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NORD: Positively Impacting the Lives Affected by Rare Diseases
Pharmatechoutlook >> news

National Organization for Rare Disorders (NORD) evolved from a group of leaders of different rare disease patient organizations. All the groups in NORD were unified to mobilize support to pass the Orphan Drug Act. Later, NORD was instrumental in...

Incorporating the Patient Voice into Trial Design: Insights Support Recruitment Success
Pharmatechoutlook >> cxoinsights

Kelly Franchetti, Vice President, Global Patient Insights and Engagement of ICON plc and Mapi Group

The expression “patient-focused drug development” can sound redundant, as, of course, life sciences companies design their products for patients. Still, the patient voice can get lost in the development process when sponsors approach...

AI Can Improve Patient Outcomes, but will Pharma Get there Quickly Enough?
Pharmatechoutlook >> cxoinsights

Ryan Billings, MS, MBA, Executive Director, Digital Engagement, AMAG Pharmaceuticals

No matter what industry you’re in, Artificial Intelligence (AI) is all the rage. It’s the shiniest of the shiny and new, and it’s everywhere. In pop culture alone it’s the central theme of HBO’s Westworld,...

IT Services at the FDA
Pharmatechoutlook >> cioviewpoint

Todd Simpson, CIO, FDA

What is service and what does it mean to be service oriented? A service is the sum of the people, processes and technologies required to enable users to achieve their desired business outcome. The Office of Information Management and Technology...

FDA Approval for First Marijuana-derived Drug
Pharmatechoutlook >> news

Marking a significant medical milestone, the U.S. Food and Drug Administration (FDA) has approved Epidiolex as the first marijuana-derived or cannabidiol-based drug for the treatment of pediatric seizure disorders such as Dravet syndrome and...

What 'Right to Try Act' Means for Pharma and Biotech Industries
Pharmatechoutlook >> news

A new law, the Right to Try Act is allowing terminally ill patients to try experimental therapies or drugs that are generally not approved by the Food and Drug Administration (FDA). The new law states that eligible patients can use the drugs that...

Empowering Clinical Research with the Right EDC system
Pharmatechoutlook >> news

There exist many different electronic data capture (EDC) systems in the market, making it difficult to find a system that is the best fit for your organization. While it is easy to be lured by attractive special features that many EDC systems...

FDA Approval for Cannabis-based Drug
Pharmatechoutlook >> news

Few months ago, the U.S. Food and Drug Administration approved the use of cannabidiol [CBD] oral solution for treating seizures in patients two years of age and older who are associated with two rare and severe forms of...

Impact of Medication-Assisted Treatment (MAT) for Opioid Dependence
Pharmatechoutlook >> cxoinsights

Brady Granier, President & CEO, Director, BioCorRx Inc

There has been a significant focus on increasing access to MAT for opioid addiction. The development of new effective treatments has risen and is of great importance given the devasting effects of opioid use disorder. This year, the Food and Drug...

Shaping the Future of Human Wellness through Modern Technology
Pharmatechoutlook >> cxoinsights

Manoj Vig, Head, Clinical Data Repository, IQVIA

Did you know the healthcare operating model has essentially stayed the same for 100 years? If you think about it, any system that is 100 years old has obviously been updated since, and it’s high time we work to bring the healthcare system up...

Healthcare Technology Disruption and Networked Solutions
Pharmatechoutlook >> cxoinsights

Dr. Chris Stout, VP, Research and Data Analytics, ATI

Much of the world is focused on the latest sizzle of big data, artificial intelligence, internet-of-things, augmented reality and machine learning. When you add a dose of predictive analytics, you have a promising and exciting formula for business...

Working toward Personalized and Precision Medicine
Pharmatechoutlook >> cxoinsights

Pranil Chandra, VP & CMO, Genomic and Clinical Pathology Services, PathGroup

Genomic research holds the key to many of today’s health challenges. Scientists have come a long way since the human genome project, identifying upwards of 2,000 genes, to an era where genomic principles are applied to the practice of...

The Emerging Phenomenon of Real World Data
Pharmatechoutlook >> cxoinsights

Dr. Chitra Lele, Chief Scientific Officer, Sciformix Corporation

Evidence-based medicine has been the mantra for patient treatment and public health for several decades, and has been the guiding principle of the pharmaceutical and healthcare industry for how treatments are tested to generate data and evaluate...

The Changing Role of CIO in the Biopharmaceutical Industry
Pharmatechoutlook >> cioviewpoint

Andy Newsom, CIO, CSL Behring

“It is not the strongest of the species that survive, nor the most intelligent, but the most responsive to change,” Charles Darwin observed in explaining his theory of evolution. Today the role of the CIO is rapidly evolving,...

The Past Decade of Quality by Design: A Perspective Overview
Pharmatechoutlook >> cxoinsights

Brad Swarbrick, Owner, Quality by Design Consultancy

In 2011 when the US Food and Drug Administration (US-FDA) published their guidance document on Process Validation (PV), this represented the first real attempt by a regulatory authority to mandate the implementation of the Quality by Design...

Increasing Clinical Trial Efficiency with Cloud-Based EDC Solutions
Pharmatechoutlook >> cxoinsights

Cynthia A. Challener, Ph.D., Scientific Content Director, That’s Nice LLC

Evaluation of the safety and efficacy of new medicines is a crucial component of the drug development process, but one that has become increasingly complex and costly. Clinical trials today are often global, multi-site studies lasting sometimes...

The Past Decade of Quality by Design: A Perspective Overview
Pharmatechoutlook >> cxoinsights

Brad Swarbrick, owner, Quality by Design Consultancy

Introduction In 2011 when the US Food and Drug Administration (US-FDA) published their guidance document on Process Validation (PV), this represented the first real attempt by a regulatory authority to mandate the implementation of the Quality...

Increasing Clinical Trial Efficiency with Cloud-Based EDC Solutions
Pharmatechoutlook >> cxoinsights

Cynthia A. Challener, Ph.D., Scientific Content Director, That’s Nice LLC

Evaluation of the safety and efficacy of new medicines is a crucial component of the drug development process, but one that has become increasingly complex and costly. Clinical trials today are often global, multi-site studies lasting sometimes...

3D Printed Drug by Aprecia Pharmaceuticals Gets a Nod from the FDA
Pharmatechoutlook >> news

FREMONT, CA: Aprecia Pharmaceutical’s SPRITAM drug has recently got approval from the U.S. Food and Drug Administration (FDA) for the treatment of epilepsy. The drug is manufactured using 3D printing technology and the company claims that it...

Lixoft: Enabling Model-based Drug Development
Pharmatechoutlook >> vendor

Jonathan Chauvin, CEO

Develops modeling and simulation software for population analysis, pharmacokinetics and pharmacodynamics (PK/PD), and other complex biochemical and physiological processes
Top 10 Clinical Data Management Solution Providers 2017

Clinical Data Management Special