Summaries of the six Pharmaceutical and HealthCare Technologies Division Presentations at SLA 2005 in Toronto

1. Monday, June 6, 2005, 11:30 a.m. - 1:00 p.m.
Generic Pharmaceuticals -- Developing a Crystal Ball to Craft Product Portfolio
Speaker: Michael Kopp, Cardinal Health

Michael Kopp provided an overview of the generic pharmaceutical market. He explained the process of moving brand products to FDA approved generic products. This included basic timelines, major challenges, and current trends for generics. Information sources needed to make key product portfolio milestone decisions for US generics were highlighted.
Summarized by Bernadette Ewen, Aventis Pasteur, bernadette.ewen@aventis.com

2. Monday, June 6, 2005, 3:30 p.m. – 5:00 p.m.
New Paradigms in Drug Safety
Speaker: Dr. Neal Shear, MD, FRCPC, University of Toronto

Dr. Shear is both a practicing physician and clinical investigator. He began with the story of sulfonamide, a drug prescribed in the 1930’s for staphylococcus infections, and given for many other indications until it killed a number of children. This led to the founding of the FDA, and the beginning of the modern drug approval process.
Drug safety is difficult, and safety modeling is very difficult, Many classic drugs would not survive today’s approval process. In Dr. Shear’s opinion, people are over-reacting to safety data. Given the need for consistent scientific testing of drugs, Dr. Shear had many examples of how medicine has become very institutionalized and by-the-book, to its detriment.
New approaches in drug testing include Phase Zero, in which ‘micro-dosing’ would test toxicity and provide bioequivalence data. Reminding the audience that adverse reactions could be the incidental injury or unrelated death of a patient, Shear emphasized that AEs should be clinically significant.
With respect to labeling, Shear questioned the current use of ‘cautions’ and ‘warnings’ as being difficult to impossible for patients or physicians to put in context. He called it ‘more art than science.’
Dr. Shear’s presentation included numerous slides not shown due to time limitations, and these slides are posted here. His presentation was wry and very well received.

Summarized by Bob Moore, Bristol-Myers Squibb Medical Imaging, robert.c.moore@bms.com

With over 70 attendees filling the room to capacity, this session proved to be very popular with attendees. Moderated by Peggy Burnett, Chiron, speakers for this session were Robyn M. Smith, senior manager for Scientific & Competitive Analysis at Millennium Pharmaceuticals, Inc., and Zorba B. Lieberman, Citeline Intelligence Solutions. The speakers gave individual presentations on the why, where and how to find information on clinical trials, along with descriptions of coverage and any limitations that should be considered about a particular source.
Robyn kicked off the program with her lively presentation “Ongoing competitive clinical trials information: mining for gold”. She made a key point that she would speak about ongoing clinical trials and not published clinical trial results. Three areas were covered: Why people ask for this information; Places to find it; and the future of the trial registry movement.
According to Robyn, there are a number of reasons why people ask for ongoing clinical trial information, including identifying principal investigators, a data point in deciding which indications to pursue, determine clinical trial activity, and competitive intelligence, among others. This information can be found on the Web at free government, association and industry sponsored sites and Robyn showed the attendees some examples of these sites. Commercial sources are also a good source, though fees are charged for access to their websites. Two companies providing these services include Trial Trove (produced by Citeline), which Millennium uses, and Recap. Other sources for ongoing clinical trial information can be conferences, analyst calls and press releases. Robyn pointed out that subject area conferences are a great source of information for attendees just by asking people at a booth about their clinical trials. This is public information, but not necessarily published or easily available.
The last area discussed by Robyn was trends in the clinical trial registries movement. Due to recent events with lack of disclosure on data from some clinical trials, new policies for formal public disclosure are being undertaken. Transparency of information about these clinical trials is the theme, which happen to coincide with the theme of the three main speakers at the SLA conference. Robyn focused on the new policy of the International Committee of Medical Journal Editors (ICMJE), taking effect July 2005, which requires that a trial be listed in a public registry as a prerequisite to reports of the results being considered or submitted for publication. She reviewed what is required to be in compliance of this new policy, and some of its shortcomings. In addition, she outlined the need for a global approach to clinical trials registration, as noted by a general consensus of stakeholders in 2004 and under consideration by the World Health Organization. In closing, Robyn noted that there are some United States government actions related to clinical trial registries under consideration. One is the ‘Fair Access to Clinical Trials (FACT) Act of 2005’ that was introduced in the United States Senate on February 28, 2005. This legislation has the support of the American Medical Association. It relates to utilization of the existing public clinical trial registry (www.clinicaltrials.gov) to create a single all-encompassing registry. The other action cited was that the Fact Act would impose civil penalties of $10,000 a day for companies that hide trial data, no doubt, negative results. Robyn indicated there is still a need for more information on pilot and Phase I studies, as well as non-US. centric trials.

Following Robyn’s presentation, Zorba Lieberman, Citeline Inc. chairman and CEO, covered in his presentation how to get more information and how to use that information, with a focus on his company’s product ‘TrialTrove’. He spoke about his company’s services and how coverage is more complete than what is found in the website www.clinicaltrials.gov. He went on to give an overview of some of his company’s tools that can assist in understanding the data available from many public web sources. He then talked about how his clients use clinical trials information to understand their competitive environment and the value of that information for competitive intelligence. In addition, he pointed out that clients make internal business decisions using clinical trials information. According to Zorba, there is a lot of very fragmented and diffuse information about ongoing clinical trials; effective assimilation of the fragments can provide a huge competitive advantage; and companies can use this information to optimize their own drug development.

After the formal presentations, there were a number of questions. One point that arose was that there was potential for analysis of the diagnostic industry, but this is a smaller, more concentrated industry and Citeline does not cover that area today.

Overall, this was a well-attended session and many people afterwards indicated they felt was a good use of their time and had good information to take back to the office and put into action. Further information can be found in the individual presentations, which are posted here, on the PH&T Division website.

Summarized by: Richard P. Hulser, Amgen Inc., rhulser@amgen.com

4. Wednesday, June 8, 2005, 11:30 a.m.- 1: 00 p.m.
Device and Pharmaceutical Reimbursement Concepts
Speaker: Rayellen Giles, Medi-Regs

Rayellen talked specifically about Medicare Program reimbursement. There are three reimbursement components:

1. Coding: Codes are essential for the proper transmission of claims, and thus reimbursement. She explained the various types of systems and briefly described how a HCPCS code is established for a new product, or reviewed for an existing product. If your product is very new or much more expensive, you have to be pro-active in getting an HCPCS code and good coverage.
2. Coverage: Payers (Medicare, BC/BS, etc.) use evidence-based medicine to make coverage decisions. They expect manufacturers to monitor their own products to see if they actually are effective.
3. Payment: Product manufactures need to constantly monitor regulatory agencies and payer/coverage agencies to keep track of changes in regulations or coding.
Summarized by Judy Blaine, ArQule, Inc., jblaine@arqule.com

5. Wednesday, June 8, 2005, 1:30 p.m. - 3:00 p.m.
Vendor Update: Medical Device Resources
Four companies presented tools to explore this research niche:
Speakers: ECRI: Anthony Montagnolo (Tony);
Windhover Information: David Cassak;
OVID Technologies: Kimberly Poelman;
DIALOG: Bonnie Snow.

ECRI: Anthony Montognolo
Publishers of numerous products -- both databases and a journal; a non-profit organization which analyzes thousands of clinical studies through literature reviews and creates EBM reports, as well as conducting evaluations in physical in-house labs. ECRI is rather novel in that it gives ratings and price ranges (cost-effectiveness ratings) for devices for hospitals, in particular, (e.g., for capital equipment purchases) to use for decision making, and provides updated re-call information and benchmarking for competitive products.
Products include:
Health Technology Assessment Information Service (HTAIS) Publishers of the journal :
Health Devices. "Target" Database: an electronic "Reader's Digest" version of EBM reports.
SourceBase – a database of manufacturers in medical device industry.
PriceGuide – a database which compares prices for supplies and implants
Health Technology Forecast -- looking ahead to new technologies

WINDHOVER : David Cassak
Probably a more familiar name to many of us, Windhover caters to the management of an organization.
Publishers of In Vivo, StartUp, and most recently (in 1999): Medtech Insight Newsletter. This last newsletter provides information for technology and market developments which impact clinical practices ( for example, devices of any kind, instrumentation, biomaterials, gene therapy, tissue engineering ).
Sponsors of Pharmaceutical Intelligence Conferences
Producers of Strategic Intelligence Systems (SIS), a suite of databases - for decision making.

OVID: Kimberly Poelman
A content aggregator with a newly renovated search interface.
The bibliographic databases of greatest use for medical device searching include: IEEE (an OVID exclusive)
Inspec Biomedical (Subset of Inspec).
Libraries with full-text linking availability to 200 journals in addition to familiar databases that index the biological/health literature, such as Embase, Medline, and Biosis Previews.
Multi-file searching and de-dup feature is available to save time. Coming soon : a Federated search to save more time. Researchers won't have to select sources to include in the search -- which they may not necessarily select wisely.

DIALOG/DATASTAR: Bonnie Snow
Really "so many resources, too little time" -- really sums up Bonnie's talk, as my hand ached after the session and she was put in position of final speaker intentionally!
Probably the largest content aggregator -- providing access to not only literature sources such as the power of EI compendex, but also to conference papers, Regulatory information (including recall information), ECRI's Health Devices Alerts (abstracts to literature -- if you aren't a subscriber), legal resources (e.g. CELEX European Union Law), Industry newsletters, subject specialty company & product directories (Health Devices Sourcebook) and pipeline databases (that also includes implants and devices), market research reports, statistical sources, and databases to intellectual property (IP or patents) publications.
Power of the system is not only the versatility and breadth, but also the ability to create alerts for both topics and TOCs.
Bonnie Snow recommends checking out a presentation from a previous session: http://www.sla.org/division/dpht/Annual2003/presentations2003/Cindy_Meisner.ppt
Summarized by Julia Parker, Amgen, parkerj@amgen.com

6. Wednesday, June 8, 2005 3:30 p.m.-5 p.m.

Session: “Canadian Pharmaceutical Information Sources: Finding Information for a Small Market”
Speaker: Maude Lethiecq-Normand

In this well-received and fast-paced session, Maude Lethiecq-Normand of Pfizer Canada provided an excellent insider’s guide to the resources needed to research the Canadian pharmaceutical and biopharmaceutical industry. She began with a basic review of the key facts about Canada (“that big country to the north of the U.S. on the map”!) to a packed room of both Canadian and non-Canadian and pharma and non-pharma attendees. The first part of the session was an overview of the biopharma industry in Canada, which identified the key players as well as the major regulatory, financial, and political issues. This information provided the context for understanding the unique challenges faced in researching this industry in this particular country.

In the second section , Maude shared her insights and experiences in using Canadian pharmaceutical information sources. She gave a comprehensive review of key sites for researching Canadian drugs, companies, health statistics, industry experts, regulatory data, and treatment guidelines. She was quite honest in her views of the pros and cons of these sources, which was much appreciated by the audience.

The entire session was full of useful details and search tips on how to research a market that is not well covered by the standard aggregate vendors. In particular, the following key points stood out:

• Lack of federal centralization/coordination - Always search each individual provincial health ministry’s website (i.e., British Columbia, Alberta, Ontario, etc) for health data, particularly benchmarking, utilization, etc. – the Canadian federal government is not the main or best source for such statistics.
• English vs. French – Many seemingly comprehensive sources of Canadian data are in English and often do not include data from Quebec, since that information is only available in French.
• Need to validate all Canadian epidemiology data – authors often use U.S. sources or very old data

Maude also handed out a list of the websites she covered.

Summarized by Barbra Rosenberg, PAREXEL International, Barbra.Rosenberg@parexel.com

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