Pharma IQ Members

Columns

136 results
of -1

The Clinical Trial Diary
View All Posts

Georger
Lowering blood pressure to decrease risk of cardiovascular events:
Lowering blood pressure to decrease risk of cardiovascular events:Globally, there are millions of people that could benefit from an intensive lowering of blood pressure (BP). An individual with lower BP decreases their chances of suffering from any cardiovascular events such as: stroke, heart disease or heart attacks. A new study shows that lowering blood pressure to less than 140 mm Hg, the current treatment standard, had significant benefits.Read more
February 2, 2016 by George Clinical Representative
Tags:
Georger
The Changing Role of the Data Manager:
The Changing Role of the Data Manager:Throughout clinical trials, the data manager (DM) is heavily involved in constructing databases, managing reports, programming quality checks and managing the collection of data in the clinical trial. The DM is responsible for managing and training users the concepts of computerised clinical data base systems as well as fulfilling other duties such as design basic reports for investigators, entering data into protocol-specific forms and ensure there is high level of quality and integrity of data. The roles that the DM play is fast changing with the prevalence of electronic data capture (EDC) as the preferred platform for data collectionRead more
January 5, 2016 by George Clinical Representative

Making Tomorrow's Medicines
View All Posts

Knowledge Exchange:
Knowledge Exchange:The phrase Knowledge Exchange (KE) describing collaborations between industry and the academic community is recognised as having been a key factor in the development of the bio-pharmaceutical sector over recent yearRead more
December 22, 2015 by
Tony Hitchcock
Fit for Purpose:
Fit for Purpose:At Cobra we have worked on the development of both naked plasmid DNA and viral gene therapy products for over 20 years. After some rather extended development times, it has been very rewarding to see a number progress out of Phase II clinical studies and customers wanting to take these products into Phase III studies.Read more
September 21, 2015 by Tony Hitchcock
Tony Hitchcock
The Rocky Road to Success:
The Rocky Road to Success:Having worked in the development and production of early stage therapeutics for over 30 years I appreciate as much as anyone that this is often a highly challenging environment, not least with regards to overcoming technical and regulatory hurdles as well as seeking to meet a highly demanding timeline.Read more
June 2, 2015 by Tony Hitchcock
Tony Hitchcock
Disposables Solutions 2015:
Disposables Solutions 2015:With this year’s Disposables Solutions meeting in Munich rapidly approaching I will focus this blog on some of the issues which I hope will be covered in presentations and discussions.Read more
February 8, 2015 by Tony Hitchcock

Artwork Matters
View All Posts

Andrew Love
Ensuring Effective Translations – Review Translation:
Ensuring Effective Translations – Review Translation:Continuing in this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you make sure that the correct quality assurance steps are undertaken to make sure the translation is correct.Read more
December 10, 2015 by Andrew Love
Tags:
Andrew Love
Ensuring Effective Translations – Prepare Translation:
Ensuring Effective Translations – Prepare Translation:Continuing in this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you make sure that the information you are giving to your service provider is well prepared.Read more
October 26, 2015 by Andrew Love
Andrew Love
Ensuring Effective Translations – Brief Translation Provider:
Ensuring Effective Translations – Brief Translation Provider:Continuing in this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you make sure that the information you are giving to your service provider is well organised and clear.Read more
October 5, 2015 by Andrew Love
Tags: Andrew Love | andrew | love
Andrew Love
Ensuring Effective Translations – Translation Specifications:
Ensuring Effective Translations – Translation Specifications:As we hit the halfway mark in this series of articles covering the basics on Ensuring Effective Translations, the next set of tips guide you through establishing a set of standards for working with your translation provider.Read more
August 17, 2015 by Andrew Love

Market Access Insights
View All Posts

Steven Bradshaw
National Guidance in Spain Attracts Regional Opposition in HCV:
National Guidance in Spain Attracts Regional Opposition in HCV:With 19 therapeutic positioning reports (IPT: informe de posicionamiento terapéutico) now published, the focus and intention of the new Spanish health technology assessment paradigm can be reviewed. And in some quarters, the guidance has attracted substantial opposition. Our columnists Dr Steven Bradshaw and Dr David Carr discuss these issues.Read more
December 7, 2015 by Steven Bradshaw
Steven Bradshaw
Austerity-Driven Policy Dictates a Challenging Environment for Pharma:
Austerity-Driven Policy Dictates a Challenging Environment for Pharma:The austerity measures put in place as part of the &'Troika' bailout after Greece's mid-2000s financial crisis included the aim to substantially reduce national drugs spend. With the country already having one of the lowest drug prices in Europe (calculated as the average of the three lowest-price countries), additional budgetary pressure has increased the challenges for pharmaceutical companies in Greece.Read more
December 7, 2015 by Steven Bradshaw
Steven Bradshaw
New Cardiovascular Drug Bucks Competitive Oncology-Only Trend in UK Early Access to Medicines Scheme:
New Cardiovascular Drug Bucks Competitive Oncology-Only Trend in UK Early Access to Medicines Scheme:One year on since the launch of the UK's Early Access to Medicines Scheme (EAMS), Novartis’ investigational heart failure drug LCZ696 (sacubitril/valsartan) has become the fifth therapy to be awarded a 'promising innovative medicine' (PIM) designation. Significantly for health technology manufacturers, LCZ696 is the first non-oncology therapy to receive a PIM, which, as Pharma IQ columnists Dr Steven Bradshaw and Dr David Carr discuss, is an important step for broadening early access to a wider range of medicines.Read more
December 7, 2015 by Steven Bradshaw
Tags:

Biopharma Trends and Outlook
View All Posts

Eric Langer
Creating Effective Leachables and Extractables Testing: Whose Responsibility Is It?:
Creating Effective Leachables and Extractables Testing: Whose Responsibility Is It?:The problem of leachables and extractables (L&E) in single-use devices continues to hound both suppliers and end-users, and remains one of the more challenging issues inhibiting regulatory acceptance of single-use devices.Read more
April 19, 2015 by Eric Langer
Eric Langer
A Fully Disposable Bioprocessing Facility: Is it on the horizon?:
A Fully Disposable Bioprocessing Facility: Is it on the horizon?:Single-use, disposable bioprocessing reached the Billion-Dollar club this year, and judging by suppliers’ sales growth, it continues to gain broad industry acceptance. The many advantages offered to CMOs and biotherapeutic developers have been well documented.Read more
February 11, 2015 by Eric Langer
Eric Langer
Single-use Disposables are Future Proofing Biopharmaceutical Manufacturing:
Single-use Disposables are Future Proofing Biopharmaceutical Manufacturing:Biopharmaceutical companies that get stuck with legacy technologies, including older stainless steel equipment, and older processes, end up watching as competitors transition to more efficient, cost-effective platforms. In this column Eric Langer breaks down the trends in the biomanufacturing industry and shows that the addition of single use systems is adding flexibility.Read more
October 22, 2014 by Eric Langer

Pharma Cyber-Karma
View All Posts

Mollie Shields-Uehling
Global Regulatory Leadership from European Medicines Agency:
Global Regulatory Leadership from European Medicines Agency:When it comes to greater efficiencies and cost savings in filing electronic submissions, the European Medicines Agency is well ahead of any other regulatory agency on the planet. They're on record stating... The Agency expects the exchange of digitally signed electronic documents to increase the efficiency of procedures and eliminate the need to archive paper documents. It may also bring about cost savings for companies, by removing the need to print documentation and reducing courier charges.Read more
September 28, 2014 by Mollie Shields-Uehling
Mollie Shields-Uehling
The Power of One:
The Power of One:There is elegance in the apparently simple solution to the complex problem. I say "apparently" because so many solutions are complicated in their detail and the people responsible for them struggle to tell their stories in simple terms -- in ways that decision-makers and end-users can understand and appreciate. That's why we at SAFE-BioPharma have been on a quest to make the... Read more
August 18, 2014 by Mollie Shields-Uehling

Using Informatics to Streamline Pre-Clinical Drug Discovery
View All Posts

Sheraz Gul
Assessing the Potential of Open Source Initiatives in Drug Discovery:
Assessing the Potential of Open Source Initiatives in Drug Discovery:Open Source initiatives have proliferated across many areas of research including drug discovery. The surge in their popularity has been largely attributed to their benefits of enabling open collaboration between multiple parties. As Open Source for drug discovery continues to increase and diversify, it will be useful to understand its potential benefits as well as any shortfalls with their use in drug discovery.Read more
June 9, 2014 by Sheraz Gul
136 results
of -1