Tag Archives: nanodiagnostics

Bio-pharmaceutical teaser from India’s Centre for Knowledge Management of Nanoscience and Technology (CNMKT)

The Dec. 13, 2012 Nanowerk Spotlight article about India’s bio-pharmaceutical industry and its nanotechnology efforts was written by Vivek Patel of India’s Centre for Knowledge Management of Nanoscience and Technology (CMKNT) and appears to be an excerpt of a larger report to be released at a later date. The article is well worth reading and might be eye-opening for some folks,

Chronic diseases such as cancer, diabetes mellitus, epilepsy, osteoporosis and cardiovascular among others are not well diagnosed, because symptoms of these diseases are often less apparent (progress slowly) than acute and communicable diseases. With the rapid urbanization and the unhealthy lifestyles, the disease profile in India is gradually shifting towards an ample growth in the chronic diseases segment. According to the World Health Organization (WHO), India has the highest number of patients with diabetes and 60 percent of the world’s cardiac patients belong to India (read more: “Background Paper: Burden of Disease in India“; pdf). It is also estimated that India has the largest number of coronary artery disease related deaths in the world. The bio-pharmaceutical industry expert says that the chronic disease-related therapeutics is the fastest growing segment in the Indian pharmaceutical market.

Patel offers an analysis of the current nanotechnology-enabled bio-pharmaceutical industry in India,

Nanotechnology-enabled bio-pharmaceutical R&D and products in the Indian industry are still in the early stages of evolution. Only modest amount of investments have been made so far and most of projects are moving through different phases of research/clinical trials (phase I-III), even though a few nano-based drug delivery systems have already reached the market. The Indian bio-pharmaceutical industry is witnessing business opportunity trends such as merger & acquisitions/takeovers/collaborations/in-licensing, increase in R&D investments, innovations in healthcare and drug delivery as well as product penetration into the tier I to tier VI markets to make significant inroads into nanomedicine and nanodiagnostics. CKMNT believes that these trends, along with the favourable macroeconomics and growth drivers, nanotechnology will propel Indian bio-pharmaceutical industry to the next level of growth. It is expected that in the next 10-20 years, market will be flooded with nano-based medicines and drug delivery systems as well as nano-enabled ultrasensitive and rapid detection devices for diagnostics and therapy.

Cientifica, an international consulting firm which specializes in emerging technologies and business, authored two analyses of the international business context for nano drug delivery systems, one is a free white paper overview and the other is a full report. The company also issued a full market report on nanotechnology-enabled medical diagnostics. (Note 1: Cientifica is offering some of its 2012 reports [the drug delivery and diagnostics reports are included in the sale] at a discount price of up to 80% until Dec. 31, 2012. Contact Cientifica at +44 7887 497630 or +44 7894 708989 or email [email protected] for pricing. Special academic discounts are also available. Note 2: The FrogHeart blog does not receive any monies whatsover from Cientifica.)

Getting back to the analysis of the nanotechnology-enabled bio-pharmaceutical industry in India, Patel provides a list of the most prolific Indian companies in this sector,

Fresenius Kabi Oncology Ltd. (erstwhile Dabur Pharmaceuticals Ltd.) made its foray into the field of oncology with the launch of ‘Nanoxel’, which is a novel nanoparticle-enabled formulation of Paclitaxel in 2007. …

Lupin Ltd., one of the world’s largest producers of tuberculosis drugs, with 12 factories and six research centres in India and Japan, has launched ‘Genexol-PM’ (paclitaxel nanoparticle) nanomedicine for cancer treatment by tie-up with the South Korean company Samyang Corporation. …

Cipla Ltd., one of the world’s largest generic pharmaceutical companies with a presence in over 170 countries, has successfully developed and manufactured Paclitax Nab (nanoparticle albumin bound) product for the treatment of metastatic breast cancer in 2012.

Sun Pharma Advanced Research Company Ltd. is engaged in creating new drugs and delivery systems such as ‘Paclitaxel Injection Concentrate for Nanodispersion (PICN)’and ‘Docetaxel Injection Concentrate for Nanodispersion (DICN)’. …

In 2012, Venus Remedies Ltd. has launched two nanotechnology-enabled products for arthritis and cancer treatments, respectively. The brand Taxedol consists of Docetaxel in nanoparticle form and company claims that it gives 11 % higher cancer cell killing potential as compared to existing Docetaxel…

Cadila Healthcare Ltd. (erstwhile Zydus Cadila) has successfully developed and launched nanotechnology-based ‘Oxalgin Nanogel’ formulation for the pain management therapy (arthritis, backache, joint pain etc.).

Shasun Pharmaceuticals Ltd., the active pharmaceutical ingredients manufacturer has entered into collaboration (50:50 joint ventures) with Nanoparticle M/s. Biochem, Inc., USA to develop gold nanoparticles-enabled radioactive medicine to treat prostate cancer.

Cadila Pharmaceuticals Ltd. has established a joint venture company, CPL Biologicals Pvt. Ltd., in partnership with M/s. Novavax Inc., USA to develop, manufacture and sell nanotechnology-based novel therapeutic and prophylactic vaccines, biological therapeutics and diagnostics in India. …

As noted earlier, this article does appear to be a teaser for a more comprehensive report due at a later date,

A comprehensive report on “Indian Nanotechnology Market: Technologies, Applications and Opportunities” is slated to be released by CKMNT in the future. Interested readers may please contact Mr. Vivek Patel at [email protected] or [email protected] for further details.

Nanodiagnostics: a roundtable at Kavli and new report from Cientifica

The Kavli Foundation, based in California, held a roundtable discussion on ‘Fighting Cancer with Nanotechnology‘ which focused largely on diagnostics and drug delivery. According to a March 14, 2012 news item on Nanowerk, the four participants were:

  • Anna Barker – Former Deputy Director of the National Cancer Institute (NCI) and current Director of Arizona State University’s Transformative Healthcare Networks;
  • Mark E. Davis – Professor of Chemical Engineering at the California Institute of Technology (Caltech), and a member of the Experimental Therapeutics Program of the Comprehensive Cancer Center at the City of Hope;
  • James Heath – Professor of Chemistry at Caltech and a founding Board member of Caltech’s Kavli Nanoscience Institute;
  • Michael Phelps – Norton Simon Professor, and Chair of Molecular and Medical Pharmacology at the University of California Los Angeles.

The researchers discussed how nanotechnology holds the promise of revolutionizing the way medicine wages war against cancer, from providing new ways to combine drugs to delivering gene-silencing therapeutics for cancer cells. [emphasis mine]

Yet again, war has been used as a metaphor for healing. I particularly appreciate the way ‘revolution’, which resonates with US audiences in a very particular way, has been introduced.

The discussion features diagnostics,

JAMES HEATH: That is certainly an important application. A typical diagnostic test measures only a single protein. But the nature of cancer—even a single cancer type—is that it can vary significantly from patient to patient. The implication is that there is probably not a single protein biomarker that can distinguish between such patient variations. Even to confidently address a single diagnostic question may take measuring several protein biomarkers. Discovering the right biomarkers is extremely challenging—you might have 300 candidate biomarkers from which you want to choose just six, but you will likely have to test all 300 on a very large patient pool to determine the best six. That’s tough to do with existing technologies because each protein measurement requires a large sample of blood or tumor tissue, and each measurement is time-consuming, labor intensive and expensive. With some of the emerging nanotechnologies, a large panel of candidate protein biomarkers can be rapidly measured from just a pinprick of blood, or a tissue sample as small as a single cell. This allows one to accelerate the development of conventional diagnostic tests, but it also opens up the possibilities for fundamentally new diagnostic approaches. These are opportunities that nanotech is bringing into play that simply weren’t there before.

Here’s one of my favourite comments,

MICHAEL PHELPS: Yes. All of us developing therapeutics want to have a transparent patient—to see where the drug goes throughout all tissues of the body, whether it hits the disease target in a sufficient dose to induce the desired therapeutic effect on the target, and where else the drug goes in the body regarding side effects. [emphasis mine] PET [positron emission tomography 'scan'] can reveal all this. For this reason almost all drug companies now use PET in their discovery and development processes.

I suspect Phelps was a bit over enthused and spoke without thinking. I’m sure most doctors and researchers would agree that what they want is to heal without harm and not transparent patients. That’s why they’re so excited about nanotechnology and therapeutics, they’re trying to eliminate or, at least, lessen harm in the healing process. It would be nice though if they get past the ‘war’ metaphors and dreams of transparent patients.

I found the comments about the US FDA (Food and Drug Administration), pharmaceutical companies and biotech startups quite interesting,

ANNA BARKER: These challenges are mostly related to perception and having the tools to demonstrate that the agent does what you say it does. It’s more difficult for nanotherapeutics than for other drugs because they employ a new set of technologies that the FDA is more guarded about approving. The FDA is responsible for the health of the American public, so they are very careful about putting anything new into the population. So the challenges have to do with showing you can deliver what you said you were going to deliver to the target, and that the toxicity and distribution of the agent in the body is what you predicted. You have to have different measures than what is included in the classic toxicology testing packages we use for potential drugs.

MARK DAVIS: There’s so much cool science that people want to do, but you’re limited in what you can do in patients for a number of reasons. One is financial. This area is not being pushed forward by big Pharma, but by biotech companies, and they have limited resources. Secondly, the FDA is still learning about these innovations, they can limit what you are allowed to do in a clinical trial. For example, when we did the first clinical trial with a nanoparticle that had a targeting agent enabling it to latch onto a specific receptor on cancer cells and a gene silencing payload, we realized it would be important to know if patients have this receptor and the gene target of the payload to begin with. Prebiopsies from patients before testing the nanotherapeutic on them to see if the tumor cells had this receptor and gene target in abundance would have been helpful. However, in this first-in-man trial, the FDA did not allow required biopsies, and they were performed on a volunteer-basis only.

It is a fascinating discussion as it provides insight into the field of nanotherapeutics and into the some of the researchers.

On the topic of nanodiagnostics but this time focusing on the business end of things, a new report has been released by Cientifica. From the March 13, 2012 press release,

Nanodiagnostics will be a $50-billion market by 2021; Cientifica’s “Nanotechnology for Medical Diagnostics” looks at emerging nanoscale technologies

Following on from Cientifica’s Nanotechnology for Drug Delivery report series, “Nanotechnology for Medical Diagnostics,” a 237-page report, takes a comprehensive look at current and emerging nanoscale technologies used for medical diagnostics.

Areas examined include quantum dots, gold nanoparticles, exosomes, nanoporous silica, nanowires, micro- and nanocantilever arrays, carbon nanotubes, ion channel switch nanobiosensors, and many more.

Cientifica estimates medical imaging is the sector showing the highest growth and impact of nanomaterials. Already a $1.7-billion market, with gold nanoparticle applications accounting for $959 million, imaging will continue to be the largest nanodiagnostics sector, with gold nanoparticles, quantum dots and nanobiosensors all easily exceeding $10 billion.

“Getting onboard with the right technology at the right time is crucial,” said Harper [Tim Harper, Cientifica's Chief Executive Officer]. “The use of exosomes in diagnosis, for instance, a relatively new technique and a tiny market, is set to reach close to half a billion dollars by 2021.”

You can find out more and/or purchase the report here.

I have written about Cientifica’s  Nanotechnology for Drug Delivery (NDD) white paper here and have published an interview with Tim Harper about global nanotechnology funding and economic impacts here.