Oncology Featured Articles
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ASCO To Invade McCormick: Clinical Leader and inVentiv Health Have It Covered
5/28/2015
The American Society of Clinical Oncology (ASCO) Annual Meeting, is a four day event that will focus on Illumination & Innovation: Transforming Data into Learning. The agenda is jam packed, with sessions covering 21 different tracks, including melanoma, breast cancer, leukemia, pediatric oncology, special sessions, and professional development.
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The Fight Against Cancer – Infographic
5/7/2015
More than twice as many people die from cancer than from AIDS, malaria and tuberculosis combined. The World Health Organization (WHO) projects that without immediate action, the global number of deaths from cancer will increase by nearly 80% by 2030, with most occurring in low-and middle-income countries.
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Intent To Treat Enrichment: A Solution For Better Clinical Trials Of Precision Cancer Medicines
1/6/2015
As cancer medicine increasingly targets specific molecular abnormalities, more of the anticancer drugs in clinical trials are precision medicines, intended to treat a highly selected niche population of patients. The opportunity for better treatment creates not only a proposition of needles and haystacks, but of hundreds of different kinds of needles sprinkled through thousands of haystacks.
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Clinical Operations Cost Variation: Oncology vs. Non–Oncology
11/25/2014
The number of products in pipeline within Oncology therapeutic area was 3436 in 2013, which contributes to more than 29% of the total R&D projects.1 Cancer related cases are also estimated to rise up to 22 million within the next two years.2 Keeping these statistics in mind, pharmaceutical companies have earmarked a major proportion of their R&D investment on cancer related research.
With more oncology clinical trials in the pipeline of most large pharma, there is question of why the operating cost for Oncology trials are higher than that of other therapeutic areas. Let us take a detailed look into this question.
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Expect The Unexpected: Daiichi Sankyo’s Glenn Gormley Shares Post Interview Insights
11/3/2014
I first met Glenn Gormley, M.D., Ph.D., at the 2014 PhRMA’s (Pharmaceutical Research and Manufacturers of America) annual meeting in Washington, D.C. At the time, I was engaged in a conversation with James (Mit) Spears, EVP and general counsel for PhRMA, and so my discussion with Dr. Gormley was brief. However, our encounter reminded me of an idea I once had for doing an article about Daiichi Sankyo. Though the company has a lengthy history, it had little experience in the area of oncology R&D. As Gormley is the senior executive officer and global head of R&D at Daiichi Sankyo Co., Ltd., as well as chairman of the board, executive chairman and president of Daiichi Sankyo, Inc, I thought perhaps he could share some insight on the company’s approach to entering into the field of developing cancer therapeutics. We conducted our formal interview on June 30, 2014. It resulted in the September 2014 Life Science Leader magazine cover feature — How Daiichi Sankyo Is Venturing Into The Unfamiliar Terrain Of Oncology R&D.
As is my custom, I provide interviewees with questions in advance to guide our discussion. After an article is published, it is rare for me to revisit these questions. Further, it is unheard of for me to receive legally approved written responses to my interview questions — especially after an article is complete. But with Glenn Gormley, I have come to expect the unexpected. What follows are the previously unpublished written responses to my interview questions, which serve to shed additional insight into Daiichi Sankyo’s approach to entering the field of oncology drug development.
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The Role Of DCE-MRI In Drug Discovery Support
10/17/2014
Incorporation of Dynamic Contrast Enhanced (DCE)-MRI modality in clinical trials can contribute to discover more powerful imaging biomarkers, compared to conventional MRI, for assessment of early disease changes and for helping select patients most likely to benefit from drug response.
- Vascular changes can be observed and quantified with DCE-MRI, which allows earlier assessment of drug efficacy and saves time and money in the drug development process.
- The use of DCE-MRI in studies increases the study’s discriminative power and helps reduce the number of patients and study sites.
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ONO Pharmaceutical Strives For Global Sales
7/31/2014
Gyo Sagara, president, representative director and CEO, challenges his company to enter the cancer field and gain big-pharma relevance.
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Millennium Carries On With The Takeda Oncology Expansion
6/30/2014
Since I’ve been writing about the pharma industry for many years, I often find it impossible to walk in any direction without bumping into a connection from the past. It seems like a thousand years ago that I interviewed Millennium’s founder, Mark Levin, soon after the launch of its hallmark cancer drug. Certainly enough has transpired since then.
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Simplifying Cancer Complexity And Improving Clinical Success with Metabolomics: Part 2
1/14/2014
Cancer is an extraordinarily complex disease involving, a heterogeneous mix of genetically mercurial cancer cells, stroma, and microenvironment across at least 200 different cancer types. Even with a specific cancer type, heterogeneity within patients impairs clinical development. Thus, the clinical challenges are substantial - to produce a meaningful regression or survival benefit based on targeting an important aspect or aspects of this complex biology.
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“Non-Traditional CROs” Find Solutions While Managing Costs
9/30/2013
In the 1970’s and 1980’s pharmaceutical and biotechnology companies started to outsource many of the clinical operations services to organizations that have come to be known as contract research organizations (CROs). “Traditional CROs” established themselves by hiring and training employees to manage and monitor clinical trials. The individuals selected included those preferably with a scientific background and were most often fresh out of college or nursing school. The training they received was essential as they lacked experience in a fledgling industry. Strict supervision was also required based on low levels of experience. CRAs with zero to two years of experience made up the majority of the workforce and it was difficult for Traditional CROs to find CRAs with the requisite experience to appoint to studies. Therefore, many organizations sought to have blended teams of the more experienced monitors (3 or more years), along with ‘green staff’ or very inexperienced monitors (0 to 2 years). Many of these organizations were financially successful using this approach, yet it was significantly inefficient in terms of time and client’s budget.