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The New Risk M anagement Paradigm

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J ill Robinson and Mary Ellen Turner of the Global Safety Surveillance, Epidemiology, and Labeling Group at Wyeth
Research discuss their approach to risk management.

Risk management has always been an intrinsic part of the world of pharma with the decisive calculation of benefit-risk for
each medicine serving as the ultimate determinant for drug and patient safety.

While the rigorous adherence to drug safety hasnt changed over the years, there has been a noticeable shift in the
approach to risk management as companies have begun to implement more standardized, formal processes in light of the
new requirements and challenges around drug safety.

Increased pressure from regulators, including stricter compliance guidelines for transparency, has placed greater
accountability on pharma to identify and make visible the true benefit-risk associated with each medicine. Clinical trial
registries have become standard, and recent federal law has even expanded the national clinical trials database to include
trials on all drugs and devices, excluding those in phase I trials.

The increased transparency of clinical trial data serves to enhance stakeholders knowledge around the complete benefits
and risks of medicines to enable more informed decision-making and, ultimately, to improve medical outcomes. In addition,
greater visibility into clinical trial data should also help to restore public confidence in the industry.

However, the multi-faceted challenges stemming from the new drug safety standards require a more formalized approach to
risk management. The industry has always had a high standard for safety and efficacy of their products and a high standard
for patient safety, says Jill Robinson, Vice President of Global Pharmacovigilance Operations for the Global Safety
Surveillance, Epidemiology, and Labeling Group at Wyeth Research.

She adds: What has changed in the new paradigm is a bigger scope where more formalized processes and communication
plans in place are needed to talk to all the stakeholders including patients, doctors, regulators and advocacy groups.

People and processes

Wyeth has responded to the new requirements by implementing an integrated risk management system that runs from drug
development throughout the product lifecycle.
Weve tried to make sure we have standardized processes and policies in place around risk management and that we have
clearly defined roles for clear decision-making who is making what decision, what kind of information needs to be
available, and then making sure that we have the right technology, Robinson explains.

Within Wyeths risk management system, the implementation of more standardized processes is geared to help better
define roles and identify the information and technologies needed for clearer decision-making around risk management.

True risk management is a process and it involves risk identification, evaluation and characterization of that risk, explains
Mary Ellen Turner, Vice President of Risk Management. She continues: It involves developing interventions to minimize that
risk, developing a strategy to communicate that risk to the appropriate stakeholders, and then developing a plan to evaluate
the impact of whatever intervention or communication plan youve chosen.

Integration is a major element of Wyeths risk management system. Not only are their formalized processes applied from the
beginning of drug development throughout the product lifecycle, they have also brought together the individuals who handle
adverse events, medical surveillance, labeling and epidemiological studies into one multi-disciplinary group for a truly
integrated approach to risk management.

With a cast of knowledgeable individuals assembled together who possess expertise across all areas of the entire product
lifecycle, it ensures a strong and broad knowledge of the impact of risk management. Wyeth has already experienced
immeasurable benefits from the formation of its Global Safety Surveillance, Epidemiology and Labeling group.

What we have found to be very helpful is bringing in people like our epidemiology group early during this planning process
because when youre looking at your strategy around benefit-risk assessment, its important to know the characteristics of
the population who will be taking the drug and what you can anticipate happening in that population, Robinson says. That
kind of early contribution from epidemiology can help you with decisions about positioning your drug in a way to minimize
risk and maximize benefit.

Its obvious that while clearly outlined, integrated processes are vital; at the heart of Wyeths risk management system are
people. Turner admits that in order to make all the pieces of their risk management system come together expertise must be
leveraged from all around the company. You have to draw on the expertise from other areas of the company to help you
effectively communicate those risks and to develop interventions and get those out to the healthcare professionals and the
patients. In addition, full buy-in from senior management has been key to successfully carrying out risk management
initiatives.

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Executing the right approach

While people and processes are critical for sustaining a successful risk management system, one overriding aspect of
importance is timing, and planning should be initiated as early as possible in development.

Having a process in place for early detection of risk is key, and bringing the right expertise to the table is really important,
Turner says. In terms of best practices, if we have some identified risk or potential risk during clinical development, starting
to think about that sooner rather than later is important, even before you start planning your clinical trial.

At Wyeth, teams are encouraged to start discussing the benefit-risk profile of a product even before it reaches the clinical
trials stage to better understand the safety profile and identify the potential safety issues as far in advance as possible.

Early planning ensures that when a red flag or an issue arises, the standard tools, processes and well-defined roles are
already in place to mitigate the issue. One prime example relates to standardized data collection methods such as with
capturing electronic data from clinical trials and reporting adverse events. By formulating a standardized way to collect
safety information, information will be more complete and reported as correctly and quickly as possible.

One overriding aspect of a successful risk management approach is that it should concentrate on each product rather than
the individual phases of a product lifecycle. Risk management is more related to the product, the treatments that the
product is going to be used for and the patient population, Robinson says. For example, if were doing a vaccine for
children and were putting a drug into healthy children, the risk level that people are willing to take is usually a lot less than if
we were treating someone with a malignant cancer disease.

In addition to the applicable patient population, other factors that need to be taken into consideration include whether its first
in class to help determine the extent of information related to benefit-risk needed to satisfy regulators, doctors and patients,
and whether its a short-term or long-term use product to better understand timing and impact.

Identifying the stakeholders and understanding their level of knowledge related to a drug is another crucial component. For
example, when HIV became prevalent in the 80s, you were dealing with patients who were very knowledgeable about their
disease and the drugs on the market, Robinson says. How you handled that was much different than, for example, if you
were giving something today to an Alzheimers patient, where were still studying the research and trying to figure out how
everything works.

Communication is obviously another major factor in successfully carrying out a risk management strategy. The key to all of
this is to plan early and keep an eye on whats going on as your clinical trial progresses. Its important to have good
communication throughout your organization so that youre flexible enough to change course if you need to and to rely on all
of the scientific tools that you have at your disposal, including some of the newer pharmacoepidemiology techniques to help
develop your strategy.

Ultimately, all of these components of formalized methods will lead to better safety strategies in development and, in the
end, better medical outcomes. Still, Turner emphasizes that safety needs to move up on the priority list to make it even with
efficacy.

In the past, clinical trials obviously have defined the product with regard to its efficacy and how theyre going to test it.
Theyve always collected adverse events. The new message now is we need to study safety as rigorously as we do
efficacy. While the length or size of clinical trials may limit the desired extent of statistical analysis able to be conducted on
various safety issues, today pharma has many tools at their disposal i.e. pharmacoepidemiology to help to better
understand clinical trial findings.

Every pharmaceutical company is being called to participate in more rigorous, formalized risk management processes, but
for the big pharma companies, risk management entails a bit more complexity. Global companies have to take into account
every country and ensure that risk management plans suit each local culture. For the major global companies, you have to
be looking at the whole global environment all the external forces make it more challenging because there are different
standards of care and different acceptable ways to communicate benefit-risk within these different communities, Robinson
explains.

An evolving process
Given its nature, risk management is a constantly evolving process and pharma companies can only look for ways to
improve their approach to and execution of risk management plans.

We all look for ways to continue to ensure that the right product is given to the right person for the right reason at the right
dose, Robinson says. There has been a lot of collaboration and everyone including regulators are going back and
looking at what we can do better. The industry does a very good job when you look across our record but theres great
opportunity to improve our processes.

One major identified area for improvement is risk communication. In talking with regulators globally and with our colleagues
across the industry, I think we all agree that one big unmet need is to do more research into risk communication, Turner
says. Theres a real need to communicate clearly and effectively to healthcare professionals and, most importantly, to
patients the risks of medicines.

While recent initiatives such as the FDAs work to make important information more prominent on labels have touched
on communication needs, theres still a ways to go in terms of refining communication methods to physicians as well as
patients to raise awareness of the full extent of the benefits and risks of medications.

A number of exciting changes and directions are already underway that will impact the industry with respect to risk
management. Robinson predicts a shift from spontaneous surveillance to more active surveillance to obtain better quality
data. And personalized medicine is one big arena thats enabling the optimizing of treatment so patients can experience
greater benefits from medicines. Going back to clinical development, there are all kinds of initiatives in the area of
pharmacogenomics and trying to identify through scientific means which patients are benefiting and which ones are not

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benefiting from medications, so that we can really get the medicines to people who will have the best outcome, Turner
explains.

Technology is another huge area thats quickly evolving, as companies and regulators are turning to new technology tools to
aid in the risk management process. Electronic capabilities have certainly opened the doors for more opportunity to improve
risk management initiatives. As healthcare systems switch over to electronic medical records, we have large insurance
claims databases and everybody is looking at all of those sources of information as potentially sources of data that we
could use to do research in safety and risk management, Turner says.

As companies begin to embrace more formalized risk management plans, theyll need to keep in mind the widening
stakeholder arena, which calls for a more comprehensive scope of risk management. Stakeholder involvement is only
expected to increase, especially as patients are taking on more active participation in earlier stages of the process. I dont
think it will be the case anymore that a company decides what theyre going to discover, what theyre going to market and
that its good for the patient, Robinson says. Patients are becoming more educated and I think theyre going to have a
larger voice in what risks theyre willing to take for what benefit.

Its obvious that the rules of the game, so to speak, around risk management have undergone a significant change. With
expanding regulatory pressures, widening stakeholder involvement, rapidly advancing technology, and even more
complicated products due to the maturation of biotechnology, risk management is an entirely new challenge and companies
can only expect to need to adapt to meet such shifting requirements. The good thing about the benefit-risk management
process is that it is a continuous process it is a process that you always get to go back and see if youre doing the right
thing and measure any outcomes so I think that well always find better ways, Robinson says.

Dr. Jill E. Robinson is VP of the Global Pharmacovigilance Operations area at Wyeth Research in Collegeville, PA. She is
responsible for directing and managing human and material resources for the Global Pharmacovigilance Operations area.
Other responsibilities include the timely and accurate reporting of all adverse medical event information for clinical
development and marketed products to all global regulatory agencies and the development and compliance of the Safety
Surveillance and Labeling databases.

Dr. Mary Ellen Turner is currently VP of Risk Management, Global Safety Surveillance and Epidemiology at Wyeth
Research. She is responsible for the development and implementation of Risk Management Strategies for Wyeths
investigational and marketed products. Prior to this she worked at Zeneca Pharmaceutical Co. in the department of Drug
Safety and Epidemiology.

http://www.ngpharma.com/article/The-New-Risk-Management-Paradigm/ 25/01/2013