Partnerships in Clinical Trials

UBC/Medco Research Chief Calls for Payers to Play in Phase One Clinical Trials

noreply@blogger.com (Marc Dresner) — Fri, 20 Jan 2012 19:06:00 +0000

“Inside Outsourcing” Podcast Series Explores Factoring Reimbursement Potential into Clinical Trials

By Marc Dresner, IIR USA

A series of high-profile research partnerships over the last year between big pharma and payers–Pfizer and Humana, AstraZeneca and WellPoint’s HealthCore, Sanofi and Medco—have exposed a growing trend: The active engagement of payers in the drug development and clinical trial process.

According to Dr. Robert Epstein, President of UBC and Chief Clinical Research & Development Officer of Medco Health Solutions, involving payers in clinical trials is a fairly nascent, but long overdue development that should begin as early as Phase I.

“For those of us in the payer community who are hoping to really help innovation make it to the market, it would help to get us involved toward the end of Phase I so that we could help inform the Phase II and Phase III program,” Epstein told Inside Outsourcing.

“What is most valuable is to actually put the payer in the room with the researcher,” said Epstein. “Allow the payer to share why it is that they feel the planned program is missing something from their perspective.”

The trend appears to signify a shift from looking at outcomes from a conventional efficacy and safety standpoint to a broader value focus that incorporates commercial viability and reimbursement potential.

In this exclusive podcast interview for “Inside Outsourcing: Spotlight on Clinical Trial Partnerships,” Epstein outlines:

- Why payers should be consulted as early as Phase I

- What payers can bring to the table

- How payer involvement may affect trial design and execution

- How personalized medicine will impact payer involvement in trials

- The impact of payers on serendipitous discovery breakthroughs

Listen to this episode of Inside Outsourcing!

Download the transcript!

EDITOR’S NOTE: “Inside Outsourcing: Spotlight on Clinical Trial Partnerships” is brought to you by the producers of the 21st annual Partnerships in Clinical Trials conference and exhibition—the world’s premier gathering for clinical development leaders and practitioners—taking place March 4-7 in Orlando, FL. Also, as a reader of this blog, when you register to join us and mention code XP1700BLOG, you'll receive 15% off the standard rate!

For more information or to register, please visit www.clinicaltrialpartnerships.com

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

21st Annual Partnerships in Clinical Trials Awards: Now Accepting Nominations

noreply@blogger.com (Jennifer) — Fri, 20 Jan 2012 18:00:00 +0000

The 2nd Annual Partnerships in Clinical Trials Award Ceremony is scheduled for 5:30 pm on Tuesday March 6th at the 21st Annual Partnerships in Clinical Trials in Orlando, FL. Submit the nomination form online before February 15th to be sure your colleagues get the recognition they deserve. Voting opens March 1st.

Award Categories:

Biopharmaceutical Leadership
This award honors an executive member from a biotech or pharmaceutical company who has excelled in leadership of a company initiative in 2011 -2012.

Clinical Trial Innovation
This award honors a person who has embraced trial innovation, applied innovative tools or techniques for clinical trial strategy, and/or implemented novel partnering strategies to improve trials and fast forward projects from candidate drug to marketed product.

Novel Application of Technology for Clinical Trials
Technology has the power to improve the way the world works and lives. This award recognizes a person and/or company for their innovative vision and use of technology to improve clinical trials.

Product Approval
As of November 2011, the US FDA had approved 35 new medicines- many of them important advances for patients. This award will honor the company that has used a novel partnering approach to receive market approval for their product.

Clinical Trial Business Women of the Year
This award recognizes a woman who has exemplified strong & innovative leadership and has set an example to other women in the clinical trials industry on a global scale.

The nominations will be received up until Wednesday, February 15th. Voting will open on March 1st and will close on 5 pm on Monday, March 5th. An award ceremony will honor the award recipients on Tuesday March 6th, 2012, followed by the Partnerships International Food & Wine Festival.

Submit your nominations here.

If you'd like to attend the 2nd Annual Partnerships in Clinical Trials Awards Ceremony at Partnerships in Clinical Trials, as a reader of this blog when you mention code XP1700BLOG, you'll receive a 15% off the standard rate! We hope to see you this March in Orlando!

Going Straight to the Source. An Interview with a Clinical Trial Subject

noreply@blogger.com (Jennifer) — Thu, 19 Jan 2012 21:58:00 +0000

Partnerships In C lini cal Trials 2012 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to this year's event.

Going Straight to the Source. An Interview with a Clinical Trial Subject

Authored by Sherry Reuter

Interview with a Patient…

We often talk about the challenges of Patient Recruitment and Retention in conducting clinical trials and speculate on ways to improve our performance. But how often do we go straight to the source to talk to study subjects about how we could do better?

I decided to do exactly this and conducted an interview with a woman who has participated in six clinical trials, so she has plenty of experience from which to tell us the good and the bad of how we treat study participants.

“I don’t want to seem negative or ungrateful for the researchers’ time. I really am a proponent of clinical trials, especially for the sake of my family, but sometimes they are just hard to take. Which of these do you think really happened to me during clinical trials? Mark True or False for which you think really happened:

1. I had been diagnosed very recently, and wanted a second opinion. I called to be in a clinical trial, and they asked me on the phone if they might get my brain when I died. True/False___

2. I have been in six trials, most of them do not help with expenses, so I have to pay costs of the flight, hotel and food for myself and caregiver, which equals around $3,000- $4,000 for each study, at least $20,000 in total for all the trials in which I have volunteered. True/False___

3. I paid for a plane ticket to fly to a study site for a 5 day study, after I was there 3 days, they decided that I didn’t have the diagnosis under study and sent me home without enrolling me in the trial even though I had previously been diagnosed with it..True/False__

4. Later that year, the same group asked if I would be in their film. Why? They said I didn’t have it. The genetic counselor asked why I wanted that diagnosis instead of what they said I had. I didn’t want either! True/False____

5. When signing in for a new study, they had my caregiver sign the paperwork, rather than me, even though I was competent. True/False___

6. I asked the researcher if he had talked to my primary doctor who had diagnosed me, he said yes. I said, that is funny, I didn’t sign paperwork allowing you to do that. True/False___

7. I was to be the “Show and Tell” for about 20 fellows, but they did not inform me in advance. True/False___

8. I phoned ahead asking how much time out of the seven 8-hour days (8 hours) I would be able to speak with the Investigator because I had a number of questions. They said 1/2 hour in the beginning and 1 hour at the end, only 11/2 out of 56 hours! True/False___

9. At one study visit, the Investigator asked why I would want to know if my condition was a family mutation or a sporadic event. True/False___

10. Another Investigator debated me on whether I was really incontinent. True/False__

11. Having any form of dementia carries with it a certain stigma. Some language used has been “possessed”, “Bizarre” and “Why don’t you just drop her off at an ER?” True/False___

###

How many of these incidents do you think actually happened to this study volunteer?

Sadly, all of them did.

Although it is especially difficult when ill to exert the energy to continue to actively spread the word about her diagnosis, she has creatively found ways to do so, even making a movie about it.

She still values clinical research, for it is the only source of hope for future understanding of her illness and treatment for her, her relatives and others suffering from the same condition.

About the Author

Sherry Reuter is President of Sherry Reuter & Associates, LLC, a consulting firm that focuses on the conduct of clinical trials, Site Selection, Study Start Up, Training, and Patient Recruitment and Retention. Sherry may be contacted at sreuter@gwu.edu or 203.775.6031.

Image: Danilo Rizzuti / FreeDigitalPhotos.net

Complimentary Web Seminar Thursday: Clinical Trial Outsourcing Dollars and Financial Sense

noreply@blogger.com (Jennifer) — Tue, 17 Jan 2012 14:00:00 +0000

Date: Thursday, January 19, 2012
Time: 2:00-3:00 PM EST
Presented by: Garen Sarafian, Vice President, Citigroup Investment Research & Analysis, Citigroup
Register here (Mention code P1700W1BLOG)

About the web seminar:
The global health care landscape is beset with multiple challenges and opportunities: regulatory, scientific, logistical and financial. This interactive Web seminar will provide a comprehensive overview of clinical trial outsourcing from a financial perspective, with a particular eye toward trends in health care technology, outsourced operations and investment considerations.

What you will learn:
- Get Wall Street’s take on the clinical outsourcing market trajectory
- Probe outsourcing financial strategies in a rapidly changing drug development environment
- Understand how clinical research outsourcing decisions can impact and improve business performance and increase your organization’s value in the eyes of investors
- Examine emerging best practices and new norms in trial outsource spending and financial management
- Explore metrics and instruments to help guide strategic decision making from a practical economic point of view

About the Presenter:
Garen Sarafian is a Vice President within the Healthcare Technology & Distribution sector at Citi Investment Research & Analysis. He has been with the firm since 2007. Most recently, Garen has been named "Best Up and Comer" in Institutional Investor’s 2010 All-America rankings. Prior to his current role, Garen covered the sector as part of a larger team that included the Managed Care sector and ranked top 3 in each of the last 8 yearly Institutional Investor rankings.

Garen also has extensive industry experience. He was a Director at Aetna, a Fortune 100 health care firm, for 5 years where he was a part of the Strategic Marketing Group. This group assessed new opportunities, identified & responded to key business issues, and advised Aetna’s various operating segments on enhancing growth.

Register to join us today!

Senior Clinical Trials Officials weigh in on the 2011 Avoca Survey

noreply@blogger.com (Jennifer) — Mon, 16 Jan 2012 18:04:00 +0000

The 2011 Partnerships in Clinical Trials Executive Summary is a richly detailed document for any clinical trial industry professional. In-depth notes taken directly from the 20th Annual Partnerships in Clinical Trials event are available at your fingertips. This week, we highlight the portion reviewing "Reducing Micro-Management of CROs while Maintaining Effective Quality Oversight." In this presnetation, executives from high profile Pharma companies, including Peter Carberry, MD, Senior Vice President, Global Development Operations, Astellas, Wayne Langlois, Vice President and General Manager, Global Clinical Development, Covance, and John Oidtman, VP, Clinical Operations, Emerging Markets, Pfizer discuss the findnigs of the most recent Avoca Gropu Survey, which examines the state of the clinical trial industry and it's key players. Take some time to look at last year's key takeaways and information as we gear up for the March Partnerships in Clinical Trials Event.

Download the executive summary here.

Here is a portion of this featured session from the panel discussion:

Building on the topic, Leuchten asked Oidtman for his take on globalization with regard to quality.

Oidtman: “When I think about quality and globalization, I really target two things: infrastructure and incentives. The first one is something that your organization should be thinking about very seriously: How do you build the infrastructure to support your portfolio in the countries where you want to operate?”

Oidtman noted that results from Avoca’s survey indicated that the countries with the greatest growth opportunities—emerging markets like China, for example—are
also the regions where respondents have the least comfort when it comes to quality. “At Pfizer, infrastructure involves finding ways to increase clinical research understanding and expertise and the ethics that go with it. And then how do we develop sites?”

For instance, Oidtman said Pfizer has worked with the Steve Biko Foundation in Africa—which, according to the data Avoca presented, is the region with the lowest trial quality comfort level—to educate new investigators on how they can run clinical trials ethically. “And the responses we got were, ‘Wow, I didn’t realize you (pharmaceutical companies) are in this with us to develop molecules.’ Up to that point, they had thought of us as the bad guys,” said Oidtman.

Oidtman emphasized that Pfizer is keen on site strategy: Distinguish and prioritize sites that deliver a large number of valuable patients; jettison those that don’t. “We’re seeing a lot of that in emerging markets. So building relationships with sites that you want to target and that will support the portfolio you have is key.

Partnerships in Clinical Trials Keynote Spotlight: Crowdsourcing Clinical Development and Medical Innovation

noreply@blogger.com (Jennifer) — Fri, 13 Jan 2012 15:26:00 +0000

The better the relationship is between the doctor and a patient, the better the care will be. Doctors Brant Rogers, RYT; Michael Christopher, Ph.D.; and Zeynep Sunbay-Bilgen, MS have all begun to realize the importance of participatory medicine, and have begun making it a priority in their practice according to Oregon Live. They've begun encouraging their patients to become e-Patients. As they've defined it, their patients have become equipped, enabled, empowered and engaged in their own healthcare. This year at Partnerships in Clinical Trials, James Surowiecki, Columnist for The New Yorker, Author, The Wisdom of Crowds, will be on hand to present "Crowdsourcing Clinical Development and Medical Innovation," which examines exactly why it's so important for patients to be empowered and in the know about their health in order to contribute to their better care.

Featured Speaker: James Surowiecki, Columnist for The New Yorker, Author, The Wisdom of Crowds

Featured Session: Crowdsourcing Clinical Development and Medical Innovation

About the session: Drive resources to your collective advantage. Jim describes systematic ways to organize and aggregate the intelligence available in your organization in order to arrive at superior decisions—often better tha n those that individuals would make, even if they are ‘experts’. The question is how can we apply the concepts and practice of crowd sourcing to clinical development? In his talk he will offer practical methods for clinical development professionals to leverage people and technology to learn what you need to know and make decisions that really serve the organization’s goals.

For more information on James and the rest of the Partnerships program, download the brochure. If you would like to see James' presentation at this year's Partnerships in Clinical Trials, as a reader of this blog, you receive 15% off the standard rate when you register and mention code XP1700BLOG.

Partnerships 2012 Offers Unrivaled Value - Join us this March

noreply@blogger.com (Jennifer) — Thu, 12 Jan 2012 20:42:00 +0000

In 2012, the Partnerships in Clinical Trials program delivers more sessions, more speakers and more answers than any other event. Over 130 sessions by 150 speakers who present the highest quality brand new content on innovative partnerships, clinical operations, e-clinical technology, global clinical trials and future trends in clinical research.

Are the sessions new, timely and practitioner led?
YES! Partnerships brings you leading visionary out-of-industry business minds that provoke change and inspire action. It combines this with the greatest representation of the world’s top clinical trial and drug development practitioners.

This unique mix of collective intelligence allows you to be inspired, think out of the box, and apply practical tools based on real-world experiences so that you leave with the knowledge required to tackle your toughest challenges.

Will I find new Partners?
YES! Every year, new companies join the Partnerships Hall and this year we have more tools to help you find exactly the partners you are looking for. With a brand new
customized matching tool and our pre-event networking tool, Partnerships makes it easy to find exactly the service provider you need in exactly the region you need it most.

Is Partnerships relevant to me?
YES! Whether you are responsible for clinical trial outsourcing or operations, Partnerships covers the perennial issues you face and drills down to meet the specific needs of small, midsize and large pharma, small and large biotech, specialty pharma, and medical device clinical trial sponsors as well as clinical sites and outsourcing providers. This in-depth approach meets the needs of the collective and brings together everyone on a level playing field to collaborate and transform clinical trials.

For more on this year's program, including sessions and speakers, download the brochure. As a reader of this blog, you'll receive an exclusive discount of 15% off the standard rate when you mention code XP1700BLOG when registering to join us this March in Orlando for the event!

Using Customer Service Techniques to Improve Patient Retention

noreply@blogger.com (Jennifer) — Thu, 12 Jan 2012 15:06:00 +0000

Using Customer Service Techniques to Improve Patient Retention

Authored by Sherry Reuter

Patient Customer Service?

Customer Service is not a term that is usually discussed in the realm of clinical research. Why has this concept not been utilized more in our industry?

For one thing, how Patient-Centric has clinical research really been? The focus has been on the research activities required per the Protocol, following directives given by the sponsor (the site’s customer), and meeting tough goals within time-lines and budgets. The focus on business and science rather than on pleasing its customers (yes, study volunteers are our customers) has been a disconnect when trying to recruit and retain human beings.

Another reason is that the medical field has not traditionally seen itself as a business, and clinical research has only recently begun to be conducted with processes used in other industries. Could using elements of the Customer Service model found to be successful in other industries help clinical research solve some of the most stubborn, expensive and time consuming problems in clinical research: Patient Recruitment and Retention?

Patient Recruitment and Retention, after all, are similar in some ways to the central challenges of many businesses: how to motivate people to use and continue to use services offered. What techniques do other businesses use to do this that would be appropriate to clinical research?

I thought about this today when I had to sit at my car dealer waiting for my car to be serviced, then when I went to the mall to several stores, and later at a restaurant. What factors appealed to me at these businesses, and which made me decide to never be their customer again? The answers were easy, did not cost much, and interestingly, could easily be used in the clinical research setting:

Closing thoughts

If we receive better Customer Service at a good restaurant or department store than we offer to people who are entrusting us with their health in order to make it possible for us to conduct our clinical trials, we can understand why there have been problems recruiting and retaining study subjects.

These are simple, low cost techniques that study subjects have indicated they appreciate in surveys and polls. They don’t ask for a lot, and these simple practices can make the difference to people. Doing our best to provide the best Customer Service can boost Patient Recruitment and Retention – it certainly couldn’t hurt!!

Sponsors, sites and other stakeholders can help to make the experience of study volunteers as positive as possible – much better than standing in line to buy an over- priced sweater from a rude saleswoman at your local department store.

About the Author
Sherry Reuter is President of Sherry Reuter & Associates, LLC, a consulting firm that focuses on the conduct of clinical trials, Site Selection, Study Start Up, Training, and Patient Recruitment and Retention. Sherry may be contacted at sreuter@gwu.edu or 203.775.6031.

Image: 89studio / FreeDigitalPhotos.net

Dr. Tamara Norton Smith on the state of regulation and clinical trials

noreply@blogger.com (Jennifer) — Mon, 09 Jan 2012 19:37:00 +0000

Download the executive summary here.

Here is a portion of this featured session from Dr. Norton Smith's presentation:

Norton Smith assured the audience that the FDA is working very closely with regulatory groups worldwide to develop a unified methodology for auditing and inspecting international trials, but stressed that “the FDA is dealing with many of the same strains that you’re facing in your own organizations.”

In fact, Norton Smith estimated the FDA currently inspects less than 1% of foreign trials, which in turn has put the onus on sponsors and their partners to keep an unusually tight grip on the reins of their international operations.

Norton Smith pointed out that in 2008, roughly 200,000 subjects participated in trials at no fewer than 6,500 different sites. Such volume would be logistically impossible for the FDA to manage from here in the US, so the FDA has set up offices around the world to test various models in order to accommodate more than 68 countries involved in drug applications, and more than 39 different countries for biologics. (Editor’s note: Figures specific to medical devices were unavailable.)

Of particular note, the FDA is increasingly relying on memoranda of understanding (MOU) arrangements internationally: training these different countries’ officials and ensuring they understand FDA regulations and are well versed in policy.

“The agency has had a great deal of experience and success with the MOU model here in the US,” Norton Smith said. “There are certain tasks that the FDA will actually defer to the state governments to take care of for them; however, the FDA still has a responsibility to make sure the state is doing what they’re supposed to be doing under their federal MOUs.” Implicitly, the same would hold true in an international model.

Clearly, international MOUs alone will not provide the coverage or security FDA requires, and Norton Smith confirmed this to be the case. “Since I’m not an FDA representative anymore, I’m going to tell you the truth: That burden is going to shift from the US government to the sponsor,” she stated.

Upcoming Web Seminar: Clinical Trial Outsourcing Dollars and Financial Sense

noreply@blogger.com (Jennifer) — Fri, 06 Jan 2012 14:00:00 +0000

Clinical Regulatory Documents: Master of your TMF Domain

noreply@blogger.com (Jennifer) — Thu, 05 Jan 2012 14:00:00 +0000

TMF Today
By Swadesh Sharma

The Trial Master File (TMF) is the heart of every clinical trial. The TMF often paper/binder based is a collection of essential regulatory documents which are required to initiate a trial within an investigative site. Being paper/binder based on the site side, requires constant manual update and management. This may seem like a easy task to deal with when in actuality, it is the research staff who maintain and update the TMFs which take away from the researchers specialty of treating patients and managing protocol procedures.
The FDA form 1572 is the most redundant document received by the FDA. Redundancy in the realm of 220,000 – 240,000 per year. That equates to ~602-657 per calendar day AND almost 25 per hour! If the FDA is receiving this many to process and maintain, then clinical sites are under-resourced when adding to their tasks – treating patients, completing eCRFs, SAE Forms, responding to audits and other non-clinical trial aspects.

The maintenance and updating the TMF lends to much of the avoidable costs within clinical research. The unrecovered costs which are linked in the thousands of dollars lie in executing, recruiting and adhering to compliance. Lost dollars that can actually lead to an expedited method from discovery to doctor.

Closing Thoughts

By establishing a robust regulatory document and workflow process on the clinical site level, the clinical site can drive growth within their clinical research portfolio, reduce redundant clinical start-up time, centralize documents and increase availability of regulatory documents.

About the author
Swadesh Sharma is a 13 year professional in the Life Science industry working across a global CRO, start-up oncology niche CRO, international pharmaceutical and mid-sized pharmaceutical companies in the capacity of business development, project management and product pipeline strategy. Currently, Swadesh is leading site start-up activities in his current position evaluating streamlined processes and solutions including TurboRegs.
Folder Image above: Renjith Krishnan / FreeDigitalPhotos.net

Vijay Govindarajan on next practices versus best practices

noreply@blogger.com (Jennifer) — Wed, 04 Jan 2012 15:32:00 +0000

At the 20th Annual Partnerships in Clinical Trials, Marc Dresner, the Communications Lead, Audience Engagement for the Partnerships in Clinical Trials Event, sat down with the outsourcing professionals who make the global clinical trials industry work. We'll be profiling each of these interviews leading up to the 21st Annual Partnerships in Clinical Trials, taking place this March in Orlando.

Today's featured interview is with Vijay Govindarajan, Harvard Business School. In this segment, Marc Dresner and Vijay Govindarajan discuss next practices versus best practices. How can companies go into emerging markets and succeed? By truly understanding them. Govindarajan also looks at how emerging markets can become the best place for Pharma innovations. With over five billion uninsured in India and China, how can medical innovations there benefit the rest of the world?

Watch the latest edition of Partnerships TV here:

What can truly understanding emerging markets do for your company's products and the future of your company's innovation?

Clinical trial outsourcing continues to increase

noreply@blogger.com (Jennifer) — Tue, 03 Jan 2012 15:30:00 +0000

More than one third of clinical trials for Pharma companies are being outsourced according to Pharma Times Online. In 2011, the industry was worth $36.6 billion, a 6.6% increase from 2009. Also in 2011, in-house development activities fell from 74% in 2010 to 62% in 2011. This proves that outsourcing is a must for the majority of Pharma companies. By outsourcing many of the Phases of drug development, these companies are taking the drug through the regulatory process and decreasing the amount of time to the market.

At the 2012 Partnerships in Clinical Trials Event, there will be a track titled, "Strategic Outsourcing" where you can hear first hand experiences on how other companies are working with and managing their strategic partners to which they outsource many of the phases of their clinical trials. As a reader of this blog, mention code XP1700BLOG to receive an exclusive discount of 15% off the standard rate when you register to join us this March!

Happy Holidays from Partnerships in Clinical Trials!

noreply@blogger.com (Jennifer) — Fri, 23 Dec 2011 14:00:00 +0000

We're taking some time off from our coverage of clinical trials to celebrate the season with our loved ones. We want to sincerely thank you for your readership, your comments and your participation. We look forward to returning to the world of clinical trials in 2011!

Here are our top Partnerships in Clinical Trials posts from 2010:

Emerging trends- CRO Marketality-care-rules-to-change-in.html
“Inside Outsourcing” Podcast Series Part 2: Size Doesn’t (Necessarily) Matter
10 Steps to Clinical Study Start Up: Step 10 – Wrap Up
10 Steps to Clinical Study Start Up: Step 9 – Preparing Regulatory Documents
Partnership 2011: Strategic Sourcing

We wish you Happy Holidays!
-Jennifer Pereira, Partnerships in Clinical Trials Manager & The Partnerships in Clinical Trials Team

Partnerships 2011 Highlight: Implement Changes to Adapt to the Increased Cost of Drug Development

noreply@blogger.com (Jennifer) — Wed, 21 Dec 2011 17:20:00 +0000

This week, we take a look at the highlights from David Windley's 2011 Partnerships In Clinical Trials Presentation, "Implement Changes to Adapt to the Increased Cost of Drug Development." In his presentation, he covered looks at the challenges faced by Pharma companies today in the evolving landscape of the world health market.

Watch highlights from his presentation here:

This year, at Partnerships in Clinical Trials 2012, David will be joining us again as a panelist for the "Wall Street and Private Equity Perspectives—Economic Outlook on Investment Areas, Growth Opportunities, and the Outsourcing Industry" panel taking place Tuesday, March 6, 2012. Joining David will be Jeffrey McMullen, President & CEO, Pharmanet/ i3, Jonathan Leff, Warburg Pincus, Board Venture Capital Association; Eric Coldwell, Managing Director, Robert W. Baird & Co.; and Michael A. Martorelli, CFA, Director, Fairmount Partners. For more information on this session, download the brochure here. And when you register to join us at the 21st Annual Partnerships in Clinical Trials, mention code XP1700BLOG and you'll receive 15% off the standard rate !

Marken Inaugurates New Argentina Pharmaceutical Service Depot

noreply@blogger.com (Jennifer) — Tue, 20 Dec 2011 14:57:00 +0000

Buenos Aires depot joins Mexico and Singapore purpose-built facilities, with more to come

London, December 20, 2011 -- Marken continues their expansion of services in Latin America, by augmenting their GMP Compliant depot network with the newly purpose-built Buenos Aires facility.

“The expansion of our services in Latin America enables our clients to better recruit in treatment naïve populations and work with previously unreachable investigator sites, assuring quality and regulatory documentation through the entire supply chain.” said Wes Wheeler, Marken’s Chief Executive Officer. “Our goal is to be the premier provider of life sciences supply chain services.”

Marken is implementing their stated plan to build the most advanced, fit for purpose clinical distribution network to serve the pharmaceutical community. The new Argentina depot builds on Marken’s current Latin America business which serves over 1200 clinical research investigator sites in the region, and enables the company to grow from its current industry-leading life sciences logistics platform. Marken is developing further depot facilities in Europe, Asia and the Americas.

The Argentina depot joins Marken’s already operational Mexico and Singapore depots offering the full range of temperature controlled storage capabilities including: controlled ambient, refrigerated (2º-8ºC), frozen (-20ºC) as well as a secured area for controlled substances. Each of Marken’s depots provides drug and equipment distribution solutions including: Pick & Pack, relabeling services, reverse logistics, reconciliation and certified destruction. Additionally the network manages specimen kit distribution, interim specimen storage and management.

Marken’s expanding Pharmaceutical Depot Network, together with the recently announced Marken Solo™ clinical distribution management application and the new version of Marken Maestro™, their supply chain management application, establishes Marken as the clear choice for innovative global clinical supply chain solutions. Visit www.marken.com for more information on Marken’s innovation in supply chain management for the life science industry.

Marken is also a sponsor of the 2012 Partnerships in Clinical Trials event, taking place March 5-7, 2012, in Orlando, Florida. As a reader of this blog, when you sign up to join Marken and mention code XP1700BLOG, you receive 15% off the standard rate!

About Marken
Marken is the leading global clinical supply chain service provider dedicated to the pharmaceutical and life sciences industries, supporting over 6,000 investigator sites in more than 100 countries. With decades of experience in the logistics, transport and distribution of temperature sensitive life saving pharmaceuticals, clinical trial supplies and specimen collection; Marken integrates Depot and Logistics services into solutions that extend the reach of clinical trials to even the most remote treatment naïve geographies. Our team members and network of facilities bridge the distance between patients and the essential resources of life science companies.
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Marken Maestro™ and Marken Solo™ are registered trademarks of Marken LTD
CONTACT: Elan Josielewski, info@marken.com, +1-347-855-3526, www.marken.com

Partnerships Keynote Session Spotlight: Disruptive Drug Development: Driving the Necessary Innovation and Change to Pioneer the Next Frontier

noreply@blogger.com (Jennifer) — Mon, 19 Dec 2011 16:30:00 +0000

Leading up to Partnerships in Clinical Trials 2012, we'll profile the keynotes, tracks and themes at the 21st annual event. For more information on Partnerships in Clinical Trials, taking place March 5-7, 2012; in Orlando, Florida, download the brochure now. If you register and mention code XP1700Blog, you will receive a discount of 15% off the standard rate!

Every pill, every diagnostic image, every surgical procedure–medical treatment in any shape or form–stems from a single source: research. Medical innovations start with the ideas and visions of committed scientists. Successful innovations then evolve over time–not weeks or months, but years–graduating through the different stages of development: basic research, translational research, and clinical research. Recently, Temple University and Fox Chance Cancer Center in Philadelphia have become affiliated in order to better care for patients and work together to develop new and innovative ways to treat cancer patients. Physicians News Digest reports the goal of joining forces for these two centers is to "a vital source of discovery, development, and delivery of the most effective approaches to cancer prevention, diagnosis, and treatment that will give patients the best of both worlds: access to the comprehensive treatments and innovative clinical-trials available at both Temple Cancer Center and Fox Chase Cancer Center."

At the 2012 Partnerships in Clinical Trials, J. Craig Venter, Founder, Chairman, and President, J. Craig Venter Institute; Founder and CEO, Synthetic Genomics Inc., will be on hand to discuss what innovative clinical trials and research methods can do for the care of patients today.

Featured Speaker: J. Craig Venter, Founder, Chairman, and President, J. Craig Venter Institute; Founder and CEO, Synthetic Genomics Inc.

Featured Session: Disruptive Drug Development: Driving the Necessary Innovation and Change to Pioneer the Next Frontier

About the session: Craig Venter is known as an innovative biologist who speaks his mind. Over a decade ago he lead the private effort in the quest to sequence all 3 billion base pairs in the human genome. He and his team then went on to sequences his complete diploid human genome, all 6 billion letters of DNA. This ushered in the era of personalized medicine, but many, including Dr. Venter himself, argue whether that era is truly upon us. In this provocative talk, Dr. Venter brings you inside his pioneering and unconventional approach to life sciences research and challenges you to join him in the disruption of traditional models for medical advancement. Specifically, he speaks to your biggest questions including:

• Why has “so little” happened in the decade since the human genome was sequenced?
• What is slowing the progress of genomic medicine?
• What do industry and academia need to do to realize the future of personalized medicine?
• Are we to risk adverse to create innovative breakthrough medicine?
• How will synthetic genomics affect future medical treatments?

The Site’s Side: IRBs what is a site to do?

noreply@blogger.com (Jennifer) — Thu, 15 Dec 2011 15:54:00 +0000

Introduction

I read with interest the beginning of this series titled “Sites – It’s Where the Patients Are!” and “The List”. What a great start to a conversation amongst some of the major players in the clinical trials arena. But I believe one of the crucial players was not mentioned – the IRB. I have seen a great shift in how sponsors and sites interact with the IRBs in the past few years some of which enhance the volunteers participation but some of which I find concerning. So this is where I will take off from Dan’s blog…

IRBs Today

We now see most, if not all, independent IRBs AAHRPP Accredited so they have to meet certain rigorous criteria to get the accreditation and stay in compliance. Much of the criteria has to do with human subject protection which enhances the sites’ ability to provide that protection with some assurance from an accredited IRB. How closely AAHRPP monitors the IRBs’ compliance with the standards I don’t know but I do think it’s a good start to have that accreditation in place.

I am not altogether sure what criteria sponsors and CROs use to select an IRB but sometimes it seems that cost may be the overriding factor. We are all now aware of the fiasco with Coast IRB (update). I suspect the choice to use Coast by many sponsors was based on their fees. I’m sure I can speak for most sites and say we hope to never have to deal with that kind of situation again or the publicity that accompanies it. Other criteria seem to be an IRB that will make the whole review and approval process easy and fast. Easy is not always best in terms of human subject protection.

Issues facing sites…

What I am seeing more of is the pharma companies making changes to the protocol and using a newsletter, conference call and/or memos to document the change instead of doing a protocol amendment. In one case the sponsor made some significant protocol changes by memo, which was then approved by the IRB. The sponsor then sent an email saying the site should just tell the study subjects about the changes and that a new ICF will come out soon – is that really informed consent? But what is the site’s recourse if the sponsor and IRB both approve it? Another situation occurred in which some information was given about how the study drug should be taken by the subjects on a conference call but that information was not in the protocol. It was stated that the subjects may experience some adverse effects if the drug was not taken with a meal. No IRB representative was on the call so they didn’t know this information was being given to the sites but it could affect not only the participant’s experience but the quality of the data being generated. Not sure how or if this information was passed along to those sites who were not in attendance on this particular call. In a third case the site received an updated informed consent with new safety information but was told they could not use it to consent subjects until it was approved by the sponsor. This was written in the protocol so the site was in a real quandary – if they consent the subject with the most current form they have a protocol violation but if they don’t then they are not in compliance with the federal regulation. Most importantly, the site is then putting the subjects at greater risk by not giving them the most up-to-date safety information. The site chose to stop screening until the sponsor approved the ICF so volunteers had to be rescheduled.

Closing Thoughts…

I could probably go on with more examples for pages but I think I have made my point. More and more research sites are stuck between needing to please the sponsor from whom they get their work and funds, following IRB policies and making sure they are in compliance with the federal regs as well as adhering to high standards for human subject protection. This is happening often enough that it is raising concerns about how much the sponsor influences the IRB to cut corners in order to save money. This puts the subject’s at higher risk and the sites with tough choices to make. This raises several questions for me: How do the sites become partners in the choice for the IRB used? How do we as sites keep this” shift” from becoming the new norm? How do we ensure all the players are using the same rules so we have a clear understanding of the process during the site selection process?

About the Author

Yvonne P. McCracken, MPH, CCRC, is Founder, President and Chief Executive Officer of Carolinas Research Associates, an Investigative Site Network founded in 1996 and located in Charlotte, NC. Carolinas Research Associates works with board certified, private practice physicians in the Charlotte area and major pharmaceutical companies to offer qualified volunteers access to clinical studies.

Ms. McCracken received a Masters of Public Health in Health Policy and Administration from the University of North Carolina at Chapel Hill and is a Certified Clinical Research Coordinator. She has been involved with clinical research since 1992 in the positions of research coordinator, site manager, business owner and consultant. She has implemented clinical research programs for numerous private practice physicians and large medical groups. She has provided consultation and training services to academic medical centers, private practice groups, and pharmaceutical companies.

Ms. McCracken is currently a member of the Clinical Trials Transformation Initiative, which is a partnership between the FDA and Duke University, as well as the Drug Information Association and the Associates of Clinical Research Professionals.

Ms. McCracken presented at the Clinical Research Conference in Taipei, Taiwan sponsored by ACRP and OHRP and was a speaker at the FDA’s Clinical Investigator Training Course in November 2010. Ms McCracken is a speaker and moderator at forums for the various research organizations including Institute for International Research (IIR), ACRP and DIA.

Fierce Pharma's Outstanding Women in Biotech Released

noreply@blogger.com (Jennifer) — Wed, 14 Dec 2011 16:20:00 +0000

Recently, Fierce Biotech recognized some of the women who have made a great impact on Pharma this year. In a typically male dominated industry, many women have risen to the top of Pharm companies and have made an outstanding impact on the industry.

Those recognized by Fierce Biotech include:

- Kathryn Biberstein, Alkermes
- Abbie Celniker, Eleven Biotherapeutics
- Kathleen Sereda Glaub, Plexxikon
- Mary Lynne Hedley, Tesaro
- Bahija Jallal, MedImmune
- Kiran Mazumdar-Shaw, Biocon
- Susan Molineaux, Calithera Biosciences
-Julie Overbaugh, Fred Hutchinson Cancer Research Center
- Anna Protopapas, Takeda
- Laura Shawver, Cleave Biosciences

To find out more about each woman's accomplishments, read the article at Fierce Pharma.

For the first time at Partnerships in Clinical Trials, there will be a Women’s Clinical Leadership Forum to foster the success of women in the clinical field. Moira Forbes, Vice President and Publisher, Forbes Woman, will be hosting an evening for women in the clinical industry to collaborate, communicate and network with women throughout various stages of their career in the clinical trials industry. For more information on that event, download the brochure here. As a reader of the Partnerships in Clinical Trials blog, you receive an exclusive discount of 15% off the standard rate when you register and use code XP1700BLOG.

Has the FDA harmed clinical trials by not pushing social media guidelines?

noreply@blogger.com (Jennifer) — Mon, 12 Dec 2011 21:39:00 +0000

Although many had hoped for social media guidelines in 2011, they still have not emerged from the FDA as a guidance for Pharma companies. In a recent article at WCG, Bryan Reid looked at how this is hurting Pharma companies. He identified brand promotion as a major loser with the lack of online guidance. Many creative ideas and campaigns can come about online, but many pharma companies stop short of them in fear that they'll get letters from the FDA for improper marketing.

What kind of social media marketing could clinical trial professionals be doing to recruit more patients? In a way, the lack of regulation also has their hands tied because many social media marketers don't know what they can and can't do either.

Even though there isn't much regulation, some companies have gone ahead and found a way to use social media to spread the word about their clinical trials. Momenta Pharmaceuticals is one of those companies. At the 21st Partnerships in Clinical Trials, they'll be sharing their experience in this field through the presentation "Momenta’s Application of Social Media in its Pancreatic Cancer Trial." For more information on this session and the rest of the agenda, download the brochure here. Don't forget, as a reader of this blog, you'll receive an exclusive discount of 15% off the standard rate when you mention code XP1700BLOG when registering to join us this March in Orlando for the event!

What can social media do for clinical trials? With regulation, do you think the number of participants who find out about clinical trials through social media would go up?

Partnerships Keynote Session Spotlight: Beating the Odds—Not Only Living with Cystic Fibrosis—Rocking It

noreply@blogger.com (Jennifer) — Fri, 09 Dec 2011 18:29:00 +0000

The Site’s Side: What Would Most Help Study Sites?

noreply@blogger.com (Jennifer) — Thu, 08 Dec 2011 15:02:00 +0000

The Site’s Side: What Would Most Help Study Sites?

The burden of running a trial today.

Study sites are key to the success of clinical research. After all, they are the link to the study subject, conduct the protocol and provide the data from the trial. Like marathon runners constantly in motion, they are incredibly busy with the numerous tasks involved in conducting trials such as keeping up with regulatory paperwork, ensuring training requirements are met, accounting for study drug, recruiting study subjects, conducting study visits, processing lab samples, entering study data and meeting with CRAs, just to name a few. They are constantly asked to speed up recruitment, and last but not least, are the stakeholder most closely responsible for protecting the safety and welfare of study subjects.

Unfortunately this struggle can take its toll. As Ken Getz reports (Getz, K. (2011) Predicting successful site performance. Applied Clinical Trials, 20 (11) p. 28.)

“Turnover among… investigative sites remains very high. CenterWatch has reported that four out of 10 US Investigators on average, between 2000 and 2009, quit participating in clinical trials each year… Sites note that an onerous compliance burden, difficulties recruiting study volunteers, slow payment cycles and the diminishing attractiveness of study grants have all contributed to the high drop out rate.”

Solutions in the making.

How can the other stakeholders involved in clinical research help study sites? Getz notes that “site support” makes a real difference, including assistance with recruitment and operational aspects of trial conduct. Quintiles has reported that its Prime Sites program, which places relationship managers at select study sites, has been successful. This extra support ensures that attention and resources required to meet the study’s goals per timeline are provided to these sites.

How can we, the clinical research enterprise, BEST help study sites to reach the goals shared by the entire team? What would sites ask for if they had only one wish?

About the Author

Sherry Reuter is President of Sherry Reuter & Associates, LLC, a consulting firm that focuses on the conduct of clinical trials, Site Selection, Study Start Up, Training, and Patient Recruitment and Retention. Sherry may be contacted at sreuter@gwu.edu or 203.775.6031.
Image: digitalart / FreeDigitalPhotos.net

The Future of Clinical Trials

noreply@blogger.com (Jennifer) — Tue, 06 Dec 2011 22:17:00 +0000

In this video from Future Med, Dr. Roni Zeiger, Chief Health Strategist at Google looks at the future of clinical trials and how today's technology is changing the way patients are behaving. Online tools are allowing patients to come together and discover their illnesses. They supply a surprising amount of data voluntarily that allows them to look at their illnesses indepth. This can't occur in many of the clinical trials that are taking place today, not to mention the lag time that comes from creating a clinical trial through a major Pharma company.

So how can the Pharma companies behind clinical trials overcome this? Many are going to have to become more innovative and flexible.

At Partnerships in Clinical Trials 2012, the Innovative Patient Recruitment and Retention Strategies full day summit will examine creative ways companies are already looking to reach out to patients in innovative ways. Join professionals from Merck, MS Clinical Trials, Shire Pharmaceuticals and more to discuss ways to connected with new patients. As reader of this blog, don't forget to mention priority code XP1700BLOG to receive 15% off the standard rate when registering to join us this March in Orlando!

What do you think online communities are doing for patient participation in clinical trials? Do you think they are increasing the awareness?

Partnerships Keynote Session Spotlight: Changing Your Game—How Clinical Executives Can Succeed by Increasing Global Competitiveness and Driving Revenue with Innovation

noreply@blogger.com (Jennifer) — Fri, 02 Dec 2011 15:54:00 +0000

• Redefine your leadership to be an innovation leader and improve your management game
• Learn how to reduce the risk of innovation failure
• Examine the impact of mergers and acquisitions on competition, partnering, and business innovation

Partnerships TV: John Hubbard, Pfizer

noreply@blogger.com (Jennifer) — Wed, 30 Nov 2011 14:50:00 +0000

At the 20th Annual Partnerships in Clinical Trials, Marc Dresner, the Communications Lead, Audience Engagement for the Partnerships in Clinical Trials Event, sat down with the outsourcing professionals who make the global clinical trials industry work. We'll be profiling each of these interviews leading up to the 21st Annual Partnerships in Clinical Trials, taking place this March in Orlando.

Today's featured interview is with John Hubbard, Senior Vice President, Global Drug Development, Pfizer. In this segment, Marc Dresner and John Hubbard discuss what the future is of clinical trial outsourcing. While many of the traditional locations will be used for clinical trials, the growing importance of BRIC countries is becoming clear to Pharma companies. Hubbard comments on which countries he believes are going to have the biggest impact along with what countries will prove to be the biggest contributors to clinical trials in the future.

Watch the latest edition of Partnerships TV here:

What nations do you believe are going to have the biggest impact on clinical trials in the next 10 years?