The InnovationWell Drug Safety
Community of Practice launches on April 25,26 at the Marriott Courtyard Hotel,
Philadelphia, bringing together a coalition of expertise and organisations to
work on safer healthcare and drug safety. Summaries of perspectives presented on the Building the Drug Safety Body of Knowledge program presented are given
below. Full program details and further
information on initiatives and activities can be found on InnovationWell.
Knowledge Management in Drug Safety; Sidney N Kahn, President, PvRM,
Inc.
The global drug development climate has undergone dramatic changes during
the past decade, and the pace of change shows no sign of decreasing. At this
crucial time, when the need for effective and safe innovative medicines has
never been greater (e.g. emergence of new infectious agents, increasing
microbial antibiotic resistance, unmet health needs in the developing world,
and large aging populations in developed regions), advances in basic science
and technology carry the promise of remarkable therapeutic advances. However,
while pharmaceutical companies spend vast sums on R&D, the number of new
molecular entities licensed appears to be steadily diminishing. Simultaneously,
a recent series of high profile drug withdrawals due to significant safety
issues has reduced the confidence of health professionals and the public in
both the current development process and the regulatory procedures that are intended
to ensure the safety of pharmaceutical products, and caused significant
financial harm to their developers. While it is unrealistic to expect very rare
undesired outcomes to be detectable during development, effective application
of knowledge management tools for integrating information from a variety of
sources could result in earlier detection and mitigation of risks attributable
to newly-marketed medicines and thus possibly prevent the withdrawal of useful
products from the market.
This presentation discusses those areas of pharmacovigilance in which Knowledge Management tools may be of greatest use in preventing unexpected and untoward safety outcomes.
Drug Safety Knowledge Management - Leveraging the Documentation of
Safety Labeling Decisions; A. Leander Fontaine, M.D., President, Pharmiceutics
LLC
Safety labeling decisions, whether for core labeling or local labeling,
capture the outcome of all discussions on a possible duty to warn about a
definite or suspected risk. Such decisions may determine a possible risk as to
be included in labeling, or as insufficiently substantiated for inclusion. The
need to provide special advice to users, and the type of advice (e.g.
contraindications, precautions) are subject to labeling decisions as well. Labeling
decisions are also made to accept or refute requests by regulatory authorities
to modify labeling.
Core labeling (e.g. in the form of Company Core Data Sheets or Core Safety
Information contained in Investigator's Brochures) does not reflect the full
spectrum of safety labeling decisions made. It does typically not mention risks
and warnings that were not considered "label-worthy", nor does it
typically contain "retired items". It can therefore usually not be
considered to be a sufficient reference point for finding a company's position
on all safety topics that ever reached the stage of formal labeling
considerations.
A complete picture can often only be obtained by reviewing all labeling
decisions for a product. Electronically searchable inventory lists of labeling
decisions can be helpful in performing this task.
Much more powerful is a database that contains an elementarized
representation of core labeling content, local labeling elements that have not
been accepted for core labeling, retired or rejected items, and topics under
labeling discussion. Such a database can form the kernel of a Drug Safety
Knowledge Management System, by linking to, e.g.,
- supporting documentation (rationales, reports, data, etc.)
- administrative information (decision records, etc.)
- tracking and audit information (implementation milestones, reasons for local
deviations, need for action, etc.)
- safety databases and electronic reporting systems.
The content of such a "Labeling Decision Register" can also be
linked to text sections and coded content in structured product labeling in the
US (SPL), EU (PIM) and in other countries with structured labeling in XML
format.
The granularity of elements in the register will depend on pragmatic considerations (granularity needs for decision recording and tracking, etc.) and will have its maximum in the adverse reactions section. The register may also capture MedDRA codes (increasing its searchability) and map possible future MedDRA group terms to PTs.
Building the Drug Safety Body of Knowledge: Safety Hypotheses and
Information Sources in the Product Life Cycle; James Averback, President, Life
Science Integration Partners
Recently, both the Pharmaceutical Industry and Regulators have been criticized for underestimating the need to fully understand and communicate the drug safety profile of a product before its use is promoted to maximize market share. Drug safety assessment is traditionally approached as a process of reducing the need to know about safety to fit within parameters required for a product's intended use and labeling as brought to market. As a consequence, new products have been exposed to withdrawal due to safety concerns which in turn has dimished the trust of patients in the industry. The cost due to liability of a withdrawn drug is high and trust takes a long time to win back. This talk proposes a strategy for proactively and continuously enhancing the body of safety knowledge relied upon by pharmaceutical companies and regulators to protect the public health and the bond of trust between them and patients.
Designing and Managing a Risk Management Tracking Program; John
Clark, Vice President of Surveillance Services, Galt Associates
The FDA recently released guidance documents for the development of risk
management plans. One important component of any risk management plan that is
not discussed by these guidance documents is the tracking/monitoring of program
impact. The tracking of adverse event report data associated with a marketed
product can be a daunting task, especially since such programs often require
technologies that plot AE data over both time and geographical location. In
addition, summaries of both prescribers and patients are frequently requested
components. This presentation will present the logistical difficulties one must
take into consideration when developing tracking/monitoring programs, will
discuss general strategies for meeting these challenges, and will describe
pertinent automated methods. The presentation will use the publicly available
AERS database to illustrate these points. Finally, the role of the
tracking/monitoring module to its overall risk management program will be
discussed in the context of risk:benefit balance.
Ontologies for Pharma; Sheryl Torr-Brown, Head of Knowledge
Management & Technology, World-Wide Safety Sciences, Pfizer
There are two givens in the pharmaceutical industry today. Firstly, we can
now generate an unprecedented amount of drug related information along the
Research and Development (R&D) pipeline, and secondly, we are more
connected to each other than we have ever been through the internet revolution
of the past 15 years or so. Both of these aspects of the modern pharmaceutical
company have brought many benefits to our business. However, the pharmaceutical
industry is currently under fire due to allegations of decreased productivity
despite significant investments in R&D, that if left to continue at this
pace, will reach almost $60 billion by 2006. The concept of Ontology and it
relevance to a new model of knowledge management is discussed in the
presentation. It is argued that systematic knowledge management will be
increasingly necessary in order to optimize the value of preceding advances in
high throughput approaches to research and development, and to fully realize
the anticipated increase in productivity.
Personalized Medicine - integration of bioinformatics and medical
informatics for safer and more efficacious healthcare practice and medicine;
Professor Peter L. Elkin, MD, Mayo Clinic, College of Medicine
Personalized Medicine is the integration of genotypic, proteomic and metabolomic data with phenotypic data in support of ordering just the right drug for the correct patient with a specific disease. As we move toward an era of personalized medicine which is driven by an understanding of each individuals genetic fingerprint and their evolving gene and protein expression, we provide an infrastructure ready to support a safer and more efficacious practice of medicine. With patients at the center of our paradigm of care we invert the current healthcare practice environment placing once again the emphasis on the needs of the patient. Dr. Elkin firmly plants us in the present and then leads us into a journey into the future where safer more efficacious practice of healthcare is coupled with an environment that generates new knowledge more rapidly and applies that knowledge at the bedside.
We must build the Knowledge Management Body of Knowledge (KMBOK™);
Douglas Weidner, President, KM Institute
We must move successfully into the Knowledge Age. To do that, we must master
the discipline that has come to be called Knowledge Management (KM) and create
a KM Body of Knowledge (KMBOK™) that is so essential to the success of KM and
its practitioners. Without a KMBOK as an enabler, we will not adequately
document for use proven solutions, methodologies, and best practices, nor
understand the roles and competencies needed for both KM leadership and
knowledge worker productivity in the Knowledge Age. Most importantly, we will
not have the robust core content for the requisite KM Learning curriculum.
Here's what the KMBOK must contain:
Methodology - KM is a Strategic Initiative; the methodology
must be strategic, not tactical. But, to be useful it must be far more robust
than a list of preferred phases or steps. Most methods today are not
sufficiently descriptive, and are mere guidance rather than useful.
Curriculum - Learning involves specifying the requisite KM
roles, competencies and learning objectives to enable them, not just a KM
course for the sake of a course. Few KM courses are competency-based because of
difficulty defining KM competencies. The KMBOK must define roles, competencies,
and learning objectives.
Proven Solution Providers - Much KM is enabled by
technology, but which ones work and solve real needs must be known and
available for testing.
Knowledge Repository - Finally, all the above depends on
having a repository of the latest thought, best practices, lessons learned,
etc. Many sources attempt this, including hundreds if not thousands of links.
This talk focuses on modern Knowledge Repositories. The KMBOK can't be just a repository of KM links. It must be technology-enriched in all KM domains/specialty areas, including intelligent agents doing searches, ability to summarize documents based on your profile, and the ability to navigate across documents by contexts, not just terms.
Capturing and Managing Research Records to support Drug Safety Knowledge
Networks; Jeff Spitzner, Chief Science Officer, Rescentris
The effective practice of personalized medicine must transform drug
development life cycles from a linear process into a network of feedback and
interplay among knowledge systems for R&D, clinical trials, and market
data. Drug safety data will be continuously re-analyzed and re-evaluated in
light of new biomarkers, pathways, genomics, proteomics, and other data coming
from upstream activities. Likewise, new research information will be applied
downstream to guide patient selection for clinical trials and drug treatments.
Creating effective drug safety knowledge networks requires overcoming a large
number of barriers. This presentation will focus on key issues for capturing
and integrating research data to support the feeding and harvesting of research
knowledge systems that can facilitate the safe and effective use of drugs.
These issues include:
1. Overview of the information products generated by research, and systems
to manage them.
2. Capturing complete research records - documents, data, metadata,
record-keeping information.
3. Three types of repositories used for every experiment - data-centric,
people-centric, process-centric - and how they can be bridged by knowledge
networks.
4. Three dimensions of collaboration and integration - vertical (the org.
chart), horizontal (cross-discipline), and time axis (product development life
cycle).
5. Use of standards and ontologies to connect and relate complex content,
including capture of scientific evidence and interpretation.
6. Other issues for capturing and managing research records while meeting needs
of enterprise stakeholders: science, business/R&D management, IT, and
legal/regulatory.
The Drug Development Process of the Future; Gene Odle, Founder,
eValueDrugs
Imagine:
· A world with fully integrated systems where the people who receive healthcare
and those who deliver it have access to the right information, at the right
time, on the right device, presented in the right way.
· A world where everyone carries his medical history and genetic profile on a
digital device and manages his well-being based on one's specific genotype and
phenotype rather than waiting to treat a disease.
· A world based on personalized medicine through leveraging a comprehensive
approach for integrating all available data & information to provide
actionable knowledge with invaluable insight.
This vision is at the foundation of eValueDrugs and drives the core
development for business tools, techniques and know-how to deliver a complete
data integration process based on innovative integrated electronic solutions.
eValueDrugs focus starts with today's highly inefficient and costly drug
development process. The Pharmaceutical industry faces daunting hurdles in
bringing new products to the market. It is common knowledge that out of 10,000
drug candidates only one will be brought to the market at an average cost of
$800 million to $900 million over 12 to 14 years. The highest attrition rates
with the majority of the cost and time spent is found in the development phases
of the overall drug development process and it is here where eValueDrugs is
building its comprehensive process integration platform for dramatically
reducing these costs & time.
A Changing Paradigm
Closer collaboration: In today's healthcare network
a much greater co-operation between the various participants is a clear
requirement. However, forming such collaboration is difficult and there are
several practical problems, including the fact that most pharmaceutical
companies use bespoke systems for managing their drug development processes in
order to compile their data and changing these systems would be prohibitively
expensive. But one way of overcoming this dilemma is to use a trusted third
party like eValueDrugs that spans the gap and acts as the bridge linking all
participants into one comprehensive integration process.
Revolutionizing the entire Drug Life Cycle
Through aggregating the multiple data collection streams between bio-pharmaceutical
companies and all other constituents in the drug development process,
eValueDrugs orchestrates and coordinates in real-time the multitude of
different data and information streams, thereby turning the data into
actionable knowledge and invaluable insight for all parties concerned.
Symyx IntelliChem's iELN: Meeting the Needs of Intellectual
Property; Ronald A. Krasnow, Esq., Vice President of Intellectual Property,
Symyx Technologies, Inc., and Scott K. Starry, Senior Project Manager, Symyx
IntelliChem
Without a doubt, the IntelliChem iELN makes an IP lawyer's job easier,
particularly on a day-to-day basis. The information is stored and accessible in
typed, uniform formats, meaning that lawyers do not have to interpret
poorly-drafted, hard-to-read handwriting. Also, the information is directly
available to the lawyer through the IntellIChem iELN search methods, which
patent lawyers can use to find data to support patent applications. There are
nine different ways to search for data, so lawyers are no longer required to
sift through notebooks of group members who might have worked on a project to
find co-inventors or other data. Another concern of some patent lawyers is uniformity of lab notebook policy
adherence. The IntelliChem iELN can reduce this concern through workflow
controls that encourage policy adherence, e.g., effectively reducing or
eliminating the sometimes common practice of bulk witnessing of documents years
after an experiment is completed. The uniform notebook format minimizes the
likelihood of incomplete or lost information, and the data can be stored for
years and years in a format consistent with corporate policy. IP lawyers may be concerned about electronic lab notebook data being
admissible in court and/or whether electronic data will be convincing to a
judge or jury. There are many issues wrapped in these two concerns, and the
bulk of this presentation addresses these issues. As a summary, IntelliChem
iELN records are as admissible and convincing in court as any other electronic
data (e.g., e-mail). For example, the IntelliChem iELN has an easy-to-explain
software architecture, which was created in a structured environment. This
makes it easy for jurors to understand the reliability of the system. Lawyers
can assist in the admissibility and cogency of the IntelliChem iELN data by
enacting smart corporate policies and insisting on adherence to those policies.
Lastly, this presentation will consider how to roll out an intelligent lab
notebook system in a corporate environment. The procedure is straightforward
but suggests participation by a lawyer to assure that the process is
competently completed in a manner approved by the legal department. Bridging the Gaps: Integrating Systems to improve Drug Safety; Jim
Cook, Director, Volutio Ltd This presentation focuses on two aspects of the drug safety problem.
Attendees will gain valuable perspectives on two areas in the typical Life
Sciences organisation that can benefit from new approaches to drug safety.
Firstly, the talk will explore the problems associated with disparate data
repositories and business processes currently prevalent in the Life Sciences
arena. Secondly, the presentation will examine the type of knowledge management
issues presented by the drug safety problem space. Finally, the talk will
present a consolidated view of typical components to the solution.
Aggregation of Relevant Clinical and Non-clinical Drug Safety
Information from Multiple Sources of Unstructured Data; Jim Walker, Jeffrey
Wolff and David Phillips, Corpora Modern knowledge workers have access to unlimited documentation, but they
struggle to locate highly relevant text and lack sufficient time to read all
pertinent documents fully. There is an unmet need in the process of
internalizing drug safety information and a requirement to proactively manage
risk related to the use of modern drug therapies. Corpora is currently
evaluating the application of its solutions to effectively and automatically
aggregate relevant clinical and non-clinical drug safety information from
multiple sources of unstructured data. The Corpora solution includes a process of event clustering,
spidering and indexing data sources, providing concept search capability, all
using linguistic technologies to return accurate, medically relevant, high
value information. When the agents return documents of interest, Summarize!
provides a fast, tailored, configurable summary for quick review. Jump! is then
used to create a workspace with multiple documents of varying formats - Word,
PDF, HTML, Text, etc. The power of Jump! is best achieved when navigating to
terms and concepts of interest, across many documents and linking directly to
the context of how the terms appear in the documents. Corpora believes that KM software providers must move beyond simplistic word
search systems to create software that understands unstructured text documents.
Although 'Search' has been around for many years, it often fails to deliver
information effectively. We are all familiar with the 'found 5000 items,
viewing page 1 of 500' syndrome!
This presentation will introduce the technique of faceted classification as a
means of organising and accessing information. Faceted classifications have
been used to organise information for over 70 years. However, it is the
organisational efficiency offered by this technique that has made it so
difficult to automate the retrieval of information from these classifications.
Recent developments have changed this, enabling information, organised using
facets, to be accessed effectively. This new technique, a hybrid of search and
browse, enables information to be 'discovered' in ways not possible with
traditional search systems. This technique is now being used to automatically
classify millions of items of information against thousands of classification
nodes. As requirements are specified, the 'search' engine is able to
dynamically update the classification to show only those sections that contain
relevant information. By showing a dynamically changing distribution of
documents in a classification, a searcher is able to visualise where information
is, and discover new areas of relevance.
The capability of Corpora tools will be outlined in the context of solving the
clustering of Adverse Event Reactions, accessing public data, pointing to and
indexing internal data in order to better understand what has been done and the
decision process that supports fundamental decisions, with regard to drug safety.
The Harvard-Partners Center for Genetics and Genomics is working in
collaboration with institutions across Harvard and MIT to implement a
biomedical computing infrastructure that will both (a) fully exploit the fruit
of the genomic revolution for clinical practice and (b) allow clinical care to
be leveraged to advance research. In this presentation, key attributes of this
project are discussed including the proposed features of a core knowledge
management infrastructure for translational medicine that fully leverages the
data and workflow application services that are in production across the
Partners Healthcare System. These components include systems for knowledge
discovery, knowledge asset management, and decision support to fuel research and
optimal decision making from the bench to the bedside.
Barry Hardy
Innovationwell Community of Practice Manager
Switzerland
Recent Comments