Is collaboration key to the evolution of personalized medicine?

Hannah Blake interviews Isabelle Tanneau

ImmunID Technologies

Continuing on our personalized medicine focus month, we speak with Isabelle Tanneau about the benefits for pharma in switching to this new model and how collaboration may be the next step.

As we enter a new era of healthcare, namely the personalized medicine era, it’s easy to question why pharma should switch to this new model. We speak with Isabelle Tanneau, from ImmunID Technologies, to find out about the benefits for pharma, as well as some of the challenges companies may face. We also ask Isabelle her thoughts on the ethical issues surrounding personalized healthcare, as issues with access are still very much present today.

In the long term, Isabelle believes that personalized medicine is not just about tailoring treatments to patients’ genetic information, but that it is about harnessing a patient’s immune system in order to fight disease. Find out more of her thoughts by reading our interview with her, below.

Interview summary

HB: Can you start by telling us a bit about your background and your current role, please? What intrigued you about the personalized medicine industry?

IT: My background is in molecular biology. I completed my scientific education with a master’s degree in management and business. I have been working for ImmunID Technologies as Scientific Business Development Manager for about one and a half years. My role consists in detecting and advancing business and partnering opportunities for the strategic development of our products and also in promoting our services on the US market.

HB: What is the aim of ImmunID?

IT: ImmunID is a molecular diagnostics company which specializes in the determination of a patient’s immune status. The company looks at the disease-patient relationship in a different way, from the immunological perspective, and aims at advancing personalized medicine by providing physicians with innovative tools to choose and adapt treatments, based on each patient’s immune status. Indeed, although there is an evident and increasing awareness about the critical role of the immune system in maintaining cellular homeostasis and in fighting diseases, the immune status of patients is rarely evaluated in the current medical practice. This may be due to a lack of reliable tools that can translate the complexity of the immune system into data that is clinically meaningful. ImmunID’s goal is therefore to bring this missing piece to the “Disease-Treatment-Patient” puzzle.

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“…the immune status of patients is rarely evaluated in the current medical practice.”

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The company has developed and patented innovative technologies to assess immune repertoire diversity, which we use as a dynamic biomarker of health status and treatment efficiency. For example, we showed that the level of T cell repertoire diversity in metastatic breast cancer patients, before treatment, was correlated to their clinical outcome. ImmunID is pursuing the validation of the biomarker in additional indications and is also providing the technology under fee-for-service to biopharmaceutical companies and clinical research centers worldwide, for patient stratification, immune monitoring and characterization of the effect of drug candidates (immunotherapy, chemotherapy) on immune diversity.

HB: Have any advances within the personalized medicine field inspired you?

IT: Of course! I have been intrigued by biology and medicine for several years and by personalized medicine in particular. The first example that comes to my mind would probably be Trastuzumab in HER-2 / neu overexpressing breast cancer patients. I believe this molecule and its companion diagnostics have been game-changing in the way people envision healthcare and have paved the way for several advances in the field of targeted therapies. Vemurafenib is a more recent example of successful implementation of targeted therapy based on the detection of mutated BRAF, allowing significant improvement in the outcome of melanoma patients. Unfortunately resistance to these targeted treatments sometimes develops in patients. I believe great promise lies in combination therapies, which simultaneously block multiple pathways, to overcome this resistance challenge. Moreover, I am really fascinated and enthusiastic about immunotherapies, which have been the rising star of cancer care in the past few months.

I think personalized medicine is not just about tailoring treatment based on the use of genetic information, it is also about harnessing the patient’s own immune system to fight the disease. T cell checkpoint inhibitors, such as Ipilimumab, have shown unprecedented response in melanoma patients. However, this significant benefit is observed only in a small portion of patients, underlining the need for reliable predictive biomarker, and the probable influence of the patient’s immune status.

HB: How important is it for the pharma industry to focus on individual treatments, and not blockbuster models like before?

IT: I would be cautious about the use of “individual treatments” and would rather use “patient stratification”. Efficiency and safety issues emerging from drugs with broad indications aimed at a hugely diverse population have certainly showed that blockbusters are not the best way to go, but individualization – in its literal sense – seems a bit extreme to me, or at least hardly achievable in the short or mid-term, both technically and economically. However, heterogeneity in diseases and in patients themselves supports the need for the development of a different model, adapted to subsets of the whole population. This model implies the development of both treatments tailored to the characteristics of these patient subpopulations and of biomarker / diagnostic tools to identify the right patients, in order to help doctors make informed decision on the treatment.

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“Efficiency and safety issues emerging from drugs with broad indications aimed at a hugely diverse population have certainly showed that blockbusters are not the best way to go…”

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I think pharma can gain a lot of value in shifting to a personalized medicine model, not only because it will generate more efficient and safer drugs (i.e. more successful and cheaper clinical trials, possibly leading to a shorter development and reimbursement / regulatory approval process), but also because it may create new opportunities for drug development, as several patient subpopulations with different “needs” will be identified.

HB: There are many challenges within personalized medicine at the moment, such as reimbursement and approval issues. How can pharma best overcome these challenges?

IT: The changing landscape of the healthcare industry is indeed very challenging for biotech, pharma and for diagnostics companies, especially in regards to regulatory approval and reimbursement of their products. The current paradigm shift in drug development models generates a need for new regulatory and reimbursement pathways, which competent authorities are currently working on and can sometimes appear very confusing to drug and diagnostics developers. Addressing medical needs in underserved areas, starting interactions with regulatory and reimbursement agencies early and being adaptable in this moving environment are probably three important points to have in mind for pharma and Dx companies, to ensure that their development and commercialization plan is aligned with the regulatory and reimbursement requirements.

Regarding companion diagnostics (CDx) specifically, I believe education of payors and regulators will be important to prove the medical and economic benefit of the drug-CDx combination. Further down the road, physician and patient education will ensure the successful commercialization and adoption of their products.

HB: Another point of debate is around access to personalized medicine, as many people in the world don’t have access to healthcare, let alone personalised healthcare. In your opinion, do you think this healthcare model will work?

IT: Personalized medicine raises several ethical issues, mostly due to the classification of patients into subpopulations. Patient access to healthcare is one of the biggest challenges, both in terms of tailored treatment availability for each patient subset and in terms of treatment affordability, considering the increasing cost of healthcare. In addition, controversies are rising regarding the risk of discrimination based on personal data, which will require the creation of specific laws to contain the use of personal information.

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“Personalized medicine raises several ethical issues, mostly due to the classification of patients into subpopulations.”

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I would like to come to back to healthcare economics, which has always been a very delicate issue. How can we define a “price” for health? Who should pay for healthcare? A look at the current health economic situation worldwide shows us that the way healthcare was managed until now – the blockbuster model – has definitely not been very successful. The implementation of personalized medicine relies on a larger investment in diagnostics (and possibly in therapeutics too) compared to the current medical practice, but in smaller patient populations, leading to significant savings on the overall cost of treatment and patient care later on. Improved patient medical benefit must also be taken into account in the equation. Medico-economic evaluation by experts will be key in “weighting” the different members of this equation and in defining the value and price of each drug and diagnostics test. I think the personalized medicine model can work for each of the parties involved in it, i.e. pharma / biotech companies, Dx companies, regulatory agencies, payors, patients and doctors, although each of them has a different stake in it, therefore benefiting the whole society in the end.

HB: Finally, where do you hope personalized medicine will be at the end of the next decade?

IT: My answer in a single word? Collaboration. Cancer is a very complex, heterogeneous disease. Great advances in personalized medicine have occurred in the last decades, fueled by the development of new technologies, such as “Omics” technologies or most recently, next-generation sequencing approaches. These technological drivers provide an unprecedented insight into the physiopathology of the disease, into the treatment impact and potentially into patient response, dramatically changing the management of the disease. However, there is still a large gap between these exciting discoveries and the commercialization of a personalized treatment. Much more basic, translational and clinical research still needs to be conducted in order to be deliver safer and more efficient drugs to patients. I believe that only a very high level of collaboration involving scientists and experts from various disciplines will enable to reach this goal, in particular for the integration and interpretation of all the data generated across different platforms. People probably realized this a few years back, and are slowly starting to find a path forward and to really “act” about it. I think the recent announcement of the TransCelerate biopharma Initiative is a great example of this collaborative trend of “open innovation” that is becoming predominant. The TransCelerate biopharma Initiative is a non-profit organization led by ten leading pharmaceutical companies which aims at identifying and solving common drug development challenges with the end goals of improving the quality of clinical studies and accelerating the development of new medicines.

This is just one example of course, which I wanted to highlighted because it is involving most of the big players of the pharma industry, engaging together in a way never seen before. But academic labs, physicians, payors, regulatory bodies and governments should also be part of the game. And the patient as well, which I hope will be, and remain, central in each party’s concern. Accessibility of medical information on the Internet, explosion of consumer genomics, development of patient communities and patient-physician interaction facilitated by social media have led to a strong patient empowerment in the past few years, which I believe will continue to grow and will be beneficial to the overall “equation”.

The biggest challenge to overcome in the next years is probably to find the best way to articulate – and educate – all of these actors, as well as to process and leverage all the data generated. But we will get there. We have to.

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European-CME-Forum-15-16-November-2012

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About the author:

Isabelle Tanneau serves as Scientific Business Development Manager at ImmunID Technologies, a molecular diagnostics company specialized in the assessment of immune repertoire diversity and immune status. Prior to joining ImmunID, Isabelle held several science and business positions in biotech companies such as Genentech and Genzyme, and in the US-based office of Ubifrance, the French agency for international business development. Isabelle is a MSc graduate of the Ecole Supérieure de Biotechnologies de Strasbourg, France and of Grenoble Management School, France.

To learn more about ImmunID please contact Isabelle directly at: itanneau@immunid.com, follow her on Twitter: @IsabelleTanneau or visit: http://www.immunid.com.

Is collaboration key to the evolution of personalized medicine?

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