Posted on February 21, 2017
Preparing for ICH-GCP E6(R2): A Former GCP Inspector Answers Your Compliance Questions
As this new rule will have an impact on all stakeholders in the clinical trials process – including study sponsors, contract research organizations (CROs), and investigator sites – it’s important that the guidelines are fully understood before GCP inspectors begin implementing them. I had a chance to speak with Gunnar Danielsson, a former GCP Inspector for the Swedish Medical Products Agency and European Medicines Agency, who now helps the industry and academia as an independent consultant.
Posted on February 17, 2017
Adding Value to your Food Products by Adding Live Cultures: Interview with a Probiotic Expert
To better understand how probiotics can be added to food products, and the benefits of probiotic fortification for both food manufacturers and consumers, I spoke with Michael Bush, president of the probiotic research and product development company, Ganeden. With over 20 years of experience in business and a degree in biomedical technology, Bush knows how formulating with functional ingredients like probiotics can help food and beverage companies add value to their products and increase sales.
Posted on February 8, 2017
Dirty Little Secret: How Clean Are Restaurant Tablets?
The digital revolution may well make it easier or more fun to process your order, but these devices shouldn’t be an overlooked source of potential cross-contamination.
Posted on February 2, 2017
5 Ways Mature Material Handling Workflows Can Benefit Your Manufacturing Business
Sometimes inefficiencies in material handling workflows are obvious, however without the right tools to improve these processes, manufacturers could get stuck with a sub-par process. So what defines a mature material handling workflow?
Posted on January 26, 2017
New Frontiers in Drug Discovery: Applying CRISPR/Cas9 Genome Engineering to the Drug Pipeline
For clinical researchers, drug development in a long and arduous process. In speaking with Dr. Anne-Marie Zuurmond, Associate Director of Genome Engineering, Discovery, Charles River Laboratories, I gained a better understanding of how the CRISPR/Cas9 genome editing tool works, and how it could streamline drug discovery.
Posted on January 19, 2017
How Pervasive is Brand Recognition in the Pharmaceutical Industry?
Chances are most consumers have heard of such blockbuster drugs as Viagra, Lipitor and Zoloft, but how much do they know about the companies behind these branded pharmaceuticals? Considering that drugmakers are continually facing tougher competition from the generics market, and US Food and Drug Administration (FDA) new drug approvals have been on the decline, pharmaceutical companies will need to start supporting their brand in order to stay competitive.
Posted on January 12, 2017
Can Automation Reduce the Risk of Product Recalls and Help Food Companies Achieve FSMA Compliance?
Labelling errors on food packaging have become a major problem in recent years, with both the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) issuing recalls due to the presence of undeclared allergens. According to Erik Phillips, US Director of Sales & Business Development, AutoCoding Systems, coding and labelling errors caused by outdated printing systems, as well as human errors in product packaging selection are major causes for this type of product recall.
Posted on January 4, 2017
Meet The App That’s Helping Consumers Manage Food Allergies
With food allergies and changing food preferences on the rise, consumers are paying more attention to ingredients labels on packaged and processed foods. Enter ipiit: The Food Ambassador, an app designed to help consumers identify and avoid products that contain allergens or other ingredients that don’t align with their personal food preferences.
Posted on December 13, 2016
mHealth: Improving Patient Recruitment, Retention and Engagement in Clinical Trials
mHealth technologies – namely mobile apps – have been on the rise in the clinical trials industry for the past few years. But in an industry known to be relatively cautious when it comes to adopting new technology, the early days of mHealth saw few early adopters.
Posted on December 6, 2016
Managing CMC Data for IDMP Compliance: What Pharmaceutical Companies Need To Know Before 2018
By end of 2018, all drugmakers who market their products in Europe will need to report their Chemistry, Manufacturing and Controls (CMC) data in a structured format, compliant with Identification of Medicinal Products (IDMP) standards.
Posted on November 22, 2016
Site Payment Paradigm Shift: Using Electronic Data Capture To Replace Excel
At a recent meeting at the Pharmaceutical Contract Management Group about site payments, pharma sponsors and clinical research organizations (CROs) outlined the complicated and manual process of paying clinical trial sites.
Posted on November 15, 2016
Risk-Based Monitoring, Remote Monitoring and eSource: A Smarter Monitoring Approach for Clinical Trials
Using risk-based monitoring, clinical research associates (CRA) at sites, and Data Quality Scientists (DQS) remotely, are able to focus their efforts on monitoring sites, events and data points which present the greatest risk.
Posted on November 9, 2016
Spotlight on Probiotics: 4 Surprising Product Categories Which Could Benefit from Fortification
Considering the growth potential of probiotics, more and more food companies are incorporating the functional ingredient into their products.
Posted on October 31, 2016
6 Questions about Carbohydrate Conjugates and Targeted Drug Delivery
While antibody-drug conjugates show promise as targeted therapeutics, alternative ligands – such as synthetic carbohydrates – could show better targeting capabilities towards select tissue. To learn more about synthetic carbohydrates and how they can be used for targeted drug delivery, I spoke with Dr. Stewart Campbell, Head of Business Development & Product Management, Carbohydrates, CordenPharma.
Posted on October 17, 2016
Colorectal Cancer: Using RNA-Seq to Identify Molecular Subtypes and Predict Treatment Response
To learn how transcriptional profiling of colorectal cancer subtypes using RNA-Seq can help researchers gain a better understanding of the disease, I spoke to Dr. Enzo Medico, Associate Professor, University of Torino, School of Medicine, Candiolo Cancer Institute.
Posted on October 12, 2016
Pharmacovigilance and Electronic Data Capture: Interview with an Expert
To learn more about how electronic data capture can be used to automate transmission of E2B-formatted serious event reports to the appropriate pharmacovigilance team, I spoke with Rich Davies, Executive Director of Business Solutions, OmniComm Systems, Inc.
Posted on October 6, 2016
Synthetic Biology Promises On-Demand Biopharmaceuticals In Any Environment
Dr. James J. Collins, Professor in the Department of Biological Engineering at MIT and his colleagues, have developed a freeze-dried, cell-free biomolecular expression system. Highly portable, this technology utilizes all of the transcription and translation machinery – including DNA, RNA, enzymes and ribosomes – found in cells, and applies them to generate biomolecules in a cell-free environment.
Posted on September 28, 2016
Meeting Consumer Demand For Cleaner Food Labels
Packaged foods benefit immensely from artificial ingredients. In recent years however, these artificial and often hard-to-pronounce ingredients have fallen out of favour with consumers, prompting the food industry to simplify their ingredients lists.
Posted on September 21, 2016
Post-Approval Research: Do You Have What It Takes?
Chances are, post-approval research represents a substantial part of a pharmaceutical, biotech, or medical device organization’s annual budget. But how much of that money is being wasted by conducting post-approval studies in an inappropriate and inefficient manner?
Posted on September 16, 2016
In an Imperfect World: Strategies for Psychiatric Clinical Trials
Studies involving psychiatry drugs may be uniquely challenging.
Posted on September 12, 2016
Establishing Medical Safety Groups Within a Biotech Startup: 6 Questions for a Medical Safety, Quality and Compliance Expert
I spoke with Dr. Ed Tucker, Senior Vice President for Medical Safety, Quality and Compliance from Acerta to discuss issues facing biotech startups when they’re considering establishing a medical safety group.
Posted on September 9, 2016
Examining the Expanding Role of Patient Advocacy Groups
Patient Advocacy groups are playing a larger role in development of drugs to treat cancer and rare diseases.
Posted on September 6, 2016
Insights on Implementing Risk-Based Monitoring: An Interview with François Torche, CEO of CluePoints
I spoke with François Torche, CEO of CluePoints, to learn about challenges and questions that arise when implementing Risk-Based Monitoring.
Posted on August 30, 2016
Getting Serious About Pharmaceutical Serialization: Advice From An Industry Expert
I spoke with Carlos Machado, Serialization Director, US, for Zenith Technologies, to get an expert’s view on what drug manufacturers need to do now in order to prepare to implement a serialization solution.
Posted on August 23, 2016
Did Athletes Use Gene Doping In The 2016 Rio Olympics?
At this year’s 2016 Olympic Games in Rio, athletes faced a battery of doping tests. In light of recent advancements made in the fields of gene therapy and gene editing, officials have now developed a new test to detect potential gene doping among athletes.
Posted on August 12, 2016
AAIC 2016: The Industry Perspective On Alzheimer’s Disease
In order to find out what those in the industry are doing to advance Alzheimer’s disease diagnosis, disease management and treatment options, I spoke to some of the veterans and the newcomers in the space.
Posted on August 4, 2016
AAIC 2016: Highlights In Prevention, Detection And Treatment Of Alzheimer’s Disease
Xtalks attended this year’s Alzheimer’s Association International Conference (AAIC), to get an idea of what advances have been made in Alzheimer’s research, and which companies are helping to support those efforts.
Posted on July 20, 2016
Controversy, Dolly and Two Decades Of Cloning Technology
Twenty years have passed since Dolly the Sheep became the first mammal to be cloned using an adult cell, but what’s become of the technique since?
Posted on July 13, 2016
Polypills: One Pill Fits All?
The most compelling aspect of the polypill is that some researchers think that everyone over the age of 50 should be taking one.
Posted on July 4, 2016
What The FDA's New Nutrition Facts Label Means for Food Manufacturers
While the updated label will help consumers make better choices at the grocery store, the changing regulations could be a nightmare for the sugar industry.
Posted on June 23, 2016
Can Chimeric Pigs Solve Our Human Organ Shortage Crisis?
By exposing pig embryos to human stem cells, it’s hoped that the resulting chimeric animals could grow specific human organs which could be harvested for human transplantation.
Posted on June 16, 2016
The Importance Of Patient-Reported Outcomes In Clinical Trials
While clinical trials may do a good job of assessing a drug or treatment’s efficacy at treating a disease, they often fail to take into account the patients’ experience when participating in a clinical trial.
Posted on June 9, 2016
Advocates’ and Critics’ Perspectives On Creating A Synthetic Human Genome
Last month, over 130 scientists, lawyers, government officials and other prominent individuals from around the world, met at Harvard University for a round-table on the topic of synthetic genomes.
Posted on June 2, 2016
Reducing Human Error In Clinical Trials: Improve Data Entry For More Robust Clinical Trial Data
Here’s a look at some of the most common sources of human error during the course of a clinical trial, and how sponsors and contract research organizations (CROs) can implement proactive measures aimed at reducing these risks, and improving the quality of the resulting clinical trial data.
Posted on May 20, 2016
Trump, Sanders and Clinton: Pharmaceutical Industry’s Friends Or Foe?
While each of their platforms varies when it comes to dealing with drugmakers, all three of the top candidates – Democrats Hillary Clinton and Bernie Sanders, and presumptive Republican nominee, Donald Trump – are siding with public opinion. All three candidates are advocating for increased transparency in the drug pricing process.
Posted on May 13, 2016
5 Ways You Might Be Compromising Your Food Safety Standards
Ignoring any one of these areas can lead a company open to a risk of product contamination, which could lead to failed FDA inspections, product recalls, consumer illness, or worse.
Posted on May 5, 2016
Making The Switch: Continuous Manufacturing vs. Batch Processing of Pharmaceuticals
As many of the issues with contamination occur during the manufacturing process, it’s important that drugmakers implement the best possible production process to limit the risk of recalls and protect consumer safety.
Posted on April 28, 2016
How To Start A Biotech Company On A Dime
While many of the lab tools required will be highly dependent on the type of research you’ll be conducting – such as protein work, human cell culture or animal studies – there are a few gadgets that are almost universally necessary.
Posted on April 22, 2016
Addressing The Challenges Associated With Site Selection For Clinical Trials
In an age of big data and fierce competition for top-performing research centers, some in the industry are urging study teams to take a data-driven approach to site selection.
Posted on April 14, 2016
The Current State Of ClinicalTrials.gov Results Reporting
Despite the legal and ethical requirements, recent research has suggested that most clinical trial results remain unpublished, both in the scientific literature and on ClinicalTrials.gov.
Posted on April 7, 2016
The Surprising Link Between Off-Label Prescribing Practices And Adverse Drug Events
It’s estimated that around 12 to 20 percent of all prescription drugs are prescribed for uses other than those indicated on the label. This has the potential to present a significant risk of adverse drug events in patients, as clinical trials were never conducted to test the safety and efficacy of the pharmaceutical in treating the off-label condition.
Posted on March 31, 2016
CAR-T and Bispecifics: Powerful Immunotherapy With Profound Challenges
Immunotherapy – treatments that harness the power of the body’s own immune system to fight disease – has been widely regarded as a potentially game-changing new tool in the field of oncology.
Posted on March 23, 2016
Six Proposed Changes To The Medicare Part B Drug Payment Model
Here are six things you should know about the proposed changes to Medicare Part B, so you can consider new strategies for demonstrating product value and ensuring your drug will be covered.
Posted on March 16, 2016
FDA Fights Back Against Price Gouging
Faced with public pressure to solve the issue of rising pharmaceutical costs, key groups – including regulators, politicians and private companies – are each approaching the problem from their own perspective.
Posted on March 9, 2016
Pharma, Doctor, Patient: Three Perspectives On The Effects Of Direct-To-Consumer Advertising
While the opinion that pricey DTC ads are at least partially responsible for the rising cost of prescription drugs is widely accepted, other views on the issue are often underrepresented.
Posted on March 3, 2016
Food Fraud: How FSMA Will Hold The Food Industry Accountable For Economically-Motivated Adulteration
As today’s food supply chain is made up of imports from around the world, food fraud – or the economically-motivated intentional adulteration of food products – is an important factor in ensuring food security.
Posted on Feb 24, 2016
5 Ways To Increase Patient-Centricity In Your Clinical Trial Operations
Patient-centricity has become a much-used buzzword by those in the clinical trials industry, but practically-speaking, how can the concept be applied to the average clinical trial site?
Posted on Feb 16, 2016
Preparing For Disaster: 10 Things To Know About Mass Notification Systems and NFPA 72
As facilities specializing in healthcare, pharmaceutical development and clinical trials become increasingly more complex, implementation of a mass notification system has become a necessity.
Posted on Feb 9, 2016
What You Need To Know About The EMA Before Setting Up A Clinical Trial In The EU
With the current trend towards patient-centricity and the drive to establish trial sites where the patients are, pharmaceutical companies and contract research organizations (CRO) are realizing the challenges in understanding international clinical trial regulations, and ensuring compliance.
Posted on Feb 4, 2016
Developing The Zika Vaccine: A Dichotomy Of Optimism and Caution
While multiple pharmaceutical companies have pledged to begin development of a Zika vaccine, the long lead time and regulatory processes associated with vaccine discovery make it unlikely that one will be ready by the end of this year, or the next.
Posted on Jan 28, 2016
Pharmaceutical Packaging: What You’re Doing Wrong
While pharmaceutical manufacturers pay a great deal of attention to ensuring they’re compliant with good manufacturing practices (GMPs) and US Food and Drug Administration (FDA) regulations when manufacturing a drug, pharmaceutical packaging can often be an afterthought.
Posted on Jan 20, 2016
3 Reasons Why Pharma Marketers Are Failing At Social Media
Pharma marketers have historically been much more comfortable with the one-sided conversation of a direct-to-consumer (DTC) ad, but as the industry moves more and more towards patient-centricity, it is becoming necessary for drugmakers to increase engagement with their stakeholders.
Posted on Jan 13, 2016
Martin Shkreli: A Timeline Of Events That Shook Up The Pharmaceutical Industry
While being taken into custody has nothing to do with his pricing decisions as CEO of Turing, the years leading up to the controversy surrounding Daraprim reveals detail about Shkreli’s entry into the pharmaceutical sector, and his contribution to the reputation of greed often conferred upon the pharma industry.
Posted on Dec 15, 2015
Top 5 Pharmaceutical Industry News Stories of 2015
As the 2015 calendar year draws to a close, the Xtalks Blog thought it would be a good idea to explore the top 5 pharmaceutical industry topics of the year, and make predictions on what people in the industry can expect for 2016.
Posted on Dec 3, 2015
Top 2 FDA Issues Affecting Compounding Pharmacies and Outsourcing Facilities
While the FDA has issued guidance on what types of compounding facilities should register under section 503B, many compounding pharmacies are unsure of whether their organization is eligible for exemptions and if those benefits would outweigh the FDA scrutiny. Still other compounders have registered with the agency, but are struggling to comply with stricter regulations.
Posted on Nov 25, 2015
Transparency in Clinical Trials: Why The Industry Isn’t Measuring Up
A recent study conducted by Bioethics International – a not-for-profit organization that keeps tabs on the way pharmaceutical companies develop and market drugs in order to determine the ethics behind these practices – found that many large pharmaceutical companies failed to achieve transparency in their clinical trial results.
Posted on Nov 17, 2015
Is Your Clinical Trial Ready For An FDA Inspection? Surprising Insights Gained From An Interview With An Inspection Trainer
I spoke with Janet E. Holwell, CCRA, CCRA, TIACR clinical research consultant, to understand why many clinical trial professionals dread FDA inspections, and how they can be better prepared to deal with one and its potential aftermath.
Posted on Nov 5, 2015
The FDA Food Safety Modernization Act: Is Your Organization Ready For Compliance?
Since January 2013, the Food and Drug Administration (FDA) has been working towards implementing new rules on food safety, as part of the agency’s Food Safety Modernization Act (FSMA).
Posted on Oct 29, 2015
Virtual Clinical Trials – Can Remote Trials Change The Clinical Trial Landscape?
Virtual clinical trials are a relatively new method of collecting safety and efficacy data from human trial participants.
Posted on Oct 20, 2015
Drug Prices: To Cap or Not To Cap?
Recent price hikes on some new drugs – along with those that were approved by the FDA decades ago – have some asking the question, are these costs justified?
Posted on Oct 13, 2015
Russia & Ukraine Cut Import Taxes, Red Tape for Clinical Trial Supplies
Clinical trial professionals are applauding changes in regulations that make it easier and less expensive to conduct global clinical trials in Russia and Ukraine – two countries whose requirements had been provoking frustration and concern.
Posted on Oct 1, 2015
Transactional Outsourcing and Strategic Partnerships: An Insider’s Perspective
To understand the benefits – and the common challenges – associated with strategic partnerships, I spoke with Richard Fazackerley, Technical Director, Aesica Pharmaceuticals, who will be speaking in more detail about strategic partnerships in a webinar on October 5th.
Posted on Sept 24, 2015
Insights Into The Emerging Health Monitoring Medical Device Market
To get an insider’s perspective on where the health monitoring medical device industry is heading, and how these devices could improve outcomes for clinical trials, I spoke with Deepak Prakash, Global Director of Marketing, Digital Health, for Vancive Medical Technologies.
Posted on Sept 17, 2015
Precision Medicine and the Paradigm Shift In The Development of Novel Cancer Therapies
To further understand how the paradigm shift in cancer research, diagnosis and treatment will affect how drugs are developed and clinical trials are conducted in Canada, I spoke to Dr. Sian Bevan, director of research for the Canadian Cancer Society.
Posted on Sept 9, 2015
Medical Device Innovation: Blurring the Lines Between Medical Necessity and Personal Accessory
As sales of wearable medical monitors rise, and healthy, average consumers increasingly look for high-tech gadgets to monitor their health, device manufacturers are developing technology which can be marketed to both healthy individuals as well as those with specific medical conditions.
Posted on Sept 2, 2015
Recent Medical Applications of 3-D Printing and the Future of Medical Device Manufacture
While the use of 3-D printers in the pharmaceutical industry is still in its infancy, three-dimensional printing technology has been used for other applications such as medical device manufacture and improvements in research tools available for drug testing.
Posted on Aug 26, 2015
Printing Your Prescription: How 3-D Printing Technology is Affecting the Pharmaceutical Industry
In the wake of the FDA’s first approved 3-D printed drug – which happened earlier this year – and the promise of three others in the works, experts are predicting that the future of the pharmaceutical industry lies in the development of printable drug products.
Posted on Aug 19, 2015
Are There Adequate Alternatives to Animal Testing?
Three promising in vitro and in silico technologies including, Modular Immune in vitro Construct (MIMIC), Organ-on-a-Chip and Computer Models of Adverse Drug Reactions, which could reduce the need for animals in research, are reviewed in more detail.
Posted on Aug 12, 2015
Infographic - Medical Device Development in Cardiovascular Disease Clinical Trials
See this infographic to give you an introductory understanding of cardiovascular disease risk, medical device industry involvement and the challenges involved when developing a medical device for a clinical trial.
Posted on July 16, 2015
Which States Are Proactively Using Google Search to Join Clinical Trials?
We used google trends to search some of the most relevant and popular keywords or keyphrases that individuals/healthy volunteers might search when trying to join a clinical trial and collected the results...
Posted on June 30, 2015
Address Your Challenges in Streamlining Clinical Testing Across Global Clinical Trials
During the recent Xtalks webinar, “Implementing a Sound Logistical Strategy to Mitigate Risk and Streamline Clinical Testing Across Global Clinical Trials - A Central Laboratory Perspective,” I outlined several key considerations for conducting clinical testing in challenging locations across the world and explained how 3P logistics principles...
Posted on June 10, 2015
Non-Alcoholic Fatty Liver Disease Epidemic?
The increasing prevalence of nonalcoholic fatty liver disease (NAFLD) and other metabolic syndromes is widespread, likely due to lifestyle factors including diet...
Posted on June 2, 2015
Echolocation Research and Technologies
Echolocation is a highly developed skill for many species, and we are learning more about the ability for humans to acquire this skill and substitute it for vision as a main sense for navigation, and developing more effective electronic mobility aids...
Posted on May 25, 2015
Brief Evolution of Genetic Technologies: Where are we Now?
The field of genetics has become a foundation in all areas of medical research. Technologies to uncover mysteries of life are continuously being developed, but this raises many concerns that require input from all pertinent parties, to move forward with ethical decisions that will benefit society...
Posted on April 20, 2015
The Beginning of Clinical Trials for Gene Silencing in Huntington’s Disease
The first clinical trials for gene silencing in Huntington's disease patients are beginning this year at various sites around the globe...
Posted on April 14, 2015
Personal Genome Service 23andMe – Expands to Drug Development
The personal genome service 23andMe that gives you insight into your own genetics, has faced criticism and FDA hurdles but has officially announced their entrance into drug development. What does this all mean?
Posted on April 6, 2015
Origami DNA Nanobots - Screen Body Health and Kill Cancer Cells
Ido Bachelet and his research team at the Wyss Institute for Biologically Inspired Engineering at Harvard University are making significant progress in the development of robotic devices comprised of folding strands of DNA, aka, DNA nanobots...
Posted on March 31, 2015
Virtually Interactive Medical Research – Wave of the Future?
There have been many exciting announcements this year regarding new technologies launched to accelerate medical research that involve the direct virtual participation of individuals. The latest announcement from Apple has people stirring about the potential of their new software platform, ResearchKit...
Posted on March 23, 2015
Heart on a Chip Technology to Accelerate Drug Development
Dr. Kevin Healy and his research team from the University of California, Berkeley, have microfabricated a 3D tissue construct that recapitulates a minimal organoid structure composed of pulsating human myocardium – essentially, a beating heart-on-a-chip. This cardiovascular microphysiological system has shown to effectively predict the cardiotoxicity of various herat drugs, consistent with pharmacological data on tissue scale references compared to cellular scale studies...
Posted on March 16, 2015
What is Food Fraud and What can be Done about it?
As you are taking a bite of that mouth-watering sandwich you got a great deal on at your corner market, do you ever stop to consider how many ingredients, or how many supply chains, were involved in making it? Do you ever question the quality and nature of your coffee or tea leaves, olive oils or fats, alcoholic beverages, spices or extracts? What about other staples like...
Posted on March 10, 2015
Exploring the Methylome: An Alternative Epigenomics Approach to Capturing Disease Variants
As the genomics information age continues to unfold, high throughput genomic sequencing technologies are becoming increasingly efficient in creating large and complex data sets. Efficient ways to catalogue this data is key to comprehend the dynamic interactions that regulate gene expression and activity through epigenetic processes in normal biology and disease...
Posted on February 20, 2015
How Bad is Food Fraud Today and are we Equipped to Prevent it?
Intentional deception using food for economic gain, or food fraud, has been an ongoing challenge for the food and drink industry since the beginning of time. However, as the global supply chain continues to grow, and becomes more and more complex, so too do the stakes for everyone linked to this chain from manufacturers, retailers, and raw ingredient suppliers to regulators and the consumer....