Research & Development: Page 32
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PharmaVoice Team/PharmaVoice
Trend: Rare Disease Innovation
It’s been almost 120 years since the word gene was coined. Today, researchers are well on their way to manipulating genes to treat diseases. With only about 400 approved treatments for more than 7,000 rare diseases — 80% of which are caused by gene mutations — scientific advances are enabling gen...
By PharmaVoice Team • Nov. 15, 2018 -
PharmaVoice Team/PharmaVoice
Trend: R&D Modeling and Simulation
The Food and Drug Administration for several years has been advocating for the use of computer modeling and simulation as a way to accelerate access to new therapies. First proposed by the agency in 2011 as part of its Critical Path Initiative, modeling and simulation are gaining traction, with t...
By Denise Myshko • Nov. 15, 2018 -
Explore the Trendline➔
Stock via Getty Images
TrendlineClinical 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
Speak Out
Looking to Simplify Your Safety Notifications Process? Consider a Cross-Trial SaaS Solution Why new centralized SaaS solutions make more sense than ever before A traffic-light is out of service during rush hour in a busy city intersection. To prevent accidents, a police officer is there directing...
By Brian Fisher • Nov. 15, 2018 -
PharmaVoice Team/PharmaVoice
Letter from the Editor
Innovation meets the market There are 977 clinical trials under way for products that use regenerative medicine technology. There are more than 150 gene therapy drugs in Phase I, II and III clinical trials in progress as rare disease research enters into a new era of patient-focused innovation. A...
By Taren Grom • Oct. 1, 2018 -
PharmaVoice Team/PharmaVoice
Innovator's Corner
Discovered by AI Dr. Vimal Mehta, CEO of BioXcel Therapeutics, talks about the company’s clinical candidates identified through an artificial intelligence and machine-learning platform. BioXcel Therapeutics is showing that investments in artificial intelligence (AI) and machine learning can pay o...
By Dr. Vimal Mehta • Oct. 1, 2018 -
PharmaVoice Team/PharmaVoice
Agencies Pay It Forward
In an open letter to CEOs earlier this year, BlackRock CEO and financial wizard Larry Fink outlined the need for companies to start focusing on the world outside their walls and find a way to serve a larger societal purpose. His thought process is that while focusing on building revenue, companie...
By PharmaVoice Team • Oct. 1, 2018 -
PharmaVoice Team/PharmaVoice
Trial Sites and Patient Diversity
Having a diverse patient population in clinical trials is important because medicines affect people differently based on age, sex, and race. Biologic, genetic, and even cultural differences between patients can impact how a treatment will actually work in practice. Industry experts say the racial...
By Denise Myshko • Oct. 1, 2018 -
PharmaVoice Team/PharmaVoice
Red Zone: Avoid Enrollment Pitfalls by Engaging with Best-Fit Sites
Perhaps the single most important consideration in selecting a site is whether it can make its enrollment. Many don’t; in fact, 20-25 percent of all clinical studies close because they fail to meet enrollment targets.1 For decades, sponsors have found their “best fit" sites and returned to them f...
By WCG Clinical Services • Oct. 1, 2018 -
PharmaVoice Team/PharmaVoice
Letter from the Editor
In the People Business According to PhRMA, 74% of the medicines in clinical development are potentially first-in-class medicines, meaning they represent a possible new pharmacological class for treating a medical condition. Furthermore, PhRMA reports that there are 822 projects, defined as unique...
By Taren Grom • Sept. 1, 2018 -
PharmaVoice Team/PharmaVoice
Innovator's Corner
A Potential Treatment for Autism Kevin Sanders, M.D., Principal Medical Director of the Autism Program at Roche, talks about the company’s research program for balovaptan, which is being investigated to help improve social interaction and communication in people with autism. Autism, a lifelong de...
By PharmaVoice Team • Sept. 1, 2018 -
PharmaVoice Team/PharmaVoice
Last Word
Innovation: As Many Questions As Answers John Nosta, President and Founder of Nosta Labs, challenges the status quo in discussing the state of innovation in the industry. PV: Can the pharmaceutical industry evolve based on its current organizational structure and incentives? Nosta: No, I don’t th...
By John Nosta • Sept. 1, 2018 -
PharmaVoice Team/PharmaVoice
Agency Executive Roundtable
Heavy is the Crown Without a doubt talent — recruitment, retention, and engagement — is the biggest challenge our agency executives face today. At the same time, technology, ideation, shared value, and time are also top of mind. Sharon Callahan. TBWA\WorldHealth. The first challenge that comes to...
By PharmaVoice Team • Sept. 1, 2018 -
PharmaVoice Team/PharmaVoice
Brain Wave: Breakthroughs Bring New Hope to CNS
In February 2018, FDA Commissioner Scott Gottlieb, M.D., emphasized the agency’s commitment to advancing the development of novel treatments for neurological conditions. His statement recognized the uneven progress made in certain diseases and pinpointed the complex nature of neurological conditi...
By Kim Ribbink • Sept. 1, 2018 -
PharmaVoice Team/PharmaVoice
Red Zone: Avoid Enrollment Pitfalls by Engaging with Best-Fit Sites
Perhaps the single most important consideration in selecting a site is whether it can make its enrollment. Many don’t; in fact, 20-25 percent of all clinical studies close because they fail to meet enrollment targets.1 For decades, sponsors have found their “best fit" sites and returned to them f...
By WCG Clinical Services • Sept. 1, 2018 -
PharmaVoice Team/PharmaVoice
Speak Out
Medical affairs is in the midst of a transformation. The dynamics of the healthcare industry, the complexity of new science, and the breadth and sophistication of communication channels that physicians have available for accessing information, are expanding the role of medical affairs and reshapi...
By PharmaVoice Team • Sept. 1, 2018 -
PharmaVoice Team/PharmaVoice
Letter from the Editor
For Their Transformative Inspiration and Influence Transformation is easy to define: a thorough or dramatic change in form or appearance. Transformation is much harder to achieve. For this special — and my favorite — issue we asked this year’s PharmaVOICE 100 to provide a short response to the st...
By Taren Grom • Aug. 1, 2018 -
PharmaVoice Team/PharmaVoice
Change Agents
Dr. Patrice Matchaba For Advancing the Quest for Global Access Title: Group Head of Global Health & Corporate Responsibility Company: Novartis AG Education: MD, University of Zimbabwe; Harvard Business School Program for Management Development A number of years ago, Dr. Patrice Matchaba’s mot...
By PharmaVoice Team • Aug. 1, 2018 -
PharmaVoice Team/PharmaVoice
Clinical Experts
Nariman Nasser For Creating Opportunities for Sites Title: VP, Site Engagement Company: Continuum Clinical Education: BS Microbiology, Arizona State University Hobbies: Swimming, biking, snowboarding, and anything outdoors that provides an adrenaline rush Associations: SoCRA, DIA, ACRP Social Med...
By PharmaVoice Team • Aug. 1, 2018 -
PharmaVoice Team/PharmaVoice
Letter from the Editor
Transforming for the Future By definition transformation means a thorough or dramatic change in form or appearance. Our thought leaders in this month’s cover story believe such a reshaping is necessary for the industry to have success in the future as biopharma companies must meet the business ch...
By Taren Grom • June 1, 2018 -
PharmaVoice Team/PharmaVoice
Innovator's Corner
A New Way to Deliver Proteins Paul Wotton, Ph.D., CEO of Sigilon Therapeutics, discusses his company’s approach for delivering cells that avoid immune detection. Encapsulated cell therapy is an emerging area of biopharmaceutical research that aims to unleash the therapeutic potential of cells to ...
By Paul Wotton • June 1, 2018 -
PharmaVoice Team/PharmaVoice
Last Word
Sanofi Pasteur’s Approach to Vaccine Deployment Dr. Joël Calmet, Senior Director of Communications at Sanofi-Pasteur, discusses the company’s efforts to bring vaccines to underserved patient populations. PV: Why is patient access to vaccines in disadvantaged countries still a challenge? Calmet: D...
By Dr. Joel Calmet • June 1, 2018 -
PharmaVoice Team/PharmaVoice
Transformation: Is the Industry Ready?
Although the pharma industry scored pretty low on a McKinsey scale of digital maturity, there is evidence that it is moving — perhaps only incrementally — toward a digital transformation that can streamline processes, generate collaboration, and coordinate data collection. The pharma sector, not ...
By PharmaVoice Team • June 1, 2018 -
PharmaVoice Team/PharmaVoice
Regenerative Medicine: The Dawn of a New Age of Biology
Regenerative medicine could completely shake up the way diseases are treated. According to Reportlinker, the regenerative medicine market will reach an estimated $50.55 billion by 2025 thanks to the rapid growth of stem cell and gene therapy in developed markets. Scott Bruder, M.D., Ph.D., founde...
By Kim Ribbink • June 1, 2018 -
PharmaVoice Team/PharmaVoice
Red Zone: Personalized Medicine Requires Personalized Measurement
CNS is the second largest area of pharmaceutical research, but the success rate has been low and approvals rare. In CNS drug development, it is common for investigational therapies to show promising effects in earlier trials, only to fail in the final stages of testing. Some of the reasons can be...
By Sofija Jovic • June 1, 2018 -
PharmaVoice Team/PharmaVoice
Speak Out
Understanding The Why Applying health psychology to deliver effective patient support As a health and clinical psychologist, I’ve spent the last ten years helping the healthcare industry address the self-management needs of patients living with long-term conditions. For the most part, this work h...
By Kate Perry • June 1, 2018
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