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

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

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

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

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

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

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

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

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

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

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

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?

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

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

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

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