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GfK HealthCare | June 2011 | |
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The Co-evolution of Cancer Therapy and Market Research  By Rishard Salie, Ph.D., Project ManagerCo-evolution is defined as "the change of an object triggered by the change of a related object.” While this idea is primarily applied to biology, it also clearly describes the relationship between the pharmaceutical industry and health care-based market research. As drug companies shift to meet the needs of their consumers, market research companies must adapt to these changes and develop novel strategies to accommodate them. Global pharmaceutical sales more than doubled from 2000 to 2009, with cancer therapeutics the most rapidly expanding segment of the market. Oncology treatment has seen a noticeable change in focus, moving away from cytotoxic chemotherapy and antihormonal therapy toward targeted therapy and immunotherapy. It is estimated that combined sales of targeted and immunotherapy will grow from $19.5 billion in 2009 to $36.8 billion by 2019. Consequently, pharmaceutical companies across the world are striving to capture a significant share in this dynamic, expanding market. To do this they require information, the commodity of the market research industry. In order to successfully meet their needs, it is important to be aware of the changes in the field and how these affect client demands. The Molecular Basis of Cancer Cancer is not a single disorder but a vast collection of diseases characterized by uncontrolled cell division and loss of cellular ability to undergo apoptosis, a type of cell suicide that occurs in damaged tissue. Cancer is a leading cause of death worldwide and accounts for approximately 13 percent of all deaths annually. Global cancer rates have been increasing, primarily due to an aging population and lifestyle changes in the developing world. Improved detection of cancer due to advances in diagnostic techniques may also contribute to the increased rates. Additionally, life expectancy for many cancers has grown significantly, further increasing the total population of cancer patients. Cancers are genetic diseases – disruptions of genes resulting in deregulation of processes that normally balance cell proliferation, differentiation and death in a state of equilibrium. Exposure to carcinogenic chemicals, radiation and some viruses can cause the mutations that create cancer cells. As the mechanisms controlling cell division and death are disrupted, other cellular processes are also corrupted, often resulting in the production of cancer cells that are genetically different from the cell that gave rise to them.  Cells in these tumors can evolve by natural selection. Tumor cells compete for resources such as space, oxygen and nutrients. A cell that acquires a mutation that increases its survival capabilities (or decreases its likelihood of death) will generate more daughter cells than its competitors. Cells that have the ability to migrate and invade other tissues can colonize new sites within the body (metastasis). Cancer cells that have the ability to acquire a permanent blood supply (angiogenesis) also have a distinct advantage. Very often the genetic profile of the predominant clone in an end- stage cancer patient can be quite different from the cancer cell that started it. This survival of the fittest also contributes to drug resistance. Cancer therapies kill sensitive cancer cells, but leave behind resistant cells. The tumor regrows from those resistant cells, the patient relapses, and the therapy that worked well previously is no longer effective. Cancer Therapy Cancer treatment has developed slowly, without major progress until the last century. Often, the most effective and obvious approach to remove a primary solid tumor is surgery. Surgical techniques were exceeding primitive until recently, not to mention excruciatingly painful. Frequently, the treatment was more deadly than the disease itself. Only in the last 50 years have surgeons developed the technical expertise to minimize the amount of healthy tissue removed with the tumor. Chemotherapeutic techniques are based on selective targeting of cells that are dividing rapidly. Use of single agents or combinations of chemotherapies is effective on some cancers but comes with the price of distressing and sometimes dangerous side effects. Most agents affect all mitotic cells they encounter, damaging healthy tissues as well as cancer cells. While exposure to radiation can cause cancer, it can also help to cure it. Advances in radiation technology and computers have made it possible to deliver radiation with great precision to destroy tumors while limiting damage to nearby normal tissues. Only in the last decades have specific genes been associated with particular cancers. Targeted therapies have been developed in a variety of drug formats, all taking advantage of the distinctive molecular nature of some cancers. Monoclonal antibodies raised against specific targets, small molecule kinase inhibitors and agents inhibiting intracellular signaling cascades have all become part of the arsenal against cancer. Currently, targeted therapies make up eight of the top 10 selling oncology-related drugs on the market.  Trastuzumab (Herceptin), approved in 1998, prompted major changes in the treatment of breast cancer. Breast cancer tumors can be subdivided based on expression of human epidermal growth factor receptor 2 (HER2). Trastuzumab is a monoclonal antibody that selectively binds and inhibits the HER2 protein, preventing uncontrolled cell division. Prior to trastuzumab, patients with HER2+ disease had a worse prognosis than HER2- disease. Currently, HER2+ disease has a better prognosis because many more treatment options are available to this patient population. Bevacizumab (Avastin), a monoclonal antibody that binds to vascular endothelial growth factor A (VEGF-A), is the current market leader of all the oncology drugs. Bevacizumab disrupts angiogenesis in order to prevent tumors from acquiring a blood supply. It is approved for use in the treatment of breast cancer, colon cancer, glioblastoma, non-small cell lung cancer (nSCLC) and renal cell carcinoma (RCC), as well as being investigated for other tumor types.  Hematological cancers are also susceptible to targeted intervention. CML is caused by a genetic abnormality that results in production of a deviant fusion protein, BCR-ABL, which is continuously active. BCR-ABL disrupts control of the cell cycle, speeding up cell division and inhibiting DNA repair, making the cell more inclined to developing further genetic abnormalities. Imatinib (Gleevec/Glivec), a tyrosine kinase inhibitor introduced a decade ago, inhibits the activity of BCR-ABL, driving the leukemia into remission in the vast majority of cases. The impact of imatinib on CML was so profound, it was featured on the cover of TIME magazine. Second-generation TKIs (nilotinib, dasatinib), have also recently been approved by many countries for use as frontline therapy for CML. Targeted therapy has changed CML from a disease that was invariably fatal into a chronic disease that can be controlled for the majority of patients. Imatinib is also approved for the treatment of gastrointestinal stromal tumors (GIST), often caused by mutations in the c-KIT (CD 117) gene; KIT protein is also inhibited by imatinib. Gefitinib (Iressa) and Erlotinib (Tarceva) are kinase inhibitors that target the epidermal growth factor receptor (EGFR) tyrosine kinase. These drugs have successfully been used in the treatment of non- small cell lung cancers (nSCLC), which express a specific EGFR mutation. Erlotinib is also approved for the treatment of pancreatic cancer. Cetuximab (Erbitux) is a monoclonal antibody also targeting the EGFR that is approved for treatment of metastatic colorectal cancer as well as head and neck cancer. Temsirolimus (Torisel) and Everolimus (Afinitor) are inhibitors of mTOR, a serine/threonine protein kinase that regulates cell growth, proliferation and survival. mTOR is activated in some tumors, driving cancer growth. Both compounds have had success in treating some kidney cancers. Kinases are not the only intervention point of targeted therapy. Bortezomib (Velcade) specifically inhibits the proteasome, the cellular machinery that controls protein breakdown within the cell. Proteasome inhibition may stop cancer cells from digesting pro-apoptotic factors, allowing the cancer cells to undergo cell death. Bortezomib is approved for the treatment of relapsed multiple myeloma and mantle cell lymphoma. In addition to the benefits, there are also drawbacks to targeted therapies. No targeted therapy has yet been developed which is truly specific to a single target molecule. Even if this was the case, pathways inhibited by these drugs often occur in many normal cells of the body. Off-target effects can affect other body systems resulting in unpleasant or even dangerous side effects. Furthermore, these are relatively expensive, lifelong therapies that can financially strain health care systems. Targeted therapies are currently only available for a handful of cancers, but it is expected that new targeted therapies will be developed as we learn more about the molecular basis of specific cancers. Personalized Medicine and Multidisciplinary Management of Cancer  Cancer treatment as a whole is also evolving toward a team-based approach. Tumor identification and assessment of size and position often rely on the imaging work of a radiologist. Pathologists analyze tissue samples and perform mutational analysis in order to define a specific cancer type. Options of surgery and/or chemo/drug therapy are decided using a multidisciplinary approach, where health care professionals involved in all facets of patient assessment confer to make therapeutic decisions. These multidisciplinary teams are not the only steps on the path to personalized medicine. There is also need for codevelopment of diagnostic techniques and biomarkers to identify specific patient subpopulations that may benefit from a particular therapeutic approach. Fast, cost-effective patient segmentation is a critical part of effective personalized medicine, but comes with its own set of problems. Testing methodology and results often need to be standardized among labs in order to produce consistency in the results. Standardization and validation of methodology and results is an expensive and logistically difficult task that creates a significant barrier in patient diagnostics and stratification. It also becomes increasingly important that education and awareness of health care professionals are encouraged. Rapid changes in therapeutic paradigms make it essential that health care professionals continuously update and inform themselves in order to provide cutting-edge treatment for their patients. Market Research and the Evolving Therapeutic Landscape As the oncology landscape evolves, market research needs to adapt accordingly. The increase in the amount and variety of oncology treatments available will make appropriate strategic marketing of these drugs a key factor in their prescription and use. This differentiation can only be achieved through research within these markets in order to determine the key priorities for patients, prescribers, payers and regulatory authorities. Definition of the market landscape for new therapies or existing therapies in new indications will be a significant contribution of the market research industry to this dynamic field. It is imperative that market research companies remain flexible in order to mold services to the shifting needs of clients. Considerations should be made for doing research with full multidisciplinary teams, instead of individual oncologists, in order to determine how the exchange of ideas among the different health care professionals impacts the interpretation of data and therapeutic decision making. In order to achieve sufficient market access, clients need to know what data is important to which stakeholder, how to package this information and when to deliver it. Aspects that may soon rise to the foreground of oncology market research are health economics, product innovation and how to bring added value to both patients and physicians by providing additional benefits, such as ease of compliance or increased accessibility. Strict regulatory restrictions, escalating client expectations, increasing emphasis on adverse event reporting and the need to adhere to best practices will also require management. As patients become progressively more educated about their cancers, the increased availability of information via the Internet and worldwide social networking of patient populations present both novel challenges and opportunities for the pharmaceutical industry. Drug companies need to adapt their marketing strategies and react quickly in order to provide appropriate information and keep up with trends in social media. Market research companies also need to embrace these changes and exploit them to the advantage of our clients. In order to remain on top, it is important not only to keep pace with these changes but to become engines of change, pushing the boundaries of market research methodologies and analytical methods in order to maximize the potential for success in a competitive market. Understanding and adapting to the dynamic oncology landscape will ensure that GfK HealthCare continues to meet client needs in an increasingly competitive environment. |
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