Biotech Strategy Blog

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

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I am off to Washington DC tomorrow for the annual meeting of the American Urological Association (AUA).

If you are not able to attend, then you can follow the Twitter coverage on Pharma Strategy Blog where Sally Church (@MaverickNY) will be aggregating the tweets.  The conference hashtag is #AUA2011.  I also expect to be live-tweeting from the conference.

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Like many medical conferences in the United States, the AUA meeting kicks off with independent continuing medical education (CME) satellite symposia on topics of interest.

As a lawyer who has to pay for his own continuing legal education (CLE) credits, I have to confess that I am somewhat cynical that other professionals such as physicians expect to have their CME paid for through free industry-sponsored events.  These symposia are certainly not cheap to run.

However, compared with Europe, CME events in the United States are usually well-produced and fair balanced, albeit with a topical theme that obviously relates to the sponsor’s interest.

The two satellite symposia that I will be attending at AUA are Friday evening’s Amgen supported “Managing Skeletal-Related Events in Patients with Prostate Cancer” and the Saturday morning Astellas/Medivation supported “Reason for Hope: Key Advances in the Management of Castration-Resistant Prostate Cancer.”

While at Quintiles, I was lead CRA/European Project Manager for the phase III trial trial of risedronate in elderly women at risk of hip fracture, so I am interested in bone related treatments, and am looking forward to hearing more about denosumab (Xgeva®) and its impact on skeletal related events (SRE).

Oliver Sartor (Tulane) raises some excellent questions in a recent paper published in the Asian Journal of Andrology, “if a patient has a SRE, does it affect the way a patient feels, functions or survives?”

Sartor argues that a better definition of the benefit a drug has on SRE’s would be “a reduction in pain, analgesic consumption or improvement in quality of life (QoL)” instead of the current “feel, function or survive” standard.

He notes that patients with bone-metastatic castrate resistant prostate cancer (CRPC) have a limited life expectancy, so that QoL is a key issue. “An asymptomatic event linked to a future adverse event is less meaningful in a patient with metastatic CRPC.

Sartor concluded his paper by saying:

“The lack of effect of bisphosphonates or denosumab on patient-reported outcomes including QoL, pain or analgesic consumption continues to be a disappointment for this entire field.”

When we talk about a reduction in SRE’s what does this really mean for the patient?  I look forward to hearing what the expert panel at Friday evening’s symposia on this topic and hope it will be addressed.

Moving on to the other satellite symposium, supported by Medivation/Astellas, that I will be attending early on Saturday morning.  I expect this symposium will focus on new drugs in the pipeline such as MDV3011 and ARN-509 that target the androgen receptor. Hopefully they will also discuss other therapeutics, such as the recently approved abiraterone acetate (Zytiga®), as well TAK-700, which has a similar mechanism of action to abiraterone, i.e. they both inhibit CYP17 and testosterone production.

I’m looking forward to hearing what the expert panel has to say about the need to take prednisone with abiraterone, and whether there are any issues surrounding long-term usage if abiraterone ends up being used earlier in the pre-chemotherapy setting.  Updated data from the COU-AA-301 trial will be presented at AUA on Monday, and I expect a lot of interest from urologists in this.

The satellite symposia are set to be a good warm up act to the start of the main AUA meeting that runs from May 14 to 19 in Washington DC.  I’ll be writing more from the AUA 2011 over the next few days.

ResearchBlogging.orgSartor, O. (2011). Denosumab in bone-metastatic prostate cancer: known effects on skeletal-related events but unknown effects on quality of life Asian Journal of Andrology DOI: 10.1038/aja.2011.33

Nanotechnology is set to have a major impact on drug development and new products for the diagnosis and treatment of cancer.  Research from UCSF and Northwestern University published earlier this year in “Science Translational Medicine” shows this potential.

Edward Chow and colleagues describe how binding the cancer chemotherapy doxorubicin (DOX) to carbon nanoparticles 2-8nm in diameter in the form of a diamond, “nanodiamond” (ND), improved drug efficacy and overcame drug resistance.  Although this pre-clinical animal research has not yet been confirmed in humans, it raises the possibility of more efficient chemotherapies and the hope of increased survival rates as a result.

The conclusion from this research is that nanodiamonds may be a viable drug delivery platform for small molecules, proteins and nucleic acids. This technology could have an application in wide range of diseases.

Why is nanoparticle-mediated drug delivery more effective? The paper suggests one reason is that the nanodiamond-doxorubicin complex (NDX) allows for a more gradual release of DOX, allowing for increased tumor retention and increased circulation time.

It’s important to note that the NDX complex does not specifically target the drug efflux pumps, such as MDR1 and ABCG2 transporter proteins, responsible for chemoresistance. Instead the NDX complex appears to overcome drug resistance passively by the way DOX is released from the nanodiamond.

This research shows that taking old drugs and combining them with new drug delivery technology may offer therapeutic benefits.  The authors conclude that this research, “serves as a promising foundation for continued NDX development and potential clinical application.”

If successful in humans, it will translate into new product development and market opportunities for emerging biotechnology and biopharmaceutical companies.

 

ResearchBlogging.orgChow, E., Zhang, X., Chen, M., Lam, R., Robinson, E., Huang, H., Schaffer, D., Osawa, E., Goga, A., & Ho, D. (2011). Nanodiamond Therapeutic Delivery Agents Mediate Enhanced Chemoresistant Tumor Treatment Science Translational Medicine, 3 (73), 73-73 DOI: 10.1126/scitranslmed.3001713

In an acquisition that highlights the importance of cancer and inflammation, Gilead Sciences today announced the acquisition of Seattle based Calistoga Pharmaceuticals for $375M.

Calistoga’s pipeline is focused on the development of PI3 kinase inhibitors for cancer and inflammation. Sally Church on Pharma Strategy Blog has written extensively about “The potential of the PI3K pathway inhibitors in lung cancer”, and discussed Calistoga’s CAL-101 compound and its development for hematological malignancies in her report on “What’s hot at ASH in 2010”.

I encourage you to read (if you already don’t) Sally’s excellent Pharma Strategy Blog for further information on the science and mechanism of action of the PI3K pathway (way beyond my pay grade) and her view on CAL-101’s potential.

Sally will also be at the timely AACR meeting on targeting PI3K/mTOR signaling in cancer that is being held in San Francisco later this week.

What makes CAL-101 interesting to me is its potential in targeting inflammatory mediators. CAL-101 is a first in class PI3K delta specific inhibitor; the delta isoform of phosphoinositide-3 kinase (PI3K) is expressed in leukocytes involved with a variety of inflammatory, autoimmune and hematological cancers. Increasingly I think we will see companies investigating the cross-talk between inflammation and other diseases.

In addition to the upfront payment of $375M, there are potential milestone payments of $225M.  The deal is set to close in the second quarter of 2011.

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The theme for the biotech strategy blog this week is innovation in bringing new drugs and devices to market.  Innovation is the lifeblood of the biotechnology industry and what drives the acquisition of companies for their pipeline by large pharma companies.

Tomorrow I will be at the Innovation in Healthcare Symposium at MIT in Cambridge, MA. See my earlier blog post for further information. I look forward to writing about the Symposium later this week.

One experienced industry professional recently told me that he believed the Ipad would revolutionize the clinical trials process.  Do you agree? On reflection, I think the IPad and similar tablets will make the clinical trials process more efficient, but is this an innovative breakthrough that will revolutionize the model? I am not so sure.

At this year’s Consumer Electronics Show in Las Vegas, analysts talked about the 80-100 new tablet computers that were on show, and the fact that an estimated 50 million e-books and tablets will be sold in 2011.  Companies have clearly innovated in bringing new technology to market, that we now have a desire for and want to use.

Health Professionals have embraced the IPad, it’s ease of use, portability and potential for a range of uses from data entry, to the viewing of medical images and access to online reference databases.  In the hospital environment, it can easily be integrated into the IT infrastructure and made HIPAA compliant if no data is stored on it.

For clinical trials, it is already being as an electronic data capture (EDC) interface for case report form (CRF) data entry, although I am not sure whether it will become the primary interface. My expectation is that IPads and similar tablets will increasingly be used as a portal for accessing study resources, the ordering of supplies, recording of adverse events and even the signing of patient informed consents.

I also expect we will see IPads being given to patients for clinical trial diary and journal entries. What’s more by using these devices with 3G wireless capability, study coordinators will be able to interact in real-time with patients, remind them of study visits and monitor medication compliance. Mobile health is set to be a real growth area.

On the medical imaging side, results from a clinical trial published at the Radiological Society of North America (RSNA) annual meeting last December showed that radiologists viewed the IPad imaging quality as equal or superior to standard LCD displays when viewing X-rays. (Erik Ridley wrote up a good post about this on AuntMinnie.com).

Reviewing X-rays to screen for TB is a lot different from diagnostic imaging in clinical trials, so I remain unconvinced that the IPad will take over for primary diagnosis, and central review of images is still going to be the gold standard.

What I think the IPad and other tablet computers will do is allow the easy sharing of images between the central review laboratory, investigators and study coordinators. This will make it easier to monitor patient inclusion, study progress and report imaging results.

So looking at the above, while I think the IPad is an innovation, I don’t necessarily think it will revolutionize clinical trials and bring products to market faster.  It will be interesting to see what industry professionals have to say at the Drug Information Association (DIA) annual meeting later this year.

What are your thoughts on how innovation will change the clinical trials process in the biotechnology industry? How can we bring products to market faster?

My theme for blog posts this week has been the diagnosis and detection of Alzheimer’s Disease, a therapeutic area I was first introduced to while working as a Global Project Director at the Canadian CRO, CroMedica before it was acquired by PRA. The then CEO of CroMedica, Erich Mohr Ph.D is now Chairman and CEO of MedGenesis Therapeutix Inc. in Victoria, BC.

This privately held biopharmaceutical company is working on developing new products for neurological diseases and the treatment of Parkinson’s Disease, Glioblastoma Multiforme (GBM) and Intractable Epilepsy. I have added MedGenesis to my list of emerging biotechnology companies to watch, and look forward to writing further as their pipeline develops.

Which brings me back to Alzheimer’s disease (AD), an area which I think will touch many of us as we and our parents become older. Last week, I was visiting my elderly mother in England who struggles to remember when I am visiting, and has little or no short term memory. It’s sad to see her in a restaurant have a completely blank face when she goes up to a buffet, then cannot remember where she was sitting.

While we all have age-related decline in our memory as we get older, how do you know if it may be something more such as AD? The Alzheimer’s Association have published a useful list of 10 warning signs, that may suggest seeing a doctor:

  1. Memory loss that disrupts daily life
  2. Challenges in planning or solving problems
  3. Difficulty completing familiar task at home, at work or at leisure
  4. Confusion with time or space
  5. Trouble understanding visual images and spatial relationships
  6. New problems with words in speaking or writing
  7. Misplacing things and losing the ability to retrace steps
  8. Decreased or poor judgment
  9. Withdrawal from work or social activities
  10. Changes in mood or personality

While there is no cure for AD, early diagnosis using biomarkers (see my blog post on Lilly’s florbetapir and blog post on Novartis’ Aß40 oligomers), could lead to slowing disease progression as new therapeutic agents come through development to market.

Dementia, AD and other cognitive disorders are challenging for caregivers and family’s to deal with. In many ways a tangible, physical illness is easier.  Not knowing the rate of progression and the future, it is difficult to plan ahead. Helping my elderly mother maintain her independence in the face of the mental challenges she faces is something that we as a family have to face up to, as I am sure many others will too.

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