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BRANY Continues to Support Clinical Trials see page 5, Booth #3425

A Passion for Patient Recruitment DSA is Advancing the Practice of and Retention see page 18, Booth #3236 Pharmacovigilance see page 7, Booth #2245

1st EDITION

Monday June 25, 2012

Philadelphia • FREE

ACM Global Central Laboratory CCO Discusses Commitment to Service

Mark Engelhart is chief commercial officer of ACM Global Central Laboratory, where he leads the company’s business development, proposals and contracts, and marketing and sales activities worldwide.

Q: Tell us about ACM Global Central Laboratory and of the types of services your company offers.

A: ACM Global Central Lab has a 10-year track record in global clinical continued on page 21

Ed Seguine, CEO of Clinical Ink Discusses What Makes His Company a ‘2012 Cool Vendor’

The theme of DIA 2012 is ‘Collaborate to Innovate.’ Drug Industry News interviews one of the ‘2012 Cool Vendors’ identified as innovators by Gartner Research— Clinical Ink CEO Ed Seguine (Booth #3104). Q: Where is the biggest opportunity for ‘Innovation’ within the industry? A: Certainly the pharmaceutical industry innovates as it relates to scientific discovery. continued on page 20

Study Visits Conducted at Home Improves Recruitment/Retention and Speeds Trials

GlobalCare Clinical Trials, Ltd continues expansion of patient-centric services to more than 25 countries across five continents. GlobalCare provides selected clinical study visits at patients’ homes, workplace or alternate settings to support phase I-IV trials across a variety of therapeutic areas and genomics research. CEO, Gail Adinamis, states that “our service model provides faster patient recruitment, better protocol compliance and higher retention rates, while decreasing development time. Our model was built on the simple continued on page 20

Drug Development Challenges: Choosing the Right Global Central Laboratory

Finding a qualified and experienced global Central Laboratory is a challenge for most drug developers, with the increasing complexity of therapeutic compounds and the rapid evolution of molecular biology, immunology and genetic science. Central Laboratories with builtin expertise specializing in assay development and validation are an excellent outsourcing option. As service providers, a Central Laboratory can become an extension of the continued on page 21

Spotlight on the Changes and Challenges of eCOA

Rachael King—CEO of leading eCOA solutions provider, CRF Health—discusses the changing face of eCOA solutions for patients (ePRO), clinicians (ClinRO) and observers (ObsRO). Q: What is driving the change to conducting more electronic Clinical Outcome Assessments (eCOAs)?

A: As drug development costs continue to escalate, our industry is increasingly recognizing the need to become more efficient and conduct continued on page 21

Quorum Review IRB General Counsel and Expert Panel Discuss Non-Interventional Minimal Risk Research in DIA Interactive Session

Quorum Review IRB’s General Counsel and Director of Regulatory Affairs will present an interactive session on minimal risk research at this year’s DIA 48th Annual Meeting on Tuesday, June 26, held in Philadelphia. Linda Coleman, JD, CIP, CHC, CHRC, will lead the expert session ‘Non Interventional Minimal Risk Research: a 360-degree Perspective.’ The continued on page 20

Verified Clinical Trials: Improving Clinical Research Communication Through Network

There is a new buzz in the clinical research community. Dual enrollment or multiple simultaneous clinical trial participation by professional research volunteers has become the hot topic and Verified Clinical Trials (VCT) has become the company to watch. Verified Clinical Trials has not only developed a novel ID metric scalable system to improve research subject safety and data quality, but has also united an industry. continued on page 17


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Drug Industry News

Monday, June 25, 2012

Penn Pharma Strengthens its Finance Team with Senior Appointment

Penn Pharma, the specialist provider of pharmaceutical development and manufacturing services, has announced the appointment of a new Director of Finance, Craig Collingwood has joined Penn at an integral point, playing an essential role in the company’s growth strategy. Craig’s appointment follows a recent £14 million investment announcement from the global pharma company in its South Wales, facility to expand its specialist high containment offer.

As a qualified chartered accountant, Craig brings more than 12 years experience having worked for KPMG in Reading, Cardinal Health, and Catalent Pharma Solutions as Group Finance Director, where he managed a number of international group businesses. His most recent experience comes from working as an independent consultant within the pharma industry for his own company. Speaking on his appointment, Craig said: “The future plans and growth

Phlexglobal Announces New Strategic Focus as ‘The TMF Experts’

Following 12 months of significant international expansion, Phlexglobal, the pioneer of the first commercial electronic Trial Master File (eTMF) solution, PhlexEview, has today announced its new corporate repositioning as ‘The TMF Experts’, with a brand new image and website—www.phlexglobal.com. Launched ahead of the DIA Annual Meeting in Philadelphia next week, the

repositioning is in response to the increasing global focus on Trial Master Files (TMFs) and international customer demand for both Phlexglobal’s eTMF solution and its paper and electronic TMF quality services. Phlexglobal’s ability to provide experienced resource at short notice to support preparation for Regulatory Inspections has also resulted in significant expansion of the UK office in Amer-

targets at Penn really appealed to me, I am excited to have joined the team at such a significant point in the company’s development. Finance is particularly important in this transitional period so I can really use my skills to ensure strong cash management during the investment in our High Containment Operations.” The construction of the new 15,000 square foot development and commercial manufacturing unit for tablets and capsules has already commenced and it is designed to meet the highest international Quality Standards. The new facility will enable the team at Penn to further build upon its established 15 year expertise in the manufacture of highly potent drugs for continued on page 20

sham, Buckinghamshire with a new site opening shortly, and a three-fold increase in headcount in the United States office in Malvern, Penn. Stella Donoghue, managing director of Phlexglobal, commented, “Our business has grown considerably in the past few years and that is largely due to the success of PhlexEview and our TMF quality services. We pride ourselves on our delivery of innovative, flexible and adaptable technology and resource solutions and it is these core values that have continued on page 17

Drug Industry News An independent publication not affiliated with any other organization Gary Cox Publisher Steve Cox Senior Associate Publisher MIchael Harris National Sales Manager Rhonda Baker John McQuaig Deborah Yarbrough Associate Publishers Valerie Wilson Art Director Elena Cruz Editor Monique Carter Tiffany Webster Administration Drug Industry News is published by Source Group LLC ©2012. All rights reserved.

6979 East Broadway Blvd., Suite 109 Tucson, AZ 85710 phone: (520) 722-2000 fax: (520) 722-2014 www.sourceg.net


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Drug Industry News

Monday, June 25, 2012

Acurian Expands its Market Leading Exco InTouch Continues Significant Position in the Direct-to-Patient Growth with Appointment Arena; Clinical Trial Recruitment of Chief Technology Officer ing the company’s focus on product inExco InTouch announces the appointDatabase Now More Than novation and efficiencies in its operament of Madhav Vattikuti as Chief Techtional tool delivery set, as it grows its nology Officer (CTO). Vattikuti’s role 70 Million and Growing presence in eClinical, mHealth and Late will see him use his significant technol-

HORSHAM, Pa,— Acurian, Inc., a leading, full-service provider of global patient enrollment and retention solutions, announced that it has expanded its marketleading, opted-in database to more than 70 million people. These are individuals who have self-reported specific ailments and provided permission to be contacted exclusively by Acurian for clinical trial opportunities. In 2011, the company contacted more than18 million people using its proprietary recruitment database, supporting clinical trial enrollment for studies of diabetes, opioid-induced constipation, depression, asthma, COPD, back pain, bipolar disorder, female sexual dysfunction, hypertension and more. While other recruitment companies and Contract Research Organizations (CROs) maintain databases that are typically gathered via online disease communities, the largest of these communities is under four million individuals. “We have a significant advantage in

trial enrollment services due to the sheer size of our patient database and unparalleled access to potential trial participants,” said Rick Malcolm, Acurian’s CEO. “Only a database with this size and scope can contribute hundreds or thousands of patients quickly across multiprotocol studies. Online disease communities are an important part of the new trial landscape, but alone they simply cannot provide the patient demand for increasingly large studies or those with complicated protocol designs.” Acurian also reported significant growth in global access to patients through both online and offline media channels. Use of social media and online health networks increased more than 200 percent from previous years, leading to hundreds of millions of clinical trial impressions and click-throughs worldwide. Penetration via television and print led to 81 percent of the United continued on page 17

ogy expertise and background to strengthen delivery and development of Exco InTouch’s market leading mobile technology into vertical markets such as eClinical, mHealth and Late Phase. Vattikuti joins Exco InTouch from Merge Clinical, where he worked as vice President of R&D. He brings a proven track record of developing products in the clinical sector and has more than 17 years experience in software development and many of which have been at a senior management and group leadership level. Vattikuti has a degree in computer science from the University of Poona and started his career in India before moving to the United States, where he worked at multiple companies, including Etrials Worldwide where he worked as Director of Product Development. Leveraging his experience in streamlining processes and engineering more effective solutions, Vattikuti joins Exco InTouch as a key member of the Senior Management Team. His role will focus on strengthen-

Phase. The appointment comes on the back of a successful year of growth and recognition for Exco InTouch. In 2011, the company received a growth investment from leading growth equity and venture capital group Scottish Equity Partners (SEP), in addition to winning several prestigious awards. These awards include the European Outsourcing Award for ‘Best eBusiness/IT strategy’ and the Deloitte Fast 50 Technology award, which recognizes the fastest growing technology companies in the U.K. In line with this success, Vattikuti is one of many significant appointments for Exco InTouch in 2012, with Pfizer’s Healthcare Informatics Director Mark Brincat also joining the company in January. “I am delighted to join Exco InTouch as the new CTO and to lead what I view as a game changing opportunity to change the patient engagement continued on page 17


Monday, June 25, 2012

Drug Industry News

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WESTMED physicians will use Optum’s analytical tools to help identify best practices for overall patient wellness and disease management, and measure their own performance in these areas over time. Participating physicians will have access to advanced tools and software applications that provide physicians and other health professionals access to detailed health intelligence on patient, system and population health, enabling them to collaborate on medical care decisions and improve health outcomes.

WHITE PLAINS, N.Y., and MINNEAPOLIS — WESTMED Medical Group announced it is collaborating with the UnitedHealthcare and Optum businesses of UnitedHealth Group (NYSE:

UNH) to launch an accountable care organization (ACO) for its more than 220 physicians in Westchester County, N.Y. Collaborating with UnitedHealthcare will enable WESTMED physicians

to be eligible for incentives based on measurements in disease management and prevention, patient safety, and appropriate care utilization. Participating physicians will be measured and rewarded based on quality health outcomes, patient satisfaction and reduction of medical costs in the Westchester market to below current, trend-adjusted levels. Bonus eligibility requires that both care quality and cost metrics are achieved concurrently to help ensure that physicians focus on providing the right level of care for patients.

VERIFIED CLINICAL TRIALS

medical care has become commonplace. These professional research subjects can cause significant harm to themselves while causing resultant faulty data.” Verified Clinical Trials has not only raised awareness, they have raised the bar by providing the industry with the necessary tool to police the industry whilst adhering to HIPAA and GCP guidelines. This anonymous research volunteer clinical trial database registry continues to expand at an incredible pace and has swept the industry in both early and late phase trials. Verified Clinical Trials appeals to both early and late phase trials and boasts an impressive array of newly added features at a dizzying rate. Verified allows the units to instantly and accurately au-

thenticate the volunteers actual age, social security number, as well as set up automatic email and SMS texts to remind of upcoming visits to reduce missed visits and protocol deviations. VCT reduces liabilities and is cost effective. It is no wonder that the Verified Clinical Trials system has become the largest North American clinical trials database registry and the company that the industry has turned to. Created by experts active in the clinical trials industry with an innate knowledge of the special requirements and nuances of the trade, the VCT system meets and exceeds all of the needs for selecting a better quality clinical research participant. “VCT’s intention was to create an af-

fordable and scalable system that would be adopted industry wide and globally. We have achieved that goal and have realized excellent uptake in both early and late phase trials” remarked Dr. Efros. He further added, “By creating this ID metric system, we purposefully avoided the need for any software or hardware installation. There is no hardware or software to purchase or replace. The user has the ability to access the system for verification anywhere in the unit. You can even verify a subject from your smartphone or tablet.” To learn more about dual enrollment in clinical trials or to join the Verified Clinical Trials database registry call 516 998-7499, email DrEfros@verifiedclinicaltrials.com or stop by Booth #1712.

search Sites. PhlexEview features the TMF Reference Model as its standard TMF structure. Global business development director at Phlexglobal and TMF Reference Model co-chair, Karen Redding, commented, “Utilizing the TMF Reference Model within PhlexEview provides a consistent standard structure across Sponsors and CROs alike. It provides a basis for re-mapping multiple disparate TMF structures, whether paper or electronic.” Uniquely, Phlexglobal can also provide the processing capability and project management behind the eTMF, either PhlexEview or other systems, helping clients adhere to complex clinical trial compliance and regulatory requirements,

controlled costs and increased productivity. Outsourcing complete TMF management in this way offers many advantages. Karen added, “centralizing the TMF in this way provides a single access for both Sponsor and Inspector, facilitates centralized reporting and searching, provides the Sponsor with independent control over the TMF and simplifies the archiving process. A recent study TMF was closed six weeks early utilizing PhlexEview.” PhlexEview can be used as an offthe-shelf package or can be highly customized, with or without the associated services offering complete adaptability and support. Phlexglobal is a market leader and specialist in the provision of local and

global technology enabled TMF document management solutions and support services. It offers a unique combination of expert clinical trial knowledge, document management skills, regulatory understanding, technical expertise and training to deliver clinical research support solutions to the pharmaceutical, biotechnology, medical device, CRO and healthcare industries. Phlexglobal counts 17 of the top 20 global pharmaceutical companies amongst its clients. For a demonstration of Phlexglobal’s PhlexEview solution or for more information about its innovative and flexible TMF solutions go to www.phlexglobal.com, visit Phlexglobal’s Booth #2842 at the DIA Annual Meeting or email info@phlexglobal.com.

continued Malcolm. “Strategic CRO alliances and new technologies sound promising on the surface, but fall short in our opinion compared to proven solutions that combine far-reaching patient access with enrollment best practices. These solutions are available today and enable our customers to complete enrollment without adding sites or time.”

About Acurian Acurian is a leading full-service provider of clinical trial patient enrollment and retention solutions for the life sciences industry. The company increases the enrollment performance of investigator sites worldwide by identifying, contacting, prescreening, and referring people who live in the local community but are

unknown to a research site. As a result, trial sponsors complete enrollment without incurring the unexpected expense of adding sites, time, or CRO change orders. Acurian’s investors include Euclid SR Partners, ProQuest Investments, JP Morgan Partners, Flatiron Partners, CDP Capital Technology Ventures and Merck Capital Ventures.

line with the company’s proven strategy of innovation and partnership.” Tim Davis, CEO of Exco InTouch, comments: “We are extremely excited to have someone of Madhav’s capabilities join the team. Despite economic uncertainty, the past five years have proved highly successful for Exco InTouch, with recent significant appoint-

ments representing the next phase of growth for the company. As we start 2012, our unique team of experts and innovators makes us better positioned than ever to provide mobile technology solutions that ensure optimized patient engagement in the healthcare and drug development sectors.” Dr Neil Rotherham, Executive

Chairman of Exco InTouch added “We have had a momentous year in 2011 and we intend to build on that progress in the coming year. Madhav’s appointment, along with our other senior appointments, gives Exco an industry leading team that will sustain and develop our leadership in the use of mobile technologies in healthcare.”

WESTMED Medical Group Launches Accountable Care Organization (ACO) in Collaboration with UnitedHealthcare and Optum

(continued from page 1)

The world’s largest companies and clinical research facilities now communicate with one another directly and through the VCT system to improve the data provided to the Food and Drug Administration and ultimately the consumer. The leading CROs, pharmaceutical companies, and research sites across the globe now have something in common. They have all joined the inclusive and expansive Verified Clinical Trials Network. Kerri Weingard, ANP, COO of Verified Clinical Trials stated “with a downturn in the economy, clinical trial participation for monetary gain or free

PHLEXGLOBAL

(continued from page 4)

helped us grow and secure a market-leading position.” Launched 12 months ago, the third generation PhlexEview solution is a customizable, quality-controlled, end-to-end process enabling electronic searching and viewing of centralized TMF documentation from sponsors, subsidiaries, CROs and field-based personnel from anywhere in the world, at any time. Incredibly simple and easy to use, PhlexEview meets the stated EMA requirements for usability, and has been presented as the primary TMF in Inspections. PhlexEview can be used as a Sponsor or CRO eTMF, or as an electronic Investigator Site File at Re-

ACURIAN

(continued from page 8)

States population being exposed to at least one clinical trial opportunity sponsored by an Acurian customer. “Our industry is struggling to find innovative ways to manage trial costs while completing enrollment on time,”

EXCO

(continued from page 8)

landscape through the use of mobile technology”, comments Vattikuti. “I look forward to optimizing the delivery of Exco InTouch’s existing solutions, in addition to leading the expansion of new product lines, in


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Drug Industry News

QUORUM REVIEW IRB (continued from page 1)

panel will provide today’s critical perspectives on Food and Drug Administration compliance and OHRP regulatory requirements for post-approval non-interventional studies, registries, safetysurveillance and REMS, as seen through the viewpoints of the Institutional Review Board, clinical trial administrators, and research sites. Using relevant case studies, the expert panel will also shed light on stakeholders’ views, including patients and caregivers, physicians administering such research, and those responsible for healthcare payment. Coleman will be joined by an esteemed panel of ethics review experts from the field, including: Ann MeekerO’Connell, Acting Associate Director, Risk Science, Intelligence, and Prioritization, Office of Scientific Investigations, CDER, FDA. Kathleen Mandziuk, MPH, Senior Scientific Affairs Director, PRA,

GLOBALCARE CLINICAL TRIALS (continued from page 1)

premise that if you make study participation convenient and comfortable, more patients will be willing and able to participate.” Adinamis founded and pioneered the service model which she introduced more than 20 years ago. GlobalCare centrally manages a network of multilingual, GCP/ICH certified country coordinators who have an in-depth knowledge of local medical practices, country regulations and cultural attitudes. The network is augmented by an extensive pool of more than 25,000 qualified local traveling

CLINICAL INK

(continued from page 1)

However, with respect to business model innovation our industry remains anchored to core processes that have existed for decades—although often these processes are now outsourced. Even when truly new models are touted, too often the innovation focuses on the technological possibilities rather than practical business results. The business reality is that clinical trials cost too much—more than $135 Billion in the last two years and most of that cost, $85 Billion, relates to the convoluted clinical trial process, according to information in the PhRMA 2012 and 2011 Industry Profile. Q: How does Clinical Ink contribute to Innovation within the industry?

A: Clinical Ink’s innovative approach

PENN PHARMA

(continued from page 4)

the worldwide market. Chief Executive,

Dr

Richard

Monday, June 25, 2012 and Lindsay Boyer Crampton, CCRP, Project Manager, Global Late Stage Research, PPD. Meeker-O’Connell joined the Office of Scientific Investigations in the Office of Compliance, Center for Drug Evaluation and Research at FDA in March 2010. In OSI, she serves as Acting Associate Director for Risk Science, Intelligence, and Prioritization, leading a team developing risk-based analytic tools for pre- and post-marketing compliance activities. Meeker-O’Connell is actively involved in a range of clinical trial policy matters, including innovative models for clinical trial oversight and implementation of the Food and Drug Administration Amendments Act of 2007, Title VIII. Mandziuk comes to the panel with more than 15 years of managing clinical late phase study solutions for biotechnology, pharmaceutical, and medical device companies. In her current role of Senior Scientific Affairs Director at PRA, a global CRO headquartered in Philadel-

phia, Pa., she supports clients across all phases of pharmaceutical and biotech drug development and clinical trial research by combining therapeutic and operational expertise with local knowledge. Crampton provides operational oversight for pregnancy registries/observational studies, Risk Evaluation & Mitigation Strategy (REMS) programs and other post marketing safety studies at PPD, a leading global CRO providing drug discovery, development and lifecycle management services, based in Wilmington, N.C. The afternoon session (#256) will be held at 1:30-3:00 pm EST, Tuesday, June 26, in Room 199b. More information can be found on the DIA Meeting Program website within the ‘Clinical Safety and Pharmacovigilance’ track, and attendees will be eligible for IACET CEUs, as outlined in the final program. About Quorum Review IRB Quorum Review IRB is an independent ethics review board fully accredited by the Association for the Accreditation of

Human Research Protection Programs (AAHRPP), and has been providing ethics review of drug and device trials since 1992. Quorum Review IRB oversees research in accordance with U.S. and Canadian human research subject protection regulations and guidelines set forth by the International Committee on Harmonisation (ICH), and principles of the Belmont Report. Quorum’s best-in-class IRB services and support includes 13 Board meetings each week plus expedited review, 24 hour site review turnaround, 36 hour amendment review turnaround, a secure web portal, and Smart Forms for online submissions. Quorum Review’s comprehensive IRB offerings include full study review in the U.S. and Canada, a specialized phase I team, and unique processes for post-approval and registry studies. Quorum Review will be a featured exhibitor at the DIA 2012 conference, and welcomes visitors to Booth #1624 to discuss their projects and questions related to ethics review and the IRB.

physicians and study nurses across North America, Latin America, Europe and Asia-Pacific. Reduction in subject recruitment time by more than 50 percent and an increase in subject retention rate of more than 95 percent are among the results that have spurred GlobalCare’s rapid growth. “Oncology, rare diseases, neurologic disorders and infectious diseases are among the therapeutic areas most demanding of these services,” said Adinamis. “We also support a wide variety of trials requiring pharmacokinetic, safety or specialty labs on a frequent or long term basis,” Adinamis continued. GlobalCare is a global niche service

provider to government agencies and the world’s biotechnology, pharmaceutical and medical device companies engaged in all phases of product development. GlobalCare offers an innovative patient-centric service model that provides selected clinical study visits in the home or alternate setting resulting in faster patient recruitment, better compliance and higher retention rates, helping to expedite time-to-market for life-enhancing products. GlobalCare’s model enables patients to participate in clinical trials regardless of study duration; frequency of visits; disease state; distance to site; and/or family, work or community commitments by conduct-

ing study visits in a location convenient to them. Services include Global Project Management, study drug administration, blood and other biologic sample collection, clinical assessments, patient training and education, device management, source documentation, and data collection. In addition, the company offers central and local out-patient pharmacy services including storage and distribution, compounding and dispensing, cold chain logistics, and sourcing of commercial products and devices. For more information, please visit www.globalcarect.com or visit DIA Booth #1148.

is to simplify the clinical trial process by focusing on the first step of the process—the clinical visit itself. Our vision is to replace paper source documents with intuitive electronic forms to capture clinical data during the actual subject visit. This simple concept, eSource, ripples throughout the clinical development process affecting everything from investigator training to site monitoring to data management.

paradigm by leveraging advancements in tablet technology and forms management software to capture data electronically at the outset.

Vendor in the life sciences.

Q: How can the effects of eSource be so pervasive?

A: Per the Food and Drug Administration, “the initial documentation of data in a clinical study is considered Source.” Most frequently source data is captured on paper documents; even with the advent of EDC systems and EMRs most of the study-specific source data is still recorded on paper. However, eSource changes the

A: The largest single cost of a clinical trial is the on-site monitoring of source documents—monitoring alone can account for more than 50 percent of the total study budget. Using eSource the data can be monitored remotely and the need for source data verification is eliminated. Moreover, the lag time in data availability during a trial, the redundant data entry work, and the monotonous process of reconciling data queries are also positively affected. Gartner cited these reasons for ‘significant cost savings’ and ‘disruptive potential’ when naming Clinical Ink as a 2012 Cool

Yarwood said: “Craig is a significant hire for Penn Pharma, we needed to recruit someone with outstanding pharma finance knowledge coupled with experience in being part of a company undergoing rapid

growth and change. We are delighted to welcome Craig to the board, and are sure that this appointment will be key to the continued success of the Penn brand.” Penn Pharma has a wealth of

Q: What do you mean by ‘eSource?’

Q: How does Clinical Ink contribute to ‘Collaboration,’ the other theme of DIA this year?

A: Clinical trials are inherently complex and require coordinated activities among potentially hundreds of individuals and groups. These people are making decisions that have life and death consequences. Clinical Ink’s vision of eSource is that these decisions can be made more quickly, more confidently and more affordably by capturing original clinical observations electronically. If the industry can make this change, the opportunities for collaboration with sites, subjects, and regulators will multiply. For more information about Clinical Ink, stop by Booth #3104 or visit www.clinicalink.com. experience in successfully providing an integrated range of services for the development, manufacture and distribution of medicinal products to the global pharmaceutical market.


Monday, June 25, 2012

ACM GLOBAL CENTRAL LAB (continued from page 1)

trials testing. People may be surprised to learn that we operate in more than 60 countries, and perform more than 14 million tests a year, spanning all medical disciplines, including pathology, microbiology, flow cytometry and specialized biomarkers.

Q: How can drug developers and CROs increase efficiency with their central lab partner?

By understanding a sponsor’s longer-term development objectives, a central lab partner can more effectively help sponsors streamline their data collection process, consolidate specimen collection and shipping, select the most appropriate esoteric assays with volume-driven protocols across the entire study program, and of course create tailored best practices to ensure consistent, two-way communication.

Q: How has clinical testing changed over the last several years? What types of requests are most prevalent today?

A: It all starts with a strong commitment to service, with flexibility, responsiveness and actively listening to our clients as the core elements. Once we’ve established that service-driven trust, operational and logistical efficiencies are realized as the relationship moves away from a transactional arrangement toward a strategic partnership.

A: For us, new biomarker tests, which offer additional options for organ toxicity testing, have recently drawn a lot of attention. We combine conventional toxicity testing with advanced biomarker testing and provide customized ‘toxicity biomarker’ or ‘safety’ panels that can be adapted according to the specific needs of the study. By working closely with our

CRF HEALTH

that may not necessarily be conducive to concentration. Add in the fact that many of the patients we’re asking to record data may have conditions that make this task tricky—a Parkinsonian tremor or impaired vision, for example – and you can see why providing easy-to-use, intuitive devices which take into account a patient’s condition and mitigate burden are crucial. Practical data input timeframes are vital, too—you never know when a patient may need to drop everything (e.g., to referee a fight between children!). But it’s a fine balancing act between making that timeframe tight enough to generate high-quality, contemporaneous data and keeping it usable.

(continued from page 1)

faster trials that generate high-quality data the first time and in real time. That’s why moving towards electronic methods of data capture could be a real game changer—particularly when it comes to collecting patient outcomes data.

While payors look for a return on investment from a product (e.g., a decrease in the number of hospital stays), harmonization means regulators are keen to see that same product make a significant difference to patients’ lives. And that doesn’t just mean that their health has improved. It means that their quality of life has improved too. Also, as patients become more vocal, they want a chance to tell their side of the story. High-quality eCOA solutions can give them that chance. After all, we not only need to hear patients—we need to hear them accurately.

Q: What are the key challenges of collecting high-quality eCOA data?

Making patients feel valued is important, too. And I’m not talking monetary—just a simple ‘Well done’ can work wonders when a patient’s enthusiasm is declining. It also helps to reassure them that they’re entering their data correctly.

Q: How can we improve patient engagement in late phase studies?

A: Many devices are used at home, without supervision and in an environment

A: Some late phase studies are short with intense amounts of data collection

CENTRAL LABORATORY

lar biology. The laboratory team should include research and development experts able to foster a scientifically stimulating environment that could positively affect the outcome of your development project. In addition, look for quality assurance and quality control programs, such as a GLP-compliant (Good Laboratory Practices) environment to ensure your data will be accurate, reliable and reproducible. Choosing a provider that combines basic research & development expertise with global Central Laboratory experience is a definite advantage considering the long term optimization of your product development. The assays developed at an early stage may be used throughout the clinical development process. By

(continued from page 1)

client’s in-house scientific team, while providing strong and diverse expertise in assay development, validation and analytical services for the duration of the clinical development process. Key components to look for in a research and development service provider are core competencies in assay development. It is important to make sure the research and development team has the required expertise in the methods required to meet your organization’s therapeutic needs. In oncology studies, for example, you should look for a team of experts in fields such as immunology and molecu-

clients, we can choose the laboratory biomarkers that best identify organ toxicity as early as Phase I or Phase II of a clinical program. Sponsors are also recognizing the value of a central lab’s on-site pathology and microbiology expertise. With centralized and adjudicated slide interpretation, test results are more consistent and timelier, which aids in faster identification of trial patients who meet inclusion/exclusion criteria. And the latest imaging technology enables a high standard of interpretation across trials conducted in the far corners of the globe. Q: How is ACM Global contributing to patient safety?

A: We’ve been leaders of new testing strategies that increase test viability and therefore patient safety throughout the lifecycle of a specimen, which for us starts at the point of specimen collection, includes innovative shipping methods, required. Others are lengthy, with relatively few data points that lead to considerable patient attrition. But no matter the structure, patient engagement is vital. Ensuring that eCOA solutions fit around patients’ lives is one way of doing this. For example, allowing data input via systems patients use every day (e.g., the Internet or their mobile) and incorporating SMS or email reminders can really help drive compliance. And if you can also offer patients other useful information (e.g., about their study progress) through a web portal, you can create a sense of loyalty. This loyalty is essential to the success of a study—a lower drop out rate means fewer patients need to be recruited, shortening the overall duration of the trial and saving money. Q: How is CRF Health driving innovation in the eCOA arena?

A: Currently, we’re investigating statistical methods that allow us to compare data between instruments. This will enable us to identify potential issues quickly. For example, take an Alzheimer’s study. We know from studies in the past that if a patient scores low on one memory test, they should also score low on another test. If a utilizing the research and development expertise within the global Central Laboratory, you benefit in the following areas:

• No transfer of knowledge is needed between suppliers since the extent of the services can be performed by one team • Scientific support team available to ensure the quality of the results produced by the technical team • Increased productivity working with an experienced laboratory • Reduced logistical and transportation costs since all assays are performed in one location • Only one laboratory to audit • Ease of communication resulting from a well established client-supplier relationship

Drug Industry News

21

and ends at database lock. We continually consult with our clients on patient safety monitoring and oversight and on safeguarding sample integrity.

In particular, we are implementing tests and methodologies that better detect organ toxicity, which is the single most frequent reason for safety-related drug withdrawal. Drug-induced liver injury (DILI) tops the list, but kidney and other organ toxicities are also of major concern, particularly because they can have serious implications when discovered in the post-marketing phase. We have found that combining expertise of the clinician, CRO and central lab along with a comprehensive picture of the patient, allows for closer monitoring and the identification of early warning signs and the development of organ toxicity.

Stop by Booth #2327 at DIA to learn more!

difference is detected, figurative alarm bells should ring so that action can be taken immediately (e.g., retraining a rater). Capturing the problem early ensures you don’t lose the data and, effectively, the patient.

One exciting innovation this year has been the launch of TrialMax Web—an online portal accessible via patients’ home computers and their mobiles to collect high-quality eCOA data. Q: How do you see the future of eCOA?

A: I think the future of eCOA lies in integration. True integration that extends beyond eCOA, into other systems. We’re very excited by the number of companies asking us to integrate their eCOA solution with their EDC, for example. Why? Because such an efficient approach will allow us to provide all sites, monitors and sponsors with access to all study data in one place in real time. And with the enormous workload generated by clinical research, avoiding inefficiencies is vital. After all, you only get real data by fitting into real lives. For more information, stop by Booth #3306.

For the past 17 years, CIRION has grown as a leading Contract Laboratory providing R&D services for Assay Development & Validation and Global Central Laboratory for Global Clinical and Pre-Clinical studies. The company offers high level scientific expertise with large molecules (biologics/biosimilars) and biomarkers in virology, immunology, molecular biology and microbiology. They offer a complete range of project management and logistical services with a broad portfolio of safety and esoteric assays and have developed expertise in the management of complex clinical projects of varying scope and size in key therapeutic areas. For more information, please visit CIRION at Booth #2502 or at www.cirion.com.


Drug Industry News - June 25, 2012 - Philadelphia, Penn.  

Drug Industry News - June 25, 2012 - Philadelphia, Penn. - distributed during the first day of the DIA Annual Meeting Exhibition 2012 in Phi...

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