Today’s clinical trials have become more complex and expensive, pressuring pharmaceutical companies to further improve their clinical trial operations. Clinical trial data management is one area where both sponsors and contract research organizations (CROs) can uncover new efficiencies, increase cost-saving measures and better meet diverse operational reporting needs across the clinical development cycle.
In this blog we begin to examine the current issues with traditional electronic data capture systems and other current “big data” approaches that attempt to address complex operational reporting needs in this historically stagnant and underserved area. We also discuss the use of two distinct data repositories – an operational data warehouse and a clinical data warehouse – the Xcellerate® Clinical Data Hub as part of a new data model through the Xcellerate Informatics Suite to provide a significant technological advance in clinical trial operations. Continue reading →
Jonathan Zung, Group President, Clinical Development & Commercialization Services, has only been at Covance for a short time, but he already has big plans for the future of our clinical and commercialization businesses, as well as fresh ideas on talent development.
We recently spoke with him to learn more about his passion for operational excellence, and ideas for helping us develop and nurture our own careers. Continue reading →
Biosimilars have dominated the headlines in the U.S. with several FDA approvals, legal battles and questions around reimbursement, placing an increased focus on how to successfully navigate this relatively new pathway from end to end.
Starting with the regulatory environment to CMC bioanalytics and pharmacodynamics, learn how drug developers can understand regulatory differences and identify a fit-for-purpose program. We will also cover how to proactively identify key issues for both PK equivalence and Phase III equivalence studies, and initiate market access and commercialization approaches. Continue reading →
Last month while at Disruptive Innovations US, Soloman Babani, Global VP, Alliance Management at Covance caught up with Valerie Bowling from The Conference Forum to discuss the role of the CRO in creating disruptive innovations in pharma and clinical development. Check out the interview below to gain expert insight into the topics discussed at this unique event, which brought together senior leaders from top CROs to discuss this issue openly and honestly. Learn about what the future looks like, specifically related to profits and R&D spending, as well as what can be done to help reduce prices.
Change is in the Air There’s reason for new hope in the ongoing battle against cancer. From standing-room-only presentations of provocative data at cancer conferences, to landmark publications and new drugs approvals, the signs are multiple and clear. Harnessing the immune system as an anti-cancer therapy–a strategy that has yet to fully deliver on its promise– is now the most exciting area of oncology drug development.
Immune Surveillance: an Invisible Malignancy Sentinel The first chapter in the story of cancer immunotherapy is a tale that provides perspective on how evolving scientific insight serves as a backdrop to the interplay between human hopes and the sometimes capricious nature of medical advances. But that story is well beyond the scope of the next 800 or so words. However, we can take advantage of hindsight to consider some of the key lessons learned. Continue reading →
Throughout my career at Aventis, Hoffmann-La Roche and Alcon (a Novartis company), we focused on the proof of concept (PoC) as the critical milestone when considering when to partner with or purchase a compound from a small biotech.
Your potential pharma partner is looking for answers to key development questions surrounding the mechanism of action and your compound, how your company has addressed those, the robustness of the results and the quality of the data. This drives their evaluation of the real stage of development and the valuation. Continue reading →
Emerging Markets in Clinical Trials: Romania Delivers Pivotal Boost in Enrollment in Challenging Indication
Intense competition for investigators and patients in traditional clinical research markets has enabled emerging regions such as Central and Eastern Europe, Russia and the former USSR to play an increasingly prominent role in the quest for high-quality clinical trial data. While well-established markets across Western Europe and the U.S. continue to play an important role in clinical research, it has become crucial to leverage the untapped patient and investigator potential of these emerging markets to ensure sufficient and timely enrollment. Continue reading →
Choosing where to conduct a global clinical trial is a critical strategic decision that can impact an entire drug development program, including patient recruitment and retention, the speed of execution, and ultimately your marketing plan. Many factors must be taken into account when selecting countries, however, the relative importance of each factor will vary depending on clinical trial design, the therapeutic area being studied, and your overall development strategy. For instance, while one study may rely on access to naïve patients or include a comparator arm, other conditions may require a more complex trial design and more robust clinical infrastructure, such as availability of specialized imaging capabilities. Continue reading →
The level of investment required and inherent risks in development of today’s new and advanced biopharmaceutical products are greater than ever posed in the history of the industry. Pharmaceutical products are more specialized, technology is more complex, the regulatory environment more tortuous, global markets for these products are more competitive and return on investment may be uncertain at the early stages of product development. Additionally, new clinical development tools and regulatory principles, e.g., enrichment strategies, adaptive trial designs, breakthrough designation, are emerging that enable more efficient clinical development, as well as, more expedited approval pathways for new therapeutic approaches to disease management. Continue reading →
Covance recently hosted a webinar “Best Practices and Solutions in the New Inflammation Paradigm,” where two Covance experts (Global Therapeutic Area Head for Inflammation Dr. Michael George and Executive Director of Operational Strategy and Planning Joan Meyer, Ph.D.) explored a profound shift in the perception and treatment of inflammation and its transformative impact on drug development and clinical trials.
Recent years have seen significant advances in the medical and scientific community’s knowledge of immunology and the pivotal role inflammation plays in disease, providing multiple new targets for anti-inflammatory therapy. A leading area of interest and activity, the global inflammatory therapeutics market is currently estimated at $55 billion per year and growing. Continue reading →