Your 2012 DIA ePRO Community Survey Results


During the 2012 DIA Annual Meeting, while folks flooded to the ERT booth to grab a cup of coffee, we asked those waiting in the queue to fill out a brief questionnaire regarding their perceptions of the Clinical Outcome Assessments/ePRO industry and likely trends they expect to see in the future. Below are your results from the nearly 200 people who responded to the ePRO Community survey.  Thanks again to all of those who stopped by the booth to learn more about ERT’s products and services!

About 30% of clinical studies currently collect some sort of Clinical Outcome Assessment. Do you think you will be collecting more PRO data in future trials?

Over 80% of respondents expect to see more PRO data in their future clinical trials.

Which of the following vendors do you associate with collecting ePRO/eDiary data?

The top five ePRO vendors recognized include: ERT, Oracle, PHT, invivodata (now ERT) and CRF Health.

How important is it for the vendor to have a scientific expert on staff to help consult and guide you in the way that the ePRO solution is commissioned?

A total of 77% of respondents indicated it was either important or very important to have a scientific expert on staff.

In terms of technology used by the patient (PDA, IVR, Web, Digital Pen), how important is the device in your decision-making process?

A total of 70% of respondents indicated device selection was either important or very important in their decision-making process.

What other factors are important to you when making a decision on what ePRO vendor to choose?

The top five other factors that are important when choosing an ePRO vendor include: Proven Track Record, Therapy Area Experience, Price, Integration with other Clinical Technologies (e.g. EDC), and Prior Experience of Collecting Data Using a Specific Gold Standard Instrument / Assessment.

In 5 years’ time what do you think will be the most widely used methods of collecting PRO data?

Not to anyone’s surprise, the combination of Tablet, Smartphone and Web responses accounted for over 75% of replies, while paper had a rating of merely 3%.  Collecting data on a Tablet or iPad had the highest percentage rating at 31%.


A special thank you to everyone who participated in this survey and also to those who visited us at the 2012 DIA Annual Meeting.  We certainly look forward to seeing you all again soon but in the meantime, you can stay connected with ERT through our Facebook, LinkedIn and/or Twitter pages!

Posted in ePRO, Patient Reported Outcomes, Uncategorized | Tagged | Leave a comment

Partnerships Series Part II: What about CROs? Strategic Outsourcing Isn’t Just for Pharmaceutical Sponsors


Written by: Tom Avery, Vice President, Strategic Business Development

Collaboration, transparency, executive oversight, mutual respect … these are all attributes we think of when we hear the words “strategic partnership.”  As mentioned in our previous blog Strategic vs. Tactical Outsourcing for Pharmaceutical Sponsors, there continues to be a huge shift from traditional, tactical outsourcing to a more strategic approach in the Pharmaceutical industry.  For Sponsors with mature partnership models in place, this means increased quality and R&D productivity as well as assurance in development timelines and ultimately costs.  For CROs, this means a greater need for innovation, an assumption of more risk and additional accountability for clinical output.  Just as sponsors are able to tap into additional resources in order to gain operational efficiencies and cost savings, CROs can do the same with specialized clinical service providers for cardiac safety, respiratory, imaging, ambulatory blood pressure, and other research related outcomes.

The increasing complexity of clinical trial activities has been driven by regulatory agencies’ growing demand for new endpoints.  Regulatory authorities are recommending new outcomes to be evaluated in both safety and efficacy trials, such as the need and expectation for quality of life outcomes in the development of oncologic drugs.  As the demand for these new outcomes increases, so will the CRO’s challenge for delivering reliable data and the need for specialty service providers whose core competencies are to deliver these outcomes efficiently.

For the CRO, a primary concern is the ability of the service provider to deliver high quality, reliable data in the context of the CRO’s service to the sponsor.  Successful collaboration between both parties is paramount since many new relationships between sponsor and CRO are built on risk and reward.  As the service provider becomes an extension of the CRO’s services, the success of a CRO’s relationship with a sponsor is directly impacted by the success of the relationship between the service provider and the CRO.  Therefore, if the service provider is unable to deliver the necessary quality outcomes data on a timely basis, then both organizations fail to deliver.

There are several considerations when laying the foundation for a successful strategic partnership.  For starters, it helps tremendously to have a basis of past collaboration and established success between the CRO and service provider.  Also, having a true understanding of the value the service provider brings to the CRO’s strategic focus and mission is imperative.  This strategic alignment, as well as mutual respect and trust must reach to the highest levels of both organizations.  Having executive buy-in may be the most important factor in building a successful collaboration.  A relationship that lacks a dedicated champion from each organization who is accountable and responsible for driving the relationship often leads to a communication breakdown.  Ensuring objectives are understood at the highest level will help prevent stakeholders from reverting back to the original, tactical touch points.  Also, establishing specific metrics and KPIs will facilitate relationship management and ensure that the standards of performance by the service provider are clearly understood.  If something does go wrong during service delivery, transparency is a must.  There cannot be an instance of finger pointing and looking to blame the other party.  Instead, there needs to be mutual responsibility and accountability.  Lessons learned meetings are a great way to measure, monitor and adjust the effectiveness of the relationship from a financial and operational perspective and to determine a strategic plan on how the relationship can be improved.  Failure to keep the executive management engaged would prove to be a huge hindrance to this process.

A strategic relationship between a CRO and an outsourced service provider can provide both organizations numerous benefits.  In the case of a traditional and contractual relationship between sponsor and CRO, you can expect an increase in operational efficiency which in turn will reduce site burden, direct costs and the probability of error in the final data delivery – leading to more usable outcomes data for the pharmaceutical sponsor.   With this success, the sponsor will understand the CRO and service provider as being aligned in terms of both quality and reliability, increasing the likelihood of moving toward a strategic relationship with that sponsor or at the very least, increasing the likelihood of repeat business. In the context of a strategic relationship, such as the Pfizer and ICON/PAREXEL partnership, where risk and reward are built into the contract, a CRO that is strategically in sync with its service providers will ultimately reduce risk of financial penalties and increase the chances of financial reward.  Finally, the expert consulting on how to conduct the sponsor’s clinical study in compliance with regulatory requirements offered by these specialized clinical service providers adds real value for the CRO and their clients.

Our advice is to be patient.  These types of relationships aren’t going to happen overnight.  Successful strategic partnerships take time, effort and other executive resources but the results are well worth the energy it takes.  Peter Gray, former CEO of ICON once said it best: “We believe the process of making these relationships work in a way that’s profitable takes time, but the whole premise behind these deals is that you align all your processes, and build and grow together, and the way you begin to interact soon enables CROs to be profitable and also allows the client to get good value for their money.”1

What do you think?  Vote on the poll below, leave your comments and as always, thank you for being a part of the global ERT community.

Posted in Clinical Research, Clinical Trial Outsourcing, Clinical Trials, Partnerships in Clinical Trials, Pharmaceutical | Leave a comment

Cardiac Safety in Obesity Drugs – FDA Advisory Committee


Written by: Dr. Robert Kleiman, Chief Medical Officer & Vice President, Global Cardiology

Obesity is one of the nation’s largest health problems and has grown into a major epidemic.  Over the past 20 years, obesity rates in the US have continued to dramatically increase.  According to the Centers for Disease Control and Prevention, more than one-third of U.S. adults and approximately 17% (or 12.5 million) of children and adolescents aged 2—19 years are obese.1  Overweight and obese individuals are at increased risk for many diseases and chronic health conditions, including: hypertension, osteoarthritis, dyslipidemia, type 2 diabetes, heart disease, stroke, liver and gallbladder disease, sleep apnea and respiratory problems, and certain cancers (i.e. pancreas, kidney, prostate, endometrial, breast, and colon).2  A 2009 study by the Centers for Disease Control and Prevention, along with RTI International, demonstrated the economic burden of obesity and estimated that medical costs were as high as $147 billion annually, which accounted for approximately 10% of all medical spending.3

To date, there aren’t any satisfactorily safe and effective obesity drugs commercially available.   Many potential weight-loss drugs have either failed or been abandoned by drug development companies and there have been several obesity drugs withdrawn from the market due to safety concerns and adverse side effects.  There is a huge opportunity for pharmaceutical sponsors to make a significant impact on the lives of obese people with long-term drug therapy.  However, there have obviously been several challenges, mounting concerns and an increasing number of hurdles required to continue development programs and ultimately gain regulatory approval for any new weight-loss drugs.  In 1997, two popular anti-obesity drugs, Fen Phen and Redux, were pulled from the market by the FDA because of potentially life-threatening heart valve damage.  Also, in 2010, the obesity drug Meridia was recalled for causing an increased risk of stroke and heart attack in populations already prone to these dangerous cardiovascular events.       

Currently, there are three obesity drugs (QNEXA, Lorcaserin, and Contrave) which are again seeking regulatory approval after being previously rejected by US regulators over safety concerns.  To put the challenge here into perspective, the FDA has not approved a new prescription drug for long-term weight since Xenical (orlistat), over a decade ago in 1999. Xenical has demonstrated to be minimally effective and presents significant side effects which have inhibited its use over time.  In general, weight loss has been tied to positive effects on the heart, but the few trials conducted on the long-term heart safety of obesity drugs have shown to actually increase heart risks, or have little to no effect on heart health.  It is clear that the FDA will no longer approve a drug for the masses based on a small treatment benefit and without evidence of future improvement on patient health.  In clinical trials, Contrave raised pulse rates and blood pressure slightly, a warning sign that the drug might increase the risk of heart attacks, strokes or other cardiovascular problems. Consequently, the FDA told the drug maker that it must first do a cardiac safety study to prove Contrave does not increase the risk of adverse cardiovascular events in order to gain regulatory approval.

The FDA has clearly been grappling with cardiovascular risks in obesity drugs and on March 29th, 2012, the FDA Endocrinology and Metabolic Drugs Advisory Committee, after hearing from experts in obesity, diabetes, cardiology and statistics, recommended that drug companies be required to submit phase II or III data to prove absence of cardiovascular risk for new obesity drugs, even if clinical trials do not initially show evidence of precipitating cardiovascular events.  Obesity trials should randomize about 3000 subjects to the active drug and at least 1500 subjects to a placebo for one year of treatment. The FDA requires that patients in phase III obesity drug trials have a body-mass index (BMI) of at least 30 (or 27 plus comorbidities).  The drug should demonstrate either mean efficacy—a >5% difference in weight loss between treatment and placebo—or categorical efficacy—at least 35% of treated patients lose >5% of their baseline body weight, approximately double the proportion in the placebo group.4  In addition to these already established requirements to prove efficacy, almost all committee members agreed that the major adverse cardiac event (MACE) data should come from either cardiovascular-outcome trials or meta-analyses. While not an easy decision, torn between recommending the new safety requirements, which could dampen research efforts, or not extending the safety requirement, which could potentially expose millions of people who would be eligible to take these drugs to serious adverse events, 17 to 6 voted in favor of the new suggested requirements.  As you may recall, back in 2008, FDA advisors had a similar kind of discussion regarding the cardiovascular safety of diabetes drugs and the FDA later published its 2008 guidance for industry.  The new recommendations for obesity drugs to enrich phase II and III clinical trials by including older, sicker individuals with cardiovascular risk factors have mirrored those in the 2008 advisory.  Although not required, the FDA usually follows panel recommendations.  This news could and will likely affect the drug makers of QNEXA and Lorcaserin, which are also vying to get their obesity drug to market in the near future.

Do you think this will be a positive thing for the industry?  Vote below and leave your comments.


Stay tuned for more news on any further recommendations or official guidances from the FDA regarding cardiac safety in obesity drugs.  If you have any questions for Dr. Kleiman, please visit our website at http://www.ert.com/contact-ert/ or write your questions/comments below. 

Thank you for being a part of the global ERT community.

Posted in Cardiac Safety, Clinical Research, Clinical Trials, FDA, Pharmaceutical | 3 Comments

FDA discussion: Evaluation of the Cardiac Safety for Serotonin Receptor Agonists as GI Therapies.


Written by: Dr. Robert Kleiman, Chief Medical Officer & Vice President, Global Cardiology

A few months ago in November 2011, the FDA brought together a group of gastroenterologists and cardiologists to discuss the history of cardiac safety issues surrounding serotonin 5-HT4 agonists and the design of cardiac safety trials for new 5-HT4 agonists which are currently under development.

There is a great need for drugs to treat GI motility disorders, as there are currently few drugs approved for treatment of these diseases, and several of the drugs which did make it to market have since been withdrawn due to cardiac safety issues.  In particular, Cisapride was introduced in 1993 and withdrawn in 2000 due to QT prolongation and fatal ventricular arrhythmias, and Tegaserod (Zelnorm) was introduced in 2002 and withdrawn in 2007 due to excess ischemic cardiovascular events.

There are currently a number of new 5-HT4 agonists in various stages of development, and there is a great deal of effort to target receptors in the GI tract more specifically in order to try to avoid off target cardiac side effects.  Indications for which these drugs are targeted include chronic idiopathic constipation, irritable bowel syndrome, chronic irritable bowel syndrome with constipation, gastroparesis, and gastroesophageal reflux disease that does not respond to proton pump inhibitors.

As with all new compounds, new 5-HT4 agonists should be carefully assessed for QT prolongation and for drug-drug interactions.  In addition, assessments of risk of excess myocardial infarction, unstable angina and strokes should also be performed.  The ICH S7B and E14 guidances describe the preclinical and clinical assessments which should be performed for all new chemical entities to assess the risk of QT prolongation, including hERG assays and a formal Thorough QT (TQT) trial.

Assays of drug-drug interactions are also well established at this time.

Less clear is how the risk of cardiovascular events should be assessed during drug development.  Possible assessments discussed in this meeting included platelet aggregation assays, evaluation of smooth muscle contraction, as well as large, dedicated cardiovascular safety studies using “enriched” patient populations with pre-existing cardiovascular risk factors or disease.

You can access the Advisory Committees meeting materials on this discussion using the link below: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/GastrointestinalDrugsAdvisoryCommittee/UCM286759.pdf

We will be sure to keep you updated on any further discussions regarding the evaluation of the cardiac safety for serotonin receptor agonists as GI therapies.  As always, if you have any questions for Dr. Kleiman or would like more information on how ERT can help support the Thorough QT trial or other centralized cardiac safety needs for your new 5-HT4 agonists in development please visit our website at http://www.ert.com/contact-ert/ or write your questions/comments below.

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Partnerships Series: Strategic vs. Tactical Outsourcing for Pharmaceutical Sponsors


Outsourcing practices have become an increasing trend as the demand for capacity, speed, an expanded geographic footprint, and cost containment continue to grow in the pharmaceutical industry.  Other factors leading to project outsourcing are the increasing complexities of clinical trial activities and the rising number of smaller sponsors conducting their own clinical research.  The Tufts Center for the Study of Drug Development revealed that spending on new drug development is growing at a rate of 9.1% annually while global spending on contract clinical services is growing almost twice as fast at 13.4%[1]. Also, according to ERT’s own internal data, just five years ago in 2006, CROs accounted for 1% of total bookings.  To date, that number has grown to represent over 17% of ERT’s business.  This data exemplifies current trends and can clearly infer what other outsourcing firms are experiencing throughout the pharmaceutical industry.

As the industry moves forward and the current market pressures cause sponsors to change their relationships with vendors, outsourcing practices have begun to evolve and mature.  Pharmaceutical companies are challenged now, more than ever, to conduct their clinical research more efficiently in order to reduce costs while enhancing productivity.  More than 92% of sponsors and service providers surveyed, felt that the levels of outsourcing relationship efficiencies in 2009 would not adequately meet future needs[2].  Mature sponsors have begun to strategically look for high quality partnerships that will deliver the greatest results and the most satisfactory vendor relationships.  Others continue to outsource projects tactically to satisfy a short-term goal for the lowest possible price.  A company’s choice to outsource tactically through a transactional relationship, or strategically as business partners is uniquely driven by each company’s internal culture and business philosophies.  However, all sponsors, large and small, should be aware that the more mature the outsourcing practices, the higher the potential to yield greater outsourcing quality, value and overall vendor relationship satisfaction.

Key Attributes of Mature Outsourcing Partners

With the benefit of our experience, we have witnessed several customers maturing from the tactical, free-for-all competitive bidding processes, to creating short lists of qualified vendors, and finally to creating a strategic partnership with a trusted vendor.  This type of customer tends to see the bigger picture, in terms of a sensible business relationship, due to a more narrow focus on quality results and relationship satisfaction.  Often searching for a win-win situation, sponsors who outsource maturely are more concerned with the strategic aspect of their clinical study, not so much the ‘nickel and dime’ philosophy where much time can be wasted on relatively insignificant issues.  Since these Pharmaceutical companies recognize that it is in their best interest to understand, they proactively ask questions in an effort to identify their responsibilities and often share pertinent information concerning their company’s business goals, objectives and requirements in an open and transparent forum.  There is also an understanding that issues may arise, so with a constructive attitude and emotionless problem solving, they are able to work collaboratively to find a practical and innovative resolution.

The Benefits of Strategic Outsourcing

Strategic outsourcing relationships and alliances often begin to take shape when the sponsor company realizes a particular contractor can provide value-added services and expertise that the company may not have the competency or resources to accomplish otherwise.  With true partnerships in place, relationships are based on trust and communication, allowing for greater transparency and service levels.  Also, having an established relationship with a short list of preferred providers who offer a broad range of services, global presence, financial stability, and best-in-class quality, can significantly increase the return on outsourced development efforts and dollars.  A Jeffries Survey of 60 Pharmaceutical and Biotech executives indicates that nearly 80% of respondents believe outsourcing provides efficiencies that reduce development times and in turn, costs[3].  An additional benefit, when working with a smaller number of best-in-class providers, is continual knowledge management.  Processes are able to become more aligned with experience, building long-term value and better integrating the operations of both companies to support business goals.  Finally, with the confidence that they are doing business with a trusted provider working in their best interest, Pharmaceutical executives are better able to focus on the strategic aspects of their roles instead of the operational day-to-day tasks.

The Drawbacks of Tactical Outsourcing

Tactical outsourcing is a fragmented approach where short-term goals and initial cost savings take priority and there appears to be less focus on quality.   Whether it is due to of a lack of financial resources, to relieve the burden of staffing in an absence of talent, or to eliminate the need for future investment, some pharmaceutical companies choose to outsource on a purely transactional basis.  This leads to the idea that every contract is done as a ‘one off’ or in a vacuum, where a high percentage of the deals have to be negotiated from a pricing perspective as individual projects, rather than as a part of a program of studies.  While sponsor’s immediate requirements (technology, price, capacity) and individual deals are satisfied, the sponsor’s future needs may be compromised.

In 2010, the Avoca Group conducted a survey in which they found that respondents, whose companies allocated 75% or more of their clinical outsourcing budgets to preferred providers, were less likely to be dissatisfied with the value received from their outsourcing relationships than those who allocated less or those without a preferred-provider relationship in place.  Only 5% of respondents whose companies outsource strategically were dissatisfied with the value obtained, as opposed to the 33% whose companies outsource in a more tactical manner[4] .   This type of adversarial, transaction based relationship may facilitate lower levels of trust and familiarity, disallowing both sides to fully benefit from the efficiencies that would otherwise be realized.  Finally, at an individual study level, much time is spent and wasted in pricing negotiations, and resources are not as well planned without visibility to the bigger client picture, access to key personnel and a well-developed outsourcing strategy where company synergies are formed.

The Future of Outsourcing

It appears change is already underway, in regards to the use of outsourced service providers within the pharmaceutical industry, as the assumptive percentage of total outsourcing market penetration is expected to rise from 40% to 46% in the next five years[5].  Despite growth and maturation of the market, the nature of these relationships continues to have dramatic room for improvement.  Due to the pressures of increasing efficiency, lowering costs and the focus on drug safety from regulatory agencies, there has been a growing concern over quality, causing a reevaluation of contracted third-party vendors.  Outsourcing relationships have begun to change considerably and will continue to push further in the direction of strategic partnerships.    In fact, a survey conducted by William Blair & Company, in conjunction with Life Sciences Strategy Group, indicated that over the past few years, roughly 60% of respondent’s companies have increased their outsourced R&D budget, and 69% of large pharmaceutical respondents expect that strategic partnership agreements will continue to increase the rate of outsourcing in the future[6] .

A recent example of this trend is the June 2011 announcement that Pfizer has selected two CROs, ICON and PAREXEL, as their strategic partners.  John Hubbard, Ph.D., senior VP and worldwide head of development operations for Pfizer, expressed that “the goal of this collaboration is to increase R&D productivity.” He also noted numerous other benefits from these relationships, including improved focus – moving from 17 functional service providers to two[7].  Based on the previously mentioned survey conducted by The Avoca Group, it appears that in the future Pharmaceutical companies will become much more selective in choosing their service providers based on their strong capabilities and the quality of their services.  When major sponsors were asked what specific changes they planned to make within the next five years regarding their outsourcing vendors, the majority responded by indicating they will be outsourcing work within preferred provider relationships, as well as begin to consolidate the number of vendors where possible.  At the time of the survey, 69% of the sponsor companies reported having preferred-provider relationships.  Sponsors also plan to modify the way they measure and manage the performance of their service providers and create stringent criteria for vendor selection.  Relationship management programs often consist of performance-metric assessments and reviews, lessons-learned meetings, issue handling procedures, and formal governance structures. Plans to change outsourcing models or to incorporate more risk-sharing clauses into their future contracts were also mentioned[8].

It is suggested that the rate of increased development effectiveness through a proper and mature R&D outsourcing strategy is approximately 15-20% in reference to improved time to market, and 10-40% in relation to efficient cost improvements[9]. As it appears, the industry is confident that the changes in outsourcing strategy toward long-term relationships, preferred-providers and relationship management programs will continue to enhance the level of efficiency and alignment between sponsor and vendor in clinical outsourcing.


References

[1] Estimates of Global Demand for Clinical Services Outsourcing.  Tufts Center for the Study of Drug Development. Outlook 2010. January 2010.

[2] The Future of Clinical Service Provider-Sponsor Relationships. http://pharmtech.findpharma.com/pharmtech/ article/articleDetail.jsp?id=707026

[3] Windley, Hilgenbrink, and Dodge, “Pharmaceutical Services: Growth Forecast in the High Singles, How Soon Will We Get There?,” Jeffries and Company, Inc., April 19, 2011

[4] The Future of Clinical Service Provider-Sponsor Relationships. http://pharmtech.findpharma.com/pharmtech/ article/articleDetail.jsp?id=707026

[5] Outsourcing Penetration Assumptions, by Phase, 2003-2015E.  Jeffries & Company

[6] “CRO Industry Update,” January 11, 2011, William Blair &Company L.L.C.

[7] Strategic Partnering For Innovation: Perspectives From The CRO Side Of The Table. Rob Wright

[8] The Future of Clinical Service Provider-Sponsor Relationships. http://pharmtech.findpharma.com/pharmtech/ article/articleDetail.jsp?id=707026

[9] Strategic review of R&D outsourcing — an essential step towards R&D transformation. http://www.atkearney. com/index.php/Our-expertise/strategic-review-of-rad-outsourcing.html

Posted in Clinical Trial Outsourcing, Partnerships in Clinical Trials, Pharmaceutical | Tagged | 1 Comment

ERT Corporate Outreach… AND THE GRAND TOTAL IS: $86,822.37!


ERT’s Corporate Outreach program was established in early 2011 with the mission to make a difference in the health and well-being of the communities we serve. A committee from each office location was tasked with choosing a core charity and offering opportunities for fundraising and volunteer involvement.  Read on to find out how ERT’s offices, around the world, managed to raise over $85,000 in donations for numerous charitable organizations.

Philadelphia – ERT Headquarters

The Philadelphia Outreach Committee met earlier this year to evaluate a large list of nominated worthy organizations. After thorough review and discussion the committee selected The American Cancer Society (ACS) as a core charity, but also chose to support Alex’s Lemonade Stand, Philabundance, and Child Advocates.

The Philadelphia Committee decided to move forward with an ambitious schedule to include as many fundraising and volunteer opportunities as possible. The first event of the year was Alex’s Lemonade Stand. Many volunteer participants sold lemonade and baked goods at stands set up in the office building of ERT’s headquarters. The event raised $1,521.28 for pediatric cancer research.

In August, Philadelphia Outreach sponsored a supply drive for the ACS’s AstraZeneca Hope Lodge. ERT volunteers served dinner and socialized with the lodge’s guests. Although it may seem just like a dinner to some people, an event like this means a lot to the patients and caregivers who are undergoing treatment in the Philadelphia area. It creates normalcy in a time when nothing seems normal and as many of the guests stated, it gives them one less thing to worry about during this trying time. During dinner, ERT hosted games of Bingo with winners receiving one of five gift cards to Target. In addition to the evening’s events, approximately $500 in items from the organization’s wish list including cleaning products, paper products, linens, towels, and food were donated by ERT employees.

 

The committee kicked off the autumn sports season in September by hosting the first annual “Tailgate for a Cause”. Participants donated money and bought raffle tickets and in turn, enjoyed a “tailgate-themed” luncheon. [Definition: A tailgate party is a social event usually occurring in the parking lots of stadiums and arenas, before a professional sports game.] The event raised $1,182.00 for ACS.

October was another busy month for the committee. A group of employees teamed up to participate in the ACS “Making Strides for Breast Cancer”, raising $910 during a huge five-mile walking event in the Philadelphia area. ERT Philadelphia also participated in the ACS “Party with a Purpose Gala” as a Bronze Level Sponsor, contributing $5,000.  Also, as the holiday season commenced, different departments competed in a competition to bring in as much food as possible for the annual Philabundance Food drive. In total, employees and the committee donated over 500 lbs (approximately $1,000 worth) of food to Philadbundance, the region’s largest food bank!

The December Outreach event was a huge success when employees banded together and sponsored 81 under privileged and neglected children by donating toys, clothes, and gift cards to the Child Advocates program. Child Advocates provides legal assistance and social service advocacy for abused and neglected children in Philadelphia County. In addition to the employee donated gifts (estimated at $3,500), the Outreach Committee donated $1,200 worth of laptops for the program.

Just as important as monetary donations, is volunteer time. A group of ERT employees at the Philadelphia office generously donated their time by participating in the ACS “Road to Recovery” Program. Volunteers went through training sessions to provide transportation for cancer patients who do not have a ride or are unable to drive themselves, to and from treatment.

In total, including monetary donations as well as sponsored events, the Philadelphia Outreach Program was able to give over $17,397.36 to their selected charities, $8,338.28 of that coming directly from employee donations!

Bridgewater, New Jersey

After careful consideration, the Bridgewater committee selected the following organizations for sponsorship:
American Foundation for Suicide Prevention (AFSP)
American Heart Association
Crohn’s and Colitis Foundation of America

On June 4-5, from dusk to dawn, ERT employees participated in the American Foundation for Suicide Prevention’s Out of the Darkness Overnight” event. Our brave participants walked an 18-mile stretch of New York City out of the darkness, shedding light on the issues of suicide and depression. Proceeds fund research, advocacy, survivor support, education, and awareness programs. The participants actively collected donations from friends and family and ERT was able to match their donations, raising a total of $5,836.

ERT participated in the American Heart Association – Heart Walk 2011 event on Saturday, October 1, 2011 in Bridgewater, NJ. Employees took a scenic 2K walk (OK, some ran) at Duke Island Park. The event consisted of a rally before the walk as well as many informational booths on the grounds to help raise Heart Health awareness. ERT sponsored each employee who participated in the walk and contributed over $5,000 in donations.  Donations were also made on behalf of ERT to the Crohn’s and Colitis Foundation of America in the amount of $5,525.

Germany

The German Outreach Team gave its support to the ANCKER.e.V. Training Center in Würzburg for sick children and their parents with a donation of €7350 ($10,000). The center works with children and parents to learn how to handle their illnesses and is involved with asthma, neurodermatitis, adiposity, anaphylasis, and ADS/ADHD.   The outreach team also wanted to make a personal contribution to the project and, with their own efforts, sold cakes to ERT employees, raising an extra €700 for the Training Center!

Peterborough, UK

The Peterborough Outreach Committee has gained momentum during 2011 and decided to give the assigned $10,000 to the Arrhythmia Alliance in support of a national advertising campaign, which encourages the formation and support of local patient groups. The launch of this campaign was on December 6 in the Peterborough office with a speaker from both the Arrhythmia Alliance and a Cardiac Nurse from the Peterborough City hospital. The Arrhythmia Alliance aims to improve awareness, treatment and diagnosis of cardiac arrhythmias as well as working to improve the quality of life for those who are suffering.

The UK office also raised £208.55 for Children in Need, an organization devoted to raising money exclusively destined for charities working with children in the United Kingdom. Additionally, several other brave ERT members in Peterborough decided to take on the mammoth 13.1-mile Great Eastern Run and raised over £500 in support of the British Heart Foundation.

Other ERT Corporate Charity Efforts

Heart disease kills more women than all cancers combined and as such, ERT decided to aid the American Heart Association’s efforts to raise money for their Go Red for Women Campaign by participating in National Wear Red Day on February 4, 2011 and raising $716 in employee donations.  Donations support medical research, awareness, education and community programs that will help women live longer heart-healthy lives.

Also, as we are sure most of you have not forgotten, in March of 2011, the north coast of Japan was hit by a horrible tsunami after an 8.9 magnitude earthquake occurred 80 miles offshore.  Tsunami waves caused massive destruction and massive loss of life in northern Japan.  During this tragedy, ERT provided the American Red Cross $5,000 USD in disaster relief aid.

One of our favorite charity events occurred on an early Saturday morning in April, when ERT contributed $3,500 to participate in the 4th annual Cystic Fibrosis Foundation Sports Challenge.  The Cystic Fibrosis Foundation Sports Challenge is a mini Olympic-style competition where teams from corporations, businesses and professional groups compete against each other in a series of fun, athletic events at the New Meadowlands Stadium (home to two NFL teams in northern New Jersey). View more photos.

Also, on September 24, 2011, ERT employees helped raise a substantial $21,767.11 dollars to help fight multiple sclerosis. ERT formed a Bike MS team for the fourth consecutive year because we know that riding 150 miles is nowhere near as difficult as confronting a lifetime with multiple sclerosis. In addition to supporting novel research projects around the globe, The National Multiple Sclerosis Society also provides much-needed education, programs, and services to everyone who is affected by MS – including the diagnosed, their friends and families, and the healthcare professionals who work with them.

Additionally, during the holiday season, ERT offered its customers a chance to nominate their favorite charity on ERT’s Facebook page for a $5 donation to be made in their name.  Popular charities included the Leukemia and Lymphoma Society, Wounded Warriors Project, St. Jude Children’s Research Hospital, The American Heart Association and others.  With 12 charities nominated, ERT donated a total of $60.

…AND THE GRAND TOTAL IS: $86,822.37!  The committee would like to express their extreme gratitude to the incredible staff and our colleagues at ERT. It is because of the time and generosity of the people, that the Outreach Program was such a huge success this year. We look forward to continuing this success in 2012!

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Evaluation of the effect on Cardiac Repolarization (QTc Interval) of Cytotoxic Oncologic Drugs


Information Provided by Dr. Robert Kleiman, Chief Medical Officer & Vice President, Global Cardiology

During the development of oncologic agents, there are many cardiovascular toxicities to consider.  Oncologic agents may produce direct cardiac contractile depression, myocardial ischemia, alterations in blood pressure, myocarditis, cardiac tamponade, hemorrhagic myocarditis, endomyocardial fibrosis, and brad arrhythmias.  However, this article will focus on Torsade de Pointes, an uncommon and distinctive form of polymorphic ventricular tachycardia (VT) associated with QT prolongation.  As shown in the telemetry recording below, torsades can be generated into ventricular fibrillation and be fatal.

We use the ECG for many things in clinical research. We look for new rhythms such as atrial fibrillation, serious bradycardias and tachyarrhythmias, new conduction abnormalities such as heart block or fascicular blocks, changes in the ST segment and T wave and new myocardial infarction patterns, but probably the hottest topic over the last five or ten years has been looking for the prolongation of the QTc interval.

The problem during drug development, and the reason for all of the commotion about QT, is that torsades is very rare – even with drugs which are the worst offenders.  For Terfenadine (which started much of this concern) the incidence of torsades is only estimated to be about 1/50,000.  For antiarrhythmic agents like Quinidine, the incidence of torsades is higher (may be as high as 1-2%).  However, for the drugs that we are mainly concerned about, the risks of torsades are so low that traditional clinical trials simply aren’t powered to detect them and therefore, we need a surrogate marker in order to properly identify the drugs which may produce these harmful effects.  We use the QT prolongation as that surrogate since all of the drugs which produce torsades also prolong the QT.

The QT interval can be difficult to accurately assess as there are many factors that can affect the measurement, such as the heart rate.  In order to accurately compare QT values before and after dosing, you have to correct for the heart rate.  This is because the QT decreases as the heart rate goes up and increases as the heart rate slows.  The most common correction that has historically been used is the Bazett correction (QTcB = QT/ √RR).  Although the Bazett correction becomes increasingly inaccurate as the heart rate increases, it is unfortunately the QT correction which is most commonly available to sites.  The Fridericia Correction (QTcF = QT/3 √RR) is a better correction, particularly at higher heart rates.  The best QT correction is the QTcI, an “individual correction” that uses a unique algorithm for each specific patient.  However, to allow the calculation, this method takes approximately 40-50 ECGs at baseline and is thus limited in use.

Another difficulty is the normal variability of QTc over time.  In normal volunteers the QTc can vary up to 75 milliseconds over the course of a 24 hour period, and even to 90ms in subjects with underlying structural heart disease throughout the course of a single day!

As a biomarker, QT is not ideal.  This measurement, which can be difficult to assess, needs to be sensitive enough to detect quite small changes.  The ICH-E14 regulatory guidance sets out the rules for how to evaluate QT for drug development trials.  All new drugs with systemic bioavailability, regardless of therapeutic area and the preclinical profile, should have a thorough QTc/QT trial performed.  Approved products brought back for a new dose, new indication, new population or route of administration should also have a thorough QTc/QT trial performed.  Generally, the trial should be performed in healthy volunteers with placebo and positive control arms (to ensure assay sensitivity) and with both a therapeutic dose arm and a supratherapeutic dose arm, using multiples of the maximum expected dose, to simulate the worst case scenario.  The trial needs to define a 5ms effect with a one-sided 95% confidence interval that excludes a 10ms effect using time matched controls.

However, drugs which cannot be given to normal volunteers are the exception to these rules and it is not required that such drugs undergo a standard thorough QTc trial.  (The other exceptions are biologics, which generally do not directly affect the QT interval, and orphan drugs).

The current Oncology Division guidance is that it is necessary to characterize the ECG effects of a new oncologic agent to inform prescribers about potential cardiac toxicity and to suggest whether any additional monitoring would be recommended.  The degree of effect could weigh on risk/benefit decisions for approval, but usually, QTc effects of oncologic agents used for otherwise lethal illnesses are a labeling issue and do not hinder drug approval.

Listed below are oncologic agents which are known to prolong the QT interval.

Compound Indication                        QTc Effect
ZD6474 (Vandetanib) Thyroid Ca AssymptomaticQTc↑
XL647 Multiple Grade 3(DLT) QTc↑
SR271425 Multiple Grade 1 -2 QTc↑
Vorinostat Multiple QTc↑, labelling
Lapatinib HER-2+ Breast Ca QTc↑

Arsenic Trioxide, used in acute promyelocytic leukemia and sometimes in acute myelogenous leukemia, is the ‘granddaddy’ of all QT prolonging drugs.  Its efficacy was established before any ECG data was collected and early reports on arsenic did not identify any QT issues.  However, a formal Phase I trial showed a dramatic increase in QTc and a retrospective analysis was conducted to determine the degree of QT prolongation in patients treated with arsenic trioxide. The mean change from baseline was 47ms, with over a third of the subjects having a greater than 60ms increase.  To put that into perspective, remember the ICH-E14 guidance is looking for basically a 5-10ms effect, so arsenic trioxide, despite having a huge QT effect, is still approved for human use.

When assessing cardiac safety in oncology patients, it’s important to consider whether a compound can be given to normal volunteers or whether there might ever be additional indications for use in less critically ill patients.  When considering a non-cytotoxic agent, particularly if it has already been administered to healthy volunteers in earlier trials, one can assume that it will be necessary to perform a standard TQT Trial.  On the other hand, when dealing with a cytotoxic agent, in order to meet the requirements for assessing cardiac safety, one may instead do PK-PD modeling in dose escalation studies or perform an intense substudy in Phase III.  Of course, there are many confounding variables.  QT results from early Phase I trials in patients may be difficult to interpret due to co-morbidities, electrolyte shifts, all of the different concomitant medicines (including some of the antiemetics commonly used), inconsistencies in various Phase I protocols or a lack of validated results and designs.  All of these issues can burden planning and regulatory submissions.  In addition, performing dedicated cardiac safety studies in oncology patients can have an adverse impact on patient care and clinical centers, as many of these centers are not accustomed to doing intense cardiac safety assessments.

In assessing the QT interval, we generally recommend the use of 12-lead digital holters which collect 12-lead ECGs continuously for 24-48 hours.  This allows the ECGs to be extracted at particular time points which one has chosen based on the preliminary PK data.  However, if necessary, one can go back and extract additional data to observe if there was a QT effect at a time point which hadn’t been anticipated up front.  Additionally, we recommend the use of a central lab for standardized, manual readings.  We also usually recommend triplicate ECGs at each time point and as many as 6-9 at baseline.  This reduces intrasubject variability and the chance of finding a 60ms QTc “increase” that’s simply related to the subject’s normal daily QTc variability.

Generally, the ECGs should coincide with PK collection time points.  One will assess each patient for the change in QTcF and each dose cohort for the mean change in QTcF.  One can also assess QT/dose response and QT/concentration response on an ongoing basis as the dose is escalated.  For the best baseline, we generally recommend 2-3 triplicates (6-9 ECGs) spaced 5-10 minutes apart.  It is critical to have the best possible baseline data, as this data will be used for all subsequent comparisons for all post dosing time points.  On Cycle 1 – Day 1, triplicate ECGs matched to PK sample collection time points are recommended (if inpatient, typically 6-8 post-dose ECG time points over 24 hours or if outpatient, 4-6 post-dose ECGs in 6-8 hours).  During Cycle 1 (after Day 1) & subsequent cycles, depending on PK, additional ECGs (generally 1 –3 per time point) may be performed pre-dose and/or at Cmax on additional days.

The definition of a positive QTc signal will be a central tendency of greater than 10ms as well as PK-PD data showing greater than a 10ms increase in QTc at Cmax.  Positive signals may also include outlier analyses showing greater than 15% of subjects having a greater than 60ms change in QTc or greater than 5% of subjects having a new QTc greater than 500ms.

What are the consequences of a positive QT study?  The good news is, it doesn’t mean you have to cancel your development program!  In the face of a positive QT effect, one will need to perform more intense ECG monitoring in Phases II-III in order to be able to give good recommendations in the drug label.  This will allow clinicians using the drug to maintain adequate safety for their patients. On the other hand, a negative QTc study will generally mean that one only needs to perform routine cardiac follow-up during Phase III.

As previously mentioned, we recommend centralized measurement and interpretation of the ECGs because our experience is that site measurements and interpretations are very problematic and carry the risks of both false negative and false positive results.  Sites generally tend to depend on unreliable ECG computer generated measurements.  Also, sites may use different ECG machines, which may employ different algorithms for the correction of the QTc.  In addition, many oncology sites are not all that experienced upfront with performing electrocardiographic monitoring, and readers may be inexperienced and inadequately trained at precise QTc measurement.  To compound matters, many of these patients will have significant T wave and U wave abnormalities (very common in oncology patients) that make the QT measurement even more difficult to assess than in normal patients.

In summary, the assessment of cardiac toxicity and QT effects has become mandatory, but for agents which cannot be given to healthy volunteers, a robust Phase I or Phase III trial can be designed to adequately assess QT effects.  Careful planning and careful implementation are key to the successful collection and analysis of cardiac safety assessments of oncologic therapies.

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Get to know Linda Deal, Senior Director of Health Outcomes Research at ERT


We are very excited to add Linda Deal to the ERT family as the new Senior Director of Health Outcomes Research. Having worked inside sponsor organizations and across a number of entities within the PRO community, Linda brings insight and perspective on the creation and implementation of Patient, Clinician and Observer reported outcomes.

A personal interview with Linda Deal:

Linda, how long have you been in this industry?

“I’ve been in the Pharma Industry since 1997, 14 years!  The majority, 12 years, has been on the Sponsor side.”

What do you enjoy most about it?

“This is easy.  Let me start by saying that for me, the best in life is people and the most important thing in life is being understood.  My career affords me the privilege to make understood some very deserving people, the patients suffering illness.  I work very hard to represent the patient experience in the complicated process of bringing safe and efficacious therapy to those in need.  That’s what gets me out of bed every morning!”

Can you tell us about your past experiences in health outcomes research?

“Absolutely. At Janssen Pharma (a division of Johnson & Johnson), as the Immunology Patient Reported Outcomes Lead, my primary responsibility was developing and integrating the PRO strategy within the end to end development process. Prior to J&J, I was head of the PRO Center in Global Health Outcomes Assessment at Wyeth Research, which is now Pfizer. I have also supported health economics and outcomes research for Wyeth, Research Triangle Institute, and Glaxo Wellcome. Also, throughout my career, I have designed a number of assessments now used in clinical trials as well as prepared over 20 regulatory briefing documents addressing PRO development and validation for supporting registration and labeling.”

In your opinion, what makes a great vendor?

“A great vendor is a partner that listens and can anticipate my needs providing experience and insights that assist in meeting my objectives.  And, of course, a great vendor delivers a quality product/service on time, managing my expectations if necessary.”

What will your role be at ERT?

“In general, I’m here to provide scientific input into the technology solutions that ERT offers to clients for collecting outcomes data that will eventually meet the clients intended purpose for the data.  I anticipate that there will be an educational component to the role as well.”

Where do you see the direction of health outcomes heading in the future?

“Now and in the future, Health Outcomes will play a central role in Sponsor organizations.  Since the release of regulatory guidance addressing the development and use of patient-reported outcomes, we’ve begun to see specific areas of expertise within health outcomes emerge in the larger and more innovative sponsor organizations.  What used to be a single generalist role is being parsed out into multiple specialized roles.

The patient and payers are being recognized and addressed as stakeholders in addition to physicians.  The specialization required to demonstrate value and measure subjective outcomes is becoming necessary to stay on the competitive edge in this industry.  These are exciting times for health outcomes scientists.”

How do you plan to play a role in shaping this space?

“I see my role in shaping this space as one of education and communication.  The health outcomes community has done a great job of organizing and spurring scientific advancements within our community.   I’d like us to reach out beyond our community to educate our clinical, biostatistics, regulatory and operations colleagues on the importance and relevance of our science.   Some still don’t appreciate health outcomes as a science.  I’d like to see that change.  How is it that I’ve been doing this for 13 years and am still asked, “What do you folks in health outcomes do?”

I’d also like to see us balance the scientific refinements of our methods with the practicality of the tasks at hand.  I’d like to play a role in prioritizing our scientific focus based upon the return on our efforts to the patients, physicians, caregivers and payers….sort of reminding the team to keep their eye on the ball.”

Do you participate in any charity or volunteer work?  If so, which is the most important to you?

“Yes, there is a wonderful program called “Communities in Schools”.  With cooperation from employers, employees can volunteer a couple of hours per week to young children in inner city schools who are having difficulty learning to read.  These are kids who simply need someone to sit down and read to them, pointing and sounding out words.  It’s very rewarding to see a child learn to read.

I once had a proposal from a 6 year old!  He even had a ring for me.  I still have that and wear it once in a while.  I told him that if I wasn’t married when he grew up and he still wanted to marry me, then I definitely would do it!”

What is your favorite vacation destination and why?

“There is no single destination that is a favorite.  I like to go any place that is culturally exotic.  I’m a true social scientist.  I enjoy observing and trying to experience the way of life of others.  No Club Med for me.”

What is your favorite motto?

“There is more than one.  The first is to “begin with the end in mind”.  Have an idea of where you’re going before you take the driver’s seat.

In the context of bringing novel and innovative therapies to market, I can be very persistent and impassioned about representing the patient perspective.  That can create a bit of irritation with my clinical and biostatistics colleagues.  I often find myself reminding them that “it’s the minor irritation that creates the pearl!”  When I insist, it’s always with the intention of delivering a better product/therapy.

In the case of evaluating the merits of an Outcomes Instrument’s ability to measure what it is purported to measure.  The motto I recognize is that, “It’s better to be generally correct, than to be precisely wrong [in what you’re measuring]”.  So, I give greater weight to accuracy than precision.”

Thank you Linda!  Have your own questions for Linda? Feel free to leave a comment below!

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NIH Releases Best Practices for Combining Qualitative and Quantitative Research


Written by Linda Deal, Head of Health Outcomes Research, ERT

On August 23, 2011, the National Institutes of Health released a guidance entitled “Best Practices for Mixed Methods Research in Health Sciences”.  The mixed methods refer to the combination of qualitative and quantitative approaches to addressing the treatment and prevention of illness and important public health issues such as treatment adherence and disparities among patient populations.

While this guidance targets researchers applying for NIH funding, it also serves as a useful supplemental reference to the FDA’s 2010 guidance to industry on patient reported outcomes.  This NIH best practices guide provides useful definitions and parallels to the challenges faced by outcomes researchers in the Pharma and Biotech industry that are tasked with exploring and uncovering novel points of medical differentiation for the products they support.  For example, in describing the nature of qualitative research and its evidence, the NIH guidance states “… Qualitative data help researchers understand processes, especially those that emerge over time, provide detailed information about setting or context, and emphasize the voices of participants through quotes. Qualitative methods facilitate the collection of data when measures do not exist and provide a depth of understanding of concepts.”  When searching for the novel point of differentiation, it is often the case that existing measures are inadequate or lack the depth to capture salient concepts that are meaningful and understood only by the patients that experience an illness and during particular circumstances.

Another parallel of interest for the outcomes researcher is a section addressing teamwork, infrastructure, resources, and training.  All four are of critical importance to the Industry outcomes researcher challenged not only to develop the measurement strategy to support a point of medical differentiation but to oversee a plan for executing that strategy.  When developing a measurement strategy, it is important to acknowledge that “the questions driving the research initiative should determine the expertise required to address them.”  Multidisciplinary compound development teams require a breadth of disciplinary membership but also the depth of subject matter experts such as health outcomes scientists.  By understanding the NIH guidance and familiarizing with its references, health outcomes researches increase opportunities for securing a seat at the strategy table, exercising the depth of knowledge to facilitate an appreciation and regard for our science.   Infrastructure, resources and training are all critical components to successfully implementing an outcomes measurement strategy.  For an organization to reap the benefits of a measurement strategy, execution must be done well.  Understanding the existing infrastructure and processes is essential before refinements addressing a measurement strategy can be addressed.  This is especially important in an industry where delays in timelines can affect the future stream of revenues and resources are allocated among competing programs within a portfolio.

For access to the full NIH guidance, http://www.nih.gov/news/health/aug2011/od-23a.htm

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Team ERT *Bike MS: City to Shore Ride 2010-2011


Editor’s Note: The number of people living with multiple sclerosis in America exceeds 400,000. This astonishing rate will only continue to increase, until we’ve found a cure. Research has made some incredible advances recently, but the world can still only offer disease management drugs and therapies to the 2.5 million people, worldwide, living with MS.

Team ERT *Bike MS City to Shore Ride 2010-2011
Written by Michael Federico

In recapping my experiences of the 2010 Bike MS City to Shore Ride, I needed to keep one thing in mind, Murphy’s law.

—  Like leaving your bike shoes at home.

So, we adapt, we work as a team, and we find a solution.  A fellow teammate will bring a spare set of pedals and shoes. No problem, even my size. Thanks, Bill!  That morning, at 6am, we swap pedals and shoes and away we go.  In the back of my weary mind they don’t look quite right and sure enough, the left pedal falls off 12 miles in.  Turns out, we put the pedals on the wrong sides, which stripped out the crank!  So we ride with just the right leg for miles 12 through 18, hoping the rest stop was at 15…it wasn’t. This way is about the same as driving a Porsche with summer tires mounted backwards, in a snow storm – you can still go, but it takes more “skill” and a bit of lunacy.  But after all, the whole ride is about dealing with disabilities, so it was worth all of the inconveniences to help this great cause.

At mile 18, two bike shop trucks stop and after appropriate frowns and consternation, we have a solution with a new left crank.  I catch the team at the next rest stop.  There we see the famous woman riding in her 30th MS City to Shore, in a dress and heels on a steel, one speed bike.  Oh, by the way – SHE IS 85!

As we take off for the next leg, I made the mistake of standing up to hump over a hill and, GREAT, the right pedal works loose and strips out.  That’s ok; my left leg is fresh from its previous rest and I motor on for about 5 miles.  Another repair guy stops, more frowns and consternation, and he declares the bike dead. Bummer.  As I am waiting for the bus, the inspirational 85 year old woman pulls in and I get my picture taken with her!

As I ride the bus, we stop and pick up disabled riders and bikes along the way.  Nice folks, however, this cruising and stopping is slower than a one legged rider!

At the next rest stop, I jump off the bus and right to the Bustleton Bike shop (genius of a guy by the way).   Again, after the appropriate frowns and consternation, Mr. Bustleton decides that the right solution is the simplest one, Achim’s Razor.  We put a correct right pedal on the right side, but just a flat pedal, no binding, which is less stress on the threads.  Cool, Great, I don’t care if we duct tape, spot weld, pop rivet, or bubble gum it, I am finishing this ride!  Both pedals are finally solid.  Sprinting to the next rest stop, I finally catch the group!

[Wait.   Do you hear that?   I can hear my biggest sponsor..my mom,  all the way from South Carolina: “Gooo Michaaaael!”]

Guess who pulls into this rest stop as we are leaving?  The 85 year old woman!  This is amazing, she is pacing us, or we her!

The rest of the ride was thankfully uneventful – finally riding with the team again, and a great team it is (check out the special video we created below).  Many, many thanks to all of the repair guys I now know personally, the support team for the ride and the ERT team – captained by Dan Wick.  We had 14 riders and raised over $11,000!  It was a great trip and I met many great people.

If you laughed, chuckled or even smiled when reading this, please help make a difference in the fight against MS and volunteer, participate, or contribute to the team’s 2011 fundraising goal. http://bit.ly/ERT-MSRIDE.  We have again formed a team for Bike MS because we know that riding 150 miles is nowhere near as difficult as confronting a lifetime with multiple sclerosis.  In addition to supporting novel research projects around the globe, the National MS Society also provide much needed education, programs, and services to everyone who is affected by MS – including the diagnosed, their friends and families, and the healthcare professionals who work with them.

See you in September 2011!

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