How Integrated Writing Services for the Pharmaceutical industry can increase efficiencies and harmonize the value story
The biopharmaceutical industry must address Regulatory, Scientific, Reimbursement and Commercial audiences, each of which requires a different type of writing. This can lead to extended development and release time lines and create cost inefficiencies within the organisation.
The types of writing below are all necessary to allow expeditious development and commercialization.
Clinical and Nonclinical Regulatory writing is aimed at a highly expert audience trying to determine the efficacy, and safety of a drug. Sadly, this captive audience must read the documents produced. The writing is exhaustive, and there are virtually no limits on length. Good regulatory writing emphasizes clarity and completeness.
Scientific writing is aimed at an expert, but more general audience. They are interested in the disease under study and how the drug will work clinical practice. Scientific writing competes for attention with the huge number of journal articles being produced, while facing severe length restrictions. Good scientific writing presents complex ideas and data with focus, scientific sophistication, and concision.
Reimbursement writing is aimed at presenting the economic story to a broad cross-section of audiences. They are interested in the disease and drug, but in the context of the economic cost to payers, providers, and patients. Good reimbursement writing requires a balance between clinical data and economic justification.
Commercial writing addresses an audience that must be educated about the disease and the drug. This requires a much livelier style to engage the attention of the audience, and must be able to convey information simply and attractively. Promotional writing requires attractiveness and intense focus on a single message.
This webinar will show how an integrated approach facilitates the transition from regulatory to scientific to promotional writing by sharing knowledge and expertise acquired during the drug development process and utilizing the overlaps and common bases of these types of writing.
Presented by
Elizabeth L. Pham,
Senior Director, Value Communications
Senior Director, Value Communications, Covance Inc.
Director, DaVita Clinical Research
Founding Partner, BiFecta Communications
Senior Manager, Onyx Pharmaceuticals
Senior Manager, Amgen Inc
Medical Writing Projects Manager, Allergan Inc
Medical Writer, RWJPRI, Johnson & Johnson Inc
Don Costello Ph.D.,
Global Strategist, Covance MW
Executive Director Covance Medical and Regulatory Writing
Scientific Director, Diabetes, MannKind Corporation
Senior Director, Clinical Communications, Pfizer Inc
Director, Clinical and Scientific Affairs, Pfizer Inc.
Director, Medical Writing, Hoechst-Roussel Pharmaceuticals
Assistant Professor, Pharmacology Indiana University Medical School
Helen Wilfehrt, PhD,
Director, Value Communications
Helen Wilfehrt leads the reimbursement and government support group within Value Communications at Covance Market Access Services. Helen has over 14 years of industry experience providing leadership to teams responsible for communications including but not limited to briefing documents, study development, regulatory documents, strategic and tactical planning for publications, and medical writing teams with global companies such as Sanofi Oncology, Amgen and Quintiles.