Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Immunotherapy

Posts tagged ‘medical imaging’

Innovation in Nanotechnology will lead to improved drug delivery, diagnostics & imaging

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.

 

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Do you have a policy for the handling of incidental findings in clinical trial medical images?

By on February 1, 2011

I was supposed to be at the Innovation in Healthcare Symposium today at MIT in Cambridge, MA, but the winter ice storm that’s set to hit the North East has forced me to change my plans and return early from Boston to New Jersey. I am hoping to outrun the storm this morning (unlikely I know).

Hopefully, the presentations will be videoed and uploaded to You Tube or Webcast. Having traveled to Boston specially, I’m disappointed not to be able to write about the Symposium as planned.

A hot topic that came to my attention courtesy of an article in the Irish Medical Times, is how companies are handling incidental findings in the medical images they obtain during clinical trials.  To me, this is the flipside of innovation in that it often yields both positive and negative consequences.

Innovative medical imaging such as positron emission tomography (PET), Optical Coherance Tomography (OCT) and Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) are now widely used in clinical trials, and have opened the door to new ways to visualize joints, blood vessels, organs and tumors.  This innovation is leading to the development of imaging biomarkers such as reduction in joint space or reduction in tumor size that became surrogates for drug efficacy.

However, in the process, these clinical trial medical images are generating “incidental findings” (IF).  An incidental finding is something that shows up in a medical image obtained during a clinical trial, but is not related to the clinical trial protocol or study objectives.  The challenges is that what the reviewing radiologist sees may impact the health of the subject, making it an ethical issue not only for the reviewer, but for investigators and sponsors such as biotechnology companies.  How companies handle incidental findings in clinical trial imaging is a hot topic at the moment.

Part of the debate is to whether this is something that companies should worry about, given that we are talking about may be a relatively low incidence.  A September 2010 paper from Fletcher et al, “Incidental Findings in Imaging Research,” published in the Archives of Internal Medicine, reported that 39.8% (n=567) of 1426 research medical images showed an incidental finding. Of these, in only 6.2% was clinical action taken upon the IF and in only 1.1% (n=6) was there resulting clinical benefit to the patient.  This raises the questions of to what extent there is an obligation to report findings, who pays for this, and whether it is ethically necessary?

The National Institute of Biomedical Imaging and Bioengineering (NBIB) has published recommendations, that states researchers should anticipate incidental findings and have a policy to deal with them.

If I were a biotechnology company looking to hire a Contract Research Organization (CRO) or other outsourcing company for central review of clinical trial images, one of the questions that I would ask is what is their policy for handling incidental findings?

While innovation in medical imaging provides new ways of measuring and detecting disease, this innovation also generates unanticipated data that has to be addressed.

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