Research & Development: Page 2


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    Widening the Lens: From Patient Engagement to Community Engagement

    To truly engage patients, we must incorporate their community support systems No patient travels through their health journey alone. To be patient-centric, and fully engage patients in clinical research, expanding our approach to be inclusive of the broader communities that support them is impera...

    By Alycia James • June 1, 2021
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    AI in Clinical Trials: An Incredible Voyage

    The 19th century English naturalist and seafarer Charles Darwin once said: “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change." He knew a thing or two about evolution. So does the life-sciences industry — especially after last yea...

    By Jonathan Burr • June 1, 2021
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    Fulfilling the Promise of Wearables in Clinical Trials

    Wearable sensors have the power to transform clinical trials and, indeed, medicine in general, by replacing sporadic, often subjective health measures with continuous, objective ones. Instead of doctors asking their patients during occasional visits whether they have been sleeping well or been ac...

    By Geoffrey Gill • June 1, 2021
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    Decentralized Trials: Moving Beyond One-Size-Fits-All

    Suppose there’s a problem with your car’s suspension, you pull up to a service station, and the mechanic starts talking about replacing the engine and wheels. The scenario sounds comical, but it captures what could happen if a hasty, soup-to-nuts research approach is misapplied to decentralized c...

    By Noolie Gregory • June 1, 2021
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    The Financial Benefits of Incorporating Decentralized Clinical Trial (DCT) Approaches

    Clinical research trials are expensive to conduct and continue to rise in cost. Studies by Tufts and JAMA in recent years calculate the average cost to bring a drug to market steadily increasing to more than a billion U.S. dollars1. These rising research costs restrict R&D budgets for drug an...

    By John Reites • June 1, 2021
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    Collaborations Across the Ecosystem

    Over the past couple of years, there has been an increase in the number of collaborations designed to accelerate progress to solve R&D and patient challenges. Daiichi Sankyo and AstraZeneca Tackle Cancer Ken Takeshita, M.D., Global Head of Research and Development Daiichi Sankyo Cristian Mass...

    By Taren Grom • June 1, 2021
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    Artificial Intelligence

    Iktos Partners with Pfizer for AI-based Drug Design Project Trend Watch: COVID-19, Parkinson’s, Alzheimer’s All Benefiting from AI Platforms Iktos, an AI-based chemical research solution provider, and Pfizer are creating a design model for the pharma company’s selective small molecule discovery p...

    By PharmaVoice Team • April 1, 2021
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    Trend Tracking

    The industry is moving fast, and we asked our community of PharmaVOICE 100 inspired leaders to weigh in on their top priorities for the remainder of 2021 as they prepare for the next normal as well as the leadership skills that got them through the pandemic. Tammy Guld Global Head Multi-TA Projec...

    By PharmaVoice Team • April 1, 2021
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    Decentralized Clinical Trials: The Way Forward

    COVID-19 prompted the need for the industry to address patient needs in the clinical trial space, and companies along the drug development paradigm pivoted successfully to the benefit of patients. Necessity is the mother of invention, and over the past 12 to 18 months because of the limitations n...

    By Taren Grom • March 1, 2021
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    SHOWCASE: Real-World Evidence: Realizing the Benefits of RWE

    The real-world evidence (RWE) market has grown significantly in recent years, supported by a favorable regulatory environment. Increasingly, companies recognize that real-world evidence (RWE) presents an opportunity to improve efficiency and innovation. One of the biggest challenges for pharma co...

    By PharmaVoice Team • March 1, 2021
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    Four Key Considerations When Using Real-World Data in Drug Development and Regulatory Submissions

    Interest in using real-world data (RWD) in drug development and regulatory submissions has grown substantially over the past several years. This development can largely be attributed to passage of the 21st Century Cures Act, which mandated that FDA establish a program to evaluate the use of real-...

    By Scott Swain • March 1, 2021
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    Leveraging RWE to Enhance Experiences Across the Patient Journey

    In a tech-driven healthcare ecosystem in which patients are engaged consumers, product value is contingent on treatment outcomes and patient success. With digital tools and resources at their fingertips, today’s patient is empowered to make informed treatment decisions; and physicians need enhanc...

    By Melissa Thompson • March 1, 2021
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    Modernizing Oncology Approvals

    Using real world evidence to bolster oncology accelerated approvals and label extensions Regulators are increasingly leveraging real world evidence (RWE) to inform their understanding of the benefits and risks of using targeted therapies in patients who are treated as part of routine clinical car...

    By Jennifer Christian • March 1, 2021
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    Shot in the Arm: COVID-19 Boost to RWD

    Times Have Changed It’s early 2021 in the Northeast and a major snowstorm has just been announced. Schools will be closed for the next two days. Kids will be home and likely, quite happy to be off from school. Under normal circumstances, parents would be home too, trying to work and probably atte...

    By Iyiola Obayomi • March 1, 2021
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    The RWE Evolution

    With so much attention being focused on real-world evidence (RWE) and real-world data (RWD), it would be easy to assume that this critical area of drug development is revolutionary. But, in fact, RWE has been around for decades and what the industry is currently experiencing is an evolution of pr...

    By David Brown • March 1, 2021
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    Best Practices in Long-Term Safety Follow-Up Studies in Oncology

    As the quest to develop more effective treatments for cancer continues, a growing number of therapies are receiving accelerated approval from the U.S. Food and Drug Administration (FDA).1 The percentage of new oncology drugs that have gone through the Accelerated Approval Program increased approx...

    By Jane Bentley • March 1, 2021
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    Speak Out: Making Your Trial Break Through: How Imaging Can Make — or Break — Your Accelerated Trial

    Breakthrough Therapy studies evaluate the effects of therapies on the most severe diseases, where patients have irreversible morbidity or mortality [IMM] or symptoms that represent serious outcomes of their sickness. The pressure to deliver quality data is immense because the cost of not deliveri...

    By Peter Steiger • March 1, 2021
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    Letter from the Editor

    Celebrating firsts… Last month we witnessed Kamala Harris sworn in as the first woman, Black, and South Asian American as the 49th Vice President of the United States by Supreme Court Justice Sonia Sotomayor, the first Latina to be named to the bench and just the third woman to be named to the hi...

    By Taren Grom • Feb. 1, 2021
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    SHOWCASE: Decentralized Clinical Trials: Building a Collaborative Alliance for Decentralized Trials

    When COVID-19 forced clinical trials across the world to shut down due to the risk it posed to patients and an overloaded healthcare system, it brought decentralized trials to the fore. Decentralized clinical trials (DCTs) have been gaining impetus for several years, supported by mobile technolog...

    By PharmaVoice Team • Feb. 1, 2021
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    Decentralized Clinical Trials (DCTs): Five Key Questions to Ask Your Partners to Optimize Strategy

    Anyone who has ever had a child with a suspicious sore throat or rash has considered the convenience of getting a diagnosis over the phone. But they know that as soon as they call the doctor’s office, they are going to have to get in the car and drive to a face-to-face appointment. Until now. COV...

    By Donna Hanson • Feb. 1, 2021
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    Decentralized, Hybrid or Traditional: Choosing the Best Option for Your Clinical Trial

    While elements of decentralized and hybrid trials existed prior to the coronavirus pandemic, the ongoing crisis accelerated the demand for an alternative to the traditional, on-site model as the pharmaceutical industry was focused on managing patient safety and ensuring data integrity for COVID-1...

    By EB McLindon • Feb. 1, 2021
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    DCTs Are Our Genie in the Bottle

    Global events often trigger cultural disruptions that forever change the way we work. In World War II, Rosie the Riveter inspired 19 million women to enter the workforce to cover for the men at war. Economists thought it would be a temporary fix, but when the war ended women kept working, changin...

    By Josh Rose • Feb. 1, 2021
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    Clinical's Crystal Ball: How the Decentralized Model Will Transform Patient Care

    It is 2022 – welcome to a new era of healthcare, where patients are No. 1. With this phrasing, you may envision a football game of healthcare with rowdy fans waving foam fingers in the air, chanting boisterous incantations of support for Team Patient. Of course, this is not a game but rather the ...

    By Alison Holland • Feb. 1, 2021
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    A Paradigm Shift Towards Better Healthcare for All

    The world and technology are racing ahead of the clinical trials industry. Digital health technologies (DHTs) continue to advance while clinical research remains slow to embrace efficient technologies and offerings that are widely being deployed in healthcare. The result is a market where a new m...

    By Isaac Rodriguez-Chavez • Feb. 1, 2021
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    Will Decentralized Trials Finally Drive Meaningful Drug Development? Transformation?

    Our industry has come a long way since the early days of clinical research. However, as time goes on clinical trials are becoming more complex, and if these complexities aren’t well managed patients bear the burden. When patients sign up to participate in a clinical study, they’re placing tremend...

    By Maria Fotiu • Feb. 1, 2021