PPD, HealthCore in Real-World Evidence Alliance

PPD and HealthCore, Inc. have established a collaboration expanding each company’s services in the pre- and post-approval research market with the goal of helping clients demonstrate more quickly and cost effectively how their products will perform and benefit patients in the real world through establishing new quality, cost and speed benchmarks.

The collaboration combines PPD’s clinical trial design, health economics and outcomes research (HEOR), medical affairs research and epidemiology services with HealthCore’s HEOR, real-world research designs and its research-enabled electronic health care data environment.

The collaboration allows companies to engage in one contract with combined services from PPD and HealthCore that has the potential to cover product research in both pre- and post- approval settings. Both companies will be able to provide analyses of medical claims data and electronic health records necessary to understand the utilization and impact of their products and to design appropriate clinical trials that address payers’ needs.

“The goals of optimizing reimbursement and increasing payer and patient value are becoming more dependent on biopharmaceutical companies’ ability to provide high-quality evidence of how products will perform for patients in a real-world setting,” said Michael Pollock, vice president of real-world outcomes at PPD. “With the collaborative expertise of PPD and HealthCore, particularly in planning, designing and implementing pragmatic clinical trials, we hope to set a new standard for the quality, cost and speed of real-world evidence generation that can help optimize patient outcomes and enable our clients to better demonstrate the true value of their products and the return on their investments in new product development.”

“By combining clinical and economic information and leveraging our access to large health care provider networks, we will have a much more robust view of how patients use and react to different therapies,” said Marcus Wilson, president of HealthCore. “This gives us an opportunity to produce relevant information that can facilitate decisions and speed to market those products that provide the most value to patients, payers and life sciences companies alike.”

PAREXEL Expands Data-Driven Monitoring Platform
PAREXEL expanded its Perceptive MyTrials Data-Driven Monitoring (DDM) solution with next generation risk-based monitoring capabilities allowing clients to perform cross-study analysis of quality, risk, and monitoring work effort by combining analytics, reporting and monitoring activity into a single solution.The enhancement aims to increase a drug developer’s ability to demonstrate oversight and control of site-related risk, quality, and performance.

“Centralized monitoring methods are being encouraged by the U.S. Food and Drug Administration (FDA) and other regulatory bodies. By combining our DDM and monitoring solution, PAREXEL clients now have the ability to bridge real-time information gaps between centralized analysts and in-the-field monitoring teams, reducing risk, ensuring documentation, and increasing quality,” said Drew Garty, senior director, product management, PAREXEL.

The Perceptive MyTrials Data-Driven Monitoring solution uses an algorithmic-based approach to clinical monitoring to determine risk and monitor workload, with the goal of enabling flexible and scalable decision-making.

ICON Launches Firecrest Patient Portal
ICON has launched the Firecrest Patient Portal enabling patients to view clinical trial information and is designed to enhance the patients understanding of treatment before consenting to participate at an investigator site.

The Patient Portal is a component of ICON’s new informatics hub designed to enhance the engagement of patient populations in the development process and is line with ICH E6 guidance, which recommends patients receive ‘ample time’ to review consent materials and ask follow-up questions.

“The opportunity for education about the trial, before a face-to-face meeting with their doctor, helps patients make truly informed decisions about participation,” said Frances Abeton, vice president, Firecrest at ICON. “Improved patient comprehension of a trial can reflect positively in patients’ relationships with investigators and subsequently lead to better recruitment and retention rates. As drug developers begin adopting electronic informed consent platforms improved regulatory-compliant education will be crucial. The Firecrest Patient Portal is a centralized solution for patients, investigators and study staff, making it easier for all involved to interact and stay informed.”

Patients using the Firecrest Patient Portal can find active trials, complete pre-screening questionnaires and select a convenient study location. Investigators can engage directly with patients that have shown interest, schedule visits, and examine live analytics about the materials reviewed by a patient. The Firecrest Patient Portal can be customized in any language, adapted to country specific requirements, and branded as required by sponsors.

ClinTec Expands Presence in Africa, Adds Directors
ClinTec International is opening a regional hub office for sub-Saharan Africa with a new larger office in Johannesburg. The office will support regional clinical research services including a new clinical FSP contract with a global biotechnology company, for which ClinTec is the sole FSP partner for South Africa.

“ClinTec has a track-record of aligning its investment program with strategically important client needs. Our continued investment in South Africa over the last five years demonstrates a consistent effort to address high-potential markets for clinical research,” said Bobby Bal, executive vice president, ClinTec.

Dr. Fraser Smith has been appointed director of Global Quality & Compliance, Jane Coward was appointed director of Client Relations, and Insook Cho joins the company as regional director, Clinical Operations – North Asia, based in Seoul, South Korea.

“ClinTec continues to grow and service clients all over the world in an innovative, fast, flexible and focused way. Our new Directors bring a wealth of experience, knowledge and innovative ideas which will support us in managing our global growth and ensuring we continue to deliver high quality clinical research” said Dr. Rabinder Buttar, chief executive officer, ClinTec.

Dr. Smith has more than 25 years of experience in the pharma industry. He joins the company from PPD where he spent the past four years serving as executive director of clinical quality assurance for their global quality and compliance function. He also acted as a European Union Qualified Person (QP) for releasing IMP and licensed pharmaceuticals for clinical trials and commercial use, prior to leading their pharmacovigilance department within the UK.

Ms. Coward is an experienced director of Functional Service Solutions & Global Clinical Resourcing. She joins the company from inVentiv Health Clinical, where she was responsible for global oversight of a variety of strategic resourcing solutions. She also managed Synergy, SRG’s niche Biometric CRO after successfully running SRG’s Scientific and Clinical Staffing divisions.
Ms. Cho has 18 years of experience in clinical research working with CROs. She joins the company from PPD, where she spent the past eight years as associate director, Clinical Management, with oversight of Clinical Operation in PPD Korea.

Oracle Health Sciences Launches InForm Cloud Service 6.1
Oracle Health Sciences has launched its InForm Cloud Service 6.1, a data capture and management platform that provides trial sponsors and CROs with an integrated solution designed to accelerate trial timelines, lower costs, deliver higher data quality, and reduce risk.

The InForm Cloud Service 6.1 platform supports complex trial protocols and environments with advanced data capture/query management and real-time, actionable visibility into data, as well as standards-based, integrated workflows.

New capabilities include: expanded risk-based monitoring capacity that enables source verification at the individual and subject level; a single location for defining and managing study administrative data in Oracle’s Central Designer, which is designed to streamline trial workflow and simplify the design, self-deployment, versioning, and maintenance of clinical studies; and an advanced modeling environment that streamlines management and validation of in-place, protocol amendments.

Quintiles Unveils New Predictive and Advanced Analytics Capabilities
Quintiles has added advanced statistical monitoring and predictive analytics capabilities to its risk-based monitoring (RBM) solution. Predictive and Advanced Analytics aims to enable study teams to identify the right signals and predict clinical trial site performance and potential patient safety issues.

Predictive and Advanced Analytics are the first such model-based capabilities fully integrated into an RBM solution on the market today. Underpinned by the Quintiles Infosario technology platform and extensive data resources, these new capabilities aim to improve precision in risk identification by better understanding underlying safety trigger processes.

Quintiles’ RBM is compliant with U.S. FDA, European Medicines Agency and TransCelerateguidance. Predictive and Advanced Analytics use unique statistical algorithms specifically designed for optimal RBM execution. The capabilities combine inputs across multiple variables including operational performance and study data to provide insights into potential study risks.

“The ultimate goal of risk-based monitoring is to increase the efficiency of drug development while improving quality and patient safety,” said Margaret Keegan, senior vice president, Data Sciences & Strategy at Quintiles. “The ability to cut through all the noise and predict potential risks before they occur means we can target the right action at the right place at the right time. It is a major step forward in improving quality and productivity in the next generation of RBM execution.”
 
Camargo Appoints Scientific, Regulatory and Legal Affairs Professionals
Marc Wiles, Ph.D., has been appointed vice president, scientific and regulatory affairs at Camargo Pharmaceutical Services, and Suzanne Beck, J.D., M.P.H., has been appointed director, contracts and legal projects.

Dr. Wiles has more than 20 years of experience in drug development, with extensive technical and regulatory expertise in assessing, developing and registering therapeutic products. Dr. Wiles was previously general manager and regulatory affairs scientific advisor at NDA Regulatory Science in England, where he was responsible for expanding the company’s U.S. operations. He also served as director of regulatory affairs and general manager at ERA consulting, and senior vice president of operations at ProImmune.

“Marc has demonstrated the ability to develop and execute regulatory and scientific strategies, and his skills and experiences will be hugely beneficial to our clients and our internal teams,” said Ken Phelps, Camargo president and chief executive officer.

Ms. Beck brings extensive legal and regulatory experience having served as an attorney for more than 15 years, including 10 years as a pharmaceutical document review attorney working across all phases of product development, as well as pre- and post-marketing and FDA regulatory filings.

“Suzanne is a great addition to Camargo,” said Jim Beach, Camargo chief operating officer. “Her experience and talent as an attorney and her extensive regulatory background make her a valued asset to our team and our clients’ development programs.”
 
Almac, Genentech Enter Research Pact
Almac Discovery has entered a research and licensing agreement with Genentech, a member of the Roche Group, to discover and develop small molecule inhibitors of a ubiquitin specific protease (USP) target.  

Almac will receive $14.5 million upfront and will be eligible to receive as much as $349 million based certain milestones, as well as royalties on sales of multiple products based on Genentech targets.  

Almac Discovery’s potent and selective small molecule inhibitors will be the starting point for a two-year joint research program funded by Genentech. Genentech will be responsible for all preclinical and clinical development and commercialization of any products resulting from the collaboration.  

Tim Harrison, vice president Drug Discovery, Almac Discovery commented “Inhibitors of ubiquitin specific proteases have been a highly sought after, yet elusive drug class, proving difficult to identify despite significant efforts from both pharmaceutical and biotech companies. Ubiquitin specific proteases have been shown to play an important role in a number of key oncogenic pathways, and the identification of potent, selective inhibitors provides an exciting opportunity to fully exploit this novel biology, as well as further demonstrating the chemical tractability of this important target class.”
 
“We’re pleased to initiate this collaboration with Almac Discovery where we hope to discover and develop therapies targeting an important USP that can potentially advance the standard of care patients with cancer” said James Sabry, senior vice president and global head of Genentech Partnering.
 
INC Research Launches Site Advocacy Group
INC Research has launched the industry’s first Site Advocacy Group (SAG) devoted to the scientific and operational aspects of clinical research. The SAG initially will focus on central nervous system (CNS) protocols—recognized as among the more complex therapeutic areas in clinical research—targeting psychiatry studies including, but not limited to, those in schizophrenia, attention-deficit/hyperactivity disorder (ADHD), depression and bipolar disorder.

“Through this forum, INC Research will collaborate with clinical research sites that have direct experience in psychiatry studies to gain their insights into the most common challenges and operational efficiencies that can be implemented for future studies,” said Clare Grace, vice president, site and patient access, INC Research Holdings.

A recent study by the Tufts Center for the Study of Drug Development found that drugs to treat CNS diseases, such as epilepsy, Alzheimer’s, autism, schizophrenia and depression, take 35% longer to develop than other drugs. Progress can be difficult to quantify with these diseases, making it even more critical for investigators and site staff to follow protocols consistently.

“Creating this SAG underscores INC Research’s commitment to better leveraging the expertise of clinical research sites worldwide in developing treatments for important health conditions,” said Michael Gibertini, president, clinical development. “Engaging with sites early on and in a meaningful way is critical to enhancing protocol design and study conduct. Our focus is on driving improved collaborations and innovative approaches to connecting more effectively with sites across all therapeutic areas as we work together to deliver on our ultimate goal of bringing new medicines to market for patients in need.”

Members of INC Research’s scientific and operational SAG specialize in psychiatry, with at least 10 years’ experience in schizophrenia, ADHD, depression and/or bipolar disorder, and have five years’ experience as a principal investigator. The group will be involved on an ongoing basis in reviewing protocols and providing feedback and solutions to enhance the conduct of psychiatry studies.

Theorem To Open New Clinical Supplies Facility
Theorem Clinical Research opened a new clinical supplies facility in Frankfurt, Germany, in June. The cGMP-compliant facility triples the company’s current clinical supplies capacity, with space for 2,700 square meters of ambient (15 to 25°C) and refrigerated (2 to 8°C) space. The facility also serves as a clinical supplies hub near the Frankfurt Airport.  

“We’re excited to have the additional manufacturing and warehousing space and, more importantly, an infrastructure to deliver the flexibility our clients rely on,” said John Potthoff, Theorem president and chief executive officer. “The new facility will enhance speed and scalability while preserving the versatility of our supply solutions.”  

The new facility enhances current practices, such as its 24/7/365 storage, continuous monitoring and backup, and provides space for future expansion.