The Dolcera Blog

A simple blood test and there you go….your complete health profile!

Or are you worried about a family cancer history?

The benefit of early diagnosis of such a deadly disease is obvious. The answer is the Wellness Chip®.

Researchers at Somalogic, Inc. have developed a diagnostic technology with high sensitivity and specificity. The Wellness Chip, the brainchild of Larry Gold and his colleagues at Somalogic, will bring together diagnostic tests for various diseases in a single, simple blood test. Currently, Somalogic has licensed its technology to Quest Diagnostics for launching a lung cancer blood test before the end of this year.

What is the Wellness Chip?

The underlying principle is nucleic acid-aptamer based proteomic technology. Somalogic’s proprietary reagents called SOMAmers (Slow Off-rate Modified Aptamers) are single strand stretches of modified nucleic acids generated by a highly selective process called SELEX (Systematic Evolution of Ligands by Exponential Enrichment). SOMAmers are capable of binding specifically to a target of interest, e.g., a marker for a particular disease. SOMAmers to various targets are fabricated on a chip at distinct positions and simultaneously detect several proteins in micro-liter scale samples. This data will then be analyzed by bioinformatics tools.

Contrary to conventional antibodies based diagnostic procedures, SOMAmers are more sensitive and specific and can be made rapidly in weeks rather than months as is the case with antibodies. It will also be economically priced -$100’s not $1000’s.

Why blood test?

Proteins present in the blood are immediate indicators of a person’s state of health.  Diseased tissues secrete proteins in the blood and their identification is essential to early and accurate therapeutic and preventative measures. The total number of blood proteins is about 4000 and the Wellness Chip can detect 1100 of these blood proteins. This protein profile will be analyzed to determine the health status of the individual. Currently available methods detect only about 20 to 30 proteins at a time.

From the laboratory to the market-

The SOMAmer technology has already found its clients in the pharma industry. In 2008, Somalogic entered into research collaboration with Otsuka Pharmaceutical Co., Ltd. for the development of diagnostic tools and to further Otsuka’s research in pharmaceuticals. On the other hand, the task of making the Wellness Chip a reality is entrusted with Quest Diagnostics.

Sources:

1.      http://www.somalogic.com/

2.      Bio.IT World.com. Turning blood into gold: The Wellness Chip

3.      http://www.colorado.edu/mcdb/goldlab/Slide%20Decks/8.%20Steve%20Williams%20slides.pdf

4.      U.S. Patent No. 7709192

5.      Gold L, Ayers D, Bertino J, Bock C, Bock A, et al. (2010) Aptamer-Based Multiplexed Proteomic Technology for Biomarker Discovery. PLoS ONE 5(12): e15004

6.      Ostroff RM, Bigbee WL, Franklin W, Gold L, Mehan M, et al. (2010) Unlocking Biomarker Discovery: Large Scale Application of Aptamer Proteomic Technology for Early Detection of Lung Cancer. PLoS ONE 5(12): e15003.

Written by:

Shweta Kumari

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“Patent Cliff” is a term used when a number of lucrative pharmaceutical patents are all on the verge of expiry at the same time. What it results in is a huge drop in revenue, due to both, decrease in sales volumes as well as a price erosion of up to 70% within months resulting from the generic intrusion. The patent cliff is going to brunt major Pharma companies big-time in the near future. IMS Health Midas estimates revenues of about $89.5 billion USD from drugs whose patents are about to expire over the period of 2010-15, the majority of them being small molecules. While, according to a report by Datamonitor, the impending patent cliff will mean that global branded pharmaceutical companies are estimated to lose $82bn in sales by the end of 2014.

The year 2011 alone will see $30 billion in sales face generic competition for the first time in the major developed markets. The world’s biggest selling drug, Lipitor by Pfizer, will go off protection in 2011. Other major drugs that would be experiencing Patent Expiry in 2011 are Plavix, used to inhibit blood clots; Leavquin, used to treat a variety of different infections; and Zyprexa, used to treat bipolar disorder. These four major drugs contributed $17 billion in the US alone. Revenues lost by patent cliffs can only be partially compensated by newly launched products, e.g. in indications such as osteoporosis, respiratory illnesses, thrombosis, multiple sclerosis and cancer.

Although, the patent cliff is a challenge that the Global Pharmaceutical Industry can’t do without facing in the coming, there are other drivers also that one has to see to see the complete picture. The much-talked about concern eases in two years. The cliff is steepest in early years, with an estimated $58.6 billion in expirations through 2010-12. The year 2012 alone is estimated to cause the industry a loss of $28.7 billion due to impending patent expiry. The cliff moderates over the following years and it estimated to reach as low as $1.3 billion in the year 2017.

While so much of furor has been created of the imminent “Patent Cliff” and about $81 billion loss that the industry is going to face due to Patent Expiry during 2011-2015, in actuality the Pharmaceutical Industry is not facing an unprecedented patent expiration, but rather a continuation of a trend that has been in place for a decade. In the five-year period from 2005-2009, this value was $90.5 billion US for sales exposed to generic competition according to the same data source. There has been no mention of the patent cliff of 2005-2010, whereas the Patent Cliff of the near future has been widely publicized, in spite of it being about 11% less than the previous period in terms of value.

The problem might be big, but the solution is simple for the major Pharmaceutical companies - fully exploit their intellectual properties and kick-start their drug pipelines with innovative new drug candidates.

References

1.       The patent cliff is set to drive global generic uptake despite tougher market conditions - Datamonitor

2.       A View from a Cliff – Frankel Group

3.       Pharmaceuticals & Biotech Industry Global Report — 2011, IMAP

Written by:

Aditi Agarwala

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The PharmaCI conference is scheduled to be held on 15^th - 16^th September 2009 at New York. Ed Rozenberg, one of the founders of Dolcera will present a talk on “Unlocking the hidden potential from the abandoned molecules. - A systematic CI driven approach!”

 With the advancement of pharma industry there are two trends which we have witnessed that each company is focusing on a handful of therapeutic areas and exiting from other therapeutic areas resulting in “orphaned” and “abandoned” molecules. More so, many other companies are targeting smaller subpopulations in many therapeutic areas based on the latest scientific understanding.

Dolcera will unfold that how competitive intelligence can help to utilize the accumulated knowledge (clinical trials, toxicology analysis etc.) of the abandoned molecules to bring them to the market very quickly. The strategy will be a combination of scientific, market and patent intelligence to help unlock very valuable opportunities.

We sincerely hope that this presentation from us would help the research community from some of the world’s top pharma, biotech and health care companies such as Global Pharma Alliance, Zymogenetics, Pfizer, Boehinger Ingelheim, Roche Diagnostics to name a few.

We welcome all our blog readers to be part of this conference and contribute to the knowledge shared.

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The discovery of RNA interference (RNAi) is one of the transforming events in biology. Gene silencing agents such as small interfering RNA (siRNA), micro RNA (miRNA) and small synthetic oligo-nucleotides (DNA, RNA or DNA-RNA complex) lead to target specific RNAi. We aim at building a one-stop comprehensive database of RNAi agents patented or described in scientific literature.Dolcera has provision to customize the database against the target gene suiting client’s requirement. Till now, RNAi agents against some of the important cancer target genes are updated to the database and the trial access is available on request. These genes include bcl2, myc (c-myc, n-myc), ras (k-ras, h-ras, n-ras), VEGF, STAT3 etc. RNAi agents can be extracted and added to the database based on client’s interest.

Dolcera RNAi database can prove helpful:

• For scientific community: RNAi agent sequences aligned to target genes, extensive experimental data and comparison matrix of data from different patents with same focus.  
• For patent attorneys: Competitor watch, assignee vs. number of publications graphs, timeline based on application and publication dates.
• For venture capitalists/ Investors: Patent ranking based on disclosed information, data useful for decision making.

Salient features of the database:

1. Interactive maps of taxonomy: 4 levels of in depth classification of patents and scientific literature allow both “bird’s-eye view” and “in-depth views” of technologies.
2. Patent and non patent dashboard: Grouping specific elements into more general categories is conceptually easier and cleaner than entertaining hundreds of specific elements separately. Dolcera dashboard has a friendly user interface. It groups the patents according to the taxonomy, patent numbers, publications and application dates at the click of a button.
3. Sequence Dashboard: The tool not only aligns all patented/ non patented siRNA/ miRNA sequences to the target gene but allow user to see the sequence related information on a simple click of the mouse.
4. Experimental matrix: Experimental data be it quantitative (eg. % inhibition of target mRNA expression) or qualitative (eg. gel blots) are compared amongst patent document with similar focuses. This allows users to compare literature with same focus. The ranking of documents can also be done based on scoring matrices, which allows user to read the most relevant patent first.

 For database related inquiries or free demo call us at, Phone: +1-650-269-7952 (US) and  +91-40-6451-0832 (India). You can also email us at info@dolcera.com

To read more about RNAi database click here

To visit Dolcera’s website and to explore more patent/ IP related services click here

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The Dolcera Sequence Dashboard video demo is available on YouTube now. Here is the link.