Personalised Healthcare Solutions (PHCS) Excellence for ... · Personalised Healthcare Solutions...

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Personalised Healthcare Solutions (PHCS) Excellence for your Biomarker-driven Strategies

Transcript of Personalised Healthcare Solutions (PHCS) Excellence for ... · Personalised Healthcare Solutions...

Personalised Healthcare Solutions (PHCS) Excellence for your Biomarker-driven Strategies

The value of In Vitro Diagnostics

The value of diagnostics as an integral part in the healthcare value chainDiagnostics are about gathering medical data … to be transformed into actionable information.

IVD testing has long been a silent champion of healthcare, influencing over 60 % of clinical decision-making, while accounting for only about 2 % of total healthcare spending.

Transforming clinical samples into informed therapeutic action is key in the healthcare value chain.

ActionInformationDataCondition

IVD accounts for~2 %

of worldwide healthcare spending 1,2

IVD influences>60 %

of clinical decision-making 1,2

IVDs provide excellent healthcare value.

Sample Test Result Evaluation Treatment Desicion

1 European Diagnostic Manufacturers Association (EDMA), 2009; based on: The Lewin Group, commissioned by Advamed, “The Value of Diagnostics”, 2005.

2 The Lewin Group, The Value of Diagnostics Innovation, Adoption, and Diffusion in Healthcare (2005).

MonitoringTreatment

Chronic disease

Roche Diagnostics are an integral part in the healthcare value chain

Today, IVDs are an integral part of decision-making along the entire continuum of a patient’s health or disease, enabling physicians to make full use of IVDs along the healthcare value chain.

Stratification

Healthy

Diagnostics

Pharmaceuticals

Asymptomatic/Symptomatic disease

PrognosisDiagnosisScreeningPrevention

Roche Leadership in Diagnostics 3

Cardiology Infectiology Oncology Women’s Health CNS

Main Focus Areas

Roche Diagnostics’ areas of expertise Roche Diagnostics covers all IVD segments in all major healthcare areas.

Performed on blood, tissue or other patient samples IVDs are a critical source of objective information for improved disease management and patient care.

Roche Diagnostics offers the industry’s broadest range of diagnostic tests. Our pioneering technologies and solutions not only help ensure an accurate diagno-sis, they can detect the risk of disease, predict how a disease may progress, and enable the right treatment

decision at the outset. We help patients gain control over chronic conditions by enabling both physicians and patients to monitor treatment progress. And, through our successful collaboration with laboratories, we provide the fast and reliable results needed for life-changing decisions.

Roche Diagnostics serves customers spanning the entire healthcare spectrum – from research institutions, hospitals, and commercial laboratories to physicians and patients.

Roche Diagnostics’ commitment – Providing innovation and excellence today and tomorrow Roche offers a pioneering partnership to make the maximum contribution to patient care. As a leader in IVD solutions,3 we are your dedicated partner supporting you through our immunoassay technologies for centralised and decentralised settings, in molecular and tissue testing, as well as automation and IT solutions.

In a pioneering partnership, we provide products that increase testing efficiency and deliver medical value, whilst supporting you every step of the way with our global and local expertise; dedicated service and support teams are available in over 130 countries. Our commitment and rich pipeline of differentiated solu-tions and technologies will facilitate your provision of improved patient care – today and also tomorrow.

20 years of innovation and experience with Elecsys®

For two decades now, Roche has been continuously investing in the development of Elecsys assays, deliver-ing fast and reliable testing solutions for laboratories all over the world.

ElectroChemiLuminescence (ECL) technology is Roche’s highly innovative detection technology for heterogeneous immunoassays.

Since the launch of the first Elecsys 2010 analyser for small to mid-range laboratories in 1996, the extraor-

dinary success story of the Elecsys platform and ECL technology has continued to set the standard in im-munochemistry. More than 35,000 instruments* testify to the outstanding success of Elecsys systems, assays and the ECL technology. Every second, 60 results are reported in laboratories all over the world, amounting to more than 1.9 billion tests in 2016.

Roche Diagnostics’ professional IVD analysers com-bine innovative technologies with accurate, precise and reliable patient results that contribute to better patient care.

7,000 Installed systems

7,000 Installed systems

29,000 Installed systems

18,000 Installed systems

1,500 Installed systems

3 Source: Roche Annual Report 2014. January 2015. * Status 2016

What is PHC all about?PHC is about providing the right treatment for the right group of patients. Roche’s strengths in pharma-ceuticals and diagnostics along with advances in science and technology have made fitting treatments

to patients possible. Did you know that previously, only half of all patients, on average, actually benefited from their treatment? Today, up to 80 % of patients respond to their targeted therapies.

Personalised Healthcare (PHC)

From better disease understanding to supporting regulatory approvals.

Before PHC

After PHC

Ferring Pharmaceuticals and Roche collaborate to develop personalised infertility treatment

“As a leader in personalised healthcare we are expanding this approach to ever more areas of unmet medical need such as infertility and women’s health. In collaboration with Ferring, we are excited to play a pioneering role in individualising fertility management while continuing to invest in medically differentiated tests.”

Jean-Claude Gottraux, Head of Centralised and Point of Care Solutions

Roche – the partner of choice for PHC SolutionsKnowledge is leading to a dramatic increase in the identification of biological targets to fight many dis-eases.

In collaboration with large and small pharmaceutical companies, we identify and develop innovative CDx to target those patients who are likely to respond to spe-cific therapies. Because we recognize the tremendous potential for these solutions, we continue to focus on addressing unmet medical needs by developing the cutting-edge tools you need.

4 Food and Drug Administration. August 6, 2014. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM262327.pdf. Accessed Aug 2016.

The integral process to support drug development with CDx At Roche we combine technical competence with ther-apeutic insight. Development of a successful targeted therapy involves both diagnostic and pharmaceutical (clinical) concurrent co-development of the drug and the IVD CDx test. From a regulatory standpoint, the identification of the biomarker and development of the IVD CDx test require extensive testing, validation and approval in parallel with the clinical development of the therapeutic product.

The Food and Drug Administration (FDA) states that, “ideally, a therapeutic product and its corresponding IVD CDx device should be developed contempora-neously, with the clinical performance and clinical significance of the IVD CDx device established using data from the clinical development program of the c orresponding therapeutic product.” 4

Roche provides the strong partnership required for development of the therapy and the CDx test, ensuring a smooth and organized development process, in order to achieve timely regulatory marketing authorisations.

FDA definition of CDx 4

An IVD CDx device is an IVD device that provides information that is essential for the safe and effective use of a corresponding therapeutic product. The use of an IVD CDx device with a therapeutic product is stipulated in the instructions for use in the labelling of both the diagnostic device and the corresponding therapeutic product, including the labelling of any generic equivalents of the therapeutic product.

Roche offers all the necessary components to meet com-plex challenges that make PHC a reality.

In-house Skills

Know-how

Tools

Structure

PHC

Excellence for your Biomarker-drivenStrategies

Roche provides the strong partnership required to achieve timely regulatory approvals for therapeutic products and their CDx tests.

Pharmaceuticals

Diagnostics

Discoveryphase

Exploratoryphase

Proof of concept

Confirmatoryphase

Research and early development Clinical development Commercialisation

Lead generation

FilingPhase 0 Phase I Phase IITarget section

Phase III Market

Phase IV

Biomarker developmentTarget identification

Companion diagnostic feasibility and utilityPatient selection

Dx launch/post-launch assessmentTailored prescribing and monitoring

Partnership throughout the drug development processIn the early stages of discovery, biomarkers can provide insights on the causes or pathophysiology of the disease biology and the mode of action of a therapeutic molecule. During these early phases of a project, the biomarker and diagnostics teams work together with the ultimate goal of developing a reliable biomarker-based test – the CDx test, which will help predict which patients will respond to targeted therapies. This is central to the concept of PHC.

A multitude of potential biomarkers have been identi-fied that can be used to evaluate disease processes, understand disease diversity, identify drug targets and recognize differences between individual patients. Once a biomarker is found, a standardized diagnostic test can be developed and prepared for regulatory approval alongside a drug. Using biomarkers early can avoid exposing study participants to excessive doses of the drug compound in development and related potential side effects.

The future of sustainable healthcare depends on diagnostics.

Delivering the promise of biomarker-driven strategies

We bring over 200 biomarker projects with over 55 pharma partners with strong track records – reliably on time and on budgetWe reduce biotech companies’ development and commercialization risksWe offer a differentiated, broad instrument and reagent portfolioVentana Medical Systems

For more information please contact [email protected]

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