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The role of Medical Affairs

The role of Medical Affairs. Gloria Aung, BSc. (Hons) Medical Product Specialist 25 May 2005. GlaxoSmithKline Australia Medical Directorate. Dr Michael Elliott Vice President Medical Director. Tony Bourke & Ann Maccarrone Research Specialist (Diabetes). Merril Wenlock

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The role of Medical Affairs

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  1. The role of Medical Affairs Gloria Aung, BSc. (Hons) Medical Product Specialist 25 May 2005

  2. GlaxoSmithKline AustraliaMedical Directorate Dr Michael Elliott Vice President Medical Director Tony Bourke & Ann Maccarrone Research Specialist (Diabetes) Merril Wenlock Personal Assistant Suzie Bratuskins & Dipal Patel Research Specialist (Respiratory) Dr Ashley Bates Head of Discovery Research Christine Weston Head of Clinical Research NZ Dr Gerard Cudmore Associate Medical Director Dr Carlo Maccarrone Head of Clinical Research Dr Amanda Clark Head of Medical Affairs Andrew Hvizdos Head of Medical Affairs NZ Patti Owen Clinical Compliance Manager Dr Malcolm Handel Clinical Pharmacology Unit Director Adrian Serone Clinical Pharmacology Scientist

  3. Medical Affairs departmentOrg chart Amanda Clark Head of Medical Affairs Julia Lee Administration Assistant CNS/Vaccines Respiratory New Products/AI Rod Stosic Aaron Guttmann Pam Stokes Senior Product Specialist Respiratory – Specialists Medical Therapy Manager Medical Therapy Manager Maggie Chow Sonja Herges Birgit Beisner Senior Product Specialist Senior Product Specialist Respiratory - GPs Product Specialist Gabrielle Formosa Gloria Aung Amber Grant Product Specialist Product Specialist Respiratory - GPs Product Specialist Jenifer Nguy Product Specialist

  4. Vision Medical Affairs unique contribution to GSK Business is our ability to acquire knowledge, evaluate it and disseminate it to enable appropriate business decisions

  5. Key Responsibilities • Successful commercialisation of key brands: provide expert scientific knowledge on our key prescription brands, competitors & the healthcare environment • Input into brand strategy and development of promotional claims • Engage external stakeholders

  6. Key Responsibilities • Promotional practices ensure ethical and credible promotion of our key brands • Promotional material review • GSK Business Essentials Asthma campaign Genital herpes campaign Erectile dysfunction campaign

  7. Key Responsibilities • Protection of GSK’s brands and reputation Manage issues which potentially threaten our brands to help maintain our competitive position in the marketplace • Challenge strategy against competitors • Defence of challenges against GSK • Issues management

  8. Key Responsibilities • Sales Force Effectiveness Deliver scientific knowledge tailored to the sales representatives’ needs so that they can sell effectively, with confidence and credibility • Training • Representative enquiries, presentations, memos

  9. Business Partners Medical Information Sales Regulatory Affairs Government and Public Affairs External Customers Medical Affairs Marketing Clinical Research Health Outcomes and Pricing

  10. Science, pharmacy or life sciences background Team player Communication skills Training skills Skills • Strategic • Commercial focus • Customer focus • Attention to detail • Writing skills • Presentation skills

  11. Discovery Research coordinate and develop collaborative projects with researchers and innovators at hospitals, research institutes, universities, and companies across Australia At GlaxoSmithKline Australia, Scientists can work in a variety of areas: Pharmacoeconomics analyse cost effectiveness data with the aim of listing GSK products on the Pharmaceutical Benefits Scheme James Lance GlaxoSmithKline Medicines Research Unit conduct early phase studies in a dedicated Clinical Pharmacology Unit, Prince of Wales Hospital, Sydney Quality Assurance monitor and ensure that GSK products released onto the market meet quality specifications Clinical Research manage clinical trials and monitor sites participating in GSK-sponsored studies Medical Information provide information to health professionals and consumers in order to ensure the appropriate use of GSK products Clinical Supplies organise the distribution of GSK products for administration in clinical trials Pharmacovigilance capture adverse event and pregnancy data in order to monitor patient safety, expand product knowledge, and comply with corporate and legal obligations Biostatistics collate, analyse, and summarise clinical trial data Medical Affairs provide medical support and scientific input into brand strategies in order to ensure successful commercialisation of GSK products We improve the quality of human life by enabling people to do more, feel better, and live longer Clinical Compliance perform audits to ensure that clinical trials are conducted in accordance with Good Clinical Practice Sales establish relationships with health care professionals and provide them with current information on GSK products Regulatory Affairs work closely with government health authority to obtain and maintain registration of GSK products on the Australian Register of Therapeutic Goods Marketing manage and implement brand strategies in order to ensure successful commercialisation of GSK products

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