PharmaWrite at the 12th Annual Meeting of ISMPP
PUBLICATION PLANNING FOR ONCOLOGY AND RARE DISEASES
Compiled for you by PharmaWrite.At the 12th annual meeting of the International Society of Medical Publication Professionals (ISMPP), an informative session was held to educate attendees and help them to better understand the unique features of publication plans in rapidly evolving immuno-oncology and rare disease areas. The session also yielded information and direction so that, in the future, the attendees could more effectively identify key considerations when they develop and execute their publication plans.
To kick off the session, Diane Reed (PharmD, ISMPP CMPPTM, Head, Oncology Medical Publications, Bristol-Myers Squibb), gave a brief introduction of the history of cancer therapies, explaining how treatments evolved from surgery, to radiotherapy, then chemotherapy, and now targeted therapy and immunotherapy. Immuno-oncology leverages a patient's immune system by removing the "breaks" established by the cancer and allowing it to resume its function of immune surveillance. Targeted therapies have led to improved survival rates, but the responses seen are less durable than with immunotherapy. When used together, better responses are seen. These therapies are very complex and necessarily lead to novel study designs. Novel treatments for disease that have few or no available treatments often are eligible for accelerated reviews and approvals. Often times, it is beneficial to establish collaboration between the pharmaceutical company and academia, and perhaps other pharmaceutical companies, in order to ensure the program's success.
Diane stressed that this is an evolving landscape. Cancer treatment involves the use of multiple agents with varying mechanisms of action that can lead to more data as well as more questions. As a result, appropriate publication plan execution and understanding interdependencies is key. It is also important to engage stakeholders and markets early.
Scott Newcomer (MS, ISMPP CMPPTM, Consultant, Davenport Scientific Services) then discussed the topic of rare diseases and how orphan drug incentives affect their development. Challenges involved in developing treatments for rare diseases include the low number of patient populations and the unmet need in these areas. Challenges for publication planning include the need to evaluate delays in diagnosis due to lack of provider awareness and the need to establish epidemiology, disease burden, and tools to measure health-related quality of life.
Provider education is key and will depend on the audience. Common sources for data can include registries and post-marketing data which can be sourced to determine the natural history of the disease and the disease burden. An industry sponsor can help to increase awareness by providing education.
TAKEAWAYS
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