Simple Cancer Biomarkers are Inadequate to Enable Personalized Medicine

It seems that researchers are finding that using single cancer biomarkers to develop companion diagnostics (CDx’s) to be used with future targeted therapeutics is very challenging. An article in the November 15 issue of Genetic Engineering and Biotechnology News, called Traversing the Cancer Biomarker Labyrinth, by Kathy Liszewski, is a very interesting read.

Apparently progress in this field has slowed in finding clinically useful biomarkers for diagnostics and making other tests that guide doctors for disease prognosis and prediction. Researchers are using a variety of reductionist technical approaches that range from analysis of certain glycans, key microRNAs, and epigenetic changes, to big data analysis of massive data stores of genomic data to tease out more clues to what is going on in cancers.

Scientists seek to develop early detection blood tests that can detect cancers of interest.  Such a blood test could be considered a ‘liquid biopsy’ and might include a panel of a dozen or more miRNAs that represent a biomarker signature.  An oncologist might one day be enabled to quickly screen certain patients with a blood test that would help them diagnose, stage or predict the potential outcome of a cancer.

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British Tech Network and New Products at MacWorld/iWorld 2014

SAN FRANCISCO (HighTech Reports), Moscone North, March 27, 2014 – MacWorld/ iWorld 2014. We watched a panel discussion session at the Second Stage presented by the British Tech Network (BTN) with speaker Paul Wheatley, User Experience Consultant and Host at the BTN. Paul and the panelists talked about the pros and cons of a bigger screen on the current or future iPhone, among other topics. He said that consumers are buying bigger iPhones, but the panel still preferred iPhones with smaller screens because they fit better in men’s pants pockets.

The panelists also talked about two interesting new products that they saw at the expo, BearExtender Edge and the Ring. The BearExtender Edge is long range Wi-Fi repeater/ booster that works with Macs, iPad/iPhone, and other devices (PCs with Wi-FI, other phones or tablets with Wi-Fi). The one-piece Wi-Fi repeater block plugs into an AC outlet and has an antenna that repeats/ boosts the Wi-Fi signal in the area. It does not require software or USB connector.  BearExtender also makes a high power standalone USB Wi-Fi radio adapter with an external antenna that increases the range of a Mac’s Wi-Fi signal by nearly four times that of an internal AirPort card. It adds Wi-Fi to older Macs or Windows PCs that do not have a built-in Wi-Fi adapter.

Paul and the panel were very intrigued by a new product called the Ring from Logbar, Inc., a San Carlos, California-based company.  It is a wearable technology product that fits on a finger as a finger ring.  The new Kickstarter funded device transmits hand movements or gestures to an iPhone or other Bluetooth enabled devices. The Ring works as an in-the-air pointing device that drew a largish crowd around its booth. A spokesperson from the Asian firm that is making the device suggested that the Ring is still in beta-test.

MacWorld/iWorld 2014 Returns to Moscone North

SAN FRANCISCO (HighTech Reports), Moscone North, March 27, 2014 – MacWorld/ iWorld 2014. It was refreshing to see that MacWorld/ iWorld returned to Moscone North, MacWorld’s former location of years ago. There were around 30,000 attendees at this year’s MacWorld. The exhibit floor seemed bigger than last year and highlighted more booths that we visited. We spent some time in the MacIT room where companies that had booths gave presentations. While there, we learned about products from Printer Logic, Lantronix, Absolute Software, Parallels, and Crash Plan.

Printer Logic sells an enterprise software app that attaches to Windows 2008R file server. The app replaces print server boxes in the enterprise. A license for up to 50 printers costs $5,000. The spokesperson said that most users have 25-30 printers. Each client driver for Mac/Windows PCs links to the printer app via Wi-Fi that scales very big in the enterprise. For example, the Department of Homeland Security used its service to reduce support calls for print servers that went down. The app solution was more efficient and saved the client money.

Absolute Software makes software that helps organizations manage all types of computer assets: PCs, laptops, tablets, phones, etc. It helps track the life cycle of all IT equipment assets to end-of-life. For example, the software helps Apple track iTunes content licensee IP assets. The firm’s solution helped the Columbine school track tablets, laptops, and thefts from intruders entering its campus. The company puts a special sticker on devices with a phone number to call if a child gets cyber bullied. The victimized child connects to a caring person to talk to and so forth. Absolute Software is also exploring other vertical markets.

 

iPhone 5 More Powerful than the Curiosity Mars Rover

SAN FRANCISCO (Takeda Pacific HighTech Reports), Moscone West, January 30, 2013 — MacWorld/iWorld 2013.  NASA experts spoke about NASA’s Curiosity Mars Rover and its connection to Apple products at a meeting here.  The session was titled “Software, Hardware, and Flying to Mars. How We Built, Programmed and Operate NASA’s Curiosity Mars Rover.”  David Oh, Lead Flight Director and Software Engineer at JPL/Caltech Mars Science Lab, asked the question, “Why are we at MacWorld?”  The answer was shown in a slide of the NASA control room at the JPL in Pasadena, California.  On the desk was a mixture of Apple products such as MacBook Pros, iPhones and iPads during the Rover’s Mars landing.  The Macs were running Mac OS X.

Ben Cichy, Chief Flight Software Engineer, compared the processing power of the iPhone 5 to Curiosity’s processing power.  The iPhone 5 has 1.3 GHz and the Curiosity has only 132 MHz.  In addition, the iPhone 5 has 1GB of memory and 64GB of storage and the Rover has 128MB of memory and 4GB of storage.  The cost of an iPhone 5 is $399 while the cost of the Curiosity was $1.8 billion.

During the session, the audience was shown a video of the landing of the Curiosity on Mars.  It only took 7 minutes, but a very tense 7 minutes.  It was very exciting watching the landing of the Mars Rover all over again.  “The Rover’s goal is to explore and see if Mars ever sustained life or is now,” Ben said.

David showed a slide that described the different parts that make up the Rover.  He added that the heart of the mission is the SAM (Sample Analysis at Mars).  The SAM analyzes the chemical and isotopic composition of the planet’s atmosphere and surface.  He said that the “Curiosity has two brains (computers) in its belly.  One is the primary computer and the other is the backup.”  This time social media plays a big part in providing people access to seeing what is happening with the Curiosity as it explores the surface of Mars.  The Curiosity has its own Facebook page and iPhone app.

Cegedim SA and Simcere Pharmaceutical Group Presented at 2013 J.P. Morgan Healthcare Meeting

SAN FRANCISCO, January 8, 2013 – Several emerging international healthcare firms presented their information to investors and potential partners at the 31st Annual J.P. Morgan Healthcare Conference held at the Westin St. Francis Hotel near Union Square in San Francisco.

Most of the smaller firms presented their talks at the conference’s smaller rooms.  This is where I found the Cegedim SA presentaiton.

Emerging European Firm

Jan Eryk Umiastowski, Chief Investment Officer gave a talk about his firm Cegedim SA, a private company that is located in France. He said that the company is a market research firm for pharmaceutical market development companies.  The company competes with companies like IMS Health.

He said that Cegedim collects prescribing information from pharmacies and doctors of what pharmaceuticals are being used by patients.  He said that they capture data that includes drug product name, quantity and so on to create databases.

Jan said that the company provides an IT application for claims transaction management.

He showed a bright green, credit card-like, card. He said that the patient goes to the pharmacy and presents the special green charge card, swipes the card and the IT application completes the transaction overnight.  Cegedim receives its revenues from pharmaceutical firms, doctors, doctors office groups, and others.

Jan said that the business model is subscription-based and there is a high switching cost to its business clients.  Jan said that the Cegedim works with Walgreens and is Number One in the countries that they operate in.  Their IT application runs on Windows 8. Their main clients are pharmaceutical companies in North America, Europe, and emerging countries.  In the future, the firm is looking for a 20% margin.  2012/Q3 was the first time that they were receiving pharmaceutical company business.

Emerging Chinese Firm

I learned that another group of emerging international firms was part of the Asia and China Forums. These meetings were located in the Victor’s room on the 32nd floor. The China meeting hosted fifteen or so presentations from China-based healthcare companies such as Simcere Pharmaceutical Group.

A woman executive gave the presentation about Simcere Pharmaceutical Group (NYSE: SCR).  The firm is located in Nanjing, China.  This young pharmaceutical firm started life as a pharmaceutical distributor.  The firm later became a fully integrated pharmaceutical company and currently has about 4,000 employees. The company recently changed its CEO and its business strategy.  Its disease focus is in oncology, strokes, cardiovascular disease, infectious diseases and pain.

According to the executive, the firm is doing cost cutting of its SG&A, and plans to grow its R&D operations.  She said that the company has partnerships with Merck and Bristol Myers Squibb.  Its pharmaceutical portfolio includes Endostar and others including branded generics.

She highlighted the financial performance and said that 2012/Q3 revenues were RMB 526 million and the first nine months revenues were RMB 1,543 million.  R&D investment has grown RMB 2009 to 2012Q1-Q3 as listed in this table:

Table: R&D Investment

Year 2009 2010 2011 2012/Q1-Q3
R&D SpendingRMB, millions 133 126 199 168

The executive said that market uptake of pharmaceuticals in China is gradual.  The company has eleven drug candidates in the pipeline.

Simcere Pharmaceuticals has several partnerships including:

  1. Merck J-V, Signed in 2011, 630 sales reps sell six products.
  2. Bristol Myers Squibb, Dev. metatinib, IND 09/2012
  3. Apexigen, antibody deal, BD0801 IND, 10/2012

Simcere Pharmaceuticals is looking for manufacturing partnerships to expand its manufacturing base. The company’s listing status in the US is part of its strategy to play in the US-based style of business to attract more US partners

New Biotech VC Investing Model Emerging

It appears that a new biotech investing model is emerging and may play out through 2013.

On October 9, 2012, I attended the BIOInvestor Forum at the Palace Hotel in San Francisco. At the Plenary Session “It Takes A Village: The New Pharma-VC Model for Biotech Investing,” moderator Alan Eisenberg said, “Thirty-nine percent of VCs reported decreased HealthCare investment in the past three years.”  This sector has continually underperformed.  In addition, there were only 16 early round financings.

Will Biotechs Play a Kind of VC “Hunger Games”  to  Survive?

One panelist believes that 2013 will be like the “Hunger Games.”  “Companies need to change how things are done to survive,” said De Rubertis. According to Brian McVeigh, Vice President of Worldwide Business Development Transactions and Investment Management, at GSK Pharma, “This is a relationship business.  Relationships with academics are also important.

Location, Location, Location

The other piece is geographic.”   Francesco De Rubertis, Partner, at Index Ventures said, “Returns have to be good enough for investors to get back in.”  Index Ventures’ strategy is to invest in early-stage, single-asset companies in Europe, U.S. and Israel.  Recently, there have been a number of high-profile funding collaborations between pharma companies and traditional VC funds such as GSK and JNJ with Index Ventures, Sanofi and Third Rock (Warp Drive), and Eli Lilly and TVM Capital.  The strategy is that by combining their resources and expertise, these firms hope to source and develop drugs that are winners.

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