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The Clinical Trial Diary
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Georger
Investigator networks cultivated through risk-factor trials, drives data diversity in dementia research.:
Investigator networks cultivated through risk-factor trials, drives data diversity in dementia research.:Extensive investigator networks, cultivated over the course of some of the world’s largest clinical trials into the risk factors for dementia, present an exciting opportunity for the future of dementia trials. Diabetes, hypertension, stroke, vascular disease, smoking, poor diet, physical inactivity and even depression have been linked to an increase in the likelihood of an individual presenting with dementia at some point in their livesRead more
August 2, 2016 by George Clinical Representative
Georger
Utilizing Clinical Research Organizations for late Phase I studies:
Utilizing Clinical Research Organizations for late Phase I studies:A key step in developing a new drug is the transition from the laboratory to the human subject in a Phase I clinical trial, where the new compound is given to humans for the first time. A Phase I trial is the gateway between scientific research and clinical medicine. Generally, in-human Phase I studies are conducted in healthy male patients or healthy male volunteers; however later Phase I-Ib trials are conducted in-human with the affected disease the compound is intended to treat.Read more
February 25, 2016 by George Clinical Representative
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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
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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

Artwork Matters
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Andrew Love
Tips For Creating A Serialisation Strategy:
Tips For Creating A Serialisation Strategy:In my last article I talked about the need to be responsive to an evolving picture both when selecting your implementation partners but also when working out what is going to be the best solution for meeting the serialisation requirements and including the make-up of your project team. In this next article, covering tips 6, 7 and 8, I talk about the ‘global versus local‘ aspects to consider, the need for flexibility in the design solutions being looked at and finally some important governance principles.Read more
June 21, 2016 by Andrew Love
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Andrew Love
Selecting Implementation Partners for your Serialisation Strategy:
Selecting Implementation Partners for your Serialisation Strategy:In the last article I looked at the starting point of developing your organisation’s strategy, the legislation and its impact. In this article I discuss defining your solution, what to look for when picking your implementation partners and the key aspects to consider when resourcing the project team.Read more
May 16, 2016 by Andrew Love
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Andrew Love
Tips for your Serialisation Strategy:
Tips for your Serialisation Strategy:In this and subsequent articles, Andrew will outline a series of tips, based on experience he has gained working on multiple serialisation programmes, to help develop and implement your serialisation strategy.Read more
April 8, 2016 by Andrew Love
Andrew Love
Ensuring Effective Translations – Translation Memory:
Ensuring Effective Translations – Translation Memory:As we complete this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you plan to have effective document management and how to start building a library of standard phrases.Read more
February 25, 2016 by Andrew Love
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Making Tomorrow's Medicines
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Tony Hitchcock
A More Balanced Understanding Of “Risk”:
A More Balanced Understanding Of “Risk”:Earlier this year I was fortunate enough to attend the Disposable Solutions meeting in Munich. A common theme of discussions was the on-going debates around the issues of leachable and extractables and the associated testing standards. This is a topic that has been debated for as long as I have been attending meetings on single use systems, and still seems to be a long way from a consensus between various end users and manufacturing bodies on how to address this issue.Read more
May 10, 2016 by Tony Hitchcock
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Tony Hitchcock
The Translation of Next Generation Therapeutics:
The Translation of Next Generation Therapeutics:When we look at the current trends with what we can refer to as “next generation therapeutics”, whether it be ADCs or cell and gene therapy products, one trend is very clear, products are becoming increasingly complex in their nature. Certainly, the complexity of the manufacturing processes used to produce them clearly reflects this; hand in hand with ever increasing product development costs and timelines.Read more
March 22, 2016 by Tony Hitchcock
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

Women in Shared Services
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Georger
Korea’s Global Clinical Trial Magnetism:
Korea’s Global Clinical Trial Magnetism:The rising presence of clinical trials (CT) in the Asia-Pacific region is predominantly driven by the East Asian region which includes China, Japan, Korea, Taiwan and Hong Kong. Over the past decade, Korea has become a global clinical trial hub and is one of the leading clinical trial destinations in the Asian region; with approximately 80% of its CTs being multinational trials from 2001-2012.Read more
March 22, 2016 by George Clinical Representative

Market Access Insights
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Dr Steven Bradshaw
Drugs Pricing in France - Balancing Innovation vs Cost Containment: The New Agreement between the Government and the Pharma industry :
Drugs Pricing in France - Balancing Innovation vs Cost Containment: The New Agreement between the Government and the Pharma industry :On January 11th 2016, the Comité Economique des Produits de Santé (CEPS - Economic Committee for Health Products) signed on the behalf of the French Government a new agreement, the Accord cadre, with Les entreprises du médicament (LEEM - pharmaceutical companies association) on how to set reimbursed drugs prices for the next 3 years. The CEPS is the body that negotiates drug prices with manufacturers.Read more
March 15, 2016 by Dr Steven Bradshaw
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Dr 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 Dr Steven Bradshaw
Dr 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 Dr Steven Bradshaw
Dr 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 Dr Steven Bradshaw
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View From The Consultants Chair
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Robert Musterer
Warning: Buyer Beware:
Warning: Buyer Beware:In the last 2 months I have received 3 requests through various networking sites to provide information on particular topics about our industry.  In these particular cases, the individuals claim to have global pharma clients seeking assistance with decisions around use of CROs, the selection of EDC systems, and the implementation of CDMS solutions.   Most troubling in all these cases is... Read more
August 9, 2015 by Robert Musterer
Robert Musterer
Seems Everyone Is Building Clinical Data Repositories, Now How Are We Going To Use Them?:
Seems Everyone Is Building Clinical Data Repositories, Now How Are We Going To Use Them?:Whether you call it a clinical data repository (CDR) or a clinical data warehouse (CDW); it seems everyone (oh, all right - at least a lot of companies) are either building, or planning to build one.  Most of these companies have grand notions of bringing together data from a wide variety of sources to be able to glean new insights.  However the big unanswered questions are; just how... Read more
February 19, 2015 by Robert Musterer
Robert Musterer
How Many Strikes Can One Support Request Gather?:
How Many Strikes Can One Support Request Gather?:The other day I had the dubious pleasure of having the hard drive on my laptop fail. I was fortunate enough that I got a warning message letting me know that something was amiss and had the presence of mind to double check to make sure that I had a backup of everything of concern.  In addition to that, I take advantage of one of the cloud based services for email and provision of desktop... Read more
January 16, 2015 by Robert Musterer

Market Access, Trends and Outlook
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Regina Au
Medical Device UDIs: What You Need to Know:
Medical Device UDIs: What You Need to Know:In this Pharma IQ interview, Regina Au from BioMarketing Insight shares her insights on the current UDIs for medical devices landscape and the impact of the FDA’s final rule on UDIs on the medical device industry, both in the US and on a global scale. Au also reveals the 5 key business benefits for medical device manufacturers.Pharma IQ: Why is the FDA requiring all medical devices to have a... Read more
July 4, 2015 by Regina Au
Regina Au
How 3D Printing has Influenced and Advanced Medicine:
How 3D Printing has Influenced and Advanced Medicine: Regenerative medicine or man-made regeneration has been influenced and advanced the most with 3D printing technology.  Scientists using stem cells and/or various forms of scaffolding have taken advantage of these technologies in such a short period of time and many different human parts have been reproduced: skin, ears, nose, eyes, bone, and parts of a skull patch that can be... Read more
May 15, 2015 by Regina Au
Regina Au
How a Leaky Gut and Gut Microbiome Can Affect Our Immune System:
How a Leaky Gut and Gut Microbiome Can Affect Our Immune System:What does a leaky gut, and our gut microbiome, have to do with our immune system?  Scientists are discovering that it has a lot to do with how well our immune system works.Our intestines have a very thin lining that prevents substances other than nutrients to pass into our blood stream.  Intestinal permeability is when the tight junctions (TJs) in the intestinal lining that control what... Read more
May 2, 2015 by Regina Au

Biopharma Trends and Outlook
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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
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