Partnerships in Clinical Trials

New Details on the Clinical Collaboration Congress!

noreply@blogger.com (Jennifer) — Fri, 24 May 2013 14:27:00 +0000

The organizers of the leading Partnerships in Clinical Trials event are proud to present the all-new Clinical Collaboration Congress. This interactive event experience was developed for clinical leaders, like you, to collaborate with your peers on how to change the way the industry does business. Forward-thinking collaborative minds combine with interactive discussions that make you part of the learning experience for the highest level of engagement.

Downloading the preliminary agenda.

What makes CCC Unique?

• Collaboration is key. CCC is the only event with a focus on cross-industry collaborations, consortia and new partnering paradigms to challenge the current clinical development model.
• Location, location, location. We're in biotech's backyard, so you'll travel less - or not at all, but get all 3 days of content and networking.
• Smaller is better. Don't get lost in the crowd! CCC brings you a dedicated track and pre-conference summit to address specific issues burdening small to mid-size pharmaceutical, biotech, and medical device companies.
• The ONLY place to meet all of your Labs vendors are under 1 roof. We're bringing back the Partnering with Labs track and the Logistics Task Force where stakeholders will tackle the biggest cost drivers and quality killers impacting clinical logistics.

Say Goodbye To The Same Old Presentation Formats!
In creating this agenda, we kept 3 things in mind - learn, engage and partner. CCC is proud to introduce unique formats that immerse you into interactive discussions that promote the highest level of engagement through Think Tank Sessions and a Tech Town Hall hosted by Marc Foster of Transparency Life Sciences.

Would you like to join us for this new, collaborative experience taking place September 25-27, 2013 in Boston? As a reader of this blog, when you register to join us and mention code XP1825BLOG, you’ll save 15% off the standard rate! What to join us for free? Check out our option to be a guest blogger. Have any questions? Feel free to email Jennifer Pereira.

Gene mapping & preventative care and how hospitals can help Pharma

noreply@blogger.com (Jennifer) — Fri, 17 May 2013 13:00:00 +0000

One of the most well-received presentations at the 2013 Partnerships event was Dr. Eric Topol's presentation where he focused on the technology we have today, how we should use it to understand our genes and take action on our health before it's too late.

Yesterday, high profile actress Angelina Jolie wrote an open letter about her choice to take the knowledge that comes with gene sequencing and acted on it to prevent possible cancers. This has brought gene sequencing and personalized, preventative medicine to the forefront of American minds. With this on the front of everyone's minds, The New York Times profiled many of the cancer centers and documented what they're doing to keep up with current technology and stay ahead of cancers in patients.

What this article also points out is that - by knowing what treatments will work in patients due to this mapping - many hospitals can become a bigger part in creating effective drug treatments. By partnering with Pharma companies and providing the information they've uncovered from mapping genomes and seeing effective treatments through, hospitals can become a valuable asset and business partner for the Pharma companies - both benefiting Pharma Companies with quicker and cheaper drug development time lines and the hospitals, which have the patients to participate in the clinical trials.

Do you believe that hospitals can truly bridge and solve some of Pharma's biggest gaps - access to the patient population as well as faster drug development timelines?

Would you like to attend the Clinical Collaboration Congress for free? Join us as a Guest Blogger!

noreply@blogger.com (Jennifer) — Wed, 15 May 2013 15:39:00 +0000

That’s right, we’re offering a few exclusive all-access complimentary passes to the Clinical Collaboration Congress– September 25-27, 2013 in Boston and you could attend the conference – on us ($3,000 value).

We’re looking for experienced bloggers who are well-versed in the clinical trial space to begin blogging now and also at this year’s event. In return for your posts, you’ll be able to attend educational sessions and training seminars delivered by industry thought-leaders and Pharma professionals through in-depth case studies featuring the industry experts from leading pharmaceutical companies including Pfizer, Eli Lilly & Company and Merck as well as out of industry insights from academic leaders, financial analysts and patient stories.

To Apply: Simply send your name, title, company, and a link to your blog if you have one to Jennifer Pereira . We will review the submissions and contact all winners directly with more details. This opportunity doesn’t come often and we encourage you to apply and join us in Boston.

Michael J. Fox Foundation & Their Approach to Clinical Research

noreply@blogger.com (Jennifer) — Mon, 13 May 2013 14:36:00 +0000

Leading up to Partnerships in Clinical Trials 2013, we sat down with some of the visionaries from the clinical trials event to go in-depth on their goals and insights into the clinical trails field. The Michael J. Fox Foundation is championing clinical trials in Parkinson's Disease finding ways to encourage participation and awareness of clinical trials. Sohini Chowdhury, Senior Vice President of Research Partnerships at the The Michael J. Fox Foundation for Parkinson’s Research sat down with us to share with us some of the insights and goals this foundations has for clinical trials awareness and participation. Today, Sohini shares with us how the foundation operates on a non-profit basis.

Sohini Chowdhury,
MJFF

As a non-profit organization, how does the Michael J. Fox Foundation approach clinical research?

That’s a great first question. MJFF’s approach to clinical research mirrors our general approach to research. That’s really built on four prongs. The first is that we focus on the unmet need within Parkinson's Disease. So, we know that one million individuals are affected by Parkinson's Disease in the U.S. and approximately 5-6 million worldwide. It’s the second most prevalent neurodegenerative disease and, unfortunately at the moment, there is no cure. So, that really provides us a context by which we think about clinical research. We need to find a cure and we need to find improved treatments for the disease.

Our second prong—when you think about clinical research and again, research in general—is to be patient-focused. What is the breakthrough or the particular therapeutic that will really have an impact on a patient’s life? That could be the Holy Grail, as we like to call it—finding a cure. Or it could it be about finding a better treatment to lessen the current symptomatic aspects of the disease to be able to improve the quality of life for patients.
We also make sure that the research we fund—whether clinical or not—is transparent and accountable. We want to make sure that it is clear where our money is going and what our money is supporting. So, we make sure that the

Download the full interview with Sohini Chowdhary here.

Next week, we'll examine the challenges of patient recruitment.

The Changing Financial Landscape of Hospitals

noreply@blogger.com (Jennifer) — Fri, 03 May 2013 16:14:00 +0000

We know that hospitals are important to the landscape and future of clinical trials - as they function often as the place where patients receive their knowledge of their health and are also the sites of many clinical trials. All of health care is changing, hospitals included. I recently came across this article from Becker's Hospital Review that shared some of the most poignant ways they are changing.

As with many business in this business climate, hospitals are finding more affordable ways to operate. This includes merging in a variety of ways including with other hospitals, physician practices or with independent practice associations. Many hospitals are also looking at outsourcing non-core competencies so that they can focus on their strengths. Patients are also starting to become more responsible for paying their costs - which leaves the hospitals often spending more time trying to collect payment in order to stay profitable.

Is there a specific ways these changes in the financial climate can be beneficial for clinical trials? Can clinical trials profit from more hospitals working together as one unit?

2013 Partnerships in Clinical Trials Awards Winners

noreply@blogger.com (Jennifer) — Wed, 01 May 2013 16:33:00 +0000

Last week at Partnerships in Clinical Trials, we presented the 3rd Annual Partnerships in Clinical Trials awards.

Congratulations to our winners!

The Pfizer/PAREXELl/ICON Team

Third Annual Partnerships Awards Winners

Clinical Trial Innovator of the Year: Tomasz Sablinski
Clinical Trial Business Woman of the Year: Deborah Brooks, Michael J. Fox Foundation for Clinical Research
Partnerships Pioneers of the Year: Pfizer/PAREXEL/ICON Partnership

Are you ready to continue the conversation from Partnerships last week? Join us this September in Boston for the Clinical Collaboration Congress!

noreply@blogger.com (Jennifer) — Mon, 29 Apr 2013 14:14:00 +0000

Thank you to all of you who joined us at Partnerships in Clinical Trials this past week! Many valuable topics were brought front and center including new partnerships that are transforming the industry, how the patients are ready and willing to connect to the clinical trials industry and more.

Now that Partnerships 2013 has concluded, we’d like to share the all new clinical event taking place this fall. This September 25-27 in Boston, we present the Clinical Collaboration Congress and the 6th Annual Biorepositories and Sample Management Conference events.

As a member of this reader of this blog, you’re able to save $800 off the standard registration rate when you register to join us by May 17th and mention code XP1825LINK. If you have any questions, feel free to email Jennifer Pereira.

If you’d like to participate as a sponsor or exhibitor email Adam Lennon.

#PCTUS 2013: Partnerships and Outsourcing

noreply@blogger.com (Jennifer) — Thu, 25 Apr 2013 20:17:00 +0000

To conclude our Partnerships experience, we learned about some of the challenges to be aware of when outsourcing to China and more about the Partnerships Award Winning partnership between PAREXEL, Pfizer and ICON.

In the presentation Overcoming Challenges in the Asia-Pacific Region: Roadblock and Opportuniites, Christina Bodurow of Eli Lilly; Warren Myers of Takeda Pharma; Patrice Hugo of Lab Corb and Stephen Porter of Dragon Bio-Consultants.

Porter believes that patient access in India and China have infinite access to patients. China has traditionally been less than the region. The market opportunity is growing at 25% a year. In terms of regulatory approval, it may be 12+ months. Guidelines on strategies to identify and mitigate risks for first-in human clinical trials. There are only 300 approved hospitals to do clinical trials in China. China is not likely to follow any contracts. The standard of care in China is different, so it’s difficult to bring a western protocol in to the country. Start in China with the concept of international registration, success will follow with faster enrollment.

What is the clinical strategy/business model and does it vary country to country? Meyers comments that his company has recently begun registering products in Asia. For legacy assets, they’re seeking local access. They also have a large number of partners who are working within the country and then they work with local providers. He is quick to point out that the local Asian market isn’t consistent. There are regulatory and quality risks. He advises developing a local expert who also knows the global supplier.

LabCorp points out that 99% of their efforts are done in China to maintain GCP. They decided to have every important role in China based in the country To expand their reach, they have opened a lab in Singapore and announced a strategic relationship with a Japanese company to harmonize their processes and have them cover the Japan only trials.

Porter also points out that different stages function differently in China, for example, life stage studies are great in China, but they’re lacking behind in the first-to-human testing. The cold chain and logistics are also a problem. On an incredibly innovative front, the country has just announced that they’re going to do a gene-screen on every new born. This will lead to tremendous opportunities when it comes to personalized medicine.

Problems can be solved from the beginning when it comes to moving some of your clinical trials into China? An internal staff needs to be built within the country with individuals who know the ins and outs of clinical outsourcing. Then, let locals learn from those individuals. Big Pharma needs to set standards and use the small team concept, sharing the knowledge and skill sets. Panelists encourage all going into the the Asian region to help and guide the sites, the sponsors and train the staff members. Also experience the work in their shoes - go into the field – visit the hospitals, sites, regulators – get to know who you’re working with.

We then transitioned into a panel that showed the true power of partnerships in clinical trials - the Pfizer/ICON/PAREXEL Partnership. Panelists included Coleen Glessner of Pfizer; Chris Hilton of Pfizer; Dana Poff of Icon Clinical Research; Conal Burgess of Parexel International; and John Oidtman of Pfizer.

Pfizer was promoted to realign their partnerships structure after prompted by the FDA. They started off by questioning how they could make their operations more efficient. The original model of outsourcing Pfizer ran had 17+ functional service providers. This prompted them to eliminate the transactional bidding process. This prompted them to go with a CRO vetting model, they needed the CROs to have the same willingness and approach to get to the same goal Pfizer was looking for – specifically why quality was going to be embedded in their work. In the model, they needed transparency into the resourcing, monitoring plans, visit schedules. The information isn’t always shared but needed it to be. They then chose a system that would focus on 12 things that would get to the essence of what they needed to do which led to these seven metrics: Control of investigator fees, control of resourcing, quality performance, investigator satisfaction survey, key milestones on critical path studies, process improvement or innovation and noncompetitive or insufficient capabilities.

What were some of the learnings from this partnership? It’s important to build trust and work with everyone involved – there is no such thing as overcommunicaiton. Coleen of Pfizer was the most surprised by commitment to quality in combination with the CRO’s implement of quality has been amazing. The infrastructure must be solid to commit to that in the long run. They had to focus on the cultures within the different sectors of the business – Pharma/CROs. These three teams had to start thinking like partners.

#PCTUS 2013: Innovation and economics in Pharma

noreply@blogger.com (Jennifer) — Wed, 24 Apr 2013 15:35:00 +0000

On our final day of Partnerships in Clinical Trials, we looked at how innovation is affecting other industries and the financial outlook for the industry.

Terry Jones

Terry Jones of Travelocity.com, Kayak.com, American Airlines and author of The Business of Innovation, started off by stating that business has entered a self-service world. Consumers are multi-channel animals and as a result, the line between sales and service is blurred. They want both services in every channel that they operate. This is resulting into companies becoming obsolete. How many things do you use your Phone for now instead of other items? Even how many jobs this is changing? Customers are getting smarter and short circuiting traditional distribution. One innovation can render any business obsolete. Jones pointed towards the traditional book store which was then replaced by Barnes and Noble, and Barnes and Noble was replaced by Amazon. And now in the mobile/social world, the Kindle App is moving everything the SmartPhone. This calls for any company to build a digital relationship with their customers where they are looking - via search engines - in the places they're looking. This is not necessarily the product you are offering but the solution your product offers.

They're also increasingly trusting word of mouth and online platforms are a go-to source for these. Give consumers a place to have a conversation online – because people trust individuals on the internet more than what the brands have to say.

How do you stand out online? Make your product part of the process – be fast and convenient to the customer. How do you get on the consumers good side? Communicate with your consumer when they want to communicate on their terms – open all the doors. Customers want to be treated like individuals and given solutions.

What is innovation? It’s about doing, putting your ideas to work. People are afraid of change because there is no incentive to change. Innovation rests on the culture of your company and your team. Then when innovations fail, learn from them. You can learn as much from failure as you can from success. Hire people who don’t fit in for new perspective and keep the innovation teams small. The leader needs to cultivate innovation and reach and encourage the innovation from the bottom layer of the company – they are the ones who are forward facing.

Economic Panel

We then transitioned popular panel: Wall Street Leadership Panel: Economic Outlook for Pharma in 2013 Opportunities Investment Areas and Effects on the Outsourcing Industry. We heard insights from Ian Lauf, Boehringer Ingelheim; Josef. H. von Rickenbach, Parexel International Daniel M. Perlamn, RPS; David H. Windley, Jefferies & Company; Tim Evans, Wells Fargo and Brian Doyale, William Blair.

Tim Evans of Well Fargo began the presentation by identifying that the backlog conversion rates have been trending down over the past decade. In 2012, the conversion rates stabilized. Every company has benefited from the increasing partnering model. Clinical has driven most of the growth in the industry since 2008. Public companies have stayed away from large acquisitions and growth has been organic. The price of growth is investing in partnerships to develop large trials – employees, technologies, geographic investment. The gross margin has seen the biggest hit – but this is where the employees costs are identified.

In the CRO industry, the free cash flow has gone up since 2008 in addition to Pharma R&D spending continuing ot be flat. The growth since 2008 has been driven by outsourcing penetration and market share gains for the largest CROs.

David Windley continued the conversation identifying that the market growth has been based on these factors and will continue: R&D Spending is growing, outsourcing penetration is continuing to increase and consolidation will continue.

R&D spending was down in 2009 by 5%, after it recovered in 2010 and 2011, it did decline 1% in 2012. In 2013, R&D Spending should go up 1% and will grow 2-3% over the next few years.

We then transitioned into a panel discussion that all panelists joined. Von Rickenbach believes that partnerships are the future and the Partnerships conference has been on target for years: there are advantages for both sides when it comes to strategic partnerships. Dan Perlman went on to further comment that when a company has developed a relationship it’s hard to undo. It then forces the stake holders to work together – so what hurts one company hurts the other. Windley believes that strategic partnerships have a lot of upfront investment. Many deals are three year deals – but – so in the time that it’s taken to set up the deal, it’s often hard to really track the revenue. So what will happen in the renewel cycle that we’re approaching?

Pre-clinical has declined since 2008. Things have stabilized and part of that is due to the Pharma companies are comfortable moving to a partnerships model in the clinical world. One future factor to consider is pharmacy costs. They account for 15% of all costs. There is a more difficult process to getting drugs on a formulary now. Insurance companies are looking at what's the best treatment at the most affordable price before they agree to cover specific drugs. It’s hard enough to find the 1 out of 10,000 compound, and it’s safe an effective, but now you’ve got formularies saying they won’t put it on and now your R&D model was evacuated.

One of the closing statements targeted the fact that partnerships are the evolution in the Pharma industry. Version 2.0 of the partnerships will focus more on how work can be done in versus out of house. RPS the future of drug approval sits in mid-Pharma. In the next year there will be major changes in the way mid-Pharma outsources.

#PCTUS 2013: How to improve your outsourcing partnership

noreply@blogger.com (Jennifer) — Wed, 24 Apr 2013 11:56:00 +0000

We started out the afternoon with the Avoca Update. This year's survey focused on risk sharing. One of the major findings to come out of the survey was that when providers are penalized, there is generally a more negative experience. Relationships between sponsors and providers require complete clarity. This changes the focus from high quality delivery to placing blame and takes away from the importance of the trials. About 50% of sponsors are using risk-related information to determine levels of over-site. Are risk-based approaches leading to better efficiency and higher quality? Not many are seeing more efficient use of resources but many are seeing increased quality. If you'd like to hear more about this year's Avoca Survey, listen to a Inside Outsourcing podcast we recorded with Partnerships Speaker Patty Leuchten.

At Millennium Pharmaceuticals, they do not do a lot of risk sharing and are working with three preferred providers. It has been discussed but the risk based approach model is something they've worked on since the risk based approach to build metrics for outsourcing because the ability to move forward is based on the risk sharing model. Coleen Glessner, Pfizer believes there are so many directions that risk management can take you. Pfizer has piloted the integrated quality management plan with the FDA. At the beginning of protocol development, they can identify where the largest risks in that trial and then they can put mitigation in place. What are you going to stop doing now that these are in place? Pfizer has shifted to quality – higher quality protocols are seen thanks to this new risk based approach. INC Research focuses on two types of risk: operational risk and clinical/scientific risk. Identify risks that you choose not to mitigate. You can’t de-risk protocols complete and you will have to accept some protocols immediately.

Next, David A. Kramer of Astellas Pharma Global Development and Nicholas Spittal of Chiltern discussed Implementing Mid-Size Tailored Functional Service Partnerships Through Strategic and Organic Means

There's been a move to functional relationships between Pharma and CROs. Ideal partnerships result in maximized efficiency with continuous improvement. The promise of the mega-FSP is reduced sponsor cost and guaranteed sponsor increase in revenues. Lilly and Covance have found their partnerships to be a win. Spittal believes that of this has not been cost savings but not cost shifting. How can small sponsors and CROs get the attention of a large counterpart? How can it be structured to benefit both organizations.

It is important start successfully from within the company, often meaning the sponsor should transfer management to the CRO and send back FSP team to the sponsor. This helps build relationships between teams. Any staff members who have had previous experience with the CRO staff should be on that team which leads to the implementation of best practices there. Upon this successful implementation the staff should be grown organically From there, the integrated staff can work on workshops, pipeline planning, policies and procedures and logistics.

With these staff members successfully in place, it's important to start pushing the team towards success. Deliverable teams meeting on a daily basis, ops meets weekly, management community and executive committee meet less frequently. A relationship manual is key because it defines: governance, ops plans and procedures, resource planning, contracts, etc. If the transfer of the clinical team moves to the CRO and stays, that shows a testament to how well the plan worked to move clinical operations. They had also opened their offices next to each other so that relocation wouldn’t be a factor.

What is needed to succeed in a successful mid-sized Pharma and CRO partnership? A cultural fit, a clear understanding of the goals, advanced planning, mutual trust and transparency, shared allocation of responsibilities, flexibility and governance and continuous communication.

For our last breakout session of the day, Christoper Erickson of Parexel and Daryl Najarian of Merck presented Adapting Strategic Partnership so the Needs of Emerging Markets

Erickson of Parexel started out identifying emerging markets as a significant place of growth and therefore a re-directed investment for the Pharma companies. Innovative products need an emerging market research component. It’s also about looking beyond the traditional products in major countries to see how it can be used in other companies. How do you ensure there’s high quality data with appropriate budgets? Scale the costs appropriately. The data from the emerging countries isn’t often as good of quality due to lack of experience. Decision makers in the partnerships space have seen that strategic partnerships have added value to their company.

Daryl Najarian of Merck identified knowing who owns the accountability as key to any strategic relationship. Regional governance should also be a clear cut. Also identifiable should be the project performance metrics and what the view of the relationship from both sides of the partnership. Feedback from stakeholders in the relationship and then share it appropriately. Other clear communication should include a sponsor is transparent about their trials in a region, then the CRO can be prepared and do a better job. Final protocol should be developed well in advanced and don’t be afraid to share the success of the trials with both parties. Detailed operational/contingency plans and share the plans of what’s driving those models.

In our last session of the day, Dierdre Bavard, Endo Pharmaceutical moderated the panel discussion among Kathleen Ford ofMerck Serono, Ed Pezalla of Aetna; Karen Kaucic of PPD, Kelley D. Davis of Express Scripts and Dalvir Gill, Transcelerate Biopharma. They looked at how innovation could spur more effective clinical trials.

Aetna uses their technology to examine claims data, diagnostic codes, laboratory values and increasingly values to identify potential patients who can participate in clinical trials. Karen Kaucic of PPD states that clinical trials are too long, too inefficient to develop molecules sustainability. They’ve approached the sponsors and stakeholders to advance the novel approach to clinical trials and are doing collaborative trials to become a driver for drug development over the next few years.

Aetna believes that they’re up to the task of dealing with tailored, personalized medicine. They can then prove the success of the medication based on the result of the medication. What does the insurance of the future look like with new personalized medicine. Coverage for entire systems of care is coming.

A frequent theme of this conference arose again - patients need to be involved earlier in design. Kathleen of Merck Serono believes that it’s difficult to go to a patient and ask what they should or shouldn't do because the procedure has to be balanced with what can be done. To test feasibility of running trials with patients in the room and having them weigh in on their willingness to participate with procedures is important. As they think about launching clinical trials, bringing patients in earlier to pressure test the operationalization of clinical trials to hear the voice of the patients would be preferred.

Rare diseases really need the insights of how patients feel about clinical trials because there are so few individuals who can actually weigh in on the procedure. Patient advocacy groups are a great way to identify this.

Anolinx™ Utilizes Real World Data To Recruit Clinical Trials Patients Faster And With Greater Precision

noreply@blogger.com (Jennifer) — Tue, 23 Apr 2013 23:00:00 +0000

Orlando, FL – Anolinx™, a clinical research and clinical trials recruitment company headquartered in Salt Lake City, Utah, announced today the launch of a new patient recruitment initiative.

Anolinx™ made the announcement in conjunction with the annual Partnerships in Clinical Trials conference in Orlando, FL.

According to Anolinx™ CEO, Aaron Kamauu MD MS MPH, the company is now poised to utilize real world “big data” for the purpose of recruiting patients for clinical trials. Dr. Kamauu, said at the press conference, “Our mission is quite simple: Use advanced analytics on current, deep and rich, real world data to identify and recruit clinical trials patients much faster and with greater precision. “

“Over the last two years we have proven the success of this model and are now prepared to launch our capabilities on a large scale. We have the analytics and the data to do this work,” he added.

Anolinx™ also announced two well-known thought leaders in healthcare as Chairman of the Board of Directors and Chairman of the Board of Advisors. Senator Robert F. Bennett will serve as Chairman of the Board of Directors and Raymond L.Woosley, MD PhD will serve as Chairman of the newly created Board of Scientific Advisors.

Senator Bennett, a former three-term Senator from Utah, is widely known for his healthcare expertise. While in the Senate he served as Chairman of the Appropriations Subcommittee on Agriculture, (the Senate committee with FDA budget oversight). He was also the co-author of the Bennett-Wyden healthcare bill, a health care proposal respected across the political spectrum as a common sense approach to healthcare reform. Senator Bennett also brings deep business experience to Anolinx™, having served as CEO of a NYSE traded public company prior to his Senate service.

“I am delighted to be joining Anolinx™,” said Senator Bennett. “I spent much of my Senate career on the committee that oversees the FDA budget. The cost and time to market of new medicines always have been major concerns, to drug manufacturers and consumers alike.What we are doing at Anolinx is the first real breakthrough I have seen in efforts to deal with these issues.”

Dr. Woosley is among the giants of medicine and clinical pharmacology in America. He was the Chair-man of the Department of Pharmacology and Associate Dean for Clinical Research at Georgetown

#PCTUS 2013: Healthcare, data management and reform

noreply@blogger.com (Jennifer) — Tue, 23 Apr 2013 18:13:00 +0000

Speaker Eric Topol

The morning kicked off with our conference chairs Deidre Bavarde and Craig Lipset, They again focused on how patients are waiting while Pharma is figuring out how to work bigger, faster and better. They encouraged attendees to be open to new connections, ideas and solutions to the healthcare problems Pharma is here to solve. Dr. Eric Topol is coming to the stage to look at the future of drug development in the digital world. Technology now allows you to bypass a doctor. The SmartPhone is the most radical change in healthcare. The webcam can do the same thing yet connect you to a doctor on the other end. DNA mapping can save a life. Top 3 drugs in 2012: Humira, Remicade, Enbrel. They’ll sell over $30 billion this year. Clinical response to these drugs is 30-35%. By doing a genomic assessment, we can increase that rate by judging who will respond to the drugs. Genomic treatments that treat those who map to the specific genome can
significantly increase the positive response rate. The democratization of medicine is the future. In the past, the doctor has had all the information and the patient had to seek the information out. Now, the doctors and patients have equal access to the information. But currently, we have 2/3rd of doctors who won’t email their patients. There are 66% of doctors who don’t believe patients should get their patient notes.

Senator Robert Bennett

Senator Robert Bennett believes that healthcare plays a large role in the government and vice versa. The deficit is significantly a result of the healthcare. If we don't get our healthcare costs under control, significant debt will follow. Bennett identified three key Rs when it comes to challenges in healthcare: Research, Regulation, Rationing. Rationing is a standard form of controlling healthcare throughout the world. healthcare is data management. The more data we get on healthcare, the more sophisticated
we become. The best healthcare is the cheapest and in Seattle, WA, Rochester, MN and Salt Lake City, Utah. The three of these places have research centers that have great data management centers. Government lacks when it comes to intervention and innovation. They don’t know how to create a market place, where the demand is, etc. Better quality healthcare means lower costs.

For the next session,Dr. Eric Topel and James Heywood joined a panel discussion with Conference Chair Lipset Key to Connectivity: Opportunities for Disruptive Innovation in Clinical Trials.

Lipset, Topol, Haywood

Topol believes that trials can be developed that can be guaranteed to work. Each individual can provide the information that can lead to the knowing of that drug working. Although many drugs are really expensive, if they’re tested and mapped, they will work. Pharma is not getting the right type of information from the technology that we have. Heywood believes there needs to better control the information Pharma is collecting during clinical trials. The cost of validation is a serious issue in clinical research. Pharma has to be asked to exploit unproven ideas. The next war is who wins the information battle. Topel believes that if a trial takes more than 100 people to conduct, it should be a slam dunk. As long as 1/100 benefits, that’s a success. A trial this small with the right framework can be really inexpensive. Each disease is a rare disease because it’s unique to the way it affects each person. Topol believes that Twitter is the nervous center of research.

Patients in Pharma Companies sponsor trials for investigate drugs, report to their investigators. They self-report into online platforms and provide the ability for scientists to mine the data an determine if they drug in clinical trials is effective or not. Pharma is concerned about patients exposing the results in real time. Heywood believes that we have to start studying the bias. We don’t have any standards in this field on that bias.

Follow the jump to see what Dr. Jonathan Gruber shared about healthcare reform.

Finally, to wrap up the morning, we heard from Jonathan Gruber, World Rebound Economist, Mass Institute of Technology on The Impact of Healthcare Reform on Drug Development: What Does The Future Hold?

Next year will be messy when it comes to healthcare reform. This law will not work well right away at implementation, but it will eventually work once the population knows the benefits of the Affordable Care Act. Pharma benefits from this rule significantly. The law is primarily a coverage law.

The cost control aspect is difficult to manage. We don’t know how to control the costs. Two factors play into this: Healthcare cost has quadrupled becoming 18% of our economy and will grow to over 40% before 2018. We also waste significant amounts of healthcare – up to one third of spending. There are also many third party factors that play into how healthcare spending is perceived including the coverage on news programming.

One way to help fix healthcare is to get patients more involved in their healthcare – they need to pay more for what they use and they need to have more knowledge. Providers need to move away from a fee per service system to outcomes based care. The flaws of the current healthcare system are three fold: It’s expensive, it’s unfair, it’s inefficient. But as the industry evolves to support the Affordable Healthcare Act, the Pharma industry will move towards cost effectiveness. It’s not about delivering the next expensive innovation but the next cheaper innovation that’s just as effective for the patient. This is where Pharma will benefit. The nature of insurance is going to change and decide what drugs they’ll reimburse. The system will allow everyone to have access to cost effective treatments.

So now that we have this new healthcare structure, how is it financed? The financing of the Affordable Care Act half of the money will go to expanding programs and the other will go to tax credits. The government has chosen to tax the two industries who will benefit the most from the new population they're serving: the Pharma Industry and the Medical Device sector. There is also a new Medicare Payroll tax. Cuts include the Medicare Advantage Program will be reduced. There is also a reduction of 1% in hospital reimbursement per year. While this seems like a significant amount, Bennett points out that growth will merely have to slow, as the expenses are running at a higher rate than can currently be sustained.

Bennett then looks at the exchanges and points out their significance in the reform. The Massachusetts Health Connector. Gruber believes that maybe not all states need to run their own exchange – look at the economies of scale. The disappointment is that states are turning down the opportunity to help design the nation-wide exchange.

The Mandate is a critical aspect that needs to be sold. The public must accept that we get health insurance – it’s subsidized and easy to get. There is no doubt that by 2016, millions more Americans will have health insurance. This will be directly dependent upon how well we sell and explain the law.

This afternoon,we'll focus on current clinical outsourcing models and good clinical practices.

New PAREXEL Report Defines The Next Generation Of Strategic Partnerships Between CROs And Biopharmaceutical Industry

noreply@blogger.com (Jennifer) — Tue, 23 Apr 2013 12:44:00 +0000

Partnerships in Clinical Trials 2013 sponsors PAREXEL would like to share the following with our readers.

Majority of biopharma executives believe Strategic Partnerships positively impact their engagement with CROs

BOSTON, April 22, 2013 /PRNewswire/ -- PAREXEL International (NASDAQ: PRXL), a leading global biopharmaceutical services organization, today released a new research report called Strategic Partnerships 2013 at the 22nd Annual Partnerships in Clinical Trials Conference in Orlando, FL. The report is the first to explore the current outsourcing landscape and the value Strategic Partnerships provide to biopharmaceutical companies of all sizes. Strategic Partnerships are multi-year, highly-integrated engagements between biopharmaceutical companies and clinical research organizations (CROs).

The report found that 85% of biopharmaceutical industry executives interviewed and who were engaged in Strategic Partnerships, believe that the relationship between their companies and CROs were positively impacted. Executives believe this more integrated approach to clinical development reduces their level of oversight, decreases fixed costs and provides them with access to capabilities not found internally.

"Strategic Partnerships 2013 highlights the growing importance to biopharmaceutical companies of engaging in Strategic Partnerships to drive greater value through seamless integration, aligned goals and mutual investment," said Josef von Rickenbach, Chairman of the Board and Chief Executive Officer of PAREXEL International. "The report also illustrates that there are further benefits of Strategic Partnerships that can be generated through additional joint focus on cycle times, shared expertise and efficient oversight models."

The industry executives interviewed for this report believe Strategic Partnerships are transforming the way new therapies are developed and commercialized. However, they also noted that the model must evolve to adequately and effectively meet the challenges of a constantly changing regulatory environment. When asked about the vision for the next-generation of Strategic Partnerships, the respondents identified increased alignment in commercial incentives, deeper team collaboration (strategic and targeted expertise) and faster time-to-market through improved cycle times as the top three areas.

Later this week at the Annual Partnerships conference (Wednesday, April 24), Mr. von Rickenbach will serve as a panelist at a session/roundtable titled, "Wall Street Leadership Panel on the Economic Outlook for Pharma in 2013 - Opportunities, Investment Areas and Effects on the Outsourcing Industry." As part of his presentation, he will discuss the benefits and implications of Strategic Partnerships based on PAREXEL's experience, and the CRO industry's future outlook.

About Strategic Partnerships 2013
For the report, Booms Research & Consulting, Inc. - an independent research firm conducted in-depth interviews among senior-level executives such as C-suite leaders as well as heads of clinical operations, R&D, and strategic outsourcing, representing global biopharmaceutical companies (n=26). The sample size included: 71% large pharmaceutical companies, 12% mid-sized pharmaceutical companies, and 17% small biopharmaceutical companies. The interviews were conducted in English in the fall 2012. Participants represent companies with 39% of industry R&D spend. The report included both quantitative and qualitative questions to better understand the current state of clinical development outsourcing and strategic partnerships. The survey includes both single and multiple response questions. As such, some percentages will exceed 100%.

For a full copy of the report, please visit www.PAREXEL.com

About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 73 locations throughout 51 countries around the world, and has approximately 14,000 employees. For more information about PAREXEL International visit www.PAREXEL.com.

This release contains "forward-looking" statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects," "intends," "appears," "estimates," "projects," "will," "would," "could," "should," "targets," and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company's actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent and anticipated restructurings; the loss, modification, or delay of contracts which would, among other things, adversely impact the Company's recognition of revenue included in backlog; the Company's dependence on certain industries and clients; the Company's ability to win new business, manage growth and costs, and attract and retain employees; the Company's ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business; the impact on the Company's business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled "Risk Factors" of the Company's Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2012 as filed with the SEC on February 4, 2013, which "Risk Factors" discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company's estimates or views as of any date subsequent to the date of this press release.

© 2013 PAREXEL International Corporation. PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a registered trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.

ANOLINX™ To Hold News Conference In Conjunction With The Partnerships In Clinical Trials Conference in Orlando, Florida.

noreply@blogger.com (Jennifer) — Tue, 23 Apr 2013 01:50:00 +0000

WHAT: News Conference and Reception in conjunction with the Partnerships in Clinical Trials conference in Orlando, FL.
WHERE: Orlando World Center Marriott, Suite 21290, Orlando FL
WHEN: Tuesday, April 23. Reception begins at 6:30 p.m. News Conference at 7:00 p.m.
WHY: Anolinx™ Chairman of the Board, Senator Robert F. Bennett (Ret.), and Anolinx CEO, Aaron Kamauu, MD MS MPH, will be discussing the launch of a new patient recruitment initiative designed to break the clinical trials recruitment logjam and bring new medicines
to market faster.

Dr. Kamauu, Senator Bennett, and Raymond L. Woosley, MD PhD, Chairman of the Anolinx™ Board of Scientific Advisors, will also be available for individual interviews.

ABOUT ANOLINX™
Anolinx™ is a data-driven clinical research and clinical trials recruitment company that digs deep into electronic health records to significantly improve recruitment and reduce the cost and time for completion of clinical trials. Our unprecedented access to current real-world healthcare data and our advanced analytics enable us to recruit clinical trial patients faster and with greater precision so that our clients can get new medicines to market sooner.

#PCTUS Summit Day: How to connect with your clinical trial community

noreply@blogger.com (Jennifer) — Mon, 22 Apr 2013 23:16:00 +0000

To continue Summit Day at Partnerships, Elsie Matthews, Brystol Myers Squibb presented Improve Patient Data Collection with Electronic Patient Reported Health Outcomes. She pointed out that the best used patient reported outcomes come in the form of good protocol development.

2013 Partnerships Exhibit Hall

What are some of the ePRO Benefits? For the sites, it provides clean, in-range and legible responses, eliminates need to transcribe data, produces little to no data queries, simplifies administration of site assessments. For sponsors, the benefits lie in the reduction in incomplete/missing data, reduced on-site monitoring time, reduce printing/shipping costs, possible reduction in clinical grants and real-time access to data. This decision will be
based on who your target audience is.

Data management is critical for ePRO. You can’t go back and query like you would with a clinical database. But because the 3rd party vendor is involved, there’s a long chain of commands that make it difficult go back and clarify the data.

When doing clinical trials, we need to focus on the ultimate stakeholder. The patient. They are now ePatients. They are informed. Approximately 61% go online for health information. Of that, 37% access user generated content and 42% believe that information online has helped someone they know. How can we get patients to use this information? It reduces their burden, the data is collected in a non-clinical setting and the data collection platform must be comfortable to use for the patients.

Your ePRO platform interface should be easy for the patient. Training to successfully use the platform should be minimal. Good instructions must be passed down the line from the vendor to the sponsor to the site to the patient.

Sponsors need to have a better understanding of the value and the power of the patient. By using electronic methodologies, we’ll get better information from the patient.

Peter Coe, Executive Director & Co-Foundor Tudor Reilly then took the main stage to kick off the conference. He focused on the changing role of clinical trial patients and how we can reach the new generation today. ClinicalTrials.gov is very difficult to navigate and even more difficult to navigate for potential trial participants. Clinical trials are critical to developing new drugs. As many as half of all clinical trial sites enroll one patient. The costs of delays in getting drugs to market is $600,000 to $8,000,000. However, things are changing. Individuals are going to the internet to find out about their health.

Deborah W. Brooks
Michael J Fox Foundation

What is an ePatient? 32% of the videos watched on YouTube are about health. Tudor Reilly has been working on creating online communities of their own, independent of any specific company. They’re focusing on creating communities that need information and hte audience. They’ve just launched the Practical Alzheimer’s.

Finally, to close our day, Deborah W. Brooks of the Michael J. Fox Foundation For Parkinson’s Research presented Patient-Centered Drug Development: The Key Role That Only Patients Can Play

Countless people are living with unmet needs created by disease. There are over one million living with Parksinson's living in the United States. They use their platform boldly to cultivate the patients to both fund and participate in research. All of their efforts go into research, including 60 clinical trials. The funding is provided by patients and families. They’ve realized that they can’t change biology but they are looking at biomarkers for clinical trial end points and they’re also looking at how they can work with the patient community to do testing. They’ve developed the Fox Trial Finder to match those with Parkinson’s Disease with clinical trials and seen huge success in getting traffic to their webpage through search, social media and relevant web pages. They know that the investment in this webpage is long term. They believe that the online tool will be successful. They are creating a long term engagement. Sharing stats and information with patients about clinical trials encourages them to join clinical trials. If you know what you’re doing a clinical trial for, then it means more than you. If you want to hear more about the Michael J Fox Foundation and the Fox Trial Finder, check out this edition of the Inside Outsourcing Podcast Series.

#PCTUS Summit Day: The Power of Technology

noreply@blogger.com (Jennifer) — Mon, 22 Apr 2013 23:05:00 +0000

Welcome to Summit Day at Partnerships in Clinical Trials 2013. We began the morning with an exclusive looking to the Investigator Open House where Janssen, Merck and Eli Lilly shared how they're using technology to streamline an industry site database. Throughout the day, we heard how technology can make the industry heather, grant access to patients and make access to information - both for patients and companies easier.

The single most question of the day ways: Have you participated in a clinical trial?

Investigator Innovator Open House
Janssen, Merck and Eli Lilly decided to pool resources and develop a site databank in 2010. Instead of looking at each other as competitors, they've decided to join forces and share their knowledge about the sites they use and develop an extensive database detailing many of the critical aspects of sites. Pfizer has recently joined the initiative and the collaboration is leading to more innovative solutions for the industry. This allows companies to share what sites have had training on procedures, protocols, clinical trial specialties. Soon, the site investigators themselves will be able to comment and share their experience through their profiles.

We then transitioned into the Patient Centered Clinical Trials track where Komathi Stem of Genentech, Melanie Goodwin of Merck and Sean Aherns of Crohnology.com shared their insights on the future of patient involvement in clinical trials. Genentech always see patients as the center of their trial, however, when they’re designing protocols, they’re often left out. They’re striving to get patients to be partners when they design their clinical trials but it is a challenge due to perceived difficulties in the process. They’re trying to learn to do this by doing instead of overthinking and processing.

When we say “Patient Centric” is there a balance between what the patients want and how the industry is trying to create drugs to treat them? Technology is outpacing legislation. Regulators and the industry want to harness the power so more collaboration is needed as an industry.

Also mentioned in the track was the importance of personalized medicine. By understanding the patient and how they're responding to medication, Pharma will get better answers. It's important to look at what a company needs to complete a trial - not doing trials on a population bases and already looking at the drugs on the market based on genetic data. When listening to patients online, everything they talk about has been going on, most likely, for years. So Pharma needs to figure out how to integrate and treat this new data.

For the next portion of our morning, we moved into the Cost and Contract Management track and hear from Zaher El-Assi of Merge and Mark Milberg of Medtronic on Leveraging Technology to Create Efficiency When Contracting with Third Party Vendors. They identified the usual methods companies use to contract with vendors: Hourly Rate Agreements, Flat Rate/ Fee for Service Agreements, Activity-Based Agreements, Milestone-Based Agreements and Hybrid Agreements.

Fee for Service can have many frequencies. Most commonly used. Pros: monthly costs are more even/predictable, ensures resources are allocated y CRO each month, Ideal for cost categories where work is less variable month over month.

Activity based contracting requires multiple cost categories. Drivers must identified. They have a strong correlation between work completed and work invoiced and there is much flexibility. On the downside, cost drivers need to be relevant and specific.

In terms of cost savings, efficiency is expected, project management waste should be eliminated, it is just as important not to have exorbitant costs. In terms of the pay as you go model, there are no sunk costs, less upfront costs, more integrity in pricing assumptions, less needs for change orders.

Next, Matthew Eckman, Genentech presented An In-House Tool for Consistently Assessing Vendors’ Financial Health in the Cost and Contract Management track. He started emphasizing that it’s important to analyze vendor health with the current trends in the global market including persistent economic troubles, drug development challenges, billions at stake outsourcing is on the increase, industry pain points and irrational competition. Eckman believes that financial evaluation of vendors is better done in house.

What did he advice that a company would need to consider to make it work? Multiple facets of financial performance, emphasis on ratios and two-step tests, avoiding using too many market-based measures and to consider using multiple metrics in the same family

How can a company translate this data into action? The presentation should include the following measures. The data and presentation should be simple to follow. Any tool will have text – give a description and teach others but don’t overload the financial analysis with text. The writer should also avoid financial jargon in the presentation. When developing numbers to present, a composite score to facilitate understanding. The composite scores give you a clear scale, have current, historical and average scores over time and can be tied to explicit risk levels.

Then this scale should be presented visually – in a graph, infographic, or another visual way to communicate the financial stability of the potential partners.

Use and Principles of Automated ECG Measurements in Clinical Trials

noreply@blogger.com (Jennifer) — Sat, 20 Apr 2013 20:32:00 +0000

Today's guest post is brought to you by Dr. Tim Callahan of Biomedical Systems. Biomedical Systems is a partner of this year's Partnerships in Clinical Trials. Visit them in the Exhibit Hall at Booth 427!

Introduction

Even before the approval of the ICH E14, automated electrocardiographic (ECG) measurements and interpretations were available from the ECG machine manufacturers. These measurements and interpretations appear on the printed ECG. Each manufacturer advised caution, however, when using these readings. The final arbiter for ECG measurements and interpretation, and thus the gold-standard has always been the cardiologist.

In the era of the E14, the number of ECGs collected in early phase drug development has multiplied exponentially. Previously, the standard was to collect only safety ECGs at the Phase 1 unit. However, a simple crossover Thorough QT (TQT) trial can consist of 4-periods, more than 40 subjects, multiple time-points, with ECGs collected in triplicate. This can lead to approximately 10,000 ECGs. It has also become a regular practice for the sponsor to collect multiple ECGs in the early development (FIM, SAD, MAD, etc.) to give some indication as to the drugs’ effect on the ECG measurements.

The large number of ECGs now collected in the short time-course of a Phase 1 study places a great burden for the reader to read all of the ECGs in a timely manner. The E14, therefore, allows for more than one person to read the ECGs from a TQT trial as long as each subject is assigned to a single “skilled reader”. Because of inter-reader variability concerns, it is best to keep the number of readers to a minimum. The effect is to reduce the time to database lock, but it can be argued that there is an alternative. This would be to use automated readings.

The rest of this paper will detail how automated readings are obtained, when they can be considered, types of automated readings, how the readings can differ between algorithms, how to check for quality, and the best practices when using automated readings.

Manufacturers of Automated Algorithms
Automated algorithms come from two main sources; ECG machine manufacturers and third-party vendors. Manufacturers such as GE, Mortara, Phillips, and Schiller can have the ECG measurements and interpretation printed on the unconfirmed copy of the ECG (as well as residing in the database).

Newer, third-party algorithms (from companies such as AMPS, OBS, Monebo, and NewCardio) can measure digital ECGs (usually in an XML format) after collection. Because the algorithm is not connected to an ECG machine, these programs usually process the data in a batch format, probably at the end of the trial. Therefore, the readings are not available at collection time.

Automated Measurements and the ICH E14
Regarding the measurement of the ECG, the ICH E14 states:

“At present, this would usually involve the measurement by a few skilled readers (whether or not assisted by computer) operating from a centralized ECG laboratory. If well-characterized data validating the use of fully-automated technologies become available, the recommendations in the guidance for the measurement of ECG intervals could be modified.”

Currently, automated measurements are being used in some situations (as described below). Regardless of the method used to measure the ECG, the sponsor is responsible for the data. Therefore, regardless of the measurement methodology, the sponsor has to be comfortable with and confident in the final database.

Why Use Automated Measurements
In the ICH E14 era traditional ECG measurements are made by cardiologists who placed electronic calipers (or annotations) on the fiducial points of the electronic ECG. Intervals are then calculated and stored in the computerized system. The process of measuring an ECG takes a discrete amount of time with the variables being the technical quality of the ECG, number of annotations to be placed, and the ability to discriminate the onsets and offsets of the ECG waveforms. Depending on the number of ECGs in a clinical trial (which can be upwards of 10,000 or more), the time it takes to measure all of the ECGs can be considerable.

With the time constraints of the clinical trial database lock, more than one reader is needed. As can be seen with the quote from the ICH E14 above, a few skilled readers may be utilized. However, because readers have their own opinions as to where the fiducial points are located on the ECG, and consistency is important, inter- and intra-reader variability needs to be addressed. ECG core laboratories have dedicated significant resources to benchmark and measure inter- and intra-reader variability.

Finally, ECGs in TQT trials are usually collected in triplicate. That is, three ECGs are collected within approximately a 5-minute window at a nominal time point relative to dosing. The triplicate ECGs are used to reduce the normal physiologic variability inherent in ECG measurements. The standard deviation of the QTcF is often used as a measure of data quality. Manufacturers of automated algorithms often tout the fact they can help lower the standard deviation of the QTcF within the triplicate ECG, thus producing a higher-quality database.

With these thoughts in mind, the fully-automated approach has been shown to be effective in many cases. This is because the time to a locked database can be reduced as the computer takes a much shorter time per ECG as compared to a human reader. Another benefit is that the computer will have little to no intra-reader variability. The result is that the consistency of the readings is of a high quality.

Follow the jump to read the rest of the post.

How Automated Measurements Work
In general, automated measurements come from a representative beat based on all 10-seconds of the digitally-acquired ECG. For example, Mortara Instruments makes automated measurements on a global complex.

The process begins by taking each lead of the ECG and creating a “median” complex from a primary, or dominant normal beat. All of the beats with the primary morphology are used for the creation of the median beat. After medians are created for each lead, a global median is created by aligning the individual median beat. From there, the earliest onset to the latest offset is measured for all variables (PR, QRS, QTand QT). The result of using the earliest onset to the latest offset will be to have a longer QT-interval measurement than the human reading, in many cases. Heart rates for automated algorithms are usually calculated over the entire 10-second ECG.

Not All Algorithms Work the Same
Kligfield, et al. published a comparison of the performance of two algorithms from two different manufacturers. The authors collected 2 sets of ECGs (one for each manufacturer’s digital electrocardiograph) at the same time. The authors’ note that the acquisition was not simultaneous due to the prerecording processing operations differs between the ECG machines.

Not only did the algorithms measure the QT interval differently, automated measurements of the QT interval differed from one version to another within the same algorithm family by up to 24 milliseconds.

This study points out the importance of standardizing the equipment, including software versions, between all of the sites and subjects if automated readings are to be used from the ECG machine.

Best Practices
Automated algorithms are being used in many clinical trials. They can be a cost- and time-effective alternative to human readings under the right circumstances. Two issues need to be thought-through when considering using automated algorithms; ECG quality and adjudication of substandard readings.

Poor ECG quality will affect the accuracy of ECG measurements, whether by a human reader or an automated reading. High-frequency is the noise at the baseline level that interferes with the ability to determine, with precision, where one feature of the ECG ends and another begins. Unfortunately, there is no adequate solution to the problem once the ECG has been collected as ECG filters can slightly alter the morphology. The only adequate solution is to collect good quality ECGs.

Since not all ECGs are of the highest quality, and sometimes the computer reading fails, using an adjudication algorithm should be part of the clinical trial when automated algorithms are used. Adjudication should be considered based on ECG values that are not in the mainstream of the normal QT/RR relationship (so-called outliers) and when certain quality control metrics are not met by triplicate ECGs.

Finding outliers is in the dataset is not difficult. These values fall outside either the pre-defined value (such as a QTc of greater than 450 ms or a change from baseline of 30 ms) or a pre-defined relative value (such as a value greater than 2 standard deviations from the mean).

Another set of issues with the data quality arise when values appear normal but are not accurate. These values, which we term “inliers” here, can affect the overall quality of the database, negatively. To find these values, we must look at metrics such as within-triplicate standard deviation, relative changes from baseline as compared the other subjects, and within-triplicate ranges (to name a few). By running data quality metrics, database quality can be assured, regardless of reading methodology.

Discussion and Conclusions
Relatively recently, the The FDA was not in favor of automated measurements of ECGs until relatively recently.. Now, however, the FDA seems to be accepting of them with the caveat that the sponsor is responsible for the data.

It is widely recognized that automated measurements are best used with ECGs from normal, healthy volunteers where the ECG intervals are easy to read. This generally means the automated measurements are best used in early phase clinical trials. It is fortuitous that these trials are mainly where data is collected digitally and can therefore be read with automated algorithms.

Automated algorithms can be found from both third-party vendors and from the ECG machine manufacturers. Both types have been used in clinical trials. Regardless of what algorithm is used, standardization is important to make sure all ECG are measured with the same version of software and an adjudication algorithm is employed.

Clinical Operations Teams Lack Confidence in Risk Management

noreply@blogger.com (Marc Dresner) — Fri, 19 Apr 2013 15:16:00 +0000

Study Suggests Risk Management Approaches to Clinical Research Improve Quality, But Inexperience Makes Pharma Companies Uncomfortable

By Marc Dresner, IIR

Risk assessment and risk management approaches to clinical research have created quite a bit of buzz recently, but according to results from a forthcoming industry study, neither sponsors nor providers feel adequately prepared to execute on them.

Patty Leuchten

"There seems to be a general lack of confidence at primarily the operational level within pharma and biotech companies regarding best practices, experience and comfort level with risk management,” said Patty Leuchten, President and CEO of The Avoca Group, which conducted the study.

“This is interesting to me,” Leuchten added, “because the operations team is the very group charged with determining and assessing which risk-based approaches make the most sense.”

The study—now in its 10th year—also found that while a quarter of respondents said it was too soon to tell whether or not risk assessment and management approaches have had a positive impact, the majority of respondents reported an increase in quality; however, fewer of that same group indicated that introducing risk management had improved efficiency.

Leuchten said the lower incidence of reported efficiency improvements may be due to the effort involved in implementation.

“It is actually quite a rigorous process to come to terms, for example, on risk-sharing agreements and to do all of the analysis and assessment that is required to put together a risk management approach,” she told Inside Clinical.

In this podcast interview for Inside Clinical, Leuchten discusses the study—the results will be covered in detail at the Partnerships in Clinical Trials conference next week—as well as why so many industry consortia are cropping up in the clinical space.

Listen to the podcast!
Download the transcript!

Editor’s note: Patty Leuchten will moderate a panel of industry experts on the topic of risk management and she’ll also participate on a consortium leadership panel at the 22nd Annual Partnerships in Clinical Trials Conference running April 21-24 in Orlando.

It's not too late to register! Sign-up to attend today and mention code XP1806BLOG to save 15% of the standard rate when you register!

ABOUT THE AUTHOR / INTERVIEWER
Marc Dresner is IIR USA’s senior editor and special communication projects lead. He is the former executive editor of Pharma Market Research Report, a confidential newsletter for market researchers in the pharmaceutical industry. He may be reached at mdresner@iirusa.com. Follow him @mdrezz.

Countdown to Partnerships: Connecting with the patients: The Michael J Fox Foundation

noreply@blogger.com (Jennifer) — Thu, 18 Apr 2013 17:00:00 +0000

At Partnerships, we strive on a yearly basis to connect to the reason why we work in the Pharma industry: to change the lives of the patients. This year, we've invited the Michael J. Fox Foundation for Parkinson's Research to join us. Deborah W. Brooks, Co-Founder and Executive Vice Chairman of this foundation will join us Monday night to bring in a new perspective of connecting with patients and encouraging them to follow through on their intentions to become involved in clinical trials. Deborah herself has volunteered particiapte in a Parkinsons clinical trial the Parkinson’s Progression Markers Initiative. Join us 4:30PM on Monday, April 22 for this opening keynote session!

If you'd like a teaser for this session, our Inside Outsoucing Podcast Series recently interviewed Sohini Chowdhury the Senior Vice President for Research Partnerships at the Michael J Fox Foundation. Listen to it here.

Inventiv Health Clinical will also be hosting a 5K Run on Tuesday, April 23 to benefit the Michael J Fox Foundation. For more information on how you can participate, visit the blog post.

As a reader of this blog, when you register to join us an mention code XP1800BLOG, you'll save 15% off the standard rate! Have any questions? Feel free to reach out to me at jpereira@iirusa.com.

Partnerships Podcast: BBK Worldwide on patient recruitment, mobile engagement and more!

noreply@blogger.com (Jennifer) — Thu, 18 Apr 2013 13:00:00 +0000

For this episode of the Partnerships in Clinical Trials podcast, we sat down with Matthew Stumm, Principal and Creative Director of BBK Worldwide. During the interview, we discussed some key reasons sponsors should optimize for mobile. For example, 35 – 50 percent of BBK Worldwide’s clients’ website traffic is coming from mobile devices. While a number of variables affect the volume of traffic – therapeutic area, disease, age of target audience, region of the world – a considerable amount of mobile traffic exists across all of them. And it’s here to stay.

Download the podcast here.
Read the transcript here.

BBK Worldwide is a Partner of this year’s Partnerships in Clinical Trials Event. Matthew will be presenting on Web-Based Patient Recruitment Insights and Mobile Data Analytics on Monday, April 22, at 2 p.m., and his colleague, André Briola, will be sharing innovative social media solutions during the Digital Expert Panel: Effective Social Media Use for Advanced Clinical Trials on Wednesday, April 24, at 2 p.m. Please look for BBK's Booth at #211. As a reader of this blog when you register to join us and mention code XP1800BLOG, you'll save 15% off the standard rate!

To connect with Matthew directly, link in with him at www.linkedin.com/in/matthewstumm

Countdown to Partnerships: Bonus Breakfast Session: Databank Open House

noreply@blogger.com (Jennifer) — Wed, 17 Apr 2013 17:00:00 +0000

In today's Partnerships In Clinical Trials countdown, we look at the Databank Open House bonus session.

It will take place Monday, April 22 at 7:30AM. We're excited to kick off the conference highlighting partnerships between competitors in the industry. Elise Felicione, Director, Clinical Trial Innovation at Janssen Pharmaceuticals; Laura Galuchie, Director, Global Trial Management and Therapeutic Area Lead for Respiratory & Immunology at Merck and Michael Luker, Sr. Advisor, Clinical Research Innovation at Eli Lilly will be joining us for this session.

They'll look at how their pharmaceutical companies working with each other to promote the advancement of drug development. Fueled by a technology connecting drug researchers across the globe, the group has started an Open Investigator Databank initiative – a cross-pharmaceutical Investigator Databank with the mission to make it easier for drug makers to locate up-to-date information on clinical trial investigators and sites, and avoid duplicating efforts along the way.

This is the first unveiling of this partnership! We hope you can join us Monday morning!

If you're not registered to join us next week, as a reader of this blog when you register to join us and mention code XP1800BLOG, you'll save 15% off the standard rate! Have any questions? Feel free to email me at jpereira@iirusa.com.

Tudor Reilly – revolutionizing clinical trial recruitment

noreply@blogger.com (Jennifer) — Wed, 17 Apr 2013 13:00:00 +0000

Today's guest post is from Peter Coë, the Executive Director and Co-Founder of Tudor Reilly. They are a sponsor of this year's Partnerships in Clinical Trials event and will be at Booth 206. If you'd like to join them, as a reader of this blog, when you register to join us and mention code XP1800BLOG, you'll save 15% off the standard rate!

Although clinical trials are on the increase, public awareness of how to take part in medical research remains limited. In fact, just 30% of patients are aware of the traditional ports of call for clinical trials such as clinicaltrials.gov. Strict regulation and a lack of general education are two reasons for this, but the willingness of many pharma sponsors and CROs to stick with traditional methods of patient recruitment also plays a part.

This situation has a significant impact on the pharmaceutical industry. Around 90% of clinical trials are extended by at least six weeks due to failure to enroll patients on schedule. And, delays in bringing a drug to market can cost a pharmaceutical company as much as $8 million a day.

At Tudor Reilly, we specialise in what we call e-patient recruitment – enabling, empowering and engaging patients with accessible and relevant information on specific health conditions, and on clinical trials, that the e-patient and their families can find and understand. We do this by building and nurturing online patient communities and by providing high-quality content that’s relevant, current and useful.

See our innovative approach to e-patient recruitment in action by visiting the Tudor Reilly team at stand 206. You’ll also have the chance to win an iPad in our exclusive e-patient recruitment challenge. And don’t miss our executive director and co-founder Peter Coë’s talk on building therapeutic communities online on Monday at 4:15pm, as part of his introduction to keynote speaker Deborah W Brooks from The Michael J Fox Foundation for Parkinson’s Research.

Countdown to Partnerships: 2nd Annual Women's Clinical Leadership Forum

noreply@blogger.com (Jennifer) — Tue, 16 Apr 2013 17:30:00 +0000

Today, we're looking at the Women's Clinical Leadership Forum! In it's second year, we're striving to make this experience just as beneficial to our women striving to achieve leaderships in the clinical trails industry. We have welcome Shantal Feltham, the CEO of Stiris Research Inc. as the chair of the event and look forward to a keynote speech from Patricia Sellers, Senior Editor-at-Large and Fortune’s Most Powerful Women Summit Chair of Fortune Magazine who has excelled as a women in her industry.

We also have the great opportunitiy to network with other women from the industry who have achieved high levels of leadership in the clinical trials field including Edwina Wyatt-Knowles of Astellas, MaryAnne McCarthy of Clinical Operations Incyte Corp, Taryn Joswick of Sucampo, Deirdre BeVard of Endo Pharmaceuticals and Peggy Doran of ReSearch Pharmaceutical Services, Inc.

The Forum kicks off at 5PM on Sunday and is a great way to start your event!

Partnerships in Clinical Trials is taking place next week, April 21-24, 2013, in Orlando, Florida. As a reader of this blog, when you register to join us and mention the code XP1800BLOG, you'll save 15% off the standard rate!

Should genes be patented?

noreply@blogger.com (Jennifer) — Tue, 16 Apr 2013 13:00:00 +0000

The Supreme Court heard an argument yesterday addressing
whether or not human genes in the body can be patented. The main question here is whether or not something in the body can be patented. Myriad Genetics currently has two pending patents linked to breast and ovarian cancer. Their argument is that so much time, money and effort goes into this research that there needs to be a way to ensure they'll be able to recoup their costs. On the other side, it could slow down research in the industry causing delays.

The Associate Press The Supreme Court has already said that abstract ideas, natural phenomena and laws of nature cannot be given a patent, which gives an inventor the right to prevent others from making, using or selling a novel device, process or application.

Myriad is seeking the patent for use in the BRACAnalysis which, from this gene, can determine whether or not a person is likely to develop those types of cancers.

What do you think? Should companies be allowed to patent genes? If the Supreme Court rules they can, how will this affect future research?

Countdown to Partnerships: MyPartnerships App

noreply@blogger.com (Jennifer) — Mon, 15 Apr 2013 18:03:00 +0000

This week, we'll feature a few of the things we're looking forward to this week at Partnerships in Clinical Trials! Today, we highlight the MyPartnerships App. Even though we're not at the event, you have the opportunity to connect and set up meeting for next week in Orlando!

How do you find it?
You can find the MyPartnerships Social Network Tool in the app stores for iPhone an Android by searching for “Partnerships”. To view the mobile website, visit mypartnerships.jujama.com

With already over 1000 Partnerships attendees signed up, we invite you to jump in and join the conversation!

And if you have any questions about the App, feel free to reach out to me at jpereira@iirusa.com. Please note that this App is for registered attendees of the Partnerships in Clinical Trials event ONLY. If you haven't registered to join us next week in Orlando, we encourage you to do so! As a reader of this blog, register and mention code XP1800BLOG and you'll save 15% off the standard rate!