Partnerships in Clinical Trials

Partnerships Asia Pacific Session Spotlight: Partnerships in Clinical Trials: East vs. West

2010-07-06T14:19:00.003-04:00

Each week leading up to Partnerships in Clinical Trials Asia Pacific, we'll be highlighting a session from the upcoming conference. It will take place October 5-7, 2010, in Singapore. For more information, visit our webpage to download the brochure.

Featured Session: Partnerships in Clinical Trials: East vs. West
Presented by: Mark Bach, PhD, Vice President, Head of R&D, Regulatory Affairs and Safety,
JANSSEN PHARMACEUTICALS KK, Japan

About the session:
Pharmaceutical companies are facing continuing pressure due to patent expirations, increasing regulatory constraints and other factors. These result in the need to increase productivity, increase speed to market and maintain quality. One approach to address these needs is strategic sourcing – CROs can bring value to sponsors through both strategic and tactical support for development. Sponsors headquartered in the US and Europe are entering into strategic partnerships with CROs, but the experience in Asia is more limited. How can the extensive experience in these markets inform and accelerate the development of such relationships in Asia?

Key issues include:
• How does the current APAC environment compare to the US/EU CRO industry 10 years ago?
• How is the Asia operation model different from US?
• What can be learned from the history of CRO and pharma partnership development outside of Asia?

Outsourcing of clinical trials expected to rise by 25% by 2013 – is your team prepared?

2009-08-25T10:11:00.000-04:00

With so much uncertainty surrounding the economy, consolidation of pharmaceutical companies, lack of funding for biotechs and drug safety concerns, one thing is for sure – there is still much work to be done to bring new medicines to market and we’re all being asked to do more with less. That’s why it’s imperative to get your clinical outsourced studies right the first time around. And, the long term view from industry experts is that outsourcing will continue to dominate.

But with so much flux in the marketplace due to career shifts, Big Pharma re-orgs and smaller pharma and biotechs ready to send new products into development, there’s a learning curve when it comes to making the right outsourcing decisions. You need to be armed with the information and contacts to get moving - the alternative can cause project delays costing into the millions.

Fundamentals of Clinical Outsourcing is a conference you can’t afford to miss!
→ If you are challenged by making decisions on full-service vs. functional outsourcing, or are struggling to convert a vendor bid into a study contract, you will benefit from the collective experience shared by our expert speaking faculty.

→ If change orders due to hurried or unrealistic scope of work or poor communication with your partners have just about stopped your trial in its tracks, you’ll find solutions for these challenges as well.

→ And, if you’re worried about quality oversight of third party clinical research data, you will hear directly from the FDA on what they expect.

Download the brochure for more information on how to do more with less and get your studies right the first time around.

We understand travel budgets are limited, so we are especially pleased to offer this program regionally in both Boston this October and San Francisco in November to facilitate your attendance.

Make sure to register before August 28th and Save up to $300! Mention Priority code 0T4JXO

Pfizer to create online networking site for clinical trials

2009-08-24T13:54:00.001-04:00

According to Forbes, Pfizer is teaming up with Private Access in order to create a social networking website that will pair potential patients to doctors and clinical trials. This site also allows for the privacy of patients, the CEO of Private Access stated the website was "privacy-enhanced search engine for personal health information.". This new social networking site will also encourage trial sponsors, patient advocacy groups and technology providers to come together. Read more here.

Medicare's Stance on Clinical Trials

2009-08-20T16:15:00.000-04:00

This post on Health PROSe discusses how Medicare is not only important to health care delivery but it is also key to all clinical research taking place across the country. Cures and treatments for diseases all require that Medicare beneficiaries participate in clinical trials, and that was exactly what President Clinton ordered back in 2000.

This memorandum though was not followed through by the Bush administration, and it was actually dismantled. Obama's administration must recognize the important of the Medicare clinical trial policy to ensure that Medicare beneficiaries are covered. It will be interesting to see if the new administration will soon address this policy and take action.

Stem cells for the heart in clinical trial

2009-08-19T10:38:00.000-04:00

The US News and World Report recently looked at a clinical trail taking place in the western United States which takes stem cells from ones body, treats them, and then injects them back into unhealthy hearts. This study is hoping to find a way to help heart failure patients rejuvenate their heart with their own stem cells. Read more about the trial here.

Biopharma in India is Surging

2009-08-17T15:56:00.000-04:00

According to this article in FierceBiotech a weakened economy and the need for cutbacks is pushing big pharma companies to drive drug development and manufacturing in India. One thing though, many Indian developers are having a hard time transitioning from manufacturing generic drugs to devising new therapies. This is certainly a huge opportunity for Indian firms to thrive if they can ease the transition somehow. It will be interesting to see how things will play out over the course of the next couple of years.

goBalto, Matchmaking for CROs and Drug Developers

2009-08-13T15:34:00.001-04:00

According to TheScientist.com, the number and depth of the connections between CROs and drug developers has grown so much, they now have their own match-making website. Last October, serial biotech entrepreneur Jae Chung (pictured at left) started what he expected to be a simple drug development directory. Now, just three months after its late April launch, goBalto boasts more than 7000 companies and consultants, including 2,200 CROs, all of which can be searched and rated by one another. With a couple of hundred companies and consultants adding themselves each week, "we're one of the fastest growing professional networking sites," Chung said. Finding partnerships, which used to take four to six weeks, can now take as little as two days, he claimed.

Have you had any experience with goBalto? Do you think that matchmaking and social networking have a place within the CROs universe? We'd like to hear your thoughts.

India Expected to Take Larger Share of Outsourcing Sector

2009-08-12T12:43:00.001-04:00

According to this article in outsourcing-pharma.com the outsourcing sector in India is expected to grow at 43 percent due to the diminishing concerns of the about operations in that country. Predictions made by Ernst & Young show that India is still ranked highest among its outsourcing peers in cost efficiency. Also, the country's technological capabilities are far more advanced than many of the other competing countries. It will be interesting to see India will grow as expected, or if Eastern Europe or China will advance in the outsourcing sector.

Clinical Trial Cost & Contract Management Agenda Finalized

2009-08-11T11:47:00.000-04:00

Greater scrutiny of financial ties to clinical investigators coupled with increased accountability and drug safety puts more pressure on contracting executives to clearly outline responsibilities from the start.

Attend Clinical Trial Cost & Contract Management West this November 9-10 and take back to the office the necessary tools to streamline processes and better define accountability and responsibilities:

∙ Gain the upper hand in your contract with a workshop dedicated to contract approach and development
∙ Avoid embarrassing and costly violations regarding financial ties to clinical investigators with a firm grasp on Fair Market Value (FMV)
∙ Bring your drug to market before your competitors by fine tuning your strategy for handling Intellectual Property (IP)
∙ Improve the quality of you’re 3rd party clinical research data with warning signals and outline methods direct from an FDA representative
∙ Improve ROI by defining best practices for handling site payment disputes with your CRO

To view the full agenda click here!

Visit the website here to place your registration.

Web Seminar: REMS, EU-RMP and FDAAA: Navigating the Clinical Trial Safety, Postmarketing Pharmacovigilance and Risk Management Alphabet Soup

2009-08-07T14:00:00.000-04:00

Join us for a web seminar presented by Stephen A. Goldman, MD, FAPM, DFAPA !

Title: REMS, EU-RMP and FDAAA: Navigating the Clinical Trial Safety, Postmarketing Pharmacovigilance and Risk Management Alphabet Soup

Date: Wednesday, September 9, 2009

Time: 2:00 PM - 3:00 PM EDT

Reserve your Webinar seat now at:
http://bit.ly/PartnershipsWebinarBlog

About the web seminar:
Current pharmaceutical safety is a sophisticated system in which benefit/risk assessment begins with animal testing and continues throughout human clinical trials, licensing approval and marketing of the product. It is critical to monitor evolving safety profiles of marketed products throughout their life cycles, and optimally employ risk management tools in service of public health.

This seminar will examine current national, regional and international perspectives and approaches to clinical trial safety, pharmacovigilance planning and risk management. Current EMEA and FDA regulatory requirements and standards, in combination with the vital ICH E2E guideline, will be discussed and also examined via case examples of risk assessment, communication and minimization methods.

Repros Therapeutics Inc. halts clinical trial

2009-08-06T09:35:00.000-04:00

Repros Therapeutics Inc. may face bankruptcy after suspending their clinical trials fro Proellex. The studies were postponed due to concerns for trial participants safety. The drug being tested treated chronic symptomatic uterine fibroids, anemia associated with this condition and endometriosis. Read the full article here.

Outsourcing to grow 10% says WSHP

2009-08-04T10:27:00.000-04:00

According to this article in outsourcing-pharma.com private equity group Water Street Healthcare Partners purchased AAIPharma's pharma development business. WSHP’s Peter Strothman mentioned that the key motivation for this purchase is the $115 billion growth of the outsourcing sector, and that it is estimated to grow by more than 10 percent over the next five years. AAIPharma has had plans to invest heavily in emerging trials in Eastern Europe as well as in Sao Paulo, Brazil. Now with the help of WSHP the firm might just be able to expand.

USA and Europe team together to monitor clinical trials

2009-08-03T10:34:00.000-04:00

The FDA announced today that they're starting the Good Clinical Practices Initiative, which will unify and ensure that both countries are conducting clinical trials uniformly, appropriately and ethically. This will be a 18 month pilot program beginning on September 1st. The FDA's Center for Drug Education and Research will front the US's efforts and EMEA will front Europe's efforts. Read the full article here.

Get Your Clinical Trial Studies Right the First Time Around

2009-07-30T16:45:00.000-04:00

This has been quite a year, since October we’ve watched global markets falter, a new president get elected and sweeping healthcare reform is being debated on the floors of congress. All this is impacting the pharmaceutical industry and companies are responding by aggressively reducing costs and how to get better results from all of their outsourced clinical research. We know you’re feeling the pressure rise as the volume of outsourced work continues to increase. In order to design a process that will save time in the long run it is important to have a firm grounding in the fundamentals.

For 2009 Fundamentals of Clinical Outsourcing has been updated with timely topics, in-depth roundtable discussions and increased networking opportunities to create a highly focused learning opportunity that will help you better manage your outsourcing partners and expedite clinical trials.

New for 2009!
• Keynote presentation from Ken Getz, Senior Research Fellow from the Tufts Center for the Study of Drug Development on tracking the transition from transaction to portfolio based relationships
• Genzyme and Milennium executives discuss relationship management and The Rules of Engagement
• FDA address from Michael Marcarelli the Director of the Office of Bioresearch Monitoring at CDRH tells participants what the FDA Expects regarding quality oversight of third parties

If you are ready to send a new compound into clinical development and you don’t have the in-house resources to execute the trial or if you are overwhelmed by the choices that need to be made every day to keep your products moving through development, Fundamental of Clinical Outsourcing is your best opportunity to obtain best practices, set your outsourcing strategy and manage successful relationships with proven rules of engagement.

Download the brochure today, and then visit the website to reserve your seat! I look forward to seeing you there.

New clinical trial for congestive heart failure

2009-07-29T13:51:00.000-04:00

According to the South Florida Business Journal, a Phase I clinical trial will begin for a treatment to congestive heart failure. If this trial is successful, it would be one of the first to combine gene and stem cell therapy for cardiovascular disease. Read more about this trial that will begin taking place next year.

India: Domestic clinical trials market booms

2009-07-28T12:21:00.000-04:00

Thomas K. Thomas of The Hindu Business Line writes, the number of clinical trials being conducted in India has doubled from 170 in 2006 to 350 at the end of 2008, according to the Central Drug Standard Control Organisation.

And going by the indications in the first six months of 2009, the number of registered clinical trials in the country is likely to touch a new high.

Already between January and June this year, 130 trials have been registered with the drug regulator. Since the drug regulator has made it mandatory for clinical research organisations to register all drug trials from June onwards, a significant jump in the actual numbers is expected this year.

What's next for India? Now a global player in both clinical trails and cros--will India take the lead?

Fundamentals of Clinical Outsourcing: Agenda Finalized

2009-07-27T16:39:00.000-04:00

The team behind the longest running event for clinical development and outsourcing professionals has assembled a top-notch lineup of distinguished speakers to help companies see the big picture as well as work through the nuts and bolts. Whether you are new to the area of outsourcing, need a refresher course, or would just like to increase your network, the 5th Annual Fundamentals of Clinical Outsourcing event is your answer. In just two days, you’ll gain the knowledge to help you do more with less and get your studies right the first time around.

Hear from expert industry professionals who will demonstrate the roles involved in the clinical outsourcing process, and present a clear view on how to effectively manage both the tactical and strategic elements.

• Create your outsourcing strategy and choose a model for your outsourced project
• Identify and select your outsourcing provider based on the needs of your organization and project
• Negotiate and draft a proper outsourcing agreement
• Utilize budget outsourcing tools and templates to streamline your efforts
• Manage successful sponsor/provider relationships with proven rules of engagement
• Use metrics to stay on track and measure results for optimal project performance.

The FDA is seeing an alarming trend of unreliable data being submitted by third parties which sponsor companies are ultimately accountable for – don’t miss crucial warning signals that will prevent your trials from moving forward. You won’t want to miss out on learning what FDA expects regarding quality oversight of third parties, direct from FDA’s own Mike Marcarelli.

Download the agenda today, and then visit the website at www.clinicaloutsourcingevent.com to reserve your seat! I look forward to seeing you there.

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New Date Capture and Reporting Service Network has been Created for Clinical Trials in Japan

2009-07-27T10:55:00.000-04:00

According to this article in Outsourcing-Pharma.com PHT, which is a US ePro specialist, has teamed up with CRO CMIC to create a data capture and reporting service network for clinical trials in Japan.

The service will include PHT's patient reporting technologies to biopharmaceutical clients running trials in Japan, and CRO CMIC will provide clinical trials services to both industry drug sponsors and clinical trials sites. They will also supply development, trial-scale production and marketing services through its network to neighboring countries like Korea, China, Taiwan, and Singapore.

Patients and clinical trials

2009-07-24T12:54:00.000-04:00

Parade Magazine recently wrote a piece explaining to everyday individuals what the value of participating in clinical trials is. Not only can it provide hope for those who have chronic illnesses, but it can benefit the lives of others around them. Even though while in the trial it may not be known if one is on the medication or placebo, it is still worth the chance if the current medicines available aren't working.

ACRO Reports that Clinical Research in Developing Worlds is Up to U.S. Standards

2009-07-23T11:23:00.000-04:00

Pharmaceutical Online reports that the Association of Clinical Research Organizations (ACRO) has released a report that says clinical trials conducted in the developing world meet the same safety, ethical and quality standards as those conducted in the developed world. Based on the report's findings, ACRO, which represents the leading global Clinical Research Organizations (CROs), is urging several steps to ensure that a robust global research infrastructure continues to facilitate accelerated drug development.

With the changing landscape for CROs, the report has several key findings:

Global trials speed drug development – The report concludes that globalized trials can reduce development time by half while lowering costs and maintaining quality and safety. For example, phase III cancer trials are conducted three times as fast if both U.S. and global sites are used, compared to U.S.-only sites. What takes 5.8 years to enroll takes 1.9 when a global trial is implemented.
Research quality standards must be met worldwide – The report found that trials in emerging countries, such as China and India, are subject to the same standards as those conducted in the U.S. and Western Europe. CROs train research staff around the world in good clinical practice (GCP) principles and proof of compliance is required by drug regulators in every major pharmaceutical market.
Clinical research improves local economies – Clinical research offers huge advantages for host countries, including an influx of advanced equipment, trained personnel and high-paying jobs. The presence of CROs also results in improvements in local health systems. Clinical trial sponsors in Poland, for example, fund 30 percent of hospital cancer therapy.
Emerging market equals growth market – CRO activity in Central European countries, South Korea and Taiwan is very robust, medical infrastructures are advanced and capabilities are just about on par with Western Europe.

For more information about this report and about ACRO, please visit the article referenced here.

Clinical Research Safety And Ethical Standards In Developing World Up To U.S. Levels

India’s CDSCO wants tighter rules for clinical trial imports

2009-07-22T09:11:00.000-04:00

PharmaTimes reports that India’s Central Drugs Standard Control Organisation (CDSCO) wants to tighten up conditions for the import of larger quantities of drugs for use in clinical trials.

Write Peter Mansell reports that, the CDSCO has issued a proposed guideline that calls for additional documentation and evidence when contract research organisations (CROs) or other companies/institutions apply to import “appreciably large” volumes of drugs.

The regulations do not specify what “small quantities” are, and recently there have been a number of cases of manufacturers, CROs and other importers “submitting applications for the import of reasonably large quantities of active pharmaceutical ingredients and/or drug formulations which do not comply with the provisions of Rule 33”, , the CDSCO notes.

According to the CDSCO, the rationale behind the guideline is to facilitate drug R&D/contract research and to “boost the scientific and technological activities in this knowledge-based industry”.

India’s CDSCO wants tighter rules for clinical trial imports

5th Annual Fundamentals of Clinical Outsourcing East

2009-07-21T16:55:00.000-04:00

This has been quite a year, since October we’ve watched global markets falter, a new president get elected and sweeping healthcare reform is being debated on the floors of congress. All this is impacting the pharmaceutical industry and companies are responding by aggressively reducing costs and how to get better results from all of their outsourced clinical research. We know you’re feeling the pressure rise as the volume of outsourced work continues to increase. In order to design a process that will save time in the long run it is important to have a firm grounding in the fundamentals.

For 2009 Fundamentals of Clinical Outsourcing has been updated with timely topics, in-depth roundtable discussions and increased networking opportunities to create a highly focused learning opportunity that will help you better manage your outsourcing partners and expedite clinical trials.

New for 2009!
• Keynote presentation from Ken Getz, Senior Research Fellow from the Tufts Center for the Study of Drug Development on tracking the transition from transaction to portfolio based relationships
• Genzyme and Milennium executives discuss relationship management and The Rules of Engagement
• FDA address from Michael Marcarelli the Director of the Office of Bioresearch Monitoring at CDRH tells participants what the FDA Expects regarding quality oversight of third parties

If you are ready to send a new compound into clinical development and you don’t have the in-house resources to execute the trial or if you are overwhelmed by the choices that need to be made every day to keep your products moving through development Fundamental of Clinical Outsourcing is your best opportunity to obtain best practices, set your outsourcing strategy and manage successful relationships with proven rules of engagement.

Download the agenda to see all the new updates to the 2009 event.

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Education on clinical trials to begin in Qatar

2009-07-21T10:31:00.000-04:00

According to the Gulf Times, Sidra Medical and Research Center of Qutar will start to educate the public on the importance of clinical trials. It will educate the public on the importance of volunteering for these trials both in terms of the purpose of the clinical research and the effects it will have on both future patients and generations.

Professor David Kerr, who has an international reputation for the treatment of and research into colorectal cancer, stated, “As we are building a research institute into a hospital, we are also building research partnerships with some of the leading institutions around the world, so that we can initiate research that can start even before the building is ready, so that we can begin to start benefiting our citizens in advance medicine.”

Clinical Trial Cost & Contract Management Agenda Finalized

2009-07-20T16:51:00.000-04:00

Greater scrutiny of financial ties to clinical investigators coupled with increased accountability and drug safety puts more pressure on contracting executives to clearly outline responsibilities from the start.

Attend Clinical Trial Cost & Contract Management and take back to the office the necessary tools to streamline processes and better define accountability and responsibilities.

* Gain the upper hand in your contract with a workshop dedicated to contract approach and development
* Avoid embarrassing and costly violations regarding financial ties to clinical investigators with a firm grasp on Fair Market Value (FMV)
* Bring your drug to market before your competitors by fine tuning you’re strategy for handling Intellectual Property (IP)
* Improve the quality of you’re 3rd party clinical research data with warning signals and outline methods direct from an FDA representative
* Improve ROI by defining best practices for handling site payment disputes with your CRO

Join the LinkedIn Group!

Follow us on Twitter!

Visit the Website

Swine Flu vaccines approaching time for clinical trials

2009-07-16T12:19:00.000-04:00

According to the Guardian, many labs have progressed with the Swine Flu vaccine to the stage of clinical trials. The WHO did point out that this doesn't necessarily mean that the final flu vaccine is ready for use by the general public.

GlaxoSmithKline recently stated:
"We have started production. We are talking to the different health authorities and the governments around the world to find out what level of clinical trials will be required, for instance, how long, [and] how many people would be involved."

Read the full article here.

PRA International opens office in Korea

2009-07-15T16:08:00.000-04:00

PRA International has opened up a new office in South Korea to manage clinical trials. It has been conducting trials in the area since 2005, but mostly through local partners.

Edward Ian, who is director of PRA’s Asia-Pacific efforts stated:
"Increasing customer expectations and project needs have prompted us to establish a legal entity and a local team of clinical professionals. We anticipate significant growth of our operations in South Korea in the next few years to conduct clinical studies across a wide array of therapeutic indications, including oncology, neurology, respiratory disorders, infectious diseases and cardiovascular, endocrinology and metabolic disorders.”

Source

Clinical Research Trials in India

2009-07-13T15:29:00.000-04:00

Here's an interesting presentation I came across from Dr. Shreyashi Ganguly in the Curious Insanity blog. The slide-show get some of his points across on the fastest growing industry segment of outsourcing clinical trials. Take a couple of moments to view it below. Enjoy!

United Arab Emirates is Set to Rise in Clinical Trials

2009-07-10T11:34:00.000-04:00

According to this post in outsourcing-pharma.com the United Arab Emirates is set to grow in the CRO industry due to the attractive of cost effectiveness there. Kermani, author of A quick guide to healthcare and biotechnology in the Middle East, predicts that with big pharma companies like Pfizer, Amgen and AstraZeneca establishing offices in UAE, many more CROs will follow.

What are some other companies that you have caught wind up that are trying to locate to UAE?

Insourcing Is The New Outsourcing In Biopharma

2009-07-09T11:35:00.000-04:00

Stephanie Wells of Life Science Leader writes, The growth of insourcing means that the future of contracted work is likely to be a blended approach. In some cases, the CRO would provide traditional external services, like general toxicology studies or Phase II clinical studies. In other cases, when a client is working in a new area and has not yet developed the necessary infrastructure, partnership with a broadly capable CRO means that many necessary services in the new field can be performed on an insourcing basis, including the help of an insourced “navigator” group of ex-FDA personnel who can guide the new compound through studies that ensure it has the best chance of proceeding efficiently through the regulatory process.

What do you think of insourcing? It is the new standard?

Insourcing Is The New Outsourcing In Biopharma

New online tool to help with compliance

2009-07-08T10:12:00.000-04:00

Thompson Publishing has released a new online tool that will allow clinical trail conductors to keep up to date with key compliance issues and continue with their operations. CT Comply is a powerful database that provides up-to-the-minute news, analysis and research tools in one place online.

J.W. Schomisch, senior managing editor at Thompson, and editor of the widely acclaimed Guide to Good Clinical Practice, states:

"CT professionals have been asking for this for years. Now, with just a few quick clicks of a mouse, CT managers can find up-to-date advice to stay in full compliance plus powerful advice to help save time and money and smoothly speed their trials."

"The huge benefit of the online format is that we're able to keep the information continuously up-to-date. That way, clinical trial professionals will always have the latest news, analysis and practical guidance at their fingertips. We've made it all very intuitive and easy to use with several ways to find what you're looking for. "

Software offers holistic insight into clinical trials.

2009-07-06T11:50:00.000-04:00

Thomasnet.com reports that TrackWise Clinical Quality Management Solution provides end-to-end system that streamlines oversight of business-critical clinical trial processes while helping to ensure compliance with global regulatory standards. Driving organizational efficiencies from pre-clinical activities through manufacturing and post-market operations, solution delivers closed-loop process support to allow issues to be reconciled and corrected before they escalate.

Sparta Systems Unveils TrackWise® Clinical Quality Management Solution

How to find the best cost-effective treatments

2009-07-02T10:43:00.000-04:00

According to Red Orbit, Congress has allotted $1.1 billion to begin finding the best treatments for certain ailments that are also cost-effective. A report came out addressing the top 100 medical issues addressed by Congress. The report said this of clinical trials:

“Clinical research provides health care providers with information on the natural history of disease, clinical presentations of disease, and diagnostic and treatment options,” according to the report.

“All too often, the information necessary to inform these medical decisions is incomplete or unavailable, resulting in more than half of the treatments delivered today without clear evidence of effectiveness.

“This uncertainty contributes to great variability in managing clinical problems, with costs and outcomes differing markedly across the country.”

Chinese CROs trial express customs clearance

2009-07-01T15:38:00.000-04:00

PharmaTimes reports that, three contract research organizations (CROs) operating out of China’s Zhangjiang Hi-Tech Park are trying out a new express customs clearance model that could eventually be extended to other CROs in the Park. Its been well-known that customs clearance for CROs has been a difficult process for many CROs, with the new customs clearance model high import/export volume and strict storage requirements could be alleviated.

What other processes can help CROs allevaite tight customs clearance requirements?

Chinese CROs trial express customs clearance

Innovation needed for biotechs

2009-06-29T13:17:00.000-04:00

An article in the San Francisco Chronicle believes that Biotech is in need of innovation, and points to diagnostics testing and biofuel production as the next possible chance, as it takes many many years to develop blockbuster drugs. Innovation was possible before because of the fact that investors were willing to risk time and money to come up with the next blockbuster drug. Innovation is critical in these few fields. What do you think? Where will innovation and production in teh biotech industry go next?

Clinical trial shows hope for no more insulin injections

2009-06-24T16:40:00.000-04:00

According to The Medical News, an Australian clinical trial will commence for the treatment of type I diabetes that will not require daily insulin injections. The trial will now move on to Auckland, New Zealand in Middlemore Hospital.

Prof. Bob Elliott, Founder of LCT and diabetes specialist, said: "We have great hopes for these trials. We already have two patients in the Russian trials that are now off insulin and we are planning to use much higher doses of our product Diabecell in these trials."

Find out more here.

New software for clinical trials

2009-06-18T16:58:00.000-04:00

TranSenda has a new software that will help the efficiency of all clinical trails. It'll improve the ability to manage the clinical study.

Cortex will enable organizations to leverage the power of access to centralized operational data from all applications used across all clinical studies.

Read more about the software here.

Finding patients in Phase I clinical trials

2009-06-16T10:07:00.000-04:00

At FiercePharma, they look at how to effectively recruit patients in a CRO's local area for Phase I clinical trials. They suggest joining your local community to spread awareness and developing new media outlets to spread the word but not over saturate the market. For more, read the article here.

Sigma-Alpha Moves Differently from Classic CROs Offerings

2009-06-15T11:37:00.000-04:00

Last week, Tony Fong of Genomeweb reported that, Sigma-Aldrich, hoping to grab a bigger slice of the biopharma industry's expanding appetite for outsourcing, (last) week expanded its services business to include mass spectrometry-based protein characterization, protein expression, and protein purification.

The idea is not for Sigma-Aldrich to collaborate with biopharmas on large-scale projects and manage them; "that's what a classic CRO does, and this is definitely not a classic CRO offering." Rather, what the company is offering is the chance for customers to choose individual services from a menu without fear of jeopardizing their intellectual property, she said.

In fact, the executive of one CRO said that because of the limited offering of services by Sigma-Aldrich, the two are not competing for the same business.

Sigma-Aldrich Debuts New Protein Services to Meet Biopharma's Growing Outsourcing Trend

Meetings Drive Business

2009-06-12T09:57:00.000-04:00

This is why companies need to continue to invest in business meetings. Not only will those who attend gain new and fresh perspectives from other attendees, but they'll hear from top companies who have lived by the same philosophy. Investment in yourself and innovation are the key to your business. What have you done recently to invest in your business?

Did you get a chance to attend Partnerships with CROs this year? What would you expect to gain from the experience?

Meetings Drive Business

Merck to cut jobs

2009-06-12T09:41:00.000-04:00

According to the New York Times, the Merck merger with Schering-Plough will eliminate 16,000 jobs from the company. After the merger, the group will be the second largest Pharma company. Pfizer will remain the largest. Read the full story here.

How do you pay the participants in your clinical trials?

2009-06-11T12:01:00.000-04:00

In an article at ClinPage recently, they look at how Greenphire is speeding up the process of paying those involved in the clinical trial process. They believe that by making payments available through prepaid cards which are also electronic payments, a lot of confusion can be saved as well as those trial participants involved who are underbanked have a way to receive payments. Read the full article here.

Women in cancer clinical trials

2009-06-08T15:48:00.000-04:00

According to a news article at the Atlanta Journal Constitution, clinical trials dealing with cancer research aren't including enough women. Doctors may not be able to identify all of the gender differences that occur between women and men, as only 37% of trial participants are women. Read the full article here.

CROs 2009 Workshop Video

2009-06-05T11:49:00.000-04:00

For those who missed the workshop last month in Orlando, we are providing unlimited access to this timely workshop to all Partnerships attendees and their colleagues. And since we understand your training and travel budgets are limited at this time, this video workshop is completely free of charge.

Simply click the link below to watch the video at your leisure, and feel free to pass along to your CRO colleagues.

www.iirusa.com/cropartners/BDWorkshop.xml

If you are in business/corporate development, sales, marketing, client relations, account management, operations or project management at a CRO or other outsourcing provider, this video workshop will help you achieve your professional development goals including:

• Demonstrate value to Sponsors who are increasingly pushed to make decisions based solely on cost
• Understand how downsizing in pharma will make micro-managing a thing of the past as CROs take over as the ‘doer’
• Access the right people (decision makers) in an organization to approach for new business opportunities -- and getting them to return your call
• And much more....

Outsourcing challenges

2009-06-03T11:14:00.000-04:00

In a recent article at the National Post of Ontario, Canada, they look at the some of the risks that are associated with outsourcing clinical trials to other countries. A few of the roadbumps could be: different culture with different standards, the application quality between the two different populations, and the treatment of patients. There have been a surge of clinical trials being conducted in different countries, India, China and Argentina. Read the full article here.

How has your company overcome these challenges? What advice do you have to other companies outsourcing their clinical trials?

Novotech in Joint Venture with Indian CRO, Focuses on Asian Expansion

2009-06-01T10:59:00.000-04:00

We invite you to download this complimentary report, "Novotech in Joint Venture with Indian CRO, Focuses on Asian Expansion."

Please feel free to add any comments to this post or continue the discussion on Twitter.

http://www.iirusa.com/upload/wysiwyg/New%20Media/cww1320_May18.pdf?utm_source=CROs%2BWebpage&utm_medium=Link&utm_term=CROs&utm_content=Novotech%2Bin%20Joint%20Venture%20with%20Indian%20CRO%2C%20Focuses%20on%20Asian%20Expansion&utm_campaign=P1400

As Sponsors increasingly look to CROs to provide expertise, what level of experience do CRO project managers need going forward?

2009-05-28T10:10:00.000-04:00

Partnerships with CROs is providing unlimited, complimentary access to the video of our highly rated premier workshop for CRO Business Development professionals, CRO Strategies for Adapting to the Changing Tides in Pharma.

This in-depth workshop provides CRO BD Execs with the strategies necessary to approach, interact and work effectively with your current and prospective biopharma clients. And it's all FREE! Tell a friend:

http://www.iirusa.com/cropartners/BDWorkshop.xml

Shifting Clinical Trial Environment

2009-05-27T15:09:00.000-04:00

Earlier today, I came across this great interactive treemap in this post in outsourcing-pharma.com that presents a unique visual analysis of the globalization of clinical trials and rise in CROs in the past 20 years. Take a couple of minutes to view this informative map.

View the interactive map

Centralized patient recruitment

2009-05-26T10:30:00.000-04:00

In a recent article at Pharma Live, they take a look at the challenge when it comes to recruiting patients and keeping clinical trials running on time. This article focuses on the three different case studies looking at the size of the study, the number of patients sourced from a central campaign, the timing of the recruitment activity, and importantly, the effect of the patient recruitment on the time needed to complete enrollment.

Read the case studies here.

Making the Business Case for Improving your Comparator Studies

2009-05-20T09:00:00.000-04:00

The globalization of clinical trials has arrived. As you know, the increasing use of comparator studies means that you’re playing by a new set of rules. At this critical junction, you can either evolve in 2009 to stay ahead of the curve or choose to play catch-up and try to deal with the challenges as they arise.

We hope you join us this July at the Global Congress on Comparator Studies in Philadelphia. Meet with visionaries from Merck, Wyeth, Schering Plough Corporation, Bernstein CMCRegulatory Consulting, GlaxoSmithKline and Allergan, among many other participating companies.

www.comparatorstudies.com.

Now available for download! Click here to view.
• Evolution of a Sourcing Strategy for a Midsize Specialty Pharmaco
Fredrick L. Naids, Ph.D., Senior Strategic Sourcing Director, Clinical R&D
• Supplier Identificationand SelectionCatie Cleary, Biogen Idec

Register by May 22 to save $400 off registration!

Recession, stimulus bill open new doors for CROs

2009-05-19T10:07:00.000-04:00

Connie Johnson Hambley, principal, Steele Executive Search recently wrote an article on Massachusetts High Tech in which she discusses how CROs can benefit from the current economy and President Obama's economic stimulus plan. Here are a few excerpts from her article that we find are particularly relevant for our readership.

Legislators, practitioners and scientists are asking how to contain the soaring costs of health care while providing the best care. The $787 billion economic stimulus package provides for two prongs of inquiry — nearly $10 billion for academic research into new drugs, devices and surgeries for cancer and other illnesses and $1.1 billion to compare existing therapies to assess their effectiveness to treat specific conditions. These areas are subject to reporting and transparency standards as well as an increased focus on using funds efficiently.

CROs can be used strategically as well. They can perform additional directed research on a promising secondary direction while the sponsor company remains focused on its primary objective. Venture capital firms are using them to validate data before investing initial or secondary rounds.

Big pharmaceutical and device firms and biotechs are having layoffs and CROs are holding steady or growing, positioning themselves for winning in this down economy.

Based on your work, do you see CROs thriving in this environment? What do you think about Hambley's thoughts on using CROs strategically? We'd like to hear your thoughts.

For the complete article, please click here.

Top Five States for Biotech Innovation

2009-05-15T09:47:00.000-04:00

Fierce Biotech recently released their annual study that shares the top five best places in the US and Canada that provide the best resources for innovative biotechs.

They are: Minnesota, Massachusetts, New York, Ontario, and Colorado.

Read why each state was chosen here.

ASKA Partners with International CROs

2009-05-14T11:03:00.000-04:00

According to Clinical Trials Today, Canadian contract research organization (CRO) ASKA Research entered into strategic partnerships with two CROs that will expand ASKA’s service offerings in North America and in Australia.

The first partnership, with Queensland, Australia-based Clinical Network Services (CNS), was made possible by the Economic Research Agreement between British Columbia and Queensland, which went into effect last June. The agreement is designed to build international relations in key sectors, such as biotechnology and life sciences.

According to ASKA, the partnership with CNS is the first business-to-business partnership resulting from the intergovernmental alliance.
ASKA also entered into a partnership with Winnipeg, Canada-based Clinical Development Solutions (CDS), which focuses on cardiovascular and metabolic disease areas. ASKA and CDS will provide services to one another and their clients to reduce the time to market and production costs.

With ASKA's partnerships going global, will we see a ripple effect from other CROs?

Encorium looking for a buyer

2009-05-12T12:21:00.000-04:00

The CRO Encorium is looking to sell its assets from Encorium Group which is fully owned by Encorium Oy of Europe. In 2008, the revenue dropped significantly, along with the abrupt departure of two CEOs of the company.

Encorium CEO David Ginsberg stated in company statement:
"Over the last several months we have been actively pursuing opportunities to enhance and maximize stockholder value. Encorium's management and board have determined a sale of our assets was the best strategy to pursue. Both purchasers are well-respected organizations with strong management teams and therapeutic and regulatory expertise and we believe that transferring our assets in these two transactions is in the best interest not only for our stockholders, but for our customers and employees as well. These transactions will enable our project teams to remain wholly intact so as to continue to provide excellent service to our customers."

Source: Clinical Trials Today

Phase III Clinical Trials

2009-05-11T12:58:00.000-04:00

Psych Central recently wrote a post about why Phase III trials may often be misleading. At this stage, the clinical trial has to prove that the drug is both safe and effective. However, the article points out that oftentimes, Phase III trials are conducted on patients that may not be the consumers of the product in normal circumstances. Read the full article here. What do you think? If clinical trials are conducted on those who are not the preferred profile for the drug, will the results still be completely reliable?

Bio-Imiging Technologies and Phoenix Data Systems combining

2009-05-04T12:55:00.000-04:00

In a recent article at ClinPage, they disclose that Bio-Imaging Technologies and Phoenix Data Systems will be merging to form BioClinic. This will be a new solution to track and manage clinical data.

Mark Weinstein, president and CEO of Bioclinica had this to say about the combined divisions. “The speed and accuracy of this combination helps to mend the current broken clinical trial process. We look forward to extending our imaging core lab leadership with comprehensive EDC services, and helping life science companies to manage their clinical trials with greater efficiency, quality and improved data visibility.”

Read the full story here.

A Look at the 18th Annual Partnerships with CROs

2009-05-01T10:25:00.000-04:00

This year's Partnerships with CROs has once again provided the ideal experience and has set the standard in outsourcing and clinical development conferences. This year the conference explored best practices on forming, managing, and sustaining clinical outsourcing partnerships. There were insightful presentations, frank and honest discussion, and invaluable networking opportunities. This year's event has set a very high bar for subsequent conferences, but I'm sure the conference team led by Lesly Atlas will continue to create a successful event.

We hope you found our coverage of the conference invaluable. Here's an opportunity to look back at all of the great presentations and speakers who were on hand:

Day 2:

Welcome to The Second and Final Day of the Conference

Leveraging Relationship Structures to Optimize Sponsor-CRO Collaborations

Inspirational Patient Perspective with NFL Legend Terry Bradshaw

How to Make Change Part of Your Competitive Advantage

CASE STUDY How Do Mergers, Acquisitions and Licensing Impact Outsourcing Decisions and the Role of the CRO?

Outsourcing Clinical Trials in Emerging Regions: INDIA and CHINA

Day 1 Keynotes and Track Sessions:

Leading Through Change: Innovation and the Future of the Bio Pharmaceutical Industry

Understanding the Concepts of Disruptive Innovation, Its Impact and What Pharma Can Do to Get Ahead of It

Virtual Pharma: Addressing Challenges and Opportunities in Biomedical R&D

MMAX: Development, Evolution, Growth and Maturation of a Large, Integrated Drug Development Solution

Clinical Trials: What Does Global Mean to You?

Wall Street’s 2009 Forecast and Analysis of Outsourcing Trends

Approaches to Address the Impact of Increasingly Complex Clinical Trials

Creating a Competitive Advantage through Sourcing

Pre-Conference Workshops:

Live from the 18th Annual Partnerships with CROs

Driving Global Growth: Strategic Considerations for Conducting Global Trials in Nontraditional Markets

CASE STUDY: How Do Mergers, Acquisitions and Licensing Impact Outsourcing Decisions and the Role of the CRO?

2009-05-01T10:06:00.000-04:00

Speakers:
Glenn Kerkhof, CEO, CHILTERN
Mac McElroy, M.Ed., Executive Director, Strategic Development, Americas, CHILTERN
Colleen Anderson, Clinical Program Director, SHIRE PHARMACEUTICALS

This session took a look at the mergers and acquisitions between a number of CROs. In 2005, Shire merged with New River Pharma. NRP104, the compound that the company was focusing on, was a good fit. Shire could easily market this compound. Shire announced the purchase a few days prior to approval of the compound being received. This was announced in Feb 2007 with targeted closure of April 2007. A communication plan was already in place for June of 2007, and Shire was able to deliver this without it affecting the outcome of the merger.

To successfully complete the merger, the companies set up a plan of action. The focus was that anyone who was not in management needed to be involved in the acquisition in the company. The management was hoping they’d be able to set up plan for everything, and leave those working on the compound available to do their job.

Then, they had to learn to work with yet another merger/acquisition with CTMS. They were running the study. They had no previous work together. Immediate discussions was a key to success, communication was constant during initial start-up work. They worked together to address concerns. The approval was issued; the product became a controlled substance. They needed to relabel all supplies, quickly found way to achieve that, and add staff, and all drugs were properly labeled by the time it was considered a controlled substance.

How did CTMS focus on the human element to all these acquisitions?
What if this happened to you scenario? It was a focused effort, and gift to receive immediate transparency and communication. Teams were committed to target, and wanted to accomplish the same goal. They needed to talk every day. They did hit the target.

Then Shire explained their position in the procedure. At the end of the day, the acquired company still had to deliver. The team members didn’t understand the acquisitions because that wasn’t their job. They needed to focus on their job. The key to transition was planning. And because of that, there wasn’t much disruption. They allowed that team to make the decisions they needed to make without experiencing the external pressures. Project was completed on time and on budget. They didn’t change the staff. To deliver successfully, you need to have a cohesive team, and that’s why the team did well. They inherited an in-license compound.

Mergers and acquisitions will continue. Change is constant, and we need to be ready and prepared for it. They faced challenges, and overcame them.

What’s the leadership thinking about? A decent amount of change and they figure out how to make sure the team keeps working. This is important for communication flow, a leader should be with the team and openly communicate with the management.

Who gets involved? More than just team: legal, development and regulations. It’s important to put up walls to keep focus. It goes back to preparations. You need to have both internal and external resources to successfully ride out acquisitions and mergers. Shire outsourced, and to go out and get additional help did not cause problems.

Chiltern took a look at another element: a CRO and a CRO merging. In context of things that go in, they kept their eye on project while a company was merging. The key was to ensure continuity and to be clear with employees in terms of management structure and processes. This is very similar to project deliverables and demands. This merger appeared to be a very seamless operation. Mergers and acquisitions will continue between CROs and Pharma/Biotech compounds.

Leveraging Relationship Structures to Optimize Sponsor-CRO Collaborations

2009-05-01T10:05:00.000-04:00

Moderator:

Kenneth Getz, MBA, Senior Research Fellow, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT; Founder & Chairman, CISCRP
Panelists:

John W. Hubbard, Ph.D. FCP, Global President, ICON CLINICAL RESEARCH

Jeffrey Kasher, PhD, Vice President and Chief Operating Officer, Global Clinical Development, ELI LILLY & COMPANY

Charles Morris, MD, Vice President, Worldwide Clinical Research, CEPHALON

Daniel M. Perlman, CEO and Chairman, RPS INCDr. R. Adrian Otte, MB, BCH, Vice President, Global Development Operations, AMGEN

Getz looks at the themes that have been constant at the events. This year’s themes have been the impact of the global economic crisis and it’s effect on the biotech sector, and the shifting characteristics of the sponsor/provider relationship. What is your operating environment? There are declining rates of MDA approval, success rates are consistently low, there are strong capacity constraints, as well as items in the environment that suggest growth. There a record number of clinical trials going on, and the number of projects worldwide has skyrocketed. How do we navigate through these characteristics?

There are more drugs in predevelopment, but they rarely make it farther. Why? Investment can’t justify support or there is an increasing number of compounds are terminated before they reach drug development.

The economy is also affecting the Pharma industry. Capacity is constrained in the Pharma industry, development has been flat within the Phase II/III arena. In past 18 months, layoffs and consolidation, 5,000 to 7,000 drug development professionals have lost their jobs. The available capital is dwindling as well.

The specialty, midsized and large major Pharma acknowledge that they need to consolidate the number of service providers. Only about 25% of relationships are defined as functional service relationships. There is a lot of interest in increasing the level of alliances over time. The primary advantages for a transactional relationship rely of flexibility and the availability to secure lower cost bids. There is a sense that the functional service relationship is a bridge that will lead to an alliance arrangement. The majority of sponsors believe they will always take a mixed a approach, depending on the portfolio. Large sponsors want to integrate risk sharing, the incentives for the CRO will be difficult to align with that of the sponsor. Higher level of relationship if there is a higher level of risk sharing.

Standardization is the main thing that will improve quality. It will also reduce costs. It’s required a change of mindset in the CRO, but in addition to the companies. At Eli Lilly, they have to understand and define processes. They have to be very clear about what they’re looking for. The company has moved to the partner model. Senior management engagement is very high with the CROs. There are fewer providers, and they’re looking to retain and maintain their core capabilities. At Icon Clinical, the issues are around the clarity of the documentation. There was a lot of dissatisfaction in the full service outsourcing model. They’ve formed a better relationship around getting the standards in place and setting the expectations in addition to the senior level involvement. This must be built into the planning. Once the foundation is set, there is stabilization. There are four strategic alliances at Icon, and the level of satisfaction of the employees is higher than in the transactional model.

At Eli Lilly, they believe that people must understand that there are bumps in the road for anything. The quality bar in Pharma keeps escalating, and that's an important. Partner has to have a robust quality system, and that they have a check and balance system. Data standardization is a constant challenge. Fluid movement of data is also challenging. The partner doing Phase III work, how do you get the knowledge back into the organization? Challenges for CROs: turnover of personnel and reliable deliver that's quality, on time and on budget.

Updated:
Here is an interview from John W. Hubbard, Ph.D. FCP, Global President, ICON CLINICAL RESEARCH who participated in the panel discussion

Here's a clip from the opening remarks by Moderator Kenneth Getz

Outsourcing Clinical Trials in Emerging Regions: INDIA and CHINA

2009-05-01T10:02:00.000-04:00

Priya Pawar, Vice-President, Business Development, SIRO CLINPHARM, USA
Dr Ross Horsburgh, VP Asia Pacific, KENDLE INTERNATIONAL

Why is India so attractive for clinical trials? There is a very large population. In addition, you can see diseases that affect both the developing world and the developed world. India has a robust infrastructure in respect to facilities and professionals. The number of physicians that have been educated in the western world then returned to India has translated into more trails being conducted in India.

In order to begin a clinical trial in India, you need to submit a dossier to the Indian government. It would take about 6-12 weeks. A faster review would happen if you’ve been approved in other countries such as the US.

Looking towards the future in clinical trials, India has to build upon traditional strengths which are infrastructure, tools, and quality. Other initiators to ensure suitable partnerships are awareness, collaboration and regulatory areas. A company should obtain an experienced partner who has already been there.

Ross J. Horsburgh talked about the opportunities in Asian countries other than India. Taiwan has the highest number of clinical trials in Asia, followed by Japan, South Korea, China and India. Vietnam is becoming an interesting place to do studies. Why Asia? If the company performing the trial doesn’t have a vested interest in the clinical trial, the quality and results will reflect that. Areas need to care about the clinical trials they are performing. Drivers for going to Asia are the science and markets involved. They have different relative markets. Phase I trials are typically conducted close to the area of the sponsor. In Phase III, the big expensive studies need access to the number of patients. We’re now seeing an increase in the science drivers. There is growth for Pharma is in Asia.

How to Make Change Part of Your Competitive Advantage

2009-05-01T09:40:00.000-04:00

Karl Schoemer, Presedent and Founder, Vision Quest

Schoemer is here to challenge us and make us think. IT’s ok to disagree, and think about Schoemer’s suggestions from another point of view. We manage change every day, and we need to get through it. The dust won’t settle. But figure out how to manage it while the dust is settling.

All the changes you’re experiencing, structures, processes, roles, etc, are coming from the outside like patients, organizations, the FDA. No manager is forcing us to change too much, the world around us is forcing us to change. Reason for change in an organization: rapid expansions, new markets, relocations, and new management teams.

Guarantees about change:

- It’s here to stay.

- It won’t be trouble free

- Your are accountable

Our expectations have got to meet reality when it comes to change.
Technology, information, and people drive change.

Individual dynamic of change:

-Sense of loss

-Ambiguity and uncertainty

-Determination of trust

-Self preservation

Updated

Here's a short clip from Karl Schoemer's keynote presentation

Inspirational Patient Perspective with NFL Legend Terry Bradshaw

2009-04-30T10:45:00.000-04:00

Inspirational Patient Perspective with NFL Legend Terry Bradshaw
Terry Bradshaw, Co-Host and Analyst, FOX NFL SUNDAY

We are all human beings and we share the same values in life. We all want to be happy. As a survivor of depression, he likes to understand the drugs that are in his system. Terry did two things this morning : he woke up and loved that he was alive, and the second thing he does is smiles. Smile is a reflection of the inner spirit and character. In any business, you’re always in contact with strangers. We’ve got to sell things other folks, so you‘ve got to sell yourself first. Laughing and smiling is one way to do this.

Those people you are selling things do don’t care what’s going on. You’ve got to put a smile on up front. You need take charge and put on a good face. You need to let everyone know that everything is fine, and you can do that by simply smiling.

We’re in too big of a hurry, if we need to get something out of life we need to be patient. We need to surround ourselves with good people. Nothing happens that is good, and you’ll need to turn around and say thank you to someone else. Terry felt different growing up. He lived with a football in his hand, and continuously failed. Never made and organized football team, but he had a love for the pigskin. He dreamed of having a football, Santa brought him one and then learn how to throw it. He knew his calling early in line. He had a purpose in life to work hard.
What we’re doing in the Pharma industry is amazing, because we’re giving other people lives.

Terry is raising pigs and taking the meat and feeding the poor. He’s helping people who are hungry. He’s breeding one and raising 300 hogs a year, and all of the meat is being given to the poor. That’s one of the joys in his life. The commitment of the pharma industry to change people’s live is a joy. It will never be taken away. It takes a passion and commitment to do these things.

If you work hard and ever say never and believe in the people around you there's no magic to anything, life is fun as long as we put forth the effort, life is a kick. Business is fun. You have to keep things simple in life. One of the most wonderful thinks about life is the love of a parent. There isn’t anything better than the love of your mother. Don’t ever stay sad, or believe that you don’t deserve. If you make a different, it won’t be that bad next week. Take charge when you wake up in the morning, thank your higher power, smile and let everyone else know they’re important. Watch them change. Do something for someone, and let them know you care about them.

Welcome to The Second and Final Day of the Conference

2009-04-30T06:56:00.000-04:00

We do hope you've been following along to our coverage from the conference. Yesterday we sat through many sessions and presentations. If you haven't had the opportunity to review our coverage, take the time to read through our highlights as well as video taken from the conference:

Leading Through Change: Innovation and the Future of the Biopharmaceutical Industry

MMAX: Development, Evolution, Growth and Maturation of a Large, Integrated Drug Development System

Virtual Pharma: Addressing Challenges and Opportunites in Biomedical R&D

Understanding the Concepts of Disruptive Innovation, Its Impact and what Pharma Can Do To Get Ahead of It

Wall Street’s 2009 Forecast and Analysis of Outsourcing Trends

Approaches to Address the Impact of Increasingly Complex Clinical Trials

Clinical Trials: What Does Global Mean to You?

Creating a Competitive Advantage through Sourcing

We also had an opportunity to conduct some excellent interviews with other conference participants:

18th Annual Parnterships with CROs sat down with Deirdre BeVard, Vice President, Clinical Operations and Data Management, ENDO PHARMACEUTICALS who participated in the conference as a speaker as well as a member of the conference's Advisory Board.

18th Annual Partnerships with CROs presents Steven Whittaker Director of Project Management and Operations, CV/Acute Care, ELI LILLY & COMPANY chairperson of conference track Strategic Sourcing: Alternative Development Models

We plan to continue our coverage throughout the day as we enter the second and final day of the conference. Be sure to subscribe to our feed to receive our regular posts.

Virtual Pharma: Addressing Challenges and Opportunities in Biomedical R&D

2009-04-30T06:40:00.000-04:00

Peter B. Corr, PhD, Co-Founder and General Partner, CELTIC THERAPEUTICS MANAGEMENT COMPANY LLLP;Formerly Senior Vice President, Science and Technology, PFIZER

Dr. Corr believes that the current crisis was very predictable. The electronic industry has suffered the same fate. We live in a world that is constantly changing, and how will we adapt to that going forward? Some of the problems are that the pipeline deficiencies exist in Pharma. The critical short term capital is not accessible to the biotechs. There are 23 new compounds a year, and each compound is approximately $2-$3 billion dollars. The average drug will bring in $750 million dollars a year. Expiring patents will result in $2 billion in loss. What’s the problem? There are over 2300 compounds in clinical development around the world. Of the compounds, 67% are in small biotech companies. They have 2% of the R&D spending, 8% of the cash and 3% of the market.

There is little to no IPO market in the United States. Why did they begin the new venture? Therapeutics is getting the compound, preclinical development is making it a medicine, exploratory development focuses on making the drug work and discovering the dose. Venture capitalists are good at getting something within early Phase II data. Large pharma tech companies try to do it all, but they can’t. They’ll have to work with partners to obtain the products they need to grow. Alliances with small biotech companies, a capital market breakdown, and they need products which will be best sought out with partnerships.

The investment strategy is to acquire ownership of potential products. They take the product through to Phase III, ready. And then distribute proceeds from sales to investors, they focus on developing their portfolio. Precompetitive alliances are essential in the success of these approaches. Information needs to be presented to the FDA about what the best way is to test a drug, and better test drugs. Everyone has a background level of information. A single format is then available to everyone. Companies will survive that effectively utilize the information. The goal was to bring all parties together. Precompetitive initiatives can save a lot of money for industry by working together. It doesn’t have to destroy the competitive nature.

Virtual Pharma is working together with a variety of CROs and other vendors in terms of bringing products to reality. The development organizations at Celtic is separate from management. Management does deals and gets the compounds. Development operations implement the overall strategy for particular product: Legal, Outsourcing, Finance, IT, HR and OA. The CRO and Development Partners work together with the Virtual Pharma company.

Advantages of virtual pharma model according to Celtic:

-Adapts more easily to strategic decisions

-Best in class

-Potential for faster development cycles

Updated:
Here is a short clip from this keynote presentation

Understanding the Concepts of Disruptive Innovation, Its Impact and What Pharma Can Do to Get Ahead of It

2009-04-30T06:37:00.000-04:00

Clayton M. Christensen, Robert and Jane Cizik Professor of Business Administration, HARVARD BUSINESS SCHOOL

Puzzles related to innovation: Most companies were at some point regarded as successful, but ten years later, they were in the middle of the pack. Why is success so hard to sustain? Why is innovation so risky? Everybody has been trying to figure out why healthcare is becoming more expensive and becoming less successful?

Models from Dr. Christensen’s research:Performance of a service or product over time: in every market there is a trajectory of improvement that customers can use. Pace of technology is growing faster than the performance that computers can utilize or absorb. Breakthrough improvements have the same basic purpose, what they’re trying to do is trying to sustain trajectory of improvement. Companies that lead their industries find themselves on top of the industry when the battles are over, no matter how technology difficult it is. They went to make better products for better products for their best customers. Disruptive innovation can show itself in a more affordable, not as quality of product. Usually an entering company comes in and kills the leaders. Who will win the battle of selling better products?

Define your battles. The odds of success when you’re starting at the bottom of the trajectory are high. By using disruption, the entrant is more likely win. Another example of this car industry. In the 1960s, Japanese Cars entered the market. Entered with small products, and the American car industry sent little cars, but saw more profit from their larger cars, so there was no reason to focus on a place where their revenue wasn’t large. Currently, the bottom of the market is Kia. Toyota isn’t defending the small cars, because they’re investing in their larger cars. This concept lies behind why Walmart and Target killed the department store. Everyone is being toppled for expensive profit, but another one bringing in an affordable but profitable for the consumers.

Players in industries are going to prioritize innovations by what is more profitable. For airlines, it’s the length of the route, and smaller independent airlines are thriving on the small routes. Same thing in the Pharma industry. Blockbusters are much more profitable than small market drugs. Emerging markets aren’t improving more revenue at the pace desired. As Pharma companies have gotten bigger, blockbusters have become a higher priority, and they’re unable to support priority on smaller market drugs. Molecules appear at unprecedented rates, but since they’re not blockbusters, they don’t have the resources to push them across the goal line. A lot of capitol is being lost because drugs aren’t going to make the blockbuster money. Each disruption brings a larger group of people a simpler and more affordable version of a product. As hospitals compete against hospitals, they drive the costs up. Sustaining innovation increases costs, it’s disruptive innovations that bring affordability and accessibility to the marketplace.

To translate this to the Pharma industry, we must drive the use of technology to patient clinics. We can begin by doing the simplest things, then bring technology to them to do more sophisticated things. They give technology to doctors offices and homes so they can progressively do the most simple things, so they don’t have to do the things that historically became a doctor. We must enable lower cost venues of care to provide the simpler procedures to introduce affordability back into the market.

Updated:
Here is a short clip from this keynote presentation

Creating a Competitive Advantage through Sourcing

2009-04-30T06:35:00.000-04:00

Speaker:Vasco Grilo, VP, Global Pharma R&D Sourcing, JOHNSON & JOHNSON

Very little reference that needs to be done internally in order to create these models in order to enhance the roles of suppliers. There are tremendous opportunities of developing strong relationships with suppliers. This is key for internal reliance with business partners. Once you have the support of the internal stake holders, you have to look at your supplier base. The tools to segment the supply base are important. J&J uses several – growth focused, risk management, Segment relationship value, which is how suppliers understand them. Are we really a customer of interest for the supplier and can they ever establish a real relationship with the supplier while also looking at the commodity market, certain commodities are strategic, some are critical. What does a strategic relationship look like? Key characteristics: assurance of supply (joint balance of power), quality (quality improvement council), service (supply chain optimization), cost/value (supply chain optimization) and innovation (first choice of new supplier in new product development). You can only do this with a certain number of suppliers.

It’s about compliance. Once you go through the relationships and capture the benefits from the suppliers. This is a key area of work for Johnson and Johnson. What are the opportunities? Identify Assumptions that must bear true, pressure test assumptions, and invest and implement.

How do you value innovation form a supplier? In terms of the ability of a particular supplier, a supplier might come forward with a new model for supply chain logistics. That might not necessarily be seen on an R&D budget. Where is it touching? Sometimes on the top line. Can you get this faster in the market? Segmentation: businesses cases or historical innovation: which stage of the process?

Updated:

Here is a short clip from this presentation

Approaches to Address the Impact of Increasingly Complex Clinical Trials

2009-04-30T05:46:00.000-04:00

Pam Atwell, Director, Operational Strategy & Planning, Clinical Development Services, COVANCE INC .
William D. O’Riordan, MD, Medical Director, eSTUDYSITE

Ensure patients safety is the most important part of the trial. The current state of affairs in clinical trials is that an overwhelming 92% behind enrollment timelines. Trial delays have impact on the registrations of the products. What have we seen over the past few years? We’re looking for patients in nontraditional countries, we’re chasing patients where they haven’t been tapped into in the past. Even though they exist, we’re waiting for investigators to catch up to the demand to give us access to the patients. With out and investigator site, we can’t get patients enrolled in our clinical trials. In India, 2% of the global investigator pool in 2007. China didn’t approach 1% of the pool. Investigators are small percentage at the moment, top 20 growth rates are all in emerging markets: China, Estonia, Russia, Peru. We have not only more complex studies, but we also have more of them, with few investigators for find patients.

What does this mean for the emerging markets? Investigator sites aren’t in place and the protocols are very complex. Will we see the same churn rate as we see in the western countries? Research for a year and then dropping off?

FMEA – Processes Failure Mode & Effects Analysis (FMEA) Systemized group of activities to identify the mission failures and their impacts. It was developed by the US government. Covance has applied this to clinical trial management. The steps that have been identified for potential failures or places that failures could occur on a clinical trial. We can identify possible places to identify failure at a site. Pick up on the places for protocol deviation and violations that occur. You can then rank your failures. Risk score for all potential failures.

What are the barriers to success? Lack of fundamental understanding of the nature of risk management, Up-front planning requires initially more time and cost, ongoing review processes also require additional resources, appears to add complexity, and cultural change in how many clinical trials are currently conducted.

William – Proactive method of addressing as far as the concerns of the research sides. Average increase of CRF pages went from 55 in 1999 to 180 in 2006. Compensation per procedure has decrease 7.9%. Pharma must plan ahead better and better to proactively manage trials.

Covance has two committees:
Protocol review committee to examine proposed protocol, each member of panel has specific task to overlook. The committee reconvenes in one week and reports on the areas they were designed. They then decide whether or not to take the protocol. This must be done very early on.

Fast Start Committee is in charge of coordinating and implementing and protocol and addressing and solving complex issues contained in the new protocol.

Updated:

Here is a short clip from this track session

Clinical Trials: What Does Global Mean to You?

2009-04-30T05:41:00.000-04:00

Speakers:Michael O’Brien, President & CEO, BEARDSWORTH

Art Gertel, VP, Strategic Regulatory Consulting, Medical Writing and QA, BEARDSWORTH

Navaneetha Rao, MS, ScD, Vice President, Clinical Research and Development, VICUS THERAPEUTICS

Renée E. Moore, President Global Operations, PROGENITOR INTERNATIONAL RESEARCH

What do we mean by globalization?

Definitions:

Regional – Localized to a distinct geography

International – multiple geographies

Global – The above plus employees in all major geographic areas in which clinical studies are being conducted.

Navaneeth Rao believed that many of the service providers are still mainly focused on execution aspect, because that’s how the CRO industry works. Many are not adapted to integrate the aspects he presents. The Service Provider looks at contextual localization. Renee Moore thought that geographical presence is a key primary concern where the study is projects. Being able to project an education strategy with the sponsor can provide this experience. Michael O’Brien thought that the drivers to globalization were lower cost basis, compress enrollment period, for marketing reasons. Very important for smaller CRO to represent where the price advantages are. It’s about value, not cost.

Partnership in a global environment. How do you best integrate the service of the sponsor? Can we maintain a partnerships moving on with the current clinical project? How do we maintain the integrity of the organism? What should sponsor considerations be? What does the staff retention look like? Loyalty, cost differential mythology, and locus of control. Renee Moore believed that the primary concern of the sponsor. Staff retention in an emerging market, the problem of increasing salary may arise. Staff retention is critical, and how do they maintain this over the period of the process. Is it appropriate to outsource outside your country? Outside your firm? Not every situation has the same solution, you must think outside the box.

Sponsor Trends – What are the trends? The advent of the outsourcing gate keeper, preferred provider, niche providers, effects of consolidation, effects of downsizing and local versus out of country. Clintrials.gov, the majority of clinical trials are ongoing in the US and Europe. The increasing competition and decreasing willingness of countries presents an overwhelming need to develop a global approach to clinical trials.

Contractual and financial consideration – Everyone structures their templates in different ways. Not all are changed. Michael O’Brien stated that there is a type of misalignment in a CRO with a sponsor. The sponsor is looking for the value of what they’re buying. It may be that the lack of clarity around the transfer of obligation to the CRO is partially the problem. CROs may take more risk in this relationship. Is the push to globalization enough of a step outside of the box to allow the relocation to the CRO. Renee Moore believed that the type of contract, service providers can and will enter into with a sponsor, driven by multiple factors. Smaller companies will have a little bit more of a challenge from a profit sharing model. Smaller may not be able to enter in to the contract without a neutral cash flow from the CROs. A built in risk when you’re working in global economies. An Example: 1.6 euros to 1.1 euros per 1 pound over six month period. Similar currencies are happening to all around the world. It is passed on to the current word. Putting in invoice that euro will be valued at what it is on the day of the contract.

Updated:

Here is an interview with Michael O'Brien and a small clip from this panel discussion:

MMAX: Development, Evolution, Growth and Maturation of a Large, Integrated Drug Development Solution

2009-04-30T05:38:00.000-04:00

Harris Koffer, Pharm D, President and COO, RPS, INC.

James Dannemiller, Director, Site Research, WYETH RESEARCH

Harris Koffer and James Dannemiller started off discussing the understanding key trend and drivers for pharma. Over the last ten years, a peak of 50 drugs were approved in 1996, then dwindling to 22 drugs approved in 2006. The cost of developing drugs over this time as doubled. The market for Pharma products has continued to grow. The risks of drug development have continued to increase. Only one in five drugs for human testing actually reaches the market. Patent expirations on drugs has been putting pressure on the industry. Companies will loose significant revenue because of this between now and 2012. We’re also faced from external burden of a declining economy. Total health care expenditure was at slowest pace in 2007. Declining utilization of healthcare coupled with patients who can no longer to afford to medication will further decrease the productivity and profit of the Pharma industry. What is MMAX? Maximizing Monitoring, Availability and Excellence. Wyeth and RPS to make this program work. MMAX was established in 2005. The goal of this program was to reduce cost, improve quality, expedite clinical development process and improve site relationships. It operates under one global process. It includes one global structure reporting to Wyeth and one governance model. The strategic intent of MMAX was to implement structure that represented culture of Wyeth, structure to expand or contract with Wyeth’s portfolio, and to maintain Wyeth’s primary image.

Key objectives of MMAX:Quality – With activities, but also the quality from a site perspective, and to identify quality site that can perform the study based on the expectations.Speed – Ability for RPS to gear up for changes. Flexibility – ability to scale up or down as the needs of the organization mergeCost Effectiveness – Cost model that provides more streamline approach to cost.

Updated

Here is a brief clip from this keynote presentation

Leading Through Change: Innovation and the Future of the BioPharmaceutical Industry

2009-04-30T05:32:00.000-04:00

Moderator: Christopher C. Gallen, MD, PhD, President & Chief Executive Officer, NEUROMED

Panelists:Jack H. Dean, PhD, ScD (Hon.), DABT, Fellow ATS, President, U.S. Science and Medical Affairs (R&D), SANOFI-AVENTIS (Ret.)

Elliott Levy, MD, Vice President, Clinical Development, BRISTOL-MYERS SQUIBB

Why are we involved in the Pharma industry? We’re in a society where humans live past the age of mid thirties, and this is the first time that that has ever happened in history. Our industries have created the conditions that make modern public health possible. Our industry is essential in giving humans an extra 60 years of living.

The macro challenges facing our economy have begun to present a problem. Massive amounts of money became available, and that’s funded the bubbles that fueled our growth. The practice of giving sub-prime loans grew. Then the bonds fell, and hundreds of billions of dollars were lost. Our real economy has been disrupted. Pharma’s point of view in all of this is that it will affect two main sectors: pharmaceutical and biotech. Pharma will mainly be facing internal industry. Small molecule products are where the funds come from, which the patents will be expiring. They won’t be replacing the revenue lost. The growth of the Pharma industry has been because of price increases. The research and productivity has to be increased to counter this diminishing aspect of revenue.

R&D productivity has been a problem. Success rates have been decreasing. Shifting tests overseas have helped the cost some. Vaccines have been focused on as a result. Blockbusters going off patent and Pharma isn’t producing enough products to meet their needs. We’ve seen sales go up, R&D expenditures have increased, and time lines have gotten shorter. Productivity has been halved.

Why is productivity declining in Pharma?Elliott Levy of Bristol –Myers Squibb sees two sets of assets that will be affected: external and internal. In external realm, the growing knowledge and interest in safety is a focus. We’ve developed ways to identify safety factors when testing drugs when they’re in development. We’re operating in an environment where the standards for safety has gone up. The competitive marketplace for drugs has become overcrowded. Hurdles for introduction to the market have gone up.
Jack H. Dean added his insights on the direction of safety issues. The industry has become too sensitive about preclinical safety. Many of the drugs that are marketed today wouldn’t be here. The other thing is that the easy things have been done. We’re battling very complicated diseases. We put too big of bet on molecular tools, we’ve forgotten the importance of the medical chemists. We’ve only explored about 10% of the chemical space. Clinical and preclinical safety presents hold backs.

The panel was also asked what they see the communications and human insights into the science? Elliot Levy stated that everyone is trying to find the right structure to expose maximum scientific talent. Drug discovery process and operational side of things, then pushes compounds that have limited potential in the market place. Do we need to become more global to exploit this? Need to tap intellect around the world. Negatively, it’s very difficult to manage global communications.

Where are our patients going to come from was another question posed to the panel. The experts believed that we have to go to places around the world where everyone else has the same problems, like diabetes. Basic R&D has been outsourced to the biotech industry. Now, we see that half of the products from internal efforts in pharma and half from biotech. Quarter of the money spent comes from biotech, making them the low cost producer. The credit crunch has closed down world IPO market. Levels of disinvestment have affected the venture capitalists, and many bioteches are running out of cash. IPO market will probably not open up in next year, and there will be a wipe out of the biotech industry before the credit crunch is over.
Universities could be the place to go in their absences. It’ll be needed to apply. To fill the gap may be impossible. Large scale Pharma between 2009-2010 will only be able to replace 39% of their Pharma revenue.

Dr. Levy stated that in the short term, larger Pharma companies will be able to inquire best talent from biotech. They’ll replenish the pipelines. In the long term, if bioteches fold, scientists will migrate to companies. But won’t happen, because no jobs for developers. So what will this do for productivity? Pharma R&D is over capacity. Could be there is no great impact.
What can CROs bring to productivity? Technology solutions are less important then talent and capability development. The industry can become much better. There are too many studies that take longer than originally planned. Companies need to decide what their core competences are. Could CROs fit into this picture?

Dr. Levy stated that in the next few years, a few macro trends not moving in same direction. Data needed, Pharma avoids fix cost investments. This favors CRO industry. Decreasing amount of spend from companies, lower money over all for CRO factors.

Dr. Dean stated that the companies will try to maintain flexibility in costs. They’ll be forced to rely on a flexible cost structure. They quality CROs who deliver good relationships and products will be favored. Cross functional integration into the cooperation will be sought after.
R&D will not increase. CRO penetration of the pharma industry will continue to accelerate as companies right size them selves because of focus on core competencies.

Updated:

Here is an interview with Christopher Gallen regarding this keynote panel:

And here is a short clip from this keynote panel:

Wall Street’s 2009 Forecast and Analysis of Outsourcing Trends

2009-04-29T20:12:00.000-04:00

Moderator:John Kreger, Equity Research Analyst, WILLIAM BLAIR & COMPANY
Speakers:Derek Gustafson, Senior Vice President, Corporate Finance Division, MACQUARIE SECURITIES (USA) INC.
Randall Stanicky, CFA, Vice President, Global Investment Research, GOLDMAN SACHS
David H. Windley, CFA, CPA, Managing Director, Healthcare Equity Research, JEFFRIES & COMPANY

David: Forecast for industry growth, there is a dramatic growth in cancellations of gross bookings in the 2008. How much backlog have you added as a percentage of your revenue? Companies are adding business to backlog long before they convert it to revenue. Two outcomes: The revenue flows through after a break, or perhaps there is a hold, and the revenue leaks.

Randall Stanicky, Golamdan Sachs discussed what was going to happen with the CRO outlook for 2009 and beyond. What’s going to go on in this space? What will be the picture for actual growth?
What will happen in the upcoming years for Pharma:
- Pharma R&D spending is slowing – 0-5% annual growth which is likely the reality. If we look at the biotech side, they have less than 3 years of cash available. Many of these companies won’t be around for very long.
- Patent cliff is coming – increasing the need for more compounds. There is a need to continue to spend and find opportunities for new drugs- Post M&A restructuring will likely result in substantial R&D synergies
- CRO industry growth is increasingly and biotech funding decreasing, CROs are more dependent on greater outsourcing – strategic alliances will be key going forward
- Expect share shift towards larger CROs in the future, larger CROs are putting up larger booking numbers
- Outsourcing will continue to movie ex-US
- We see stable long term growth despite near-term headwinds
- “Street” view – tough 2009 but improvement in 2010. All 2009 growth was decelerated, but look to pickup in 2010. Consensus analysts 2009: -6% in w009, but 20% in 2010. But analysts her believe that things change quickly and meaningfully.
- CROs will be valued differently from the future John Kreger of William Blare and Company pointed out that stock prices and value prices, M&A is still pretty robust and will continue to be that way. Outsourcing stocks have performed nicely, but underperformed since September 2008.

Then the audience had a chance to ask their questions.Gross margins are holding in contrast at odds with specific contracts. Do you expect more of this to hold? The panel stated that looking at the fourth quarter of 2008, a lot of commentary about price discounting and offers of significant volume discounts. This will be detrimental effect on the margin. Key question is staffing levels. Companies retain too much capacity for the real amount of work that was there to be won. This time, can we get right amount of man power to get the job done?

Why are large Pharma companies are cutting back on R&D when the opposite needs to happen? Steve –Companies need to find ways to be more productive. They can focus on cutting R&D on short term basis, at the same time, they’re looking internally to be more productive to find more ways to be the same.

Preclinical companies are doing worse. Do you see any vertical integration, Pharma buying them rather than let them go out of business?It will come down to the strategic type of deals and if they evolve. Industries may strategically partner, which would be linking to early development to later development. So far, this hasn’t happened. If we see all Phases overlap, then there’s a very strong argument for companies to go vertical. Other industries viewing disruptive change, companies will come in and do it better, the displacement of existing large companies is inevitable. Short term versus long-term. Pharma deferring studies that are important to long-term growth but at the same time Pharma needs new drugs to come out of the pipeline in order to gain more profit.

What are some of the current struggles with Pharma currently? Lack of compounds, Patent cliff, growth forecast leads a significant challenge to meet the top line. How much money does pharma have to spend? Secondly, macro level, find out what the biggest drivers are. IMS, updated growth forecast, 2 ½% and it’s negative in the US, there is a precedence in the US industry. This panelist believes that they haven’t found the magic bullet to keep R&D spending from going up. The FDA’s demand on safety aren’t going to let up, we’ve got to offset to make the million dollars a compound number go down. The Pharma industry needs to let R&D grow to let compounds come through the pipeline to end up as a revenue.

What level of consolidate in the generic industry?If you are a US based generic manufacture, the global generic industry, they’re getting much more aggressive, in every aspect of their pursuit. If there is going to be a next wave to save the train wreck in 2012, the follow will be on biologics. The momentum is on a regulatory requirement on clinical trials for generic drugs.

Biotechs are running out of cash. Who will rescue them?This industry needs novel drugs. Good technology will get funded. Next wave of consolidation, pharma will acquire biotech. We’ve seen mega mergers over the past few months. Panelists assumes that strategic money will flow from
Pharma into Biotech companies.

Live from the 18th Annual Partnerships with CROs

2009-04-28T18:18:00.000-04:00

We're coming to you live from this year's Partnerships with CROs, kicking off our live coverage of conference activities. We'll be posting updates daily here on our blog so be sure and subscribe to our feed to get our regular updates. But you can also follow along on our twitter stream where we'll be sharing thoughts and perspectives through each day. For those of you in attendance, share you're own thoughts and tweets by using #CROS where other clinical and pharma professionals will be sharing their impressions.

The first day involved in-depth workshops that covered topics such as Implementing Standardized CRO Performance Metrics, Strategies for Small Pharma and Biotech, and Conducting Clinical Trials in Non-Traditional Markets. We had the opportunity to sit through the afternoon workshops and will be sharing details with you here.

We also had an opportunity to meet with Lesly Atlas, Conference Director for this year's Partnerships with CROs as she welcomed attendees to the conference.

This conference promises to bring industry leaders and professional to network, discuss and share insights, ideas and perspectives. We look forward to bringing you posts daily of the great presentations and activities. Be sure to check back often to follow all of the coverage.

Driving Global Growth: Strategic Considerations for Conducting Global Trials in Nontraditional Markets

2009-04-28T17:55:00.000-04:00

Moderator: Mark Roseman, Vice President, Account Manager, PPD, INC

Workshop Faculity: Simon Britton, Vice President, Account Management, PPD, Inc

Mitchell Katz, Vice President, Business and Clinical Operations, Eisai Global Clinical Development

Jorge G. Guerra, Senior VP, Global Clinical Operations, Biogen Idec

Jose Eduardo Neves, Medical Director, Astrazeneca

Earlier today at this panel, members of the CROs industry discussed the best ways to conduct clinical trials in nontraditional countries.

What are the issues facing in the pharma and biotech industry today? The panelists stated that cost was an issue in addition to understanding the regulatory climate outside the US. Keeping on top of the ever-changing environment also presents a challenge. It’s also important to recognize that going into new markets and keeping the costs down while ensuring the quality. It is also difficult to address the concerns of the people about the safety of the trials.

When looking to expand to other areas, the majority of the panel members agreed that Europe and North America have similar standards. For Japan, they’re looking to expand past Japan, to Korea, China and even India. Large pharma have offices in Japan, and they’re trying to force Japan to be part of the global studies.

The panelists were asked whether companies expanding or relying on CROs? The panelists responded: Astrazenica uses CROs are in terms of individual programs. Mitchell Katz states that Eisai Global Clinical Development has affiliates in offices across the globe. Experience in the country will come from the service provider. PPD states that it’s understanding what’s in the country. Some companies are trying to grow in global needs, others are trying to grow in terms of registration studies. Many of the CROs were already running studies, so Astrazenica saw the opportunity to be in that country. PPD, Inc says pharma growing commercial groups and taking research out. Mitchell Katz of Eisai Global states that it’s not where to go, based on the practice of medicine. Their protocols depend collaboratively on CROs who already have experience with that particular country.

When conducting Mitchell: It’s not about cost savings, it’s about the right countries and people to focus your studies on. Planning on the front end, do global trials (regulatory issues), but not practical in competitive to be able to do all trials in US.Jorge: Ideal to attract all patients in US. But all in US, you could gain a lot of time if you could guarantee acceleration.

Two-thirds of trials are still being conducted in regional market. Will this change soon? Astrazeneca provided the example in terms of the current state of China. If China wants to become world power, it must reform some institutions. Same to clinical, we’ll still see growth, but in nontraditional markets, they have to adapt to the system as well. Mitchell- will be balanced. Traditional drug development was all domestic at one point. Most small and medium sized companies didn’t have structure. But now we’ll see that the industry has allowed us to go global. This is a very approved approach for drugs being approved. Can’t afford to do that, and will be more balanced in terms of globalization.

Regulatory challenges are real because of the constantly changing climates. For regulatory approval process, there needs to be planning. But is this reality? No. Patient population is opportunity in China, it’ll be a realistic place to plan a study. We depend on CROs to guide us through these countries. Critical to stay on changes, some countries are getting better and some are getting worse, and CROs can guide small companies in these matters.

Governance and Supplier Relationship Management

2009-04-28T16:20:00.000-04:00

SRM Case Study of Bristol-Myers Squibb Frances Grote, BMS Supplier relationship management

BMS instituted supplier relationship management in 2005 to work with their suppliers. They grew into a partnerships approach when working with their CROs. The companies needed added value, so they looked at supplier relationship management.

Key to success for supplier relationship management:
-Someone needs to be the driver. A group that is not the direct user of the services, and the ideas need to have a person to implement them, but isn’t’ there to get the job done. It’s a full time commitment, but after it’s in place, doesn’t need full time oversight.
-Senior leadership within business unit. They people who will use it need to buy in. They’re the stake holders and they’ll build your culture.

If someone sits in the suppliers side, that doesn’t mean that they’re another person. If it’s our project, they’re on your team. If you’re improving process, you’ll need to make improvement available to suppliers. If suppliers supply info to other customers, you’re receiving it as well. You all sell what you’ve created to the public, so share and benefit when you can.

If you do SRM well, you could become as important as you are to your suppliers. They’ll want to go back to you, if you have strong SRM, they’ll continue coming back to you. The governance success factors are that you do need committees, as they are key for relationship health but key to keeping internal people. Very strong issue escalation pathways. They need to know who to take it to, someone to hear it, and that’ll help them solve that problem.

Performance management:
- KPIs need to be tied to deliverables
- Deliverables based contracting seems to be key
- KPIs need to be tied to deliverables- Scorecards and KPIs are in place

At BMS, management changes that stayed because of MSAs (before SRM) not service level agreements but expectations about quality, governance. Neither side is up on all, but they’re there. SRM was in the philosophy, and it was more sophisticated. Governance proved to be very powerful. KPIs with metrics and score cards prove the data.

FierceBiotech is the Official Digital Media and Live Coverage Partner at Partnerships with CROs 2009

2009-04-28T16:16:00.000-04:00

NEW YORK, NY and ORLANDO, FL (April 27, 2009) - FierceBiotech, the biotech industry's daily news monitor, has joined the Institute for International Research as the official digital media and live coverage partner of the 18th Annual Partnerships with CROs event. From April 28-30, FierceBiotech editors will provide coverage of the event including live reports on its homepage, e-newsletter, and Twitter. The Partnerships with CROs team will also highlight FierceBiotech's coverage through their official communication to attendees and the event website.

"FierceBiotech readers consistently rank Partnerships with CROs as one of their top event priorities of the year," says Arsalan Arif, Publisher of FierceBiotech. "Because FierceBiotech is the first place biotech leaders turn for news, providing live coverage through our unparalleled digital platforms fits our core mission to serve our readers with timely, relevant information."
FierceBiotech's coverage will be live at FierceBiotech.com on Tuesday, April 28. Live coverage will also be available through Twitter by following @FierceBiotech or tracking the official Partnerships with CROs discussion tag #CROs via Twitter search.

About Partnership with CROs
Partnerships with CROs, created and developed by IIR, has set the standard in outsourcing and clinical development conferences. The event provides the information to engage clinical development and outsourcing partners to foster relationships that bring critical therapies to patients safely and efficiently. The event is designed for VPs, Directors and Senior Managers of: Clinical R&D, Clinical Operations, Global Outsourcing, Strategic Sourcing, Contracts Administration, Procurement/Purchasing, R&D Finance, Regulatory Affairs, Clinical Affairs, and more. To learn more about this event, please visit: http://www.cropartners.com/.

About FierceBiotech
FierceBiotech, a FierceMarkets publication, is the biotech industry's daily monitor and first place to turn when news happens. Published daily on multiple platforms--e-mail, web, mobile edition, RSS, and Twitter - FierceBiotech is the most actively read daily publication in the life sciences. For more and to sign up today, please visit: FierceBiotech.com

About FierceMarkets
FierceMarkets, a leader in B2B e-media, provides information and marketing services in the Telecommunications, Life Sciences, Healthcare, IT, and Finance industries through its portfolio of e-mail newsletters, Web sites, webinars, and live events. Every business day, FierceMarkets' wide array of publications reaches more than 800,000 executives in over 100 countries. For more, please visit: Fiercemarkets.com

About IIR
IIR is the world's leading knowledge and skills transfer company with a global network of 47 companies and 112 operating units. Every year, IIR works with 650,000+ business executives providing them with knowledge and skills through training, conferences, seminars, e-Learning, blended solutions, exhibitions, consulting and mentoring. To learn more about IIR, please visit http://www.iirusa.com/.

Speaker Profile: Peter B. Corr

2009-04-27T13:00:00.000-04:00

Dr. Peter B. Corr is Co-Founder and General Partner of Celtic Therapeutics Management LLLP. Dr. Corr retired from Pfizer Inc in December 2006 where he was Senior Vice President for Science and Technology. In 2002 and 2003, he also headed worldwide pharmaceutical research and development for Pfizer.

Previously, Dr. Corr served as Executive Vice President, Pfizer Global Research & Development; and President, Worldwide Development. He also served as Senior Vice President, Discovery Research, at Monsanto/Searle and then, President of Pharmaceutical Research and Development at Warner Lambert/Parke Davis.

Dr. Corr, who received his doctorate from Georgetown University School of Medicine, spent 18 years as a researcher in molecular biology and pharmacology at Washington University in St. Louis. When he left Washington University, Dr. Corr was Professor, Department of Medicine (Cardiology) and Professor, Department of Pharmacology and Molecular Biology. His research has been published in more than 160 scientific manuscripts.

Speaker Profile: Harris Koffer, Pharm.D

2009-04-27T10:00:00.000-04:00

Dr. Harris Koffer is President and Chief Operating Officer for Research Pharmaceutical Services (RPS), a clinical research organization providing services to the Pharmaceutical and biotechnology industries in support of clinical drug development.

Prior to joining RPS, Dr. Koffer served as Vice President, Clinical Trials and Pharmaceutical Business Development, for Quest Diagnostics; Vice President and General Manager of Covance Clinical Services and President of Covance Periapproval Services. In these roles, he was responsible for global central laboratory services as well as full service clinical research and development capabilities for Phases 1 through 4 of drug development.

In addition to over 28 years of experience in clinical drug development, he has served as Adjunct Assistant Professor of Pharmacy in Medicine at the University of Pennsylvania School of Medicine and Clinical Associate Professor of Pharmacy at the Philadelphia College of Pharmacy and Science.

Dr. Koffer has published and presented numerous papers in the fields of cardiovascular clinical pharmacology and pharmacoeconomics.

He earned both a BS in Pharmacy and a Doctor of Pharmacy degree from the Philadelphia College of Pharmacy and Science and completed a Fellowship in Clinical Pharmacology at Thomas Jefferson University Hospital in Philadelphia.

Harris Koffer will be presenting MMAX: Development, Evolution, Growth and Maturation of a Large, Integrated Drug Development Solution along with Jim Dannemiller, M.S., Wednesday, April 29 at 9:15.

Speaker Profile: Christopher C. Gallen, MD, PhD

2009-04-27T09:00:00.000-04:00

After receiving his M.D. and Ph.D. (Biochemistry) degrees and completing a medical internship at the Emory University School of Medicine, Dr. Gallen went on to complete Psychiatry residency training at Stanford and Neurology residency training at the University of California, San Diego. He then joined the Neuropharmacology Department of The Scripps Research where he developed an international reputation in brain functional imaging, published the first definitive demonstration of human cerebral plasticity, and was as a scientific support to the successful IPO and secondary offerings of Biomagnetic Technology Inc (BTi). Dr. Gallen next took on responsibilities rising to Senior Director of Medical and Scientific at Quintiles directing several successful registration programs. Dr. Gallen then started the Premier Research Worldwide CRO, led its IPO, grew it into a successful trans-Atlantic CRO and conducted trials in a wide variety of therapeutic areas and approaches. Dr. Gallen subsequently moved to work in big pharma with responsibilities as Vice President of Medical Development at Pharmacia including three major roles, Head of Global CNS Medical Development, Head of Clinical Operations managing the “internal CRO” for conduct of all clinical trials in all Therapeutic Areas in the Western Hemisphere and eventually, after helping lead a successful re-engineering, as Kalamazoo R&D Site Head CNS and ID, Dr. Gallen subsequently became Vice President and Chief of Operations for Clinical Research and Development at Wyeth in charge of a range of global clinical development functions. In this role Dr. Gallen partnered with Accenture to help create the Alliance for Clinical Data Excellence (ACE) outsourcing of Wyeth Clinical Data Management to Accenture and to drove the successful re-engineering of Wyeth to the top quintile of clinical research performance. Dr. Gallen subsequently became President and CEO of Neuromed, a Philadelphia and Vancouver-based biopharma company developing products to manage and treat complications of pain, epilepsy and hypertension.

Christopher Gallen will be hosting the panel discussion "Leading Through Change: Innovation and Future of the BioPharmaceutical Industry," Wednesday, April 29, 2009 at 8:30 AM.

Clinical trial begins for a malaria vaccine

2009-04-24T10:58:00.000-04:00

According to The Washington Business Journal, Sanaria will begin its first human clinical trials for a malaria vaccine. The new vaccine hosts a weakened version of the entire malaria parasite. It will be tested on 104 healthy volunteers. Read the full story here.

The Use of Bid Grids for Selecting a CRO as a Partner

2009-04-23T08:00:00.000-04:00

This article in Applied Clinical Trials details how most companies use bid grids in order to establish both an overall outsourcing budget and the expected budget for individual major outsourced studies. So who's using bid grids?

According to the article 90% of the American participants of a suvey conducted by the University of Health Sciences and TTC reported using a common bid grid, in contrast to just over half, 52% percent of locations worldwide. 81% of larger pharma companies reported using a common bid grid as opposed 49% of participants from smaller companies that use a common bid grid.

Do you think bid grids are useful?

Partnerships with CROs April LinkedIn Update: Mergers & Acquisitions in Pharma

2009-04-22T13:49:00.000-04:00

Click on the link below for this month's edition of the Partnerships with CROs Newsletter. If you haven't had a chance to join our Partnerships with CROs LinkedIn group, join today!

We look forward to meeting those of you who will be joining us next week in Orlando for the Partnerships with CROs event! If you're not registered yet and would still like to join us, check the newsletter for a special discount code!

View the newsletter here:
http://www.iirusa.com/upload/wysiwyg/New%20Media/CROSAprilFinal20090421-1b.html

We've also got a great workshop to let you know about on April 28:

Developing and Implementing Standardized Clinical Trial
Performance Metrics to Drive Time, Cost and Quality & Enhance Partnership Performance.

This workshop will include:
•an update on MCC activities
•an overview of industry best practices
•release of the MCC Clinical Trial Performance Metrics (beta version)
•work group breakout sessions
•MCC Clinical Trial Steering Committee panel discussion

What: Workshop B1: Developing and Implementing Standardized Clinical Trial Performance Metrics to Drive Time, Cost and Quality & Enhance Partnership Performance.
Where: Rosen Shingle Creek Hotel, Orlando, FL
When: April 28, 2009 9am-4:30pm

Full Details are Required for Indian Clinical Trials

2009-04-21T09:36:00.000-04:00

According to this article in outsourcing-pharma.com CROS and drug companies that are conducting clinical trials in India will now be required to record full details of all their research including the funding source.

Up until now, registration on Indian Council of Medical Research (ICMR) website was done voluntarily, but now that will all change come this June. Last summer 49 infants died in clinical trials in India, and an infant that died in October should have never been part of the trial because the baby had existing heart problems. As a result of this, the committee wants to be able to regulate and monitor all patients before they are enrolled.

Join us: Global Congress on Comparator Studies

2009-04-20T10:41:00.000-04:00

Global Congress on Comparator Studies
July 20-22, 2009
The Ritz-Carlton Philadelphia

The Global Congress on Comparator Studies provides pharmaceutical and biotech executives the tool set required to establish a comprehensive strategy for sourcing comparators and overcoming regulatory challenges.

We’re looking to make GCCS an interactive experience to foster networking and knowledge sharing. The benefit is that attendees get to interact with peers in an informal setting and really get some of your challenges answered.

· Roundtable breakout sessions for regulatory and supply chain executives
· Interactive panel discussions with a cross section of industry leaders

To stay informed, please visit our event webpage and join our LinkedIn group

Partnerships with CROs & Other Outsourcing Providers: Special Invitation

2009-04-16T16:06:00.000-04:00

Partnerships with CROs & Other Outsourcing Providers

The #1 Event for Clinical Development & Outsourcing Professionals
April 28-30, 2009
Rosen Shingle Creek
Orlando, Florida

We'd like to invite you to the 18th Annual Partnerships with CROs event! This event has set the standard in outsourcing and clinical development conferences and we are proud to bring you THE event that explores best practices on forming, managing, and sustaining clinical outsourcing partnerships.

Network with 1400 Clinical Operations, Outsourcing and Business Development Executives Under One Roof!

As a reader of the Partnerships with CROs blog, you will receive a 20% discount off of the registration rate (use code XP1400BLG when registering). To register, please call 888.670.8200, email: register@iirusa.com, or visit our website at www.cropartners.com.

Patient recruitment costs continue to increase in clinical trials

2009-04-16T10:34:00.000-04:00

According to Earth Times, the patient recruitment step in clinical trials accounts for 23% of the clinical trial time line. They also contribute to the increasing costs of performing clinical trials.

Emerging means for screening potential patients, such as genetic tests, mean that companies must plan for higher lab-testing costs and a lower rate of prospective patient enrollment. And the Canadian Medical Association Journal (CMAJ) in February published an article claiming that drug development costs had increased at a rate 7.4% higher than inflation.

Read the full story here.

Key Findings on CRO Industry

2009-04-14T09:44:00.000-04:00

Over at FierceBiotech they've recently summarized some key findings from the Top 10 Contract Research Organizations, which is a report published by Business Insights that examines the competitive landscape of the global CRO industry. Here are some of the issues they've uncovered:

The CRO market will grow at an annual rate of about 14% over the course of the next 3 years.
Quintiles leads the CRO market this past year, but the 10 major CROs accounts for 56.1% of the market. There are over 1,100 players in the industry.
In an attempt to expand services and offerings, it has led to increased alliances, joint-ventures, and other partnership deals.
Covance is the 2nd largest CRO only trailing Quintiles
Biomarkers will become an important part of clinical research after the FDA has recommended their usage

France focuses on Clinical Trials

2009-04-13T11:32:00.000-04:00

Global Atlanta recently sat down with Michel Abiteboul, the President of AFCROs on France. In the interview, he discussed the goals of how to bring and achieve high quality clinical trials in France. His interview is below:

CardioNet Expands into CRO Industry by Acquring Biotel

2009-04-08T10:56:00.000-04:00

According to this article in Outsourcing-pharma.com CardioNet, a US company that specializes in cardiac monitoring devices, has broken into the CRO sector by purchasing Biotel for $14million.

CardioNet sees a lot of potential in the CRO industry, especially in monitoring its current product portfolio. Biotel will provide provides event, Holter and electrocardiogram (ECG) monitoring services for CardioNet. This is just the first step CardioNet is taking to expand to the clinical research sector.

The Political Economy of Pharmaceutical Clinical Trials

2009-04-07T10:59:00.000-04:00

Metapsychology has a review on a new book following 20 clinical trials from around the US analyzing for profit clinical trials.

Medical research for hire combines indeed ethnography and ethics. The former prevails: the book is rich in quotations from the many interviews conducted by the author and we get to know how the participants in the private clinical trials studied perceive themselves. However, the author only visited a minor fraction of the many organizations conducting trials in the USA and had unequal access to the different types of participants.

Read the full review of the book here.
Buy the book here.

ICON teaming up with MedAvante

2009-04-02T10:52:00.000-04:00

To improve clinical trials dealing with central nervous systems, ICON has teamed up with MedAvante. This alliance will allow a better look into the trials, as they are often difficult to monitor. It will also allow for the two groups to offer new services to drug companies developing drugs to treat central nervous system disorders. For the full story, read here.

Partnerships with CROs now has a Twitter! Follow us here.

New CenterWatch Report Examines Japan’s Surging Clinical Trials Market

2009-04-01T15:12:00.000-04:00

Healthplannews.com reports that Japan is participating in global drug development at historic levels; however, there is still work to be done there to sustain that growth. Japan's importance in the global drug development arena hasn't had near the impact of India's but could that change? We'd like to know your thoughts on this shift in leadership and in development, do you see more changes happening with Japan's CRO market?

Tips and Trends on Global Clinical Trials Outsourcing

2009-03-31T10:53:00.000-04:00

I came across this great podcast from PharmaVoice on their blog where Patrick Durbin, VP of Fisher Clinical Services, offers some best practices for developing a strategic partnership with outsourcing providers, discusses some of the biggest challenges and missteps in global clinical trials outsourcing, covers emerging opportunities at the global level, and lists some of the most important emerging trends in this arena. Take a couple of moments to listen to the podcast.

Play the PharmaVoice Podcast

Expert Opinions on the Current State of the CRO market

2009-03-26T12:51:00.000-04:00

I came across this podcast from Outsourcing-Pharma.com where Barath Shankar, Frost & Sullivan analyst offers his opinion on the state of the contract research market now that it is having to evolve and adapt to the turbulent environment. The podcast is about 5 minutes long, so take a few moments to listen to it.

Listen to the podcast

March Partnerships with CROs LinkedIn Roundup

2009-03-25T12:35:00.000-04:00

The March Partnerships with CROs LinkedIn Roundup is here! Read the newsletter here. If you haven't had a chance to join our Partnerships with CROs LinkedIn Group, join now!

We also had a special message from Lesly Atlas, the Partnerships with CROs Event Director, about what benefits you'll find at Partnerships with CROs as a LinkedIn member.

Premier Acquires Pivotal Research Centers

2009-03-23T14:23:00.000-04:00

According to this article in Clinical Trials Today Premier Research, a CRO based in the UK, has finalized its deal with Pioneer to acquire Pivotal Research Centers, which is a site management organization that specializes in phase II and phase IIa clinical trials.

Pioneer’s president and CEO Bruce Shear recently mentioned, “The completed sale of Pivotal advances our plan to focus on our faster growing core business of delivering behavioral health care.”

More suicidal monitoring needed in clinical trials?

2009-03-20T12:14:00.000-04:00

In a recent post by Dr. Michael McKelvey, he addresses the issue of suicide monitoring in clinical trials. He states that the number seeking regulatory approval is increasing. And the FDA has recently issued guidelines for the topic. However, there needs to be a fully structured, procedurally reliable and replicated process for monitoring suicidality. What do you think? Is this an issue for your clinical trials?

i3 Launches New Software to Manage Clinical Trials Activities

2009-03-18T15:27:00.000-04:00

This article in Clinical Trials Today discusses how i3, a contract research organization, has launched a new web-based clinical trials and data management program that will replace the need for multiple systems to manage all of these activities.

i3 CEO Glenn Bilawsky mentions, “i3Cube was designed to provide our clients and clinical investigators with a simple, easy-to-use, and streamlined experience. We brought together our use of proprietary health care claims data with our clinical research expertise and developed i3Cube to create time and cost efficiencies for our customers.”

It will be interesting to see what other web-based applications will be released in the upcoming months to help improve efficiency in outsourced clinical trials.

Staffing services now offered by PharmaNet

2009-03-17T10:48:00.000-04:00

CRO PharmaNet has expanded its services to now provide clinical trial staffing which will include on-demand staffing, strategic alliances, functional service staffing and quality control services.

PharmaNet president and CEO Jeffrey P. McMullen said "Our solutions-based staffing business provides another entry point with large pharmaceutical clients by offering them a new alternative with PharmaNet quality built-in."

For more on the story, read here.

Contract work for clinical trials on the upswing

2009-03-12T11:22:00.000-04:00

The Pharma Times reported yesterday that 84% of respondents claimed that they'd be interested in contract work when it comes to clinical trials.

While the perceived benefits of contracting – better remuneration, independence and flexible working – were offset in the survey by inhibitions about job security and loss of company benefits, 55% of the respondents recognised there was an increasing shift towards contract-based employment in the sector, with more than 20% seeing it as the prevailing dynamic.

For the complete article, read here.

A New Low in Drug Research: 21 Fabricated Studies

2009-03-11T12:14:00.000-04:00

According to WSJ.com, Baystate Medical Center in Springfield, Mass., has asked several anesthesiology journals to retract the studies, which appeared between 1996 and 2008, the WSJ reports. The hospital says its former chief of acute pain, Scott S. Reuben, faked data used in the studies.

Some of the studies reported favorable results from use of Pfizer’s Bextra and Merck’s Vioxx, both painkillers that have since been pulled from the market. Others offered good news about Pfizer’s pain drugs Lyrica Celebrex and Wyeth’s antidepressant Effexor XR. Doctors said Reuben’s work was particularly influential in pain treatment and that they were shocked by the news.

CROs in disguise

2009-03-10T10:15:00.000-04:00

Brian Orelli at The Motley Fool writes on the basics of CROs, or CROs 101 for the non-industry professional. Orelli outlines a few characteristics of CROs but what was most interesting was his claim that some CROs can be disguised and, according to Orelli, it seems (to me) that pharmaceutical companies are essentially turning into holding companies that license or purchase drug candidates, escort them through the regulatory maze, and produce and hock them once they get past the FDA. Which he claims isn't a bad business model. Check out his piece here and let us know your thoughts.