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Columns

Market Access Trends and Outlook

Regina Au

What Are the Next Game Changing Drugs in Cancer Therapy?:

Why are IO therapies buzzing today? If we look back at the history of cancer treatment, the survival rate was measured in months, which according to oncologists was a lot back then, because the mortality rate in most cancers was 100%. Most traditional chemotherapies were not well tolerated, because they would kill both cancerous and healthy cells, leading to major side effects such as loss of hair, nausea and vomiting, and risk of infection. Survival was sometimes better, but not much better, depending on the type of cancer and the patient's own genetic and physiological make-up. The big advantage of IO therapies is that they can target specific receptors on the cancer cells and destroy them while leaving the healthy cells alone. This will also help reduce some of the traditional side effects when healthy cells are destroyed.

by: Regina Au
Published: October 25, 2016
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Regina Au

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.

by: Regina Au
Published: July 4, 2015
Tags: UDIs, UDI, Unique Device Identification for Medical Devices, REgina Au, medical device UDIs

Regina Au

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 manufactured in a fraction of the time with details that can be easily customized.[i]

by: Regina Au
Published: May 15, 2015
Tags: REgina Au, 3d printing, 3D Printing Biotech

Regina Au

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.

by: Regina Au
Published: May 2, 2015
Tags: REgina Au, immune system, leaky gut, gut microbiome, immune response balance

The Clinical Trial Diary

Georger

George Clinical harnessing innovation to improve patient retention in clinical trials :

George Clinical’s parent organisation, The George Institute for Global Health and its TEXTCARE application, has been named a top 10 finalist in this year’s Google Impact Challenge. With a top prize of AUD $750,000, The George Institute has the opportunity to use its proven text messaging platform to tackle chronic disease on a global scale.

by: George Clinical Representative
Published: October 21, 2016
Tags:

Georger

EDC Platform Investment Is Critical To A CRO’s Survival :

As the costs and complexities of running clinical trials increase, so does the impetus, indeed obligation, to invest in fully integrated eSystems that are essential to simplifying the overall clinical trial process.

by: George Clinical Representative
Published: October 11, 2016
Tags:

Georger

Case Study: Scientific Leadership in complex, multi-regional trials boosts recruitment across the board:

The scientific leadership model for conducting clinical trials is relatively new. Despite its novelty, scientific leadership continues to prove its worth when comparing recruitment metrics both before and after the addition of scientific leadership into some of the world’s most complex, multi-regional trials. The implementation of scientific leadership into any clinical trial has shown to motivate and engage investigators, many of whom maintain their connection with the scientific leader (and their affiliate CRO), long after any one trial finishes. As such, the scientific leadership model illustrates its utility through its capacity to develop (and maintain) robust, engaged clinical networks from which to draw data of the highest scientific standards.

by: George Clinical Representative
Published: October 4, 2016
Tags:

Georger

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 lives

by: George Clinical Representative
Published: August 2, 2016
Tags: investigator network, clinical, clinical trials, clinical trial supply. george clinical, dementia, dementia trials, George Institute for Global Health, Dr Candice Delcourt, Professor Bruce Neal, Professor Craig Anderson

Artwork Matters

Andrew Love

Lessons Learned On The Road To Serialisation:

This next series explains, in a series of learning points, some of the key things that we wish we had known before embarking on our early projects.

by: Andrew Love
Published: September 6, 2016
Tags:

Andrew Love

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.

by: Andrew Love
Published: June 21, 2016
Tags:

Andrew Love

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.

by: Andrew Love
Published: May 16, 2016
Tags:

Andrew Love

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.

by: Andrew Love
Published: April 8, 2016
Tags: pharma, pharmaceutical, serialisation, serialization, track and trace, anti-counterfeit

Making Tomorrows Medicines

Tony Hitchcock

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.

by: Tony Hitchcock
Published: May 10, 2016
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Tony Hitchcock

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.

by: Tony Hitchcock
Published: March 22, 2016
Tags: manufacturing, pharmaceuticals, pharma, biotechnologies, biotech, biopharma, therapeutics, gene therapy, cell therapies,, disposable manufacturing, vaccinces,, CMOs, pharma firms, Big Pharma, SME pharma, drug developer, Tony Hitchcock, contract development

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 year

by:
Published: December 22, 2015
Tags: knowledge exchange, partnership, academic groups, pharma, biotech, market access, mergers and acquisitions,

Tony Hitchcock

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.

by: Tony Hitchcock
Published: September 21, 2015
Tags: manufacturing, technologies, Tony Hitchcock, processes, DNA, gene therapy, genomics, clinical evaluation, clinical experience

Women In Shared Services

Georger

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.

by: George Clinical Representative
Published: March 22, 2016
Tags: clinical, south korea, korea, clinical trial, clinical sites, multinational clinical study, local clinical study, Korea National Enterprise for Clinical Trials, KoNECT, CRO, contract research organisation, R&A

Market Access Insights

Dr Steven Bradshaw

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.

by: Dr Steven Bradshaw
Published: March 15, 2016
Tags:

Dr Steven Bradshaw

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.

by: Dr Steven Bradshaw
Published: December 7, 2015
Tags: Spain, Spanish market, Dr Steven Bradshaw, Dr David Carr, Spanish health technology assessment paradigm

Dr Steven Bradshaw

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.

by: Dr Steven Bradshaw
Published: December 7, 2015
Tags: austerity measures, pharma, Greece

Dr Steven Bradshaw

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.

by: Dr Steven Bradshaw
Published: December 7, 2015
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View From The Consultants Chair

Robert Musterer

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 that the... Read more

by: Robert Musterer
Published: August 9, 2015
Tags: Robert Musterer, EDC systems, CROs, Contract Research Organisations, Clinical Trials, Solutions, Pharma clients

Robert Musterer

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 are these... Read more

by: Robert Musterer
Published: February 19, 2015
Tags: clinical data repositories, clinical data, Robert Musterer, Clinical Data Repository, clinical data wsarehouse

Robert Musterer

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 software... Read more

by: Robert Musterer
Published: January 16, 2015
Tags: Robert Musterer

Biopharma Trends and Outlook

Eric Langer

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.

by: Eric Langer
Published: April 19, 2015
Tags: leachables, extractables, leachables and extractables testing, single-use devices, Eric Langer, 12th Annual Report and Survey of Biopharmaceutical Manufacturing, biomanufacturing

Eric Langer

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.

by: Eric Langer
Published: February 11, 2015
Tags: single-use, disposable bioprocessing

Eric Langer

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.

by: Eric Langer
Published: October 22, 2014
Tags: biomanufacturing, single use systems, disposable solutions, pharma manufacturing, Eric Langer

Eric Langer

Biopharma Suppliers’ Budgets Increase: Bellwether for Better Times:

Biopharmaceutical companies have weathered a rough recession, layoffs, and budget trimmings. These cutbacks have affected their vendors as well. In BioPlan Associates’ 8th Annual Report and Survey of Biopharmaceutical Manufacturing, we surveyed 352 biotherapeutic manufacturers, and 180 of their vendors, in 32 countries. The substantial budget cuts at vendors that started in 2008 have begun to turn around. We measured 10 budget areas for vendors to this industry. Sales budgets, the only area that did not take a downturn, continued to increase, this year, by an average of 5% globally.

by: Eric Langer
Published: December 14, 2011
Tags: Eric Langer, manufacturing, surve, biopharmaceutical, BioPlan Associates, R&D

Pharma Cyber-Karma

Mollie Shields-Uehling

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.

by: Mollie Shields-Uehling
Published: September 28, 2014
Tags: Mollie Shields-Uehling, global regulatory leadership, European Medicines Agency, electronic documents, digitally signed electronic documents, Digital Signatures

Mollie Shields-Uehling

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 standard easier... Read more

by: Mollie Shields-Uehling
Published: August 18, 2014
Tags: digital workflows, Systems, Mollie Shields-Uehling, SAFE-BioPharma, SAFE-BioPharma systems

Mollie Shields-Uehling

What Every CRO Should Know When Becoming Fully Electronic:

As the global CRO community studies how to most efficiently move to fully electronic business processes, there are numerous issues that must be addressed to assure secure global collaboration. These include identity trust, data integrity, regulatory compliance, and time and cost savings.

by: Mollie Shields-Uehling
Published: November 29, 2011
Tags: Mollie Shields-Uehling, SAFE-BioPharma standard, SAFE-BioPharma, electronic laboratory notebooks, ELNs, ELN, electronic business processes, informatics, SAFE-BioPharma digital identity, CRO

Mollie Shields-Uehling

Six Questions to Ask Before Investing in a Digital Identity or Digital Signature Solution:

When evaluating any digital identity or digital signature solution, ask these questions. The answers will help determine if you’re about to get full value for this important decision

by: Mollie Shields-Uehling
Published: October 4, 2011
Tags: Mollie Shields-Uehling, digital identity, digital signature, digital signing solutions, SAFE-BioPharma, digital identity standard, digital signature standard, DEA compliant, SAFE-BioPharma standard

Using Informatics to Streamline Pre-Clinical Drug Discovery

sheraz-gul

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.

by: Sheraz Gul
Published: June 9, 2014
Tags: Drug Discovery, Open Source, Open Source for drug discovery, Sheraz Gul

sheraz-gul

Cloud Computing and Drug Discovery:

Cloud computing is likely to become an essential technology in the pharmaceutical industry. While some of the purported benefits such as the computer-aided screening are not likely to transform the pharmaceutical industry, its many other advantages such as the ability to afford a potentially vast amount of computational power will remain crucial in augmenting the competitiveness of a pharmaceutical company.

by: Sheraz Gul
Published: July 22, 2013
Tags: cloud computing, Drug Discovery

sheraz-gul

REVIEW: 8th Annual Smartlabs Exchange:

Columnist Sheraz Gul shares highlights of the recent 8th Annual Smartlabs Exchange. The main themes included the future of lab informatics, implementing solutions to improve efficiency, data integration and smart knowledge sharing, enabling a more efficient lab.

by: Sheraz Gul
Published: April 3, 2013
Tags: 8th Annual Smartlabs Exchange, Sheraz Gul, informatics, lab informatics, data integration, smart knowledge sharing, Big Data

sheraz-gul

The role of IT initiatives by the European "Innovative Medicines Initiative" in supporting drug discovery:

We are currently witnessing an expansion in the disciplines encompassing drug discovery outside the pharmaceutical industry. This is most notable with a significant number of Universities worldwide now hosting infrastructures such as compound libraries and automated screening systems.

by: Sheraz Gul
Published: February 27, 2013
Tags: informatics, Drug Discovery, Innovative Medicines Initiative, IMI, bioinformatics, cheminformatics

Laboratory Automation

Joe Liscouski

Labs In Transition: Externalization, Virtual Labs, and Lab Managements Role:

The interest in virtual labs may be the catalyst for driving the development of data interchange standards for lab instrumentation and informatics systems.

by: Joe Liscouski
Published: September 8, 2013
Tags: lab automation, pharma informatics, pharma technology, LIMS, ELN

Joe Liscouski

Labs In Transition: Moving beyond the Lab IT function:

There is a gap between the experience of both lab and IT professionals when it comes to the details of planning, implementation, project management, etc. that is needed to successfully exploit the capabilities of modern lab technology. Joe Liscouski describes the need for a new discipline of Laboratory Automation Engineering

by: Joe Liscouski
Published: July 16, 2013
Tags: Lab engineering, labroratory automation, Joe Liscouski, ELNs, LIMS

Joe Liscouski

Labs in Transition: The Digital Face of Laboratory Science:

The problems facing modern laboratories in informatics are significant, with the regular implementation of new software and hardware labs can quickly find themselves overwhelmed. Our columnist Joe Liscouski guides you through the planning required for an implementation.

by: Joe Liscouski
Published: May 20, 2013
Tags: informatics, LIMS, ELN, laboratory automation, Change Management

Joe Liscouski

Lab Automation: What we need to accomplish in 2013:

If we accomplish one thing in 2013 it has to be a change in mindset, from “lab automation/computing is about products” to “lab automation/computing is about systems design”.

by: Joe Liscouski
Published: February 20, 2013
Tags: laboratory automation, informatics, systems design, LIMS, ELNs

Drug Delivery

René Holm

The Search for New and Innovative Excipients – Possible Applications of Semi Fluorinated Alkanes:

Identifying delivery routes to optimise bioavailability is a core topic in delivering safer, more effective drugs to market. In his latest column, René discuses the chemically curious compounds, semi-fluorinated alkanes and their uses as excipients

by: René Holm
Published: May 6, 2013
Tags: SFA, drug delivery, René Holm, bioavailability, excipients

René Holm

Buccal Delivery: Simple Physical Chemical Considerations:

Efficient treatments options that are acceptable for both the patients and the physicians are the corner stones in drug development within the pharmaceutical industry. In his new column, 'Drug Delivery', René Holm, Head of Pre-formulation at Lundbeck looks at how Buccal delivery has been explored intensively during the last decade to overcome the disadvantages of oral drug delivery.

by: René Holm
Published: September 4, 2012
Tags: drug delivery, Buccal Delivery

Change Is Good

Jon Wetzel

OpEx for 2013 – Crystal Ball Predictions:

To look forward we need to first look back. From 2008-2012 we saw big pharma collide creating larger companies. Genentech-Roche, Novartis-Alcon, Pfizer-Wyeth and GlaxoSmithKline-Human Genome Sciences just to name a few. During this same time frame the economies of the world have seen crashes and upheavals causing some of these same companies to “trim” their workforces. What does all this mean for 2013?

by: Jon Wetzel
Published: March 7, 2013
Tags: biotech, small biotech, Operational Excellence, OpEx, pharmaceutical excellence, Genentech-Roche, Novartis-Alcon, big pharma 2013, pharma predictions 2013, Jon Wetzel, GlaxoSmithKline-Human Genome Sciences, Pfizer-Wyeth

Jon Wetzel

Doctor Who – Change Agent with a TARDIS:

What lean business knowledge can we learn from a fictitious doctor that travels through space and time in a shiny police box? Let’s discuss.

by: Jon Wetzel
Published: January 13, 2013
Tags: Lean, lean business knowledge, lean pharma, Jon Wetzel

Jon Wetzel

Chunk it or Choke on it!:

We’ve finished the future state map on how to fix the entire system but it’s going to take us at least a year, involve a ton of man hours and cost a lot of money. It also involves every department and it’s going to triple our daily work load until we get all the bugs worked out.” Have you heard this before? Did the idea flash and then fizzle? Next time….Chunk it!

by: Jon Wetzel
Published: October 17, 2012
Tags: Jon Wetzel, project management, future state map, Project Management Professional

Jon Wetzel

Hand Waver or Hand Shaker:

The Queen waved to 80,000 attendees and 700 million viewers at the opening ceremonies of the 2012 Olympics. I doubt we all saw her wave and I’m certain she didn’t see me wave back.

by: Jon Wetzel
Published: August 6, 2012
Tags: Jon Wetzel, Communication, business relationships

LPHII LifeSciences Pharma Healthcare Innovation and Integration

Shirley Williams

7 Key Highlights About Socializing Health Care:

Under the umbrella of socializing health care, I recently had the opportunity to interview Colleen Young, Founder of Healthcare Social Media Canada. The topic was: “What is the social activity in the health care space and how is it enabling our approach on health care?” I was thrilled that I could get into her schedule on two separate occasions to have this discussion. Below I capture 7 key highlights from those interviews:

by: Shirley Williams
Published: December 2, 2012
Tags: social media tools, social media health care, Shirley Williams, public health

Shirley Williams

10 Reasons Why Patients Blog and The 5 Reasons Why They Don’t Tell Their Doctors.:

I was struck by the number of patients that do indeed blog and the reasons why they have turned to the social web. However what was more enlightening, and at the same time emotionally dampening, were the reasons why many do not tell their doctors about their blogging activities.

by: Shirley Williams
Published: September 30, 2012
Tags: patient communication, patient bloggers panel, Shirley Williams

Shirley Williams

3 Key Drivers that Have Enabled the Rise of the Patient:

What exciting times we are living in. Well I guess it depends on what side of the table you happen to be sitting but I think it exciting regardless. It is fair to say marketing as we know it has radically changed. The arrival of the social environment has forced traditional Marketers to rethink their strategies and tactics in the marketplace. Well, if it hasn’t, it should! Here are the reasons why:

by: Shirley Williams
Published: August 27, 2012
Tags: active patients, patients, social media pharma, social media marketing, pharma marketer, pharmaceutical marketing, patient involvement, e-Patient, participatory healthcare

Ensuring a Change for the Better

Cristina Falcão

Big Pharma Logistics: E-Pedigree, RFID and Cell-Phones:

Globally, commercial goods, pharmaceutical, biomedical/biologics including commercial and military aerospace industries all experience product infiltration with unknown, non-genuine, stylish imitation, countless after-market knock-offs. Within these mentioned applications, the basic method of applying an adhered seal is lacking and insufficient as the seal is quite easily substituted or replaced.

by: Cristina Falcão
Published: October 22, 2012
Tags: Cristina Falcão, pharma logistics, logistics, RFID

Cristina Falcão

Fighting the Battle against Drug Counterfeiting; How Document Automation Can Assist:

Today’s Supply chain companies demand a near perfect order record to reduce the cost of labor, transportation and errors within their distribution centers. We interviewed Tom Napier from PSI Engineering, which provides tailored products to the pharma industry.Their systems not only reduce costs, but also helpfight counterfeiting and secure the integrity of the pharmaceutical supply chain.

by: Cristina Falcão
Published: August 28, 2012
Tags: Cristina Falcão, Tom Napier, PSI Engineering, droug counterfeiting, counterfeiting, supply chain, document automation

Cristina Falcão

Pharmacy Logistics Knockout Reimbursement Schemes:

It is pretty amazing how, with only one strike, the pharmacy logistics of an entire country knocked out all the reimbursement schemes and it took two years to understand the problem and try to fix it to some extent. I was so fascinated by this mystery that I decided to investigate and published my conclusions some years back

by: Cristina Falcão
Published: July 22, 2012
Tags: Cristina Falcão, payers, invalid prescriptions, pharmacy logistics, reimbursement schemes

Cristina Falcão

The Portuguese Pharmacy and Supply Chain:

We don’t handle drugs inside the pharmacy, we have packages, sealed, and with the bar code, batch number and expiration date in the label and in the blisters or any other pharmaceutical form labels inside the outer package.

by: Cristina Falcão
Published: June 24, 2012
Tags: Cristina Falcão, portuguese pharmacy, supply chain, INFARMED, OTC, counterfeited medicines, pharmacy

Pharma Industry Excerpts

Tye Spillum

Raising the bar: 5 Areas for Improvement within the Pharmaceutical Outsourcing (CDMO model):

Within the last few years the Pharmaceutical industry has taken a change in direction. Outsourcing (CDMO - external manufacturing model) has become a normal course of business.

by: Tye Spillum
Published: September 19, 2012
Tags: pharma outsourcing, CDMO

ELN Project and Program Innovations

Anthony Chambers

The Art of Measuring the ROI of ELNs - Keep it Real:

Typical corporate business cases are created to demonstrate strategic alignment, define scope, identify risks, target resource requirements, obtain funds, and show the financial and operational benefits after the project has gone live, i.e. ROI. It’s this last set of measures that often remain elusive for ELNs, but are critical for project justification.

by: Anthony Chambers
Published: May 14, 2012
Tags: Anthony Chambers, ELN, ELN ROI, electronic laboratory notebooks

Anthony Chambers

Sustain Your ELN – Before You Start Your ELN:

Change management can be found as a bullet under “critical success factors” in many Electronic Lab Notebook project charters. Touted as crucial in determining the success of an ELN, many agree in principle that change management is needed, but don’t know how to go about making it effective, tangible, and measurable.

by: Anthony Chambers
Published: January 24, 2012
Tags: ELN, ELNs, Anthony Chambers, electronic laboratory notebooks

The Q Pages

Peter Boogaard

Implementing QbD Initiatives:

But what is Quality? How do you measure Quality? Is Quality related to a product, a process or a system or all above? The Quality Transformation is a culture of commitment to continual improvement

by: Peter Boogaard
Published: February 19, 2012
Tags: Quality by Design, Peter Boogaard, continual improvement, quality, QbD, ICH Q10 guidelines

Market Access and Value Based Pricing

Stuart Carroll & Alasdair Williams

Value-Based Pricing in 2012 – Is it Still Worth the Trouble?:

As the old aphorism goes, a New Year means a new beginning. It also provides an opportunity for all of us to make New Year resolutions – promises we make to one or more lasting personal goals, projects, or the reforming of a habit. In the world of health policy, this has added meaning. The Government continues to face opposition to its NHS reforms.

by: Stuart Carroll & Alasdair Williams
Published: February 7, 2012
Tags: value-based pricing, VBP, Stuart Carroll, Alasdair Williams, pharmaceutical pricing, Pharmaceutical Price Regulation Scheme, PPRS, NHS reforms, Andrew Lansley, George Osborne, UK Government, NHS drug availability, health economy, health economics, NHS

Managing the Laboratory Ecosystem

John Trigg

Peace in our Time? R&D and the IT Department:

One of the consequences of the increasing convergence of science and technology is the nature of the relationship between R&D and IT. As scientists increasingly depend on information technology as an integral component of laboratory work, they become increasingly dependent on the IT infrastructure and IT resources.

by: John Trigg
Published: December 19, 2011
Tags: John Trigg, informatics, laboratory informatics, R&D, IT, IT infrastructure, pharma IT, pharmaceutical IT

John Trigg

Management Buy-in and User Acceptance in an ELN Project:

But the management commitment is also required throughout the implementation phases. Getting the balance right between hands-off and hands-on is critical; too much hands-off, and the project team and users get concerned whether management cares; too much hands-on and it can feel like interference and a lack of trust.

by: John Trigg
Published: September 11, 2011
Tags: John Trigg, phaseFour Informatics, ELN, ELNs, electronic laboratory notebooks, ELN project informatics, advanced laboratory solutions

John Trigg

Where Do the Ideas Come From?:

When it comes to purchasing and implementing laboratory systems’ software, return on investment is inevitably one of the key drivers. The up-front requirements to justify the expenditure are usually aligned to process improvement and productivity often driven by a functional need to work with dispersed teams, across different sites, regions and time zones. But there’s usually a secondary, softer requirement aligned to return on investment, but more difficult to quantify, that alludes to an improvement in knowledge management within the organisation by making laboratory information explicit, accessible and reusable.

by: John Trigg
Published: June 6, 2011
Tags: John Trigg, laboratory informatics, implementing laboratory systems, laboratory systems, knowledge management, KM, Data Management, Information Management

The Future of Regenerative Medicine

Amy Patel

The Future Potential of Human Limb Regeneration:

Salamanders and newts can regenerate missing legs, tails and eyes in just weeks! Why can’t mammals possess the same super powers of regeneration as these smaller animals?

by: Amy Patel
Published: September 19, 2011
Tags: Amy Patel, regenerative medicine, human limb regeneration

Amy Patel

Solving the Challenges of Stem Cell Tissues:

Although there are many political and scientific hurdles that need to be overcome, the future of regenerative medicine is strongly racing forward.

by: Amy Patel
Published: August 18, 2011
Tags: Amy S. Patel, stem cells, stem cell tissues, regenerative medicine, stem cell implantation

Pharma Patents

Alpesh Pathak

Patent Drafting and Claim Construction:

To determine whether the patentee has right to exclude for a particular claimed invention, it is essential to know what is claimed and this process is called determining the scope of the invention or claims construction.

by: Alpesh Pathak
Published: July 14, 2011
Tags: Alpesh Pathak, Alembic Pharmaceuticals, patent cell, patents, claim construction, patent infringement litigation, pharma IP, pharma patents, claims construction, IP, intellectual property, patenting crystalline forms, IP strategies crystalline forms

Drug Safety Please Read the Insert

Elie Magdalani

Pharmacoepidemiology and Pharmacovigilance:

As an important arm for pharmacovigilance, recently many voices are raised to consider using clinical trials in the post-marketing surveillance phase and not only depending on non-clinical or experimental methods to study drug safety issues after marketing the drug.

by: Elie Magdalani
Published: July 3, 2011
Tags: Elie Magdalani, pharmacoepidemiology, pharmacovigilance, epidemiology, drug safety, clinical pharmacology, adverse drug reactions, Adverse Drug Reaction, ADRs, Adverse Event, AE, pharmacovigilance activity

Elie Magdalani

Medication Errors - A Shared Responsibility:

We can not separate pharmacovigilance from medication errors, pharmacovigilance had always been concerned with minimizing the risks of adverse drug reactions and medication errors. Pharmacovigilance contributes to the detection and prevention of medication errors, collaboration of all parties will improve the quality of data collected, and enhancing patient safety. A shared responsibility, in detecting Medication Errors depends on the collaboration of the patient, the pharmaceutical companies, the pharmacovigilance centers, and poison control centers.

by: Elie Magdalani
Published: June 2, 2011
Tags: Elie Magdalani, Ranbaxy Egypt, medication errors, ME, pharmacovigilance, detection medication errors, prevention medication errors, pharmacovigilance ADRs, patient safety, drug safety, error analysis, drug labeling and packaging

Elie Magdalani

Global Drug Safety and Risk Management:

The role of pharmaceutical companies is to decide how to manage the results of an AE signal. Some drug companies develop and prepare the safety programs that are implemented from the moment drugs when enter their product portfolio. Also collecting and analysing data in an advance way is an important tool in drug safety and risk management program. In this concern, whatever the approach selected, each program needs to be reasonably relevant to the nature of the risk. When a signal of a potential side effect is detected it should be documented with its response.

by: Elie Magdalani
Published: May 5, 2011
Tags: Elie Magdalani, Ranbaxy Egypt, pharmacovigilance, drug safety, Risk Management, global drug safety, reported adverse events, AEs, adverse events, ADR, risk assessment, signal detection, AE signal

Elie Magdalani

Patients Safety and Clinical Trials:

Emerging new safety data may result in an action plan by the pharmaceutical company producing a drug to review its data retrieved during the clinical trail phases and especially in Phase II conducted to demonstrate and assess the product’s safety.

by: Elie Magdalani
Published: February 3, 2011
Tags: Elie Magdalani, Ranbaxy Egypt, pharmacovigilance, Clinical Trials, drug safety, AE, ADRs, post-marketing surveillance

Risk Based Implementation of Single Use Systems

Stephen Brown

Implementing Single Use Systems:

The deployment of Single Use Systems (SUS) has become a hot topic within the biopharmaceutical industry. From its origins in filtration technology and blood containers, the technology has developed rapidly. In the last couple of years and in response to end-user demand, all of the major suppliers have improved their capabilities and technology offering and it’s now possible to exploit single-use technology for practically all upstream and downstream bioprocess and fill and finish operations.

by: Stephen Brown
Published: June 30, 2011
Tags: Stephen Brown, single use systems, SUS, downstream bioprocess, single-use system, SUS Implementation Plan, disposable solutions, biomanufacturing