Thursday, January 23, 2014

Partnerships One-on-One: Marisa Co, Vice President R&D and Global Procurement, Bristol-Myers Squibb

Recently Partnerships in Clinical Trials speaker Marisa Co, Vice President R&D and Global Procurement, Bristol-Myers Squibb sat down to address some of the key issues in the clinical trials industry facing procurement, the trends facing Big Pharma, clinical innovation and more.

Speaker Marisa Co
How has the role of procurement changed in the pharmaceutical industry within the last 5-7 years?
Marisa: As pharmaceutical companies search for new approaches to increase revenues and generate efficiencies, senior executives are looking at Procurement as an untapped value-driving organization. Thus, the role of Procurement has changed.

Over the last 10+ years, the emphasis in the industry has been more on supplier development and improvement. Given this focus, procurement’s role will continue to evolve toward forging relationships more collaborative with suppliers to drive innovation in all aspects of the supply chain. Finding sources of such innovation requires knowledge of markets, access to competitive intelligence and technology. In order to play a key role in helping shape business strategy, Procurement would need to re-define its value proposition from being an organization solely focused on cost to an organization that measures value creation such as project efficiency, ROI, time-to-market and program success. The transition will not be easy as it requires a cultural shift from tactical, category-focused, adversarial mindset to a more strategic, decision-making, collaborative one fully aligned with the functional unit leaders. Thus, the traditional background and skill set of the sourcing professional will evolve to focus more on developing collaborative relationships with internal partners and suppliers, driving innovation through deeper understanding of the supply base, market technologies and their applications. By applying an entrepreneurial mindset, companies will leverage a broader range of technical skills and experiences to develop and execute new strategies.

What trends are you seeing within Big Pharma and why are they developing that way?
Marisa: Higher reimbursement hurdles for therapies that add incremental value to the ones already on the market, as a mean to limit coverage for “me too” drugs and contain the rising healthcare costs.  Healthcare providers investing significantly in information technology to drive quality of care, incentives and drug efficacy assessment.  There is more focus on developing partnerships with providers, patient advocacy groups and research groups to drive innovation and new R&D models. Patient-centric models not only as it relates to healthcare delivery but also from a clinical research standpoint.

More rationalization of therapeutic areas amongst pharmaceutical companies and increased focus on more flexible, variable R&D models to continue to decrease drug development costs. New and improved collaborative partnerships between sponsors and CROs will emerge.  There is also earlier interaction with payors and higher collaboration with Health Authorities to share data and assess therapeutic and economic value of new drugs at an early stage of development.

Non-traditional commercialization and supply chain models customized for specific regions and countries with less emphasis on the prescribers.  Stronger collaboration between R&D and Commercial to design experiments that demonstrate value to payors, regulatory agencies, patients, and other stakeholders during the early phases of drug development

With sustainability of the R&D business in question, how are pharmaceutical companies responding to the need for clinical innovation?
There is a stronger integration with partners with various risk/reward incentives starting in early phases of development in addition to the creation of more open innovation networks with academic research centers, leading media and technology companies, biopharmaceutical companies, large healthcare networks and pharmacy benefits to increase R&D pipelines and expand commercialization channels.
There is also integration of massive amount of data into centralized, decision-making units to support validation of hypotheses through analytics as well as increase use of point of care diagnostics to better match inclusion/exclusion criteria to the right patient and decrease failure rate.

Greater adoption of adaptive clinical trial design from simple ones to early study termination due to futility or sample size re-estimation to more sophisticated designs. CRO moving into adaptive designs more aggressively.  Portfolio management whereby selecting the best suppliers to partner with for each compound in development.  And finally, increases in outsourced activities and / or functions due to downsizing, becoming more flexible to enable faster decision-making, i.e., data management, SUSAR (pharmacovigilance reporting), medical writing, monitoring, analytical, PK, PD services. Increase in flexible staffing.

What are you most looking forward to at the 2014 Partnerships in Clinical Trials conference?
New partnering models between CROs and sponsors, a focus on patient-centricity: what are the CROs doing to increase patient recruitment and improve retention.  Also, the emerging technologies, big data and their use to improve clinical study timelines and selective integration models that work and the reasons for their success

Marissa is featured this year as one of the 2014 Executive Boardroom Members.  She will also be participating in the panel The State of Clinical Outsourcing: The Impact of Outsourcing Partnerships on Clinical Trial Optimization.  For more information on Marissa's session and the rest of the program, download the agenda.  If you'd like to join Marisa at Partnerships in Clinical Trials this March 30-April 2, 2014, as a reader of this blog when you register to join us and mention code XP1900BLOG, you'll save $100 off current rates!




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