Innovation in drug delivery presents opportunities for biotechnology companies, and is an area I expect we will see major leaps forward through nanotechnology.
Nanotechnology is the application of science and engineering to materials that are between 1 and 100 nanometers (nm) in size. The Environment Protection Agency (EPA) defines nanotechnology as “the creation and use of structures, devices, and systems that have novel properties and functions because of their small size.”
1nm is one-billionth of a meter. To put this in context, 1nm is one seven-thousandth of the width of a red blood cell or one eighty-thousandth of the width of a human hair. These are unimaginably small materials that are engineered to operate at the molecular and atomic level.
What’s more, there are now more than 1000+ consumer products on the market that utilize nanotechnology from the titanium particles in sunscreens to the silver contained in advanced first aid strips/plasters. Nanotechnology will impact more than $2.5 trillion of manufactured goods by 2015.
Lux Research predicts that by 2014, 16% of manufactured goods in healthcare and life sciences will include nanomaterials.
To date, the United States leads the way in the fast evolving field of nanotechnology. Between 2001 and 2010, the U.S. Government invested $12.4 billion in nanoscale science, engineering and technology through the U.S. National Nanotechnology Initiative (NNI).
The National Cancer Institute’s “NCI Alliance for Nanotechnology in Cancer” has an excellent website that outlines the potential impact of nanotechnology.
Some of the promising new cancer diagnostics and therapies based on nanotechnology include:
- Positron Emission Tomography (PET) imaging agents that can be used to assess the responsiveness of tumors to chemotherapy
- Chemically engineered adenovirus nanoparticle that stimulates the immune system. This is in phase 1 trials for chronic lymphocytic leukemia (CLL).
- Cyclodextrin-based nanoparticle that encapsulates a small-interfering RNA (siRNA) agent that shuts down a key enzyme in cancer cells
- CRLX101, a cyclodextrin-based polymer conjugated to camptothecin is in clinical trials with solid tumor patients
- A nanoparticle based magnetic resonance imaging (MRI) contrast agent that binds to αvβ3-intregrin, a protein found on newly developed blood vessels associated with tumor development. This is in early clinical trials
- Technology for the detection of cancer biomarkers such as prostate specific antigen (PSA)
- Use of carbon nanotubes to improve colorectal cancer imaging.
Emerging companies such as Bind Biosciences are focusing on targeting cancer, inflammatory, cardiovascular diseases and infectious diseases with therapeutic nanoparticles. Their lead product BIND-014 is currently in phase 1 development.
Innovations in nanotechnology will continue to present new product opportunities for biotechnology, pharmaceutical, medical imaging and diagnostics companies, and should be on everyone’s radar.
After I wrote my previous blog post about the emerging biotechnology region around Austin, TX, one of the comments I received was about the importance of networking opportunities within a cluster or region.
So I am pleased to have been invited to a medical technology-life science networking event in New York City (NYC) organized six times a year by Ted King of Saddlerock Advisors, Wendy Brown of Merrill Lynch and John Lieberman of Perelson Weiner.
The event, later today, has a format of a featured speaker and presentations by three emerging companies that provides them with the opportunity to network and showcase their technology, new drugs or medical devices to investors, industry partners, academics and researchers.
This evening there is a presentation on the proposed changes to the FDA’s 510(k) clearance process for medical device approval. This is the route by which the majority of medical devices come to market by showing they are comparable to an existing approved or marketed product.
The three featured companies include BioView (an Israeli technology company involved in cell imaging and automation of genetic testing), Cel-Sci (a Virginia based biotech company that has as immunotherapy product in development about to enter a global phase III clinical trial in head and neck cancer) and PatienTech (a company that develops elastic-sheet, pressure sensing systems that can be used with medical devices).
It will be interesting to see who attends, and whether the presentations by the companies are what I consider to be the typical investor “puff and fluff” presentations, or whether there is any meaningful discussion of science, marketing strategy and new product development.
Intellectual property (IP) rights are important in the biotechnology industry; one only has to look at a licensing, consulting or service agreement to appreciate this.
If you are a non-lawyer new to the area, and wish to gain a basic understanding of the different types of intellectual property protection such as copyright, trademarks, industrial design, patents and unfair competition, then the World Intellectual Property Organization (WIPO) Academy offers a free general course (DL-101).
The course is delivered online, twice a year, over 6 weeks. If you are a native English speaker, it takes far less time to complete than the 50 hours suggested. What makes the course work well is you can download the study material as PDF files. These can then be read anywhere – I used my kindle.
An additional benefit, if you have an ego wall in your den or office, is that WIPO send you a certificate after you pass a final exam. When I lived in the UK, I put all my certificates on the wall in the downstairs toilet, an idea I “borrowed” from Mrs Thatcher’s eye surgeon when I had dinner at his home. British understatement at its best.
Although the WIPO general course is not focused on biotechnology or the life sciences industry, it does provide a useful overview of international treaties and IP regulation to build upon. It is worth considering if you are new to the area.
With best wishes for the New Year, may it bring you good health, happiness and prosperity.