Mobile Devices in Medicine

There’s been a lot of interest in expanding the use of mobile electronic devices as a part of medical treatment. They’ve been in use in clinical trials (for Patient Reported Outcomes, or ePRO) for years starting with Palm Pilot devices with both good and bad results. A lot has been learned in that time; security and data integrity safeguards are improving. However, as devices get more powerful and more complex, new issues are being discovered…..even in the “Apple Magic Bullet” that is touted (and marketed) as being superior on that front. Case in point (Click Link for Full Article):

Germany warns of Apple security problem

By JUERGEN BAETZ, Associated Press Writer – 04 AUG 2010
BERLIN – Several versions of Apple’s iPhone, iPad, and iPod Touch have potentially serious security problems, a German government agency said in an official warning Wednesday.
Apple’s iOS operating system has “two critical weak points for which no patch exists,” the Federal Office for Information Security said.
Opening a manipulated website or a PDF file could allow criminals to spy on passwords, planners, photos, text messages, e-mails and even listen in to phone conversations, the agency said in a statement.
“This allows potential attackers access to the complete system, including administrator rights,” it added, urging users not to open PDF files on their mobile devices and only use trustworthy websites until Apple Inc. publishes a software update.

There’s enormous opportunity with new technologies, but a profround responsibility to be diligent in assessing them and protecting their data.

~TJK

More Bad News for Travel

As reported by the BBC, British Airways flight crews will begin their strike soon.

Continental to Cancel Flights to Avoid Fines

As a business traveler, this is troubling news:

http://news.yahoo.com/s/ap/20100309/ap_on_bi_ge/us_continental_airlines_cancellations

Due to the government’s knee-jerk reaction, the cost of travel will be rising sharply. Now, I hate getting trapped on the plane too, but the cost of these fine (and the costs associated with avoiding them) *will* be passed on to consumers….as will difficulty in getting where we’re going. Sounds like a great idea, doesn’t it?

TJK

New Drug Development – 1.5 Billion Dollars

I was sad (though not surprised) to hear of JnJ’s pending layoffs. I have friends who work there. However, the thing that really caught my attention in this article is that the cost to develop a new drug has moved from US $800 Million to US $1.3-1.5 Billion in just a few years. I don’t have a lot of time to expound on this, but thought it worth flagging.

~TJK

J&J to slash 7,000 to 8,000 jobs

By Ransdell Pierson –

NEW YORK (Reuters) – Johnson & Johnson plans to cut up to 7 percent of its workforce in order to generate cost savings needed to finance increasingly costly drug research and to weather future challenges, the diversified healthcare company said on Tuesday.
J&J said the planned restructuring will eliminate 7,000 to 8,000 jobs and generate annualized cost savings of $1.4 billion to $1.7 billion by 2011…..[snip]

The typical cost of developing a new medicine has now climbed to between $1.3 billion to $1.5 billion, from a cost of $800 million only a few years ago, Weldon said. He noted that J&J and other drugmakers increasingly are partnering with rival companies in order to share such financial gambles…..[snip]

Defending Pharma

As all of the discussion on Healthcare reform comes to a head, I think it warrants some comments from me regarding “The Greed of Pharma”.  Let me start by saying that Pharma is a for-profit business like any other.

I think it is important to note that neither pharma (nor the insurance industry for that matter) has particularly high profitability (ROE %’s). The following industries have a higher ROE % (Return on Equity rating) than Pharma (21 of them, and in the order listed). Cigarettes has nearly triple Pharma’s profitibility (and the US Gov is a de facto share holder); Aerospace has double. So why would Pharma be expected to foot the healthcare bill (and squeal like a pig -to paraphrase Congressman Marion Berry of Arkansas) when there are so many other more deserving candidates?

 

Cigarettes

Aerospace/Defense – Major Diversified

Information & Delivery Services

Diversified Computer Systems

Cleaning Products

Beverages – Wineries & Distillers

Processed & Packaged Goods

Auto Parts Stores

Education & Training Services

Application Software

Personal Services

Food Wholesale

Industrial Metals & Minerals

Restaurants

Gas Utilities

Management Services

Personal Products

Personal Computers

Agricultural Chemicals

Diversified Communication

Electronics Stores

 

~TJK

SQA Abstract 2 – Building a Better Way

And here’s the second abstract I submitted. This one is with colleagues from Data Management and Systems Validation (IT). It should be a really good session. Again, fingers crossed.

~TJK

Building a Better Way: The Evolution of eDC/Clinical Database Validation Processes

The power and real-time feedback made possible by implementing “eDC”/eCRF systems makes them indispensable to Clinical Research. However, the Data Management groups that typically own these systems often struggle with the appropriate way to implement and validate them; and then struggle in their attempts to appropriately validate the study-specific databases that they build within them. There are many reasons for this including: cGMP-centric concepts and terminology associated with validation, inflexible/inscalable validation methodologies, Data Management groups often being “semi-technical” in expertise-level, the dual role Data Management has in terms of being both Developers and Users of the system, etc. By partnering with the right resources and using the right tools, a Data Management group can move to a more dynamic validation paradigm with processes that make their validation more meaningful, their testing more robust, and their timelines shorter.

I. From the QA Perspective: This session will identify the challenges encountered in the implementation of eDC, the tools and ad hoc methodologies that were used, the processes that were developed, and the evolving role of QA moving from “a police” role, to a “partner” role, and ultimately to a fully independent role in which QA audits a process in which they are not involved day to day.

II. From the IT Validation Perspective: This session covers the challenges of providing validation services to a GCP-regulated area, the importance of understanding the more dynamic nature of Clinical Research as contrasted to the cGMP/GLP environments with which most Validation Engineers are familiar, methods for evaluating, adapting, and supplementing a vendor’s “canned scripts”, the importance of managing external vendors who are conducting testing on behalf of the Validation Manager.

III. From the Data Management Perspective: This session explores the challenges experienced by a Data Management/Programming group while moving from a “The Vendor builds our trials” model to a “We build our own “eDC” trials. We will share our journey through the frustration of finding that none of the Validation tools/templates that were available met the needs of our DM (and Client) groups, through working with our IT, ClinOps, and QA partners to build the tools we need, through reluctant skepticism regarding timelines, and ultimately to a point where the process is both improving our output and shortening our timelines.

SQA Abstract – Impact of eSystems, etc.

I’ve submitted this abstract to the SQA for their annual meeting in April and am really hoping it is accepted. A very similar one that I posted last year was not….but this year, it seems that this sort of stuff is on their “hot topic” list. Fingers crossed.

~TJK

The Impact of Electronic Systems, eHRs, and eData on Clinical Research

Although the use of electronic data in the pharmaceutical industry is by no means a new phenomenon, its impact has evolved over time. Technology has revolutionized our lives in many ways; in the way we access information, in our entertainment, in the way we do business, and in the way we interact. This technological revolution has had very pronounced impacts on the GxP industries: eRecords, eData, eSignatures, Data Processing, Data Mining and the Regulatory Standards associated with them.

These impacts have been most apparent in the cGMP and GLP areas and there is a fair level of comfort with eData and Validation in those areas. Increasingly however, the impact of eData and the need for controls around its use can be seen in the GCP area. Due to its large reliance on external sources of data, Clinical Research has some unique challenges. This session will cover:

I. Technology in Pharma and Validation Overview: a discussion of these concepts (which are widely felt to be cGMP artifacts) and relating them to the GCP area through analogies.

II. Centralized GCP Technology: The use of centralized eData and eSystems, primarily on the “sponsor side” has some unique challenges due to very short timelines and the external nature of clinical data inputs. Also the challenges of study-specific validation activities will be addressed.

III. De-Centralized GCP Technology – “Technology at the Clinic”: The advent of electronic Health Records (eHRs) has had a profound impact on Clinical Research and the way in which source data is handled, however the adoption of eHRs has been uneven, piecemeal, and largely independent of any research concerns . Resultantly, source data at clinical sites varies widely in format, from purely paper systems through purely electronic integrated source systems. However, a large and growing number of sites use a hybrid paper/electronic model with various sources of data, scans of source destroyed by hospital systems, paper notes, dictated notes, email notifications, and central sponsor data collection systems. Some ideas on how to address various hybrid source data scenarios will be presented.

Level: Basic Validation, Intermediate Clinical
Key Words: GCP, Electronic Data, Hybrid Source, Validation

Fundamentals of Quality

I’ve gotten some questions of late that have had me thinking about the core of what I do; fundamental questions as to what it is and why. This is a good thing and I feel that now is a good time to till this fertile soil and see what can be learned (or remembered).

Over the next few weeks, I plan to explore these ideas in a series of posts. I’m planning on submitting an abstract or two to the SQA conference and this will be a good stepping-off point to get that effort underway. I plan to present on a subfield in which I am working very heavily in my current role; Clinical System Validation. That is, Computer System Validation for the Clinical (GCP) arena within the greater pharma landscape (pharma, medical devices, and related industries).

In any case, its been too long since I’ve added some really good content here. Keep your fingers crossed that I’ll be able to put up something useful, interesting, or both.

~TJK

SQA

The Society of Quality Assurance is a great professional society for those of us working in Quality Assurance, etc. in Pharma and related industries. I just received email notification that the Quality Assurance Journal from April is now online……This is the one that contained all the abstracts from the annual meeting. A bit slow to move from print to electronic, but I suppose better late than never:

Quality Assurance Journal Volume 12, Issue 2 Content Alert
Dear SQA Colleague:

The Quality Assurance Journal, Volume 12, Issue 2 is now available online! To access the content, please log into the SQA members-only website at www.sqa.org and visit the My Membership page from the menu at the top. The link to the Journal is available on the right side of the page under Publications. SQA Members do not need a separate login to access the Journal through the SQA website. The content listing for this issue is available below. All paid members of SQA receive an online subscription to the QA Journal, included with membership in SQA. If you are interested in contributing to the Journal, please review the information regarding submissions available on the SQA website.

We hope you find this information useful.

Sincerely,

Elliott Graham, RQAP-GLP, Executive Director

Allison Travis, Program Director

Society of Quality Assurance
154 Hansen Rd, Suite 201, Charlottesville, VA 22911 USA
Phone – +1.434.297.4772 Fax – +1.434.977.1856
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Additionally, I would encourage any Quality professional (in the Pharma or related space) who does not yet belong to SQA to consider joining. You can learn a lot and remind yourself of things you already know.

Oh, I nearly forgot. There is also an SQA group on LinkedIn. I encourge you to join that as well.

~TJK

Not a real blogger?

When I first started this blog up, I was flattered that Shel Israel picked up on it. He was excited to find a real Pharma blogger. He actually wanted to interview me for some project or other he was working on, but his interest fizzled as he saw how my blog developed. It wasn’t the content (at least I hope it wasn’t), rather it seemed that he had hoped that it would be a real-time interaction, that I would post often and with reckless abandon, that I would name names, and put it all out there.

Shel (if you’re reading this and I’m sure you are since I linked to you), let me remind you:  I work in PHARMA….And to add to that, I work in one of the most sensative areas of any Pharma company, Quality Assurance – I handle our dirty laundry. Maybe that’s why you found my blog so intriguing at first, you thought I was going to put it out there anyway. Maybe I’m overstating your disappointment. You’re a busy guy (I know, I follow you on Twitter), but I think I’m at least 80% right on this.

Enough picking on Shel. He’s not alone in his disappointment. Pharma, being subject to what is arguably the most demanding body of regulation of any industry, will continue to frustrate the Web 2.0/interactive social media evangelism/technologist/Twitterite set. Pharma is conservative. Pharma is a late adopter of new technologies and paradigms.

Pharma is very, very gun-shy about being served by a regulatory body, fined, demonized, sued, condemned by congress, or otherwise censured. I have former colleagues who have had to testify before congress about questionable clinical data…not a fun time and I’d like to avoid the experience (at least in that context)

So in conclusion, maybe I’m not a real blogger. Maybe I’m a self-edited, self-published, web columnist who publishes on a very sporadic schedule…that’s a mouth full. I guess I’ll just call myself a pseudo-blogger. And I’m ok with that…at least for now.

~TJK