Partnerships in Clinical Trials

Planning for Hope: Follow-up Interview with a Study Subject

noreply@blogger.com (Jennifer) — Thu, 09 Feb 2012 19:06:00 +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.

Planning for Hope: Follow-up Interview with a Study Subject

Authored by Sherry Reuter

The follow up…

A few weeks ago, one reader commented on the list posted from my interview with a study subject, saying she:

“ …wished the patient had gone into more detail on some of her positive experiences. While we can continue to learn from these awful experiences, none of us think WE would ever commit these thoughtless (and some borderline or outright non-compliant) incidents. But knowing what makes a truly positive experience for a patient could perhaps help us appropriate budgets more realistically, train staff more specifically, or create innovative motivational opportunities.”

This comment is absolutely right, and it prompted me to get back in touch with the person I interviewed. When I relayed our reader’s comment, the interviewee responded:

“What a great question. I think it is so valid, I feel funny I didn’t include the do’s the first time. I really want to put some thought into it. I do know I would not be alive today without medical research. I have such a positive view about it that when I named the documentary I filmed I named it ‘Planning for Hope’ because this is what clinical research gives us, which is so important.”

Being Positive

“I have an appointment this week for a clinical trial that I have been in since 2003. The fact that I stayed in this study for so many years shows that they are doing a lot of positive things. I will think about this during my appointment this week.”

She went on to tell me that participating in clinical trials has given her access to some of the best specialists in the area she needs, sites with some of the newest diagnostic equipment in the world, and people doing some of the most leading-edge work in medicine:

“Being in clinical trials has had many advantages. I have benefited from sites that have the best equipment in the world and people who are doing leading-edge work. Here are some wonderful things that have happened to me from participating in clinical trials and as a result of being involved with people I have met through them.”

- An investigator from one of my previous clinical trials was the first to diagnose my condition. He had a scanner that played a role in finally making my diagnosis.
- The study site for one of my clinical trials has a new PET Scanner that is the largest and most sophisticated in the world, which makes a big difference in my case.
- One investigator spent a total of 4 hours talking to us after a visit that lasted an entire week.
- An investigator for one of my previous clinical trials met with me for lunch when I was in town.
- I have met an investigator running a trial on investigators and study subjects (not just their caregivers) using Social Media, a leading edge concept I get to be involved with.
- Another person I met through participating in clinical trials did a trial which led to the development of software that I use.
- I get hugs from many of the site staff from my clinical studies – genuine great people!

She has offered to send us more information after her study visit – about the good and the not-so-good, but knowing that clinical trials are one of the main sources of hope.

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.

Pharma Industry Consortium Tackles Clinical Trial Quality Management

noreply@blogger.com (Marc Dresner) — Wed, 08 Feb 2012 14:00:00 +0000

Inside Outsourcing Interview Series Probes Push for Standardized Quality Metrics

By Marc Dresner, IIR

The clinical outsourcing industry got a jolt in December when a dozen bio-pharmas—including five of world’s largest manufacturers—announced they had formed a Quality Consortium to establish and standardize metrics and best practices in clinical trial quality management.

The initiative is being coordinated and managed by clinical outsourcing research and consulting firm The Avoca Group, whose 2011 industry report on quality and CRO oversight identified widespread dissonance between sponsors’ quality expectations and CROs’ ability to deliver on them given years of downward pricing pressure and compressed timelines.

(Editor: To purchase The Avoca Group report at a 15% discount click here and enter the code PARTNERSHIPS.)

According to The Avoca Group’s executive director of survey research and relationship management, Denise Calaprice-Whitty, “sponsors and service providers have realized that they really need to get on the same page, but this is relatively uncharted territory, and many of them aren't sure what to include in their quality agreements.”

Mitchell Katz, executive director of medical research operations at Purdue Pharma—a founding member—added that the FDA’s dual mandate for closer oversight of outsourced trials by sponsors and the inclusion of quality management systems to ensure compliance prompted sponsors to unite in pursuit of an industry-level solution.

“We are in desperate need of something that is not just defined by each individual company; we need to set a standard for all companies,” Katz told Inside Outsourcing.

In this exclusive podcast interview for Inside Outsourcing: Spotlight on Clinical Trial Partnerships, Katz and Calaprice-Whitty discuss:

- Quality agreements: components and negotiation
- Challenges facing sponsors and CROs
- KPIs vs Quality Metrics
- Quality Consortium plans and progress

Listen to this episode of Inside Outsourcing!

Read the interview 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.

As a reader of this blog, when your register to join us this March in Orlando and mention code XP1700BLOG, you'll receive a 15% discount off the standard rate. Visit the webpage for more information.

Learn more about the Quality Consortium.

Ps. For a candid take from senior executives on the state of sponsor/CRO partnerships and industry trends, tune in to PartnershipsTV™ —the official streamcast network of Partnerships in Clinical Trials!

ABOUT THE AUTHOR/INTERVIEWER
Marc Dresner is IIR USA’s communication lead for audience engagement. 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. Meet him at the 2012 Partnerships in Clinical Trials conference in Orlando this March!

Is it time to change from a paper based Trial Master File?

noreply@blogger.com (Jennifer) — Tue, 07 Feb 2012 14:00:00 +0000

Investigators/institutions and sponsors of a clinical trial are required to maintain a collection of essential regulatory documents known as a Trial Master File (TMF). The TMF enables scrutiny, by independent auditors and regulatory authorities, of the conduct of a trial and the quality of the data produced at all sites involved with the trial. These essential regulatory documents are critical to substantiate adherence to GCP standards and regulatory compliance by the trial's investigators/institutions and sponsors. With over 50 categories of documents to track for numerous individuals spanning the three major phases of a trial, a paper-based TMF represents a tremendous financial and governance risk to all parties invested in a trial's outcome.

Challenges with a paper-based TMF

• Extremely difficult to ensure regulatory compliance throughout all phases of a trial
• Costly and labor-intensive to manage and maintain
• Does not track the status of required document submissions or follow up action items
• Requires auditors and reviewers to access hard copies in person
• Prohibits analysis and mining of the data
• Substantially increases risk

Osprey eTMF RiskManager™ with Electronic Trial Master File
Osprey eTMF RiskManager™ is web-based which provides authorized individuals access from anywhere. Powerful querying capabilities enable them to quickly and easily locate documents in ways not possible with paper-based TMFs. The time required for the final close-out of a trial will be significantly reduced since verifiable compliance levels will be immediately available to auditors and authorities. Investigators/institutions and sponsors have access to real-time status on submissions from all sites participating in a trial. Osprey eTMF RiskManager™ automatically alerts appropriate individuals when a document requires follow up based upon customizable thresholds and conditions. Tasks are automatically assigned to track the status of the follow up actions through to completion.

About Osprey Software Solutions Osprey Software Solutions, Inc. is a premier team of experts in the design and development of complex business applications. Osprey has assembled one of the most highly regarded teams of architects, engineers, and consultants in the software development business. The Osprey team has an outstanding track record in the design and delivery of large scale, advanced business systems in a variety of industries, including: Financial Services, Lending, Energy, Healthcare, and Defense. For more information about Osprey’s eTMF RiskManager please contact Michael Vidoni, author of this article, at contact@ospreyss.com or by phone 888.677.7394, ext.1004

Pooled Drug Inventory 101

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

By Kimberly Sierk, Principal, eClinical Solutions, BracketGlobal

An Overview

Pooled drug inventory is the current hot topic in supply management, similar to the way adaptive trial design was a relatively new and popular subject a few years ago. An increasing number of Sponsors are exploring pooled drug inventory as a way to:

• Reduce overage in packaging runs
• Maintain stock of drug available for multiple simultaneous trials
• Manage the supply chain in a more efficient manner

Pooled drug inventory occurs on three different levels: country, depot and site level.

Pooling at the country level has been an industry standard for many years and is essentially earmarking and labeling drug to support distribution to multiple countries. Many do not consider this to be actual drug pooling, but is important to include as a starter concept for the more novice students of drug pooling, as it sets the ground work for understanding how one unit of drug may be used in multiple supported sites or countries.

The second level of drug pooling occurs at the depot, where units of drug reside at a depot and may be used across multiple protocols. However, once a shipment request is raised (utilizing all available drug units at the depot based on lowest expiry), the drug unit is associated with an individual protocol and may only be used for that protocol.

Site level is the third kind of drug pooling. This is the most flexible and yields the highest cost savings. For Sponsors that utilize the same sites across multiple protocols which dispense the same types of drug, shipments requested encompass all drug needed across all protocols at a site. Drug is sent and associated to that site. An individual drug unit can then be utilized in a first-in, first-out fashion and associated to a protocol at the time of dispensation to a subject.

One of the key aspects for success of pooled inventory is the utilization of an IVRS (Interactive Voice Response System) or IWRS (Interactive Web Response System). Bracket, a leading IVRS/IWRS vendor, has worked with a variety of Sponsors for both blinded and open label trials that successfully utilize pooled inventory models and have been able to effectively guide and administrate all three pooled inventory groupings.

A rate limiting step in the broader acceptance of drug pooling is in the unknown territory of country specific regulations. Much like the European Medicines Agency (EMA) Reflection Paper On The Use Of Interactive Response Systems as it pertains to expiry management, a thoughtful exploration of pooled inventory should be investigated using input from industry experts. Such a reflection would serve to better guide and grow the industry as a whole, benefiting both the solution providers and Sponsors involved.

Bracket Global will be an exhibitor at the 21st Annual Partnerships in Clinical Trials. If you'd like to join them, as well as over 2000 other clinical research professionals, join us in Orlando from March 4-7, 2012! For more about the program and information on all of the networking opportunities, download the brochure here. If you register and mention code XP1700BLOG, you'll receive a 15% discount off the standard rate.

About the Author:
Kimberly Sierk has extensive experience with IVRS/IWRS and system design, starting with Bracket as a Project Manager in 2002, when the company was known as Dynarand.
Kimberly’s current role at Bracket is Principal, eClinical Solutions where she is intimately involved in the design product offerings of Bracket’s IVRS/IWRS services, providing expertise on system design considerations, as well as liaising with the Engineering, Project Management and Business Development departments.
Prior to Bracket, Kimberly held positions in Production, Vendor Relations and Business Development. She holds a BA from California State University, Northridge.

Partnerships in Clinical Trials Keynote Spotlight: Wall Street and Private Equity Perspectives—Economic Outlook on Investment Areas, Growth Opportunities, and the Outsourcing Industry

noreply@blogger.com (Jennifer) — Fri, 03 Feb 2012 17:58:00 +0000

Last month, Garen Sarafian, Vice President, Citigroup Investment Research & Analysis, Citigroup and Ian C. Lauf, MBA, Global Sourcing Manager, Medical & Clinical Trial Central Services, Boehringer Ingelheim Pharmaceuticals, Inc. joined us to present the web seminar "Clinical Trial Outsourcing Dollars and Financial Sense" in a precursor to the financial session at this year's Partnerships in Clinical Trials. If you haven't had a chance to watch this informative web seminar, you may do so here.

This year, at Partnerships in Clinical Trials, leading our traditional panel on the future of the financial aspect of clinical trials, we'll have David Windley moderating a panel featuring CEOs and Directors from companies such as Pharmanet/i3, Robert W. Baird & Co and Fairmount Partners. If you'd like to join us for this panel, and the rest of the event, register today and mention code XP1700BLOG, you'll receive 15% off the standard rate! For more information on this year's event, download the complete agenda.

Panelist David H. Windley

Featured Panelists: David H. Windley, CFA, CPA Managing Director - Healthcare Equity Research, Jefferies & Compa ny, Inc.
Jeffrey McMullen, President & CEO, Pharmanet/ i3
Jonathan Leff, Warburg Pincus, Board Venture Capital Association
Eric Coldwell, Managing Director, Robert W. Baird & Co.
Michael A. Martorelli, CFA, Director, Fairmount Partners

Featured Session: Wall Street and Private Equity Perspectives—Economic Outlook on Investment Areas, Growth Opportunities, and the Outsourcing Industry

About the session:
Publicly traded CROs have been playing a disappearing act. During the past eight years, 13 contract clinical research service providers that were formerly public companies have moved into the private equity markets. Behind the veil afforded by the private markets, CROs have far greater latitude to not only complete transactions that complement their capacity and expertise and permit a founder to exit, but also to pursue novel leading strategies that may ultimately redefine integrated drug development services in the future. CROs now double the global capacity of drug development professionals and play a critical and essential role in supporting pharmaceutical and biotechnology company R&D operations. With a global perspective, this distinguished group of financial leaders offers multi-stakeholder perspectives on the industry’s key threats and opportunities.

• Does a public to private switch gives CROs better chance to “fix” and transform themselves?
• Assess the difference in strategies between PE owned CROs, Private CROs, and public CROs. What value, if any, are private equity firms bring to managing CROs?
• Evaluate the drivers of rising costs of CRO Services and service providers and its impact on outsourcing
• Why are private equity firms increasing their investments in CROs? How valuation methodologies to they use to decide what companies to invest in?
• Is there a conflict of interest in Private equity firms investing in pharma and investing in CROs?
• What is the financial impact of recent M&A activity on future the outsourcing industry and future investment areas?

Research Clinics: You’re Leaving Too Much Money On The Table!

noreply@blogger.com (Jennifer) — Thu, 02 Feb 2012 16:04:00 +0000

Research Clinics: You’re Leaving Too Much Money On The Table!

Authored by: Dan Sfera

I just wrapped up an hour long interview with Ana Marquez for my clinical trial talk show, “The Clinical Trials Guru”. What we discussed during that interview actually inspired me to delve deeper into the subject of research clinics and their handling of cash flow, invoicing, contract negotiations and the like.

As Ana mentioned in the interview, while we are all very privileged to be able to work in this exciting industry, at the end of the day clinical research is a business and should be treated as such. Unfortunately for many sites, they realize this a little too late and ultimately are forced to close the doors on their business. In fact, according to my chat with Ana, 58% of sites report to be in more debt this year than last, while other sites that were in operation a few years ago are no longer in business today. While this lack of attention towards the financial aspects of clinical trials may certainly be due to many research clinics being primarily run by clinicians or other clinically minded individuals who understandably focus first on clinical operations, ignoring your site’s cash flow and financial performance may put your company and all its stakeholders (patients included) at risk of losing what you’ve worked so hard to build.

Tips when negotiating the Contract and Budget

The first and most important financial-related activity you need to focus more on is the contract and budget negotiation. This is the event at which research clinics can make the biggest impacts to their financial well being. The key to successfully negotiating a lucrative contract is being able to clearly explain why your site requires anywhere from a 20-120% (yes that’s right!) increase in its budget. You may not be able to double your budget in all cases, but it has happened plenty of times from my experiences as well as those of others. Don’t allow the negotiator on the other end to compare your site to other clinics. If you are given such a statement, respond by telling them that you have no idea what other sites are getting, but this is in fact what the procedures will cost you. It is, of course, important to know what you are talking about here and make sure you do your homework on what these procedures will actually cost you (including overhead).

Don’t forget to invoice these items

Another way sites tend to lose money is to forget to invoice for certain items such as: transportation costs for bringing subjects to the clinic, meal reimbursement for subjects, time required for staff members to be retrained on protocol amendments, record storage fees, time required to re-consent subjects, time required to process, document, and report all SAE’s, and much more. Make sure you negotiate for these costs in the budget, and when it comes time to bill the sponsor for doing these activities, make sure that you actually remember to invoice them. Our video interview explains just how to go about invoicing for these and other often-forgotten activities that are necessary for conducting any study these days.

Get paid in a timely manner!

A third concept to gain a better understanding and mastery of is receiving study payments in a timely manner. You should strive for ensuring monthly payments from sponsors. Although some sponsors/CRO’s are really trying to push for quarterly payments, I along with my interviewee, Ana Marquez, feel it is critical that sites receive monthly payments in order to reduce cash flow anxiety. After all, we pay all of our bills on a monthly cycle, why should we wait 3 or even 4 months for a sponsor to pay us? Whenever possible, insist on a monthly pay schedule in your contract. I’ve heard some rumors that sponsors and CRO’s may even begin to have sites invoice for regular patient/study visits. If and when this happens, your site better be very knowledgeable and efficient in terms of getting these invoices processed and sent out to the sponsor for billing.

Closing Thoughts

It is important for research sites to understand how to accomplish and retain profitability in order to continue serving their communities, keeping their employees and support staff focused on actually conducting studies and not worried about whether their next paychecks will arrive. If we all can get better at negotiating budgets and maintaining profitability, then ultimately, we will all do a better job at conducting the actual clinical trials. I’d love to know what you guys think about this. Email me anytime at dan@southcoastclinicaltrials.com.

About South Coast Clinical Trials:

SCCT was founded in 2001 by Dr. Adonis Sfera, M.D. who has been serving the community in his general and geriatric pyschiatry private practice for more than 15 years, and who continues to do so at our principal trial site in Anaheim. Dr. Sfera created SCCT in hopes of aiding in the discovery of new and more effective treatments for the very challenging disorders and conditions he encountered daily in his practice. He has since assembled a team of highly experienced professionals to assist in bringing these promising treatments to the people who need them.

About Dan Sfera:

Dan Sfera, BS, MBA, is a regulatory and contract specialist, is responsible for business development and is the Anaheim Site Director. In addition, Mr. Sfera is the site liaison for the company and is in charge of obtaining new studies as well as handling all of the necessary study start-up activities for our multiple sites. Dan serves as the liaison between South Coast Clinical Trials and SCCT’s pharmaceutical sponsors or Contract Research Organizations, ensuring that each and every facet of the trials are in full compliance with the Food and Drug Administration and Institutional Review Boards.

To contact Dan, please click here.

Follow Dan’s blog: http://www.TheClinicalTrialsGuru.com

Craig Lipset on the greatest promise that virtual trials hold for the pharmaceutical industry

noreply@blogger.com (Jennifer) — Wed, 01 Feb 2012 19:16:00 +0000

Recently, Partnerships in Clinical Trials Program Director Danya Burakoff, discussed some of the benefits of conducting patient directed clinical trials with Craig Lipset, Head of Clinical Innovation, at Pfizer Inc. Even though many of the tools Pfizer is using to successfully conduct these trials have been around for years, with education, they're allowing patients to become more involved in the process, and allowing them to become more engaged and a bigger participant.

Download Craig's podcast audio here and the full transcript here.

Here's an exclusive excerpt from Craig's Podcast:

What is a virtual trial and what is the greatest promise that virtual trials hold for the pharmaceutical industry?

Craig: Well, to us the virtual trial is about really putting the patient at the center of the clinical trials and embracing them as a real participant in clinical research. So, what does that mean to us? I think that historical trials are very investigator-centric. We choose investigator sites and then we target and recruit patients who are in geographic proximities of those sites so that they can travel in and out. What we are looking at here is our ability to decentralize that process, to bring the clinical trials to the patient instead of taking that hub and spoke approach. And enable participants to join clinical trials from just about anywhere.

We are also looking at this as a way to improve our engagement with patients with real participants and partners in the research process that it is beyond just pulling data off of a patient and get it into our database, but sharing data and sharing learnings with patients, similar to how patients are looking to be engaged as partners and participants in their healthcare. To us, we believe that this will improve engagement in clinical trials for patients and improve convenience and accessibility. We also think it will improve access to more diverse patients and populations to participate, rather than just the patients of elite academic medical centers.

At Pfizer, we look at this as an opportunity to explore improving quality and convenience because of that type of increased engagement of patients. It’s potentially about accelerating the drug development process, but it is really about making this more sustainable because we all know that the way we are doing trials today, it is largely an unsustainable model.

Craig Lipset will be the Chair in addition to speaking in the Virtual Clinical Trials Summit at the 21st Annual Partnerships in Clinical Trials. For more invigoration on this symposium and the rest of the program, download the brochure here. As a reader of this blog, when you register to join us in Orlando and mention code XP1700BLOG, you'll receive 15% off the standard rate!

Who can you meet at Partnerships in Clinical Trials 2012?

noreply@blogger.com (Jennifer) — Mon, 30 Jan 2012 16:34:00 +0000

A record number of sponsor executives are already scheduled to be at the Partnerships in Clinical Trials 2012 event! With attendee numbers running way ahead of last year, we have many more networking and business opportunities for you!

Who can you meet at Partnerships in Clinical Trials 2012?

Abbott Labs * Genzyme * Abbott Molecular * GlaxoSmithKline * Academic Alliance for Clinical Research* Heartland Regional Medical Center * AccuMed Research Associates * Hoffman La Roche * Acorda Therapeutics * Human Genome Sciences * Actelion Clinical Research * ImClone Systems * Actelion Pharmaceuticals * Infinity Clinical Research * Acumed Research Associates * Infinity Pharmaceuticals * Advanced Clinical Research Institute * Inovio Pharmaceuticals * Allergan * Jedidiah Clinical Research * AMAG Pharmaceuticals * Johnson & Johnson * Amgen * MacroGenics * Apotex Research * Mannkind Corporation * Array BioPharma * MedImmune * Aslan Pharmaceuticals * Medtronic Vascular * Astex Pharma * Merck & Company * AstraZeneca * Merck Research Laboratories * Asubio Pharmaceuticals * Merck Sharp & Dohme * Baxter Healthcare * Millenium Pharmaceuticals * Bayer Healthcare * Molecular Insight Pharmaceuticals * Bayer Vital GmbH * Momenta Pharmaceuticals * Becton Dickinson * National Jewish Health * Biogen Idec * Neurotrials Research * Blood Center of Wisconsin * New Orleans Center for Clinical Research * Boehringer Ingelheim Pharmaceuticals * Novartis Pharmaceuticals * Boehringer Ingleheim Canada * Novo Research Institute * Bristol Myers Squibb * Nycomed * C R Bard * Otsuka America Pharmaceuticals * Celgene * Pfizer * Celtic Pharma * Development Services America * Pharmasset * Central Kentucky Research Associates * Prism Research * Central Utah Clinic PC * Purdue Pharma * Cephalon * Questcor Pharmaceuticals * Cerexa * Reckitt * Benckiser Pharmaceuticals * Cincinnati Childrens Hospital * Regeneron Pharmaceuticals * Clinical Research Consortium * Research Across America * Clinical Research of South Florida * Rigel * Covidien* Rochester Clinical Research * Cubist Pharmaceuticals * Sandoz * Daiichi Sankyo * Sanofi Aventis * Dyax Corporation * SDS Clinical Trials * Eisai * Shire Pharmaceuticals * Elan Pharmaceuticals * Streck Inc * Eli Lilly & Company * Stryker * Endo Pharmaceuticals * Sunovion Pharmaceuticals * Essentia Health * Takeda Global Research & Dev * Exelixis * TEVA Pharmaceuticals * Forest Laboratories *VDDI Pharmaceuticals * Genentech * Vertex Pharmaceuticals

Make sure you are registered to take advantage of "myPartnerships" – the online networking system that allows you to see and search the attendee list, make connections and set up meetings to maximize your time at the event. This tool will launch next week, so if you register today, you will have 5 weeks to contact and schedule meetings with executives from pharmaceutical, biotech, medical device and sites including:

As a reader of this blog, when you register to join us March 4-7, 2012, in Orlando, Florida and mention code XP1700BLOG, you'll receive 15% off the standard rate! For more information on the event, visit the webpage. If you have any questions or need any further information, feel free to email Jennifer Pereira at jpereira@iirusa.com.

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

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?