Life sciences research and development
New opportunities to improve R&D efficiencies and returns
Clinical innovation remains imperative amid increasing pricing pressures, growing market share for generic pharmaceuticals and biosimilars, looming patent cliffs, and heightened scrutiny by regulators. With many new avenues enabled by the 21st Century Cures Act, real-world evidence, translational medicine, big data analytics, and digital technologies, new opportunities abound – if strategically harnessed – to improve R&D efficiencies and returns.
- Changing the R&D equation
- External innovation
- Getting real with real-world evidence
- Balance the R&D equation
- Explore related R&D insights
Changing the R&D equation with real-world evidence and regulatory flexibility
The volume, variety, and velocity of real-world evidence (RWE) are exploding. Bolstered by the 2016 passage of the 21st Century Cures Act, the doors have been opened for applications of RWE to expand.
Life sciences R&D organizations have long been challenged to increase pipeline value, improve efficiency, reduce costs, and deliver sustainable returns on investment. Today’s new avenues for real-world data to support the approval of new indications for previously approved drugs, identify unmet needs and/or populations that benefit from existing therapies (based on ethnicity, genotype, comorbidities, etc.) have the potential to shift, speed, and rebalance the R&D investment vs. return equation.
Life sciences companies should consider embracing new strategies, partnerships, and technologies to realize opportunities to discover, optimize, and demonstrate value through the application of RWE. The same is true to fully harness the new channels opened for biomarkers, surrogate endpoints, and patient-generated data captured via biosensors or apps, and other similar emerging, adaptive frameworks. The Cures Act challenged the FDA with new regulatory flexibility to apply recent advances in technology, analytics, and scientific and evidentiary models. Life sciences companies may risk being out of date and competitively disadvantaged if they are not actively exploring avenues to optimize these new pathways to drive regulatory approvals, commercialization, and market success.
External innovation: How biopharma companies are bolstering R&D pipelines through deal-making
Biopharma companies are under pressure when it comes to generating returns on innovation: they’ve declined from 10.1 percent in 2010 to 3.7 percent in 2016. Sourcing drugs externally may help reverse this trend… but which deal type will be most successful?
Explore our new research which evaluates three popular deal types – joint ventures, M&A, and licensing – and success rates for launching a drug or progressing through the R&D lifecycle under each.
Getting real with real-world evidence: Deloitte’s 2017 benchmark survey
Deloitte’s 2017 RWE benchmark survey shows that life sciences companies are strengthening RWE capabilities but still have significant opportunities to expand applications across the value chain, consider new channels to access real world data, and improve overall capabilities. As the demand for RWE increases, companies are turning to new technologies to compress the workflow and improve “time to insight.” To take advantage of opportunities and thrive in today’s technology-enabled, value-focused health care market, companies should consider embracing a new operating model based on end-to-end (E2E) evidence management from R&D through commercialization. This includes establishing an effective governance strategy, leveraging technologies such as the cloud and self-service analytics, and making sure that the organization has the ability to integrate data sets. Importantly, companies may also want to adopt new strategies to support collaborations with data aggregators such as health systems and patient advocacy groups.
- Read the Pharmaceutical Executive article: Pharma’s big push for value
- Blog: Real-world evidence: Four shifts ushering in a new era of evidence in life sciences and health care
Balance the R&D equation: Measuring the return from pharmaceutical innovation
Deloitte’s seventh annual pharmaceutical innovation study looks at the challenges the industry faces in generating returns from its R&D investments. After reviewing the estimated returns of 12 leading biopharma companies and comparing their performance with four mid-to-large-cap companies, the study finds:
- Annual projected pharma R&D returns continue to decline to 3.7 percent
- Peak sales per asset fall 11.4 percent year-over-year since 2010
- Costs to bring a product to market stabilize, from $1,576 million in 2015 to $1,539 million in 2016
The report also highlights key strategies to help increase pipeline value while reducing R&D costs to generate sustainable returns.
- BLOG: Defining a drug’s value: Is beauty in the eye of the beholder?
- Read previous versions of the report: Measuring the return from pharmaceutical innovation 2015
Look deeper. Explore Deloitte's latest insights on life sciences R&D.
Solutions for multi-faceted challenges
Life sciences companies that aim to streamline and power-up their R&D operations face a multifaceted challenge, and a partial solution may do more harm than good. Deloitte has a full set of solutions that won’t leave out any part of the R&D puzzle. With Deloitte’s work across all sectors of the health care and life sciences industry, we build in insight from providers, plans, Federal and other regulatory agencies, and other ecosystem participants whose point of view is vital to understanding R&D strategy.
Deloitte’s Life Sciences Research & Development practice understands the unique challenges facing R&D organizations at emerging and established companies large and small, and helps clients transform the value R&D brings. Deloitte can help drive innovation, productivity, and a successful portfolio:
R&D strategy: Helping R&D organizations transform their strategies and operating models to address continued pressure to innovate, increase productivity, and grow efficiently.
Medical affairs: Transforming organizations to more effectively bridge the gap between R&D and Commercial, integrate market input into science, and communicate medical insights and product knowledge across providers, payers, patients, and other stakeholders throughout the product lifecycle.
Regulatory affairs: Offering solutions to help regulatory organizations better understand and proactively address trends, operational efficiency, and regulatory compliance in the global regulatory environment.
Drug safety and pharmacovigilance: Providing a unique perspective and approach to help companies address complex issues and implement solutions to transform operations, promote patient safety, and improve quality. (Learn more about ConvergeHealth Safety, Deloitte’s evidence-based platform for safety intelligence.)
Clinical: Providing transformation services to improve clinical research and operations to generate better performance, improve quality, and achieve faster time to market.
Translational science and evidence: Providing life sciences innovators the integrated services and ConvergeHEALTH evidence mining and management solutions to accelerate, improve, and mature the use of evidence across the pharma/biotech lifecycle.
R&D Technology: Providing services and solutions to enable collection, integration, and analysis of information assets to drive insights and improve decision-making.
R&D tax incentives and credits: Helping clients navigate the increasingly complex landscape of incentives and tax credits to add greater impact within their organization. (See Deloitte’s tax solutions for life sciences for additional insights.)