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Pharma Readiness For Personalized Medicine

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Diaceutics Group

on 19 November 2014

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Transcript of Pharma Readiness For Personalized Medicine

Which stormy events have shaped PM in the last 4 years?
Any competitive benchmarking needs to be seen in the context of significant changes in the PM marketplace in the last 4 years (since our last report). We have listed our top 10 2010-2014 events that we believe will continue to shape the competitive market for our Pharma clients.
Top 12 Pharma Pipeline - A PM Tidal Wave
This 2015 report is a follow-up from the 2010 ‘Pharma Readiness for Personalized Medicine’ report published by Diaceutics.

The pharmaceutical industry is on the cusp of a major change to its overall operating model. Gone is the scientific uncertainty that once surrounded the translation of an explosion in genomics and biomarker science into treatments. A small but growing body of personalized therapies are now on the market and many more are in the pipeline. The terms “personalized medicine” and “targeted therapy” are used synonymously throughout this report.
A large, entrenched industry will find it a challenge to make even minor changes to a well-established operating model. Any industry that is embedded around one type of product, revenue model and development process will find it difficult or even impossible to converge with another that is running on a different track, at a different pace, with different engines for growth. That’s what the pharmaceutical industry faces with personalized medicine: therapy development is proceeding on a different track and at a different speed than for patient diagnosis, prognosis and stratification.

Further, the activity around personalized medicine is so voluminous, with new concepts, companies, economics, channels, conferences, papers and experts, that it can be hard to spot what activity is actually happening on the ground is indeed relevant. A virtual fog of information obscures a clear path to a reformed and personalized-medicine-specific pharmaceutical operating model.

Pharmaceutical companies are summoning a range of responses to personalized medicine, with some thinking more strategically than others about the means to incorporate this new paradigm. Others are implementing market-changing initiatives, which promise to disrupt the industry’s competitive dynamics. Still others see no compulsion for rapid change. Such sharply different reactions are themselves the hallmark of a period of profound industrial reform.
Ultimately, pharmaceutical companies will be winners or losers in the future depending on the choices they make about personalized medicine now. Their status and size will shift depending on how well they have prepared to introduce future personalized therapies to market.
This report examines how ready pharmaceutical companies are—right now—to capitalize on new discoveries in genetic and non-genetic biomarkers and translate them into personalized therapies.

Through analysis of changing trends in Personalized Medicine – operational readiness for CDx-PM therapy pairings, financial performance of PM therapies, volume of PM communications and others.

Diaceutics goal in this report is to cut through the fog of hyperbole and preconceptions surrounding personalized medicine, in the interest of furthering the debate over the role the pharmaceutical industry will play in it. We hope you will find the information useful.
Public demonstrates its responsiveness to celebrity genetics with test demand increases witnessed after Angelina Jolie and Kylie Minogue both herald genetic testing as key to their health.
$1000 genome threshold crossed
Novartis purchased laboratory and diagnostic companies (Genoptix and Vivacta) in support of its therapy portfolio
US Supreme Court ruling that human genes cannot be patented (Myriad case)  - gives many players much more freedom to operate  
Big IT moves finally as serious new entrants into healthcare, with Google funding Calico and Apple finally launching ihealth and associated applications.

FDA approved 6 new PM drugs and retrofitted 25 with a PM stamp by 2014.
Express scripts, CVS – two PBMs divesting or ending PM programs, shows US market still not willing to make investment in innovation.
Illumina acquires a regulatory company in one gulp heralding its intent to work with the FDA and commercialize its core NGS testing platforms and NGS has a faster than expected adoption in the US.

FDA continues to vote support for PM with fast tracking of PM drugs and action on laboratory developed tests.
First shots fired in the pending PDL1 arms race with Opdiva achieveing approval in Japan and Merck filing first in the US.

Accelerated approvals of Zelboraf and Xalkori in 2011 - demonstrated that targeting can significantly shorten development time and cost.

The number of therapies associated with a biomarker and on the FDA PGx list have almost quadrupled since 2010. Similar increase was seen in the number of therapies classified as PM according to Diaceutics’ broader PM definition. See small print.
What's new in the industry?
What’s changed in PM in the last 4 years?
What’s been happening with top 10 Pharma companies in PM between 2010 - 2014?
Only 7 new Rx with CDx launched
But 53 existing Rx labels retrofitted with safety biomarkers by FDA
Launched Portfolios On The High Seas
Who is making the most noise?
Where Are You On The Readiness Radar?
2010 PM Readiness Radar
Commercial Readiness
Organizational Readiness
Commercial Readiness
Organizational Readiness
2014 PM Readiness Radar
PM Deviation Index
When looked at through the lens of the average total PM Readiness scoring, 2010 vs 2014, the top ten companies fall into two clear groups, those institutionalizing corporate capability for a PM predominant future and those still in the learning curve.
Consequently the proportion of Dx in label now (for top 12 Pharma) amongst marketed drugs has more than tripled since 2010
Number of biomarker-associated drugs or drugs that could benefit from PM strategy in the pipeline increased by over half, from 114 in 2010 to 178 in 2014.
Most companies slightly increased number of total therapies in the pipeline (PM & Non PM).
But the jump in percentage of PM in Ph. III was even more obvious.
The percentage of PM therapies in Ph. III pipeline increased for all the companies, apart from Amgen.
All companies reached a 50% threshold of PM therapies in Ph. III/registration
The PM as percentage of pipeline increased to over 50% for all 12 companies analysed.
Ongoing PDL1 clinical trials pipeline by competitor
Melanoma, NSCLC & Renal are likely to be highly competitive indications for PDL1
The Small Print
PM now constitutes a quarter of the Pharma news flow
There is a trend of increasing press coverage related to PM therapies from all 12 companies, with the proportion of PM related releases having almost trebled since 2010
With some companies doubling or tripling the PM share of external news flows.
All companies focus more on PM communication and Roche and BMS now refer to PM therapies in 4 out of 10 releases.
The PDL1 Fog Horn
Roche shouting loudest.
Whilst the number of commercialized assets of our 12 “companies in focus” remained comparable.
The proportion of PM amongst marketed drugs more than tripled since 2010
The retrofitting of drug labels by the FDA means that proportion of drugs on market, guided by biomarkers in the label, more than tripled.
Clear PM “advancers” since 2010 emerging
Everyone increased the relative percentage of PM therapies on market from where they were in 2010 but Amgen and BMS lead the way, with 42% and 34% respectively. AZ, Janssen, Novartis, Roche and Sanofi are all boasting 1 in 5 therapies with a PM approach. *BI and Janssen not included in 2010
Sales of PM therapies increased, despite some biomarker-associated blockbusters coming off patent
BMS, AZ and Amgen enjoyed the greatest jump in percentage of revenue from PM sales. Merck, Lilly and GSK still not feeling the financial benefits of a PM approach. Janssen and BI both coming in strong with over a quarter of revenue from PM assets. *BI and Janssen not included in 2010
Oncology only PM sales are also increasing
Oncology is a major driver of PM sales for Roche and Novartis. BMS and Janssen both achieved more than 10% revenue from oncology PM sales. However, the other companies rely on other therapeutic areas. *BI and Janssen not included in 2010
With an average increase of $642m in sales per brand over 2010.
Sales of older oncology PM therapies still on patent have increased modestly compared to 2010 sales (Herceptin, Gleevec). Newer drugs such as Afinitor, Sprycel and Tasigna are picking up growth.
Total PM sales from companies analysed increased 1.5 fold, from $6Bn in 2010 to almost $9.5Bn in 2013
Sales of therapies now classified as PM increased for most companies, apart from BMS and Sanofi. Roche is an undisputed leader with Rituxan and others bumping up sales by nearly $10B compared to 2010.
Pharma Readiness For Personalized Medicine

2010-2015 Trends Report

How is ONEH Different?
ONEH In The MarketPlace
We will come back to this later!
What does PM paradise look like?
If you wish to know more about PM Readiness please contact mark.reis@diaceutics.com
Now back to the small print
What’s New in This 2015 Report?

We have added 2 new companies to the original 10 in focus
Apologies to our friends at Janssen and Boehringer Ingelheim for our omission from the 2010 report.
PM readiness index now based on 8800 data points (versus 3600 in 2010)
As the PM market evolves and we have a greater N of Dx and Lx deals, targeted therapy and test launches, so too our observation of achievement and impact within the PM competitive market place becomes ever more specific. Consequently we believe this report provides an even greater competitive snapshot of the public face of Pharma in PM than in 2010.
PM Readiness Report now tracks competitive changes from the 2010 situation for the first time.
We naturally think all companies should advance, however our readiness index tracks backward steps aswell as forward.
PM Readiness Report now includes a whole new metric to illustrate how Pharma is executing PM on the ground.
We have added a unique PM brand index score to our commercial readiness axis.
PM Readiness Report now tracks to a vision of PM readiness health.
To help us articulate our vision of PM readiness health we have included the profile of a new (fictious) company called ONEH (ONEHealthcare).

In compiling the data and information underlying this report, Diaceutics used both primary and secondary source materials.
Primary data and information have been gathered from an extensive variety of different sources, including the websites of pharmaceutical companies (listed as corporate sources in Bibliography), the U.S. Patent and Trademark Office, and the U.S. Food and Drug Administration (FDA), among other sources. Further information was obtained from publicly available scientific and personalized medicine publications, both print and online. In addition to corporate annual and quarterly reports, data was obtained from various public speeches given by key officials in the pharmaceutical companies, scholarly reports and other research. In some cases, data was extracted from electronic sources using specific key words (such as personalized medicine, companion diagnostic, targeted therapy, personalized healthcare, pharmacogenomics). Please refer to the Bibliography for a full list of sources.
Primary sources: companies’ websites, quarterly and annual reports, press releases, conference presentations.
Secondary sources: currentpartnering.com, PMLive.com, FiercePharma.com, FierceDiagnostics.com – cross-checking the CDx-related deals not reported in press releases.
Table of Pharmacogenomic Biomarkers in Drug Labeling, the U.S. Food and Drug Administration (FDA): up-to-date list of PM therapies associated with Pharmacogenomic Biomarker.

In relation to the data analysis, the data on pharmaceutical companies is based only on what the companies themselves have reported publicly.
The analysis of individual companies’ readiness for personalized medicine was conducted by examining each company’s internal operational and external commercial activity.
Operational and commercial activity was analyzed from publicly available data on each company, e.g., Internal PM/Dx teams, therapies on the market, sales, reported deal flow and activity seen in press releases, PM brand Index and news. For each company, personalized medicine data was extracted with keywords similar to those described above.
Therapies identified herein as “targeted therapies” were chosen by examining the FDA’s list of therapies that have pharmacogenomics biomarker information on their labels. Selection of therapies was made based on a set criteria to include therapies that had warnings or boxed warnings, ability to use the therapy for specific populations and clinical study data or pharmacology information. A few therapies have been additionally included that Diaceutics regards as personalized (such as Merck’s Fosamax) even though they are not on the FDA’s list.
Due to the set criteria used, this report defines therapies identified as “targeted therapies” very broadly; likely more broadly than most pharmaceutical companies. The definition does not discriminate between therapies thought to be classically targeted by a biomarker developed proactively during the development phase and therapies which, due to unfolding science and clinical experience, have been shown to be targetable, post launch.
A primary reason for the use of this definition throughout the report is Diaceutics analysis and observation that sales of a therapy, which have been positively or negatively affected by the presence of a diagnostic regardless of whether it was reactively developed, behave in exactly the same way as therapies which are more often narrowly defined as personalized and have been clearly proactively developed. In addition it should be noted that the longer term view that, just as Erbitux and Iressa have been shown to work better in subpopulations that were only identified via a diagnostic post launch of these therapies, so exactly the same can be said for such therapies as Plavix, and Crestor.
Diaceutics of course acknowledge that the majority of the companies mentioned in this report may not consistently regard therapies targeted post launch by a diagnostic as "personalized medicine", nonetheless for the purposes of the assessment of readiness for personalized medicine, the principles of driving access to a diagnostic to in turn drive access to a therapy are initiatives universally relevant to personalized medicine product marketing. Diaceutics believes that as more personalized medicine products are launched into the market a set of universally relevant marketing initiatives will be better defined.
To enable competitive ranking of the pharmaceutical companies by personalized medicine readiness, the factors described above were further analyzed and compared through qualitative metrics, as described elsewhere in the report where Diaceutics reviewed the 12 pharmaceutical companies* along 2 axes as competitiveness in this space involves both static and dynamic components: the Y axis, which represents their organizational readiness for personalized medicine and the X axis, which represents their commercial readiness for personalized medicine. From these2 metrics, a composite score was determined in order to rank the companies in relation to their competition.
* Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Novartis, Merck & Co., Pfizer, Roche Holding AG and Sanofi-Aventis, Boehringer Ingelheim, Janssen Pharmaceuticals

The Really Small Print
Full transcript