Personalized Medicine: The Partnership Imperative
Cecilia Schott, business development director for personalized healthcare with AstraZeneca, on why partnerships between pharmaceutical and diagnostics companies are key to the success of personalized medicine.
AstraZeneca realizes it cannot achieve its mission "to make the most meaningful difference to patient health through great medicines" without making external collaboration a large part of its strategy, Cecilia Schott, business development director for personalized healthcare with AstraZeneca, told attendees at last year's Personalized and Translational Medicine USA conference.
The pharmaceutical development landscape is perpetually changing, and the personalized approach is recognized as a major opportunity for increasing the probability of a candidate drug's success and decreasing the time and cost to launch.
The company's commitment to introducing personalized healthcare extends throughout its entire product portfolio and involves all its activity. The area of regulation is a key one; for the greatest chance of success, a drug and its companion diagnostic test must go through the regulatory process at the same time. (For more on companion diagnostics, see 'Personalized medicine: Regulating companion diagnostics'.) This means that the exact diagnostic assay must be chosen and "locked" into place by the time the drug reaches Phase II or III clinical trials, Schott said, although clearly diagnostics development must continue in preparation for further cycles.
AstraZeneca, in common with most but not all large pharma companies, has no diagnostics arm and so no experience of or expertise with the development, regulation, or marketing of diagnostics. It aims to acquire these skills by working closely with biotech companies, such as the Danish cancer diagnostics company Dako, academic groups, and individual consultants.
The company's experience with personalized medicine to date has been mainly in oncology, following on from the success of IressaTM in treating non-small cell lung cancer in patients with EGFR mutations. However, it is now exploring its relevance to another key therapeutic area, that of infectious disease. Here, pathogen identification is more important than patient stratification. The current gold standard for precise identification of an infectious agent, blood culture, takes 48-72 hours. AstraZeneca aims to develop much more rapid diagnostic tests but will face regulatory difficulties until these can be made as precise as this gold standard.
Schott concluded by re-iterating the importance of partnership and emphasizing her company's flexible approach to deal making: "No two deals are the same." What AstraZeneca looks for in industrial partners, however, is always the same: robust science and technology coupled with an awareness of the clinical, regulatory, and commercial issues involved, robust finances, and common goals.
For all the latest discussion in personalized medicine, join the sector's key players at Personalized Medicine & Diagnostics Europe on March 9 and 10 in London.
Source:
Eyeforpharma
In ACL Knee Reconstruction, Hamstring Grafts Prove More Effective
"While we have seen excellent results in terms of knee symptoms and function with both graft types, comparing the two definitely showed differences, "said Leo Pinczewski, MD, lead researcher and surgeon with the North Sydney Orthopaedic and Sports Medicine Center in Wollstonecraft, Australia. "Patients with a hamstring graft reported less knee pain and discomfort and demonstrated a higher activity level."
Surgeons performing ACL graft surgery aim to eliminate instability and quickly return patients to pre-injury function levels. Since ACL ruptures are relatively common, especially in young athletes, surgical procedures are routinely performed.
This study adds to Pinczewski's most recent work exploring the overall success rate of ACL knee reconstruction in athletes after 15 years. "We know that these surgeries work, but this information helps us determine which approaches can be most effective. Getting athletes back on the field is certainly important, but long term success rates are crucial as well," said Pinczewski.
The study followed 180 knee reconstruction patients, with 90 (48 men and 42 women between the ages of 15-42 years) receiving a patellar tendon (PT) graft and the other 90 (47 men and 43 women between the ages of 13-52 years) receiving a hamstring tendon (HT) graft. After 15 years, 80 percent of the PT group and 73 percent of the HT group were assessed based on their symptoms of pain, swelling and knee mobility.
The HT group demonstrated significantly higher activity levels, with 77 percent performing at least strenuous activities, compared to 62 percent being able to perform strenuous activity in the PT group. In evaluating pain when kneeling, 42 percent of the PT group patients reported moderate or greater pain, while 26 percent of the HT group reported pain. The PT group also showed worse outcomes in tests for motion loss and osteoarthritis.
Reasons for increased osteoarthritis in the hamstring tendon graft were uncertain and recommended for further investigation.
Source:
Lisa Weisenberger
American Orthopaedic Society for Sports Medicine
