Untitled

April 2012
A CenterWatch Publication
Volume 19, Issue 04
Global sites see growth in trials, revenue, staffing

But remain wary about expansion, economic recovery
By Karyn Korieth and Annick Anderson
Global investigative site staffing

Mean number of employees
11.3 +5.0% 7.9 8.3 8.2 +14.7% 3.4 Overall
2010
15.6 14.1 +7.1% 8.4 6.3 +4.0% +15.8% 5.2 Europe

2011
12.2 10.6 +4.9%
11.4
11.4 -1.6%
11.5
9.0
Part one of a two-part series
8.6
6.4
lobal investigative sites saw encouraging signs of financial recovery during the past year, according to new CenterWatch data, with the average site reporting growth in clinical trial activity, site staff, patient volume and revenue. While clinical trial activity is expected to increase another 10% in 2012, sites remain wary about the lingering effects of the global economic crisis and the majority wont expand operations this year. Sites report clinical research activity has begun to rebound after a couple of difficult years brought about by the downturn in the global economy and the fallout from merger and acquisition (M&A) activity in the biopharmaceutical sector. In 2011 we had a strong financial year, and we are off to an even better start in
3.9 Overall
2011
+16.7% 2.4 North America

2010
2.8 North America

2011
5.0 Europe
2010
5.7 Rest of world

2010
6.6
Rest of world
2011
Full-time
Part-time
Source: CenterWatch, 2012 Survey of 257 Global Investigative Sites
2012, said Michael Good, COO of Kansasbased Via Christi Research. Weve had a couple of good years. Survey data also found improvement in site cash flow, and the majority of sites can pay their bills promptly, usually no later than 45 days. But even though the investigative site landscape has seen growth during the last year, survey data indicate the outlook for
recovery remains fragile. Global sites report their profitability suffered during the past year, and only one-third of respondents believe economic conditions for sites will improve this year. More than half of sites are not planning to hire in 2012. At this point, caution is key for many sites, said Kathy Jones Beals, vice president of business development and COO of
see Survey on page 9
Industry struggles with prospect of trials leaving U.S.

Must grapple with issues of quotas, populations, differences in dosing
Should the FDA have a quota for what percent of trials are conducted in the U.S.? Should other regulations or incentives be used to staunch the flow of trials to developing nations? Does it matter whether or not the patient population comes from the U.S.? Rescuing Clinical Trials in the U.S.: A Call for Action, a meeting organized by Duke University last October, was an effort to spur the conversation among high-level industry, academic and government leaders. A series of white papers are expected to come out of the gathering. This is not a group that is against global clinical research, said Dr. Robert Harrington, M.D., chairman of the department of medicine at Stanford University and former director of the Duke Clinical Research Institute. But we want to make sure the U.S. remains a part of the global clinical research, particularly if were studying an intervention that might
see Trials on page 14
By Tamara Lytle
s the clinical trials industry continues to expand around the globe, some industry leaders have begun questioning whether action is needed to keep more trials in the United States.
Copyright 2012. CenterWatch. Duplication or sharing of this publication is strictly prohibited.
April2012
Dear Readers, This past month I spent three days in Orlando at the Institute for International Researchs Partnerships in Clinical Trials conference. Among the food, drink and conversation was a most enthusiastic group of pharmaceutical, biotech, academic, CRO, niche providers and investigative site research participants, all dedicated to the long-term benefits of drug development. I met with CROs, IRBs, technology companies, clinical supply vendors and more, each more excited than the last about their roles in helping to bring new medications to patients more quickly. I made new contacts, gleaned new industry insights and even ran a sunrise race to benefit the Rock CF Foundation for Cystic Fibrosis. That last activity made me feel the bestaside from having the privilege to travel and attend the conference, it was great to be able to do some good at the same time. Having the opportunity to travel and be away from the office and connecting with other professionals in the industry can be just what the doctor (or the researcher) ordered to reinvigorate and motivate us. It provides a fresh perspective and reminds us of why we entered this industry in the first place. In this issue of The CenterWatch Monthly, we examine the perspectives of 257 global investigative sites with the results of our newest survey, which shows encouraging signs of financial recovery over the past year. The average site reported growth in clinical trial activity, site staff, patient volume and revenue. But while clinical trial activity is expected to increase another 10% in 2012, sites remain wary about lingering economic effects and most wont expand operations this year. In our second news feature, we look at the continuing expansion of clinical trials around the globe. Some industry leaders have begun questioning whether action is needed to keep more trials in the U.S., as they grapple with issues of quotas, target patient populations and dosing requirements in different countries. Also this month, weve enhanced our Pipeline News section. Investigative sites have told us they rely on CenterWatch for study grant leads. New this month, we are proactively using our drug intelligence service to provide advance notice of trials that soon should be entering the next phase of clinical development. As part of this Grant Lead Opportunities service, if you are a sponsor or CRO and would like to list your upcoming trial in The CenterWatch Monthly or initiate a search to identify sites for your upcoming trial, or if you are a site and would like your profile included in our database, contact Claire Gross, (617) 948-5121, claire.gross@centerwatch.com. We hope both the sponsor/CRO and site communities will make this added resource an integral part of the ongoing site selection process. Yours truly,
In this issue
4 In Review Regulatory Update Month in Review CRO Industry Update 8 Action Items Portals can bring social media benefits By Susan MH Lewenz Here comes the Sun(shine Act) By Samuel Whitaker 21 Pipeline News Grant Lead Opportunities Eye On Lundbeck
Coming in May
Site financial checkup Part two of CenterWatchs 2012 review of site health looks at profitability by size. Risky business While the industry endorses risk-based monitoring, CROs grapple with the possible loss of revenue it could mean. Eye On Millennium
The CenterWatch Monthly ISSN 1556-3367 Editor-in-Chief Cheryl Appel Rosenfeld Drug Intelligence Tracy Lawton Production Holly Rose 2012 CenterWatch, LLC. All rights reserved. No part of this publication may be distributed or reproduced in any form or by any means without the express written consent of the publisher. Permission requests can be obtained via fax at (617) 948-5101 or emailed at editorial@centerwatch.com. Singleuser annual subscriptions start at $399. For inquiries on multi-reader and corporate subscription rates and article reprints: Sales, Tel: (617) 948-5100 Email: sales@centerwatch.com For inquiries regarding your subscription: CenterWatch Customer Service Tel: (866) 219-3440, Fax: (617) 948-5101 Email: customerservice@centerwatch.com For inquiries regarding advertising: Sales, Tel: (617) 948-5100 Email: advertising@centerwatch.com POSTMASTER: Send address changes to: CenterWatch Customer Service 10 Winthrop Square, Fifth Floor, Boston, MA 02110 CenterWatch Main and Editorial Ofces: Tel: (617) 948-5100 Fax: (617) 948-5101 Email: editorial@centerwatch.com
Cheryl Appel Rosenfeld Editor-in-Chief
April 2012 | The CenterWatch Monthly
CenterWatch Information Services

CWWeekly A newsletter that reports on breaking news in the clinical trials industry. Available every Monday in a digital format, annual subscriptions are $249. Contact Sales, (617) 948-5100, or sales@centerwatch.com. CenterWatch News Online A free, virtual newsletter that covers news, developments and drug and professional updates of the clinicial research enterprise as it unfolds. www.centerwatch.com/news-online/ Research Practitioner A bi-monthly publication that provides educational articles and practical insights and tools for study conduct professionals. Subscribers can earn up to 18 nursing contact hours each year. Annual subscriptions start at $139. Contact Sales, (617) 948-5100, or sales@centerwatch.com. JobWatch A web-based service listing clinical research jobs, career resources and a searchable resume database. Contact (617) 948-5100 or jobwatch@centerwatch.com. Drugs in Clinical Trials Database A searchable database of more than 4,000 detailed profiles of new drugs in development in hundreds of disease conditions worldwide. Request a complimentary 5-day trial. Contact Sales, (617) 948-5100, or sales@centerwatch.com. Clinical Trials Listing Service www.centerwatch.com An international listing service of actively enrolling clinical trials to support sponsors and CROs in their patient enrollment initiatives. Contact Steve Zisson, (617) 948-5142, or stephen.zisson@centerwatch.com. CW Publications
l l
InReview
Regulatory Update
Good guidance practices
At the close of 2011, as part of its Transparency Initiative, the FDA announced the availability of a report titled Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency (GGP Report). This GGP report was prepared in response to an earlier report (FDA Transparency Initiative: Improving Transparency to Regulated Industry, dated January 2011), which contained several action items and draft proposals to make the FDAs operations and decision-making processes more transparent and foster more efficient and cost-effective regulatory processes. In response to one action item in the earlier report, FDA Commissioner Dr. Margaret Hamburg called for an agency working group to prepare a report identifying the FDAs best practices and making recommendations to streamline guidance document development, reduce the time between issuing draft and final guidance documents and make it easier to find guidance documents on the FDAs web site. More information about the FDA Transparency Initiative is available at www.fda.gov/AboutFDA/Transparency/ TransparencyInitiative/default.htm. The follow-up GGP report identifies current best practices and recommends strategies to make the FDAs guidance processes more efficient and transparent. These best practices and strategies are critical to the FDA because developing and issuing guidance documents is an enormous undertaking and critical to fulfilling the FDAs mission. In fiscal year 2009, the FDA issued approximately 124 guidance documents. Since then, guidance activity has been trending upward, with the FDA issuing approximately 133 guidance documents in FY 2010 and 144 in FY 2011. These numbers include draft and final Level 1 and Level 2 guidance documents. Guidance documents are prepared for FDA staff, regulated industry and/or the public, and describe the FDAs interpretation of or policy on a regulatory issue. The regulations are written in Title 21 of the Code of Federal Regulations (21 CFR), in Part 10.115. Unlike statutes (laws) and regulations, guidance documents do not establish legally enforceable rights or responsibilities. There are two types of guidance documents. Level 1 guidance documents are those that (1) set forth initial interpretations of statutory or regulatory requirements, (2) set forth changes in interpretation or policy that are of more than a minor nature, (3) include complex scientific issues or (4) cover highly controversial issues. Level 2 documents set forth existing practices or minor changes in interpretation or policy. Level 2 includes all guidance documents that are not classified as Level 1. The FDAs GGP regulations govern how guidance documents are developed and issued and give interested persons a number of opportunities to provide input into the development process. Generally, the FDA solicits public input on Level 1 guidance documents before implementation. It posts draft Level 1 guidance documents on its web site with a Notice of Availability (NOA) posted in the Federal Register. Generally, the FDA accepts public comments on the draft for 60 days. In some instances, it also may hold public meetings or workshops on draft Level 1 guidance documents to solicit additional comments or present the draft Level 1 guidance document to an advisory committee for review. Once the comment period has closed, the FDA reviews the comments and considers them as it prepares the final guidance document. The FDA also posts final Level 1 guidance documents on its web site with an NOA in the Federal Register. Generally, the FDA does not solicit public input on Level 2 guidance documents or on Level 1 guidance documents intended for
Global Regulatory Systems The CRAs Guide to Monitoring Clinical Research - NEW EDITION The CRCs Guide to Coordinating Clinical Research - NEW EDITION Becoming a Successful Clinical Research Investigator Protecting Study Volunteers in Research A Guide to Patient Recruitment and Retention Global market intelligence reports
The CenterWatch Monthly | April 2012
immediate implementation, i.e., for which prior public participation is not feasible or appropriate before implementing the guidance document. However, the FDA publishes an NOA in the Federal Register for Level 1 guidance for immediate implementation. The FDA also posts both Level 2 and for immediate implementation Level 1 guidance documents on its web site. The public may comment on them at any time after they have been issued and the FDA will review the comments and consider them for document revision, as appropriate. This streamlined approach permits the FDA to issue Level 1 guidance documents for immediate implementation and Level 2 guidance documents more quickly than standard Level 1, while still providing stakeholders with an opportunity to comment. Importantly, the additional administrative steps required for standard Level 1 guidance documents (i.e., issuing a draft, providing a comment period and issuing a final guidance document) generally make their release a longer process. In addition to the opportunity to comment on guidance documents themselves, interested persons have opportunities to provide input to the FDA on topics for guidance documents. The FDA publishes an annual guidance agenda, listing possible topics for future guidance document development or revision during the next year. Interested persons may submit comments on the topics listed or comments suggesting additional topics for guidance. Interested persons also may identify issues in citizen petitions the FDA may decide to address through a guidance document. The procedures for filing citizen petitions are in 21 CFR 10.30. Requests for guidance documents also come to the FDA informally. Frequently, interested persons identify issues that would benefit from guidance at advisory committee meetings, industry meetings, roundtables and listening sessions, or by contacting the appropriate FDA office. Interested
see Regulatory Update on page 6
Month in Review
Here are the top headlines from the past months CWWeekly feature stories:
ACRO lobbying against Sunshine Acts inclusion of reporting research payments to physicians Calls to CISCRP rise as patients seek human touch Unreported trial data becoming a hot-button issue for government, business boon for service providers Icon acquires health consultancy PriceSpective, as trend toward postapproval market access grows Synteract founder launches first nonprofit CRO, PHACT, to focus on trials for neglected diseases Report: Over one-third of clinical trials are outsourced Survey: Sponsors, CROs making changes to their business models to demonstrate value to payers Cegedim ranks top pharma companies on their use of, and success with, social media
Topics of the past months Pulse columns:
The Pulse on Recruitment: How innovation is driving patient recruitment; Sites catch-22 of tracking the status of referred patients The Pulse on Latin America: Ethical issues in choosing countries in which to conduct studies The Pulse on Multinational Studies: The reasons for and means to address study delays
Executives interviewed in the past months Insider Insights columns:

Patricia Leuchten, chief executive officer of Avoca Group Edward J. Stepanski, Ph.D., chief operating officer of Acorn Research
For more information about any of the above articles, please refer to Volume 16, Issues 7-9. To subscribe to CWWeekly, visit http://store.centerwatch.com, or contact: Emily Greenwell, (617) 948-5152 or Susan Dancewicz, (617) 948-5120, or sales@centerwatch.com.
InReview Regulatory Update

continued from page 5
persons sometimes submit a proposed draft guidance document to the FDA. Submitting proposed draft guidance documents, rather than topics, enables the FDA to approach a topic with a better understanding of the issues that interest the stakeholder. This may expedite the guidance document development process, particularly if the topic involves novel scientific issues. The FDA solicits proposed draft guidance at a variety of different venues, such as trade association meetings and on its web site. Interested persons may submit proposed draft guidance documents on unsolicited topics as well. All guidance topic suggestions and proposed draft guidance documents will be considered, but the FDA might not respond to or take action on every suggestion.
Access to data
The FDA has announced the availability of the report Food and Drug Administration Transparency Initiative: Exploratory Program to Increase Access to the Agencys Compliance and Enforcement Data as another part of the Transparency Initiative. This report includes eight initiatives adopted by the FDA Commissioner to explore avenues for making the FDAs publicly available compliance and enforcement data more accessible and userfriendly. The FDA is responsible for a broad range of compliance and enforcement activities. Increasing their transparency enhances the publics understanding of the FDAs decisions and promotes accountability of both the FDA and regulated industry. The current report incorporates public comments received to an October 2011 Federal Register notice that presented these eight initiatives in draft form.
Final guidance for knee products

The FDA has announced the availability of a final guidance document titled Guidance
for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage dated December 2011. The guidance provides sponsors of investigational device exemption (IDE) or investigational new drug (IND) applications recommendations about certain information that should be included in a submission describing a product intended to repair or replace knee cartilage. This guidance document does not apply to prostheses such as unicondylar or total knee implants, or meniscus replacement products. Human cells, tissues and cellular and tissue-based products are beyond the scope of this document. A product intended to repair or replace knee cartilage may include a biologic, medical device or combination product (comprised of two or more different types of regulated constituents) whose components would individually be regulated by the FDAs biologics or medical device review centers (the Center for Biologics Evaluation and Research, or CBER, and the Center for Devices and Radiological Health, or CDRH). This guidance document addresses issues that may arise in the development of articular cartilage repair or replacement products. The guidance supplements other FDA publications on IDEs and INDs that may be relevant to development of these products. It also makes final the draft guidance document of the same title dated July 2007. The FDA received numerous comments on that draft. In response, changes incorporated in the final guidance include adding new sections and clinical study schedules, elaborating on nonclinical data considerations and updating the references. Some terminology was changed to harmonize terminology within the FDA and does not change the intent of the guidance. The guidance also reflects input received from the public and the Cellular, Tissue and Gene Therapy Advisory Committee meeting held May 15, 2009. Interested persons may submit either electronic or written comments on final
guidance documents at any time. Send only one set of comments. Submit electronic comments to www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane Room 1061, Rockville, MD 20852. All comments should be identified with Docket No. FDA-2007-D-0020 (formerly Docket No. 2007D-0249).
Live biotherapeutic products

The FDA has announced the availability of a final guidance document titled Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information dated February 2012. This guidance document provides certain IND sponsors with recommendations on submitting INDs for early clinical trials with live biotherapeutic products (LBPs) in the U.S. The guidance focuses on the chemistry, manufacturing and control information that should be provided in an IND for early clinical trials evaluating LBPs. The guidance is applicable to INDs of LBPs, whether clinical trials are conducted commercially, in an academic setting or otherwise. This final guidance makes final the draft guidance of the same title dated September 2010. Interested persons may submit either electronic or written comments on final guidance documents at any time. All comments should be identified with Docket No. FDA-2010-D-0500. The Regulatory Update is excerpted from Research Practitioner, Volume 13, Number 2, March-April 2012. Correction: In the graphic Major CRO proclivity to acquire companies on page one of the March 2012 CenterWatch Monthly, the year given as Parexels incorporation was incorrect. Parexel was incorporated in 1982.
CRO Industry Update

Data and analysis provided by Plutus Capital Partners.
CRO Partnerships
February was a busy month for CROs. The key theme was geographic expansion, with an intent to acquire service capability or client pipeline. Date Feb. 28 Feb. 28 Feb. 23 Feb. 23 Feb. 16 Feb. 7 Feb. 1 Feb. 1 Category Globalization CRO services Globalization Globalization Globalization CRO services Globalization CRO services Partnering companies Quintiles/Russian Venture Company (RVC) Charles River/Millipore Inclinix/JSW Life Sciences Frontage/Fanghui Pharma Quintiles/Dayarn Pharma ESTERN Medical/Nextrials Parexel/ASAN PPD/VirtualScopics Description To strengthen Quintiles service capability in Russia, which it believes will experience rapid growth in the coming years. An exclusive licensing arrangement to use Millipores TrueSpike Technology to enhance Charles Rivers viral clearance studies offering. To strengthen Inclinixs patient recruitment capabilities in Europe. Frontage will provide support in infrastructure, development, regulatory and facility consultation to Chinese pharma companies in a $10 million agreement. To strengthen Quintiles service offerings in the Middle East and North Africa (MENA), a region witnessing annual pharma growth rates of 12%-15%. ESTERNs clients will be able to access Nextrials EDC system that enables EHR integration. Nextrials will be able to provide services in Latin American markets. Parexel has collaborated with South Korea-based ASAN Medical Center to provide early-phase clinical trial services to sponsors in Asia. Alliance expanded (formed in October 2010 focused on Oncology) to include clinical and medical imaging services across CNS, Cardiovascular, general medicine and medical devices.
CRO services: collaboration with the objective of strengthening the clinical service offerings of both companies. Research collaboration: partnership with the objective of building research capabilities. Globalization: partnership with the intent to gain access to clients in new geographic regions.
Multiples
Plutus tracks trading multiples of public CROs. Company Covance Parexel Charles River Laboratories Icon WuXi PharmaTech Ticker CVD PRXL CRL ICLR WX Revenue 2,240.0 1,260.0 1,140.0 945.7 387.2 EBITDA 310.2 138.5 260.0 76.6 112.3 Market Cap 2,910.0 1,490.0 1,740.0 1,280.0 929.3 EV 2,520.0 1,610.0 2,400.0 1,100.0 786.2 EV/Revenue 1.1x 1.3x 2.1x 1.2x 2.0x EV/EBITDA 8.1x 11.6x 9.2x 14.4x 7.0x P/E (Forward) 17.1x 16.5x 12.1x 14.3x 11.1x
In millions, except multiples data. Data as of Feb. 29, 2012.
M&A Tracker
This table tracks the private equity and M&A activity in the CRO space for February 2012. Private equity interest in the CRO space continues, with the acquisition by Linden Capital Partners of SeraCare. Please email news of M&A transactions or CRO partnerships to sushaant.bakhru@plutuscp.com. Type CRO expansion CRO expansion PE investment Rationale Strengthen existing capability New service offering Acquirer Venn Life Sciences/Encorium Ockham Linden Capital Partners Nexus SeraCare Target Description Merger of the two CROs will be headquartered in Ireland and have additional working capital for growth. Oncology CRO Ockham has acquired Nexus Oncology to gain capability in regulatory and EMEA pharmacovigilance services. SeraCare has accepted an $82 million offer from Linden, a Chicago-based, healthcare-focused private equity fund.
CRO expansion: acquisition by a CRO with the objective of strengthening existing capability, adding new service offerings or gaining access to new geographic markets. Business expansion: strategic acquisition by a healthcare-focused entity. PE investment: recapitalization or private placement by a PE fund.
PLUTUS
Global Thinking. Local Solutions.
A boutique advisory firm that provides investment banking services including M&A, private placement and drug licensing to the global healthcare and life sciences industry, Plutus assists global CROs with their growth, acquisition and exit strategies.
ActionItems
Portals can bring social media benefits

By Susan MH Lewenz
T
Susan MH Lewenz is CEO of Axxiem, creator of the AxxiTRIALS CTCP, a core platform that can be customized and branded to each companys needs, with motivating features for both sponsor and study site participants. www.axxitrials.com
he latest hot topic in clinical trials is how social media is a must for patient recruitment. There is little doubt this new public forum holds an important place in patient enrollment and participation. But what about using similar, albeit private, social media tools with communities that already exist internally to clinical trialsthose between sponsors/CROs and their sites? Few sponsors recognize these private communities, let alone garner their benefits. A Clinical Trials Community Portal (CTCP), which plugs in to existing systems through web services, is relatively simple to add. The CTCPs primary function is improved communication between the
sponsor/CRO and sites. The operational benefits, savings and efficiencies come from features including: Send/Receive/Track documents electronically 21 CFR Part 11 compliant signatures Immediate and secure communications via secure Live Chat News and alerts 24/7 online training available Enrollment trackingsites can see how they are doing vs. others; sponsors can evaluate site performance over time. The community component of the CTCP also can have a great impact on trials. Private and secure forums, blogs and image galleries can motivate CTCP usage and, by extension, keep sites focused on the objectives.
The investigators involvement in the day-to-day operation of a trial can be critical to recruitment success. The CTCP enables the physician to provide insights, opinions and input on his schedule on any device. According to Frost & Sullivan, 70% of healthcare professionals use social media to communicate with other professionals. By using a CTCP, sponsors save sites time and provide motivational tools, including the sharing of ideas and best practices with colleagues in a private, moderated forum. Sponsors and CROs can harness the power of social networking to change how their own clinical operations teams interact with their sites, facilitating the flow of communication. The key to improving trial quality will be engaging the trial community in dialogue throughout the duration of a study.
Here comes the Sun(shine Act)

By Samuel Whitaker
s pharmaceutical, biotechnology and medical device manufacturers are discovering in the wake of 2010s Patient Protection and Affordable Care Act (PPACA), big legislation can mean big changes for clinical trials. As the industry mobilized to comply with immediate changes, preparation for later provisions was deferred. But time moves quickly, and now a tiny statute comprising about 1% of the PPACAs text and receiving even less attention from policy analysts has become increasingly prominent. As 22 short pages tucked neatly into PPACA, the Physician Payments Sunshine Provisionthe Sunshine Actmandates that drug, biological supply and medical device manufacThe CenterWatch Monthly | April 2012
turers annually track all payments of over $10 made to investigators and research sites. Penalties of up to $10,000 per omission mean sponsors need robust methods to manage investigator, vendor and site payments. Whether in-house or outsourced, global clinical payment traditionally has been undertaken manually, with limited use of automated resources. This drives payment distribution through several sources and makes consolidation for disclosure purposes difficult, if not impossible. Given the scale of modern clinical trials, delivering, tracking and reporting thousands of these transactions can drive significant administrative costs; in light of the Sunshine Act, payment management also is emerging as a regulatory liability. But just as technology has en-
hanced other aspects of clinical trials, clinical technology developers recently have shifted toward streamlining payment delivery and management processes. By centralizing global payments through a web-based system, technology enables detailed tracking, reporting and financial analytics across multiple CROs, vendors, sites and investigators, for which manual processes would be prohibitively costly and alarmingly unreliable. Efficiently and accurately tracking and reporting payments is no longer the purview of only internal accounting and finance departments; conformity with the Sunshine Act will demand the attention of compliance, regulatory and top management. In advance of the Sunshine Act, forward-thinking executives should capitalize on technology-based solutions for clinical payments.
Sam Whitaker is founder and CEO of Greenphire, a provider of clinical payment technology solutions. Sam has developed and deployed two global clinical payment technologies at Greenphire designed to automate site payments, patient payments and vendor payments. Previously, Sam was a vice president in Citigroups prepaid card division, where he developed new payment technology platforms. www.greenphire.com
IndustryNews Survey
Investigative site plans to hire personnel in 2012

43% 38%
Georgia-based NeuroTrials Research. But I see indicators that things are coming back in a healthy way. I dont think we will be there this year. But certainly all of the signs, such as inquiries for new projects, are coming in. Hopefully we will see a nice, healthy economy for our industry next year.
51%
57%
57%
62%
49% Europe
43% Rest of world
Total
North America Do not plan to hire
Increased level of activity

During January and February, CenterWatch conducted its most extensive study of investigative site operations in a decade. In the survey, 257 global investigative sites with an average of 14 years experience in clinical research provided detailed information about their staffing levels, level of research activity, financial operations and
Plan to hire
outlook for the future. The data establishes industry benchmarks for site operations and gives sponsors and CROs a chance to better understand the overall health and structure of this landscape. More than four-fifths (81%) of clinical trials managed by the typical site are industry
sponsored, which isnt surprising given that pharmaceutical and biotechnology companies account for 90% of clinical research spending. The typical respondent conducted an average of 12 industry-sponsored trials and 2.7 government-sponsored trials in
IndustryNews Survey
Global investigative site mean revenue and profitability
In U.S. dollars Clinical grant revenue Average revenue per investigative site Profit Average profit per investigative site Percent of gross clinical grant revenues (based on average profit) 2010 $504,938 2010 $50,724 10.0% 2011 $534,207 2011 $50,144 9.4% Percent change +5.8% Percent change -1.1% continued from page 9
2011, representing a nearly 6% increase in the total number of trials per site. Sites are expected to conduct an average of 16.2 trials each this year, a 10% increase from 2011. Globally, the size of a typical site increased 8% last year, reaching an average of 12 employees. This growth was driven mainly by adding investigators/subinvestigators or study coordinators to the staff. At SDS Clinical Trials, a dedicated research site in Southern California, CEO Nanci Hook-Seid hired four new coordinators during the past six months and has plans to hire two more to help organize an influx of new studies. When I first started in this industry in 1993, you could have one coordinator for three or four studies. Now, the way our studies enroll quickly, you need one coordinator designated for each study when they are enrolling, she said. Overall, the typical site across the globe enrolled an average of 220 patients in 2011, a 7.3% increase from 2010. Sites in North America enrolled an average of 246 patients in 2011, compared to 151 per site in Europe and 200 in other regions surveyed.
Sites financial health

Although clinical grant spending overall has increased, sites are being forced to do
more with fewer dollars. In 2011, the typical global site received $534,210 in clinical grant revenue, representing a 5.8% increase from 2010. Yet, at a time when protocols have become more complex and require a greater number of procedures, the size of an individual clinical grant for an industrysponsored study remained unchanged in 2011 at about $43,650. With increasing competition for studies and tight budgets, the per-trial amount for industry-sponsored grants is expected to fall to $42,490 this year. The budgets have definitely not kept pace with the complexity or the labor intensity of these studies, said NeuroTrials Jones Beals. When there are fewer opportunities, as there were a year or two ago, that puts the sponsor completely at an advantage. If they dont offer a grant that is as healthy as it might have been, the sites are more accepting than they might have been
Distribution of total investigative site expenses

Investigator fees Study coordinator salaries and fees Rent All other sta salaries Training and certi cation Regulatory fees/protocol amendment fees Information technology Patient recruitment support General site marketing initiatives Other expenses 3% 14%
24% 18% 9% 9% 7% 6% 5% 5%
before the downturn in the economy. Meanwhile, federal grant funding has not kept pace with the for-profit sector. The average individual grant for a governmentsponsored trial dropped to $13,170 last year, less than a third the size of the average industry grant. Although the grant amount for government-sponsored trials is expected to increase 14.5% this year, governmentsponsored grants represent only about 6% of total clinical trial revenue for the average survey respondent. Most sites see little value in going after federal funds when the resources invested in competing for them nearly cancel out the revenue they might receive. Via Christi Research has government grant specialists on its staff, for example, but it no longer aggressively pursues NIH funding opportunities. The funds have dried up, so the competition is a lot more intense, said Good. We have people looking at what is available to compete for and every now and then we will pick one. But we dont chase them anymore. We let them fit with what we need. If we get the grant, fabulous. If we dont, its a system or program we need to put into place anyway. Significantly, survey data found sites overall no longer depend on clinical research for their main source of revenue; more than 60% of site revenue globally comes from other sources. In the U.S., the percentage of income sites receive from clinical research has reached its lowest point in a decade. In 2007, sites received 76% of their revenue from clinical trial grants.
10
That amount dropped to 37% for U.S. sites in 2010 and remained unchanged for 2011. Perceived economic conditions A U.S. sites average revenue from industry2012 compared to 2011 2% 3% 4% sponsored trials is less than half what it was 8% a decade ago, falling from $1.3 million in 28% 34% 32% 2001 to $631,000 last year. 29% Dedicated sites typically must derive all of their revenue from clinical grants, al28% though some earn a small portion of income 32% 34% from activities such as consumer product 48% research. But private-practice physician in32% vestigators can fall back on their practice 26% 29% revenue if clinical research becomes too 12% 4% 2% 2% 10% difficult or less profitable. The survey data North America Europe Rest of world Overall suggests experienced private-practice inWorsen Worsen Stay the Improve Improve vestigators may have less of an incentive to greatly somewhat same somewhat greatly stay in the clinical research business if they Note: Percents rounded to nearest whole number Source: CenterWatch, 2012 Survey of 257 Global Investigative Sites continue to lose studies to lower-cost, novice sites and if the increasing complexity of As for how the grant dollar is spent, sala- a higher percentage of clinical research revstudies makes it difficult to find patients eliries consume 51% of revenue for global sites: enue to regulatory fees and global marketing gible to participate in their trials. If the studies they select are not a profit- investigator fees across all countries com- initiatives than sites in other regions. At Meridien Research, which operates able use of their and their staffs time, they prised nearly a quarter of the budget, while will increase their appointment schedules study coordinator and other staff salaries four dedicated research centers in the Tamon the practice side to compensate at the comprised another fourth. While salaries pa Bay, Fla., area, a tiered-employee support expense of the sponsors clinical research still make up the largest portion of the bud- system has been developed to help manage objectives. Its really difficult to be a practic- get, the percentage of money spent on salaries higher salary costs. Trials have become ing physician researcher today and be prof- has dropped 26% during the past five years as more complex, so you have to be smarter itable in both endeavors, said Daniel Ulrey, other expenses, including rent, training, cer- about how you do business, said CEO president and CEO of MCSI, a U.S.-based tification and regulatory fees, have increased. Cathy Collins. One of the ways weve been 04_TrafalgarEthicsBoard_3p.pdf 3:47 PM sites in Europe tend to allocate In addition, site network with 391 independent sites. 1 3/15/12 see Survey on page 12
CM
MY
CY
CMY
11
IndustryNews Survey
successful is to segregate out functions that higher-level employees dont necessarily need to do. Our coordinators are not doing regulatory, laboratory, phone screening or data entry work. Instead of having a highlevel employee doing all of these ancillary activities, we have support employees that dont make as much money. The model is efficient, effective and economical.
Waning profitability
Globally, survey results show sites struggle with profitability. The average profit for global sites dropped 1.1% in 2011, allowing sites a profit margin of 9.4%. In North America, profit margins dropped slightly to 12% in 2011, while European respondents reported profits fell to 8% last year. Site profitability has been negatively impacted by a new budgetary practice recently adopted by some drug sponsors and CROs. Many sites receive a total budget number for a clinical research project that doesnt delineate what is included, such as whether it covers study start-up costs or specific amounts for each procedure. Sites must
determine whether the total amount will meet their study costs and defend any request for an increase. We go back and ask for specific details as to what they have bundled into a fee and often find out there are a lot of very expensive procedures, said Aspen Clinical Research CEO Jon Ward. Once highlighted, the sponsors/CROs are not delighted to pay for the procedures, but they usually will pay for or revise and remove the specific items from the protocol. This, of course, is another cost, due to the waiting and entire amendment process. In addition, sponsors and CROs typically dont give sites completed protocols and budgets until after they have invested a significant amount of time preparing for the study. Sites generally must complete feasibility questionnaires, go through pre-study site visits, submit IRB and regulatory documents and attend investigator meetings before they see budget figures. The average site spends from $8,000 to $10,000 in direct and lost opportunity costs preparing for a study, said Ulrey. After they have invested their time and money, they are offered a budget. Because of the increasing complexity of the protocols offered today a lot of experienced PIs and administrators are
Profit expectations for 2012

9% 8% 30% 40% 42% 44% 29% 26% 19% 47% 22% 17% Overall Increase greatly 4% 4% 19% Europe Stay the same Decrease somewhat 6% 8% Rest of world Decrease greatly 4% 19%
North America Increase somewhat
Note: Percents rounded to nearest whole number
saying, I need to know what the budget and the timelines are going to be beyond completing the feasibility before we invest further time. Many sponsors understand this and say they will do their best to give the information to the sites. But many sponsors start the process of site identification months in advance of the protocol being completed, internal and FDA approval or a budget being finalized. To improve their profit margins, sites in general are becoming more business savvy. Experienced sites increasingly turn down complex protocols they wont be able to execute. They also apply tighter scrutiny to budgets, pushing sponsors to pay costs that arent always reimbursed such as start-up fees, screen failures, document storage and travel for training. Some sites are diversifying to make up for waning profitability. Via Christi Research, for example, which started in the industry three decades ago as a psychiatric research institute, now runs clinical studies in 16 therapeutic areas, most recently adding specialties in rheumatology, ophthalmology and endocrinology. The facility also has aggressively pursued work from smaller biotech firms and has begun developing relationships with large pharmaceutical companies in China that might want to bring studies to the U.S. for FDA approval. Its very much a rollercoaster, said Good. Five to eight years ago our profit margins were probably higher, but we werent doing the dollar volume. Overall, the margins are tighter. But we have to make that up with more studies and more volume. As profitability has fallen, many sites have become more careful about working with financially risky companies. Some sites insist on monthly payments, rather than quarterly, from single-asset biotech companies. Others decide against working with riskier venture-backed companies altogether. As a result, bad debt write-off in 2011 was only about 5%, unchanged from 2010. Weve become more selective on agreeing to take on new clinical trials, said SDS
12
Clinical Trials Hook-Seid. If its a new sponsor, I will research that sponsor or CRO and make sure they have good financial backing.
Sponsor payment improved

Although slow payments and reimbursements from sponsors has been a long-standing problem for sites, survey data indicates cash-flow issues improved last year. The majority of sites pay their bills promptly, typically no later than 45 days. About one-third of sites report sponsors pay their invoices within 60 days; the average receivable days for work performed reached an all-time high in 2003 when sites waited more than 140 days for payment. Payment schedules have improved as some sponsors have adopted monthly, as opposed to quarterly, systems, and electronic data capture (EDC) helps expedite
payment approval processes. Many sites also have modified their own practices to ensure they are paid promptly. Staff members track milestones in various contracts and follow up on outstanding invoices. Weve gotten a lot better at monitoring and being able to head off problems early, said Meridien Researchs Collins. Sites that dont have good financial management get themselves into trouble because the longer you let an outstanding balance go, the longer it will take to collect that balance. We dont let things go very long. We know how many accounts receivable we have in the 0-to-30-day bucket, the 30-to-60-day bucket and the 60-to-90-day bucket. We are instituting a new policy by which right at the 30-day mark, we are going back and saying, We just wanted to confirm that you received our receipt and you have all of the information you need to pay the bill.
While sites often believe when a CRO manages a study they arent paid as promptly or as well, the CenterWatch survey found CROs have become less of a factor in site profits. More than half of global sites surveyed (57%) said the promptness of grant payment was either about the same or faster when a CRO was involved in managing a study. In addition, almost half (44%) of U.S. sites reported study grants were the same or higher when a CRO was involved in managing a study, compared to just 27% in 2002.
Looking ahead
The outlook for the clinical trials landscapes mirrors the slow, cautious recovery seen across the global economy. Although survey data shows the financial situation improving, sites indicate concerns about
13
IndustryNews Survey
Sponsor payment promptness

37% 37% 42% 27%
the stability of the environment. Only 30% of respondents believe economic conditions for sites will improve this year, while the majority believe their financial situations will either stay the same (34%) or worsen (36%). Although clinical grant spending has increased, sites across the globe have seen their profit margins shrink. Looking forward, sites are evenly split about their profit expectations for this year. About half of sites anticipate profits to increase in 2012, while the other half believes profits will either stay the same or decrease. Sites in Europe are less optimistic than other countries about profit expectations for 2012, with 66% of sites believing profits will either stay the same or worsen. As a result, despite an expected increase in clinical trial activity this year, sites are reluctant to build their infrastructure57% of global sites have no plans to hire in 2012. Certainly the economic downturn has taken its toll, said NeuroTrials Jones Beals. Caution is key. If they dont absolutely have to replace someone who is leaving,
45%
49%
34%
45%
18% Overall
13% North America
25% Europe
28% Rest of world Between 30-45 days
Greater than 90 days

Note: Percents rounded to nearest whole number
Between 45-90 days
they probably arent hiring as much as they might have a couple of years ago. Coming next month: an in-depth analysis of profitability at sites by volume of clinical research activity and infrastructure. Annick Anderson has been conducting market research since 1998 in both the healthcare and consumer packaged goods industries. She can be reached at annick.anderson@ centerwatch.com. minimum number of U.S. patients for trials evaluated by the FDA. Dr. David L. Fried, M.D., F.A.C.P., chief principal investigator and medical director of Omega Medical Research in Rhode Island is in that camp along with owner Johnna Pezzullo, R.N. Pezzullo, whose site runs 20 to 25 trials a year, concedes she is biased: The downturn in the economy already has hurt sites, and now even more business is being lost to overseas locations. But Alberto Grignolo, Ph.D., corporate vice president of Parexel, said theres no turning back the clock on globalization. The world is the stage, he said.
Karyn Korieth has been covering the clinical trials industry for CenterWatch since 2003. Her 30-year journalism career includes work in local news, the healthcare industry and national magazines. She can be reached at karyn.korieth@centerwatch.com.
To obtain a copy of the summary results report of the 2012 CenterWatch Survey of Global Investigative Sites, contact Steve Zisson at (617) 948-5142, stephen.zisson@centerwatch.com.
Trials
be widely used in U.S. clinical practice. For example, when Plavix was part of the pivotal CURE trial, only 600 of the more than 12,000 patients were from the U.S., said Harrington. That formed the basis of what we do in clinical practice. For a drug thats going to be used as widely as that, why so few patients in the United States? Harrington and others raise questions of how globalization is affecting trials, whether where patients come from makes a difference and what solutions should be pursued. The questions echo through the larger clinical trials industry. One solution popular with some research sites and their advocates is to require a
The trend toward non-U.S. trials

Currently, more than half of all FDAregulated principal investigators are in
North America, compared with more than 80% a decade earlier. We are increasingly seeing marked drop-off in U.S. enrollment, added Harrington. One example of that shift, he said, is the stark difference between the GUSTO trial in the 1990s, in which 50% of patients were from the U.S., and the PLATO trial reported in 2009, in which only 10% of patients were from the U.S. The number of U.S.-based principal investigators rose from 6,000 in 1991 to 14,000 in 2007, according to Grignolo. But the number for the rest of the world exploded during that time, from 500 to 12,000. Jonathan C. Fox, M.D., Ph.D., vice president of the CVGI clinical therapeutic area for AstraZeneca, said costs are lower outside the
14
U.S. Rent, electricity, the doctors time, the nurses time, its all cheaper, he said. Mean patient costs in Eastern Europe are half of those in the U.S., and in Asia the figure is 48%, according to TTC. But labor costs change over time. They are lower when a country first begins to conduct clinical trials, then rise with the increased demand for workers, according to John Lewis, vice president of public affairs at ACRO, the trade group representing the eight largest CROs. Indian labor costs, for instance, have risen to U.S. wage levels, he said. And labor savings have to be balanced against the costs of regulatory delays in those countries and expenses such as shipping medicines to a developing country or transporting tissue samples to a central lab in another country. Mark Lacy, president of Benchmark Research in Austin, Texas, said sponsors are CWMonthly_Chiltern_Gallery_Half Page taking trials elsewhere for more than just
Are global trials really faster?

Western Europe Average time to activate each site (months) Average monthly patient enrollment rate (per site) 8 9 North America 5 10 Emerging regions 16 21
Source: CenterWatch, 2011 (N= 236 phase III global trials)
cost savings. They are leaving the United States to get around rules and regulations. In India, for instance, stipends can amount to a quarter of a patients annual income, which would not happen in the U.S. But Lewis said evading good regulation only yields bad datawhich would be a waste of money. ACRO analyzed 22 multi-regional trials and found no statistical difference in quality among the data from different countries, 10/3/11 11:56 Page 1 Lewis said.
Lewis, Grignolo and Fox agree there are important benefits to globalization. There are a lot of human beings living outside the United States on planet Earth, and we care about them, too, Fox said. Its not all about us. Conducting trials in other countries helps sponsors with both regulatory approval and sales in those countries. And it helps get medicines to patients faster. Lewis said, for example, phase III cancer trials
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IndustryNews Trials
Mean per patient costs 2008-2011 relative to North American rates

All phases and therapeutic areas 100%
would take on average nearly six years with U.S. patients only, compared with less than two years with a global patient base. FDA Deputy Director Doug Throckmorton said, Good data, whether it comes from the United States or other parts of the world, help us understand if a new drug works. And the global population makes it easier to fill studies. In the U.S., patients have other treatment options and many arent interested in participating, said Grignolo, while in countries with less modern medicine, patients are more eager to enroll.
65%
59%
50%
48%
North America
Western Europe
Latin America
Eastern Europe
Asia
Source: TTC, LLC
Population differences
Trials sites, academics and CROs differ on whether trial location makes a difference. Some experts argue that demographics, lifestyle and health systems are different in the U.S., so the impact of a drug can be different, too. Youd like enough patients in the U.S. to gain a sense of comfort that the results in the U.S. are consistent with whats observed in the rest of the world, said Harrington. But CROs argue the location of the trial often does not affect the results. Grignolo said regulators can and should look at whether a drug works for their population, but it should be done on a case-by-case basis, not as a requirement that a certain percentage of all trials be conducted in that country. A blanket requirement misses the point, said Grignolo. Every drug can be different. Every disease can be different. Medical practice may be different or similar. Throckmorton said the FDA looks at population differences in approving drugs. Genetics can mean some populations metabolize drugs differently. And practice patterns, lifestyle and other medications can have an impact on a drugs effectiveness. We understand we are regulating the U.S. market, he said. We really do want
to make sure the medicines we approve do work in the U.S. But demographics may not be the best way to understand differences between populations, said Grignolo. Scientific knowledge from the human genome is playing a role. In some cases, he said, differences between Northern and Southern European people may be more pronounced than differences between Asian and European populations. Because of that, looking at biology and genomics is becoming more important than geography and ethnicity, he said. But critics say when the U.S. is a smaller portion of the trial population, demographic groups within the U.S. get even shorter shrift. Systemic differences in the U.S. also raise questions. Harrington said the U.S. practice of medicine can be very different than in other parts of the world when it comes to concurrent medicines, different procedures and interventions for repeat symptoms. Disease prevalence and lifestyle also vary by region. U.S. patients, for example, typically have heavier body weight, he said. And, he added, about 25% to 30% of U.S. patients in cardiovascular trials may have diabetes, compared with 15% in the rest of the world. Fox said an arbitrary quota would hit trials where population differences affect the
trial as well as those that dont. Instead, requiring U.S. patients be included in trials should have some scientific basis for that particular disease.
Solutions
Fried would like to see the FDA impose a minimum requirement for U.S. participants in clinical trials for drugs it approves. The FDA is the safeguard, he said. Fox warns that any quota would still leave U.S. patients as only a percentage of the trial. And under the laws of statistics, drawing conclusions from that smaller percentage of the whole study will not always guarantee accurate results. Lewis, of ACRO, said quotas are downright impractical. If you designed trials to match U.S. demographics, he said, youd never finish the trial. Its difficult enough to recruit patients now. And whos to say the real difference is not between countries but, say, between populations in Baltimore and rural Kentucky. Sponsors and the FDA already can look at the global results to see whether theres a difference in effectiveness among different populations. Thats the current system and we think that works pretty well, Lewis said. That should be the presumption going in that people are people.
16
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IndustryNews Trials
Throckmorton said Congress already calls on regulators to look at the effects on the U.S. population. Only rarely is that effect different than for the overall trial population. In those cases, the FDA can request the sponsor provide more information or conduct additional trials. For example, he said, with the blood thinner ticagrelor, questions arose about whether it affected the U.S. population in the same way. When the FDA approved the drug, regulators modified how it was used for U.S. patients. The FDA, said Throckmorton, has other methods than quotas to achieve the same ends. Lewis does not expect the FDA to adopt a quota. In what is already a very complicated, not always transparent, approval pro-
cess that everyone concedes takes too long and costs to much, we see no justification for complicating it with a quota, he said. But other countries do impose requirements that clinical trials be conducted on their populations. Grignolo, who is based in Japan, said Japanese regulators feel Caucasian doses often are too high for their populations. One-third of drugs approved in Japan have an effective dose that is 50% of the Caucasian dose, he said. Sponsors must meet Japanese patient minimum levels in trials and show data comparing those patients to the overall results. And Grignolo said China (where Parexel has four offices), requires that some phase II and phase III data be produced in China. The exact percentage is negotiated between regulators and sponsors for each trial. Other options are being discussed for encouraging U.S. trials.
Fox would like the government to find ways to encourage community physicians to run trials and attract more American patients to participate. Harrington would like to see the National Institutes of Health use its funding and influence to encourage more U.S. universities to conduct trials. And Fried would like to see private insurers require that drugs they cover have U.S. trials. Who else can make a difference? The people who pay for drugs at the consumer level. But Lewis said government and private insurance programs just want to know if a drug is effective. That has nothing to do with where the trial is conducted. I dont see insurer interest there. Lewis said the way to keep more trials in the U.S. is to provide incentives to doctors to conduct trials. But he worries health care reform will do just the opposite. The new
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rules aimed at transparency, known as the Sunshine Act, require pharmaceutical firms to publicly disclose payments to doctors, including those for clinical trials. A recent survey conducted by ACRO showed 24% of investigators said they would be less likely to conduct research if that income was disclosed to the public. Lewis also would like to see tax law changes to allow sponsors and CROs to bring profits from overseas operations back to the U.S. to reinvest in more research without paying 35% tax rates. Lacy said companies take advantage of all sorts of tax loopholes that encourage them to move trials out of the U.S. The American sites, American people are being shortchanged. The U.S. unwittingly encourages companies to conduct trials elsewhere by doing much more auditing of U.S. sites than of
Estimated time to enroll FDA-regulated phase III cancer studies

Total FDA-regulated, actively enrolling phase III cancer trials worldwide 1,218 Number of willing and eligible patients per study in the U.S. Years to ll trial with U.S. patients only 120 5.8 357 1.9 Number of willing and eligible patients per study worldwide Years to ll trial with global patients
Source: VOI Consulting, based on data from American Cancer Society, Globocan and clinicaltrials.gov
foreign ones, he said. The FDA should take a tip from the British system and charge drug companies for audits performed at sites outside the country. Were not asking for anything more than parity and equal treatment, Lacy said. But he doubts anything will change because of the lobbying power of the pharmaceutical industry. But Throckmorton said the U.S. has a different systema single fee for trials does
go toward inspections, both foreign and domestic, among other things. Some audits are conducted abroad, but the choice of whether to audit is based on issues such as past record, size of trials and data anomalies detected. I dont see us making our choice based on geography, he said. FDA figures compiled by the Office of Biostatistics show that in 2008, 1.9% of
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IndustryNews Trials
Global distribution of FDA-regulated clinical trials

Total number of unique, active investigators
3,578 3,578 3,865 2,319 5,828 4,440 6,787 4,072 8,358 3,343 4,663 2,869
domestic sites were audited, but only 0.7% of foreign sites were audited. The FDA has access to audits the sponsors perform themselves. Whether or not we are in the door, there are other ways to get information, Throckmorton said. He said the FDA is working to improve the clinical trials infrastructure, which would help keep more trials in the U.S. The FDA is trying to clarify regulations for the adverse events reporting system, for instance, to make the process less time consuming. And changing rules to make it easier for clinical investigators to become part of trials also will help encourage domestic trials. Throckmorton said the Clinical Trials Transformation Initiative Program (CTTI) is an effort to improve the way clinical trials are conducted in the U.S. If we make it efficient, they will continue to want to have their trials in the U.S., he said. Grignolo, an executive board member of CTTI, echoed the call for simplification. Bureaucracy and inefficiencies drive some trials out of the U.S. The average National Cancer Institute trial takes 800 days to enroll, he lamented.
18,401
19,585
17,483
16,239
16,159
14,568
2000 Other
2002 Western Europe
2004
2006
2008
2010E
North America
Source: Tufts CSDD; <csdd.tufts.edu>
That is a remarkable inefficiency that does not serve the patient well, he said. Hed like to see academic centers agree on templates for contracts with sponsors, so sponsors dont have to negotiate separately with each academic center for the same trial. Standardized case reporting forms and other documentations also would streamline the process greatly. Finding ways to keep trials in the U.S. is important for keeping the industry healthy, said Pezzullo of Omega Medical Research. If big companies are allowed to run most of their trials outside the U.S., its going to hurt the industry. We have good safeguards,
quality data. One thing people on all sides of the issue agree on is that globalization will continue. Fox hopes the U.S. doesnt leave all research to other countries. Society loses if we as citizens of the United States with a long history of successful innovation dont continue to make those kinds of innovations. Tamara Lytle is a Washington, D.C.-based freelance writer. She has covered government policy, healthcare reform, politics and Congress for more than 20 years. She writes for newspapers, national magazines and web sites.
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Grant Lead Opportunities

Drug name LX7101 Not Provided HuCNS-SC Indication glaucoma or ocular hypertension Schizophrenia dry age-related macular degeneration Alzheimers elevated intraocular pressure influenza type I diabetes kidney transplant rejection pain non-tuberculous mycobacteria high-grade glioma H5N1 avian influenza dyslipidemia melanoma genotype 1 hepatitis C Company name Lexicon Pharmaceuticals Reckitt Benckiser Pharmaceuticals StemCells Projects soon to be entering phase I/II
CenterWatch analyzes data in its drug intelligence service to provide advance notice of clinical trials expected to be entering the next phase of clinical development soon. Contact information is provided to inquire about trials. If you are a sponsor or CRO and would like to list your upcoming trial here or initiate a search to identify sites for your upcoming trial, or if you are a site and would like your profile matched to sponsor and CRO requests, contact Claire Gross, (617) 948-5121, claire.gross@centerwatch.com.
Contact information Anne Turnage, aturnage@lexpharma.com (281) 863-3740 Angela Smith, angela.smith@rb.com (804) 594-4661 Rodney Young, chief financial officer (510) 456-4128 Alison Torres, alison.torres@abbott.com Betty Prine, betty.prine@abbott.com Brian Levy, blevy@aeriepharma.com (908) 470-4320 (425) 354-5038, avi@avibio.com (858) 729-6500, www.cebix.com U.S. GSK Clinical Trials Call Center GSKClinicalSupportHD@gsk.com, (877) 379-3718 (919) 941-5206, www.icagen.com Catherine Kessler, NTM@insmed.com Dr. Daniel Pertschuk, dpertschuk@tocagen.com (415) 437-0132, www.vaxart.com (415) 283-2200 (646) 214-0700, www.ziopharm.com Peter DiBiaso, peter_dibiaso@vrtx.com
Projects soon to be entering phase II ABT-126 AR-13324 AVI-7100 Ersatta belimumab Nav 1.7 Arikace Toca 511 H5N1 avian influenza vaccine VIA-3196 ZIN ATI-001 Incivek + VX-222 + ribavirin eculizumab imetelstat IPI-504 MEDI-563 Reolysin SQ109 Not provided Multi-phase trials Not provided renal failure ProMedDx, LLC. Marion M. Santa Ines, MA, CCRA, marion@promeddx.com (508) 285-7877 Abbott Aerie Pharmaceuticals AVI BioPharma Cebix GlaxoSmithKline Icagen/Pfizer Insmed Tocagen Vaxart VIA Pharmaceuticals ZIOPHARM Oncology Vertex
Projects soon to be entering phase IIb
Projects soon to be entering phase III atypical Hemolytic Uremic Syndrome Alexion recurrent or metastatic breast cancer Geron non-small cell lung cancer Chronic Obstructive Pulmonary Disease ovarian, fallopian tube or primary peritoneal cancer H. pylori-related duodenal ulcers acute bacterial skin and skin structure infections Infinity Pharmaceuticals MedImmune/ AstraZeneca Oncolytics Biotech/ Gynocologic Oncology Group Sequella, Inc. Synteract, Inc. (203) 272-2596, www.alxn.com (650) 473-7700, www.geron.com Rob Ross, rob.ross@infi.com (301) 398-0000, www.medimmune.com Dr. Gerard Kennealey, gkennealey@oncolytics.ca (301) 762-7776, www.sequella.com Heather Bentley, hbentley@synteract.com (760) 476-8854
21
PipelineNews
Eye On
By Laurie Barclay, M.D.
undbeck aims to become a world leader in psychiatry and neurology, and improve the quality of life of people suffering from disorders in these areas, by developing and providing innovative specialty therapies. Its web site describes its core values as imagination, passion and responsibility. The companys focused expertise, global resources, extensive academic and institutional research network, and reputation for effective partnering, make it a logical choice for other companies seeking mutually beneficial partnerships to advance clinical-stage and commercial pharmaceutical products. Diseases targeted by Lundbeck include psychiatric conditions of depression and anxiety, psychosis, bipolar disorder, Alzheimers disease and alcohol dependence. In addition, Lundbeck is involved in developing treatments for neurological diseases including Parkinsons disease, Huntingtons disease, epilepsy, stroke and LennoxGastaut syndrome. Its state-of-the-art technologies focus on mechanisms of synaptic transmission, neurodegeneration and neuroinflammation. Corporate development for this mediumsized pharmaceutical company is based in Copenhagen, with offices worldwide. Multidisciplinary research teams in Denmark and in the United States integrate their advanced knowledge in research and development disciplines with clinical and therapeutic expertise. Lundbecks Psychiatry/Psychology pipeline contains four drugs in phase III, one in phase II/III and three in phase II. In Neurology, Lundbeck has two drugs in phase III development. A once-monthly, depot injectable formulation of aripiprazole, a dopamine D2 partial agonist for maintenance treatment
of schizophrenia, was co-developed with Otsuka Pharmaceuticals. A phase III, multicenter, randomized, double-blind, placebo-controlled U.S. clinical trial assessed the efficacy, safety and tolerability of the intramuscular formulation. Although this study was originally designed to continue for 52 weeks, interim analysis showed the drug successfully met efficacy criteria and the study was stopped. In November 2011, the FDA accepted the New Drug Application (NDA) for aripiprazole depot formulation for maintenance treatment of adults with schizophrenia. Also in phase III testing for schizophrenia is zicronapine (previously known as Lu 31-130), a monoaminergic agent that preferentially acts at the dopamine D4 receptors, with potent antagonistic effects at dopamine D(1), D(2) and 5-HT(2a) receptors. Pharmacological data suggest zicronapine has antipsychotic activity as well as good tolerability. Findings from two randomized phase II clinical studies were significantly and strongly positive, with clear differences from placebo at zicronapine doses of 7mg and 10mg. In addition, efficacy and safety data were favorable in comparison to olanzapine. For schizophrenia and adjunctive treatment of major depressive disorder (MDD), Lundbeck and Otsuka Pharmaceuticals are in phase III development of OPC-34712, a novel psychotherapeutic agent intended to offer improved efficacy and tolerability with less akathisia, restlessness and/or insomnia than currently available agents. It affects multiple monoamine systems and has reduced partial agonist activity at D2 dopamine receptors and enhanced affinity for specific serotonin receptors. Also in phase III trials for depression and anxiety is Lu AA21004, a multimodal an-
tidepressant with reuptake inhibition and receptor activity as a 5-HT3 and 5-HT7 receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the 5-HT transporter. In nonclinical studies, Lu AA21004 has been shown to increase serotonin, noradrenaline, dopamine, acetylcholine and histamine in specific brain regions. Preclinical as well as clinical data suggest potential efficacy and good tolerability of Lu AA21004. All tested doses met the primary efficacy endpoint in a placebo-controlled, European study enrolling 560 patients with MDD. In addition, a relapse prevention study enrolling 639 patients showed Lu AA21004 had long-term efficacy in MDD maintenance treatment. Most adverse events were judged to be of mild to moderate severity. Nalmefene (Selincro), a specific opioid receptor antagonist with a distinct mu, delta and kappa profile, is in phase II/III testing for pathological gambling and in phase II testing for smoking cessation. It has been evaluated for the past two decades as a potential treatment for substance use disorders, and it has been shown to help regulate alcohol intake through its activity at the cortical mesolimbic circuit. Treatment, therefore, can be individualized to limit alcohol consumption rather than requiring full abstinence. In multicenter, randomized, double-blind, placebocontrolled, phase III trials, alcohol-dependent patients reduced their total alcohol intake by an average of two thirds after six months of treatment with 18mg nalmefene. The drug was safe and well tolerated, and efficacy was maintained and even improved after one year of treatment. For treatment of depression, Lundbeck is partnering with Takeda on phase II testing of Lu AA24530, a monoamine enhancer with reuptake inhibition at monoamine transporters and antagonist activity at 5-HT3 and 5-HT2c. Animal models showed increases in acetylcholine, noradrenaline,
22
Pipeline activityLundbeck
dopamine and 5-HT levels in brain regions involved in mood regulation and suggested Lu AA24530 would have improved efficacy and more rapid onset of action in the treatment of depression. In a dose-finding, phase II clinical trial in patients with MDD, six weeks of treatment with Lu AA24530 was well tolerated and associated with statistically significant improvements compared with placebo on the primary efficacy endpoint and on key secondary endpoints. For Alzheimers disease, Lundbeck is in phase II testing of Lu AE58054, a potent and selective antagonist of the 5-HT6 receptor, which is mostly located in brain regions implicated in cognition. A long-term, multicenter, placebo-controlled trial of Lu AE58054 as add-on therapy to donepezil is underway in patients with moderate Alzheimers disease. In the Neurology arena, intravenous carbamazepine is in phase III development for epilepsy. This sodium channel blocker is a novel injectable formulation of the oral antiepileptic drug, which has been in widespread use for nearly four decades for treatment of complex partial seizures. The intravenous formulation would be useful for patients who temporarily could not take carbamazepine by mouth because of surgery or for other reasons. A clinical trial is underway to assess bioequivalence of intravenous and oral doses and to compare the safety, tolerability and pharmacokinetics of the two formulations. Also in phase III trials is desmoteplase, a novel plasminogen activator and highly fibrin-specific thrombolytic agent, licensed from Paion for treatment of acute ischemic stroke. When compared with alteplase, currently used to dissolve thrombosis in acute ischemic stroke, desmoteplase has high fibrin selectivity, no neurotoxicity, no apparent harm to the blood-brain barrier and a longer half-life (about four hours compared with about five minutes). The FDA has issued Fast Track designation to
see Lundbeck on page 24
Total revenue 2011: $2.9 billion Total R&D spending 2011: $620 million Pipeline activity by phase
Phase II
Psychiatry/Psychology
Phase II/III
Phase III
50%
Neurology
100%
Comparing phase IIII pipeline distribution

Lundbeck Industry Benchmark 60% 40% 0% Phase I Phase II Phase III 30% 39% 21%
Distribution of drugs in development by primary therapeutic area focus

Neurology 2
Date major drugs entered current clinical phase

Phase III Drug Name OPC-34712 -depression -schizophrenia zicronapine intravenous carbamazepine Lu AA21004 -anxiety -depression Aripiprazole depot formulation desmoteplase nalmefene -pathological gambling Lu AE58054 Lu AA24530 nalmefene -smoking cessation Date Jun 2011 Jul 2011 Apr 2011 Jun 2010 Jun 2008 Dec 2007 Jul 2008 Apr 2005 Aug 2005 Dec 2009 Oct 2007 Sep 2005
III III III
III III II/III II II II
April 2012 | The CenterWatch Monthly 23
Drug development practicesLundbeck

Global distribution of active phase IIII clinical trials
PipelineNews Lundbeck
100%
400+ sites 300399 sites 200299 sites 100199 sites 099 sites
Average number of countries, by phase, where clinical trials are conducted

Phase II 21 Phase II/III N/A Phase III
Top ve countries where clinical trials are conducted

1. United States 2. Germany 3. Poland 4. Russia 5. France
54
Average number of investigative sites by region

Average Phase Drug number of sites Average number of sites in the U.S. in W. Europe in E. Europe rest of world
III
III III III
III III II/III II II II
OPC-34712 -depression -schizophrenia zicronapine intravenous carbamazepine Lu AA21004 -anxiety -depression Aripiprazole depot formulation desmoteplase nalmefene -pathological gambling Lu AE58054 Lu AA24530 nalmefene -smoking cessation
63 19 24 29 52 47 174 90 51 72 1
40 31 29 46 32 86 56 1
5 4 9 13 17 20 21 12 -
17 1 18 23 13 58 9 16 21 -
3 3 2 56 17 100 38 14 39 -
desmoteplase, a genetically engineered version of a thrombolytic protein found in the saliva of the vampire bat. Studies to date have suggested desmoteplase was more effective than placebo in patients with visible arterial occlusion or high-grade stenosis on baseline angiography, and these patients had less severe strokes and smaller mismatch volumes when treated with desmoteplase. Lundbecks long track record of success in the Psychiatry and Neurology fields should continue to apply to the drugs in its pipeline, which primarily target highly prevalent conditions including depression, Alzheimers disease, epilepsy and stroke. In the Psychiatry arena, most of Lundbecks candidates involve neurotransmitter manipulation through receptor agonists or antagonists. In Neurology as well as in Psychiatry, some candidates are novel formulations of drugs with a long history of widespread use. Laurie Barclay, M.D., is a neurologist who has published more than 60 peer-reviewed journal articles concerning her research on Alzheimers disease and other dementias. Following her medical internship and neurology residency at the New York HospitalCornell, her neurobiology fellowship was at the Burke Rehabilitation Center-Cornell, where she also served as chief of the Spinal Cord Trauma Unit and clinical director of dementia research. Dr. Barclay was an assistant professor of neurology at the New York Hospital-Cornell, 1983-1987, and at the University of South Florida, 1987-1992, and then went into private practice, medicolegal consulting and medical writing. She retired from practicing neurology in December 2005 to become a full-time medical writer and journalist, and to devote more time to professional ballroom dancing with her husband and partner, Richard Collett.
24
The CenterWatch Monthly |April 2012
Phase Drug Name Neurology III III intravenous carbamazepine desmoteplase
Indication
Mechanism of Action
Additional Information
epilepsy stroke
A sodium channel blocker A plasminogen activator Licensed from Paion
Psychiatry/Psychology III III III III II/III II II II OPC-34712 zicronapine Lu AA21004 Aripiprazole depot formulation nalmefene Lu AE58054 Lu AA24530 nalmefene depression and schizophrenia schizophrenia depression and anxiety schizophrenia pathological gambling Alzheimer's disease depression smoking cessation Monoaminergic; preferentially acts at the Dopamine D4 receptors A multimodal antidepressant with reuptake inhibition and receptor activity A dopamine partial agonist co-developed with Otsuka Pharmaceuticals co-developed with Otsuka Pharmaceuticals
Register by A monoamine enhancer with reuptake inhibition at monoamine Partnered with Takeda March 16 transporters and antagonist activity at 5-HT3 and 5-HT2c and save up A specific opioid receptor antagonist to $400
A selective 5-HT6 receptor antagonist
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April 2012

Volume 19, Issue 04

Global sites see growth in trials, revenue, staffing

Global investigative site staffing

15.6 14.1 +7.1% 8.4 6.3 +4.0% +15.8% 5.2 Europe

12.2 10.6 +4.9%

Part one of a two-part series

+16.7% 2.4 North America

2.8 North America

5.7 Rest of world

Source: CenterWatch, 2012 Survey of 257 Global Investigative Sites

Industry struggles with prospect of trials leaving U.S.

Copyright 2012. CenterWatch. Duplication or sharing of this publication is strictly prohibited.

Cheryl Appel Rosenfeld Editor-in-Chief

April 2012 | The CenterWatch Monthly

CenterWatch Information Services

The CenterWatch Monthly | April 2012

Topics of the past months Pulse columns:

Executives interviewed in the past months Insider Insights columns:

April 2012 | The CenterWatch Monthly

InReview Regulatory Update

Final guidance for knee products

Live biotherapeutic products

The CenterWatch Monthly | April 2012

CRO Industry Update

In millions, except multiples data. Data as of Feb. 29, 2012.

Global Thinking. Local Solutions.

April 2012 | The CenterWatch Monthly

Portals can bring social media benefits

Here comes the Sun(shine Act)

Investigative site plans to hire personnel in 2012

43% Rest of world

North America Do not plan to hire

Increased level of activity

Source: CenterWatch, 2012 Survey of 257 Global Investigative Sites

April 2012 | The CenterWatch Monthly

Source: CenterWatch, 2012 Survey of 257 Global Investigative Sites

Sites financial health

Distribution of total investigative site expenses

The CenterWatch Monthly | April 2012

April 2012 | The CenterWatch Monthly

Profit expectations for 2012

North America Increase somewhat

Note: Percents rounded to nearest whole number

Source: CenterWatch, 2012 Survey of 257 Global Investigative Sites

The CenterWatch Monthly | April 2012

Sponsor payment improved

April 2012 | The CenterWatch Monthly

Sponsor payment promptness

13% North America

28% Rest of world Between 30-45 days

Greater than 90 days

Between 45-90 days

Source: CenterWatch, 2012 Survey of 257 Global Investigative Sites

continued from page 1

The trend toward non-U.S. trials

The CenterWatch Monthly | April 2012

Are global trials really faster?

Source: CenterWatch, 2011 (N= 236 phase III global trials)

The Fine Art of Clinical Research

PLEASE VISIT US AT ACRP Booth #630 April 14-16

smart phone link

April 2012 | The CenterWatch Monthly