June 2019

Letter from the Editor

June 1, 2019

Trending Now… As we head into the second half of the year (as hard to believe as that is) this is a great time to hit pause and evaluate what’s coming down the pike. In this issue, in particular, we are looking at a couple of areas that will have a lasting impact on the […]

Upfront

June 1, 2019

Merck Debuts Documentary A Touch of Sugar Merck’s documentary film, A Touch of Sugar, debuted during the Tribeca Film Festival in April as a part of the company’s America’s Diabetes Challenge: Get to Your Goals. Narrated by award-winning actress and documentary spokesperson Viola Davis, the film dives into the type 2 diabetes healthcare epidemic that […]

Innovator’s Corner

June 1, 2019

Colon Cancer Screening without the Prep Alex Ovadia, CEO of Check-Cap, talks about the company’s ingestible imaging capsule-based system for colorectal cancer screening. Colorectal cancer (CRC) — the term referring to both rectal and colon cancers — is the third most common cancer diagnosed in both men and women and the second-leading cause of cancer-related […]

HealthTech

June 1, 2019

A Mobile Game That Can Detect Alzheimer’s Risk Trend Watch: From Games to Wrist Bands to at Home Diagnostic Tests, Healthtech Applications Expand Personalized Treatment or Therapy  A specially designed mobile phone game can detect people at risk of Alzheimer’s, according to research from the University of East Anglia. University researchers used the smartphone game […]

Artificial Intelligence

June 1, 2019

IBM to use ML and AI to Diagnose Alzheimer’s Trend Watch: From drug development to diagnoses, pharma uses AI across the spectrum IBM has discontinued the development and sales of its Watson for drug discovery product due to poor financial performance, however, it will continue to serve pharmaceutical companies already using the software. In the […]

Last Word

June 1, 2019

Anything But Generic Leadership Marc Kikuchi, the newly appointed CEO of Dr. Reddy’s North America — and a 2015 PharmaVOICE 100 — discusses trends in the generics industry and how he is positioning the company for success. PV: What are some of the biggest issues impacting the U.S. generics industry? Kikuchi: Two of the biggest […]

The Realities of VR and AR in the Industry

June 1, 2019

Pharma brings complicated material to life with augmented and virtual reality. Imagine you are standing in your exhibit booth on a very crowded scientific and educational meeting floor, armed with fascinating, yet difficult-to-understand medical content that needs to make its way to the many passing physicians in order to educate them on the science your […]

SHOWCASE: Clinical Trial Solutions: Technology the Key to Improving Efficiencies and Retention in Clinical Trials

June 1, 2019

The use of technology has become ubiquitous in clinical trials as the industry looks to streamline and improve processes. Most pharmaceutical companies and contract research organizations have adopted technology solutions, including electronic data capture solutions and clinical trial management systems to increase efficiencies, reduce costs, and improve the patient experience. These solutions have been instrumental […]

Addressing E6(R2) as an SMB: Why Small Pharma and Emerging Biotechs May be Falling Behind

June 1, 2019

It’s been three years since ICH added the E6 (R2) addendum to its Good Clinical Practice guidelines. The addendum was intended to create harmonization between US and EU clinical research regulations, and to drive adoption of quality risk management methodologies in clinical trial design, conduct, and oversight. To achieve compliance, sponsors must implement an end-to-end […]

Data Ownership: Setting Up Your Study for Success

June 1, 2019

A small-to medium-size biotech or medical device company typically succeeds or fails on one pivotal study. It cannot be underestimated how important the study and operational data are to the success of that organization. The paramount consideration needs to be, do you have ownership of that data? Let’s talk about that now. Whether you are […]

Simplifying the Patient Experience Through Technology

June 1, 2019

Most businesses and individuals involved in clinical research would argue that an industry priority should be improving the patient experience. The reality, though, is often quite different. Patient focus potentially simplifies the research conducted today and accelerates potential future benefits of wearable devices, mobile apps and other services and technologies. Extending the simplicity and reach […]

The Vital Role of Imaging in Clinical Trials

June 1, 2019

Technology and innovation are reshaping clinical trials. Nowhere is this more evident than in the use of imaging in drug and device research. Over the last 10 years imaging has evolved from mostly qualitative assessments to more and more truly quantitative measurements. This is driven by the increasing need to visually demonstrate safety and efficacy […]

Increasing Predictability in Patient Recruitment

June 1, 2019

Protocol Complexity and Optimization According to industry research1 there is increasing complexity in protocol design. This same research suggests that the demands on patients participating in trials are rising as a result of this and that there has been 70% increase in the total number of patient procedures in a typical Phase III trial. Assessing […]

Virtual Trials Have (Finally) Arrived: How this remote model is transforming the clinical research experience, leading to lower costs and easier recruiting.

June 1, 2019

The pharma industry has been talking about the benefits of virtual trials for years, but it’s only recently that the promise of conducting complex efficacy studies in patients’ homes has finally become a reality. Industry leaders began singing the praises of virtual models around 2012, shortly after Pfizer conducted the first-ever randomized clinical study that […]

The AI Revolution in Multivigilance

June 1, 2019

Advanced Technology Helps Protect Patients and Billions in R&D Investment. Bringing a new medicine, medical device, vaccine, or combination product to market today requires enormous investment. PhRMA estimates that a new drug takes nearly a decade to make it from discovery to approval and an overall investment of more than $2.6 billion. During that journey […]

Leveraging Patient-Centric Data Analytics to Accelerate Clinical Trials

June 1, 2019

We are all familiar with the figures — it takes over a decade and $2.6 billion to bring a new drug to market. While these objective statistics are daunting and do give pause, almost every life science professional will agree that they don’t begin to tell the true story of the human element below their […]

Clinical Trial Solutions: Technology Disrupters

June 1, 2019

The biopharma industry faces myriad challenges in the pursuit of its mission to bring new treatments to patients in need of cures, chief among them the “Iron Triangle” of time, cost, and quality with respect to clinical research. The cost of conducting clinical trials is escalating, quality remains paramount and the importance of accelerating insights […]

Marketing High Science Brands

June 1, 2019

The Challenge: Creating compelling campaigns for complex science Cancer immunotherapies and other high-science brands will be busting the market at $34 billion by 2024, according to GlobalData. As the science around these types of treatments continue to drastically change therapeutic options, their commercial success will depend on the speed with which they enter the market, […]

The Agile R&D Organization

June 1, 2019

A project management philosophy popular among technology companies has learnings for pharma R&D. Agile project management, first introduced in 2001, started out as a method used in software development that challenged the traditional, linear development model. The same benefits realized by the software industry, experts say, can be realized in pharmaceutical R&D. Agile takes a […]

Charting Their Own Course

June 1, 2019

Every entrepreneur’s journey is as unique as he or she is. The common denominator:  a passion to improve the lives of patients. Risk-takers, disrupters, change agents, visionaries — more than a dozen industry entrepreneurs discuss what it takes to make the bold step to create something new and the twists and turns of their journeys. […]

Speak Out

June 1, 2019

Disruptive Innovation Drives Positive Outcomes Best Practices for Adopting the Shared Investigator Platform The Cognizant Shared Investigator Platform – SIP – is the disruptive innovation our industry sorely needs to reduce the burden placed on sites conducting clinical trials. Stakeholders from across the industry have expressed that sentiment to me countless times since I joined […]

Executive Perspective

June 1, 2019

Transforming the Lives of Patients: A Conversation with Ron Menezes When Ron Menezes, President and General Manager of Almirall, LLC, took the helm of the U.S. market for the global, Spanish-based company, his mission was clear: become a leader in innovation in the dermatology market. The company set out to refine its pipeline by focusing […]

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