29Jun/06

I Lost the Cure for the Common Cold!

By Daniel R. Matlis 

It’s 3:00 AM and your newborn baby wakes up crying. You want to go back to sleep, but his circadian rhythm is set for Beijing, not Philadelphia, and he is wide awake.So you get a cup of coffee, turn on your laptop and start to do some work. In a moment of inspiration, you discover the cure for the common cold. It’s all there on the screen right in front of your eyes and then your baby kicks, the coffee spills on your laptop and, just like that, the cure is gone. Who do you call?

Monday, at the Corporate Computing Show in NY, I met the people for the job. DriveSavers Data Recovery is a company that recovers data from crashed and damaged media. They have been doing this for over 20 years and when James Bond looses the data in his laptop he doesn’t call Q. Instead he deals with Kelly Chessen, Data Crisis Counselor DriveSavers (Yes, Sean Connery is a client).

With the prospect of irretrievable information loss, many of the callers with whom Chessen deals are as distraught. The emotional trauma associated with the loss of critical data can be disruptive both at work and at home.

Chessen came to DriveSavers with a background in psychology that serves her well in her dealings with often-frantic customers. She worked with a suicide prevention hotline for more than five years, including one year as the manager and trainer. This is exactly the kind of training I want the person on the other end of the line to have under these circumstances.

In addition to the soft skills, DriveSavers has technical skills and facilities to back them up. They have recovered data from drives that have been damaged, dropped, deleted, burnt, crushed and drowned in the Amazon River. The company has a success rate of over 90%, and recovers data in as little as 24 hours from all operating systems and storage media including hard drives, disk arrays, floppies, CD-ROM, DVD, removable cartridges and digital camera media. They have they own calls 100 clean room, and if they work on your drive, the manufacturer’s warranty is still good, although I’m not sure that a drive full of Amazon River water is covered.

So the next time your husband, wife, son, daughter, dog, cat or self spill a cup of coffee on your laptop containing the cure for the common cold, or the therapeutic area you are working on, don’t sweat it, lay on the couch and call the Data Shrink.

26Jun/06

Johnson & Johnson to Acquire Pfizer Consumer Healthcare

By Daniel R. Matlis

Johnson & Johnson already had the title of the world’s most comprehensive and broadly based manufacturer of health care products, but with today’s announcement, it also becomes the World’s Premier Consumer Health Care Company.

With the levels of disposable income in developing nations increasing, and the profit margins for prescription drugs and decreasing, the acquisition provides a strong diversified footing for J&J in the healthcare arena. As consumers take greater interest and responsibility for their own health, OTC products are an attractive compliment to Johnson and Johnson’s Pharmaceutical and Medical Device sectors. 

This acquisition continues J&J’s long standing practice of broad diversification in the Life-Sciences and Healthcare markets.  “Being broadly based in health care allows us to leverage our expertise in science and technology across our businesses,” Weldon said. “Through this acquisition, we look to benefit both from Pfizer Consumer Healthcare’s excellent product portfolio and pipeline and from the valuable skills and experience of its employees.”

As our world continues to flatten, it is key to look at emerging markets as consumers not just producers.

This is a fine strategic move by Johnson & Johnson.

23Jun/06

What’s your FDA Site Selection Score?

By Daniel R. Matlis

According to the Food, Drug, and Cosmetic Act, FDA statutorily required to inspect domestic drug manufacturing establishments at least once every 2 years.

There is just one problem,  the number or  registered human drug establishments has increased in the last 25 years while the number of FDA human drug inspections has decreased over the same period.   To address this issue, the FDA has implemented the “Risk-Based Method for Prioritizing CGMP Inspections of Pharmaceutical Manufacturing Sites”. This model, commonly known as the Site Selection Model, utilizes a risk-based inspection approach for prioritizing drug manufacturing establishments for routine cGMP inspection. The model is based on a risk-ranking and filtering method that is well-recognized, objective, and rigorously systematic. Currently there are 3 empirical factors used to calculate a site’s selection score. 

They are:

  1. Product Risk: Factors such as sterility, medical gas, and the determination of prescription (Rx) versus over the counter (OTC) currently in the model are crude surrogates to distinguish between products with higher and lower potential for public health consequence should there be a drug defect.
  2. Process Risk: Some processes are more complex and more susceptible to problems than other processes. The key issues in the implementation of the risk-ranking model involves questions concerning the relevant inherent process risk factors, the relevant process control and risk mitigation factors, and how to weigh/rank them
  3. Facility Risk: Currently, the facility component of the risk ranking model includes 4 factors:
    • History of violation (e.g., CGMP deficiencies have higher weights)
    • History of inspection (e.g., no prior inspection, newly registered/licensed or no CGMP inspection in the past 2 years have higher weights than those with recent CGMP inspection)
    • Estimated volume of production output (surrogate for exposure, e.g., higher volume and production output, higher weights)
    • Type of establishment (e.g., manufacturer, repacker, contract lab)
       

According to Joseph Famulare, acting Director of CDER’s office of compliance, in addition to these three empirical factors, “expert elicitation with emphasis on current FDA priorities is used to determine site selection”. “For example, last year trans-dermal patches were a priority at the agency” said Famulare, so the number of inspection in that area increased.

Famulare said “just under 50% of the cGMP inspections last year were based on the Site Selection Model, with the remainder done at the districts discretion.”

Next year, a new category will be factored in the empirical portion of the calculation. Recall data has already been entered in the database and will be used for Site Selection Model.

You heard about your credit score, it’s time to keep and eye on your Site Selection Score.

22Jun/06

Efficiency, Effectiveness and FDA All In The Same Sentence?

By Daniel R. Matlis

In the past few years, CDER has made significant changes to advance and facilitate the review of electronic regulatory submissions. These include spearheading projects to standardize information management processes, publish regulations and guidance documents to support electronic submissions, and facilitate the development of information management project proposals, which will benefit the consumer and the pharmaceutical industry.

As evidence of the positive impact of these changes, over 3000 e-CTDs have been submitted to the FDA since the it began accepting them 2 1/2 years ago.

Many of these improvements are the work of the Office of Business Process Support (OBPS) at CDER.   “Through the use of the Project Development Staff and other resources within OBPS we started to develop more specialized experience so that over time we are able to turn around this projects more quickly and with higher quality” said Gary M. Gensinger Director of Regulatory Review Support Staff, OBPS at CDER. He continued “that’s what it’s all about.”

Another key area addressed by OBPS is standards. “It’s not about doing the same thing for the sake of doing the same thing, but trying to find out what’s the best practice” said Gensinger. To my surprise and delight he went on to say ”it’s about finding what is the most efficient and most effective way to move forward, so that what limited resources we do have, we can spend that in the review process”.

The FDA is making a concerted effort to harmonize internally as well as externally to focus as many resources as possible on the “Receive, Review, Report” process.

With all this talk about doing more with limited resources, and looking for the most efficient and effective ways get things done, can regulatory outsourcing offshore be the next step?

 I certainly hope not. Regulatory Oversight is not a function we want to outsource.

21Jun/06

FDA Must Become An Information Provider As Well As A Regulator

By Daniel R. Matlis

“This is a Challenging time for the FDA and the Industry” said Janet Woodcock, MD, FDA’s Deputy Commissioner of Operations and Chief Operating Officer, at the Drug Information Association’s 42nd Annual Meeting.

She listed 6 key trends facing the industry:

1-Biomedical Science Investment by industry is beginning to pay off with new personalized medical treatments and combination therapies.

2-Healthcare is entering the Information Age in the US where patients are not waiting for Doctors to assess their condition. With access to information on the internet, patients are going to the doctor’s office armed with information on their condition and possible treatments options.

3-The shift in population trends and level of activities have caused obesity and nutritionally related illnesses to reach an alarming level.

4-The cost of healthcare has had a severe impact on industry competitiveness. Healthcare economics, not outcomes are directing patient care.

5-Globalization is requiring the FDA to look outside of its originally mandated domestic jurisdiction.

6-Constraints on FDA resources are challenging the agency in the face of higher expectations from Congress and the American public.

To respond to these realities, the FDA must undergo a transformation. The agency must become an “enterprise agency instead of separate centers” said Woodcock alluding to the silos within the agency.  “The public wants to interact with one FDA, not separate centers” she added. 

As we move away from therapeutic areas and into solutions based medicine, including pharmacogenomics, personalized medicine and combination products, “FDA must become an information provider as well as a regulator” said Woodcock. Her mandate is to re-assess the agency’s structure to leverage technology investment and human capital across the agency.