Pharmaceutical and biotechnology companies need to address the root cause of their drug development inefficiencies. Most companies focus their efforts on “enhanced clinical trial designs” that use biomarkers and adopt advanced statistical analyses, but they still need to hone their efforts at streamlining their drug development process, according to a recent report by the Tufts Center for the Study of Drug Development.
Kenneth Kaitin, Tufts CSDD director, lauded pharmaceutical companies’ efforts in using enhanced clinical trial designs to help reduce their drug development costs, but it might not be enough. “It’s a good start, but in a world shaped by increased patent expirations, diminished cash flow, and fewer promising breakthrough products, companies will need to hone their efforts to streamline development,” he said. (1)
NEAR TERM INDUSTRY TRENDS
Kaitin made the comments when the center released its “Outlook 2013” report in January. The report, which the center releases annually, included the following near-term trends for the pharmaceutical and biotech industry:
- More Partnering in the Horizon: Facing rising R&D costs, drug companies will seek more integrated partnering agreements with academic centers, CROs, patient groups, and other stakeholders to boost discovery and speed development of new compounds.
- Moving Toward Streamlined Approval Process: Regulatory agencies, especially in the U.S. and Europe, are facing growing pressures to approve breakthrough drugs more quickly; in response they will increasingly rely on new analytical and information tools to streamline the approval process.
- New Strategies for Improving Performance: Greater integration and risk sharing with contract service providers, combined with new approaches to optimizing protocol design and simplifying global clinical trial activity are key strategies drug developers will use to drive efficiency, lower cost, and improve performance.
ADDRESSING R&D INEFFICIENCIES
Now more than ever, it behooves pharmaceutical and biotech companies to address fundamental R&D inefficiencies. Partnering with CROs, especially during the clinical research phase, can help improve overall efficiency. Clinical trial is the third most frequently outsourced service by pharmaceutical and biotech companies (next to hiring consultants and analytical testing), according to a survey conducted by Nice Insight. (2)
If your company is currently utilizing CRO services to conduct a clinical trial, or if it’s a CRO conducting clinical research for a sponsor, how can you increase efficiency? Here are two key areas that affect sponsor-CRO efficiency:
- Collaborative Environment: Most sponsor-CRO problems stem from poor communication, which is essential in establishing a collaborative environment. Contracts (quality agreement, service contract) can help define a collaborative environment by defining expectations, study requirements, corresponding deliverables, applicable GCP regulations, and audit requirements. A sponsor should be informed immediately if the CRO plans to use a subcontractor. The sponsor has to refrain from micromanaging, but at the same time it has to be vigilant in monitoring clinical trial activities.
- Compliance Responsibilities: FDA regulations (21 CFR 312.25) and ICH E6 GCP Consolidated Guidance (Section 5.2) both allow transfer of clinical trial duties from the sponsor to the CRO, but the sponsor retains the ultimate responsibility for the clinical research. For practical purposes, however, a sponsor and its CRO are partners and should share compliance responsibilities. This “sharing” of responsibilities should be reflected in a project management plan that should be developed through a collaboration of all stakeholders.
CONCLUSION
Having the right tools can go a long way in establishing a collaborative environment, sharing compliance responsibilities, and increasing overall efficiency. When a sponsor and a CRO use disparate tools, efficiency is more difficult to attain.
For example, a sponsor may be using an electronic quality system but the CRO may still be using a paper-based process. Even when all parties involved use electronic tools, they may not have the capability to consolidate their different tools into one platform or to connect with each other for collaboration. Simple tasks such as searching for and tracking of SOPs and essential documents, and routing, review and approval of documents can take longer.
Establishing a collaborative environment is easier with the help of an electronic system that the sponsor and CRO can share. Compliance efforts can be shared more equitably between the sponsor and the CRO with a system that automatically notifies the sponsor of any serious CAPA or other issues in a timely manner.
To a large extent, improving efficiency, especially during clinical research, rests on the ability of sponsors and CROs to work together successfully, and having a common electronic platform and tools can play a key role.
REFERENCES
From Tufts CSDD press release, Jan. 8, 2013, viewed on May 13, 2013: http://csdd.tufts.edu/news/complete_story/pr_outlook_2013 From a Q4 2011 survey conducted by Nice Insight, a firm that provides quarterly marketing intelligence reports in the materials science and life science. Facing rising R&D costs, drug companies will seek more integrated partnering agreements with academic as cited by Kate Hammeke, Nice Insight Research Manager, “Outsourcing Trends for 2012: Top Services by Customer Segment and the Prevalence of Contracting to Emerging Markets,” GxP Lifeline, http://www.mastercontrol.com/pharma/outsourcing-trends-2012.html?source=n3w5pharma|70130000000XEps
Note: This article is used with permission from GxP Lifeline and has been previously published at www.mastercontrol.com.”
Bio:
Cindy Fazzi, a copywriter at MasterControl Inc., writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master’s degree in journalism from Ohio State University.