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To fully exploit the commercial advantages of companion diagnostics, Pharma companies need to rethink fundamentally their drug development and marketing strategies.

Everyone is a winner with companion diagnostics. The ability to accurately diagnose specific patient subsets is allowing drugs to be targeted only at those patients who will respond to treatment. Patients benefit from effective treatment and reduced side effects. Payers benefit from drugs that are now only used in patients for whom they are effective whilst the pharma industry, cautious about the potential impact of lower prescribing volumes, can benefit in the long term from effectively positioning its product.

Despite these advantages there remain a number of challenges for the sector. Regulation has failed to keep up with the speed of market development, differing cultural preferences - sharply contrasted in the US and Europe - are affecting take up, not all stakeholders are sufficiently informed and onboard while the uncertain reimbursement status in some markets is frustrating the sector’s development. What can Pharma and Diagnostic companies do to effect change?





Key Benefits

Through detailed case studies and expert industry input this invaluable report identifies the essential ingredients needed to successfully market a biologic drug and its companion diagnostic. Old models of selling and branding need to be adapted to the new market realities and partnership working with wider stakeholder education and integrated sales training all have a part to play. Learn from the experience and insights of front line experts from industry leading companies such as Pfizer, Boehringer Ingelheim, Qiagen and Diaceutics.






Key Questions Answered


How can you work with laboratories to ensure that companion diagnostics are seen positively and not competitively?
What role can patient advocacy groups play?
At what development stage should Pharma and Diagnostics teams be working together?
To what degree should the value proposition of the brand be related to the role of the accompanying diagnostic?
What alternatives are there to company funding of testing in markets where diagnostic reimbursement is not available?


This report will help you to:


Appreciate the complex and evolving regulatory environment which is shaping the market
Understand why clinical laboratories are critical in ensuring wide adoption
Incorporate joint working at an early stage to ensure harmonised approval with integrated marketing messages and programmes
Develop education programmes which will support patient confidence and clinician support
Introduce support and marketing structures which encourage diagnostic testing






Expert Views Include:


Dr Austin Finley, consultant, RxDxExperts (US)
Susan Holz, associate director of public relations, Boehringer Ingelheim (US)
Peter Keeling, chief executive office, Diaceutics (Northern Ireland)
Kevin Lokay, vice-president and business unit head, oncology, Boehringer Ingelheim (US)
Andy Schmeltz, US region president, oncology business unit, Pfizer
Dr Thomas Theuringer, director public relations, Qiagen (Germany)
Dr Carole Welsch, associate director, regional marketing of personalised healthcare, North America, Qiagen


Key Quotes

“This is a multidisciplinary approach. This is really a joint effort between global colleagues who want to ensure that there is a global strategy being implemented from the launch perspective, so the same drug and same test are being launched across the globe.” – Dr Carole Welsch, associate director, regional marketing of personalised healthcare at Qiagen North America

“The group sitting beside the physician and therefore often helping the physician take the decision around what the test result was is the laboratorian and pathologist - not the diagnostic company, not the payer, not the regulator, but the lab. The labs are the ones that are in the frontline.” – Peter Keeling, chief executive officer, Diaceutics

“The whole concept of personalised medicine is that you’re selecting in the clinical trial this patient population, so there needs to be a diagnostic technology and platform that’s used in those pivotal Phase III trials, the registration trials, that’s going to be part of your label. Therefore thinking about this is definitely something that has to come early in your clinical development programme when you think about the Dx technology platform that’s going to be most appropriate not only for the clinical trial programme to select the patients but also to ensure that that technology or technical platform is going to be widely available so that it’s not going to be a barrier to patients once the drug’s approved.” – Andy Schmeltz, US region president, oncology business unit, Pfizer


Table Of Contents

Effective sales and marketing strategies for drugs with companion diagnostics
1. Executive summary
2. Introduction
2.1.Rx meets Dx: challenges and opportunities
2.2.Regulatory inconsistencies
2.3.Transitioning from development to successful commercialisation
3.Personalised medicine - an emerging market with significant potential
3.1.Room for changes in pharmaceutical RandD strategies
3.2.Rx/CDx co-development model not without risk
3.2.1.Case study: Zelboraf rapidly penetrates melanoma market
4.requires a co-ordinated approach
4.1.Different stakeholders add to the complexity
4.1.1...labs the forgotten stakeholder
4.2.value proposition is key
4.3.Sales and marketing teams need to address specific market needs
4.4.education, education...
4.4.1.Case study: Boehringer Ingelheim's ‘Let's Test' programme raising awareness of biomarker testing for lung cancer
5.Diverse diagnostic regulations influencing commercialisation strategies
5.1.US drug label linked to CDx choice
5.1.1.CDx devices approved by the US FDA
5.2.EU regulations
5.3.Lab-developed tests versus kits
5.3.1.Case study: Conversion from LDTs to Qiagen's KRAS assay
5.3.2.LDTs find favour in European market
5.3.3.Case study: Study underway to standardise BCR-ABL1 testing
5.4.The testing challenge
5.5.Case study: Challenges in setting the standard for testing HER2 in breast cancer patients
5.6.study: Changing the lung cancer treatment paradigm
6.Pricing and reimbursement remain barriers to market access
6.1.Linking the value proposition to reimbursement
6.1.1.Case study: NICE assessment of EGFR-TK mutation testing options
6.2.Multiple modalities point to future commercialisation models
7.Conclusions
7.1.Methodology and acknowledgements

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