UBC In the News

With funding from the National Pharmaceutical Council (NPC; Washington, DC), Drs. Bryan Luce, SVP of science policy at United BioSource Corp. (Bethesda, MD) and Robert Dubois (chief science officer at NPC) and five academicians developed the principles and vetted them using an iterative process of gathering opinions from successive groups of healthcare stakeholders and experts. "The reality is, CER is more of an aspiration than a methodology,” says Luce. “If you gathered 10 CER experts in a room and asked them what it actually entails, you would not get a clear answer."

Nurses trade scrubs for business attire at patient call center. 150 nurses use their clinical skills to help patients and providers telephonically at a call center, also known as a clinical contact support center, at United BioSource Corporation in Overland Park. There, nurses provide support services on behalf of pharmaceutical manufacturers for patients who are prescribed high cost, self-administered biologics.

A cost-effectiveness study comparing dabigatran, used to prevent stroke in atrial fibrillation (AF), and warfarin, aspirin or no therapy found that the drug could be cost-effective as a first-line treatment for the prevention of stroke and systemic embolism (SE) in AF patients in the U.K. The study, conducted by UBC, was published April 23 in Heart.

"For 2012, I believe the most important business objective UBC shares with its clients is to develop and implement custom evidenced-based strategies to ensure commercial success. We are leveraging our longitudinal prescription patient databases to analyze real-world issues and translate them into oppor- tunities that are meaningful to client and payers."

Dr. Stemhagen, Senior Vice President, Safety, Epidemiology, Registries, Risk Management at United BioSource Corporation, was named as an instinctive innovator in the clinical arena who is evolving research and development practices, technologies and development models to help bring new products to market faster, more cost effectively, and with improved safety profiles.

Pharmacy benefit manager Medco Health Solutions Inc will provide services to Sanofi SA that could help the French drugmaker navigate increasingly difficult reimbursement and regulatory waters.

The top five attributes that pharmaceutical companies are looking for in a CRO are therapeutic expertise, low cost, a global footprint, clinical research associates quality and upfront contingency planning, according to the survey. MedPace and another mid-sized CRO, Maryland-based United BioSource Corporation, received the highest marks for upfront contingency planning — having backup plans to manage changing circumstances as a clinical trial progresses.

Social media offer sponsors and CROs a greatly enhanced ability to improve patient retention and compliance with both clinical and post-marketing studies. The first step to determining if and how social media can help is to assess the target populations.

Hugh P Levaux and Jaime Lau at UBC assess the benefits of leveraging interactive voice/web response technology to power clinical trial globalisation in Asia.

Adam Barak examines the details of the UK government's VBP proposals.

Mark Clein, President of United BioSource (UBC), discusses the company’s recent acquisition of Total Healthcare Group, a London-based consultancy on payer research, strategic planning and global value dossiers for the biopharma industry. Clein also discusses the current focus on comparative effectiveness, evidence-based research and value in medicines and how that impacts the Phase I through III development environment.

"When warfarin is prescribed correctly, it is cost-effective, and if it was used more in the (atrial fibrillation) population and used appropriately, then we'd see even bigger reductions in cost," said lead author Catherine J. Mercaldi, an epidemiologist at United BioSource Corp, a research consulting firm in Bethesda, Md.

Top-line assessment data from eight REMS programs show that a mean average of 83% of patients received the MedGuide, with 70% saying they actually read the document and 63% indicating they understood the key risk messages, according to data from United BioSource Corp.

When an organization's first product is introduced to the market, the most challenging period is during the transition. This article focuses on what to expect from a pharmacovigilance perspective, and provides a guideline for getting organized at the time the first product is introduced to the market.

Guidances from FDA often cause a high-level of interest, if not concern, among the sponsor and CRO community because of changing or incremental requirements. In this case, the community was largely prepared for this Draft Guidance, according to Mark Ammann, Vice President, Regulatory Affairs, United BioSource Corp. "Industry really dealt with this a year-and-a-half ago," explained Ammann.

Comparative effectiveness research is going to have a huge impact on every stakeholder in healthcare delivery. It requires a much broader view of the healthcare system so that information will exist about a patient's outcome as he or she moves from diagnosis to treatment in the healthcare system.

Pharmacy company Medco Health Solutions Inc. said it will buy closely held research firm United BioSource Corp. for $730 million, in the pharmacy-benefit manager's latest move to expand beyond its core business.

Medco is adding a new business capability - drug outcomes research for biopharmaceutical companies - with the planned acquisition of information services company United BioSource.

Pharmacy giant Medco Health Solutions will buy Bethesda-based United BioSource for $730 million, the companies said Monday, just seven years after the local company's founding.

Making the switch from a small entity that he founded and oversaw to leading large teams to achieve common goals entailed overcoming a learning curve, but Chad Clark has thrived and excelled at meeting the challenges in his role as General Manager, Registries and Risk Management, at United BioSource Corporation.

Since detection of exacerbations is dependent on a patient's decision to contact their health care provider in response to worsening symptoms, and the decision to alter treatment is largely based on patient report, it is logical and desirable to standardize these assessments through a patient-reported outcome (PRO) instrument. The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) was developed as a daily diary based on COPD patients' descriptions of their exacerbations with input from experts in pulmonary medicine. The instrument development process has been led by Drs. Nancy Kline Leidy with the assistance of Dr. Teresa Wilcox and a scientific team from the United BioSource Corporation.

While there are many fears that comparative effectiveness research will be used to pick winners and losers when products are pitted against one another, United BioSource Corp.'s Bryan Luce does not see head-to-head trials becoming the primary focus of CER activity in the U.S, at least on the federal level.

Adaptive trial designs have the potential to speed development and reduce overall costs — that is, if sponsors invest in up-front planning and can implement these designs correctly. Interest in adaptive designs has risen in recent years. These types of studies involve a broad class of methods and can have a positive impact on any program across the different stages of development. Experts say the flexibility of an adaptive design allows sponsors to make course corrections during a trial based on interim data. But experts stress these changes should be preplanned decisions based on simulations and well-thought out, up-front planning.

Applied Clinical Trials spoke with Nancy Kline Leidy, PhD, Senior Vice President, Scientific Affairs, United BioSource Corporation, about recent developments in the PRO field and about her presentation “Development and Documentation of PRO Tools for Regulatory Review.” “The EXACT PRO-Initiative was the first consortium to develop a PRO instrument for use in clinical trials and we’ve learned a lot since its inception,” said Leidy.

The industry is in the midst of a cycle of disruptive change that has transformed much of its business model. Consolidation, pipeline pressure, and scrutiny of pricing, safety and business practices have contributed to a siege-like environment. Amidst these pressures, one new trend is reshaping much of the biopharmaceutical industry – an unmistakable shift toward utilizing scientific evidence to navigate and enable access to products by patients and health care professionals.

United BioSource Corporation (UBC) acquired Abt Bio-Pharma Solutions (ABS), the pharmaceutical and medical device research and consulting arm of Massachusetts-based Abt Associates, for an undisclosed sum. ABS provides contract services in biometrics, clinical trials, health economics and outcomes research, registries and observational studies, and commercial strategy to the pharmaceutical, medical device and diagnostics industries. Founded as Abt Associates Clinical Trials division in 1997, ABS expanded its services from clinical trial management to include pricing and reimbursement and marketing consulting and research services as an Abt subsidiary in 2008. ABS does very little business in the area of clinical trial management now, said UBC CEO Ethan Leder.

Traditionally the development of cognition enhancers has been limited to drugs to treat the cognitive deficits associated with dementia. Research in dementia is currently at a crossroad, in part due to widely recognised limitations of the current evaluation technique used in pivotal trials, the Alzheimer’s Disease Assessment Scale (ADAS-Cog), and also in part the result of recent failures in high profile studies. However, the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative has expanded this opportunity to schizophrenia.

A key element of the 2007 FDA Amendments Act (FDAA)—the change from "requested" post-marketing compliance plans to mandated Risk Evaluation and Mitigation Strategies (REMS)—has now come to the forefront for both newly approved and commercial biopharmaceuticals. While some REMS are little more than a beefed-up patient medication guide, others can involve complicated patient registries and certifications of physicians, pharmacists and even distributors.

According to The Experience of Frequent Heartburn in America, 2009(2), a study of 1,075 frequent heartburn sufferers conducted by Center for Health Outcomes Research & Evidence Based Medicine, LLC and United BioSource Corporation, frequent heartburn can significantly impact sufferers' lives by affecting their ability to get a good night's sleep, be productive at work, have positive personal relationships and enjoy social activities.

Understanding the nuances of setting up an effective global registry is becoming increasingly important, since this kind of study enables manufacturers to gather and analyse data about the actual use of their products in every country where a product is marketed, while meeting stringent new regulatory requirements.

Postapproval studies are typically initiated to gather additional product safety information, comply with a postmarketing requirement (PMR), or support overall market access. Many times, these studies require enrolling very large numbers of patients at often research-naïve investigative sites to address pressing study objectives. Many sponsors and CROs erroneously believe that a phase III operational approach will meet all needs of a postapproval study. However, applying phase III processes can result in study delays, astronomical budgets, and dissatisfied study investigators. Streamlining all aspects of postapproval studies is key to overall success.

Once considered a rarity, the "rescue" or transition study is becoming more commonplace in today's fast-paced world of clinical trials. For a variety of reasons, more and more sponsors are finding the need to switch vendors mid-study. Examples include vendor inability to meet sponsor requirements, issues with the data capture system, and vendor collapse or acquisition.Once considered a rarity, the "rescue" or transi- tion study is becoming more commonplace in today's fast-paced world of clinical trials. For a variety of reasons, more and more sponsors are finding the need to switch vendors mid- study. Examples include vendor inability to meet sponsor requirements, issues with the data capture system, and vendor collapse or acquisition.

For more information on this topic or the actual report, please contact analytics@unitedbiosource.com or +1 301 654 9729.

While advances in medical science have led to continued improvements in medical care and health outcomes, evidence of the comparative effectiveness of alternative management options remains inadequate for informed medical care and health policy decision making. The result is frequently suboptimal and inefficient care as well as unsustainable costs. To enhance or at least maintain quality of care as health reform and cost containment occurs, better evidence of comparative clinical and cost-effectiveness is required

Obtaining optimal product positioning and market uptake requires thoughtful planning and a fresh perspective in this turbulent global economy. While the need for product differentiation and comparative assessment has been a constant, there are increasing pressures from formulary decision makers and payers demanding evidence backed by an increasing level of scientific rigor. The economic environment is acting as a catalyst in the movement, truly signaling that it is time to provide value-based evidence data to support formulary positioning and product access.

In both Europe and the US, a heightened focus on drug safety and risk management has led to new regulations that will result in significant changes for the pharmaceutical industry, particularly during the post-approval phase of drug development. Regulators at both the European Medicines Agency (EMEA) and the Food and Drug Administration (FDA) have embarked on new initiatives to update and expand methodologies used to monitor product safety after approval.

While Electronic Data Capture (EDC) has been considered a technology of choice to run Phase II–III studies, the industry is now finding that EDC can be particularly effective for late-phase programs, improving the speed and even the quality of real-world postmarketing research.

Rater reliability is the cornerstone of data accuracy for drug trials that depend on clinician-rated subjective instruments to assess efficacy. Every pharmaceutical company seeks unambiguous evidence that its product is the new best treatment for a given disorder. Increasing governmental scrutiny of new drug applications combined with rising costs of product development and rising industry competition are pushing companies to improve the margin of success for their clinical trials.

Given their focus on discovering and rapidly building scientific evidence to support the safety and efficacy of their compounds, emerging pharma companies often direct their limited resources to near-term activities. In doing so, they are often unaware of or undervalue the importance of getting early regulatory guidance on long-range development strategies.

The world of pharmacovigilance is changing quickly and dramatically in response to a set of new guidelines and regulations developed over the past four years. The goal of these documents is to aid industry in planning risk management activities throughout the drug development life cycle. Specifically, they define three types of activities: (1) pre-license efforts required to evaluate the safety of a product, (2) pharmacovigilance actions to be implemented in the early postmarketing period to monitor the products’ safety profile, and (3) steps to minimize risk. As such, these guidelines and regulations describe a method for summarizing important safety issues and propose a structure for a risk management plan.

Adaptive design, sometimes referred to as flexible design, is more than another new statistical methodology, tool or formula in the hands of biostatisticians. It’s a new technology that changes the entire clinical research process.

Since its founding in 2003, United BioSource Corporation (UBC) has focused on building a company that can harness the power of science and technology in new ways. As part of this strategy, the company announced two significant acquisitions in September 2007. First, it acquired an ownership interest in ClinResearch GmbH, a Cologne-based company specializing in adaptive design. Its second acquisition was Caro Research, a Massachusetts-based company focused on applying simulation techniques to understand the economic impact of drugs and devices.

Clinical trials frequently rely on subjective clinician-rated outcomes as pivotal endpoints. The scoring of these assessments is often based on clinical subjectivity and individual interpretation, which can increase variability across sites and raters – potentially contributing to failed or inconclusive studies.

In the ever-changing world of clinical trial management, there is a noticeably constant flow of new technologies and strategies. These new options offer organizations the chance to obtain better and more accurate information faster, leading to quicker clinical development of a drug. Two such emerging strategies are the use of adaptive design and the implementation of simulation modeling in clinical trials.

The fastest-growing area in outsourcing these days is late-stage clinical research. That's no surprise, since late-stage studies are the fastest growing part of clinical research. In 2006, CenterWatch estimated that the development spend for Phases IIB and IV would go from $9.2 billion in 2005 to $15.4 billion in 2009 - a jump of more than 60 percent. With the dramatic rise in late-stage studies, there is increasing emphasis on strategic planning to determine how sponsors should spend their budgets within the preapproval space.