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

Medical Affairs department Org chart

Amanda Clark

Head of Medical Affairs

Julia Lee

Administration Assistant New Products/AI

Aaron Guttmann

Medical Therapy Manager CNS/Vaccines

Pam Stokes

Medical Therapy Manager

Sonja Herges

Senior Product Specialist

Amber Grant

Product Specialist

Birgit Beisner

Product Specialist

Gloria Aung

Product Specialist Respiratory

Rod Stosic

Senior Product Specialist Respiratory – Specialists

Maggie Chow

Senior Product Specialist Respiratory - GPs

Gabrielle Formosa

Product Specialist Respiratory - GPs

Jenifer Nguy

Product Specialist

Vision

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

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

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

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

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

Business Partners

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

Skills

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

Discovery Research

coordinate and develop collaborative projects with researchers and innovators at hospitals, research institutes, universities, and companies across Australia

James Lance GlaxoSmithKline Medicines Research Unit

conduct early phase studies in a dedicated Clinical Pharmacology Unit, Prince of Wales Hospital, Sydney

Clinical Research

manage clinical trials and monitor sites participating in GSK-sponsored studies

Clinical Supplies

organise the distribution of GSK products for administration in clinical trials

Biostatistics

collate, analyse, and summarise clinical trial data

Clinical Compliance

perform audits to ensure that clinical trials are conducted in accordance with Good Clinical Practice

Regulatory Affairs

work closely with government health authority to obtain and maintain registration of GSK products on the Australian Register of Therapeutic Goods At GlaxoSmithKline Australia , Scientists can work in a variety of areas: We improve the quality of human life by enabling people to do more, feel better, and live longer

Pharmacoeconomics

analyse cost effectiveness data with the aim of listing GSK products on the Pharmaceutical Benefits Scheme

Quality Assurance

monitor and ensure that GSK products released onto the market meet quality specifications

Medical Information

provide information to health professionals and consumers in order to ensure the appropriate use of GSK products

Pharmacovigilance

capture adverse event and pregnancy data in order to monitor patient safety, expand product knowledge, and comply with corporate and legal obligations

Medical Affairs

provide medical support and scientific input into brand strategies in order to ensure successful commercialisation of GSK products

Sales

establish relationships with health care professionals and provide them with current information on GSK products

Marketing

manage and implement brand strategies in order to ensure successful commercialisation of GSK products