Kristin Brooks06.24.14
The 50th Annual DIA Meeting, held last week in San Diego, from June 16-18, hosted more than 450 service providers dedicated to the life sciences, including CROs, technology vendors, research centers, and academia. Clinical technology solutions had a dominant presence, not surprising in an industry focused on greater efficiencies to quell rising development costs and produce better outcomes. Below are some of the latest news releases and product announcements made at the annual meeting.
Additionally, several sessions addressed key topics on the state of clinical outsourcing, continued efforts to streamline drug development, and a look at sponsor/CRO relationships, then and now, highlighting progress and continued challenges along the way.
The forum, Collaborating to Streamline Drug Development: Case Studies of What Works (and What Doesn’t), moderated by Douglas J. Peddicord, Ph.D., executive director, Association of Clinical Research Organizations (ACRO), explored innovative projects aimed at streamlining product development undertaken during the past year. The panelists included: Dalvir Gill, Ph.D. chief executive officer, TransCelerate Biopharma; Christine K. Pierre, president, Society for Clinical Research Sites; Pamela Tenaerts, MD, executive director, Clinical Trial Transformation Initiative; and Ann Meeker-O’Connell, senior director, QA Clinical Strategy Team Lead, Janssen Pharmaceuticals.
R&D takes 17 years from research to patient. What would it take to transform drug development? In short, R&D is too costly and collaborations with CROs can help. Also, a key to streamlining drug development lies in the establishment of global standards, for which the panel noted the dedicated groups of CTTI (Clinical Trials Transformation Initiative), CDISC, and C-Path that have, and continue to drive these efforts.
These groups are working to feed the discovery cycle, establish site accreditation and standards for sustainability and best practices. In addressing inefficiencies and establishing standards faster, Dr. Gill noted a few examples, “don’t buy more batches than needed, not wasting resources helps to save; establish a common protocol template with the FDA; and, with a single quality management system for pharma and biopharma, data will flow end to end.”
On the landscape of R&D collaborations, Ms. Meeker-O’Connell noted the importance of overcoming risk aversion. Also, to improve quality, include all stakeholders, patients, academia, FDA, pharma and biopharma. To streamline development, take evidence and suggest changes. With respect to QBD (quality by design) monitoring practices, make clear the goal of monitoring is quality data. In other words, we can’t continue to do the same things as in the past. For example, with protocols, you can’t have 23 endpoints, don’t worry about things that don’t matter.
In trying to move the landscape forward to develop more drugs in the future, there will be a reliance on collaboration and innovation, as ACRO and CDISC work together on standards for data, quality and security.
Another session entitled, The Present and Future of Pharmaceutical Development Outsourcing: Where Are We Today and Where Are We Going?, chaired by Jon Meyer, co-founder and managing member, Life Science Strategy Group, examined the CRO/Sponsor Relationship, then and now, providing a look at past outsourcing models and their impact on future relationships. Panelists included: Andrew Townshend, vice president of Alliance Development at INC Research, and Mitchell A. Katz, Ph.D., executive director of Medical Research Operations at Purdue Pharma L.P.
This past decade, the pharma industry has increasingly employed the services of increasingly sophisticated CROs for drug development as part of its overall R&D strategy to reduce internal costs, accelerate timelines, and increase efficiencies. This has been carried out through various strategies such as CROs serving in functional roles, use of a limited number of preferred partners, as well as forming strategic partnerships. The forum addressed some of these outsourcing models and how outsourcing strategies are expected to evolve over the next five years.
While the challenges around efficiencies and cost containment for pharma companies are more acute now, they have always existed. CROs have and continue to play an increasingly greater role in drug development as a result. However, many of these relationships continue to experience a continued challenge—oversight. With no clear guidelines for oversight, a more hands on approach is often taken by pharma, making it hard for CROs to operate more independently.
While the panel agreed the level of flow has gotten better, oversight remains a challenge and more interaction is needed to get the most out of outsourcing. CROs are moving away from a protocol to protocol approach to more of a compound management strategy and therapeutic focus areas. Also, in the future, according to the panel, we’ll see more CRO partner involvement, from the execution of a trial to the development plan, including, more autonomy with site selection, SOPs, protocol, resource allocation, and operational decisions.
DIA News
BioClinica Acquires Blueprint Clinical
BioClinica, Inc. has acquired Blueprint Clinical, a provider of Risk-Based Monitoring (RBM) strategies for clinical trials. BioClinica will gain Compass, a cloud-based site scoring tool to its eClinical platform.
BioClinica will now offer a comprehensive “Intelligent Monitoring” solution designed to enable pharmaceutical companies and CROs to utilize the reduced source documentation approach outlined by the FDA.
Compass is used to evaluate potential risks to patient safety and clinical trial operational performance. It assigns a performance-based score to each investigative site based on quantitative data and qualitative information. The platform is designed to provide optimized site quality performance, reduced costs, and effective use of monitoring resources.
BioClinica president and chief executive officer Mark Weinstein said, “Ever since the FDA issued its final guidance to industry on risk-based monitoring last year, there’s been an explosion of interest in technology to make it a reality. Compass provides a transformative risk-based monitoring solution that enables the industry to move forward.”
President and co-founder of Blueprint Clinical, Courtney McBean added, “Compass is a powerful and proven tool that enables you to monitor what matters, when it matters. It’s an intelligent monitoring solution that replaces 100 percent source data verification with greater use of off-site and central monitoring.” Ms. McBean and her team will join BioClinica.
Celerion Appoints Global Medical Director of Cardiac Safety
Robert Lester MD FACC, has been appointed chief cardiologist, global medical director of Cardiac Safety Services at Celerion. Dr. Lester will develop and lead Celerion’s Cardiac Safety Services and will be based at the company’s facility in Phoenix, AZ. He will provide advice and lead client programs using the company’s Automated ECG Core Lab, which is designed to expedite ECG.
Dr. Lester has more than 25 years of experience in clinical medicine and academia, as well as 13 years serving as a director and senior cardiologist at several leading CROs and ECG Core labs.
“The appointment of Robert continues to reinforce Celerion’s leadership role in the area of cardiac safety studies,” said Phil Bach, vice president of Global Clinical Research at Celerion. “His comprehensive expertise and knowledge in the area of cardiac safety will be invaluable for Celerion and for our clients. Robert will also lead the efforts to ensure we meet the needs of our clients, as the regulatory landscape changes.”
Oracle Introduces New Data Management Workbench
Oracle has introduced its Health Sciences Data Management Workbench for life sciences organizations conducting clinical trials. The platform is designed to aggregate, reconcile, manage, and control data from internal and external sources.
According to the company, the platform automates data load, transforms and cleanses processes, resulting in faster, more informed decisions that improve control, support adaptive studies and accelerate clinical trials and time to market.
The solution integrates and reconciles data, including electronic data capture, lab, safety/pharmacovigilance, and drug supply systems. Using this standardized data transformation, the workbench automates the identification and correction of discrepancies in multi-source data. Also, according to the company, the standardized data formats used within the system are repeatable and reusable and can help streamline compliance with full traceability of data discrepancies, as well as provide security and audit trail capabilities.
“As the industry’s only true end-to-end data management solution, Oracle Health Sciences Data Management Workbench enables health sciences organizations to improve clinical program productivity and reduce costs and risk by reducing study cycle times, improving data quality and decision making,” said Steve Rosenberg, senior vice president and general manager, Oracle Health Sciences.
PAREXEL Launches New Version of Clinphone RTSM
PAREXEL has launched a new version of its industry standard ClinPhone RTSM services designed to help clients start clinical trials more quickly. The randomization and trial supply management (RTSM) solution, developed by PAREXEL Informatics, is a major component of the Perceptive MyTrials platform, a suite of applications for managing clinical trials.
ClinPhone RTSM can be implemented using pre-built, interactive web modules for patient, supply and site activities for studies. Also, PAREXEL Informatics provides system review and approval for clients via a visual design approach.
“Based upon our experience across thousands of studies, we have identified ways to standardize common functionality for patient screening, medication re-supply and other fundamental study activities,” said Xavier Flinois, president of PAREXEL Informatics. “Our customers can simplify trial management activities, and ultimately start their trials more quickly, using our powerful and flexible RTSM technology.”
“There is a growing need for faster, more efficient clinical trials, yet conducting them has become increasingly complex,” said Mark A. Goldberg, M.D., president and chief operating officer, PAREXEL. “Trial success often hinges on start-up speed and effectiveness. At PAREXEL, we view drug development as a journey, and have made considerable investments in developing cutting-edge technology to help simplify it from beginning to end.”
ClinPhoneRTSM is available through the Perceptive MyTrials platform and as a standalone solution.
Techorizon Launches TH-eClinical Suite
Techorizon, a provider of clinical technology solutions, launched the TH-eClinical suite of clinical research products at DIA. The suite consists of four research modules, including TH-eCRF (21 CFR Part 11 compliant electronic case report form), TH-eDiary (ePRO patient diary), TH-eSurvey (electronic questionnaire) and TH-eLearning (a validated remote learning application). According to the company, all applications can be fully integrated or deployed independently and are accessible securely in real time via computer, tablet or smartphone connection with the Cloud.
“TH-eClinical and its individual applications provide a flexible, highly advanced and cost- effective alternative for global research and development,” said Silvio Severini, managing director of Techorizon. “Each TH-eClinical application can be quickly tailored to meet the unique requirements of individual clients and data is validated to GAMP 5 standards and securely archived within our own state-of-the-art infrastructure.”
Additionally, several sessions addressed key topics on the state of clinical outsourcing, continued efforts to streamline drug development, and a look at sponsor/CRO relationships, then and now, highlighting progress and continued challenges along the way.
The forum, Collaborating to Streamline Drug Development: Case Studies of What Works (and What Doesn’t), moderated by Douglas J. Peddicord, Ph.D., executive director, Association of Clinical Research Organizations (ACRO), explored innovative projects aimed at streamlining product development undertaken during the past year. The panelists included: Dalvir Gill, Ph.D. chief executive officer, TransCelerate Biopharma; Christine K. Pierre, president, Society for Clinical Research Sites; Pamela Tenaerts, MD, executive director, Clinical Trial Transformation Initiative; and Ann Meeker-O’Connell, senior director, QA Clinical Strategy Team Lead, Janssen Pharmaceuticals.
R&D takes 17 years from research to patient. What would it take to transform drug development? In short, R&D is too costly and collaborations with CROs can help. Also, a key to streamlining drug development lies in the establishment of global standards, for which the panel noted the dedicated groups of CTTI (Clinical Trials Transformation Initiative), CDISC, and C-Path that have, and continue to drive these efforts.
These groups are working to feed the discovery cycle, establish site accreditation and standards for sustainability and best practices. In addressing inefficiencies and establishing standards faster, Dr. Gill noted a few examples, “don’t buy more batches than needed, not wasting resources helps to save; establish a common protocol template with the FDA; and, with a single quality management system for pharma and biopharma, data will flow end to end.”
On the landscape of R&D collaborations, Ms. Meeker-O’Connell noted the importance of overcoming risk aversion. Also, to improve quality, include all stakeholders, patients, academia, FDA, pharma and biopharma. To streamline development, take evidence and suggest changes. With respect to QBD (quality by design) monitoring practices, make clear the goal of monitoring is quality data. In other words, we can’t continue to do the same things as in the past. For example, with protocols, you can’t have 23 endpoints, don’t worry about things that don’t matter.
In trying to move the landscape forward to develop more drugs in the future, there will be a reliance on collaboration and innovation, as ACRO and CDISC work together on standards for data, quality and security.
Another session entitled, The Present and Future of Pharmaceutical Development Outsourcing: Where Are We Today and Where Are We Going?, chaired by Jon Meyer, co-founder and managing member, Life Science Strategy Group, examined the CRO/Sponsor Relationship, then and now, providing a look at past outsourcing models and their impact on future relationships. Panelists included: Andrew Townshend, vice president of Alliance Development at INC Research, and Mitchell A. Katz, Ph.D., executive director of Medical Research Operations at Purdue Pharma L.P.
This past decade, the pharma industry has increasingly employed the services of increasingly sophisticated CROs for drug development as part of its overall R&D strategy to reduce internal costs, accelerate timelines, and increase efficiencies. This has been carried out through various strategies such as CROs serving in functional roles, use of a limited number of preferred partners, as well as forming strategic partnerships. The forum addressed some of these outsourcing models and how outsourcing strategies are expected to evolve over the next five years.
While the challenges around efficiencies and cost containment for pharma companies are more acute now, they have always existed. CROs have and continue to play an increasingly greater role in drug development as a result. However, many of these relationships continue to experience a continued challenge—oversight. With no clear guidelines for oversight, a more hands on approach is often taken by pharma, making it hard for CROs to operate more independently.
While the panel agreed the level of flow has gotten better, oversight remains a challenge and more interaction is needed to get the most out of outsourcing. CROs are moving away from a protocol to protocol approach to more of a compound management strategy and therapeutic focus areas. Also, in the future, according to the panel, we’ll see more CRO partner involvement, from the execution of a trial to the development plan, including, more autonomy with site selection, SOPs, protocol, resource allocation, and operational decisions.
DIA News
BioClinica Acquires Blueprint Clinical
BioClinica, Inc. has acquired Blueprint Clinical, a provider of Risk-Based Monitoring (RBM) strategies for clinical trials. BioClinica will gain Compass, a cloud-based site scoring tool to its eClinical platform.
BioClinica will now offer a comprehensive “Intelligent Monitoring” solution designed to enable pharmaceutical companies and CROs to utilize the reduced source documentation approach outlined by the FDA.
Compass is used to evaluate potential risks to patient safety and clinical trial operational performance. It assigns a performance-based score to each investigative site based on quantitative data and qualitative information. The platform is designed to provide optimized site quality performance, reduced costs, and effective use of monitoring resources.
BioClinica president and chief executive officer Mark Weinstein said, “Ever since the FDA issued its final guidance to industry on risk-based monitoring last year, there’s been an explosion of interest in technology to make it a reality. Compass provides a transformative risk-based monitoring solution that enables the industry to move forward.”
President and co-founder of Blueprint Clinical, Courtney McBean added, “Compass is a powerful and proven tool that enables you to monitor what matters, when it matters. It’s an intelligent monitoring solution that replaces 100 percent source data verification with greater use of off-site and central monitoring.” Ms. McBean and her team will join BioClinica.
Celerion Appoints Global Medical Director of Cardiac Safety
Robert Lester MD FACC, has been appointed chief cardiologist, global medical director of Cardiac Safety Services at Celerion. Dr. Lester will develop and lead Celerion’s Cardiac Safety Services and will be based at the company’s facility in Phoenix, AZ. He will provide advice and lead client programs using the company’s Automated ECG Core Lab, which is designed to expedite ECG.
Dr. Lester has more than 25 years of experience in clinical medicine and academia, as well as 13 years serving as a director and senior cardiologist at several leading CROs and ECG Core labs.
“The appointment of Robert continues to reinforce Celerion’s leadership role in the area of cardiac safety studies,” said Phil Bach, vice president of Global Clinical Research at Celerion. “His comprehensive expertise and knowledge in the area of cardiac safety will be invaluable for Celerion and for our clients. Robert will also lead the efforts to ensure we meet the needs of our clients, as the regulatory landscape changes.”
Oracle Introduces New Data Management Workbench
Oracle has introduced its Health Sciences Data Management Workbench for life sciences organizations conducting clinical trials. The platform is designed to aggregate, reconcile, manage, and control data from internal and external sources.
According to the company, the platform automates data load, transforms and cleanses processes, resulting in faster, more informed decisions that improve control, support adaptive studies and accelerate clinical trials and time to market.
The solution integrates and reconciles data, including electronic data capture, lab, safety/pharmacovigilance, and drug supply systems. Using this standardized data transformation, the workbench automates the identification and correction of discrepancies in multi-source data. Also, according to the company, the standardized data formats used within the system are repeatable and reusable and can help streamline compliance with full traceability of data discrepancies, as well as provide security and audit trail capabilities.
“As the industry’s only true end-to-end data management solution, Oracle Health Sciences Data Management Workbench enables health sciences organizations to improve clinical program productivity and reduce costs and risk by reducing study cycle times, improving data quality and decision making,” said Steve Rosenberg, senior vice president and general manager, Oracle Health Sciences.
PAREXEL Launches New Version of Clinphone RTSM
PAREXEL has launched a new version of its industry standard ClinPhone RTSM services designed to help clients start clinical trials more quickly. The randomization and trial supply management (RTSM) solution, developed by PAREXEL Informatics, is a major component of the Perceptive MyTrials platform, a suite of applications for managing clinical trials.
ClinPhone RTSM can be implemented using pre-built, interactive web modules for patient, supply and site activities for studies. Also, PAREXEL Informatics provides system review and approval for clients via a visual design approach.
“Based upon our experience across thousands of studies, we have identified ways to standardize common functionality for patient screening, medication re-supply and other fundamental study activities,” said Xavier Flinois, president of PAREXEL Informatics. “Our customers can simplify trial management activities, and ultimately start their trials more quickly, using our powerful and flexible RTSM technology.”
“There is a growing need for faster, more efficient clinical trials, yet conducting them has become increasingly complex,” said Mark A. Goldberg, M.D., president and chief operating officer, PAREXEL. “Trial success often hinges on start-up speed and effectiveness. At PAREXEL, we view drug development as a journey, and have made considerable investments in developing cutting-edge technology to help simplify it from beginning to end.”
ClinPhoneRTSM is available through the Perceptive MyTrials platform and as a standalone solution.
Techorizon Launches TH-eClinical Suite
Techorizon, a provider of clinical technology solutions, launched the TH-eClinical suite of clinical research products at DIA. The suite consists of four research modules, including TH-eCRF (21 CFR Part 11 compliant electronic case report form), TH-eDiary (ePRO patient diary), TH-eSurvey (electronic questionnaire) and TH-eLearning (a validated remote learning application). According to the company, all applications can be fully integrated or deployed independently and are accessible securely in real time via computer, tablet or smartphone connection with the Cloud.
“TH-eClinical and its individual applications provide a flexible, highly advanced and cost- effective alternative for global research and development,” said Silvio Severini, managing director of Techorizon. “Each TH-eClinical application can be quickly tailored to meet the unique requirements of individual clients and data is validated to GAMP 5 standards and securely archived within our own state-of-the-art infrastructure.”