical trial landscape has been going through a period of rapid and profound change. Even before the COVID-19 pandemic, trial sites have faced m...
By Kim Ribbink • Oct. 1, 2020
PharmaVoice Team/PharmaVoice

Innovator's Corner

Turning on the Switch Fulcrum’s proprietary product engine identifies drug targets that can modulate gene expression to treat the known root cause of gene mis-expression. Bringing more than 30 years of R&D experience to his role as president and CEO of Fulcrum Therapeutics, Robert Gould, Ph....
By Robert Gould • Sept. 1, 2020
PharmaVoice Team/PharmaVoice

Turning Data into Storytelling

Beyond communications skills, creating a good data story requires research. Nobody wants to listen to a boring story. And for some, data can be boring, or at best, confusing. Telling an enthralling story takes a certain skill, and when the topic is a mound of eye-glazing data and analysis, it bec...
By Robin Robinson • Sept. 1, 2020
PharmaVoice Team/PharmaVoice

Commanders & Chiefs: Chief Medical Officers

Chief Medical Officers have a big remit when it comes to overseeing their organization’s clinical trial strategies as well as keeping the patient voice top of mind. Dr. David Andrews Tracking Neo-Antigens The biggest trend in the immuno-oncology space is the pursuit of a successful solid tumor im...
By PharmaVoice Team • Sept. 1, 2020
PharmaVoice Team/PharmaVoice

Mentors

These champions of diversity and inclusion are dedicated to developing the next generation of leaders and setting an example for others to follow. An Ally for All Raising the bar… by bringing people together Peter Anastasiou Title: Executive VP & Head of North America Company: Lundbeck Indust...
By PharmaVoice Team • Aug. 1, 2020
PharmaVoice Team/PharmaVoice

Technologists

Big data and technology are key drivers of future innovation in the industry, and these leaders are always looking forward to the next big idea. Creating a Digital Health Transformation Raising the bar… by delivering solutions that reach from bench to bedside Rama K. Kondru, Ph.D. Title: Executiv...
By PharmaVoice Team • Aug. 1, 2020
PharmaVoice Team/PharmaVoice

SHOWCASE: Clinical Trial Solutions: Improving Trials with Technology

Technology is taking center stage as a way to mitigate clinical challenges and improve patient outcomes. The clinical trials market is massive and continues to grow. According to a report from Grand View Research, the global clinical trials market will be worth $65.2 billion by 2025. At the same...
By PharmaVoice Team • June 1, 2020
PharmaVoice Team/PharmaVoice

Effective Design and Implementation of Sponsor/CRO Governance — Reducing Risk While Enhancing Transparency

Governance board meetings have always been an important venue to ensure quality and maintain a healthy and productive relationship between sponsors and CROs. As the demands of the clinical research industry continue to evolve with a pandemic now amongst us, the need for effective program governan...
By Melissa Mauriber • June 1, 2020
PharmaVoice Team/PharmaVoice

Virtual Trials: The Silver Lining of the COVID-19 Pandemic

Many of us are identifying the proverbial silver linings associated with the changes we have been forced to make in response to the COVID-19 pandemic. One rather sweeping silver lining is the increased and accelerated use of technology in both our business and personal lives, with an obvious exam...
By Jim Mahon • June 1, 2020
PharmaVoice Team/PharmaVoice

How COVID-19 Changed the Way We Recruit

Amplifying the need for a new era of strategic patient recruitment and retention. The need for rapid and adaptive recruiting strategies has never been more urgent than in response to COVID-19. This pandemic is pushing those working to develop new treatments to pursue more agile and innovative str...
By Erica Prowisor • June 1, 2020
PharmaVoice Team/PharmaVoice

Real-World Data for R&D

Developing a much-needed new therapeutic, maybe even for Covid 19? Seeking approval to expand labeling for an existing treatment? Wanting to understand the standard of care, design a trial, create a comparator cohort, identify a new biomarker, or model patients most likely to benefit from a parti...
By Richard Gilklich • June 1, 2020
PharmaVoice Team/PharmaVoice

Leveraging Remote Monitoring to Increase Safety, Results and Efficiencies During the Pandemic and Beyond

In 2020, the phrase “clinical trial solutions" takes on a new — and more relevant — meaning than ever before. The world needs a solution to the global COVID-19 pandemic, and we in the life-sciences industry can contribute to that solution through innovative, state-of-the-art technology that enabl...
By Gergory T. Simpson • June 1, 2020
PharmaVoice Team/PharmaVoice

Age of the Machine: Using Algorithms to Advance Outcomes

Machine learning is being applied across the industry to support decision-making in clinical trials, R&D, regulatory, and commercial processes. What’s the difference between machine learning and artificial intelligence? The answer lies in the word intelligence, since AI is about enabling mach...
By Kim Ribbink • June 1, 2020
PharmaVoice Team/PharmaVoice

Executive Perspective: Transforming the Clinical Experience As a Digital Care Option for Patients — A New Age of Care

A Conversation with MaryAnne Rizk, Ph.D. For MaryAnne Rizk, Ph.D., Senior VP, Digital R&D Strategy at IQVIA, improving the patient experience is more than a calling; it’s a passion. She is driven by an inherent desire to improve the quality of life for patients. Her particular area of experti...
By Mary Ann Rizk • June 1, 2020