Global Medicines Development Transforming patients' lives

Global Medicines Development Transforming patients’ lives

Transforming patients’ lives 32 ©AstraZeneca 2015

This is an exciting period in the history of AstraZeneca. Our strategy and ability to transform our portfolio means we have a late stage pipeline that presents incredible opportunities to push the boundaries of science to deliver life- changing medicines.

In Global Medicines Development (GMD) we have a crucial role to play. Faced with complex disease challenges, we’re focused on exceptional performance to drive the best and most transformative drug programmes ever.

To achieve that, we need talented, committed people across our functions. We’re making a significant investment in helping them reach their full potential, building the extensive drug leadership capabilities and experience that could make a difference to millions of patients.

Focused on science

Exciting times

At AstraZeneca, we believe the best way we can help patients is to focus on breakthrough science. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines.

We invest in distinctive science in three main therapy areas where we can make the most meaningful difference: oncology; cardiovascular and metabolic disease; and respiratory, inflammation and autoimmunity.

As a global, innovation-driven pharmaceutical company that spans discovery, development, manufacturing, distribution and worldwide commercialisation, we are well placed to turn innovative modules into medicines that are life-changing. In GMD, we have a critical role to play.

Achieve scientific leadership by delivering the full potential of our unique combination of discovery and development strengths in small molecule and biologics, immunotherapies and protein engineering technologies.

Return to growth by focusing our expertise on key disease areas (respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; and oncology), prioritising drug projects and accelerating and simplifying our best programmes.

Be a great place to work by developing a culture that is science-led, patient focused, high-performing, vibrant and collaborative.

Across our organisation we are focused on the future, united by a clear strategy


In GMD, our mission is to transform innovative molecules into medicines that change lives. We are responsible for enabling the business to make critical pipeline and investment decisions, to ensure they select the right molecules to progress and to seize the right lifecycle management opportunities – generating the data required to drive regulatory submissions for new medicines and expanded indications and generating the evidence that shows their true value.

To do this, we work with our two biotech units – Innovative Medicines and Early Development (IMED) and MedImmune – and the Global Portfolio and Product Strategy (GPPS) organisation to understand where there is unmet medical need, to shape our therapy area strategies from early development through to commercialisation, and to identify the medicines we need to invent, develop and deliver to patients around the world.

They are counting on us. And with more complex scientific challenges than ever before, it means finding solutions from our own biotech laboratories and openly collaborating with partners to deliver the best science, and also along our GMD ‘four-step path’.

Our GMD capabilities in close-upAcross the world, patients rely on us to deliver. They need us to design and deliver perfect clinical trials, generate evidence to show the life-changing value of our medicines and ensure prescribers have the information they need to make the right treatment choice. We have built exceptional scientific and drug development capabilities within GMD to help us deliver.

Clinical trial design and implementationWe design smart programmes that give us clear evidence and data to answer the right questions and enable high-quality decision-making.

Statistical modelling and analysisWe take small amounts of study data and use computer modelling and simulation to predict what will happen in larger-scale studies. This informs trial design, dose decisions, go/no go decisions, in-licensing opportunities and ultimately enables us to develop better and safer medicines.

Translational patient safetyWe focus on getting patient safety input into preclinical projects to ensure the right safety assessment in early clinical trials.

Delivering large outcome trialsWe have developed world-leading capabilities in delivering extensive, multi-country, multi-site studies involving thousands of patients. To do this effectively and quickly, we often partner with academic research organisations and contract research organisations.

Delivering innovative drug formulations and devices, including intelligent pharmaceuticalsWe supply products for use in early toxicology studies and clinical trials through to developing the technology to ensure drugs can be scaled up for global manufacture. We also go further. We explore opportunities for ‘intelligent pharmaceuticals’ – going beyond the medicine to allow patients and healthcare professionals to track and manage chronic conditions using mobile phone and internet-based technology.

Payer evidenceWe provide the data, analysis and evidence to show the value of our medicines. Our work is driven by patient need and our early stage drug development work reflects this, ensuring we secure reimbursement and maintain patient access.

Programme and project managementWe apply our project management expertise to drive drug programmes, manage co-development partners and work with third parties.

External medical insightWe bring an outside view to our clinical development programmes, connecting our science with the needs of physicians and other healthcare professionals. We also support Investigator Sponsored Studies and other research programmes to generate evidence beyond our own clinical trials.

Regulatory affairsWe have therapy area regulatory expertise that supports regulatory interactions across the globe to secure fast submissions for our medicines in development.

Across the world patients rely on us. Our GMD structure is set up to deliver.

Global MedicinesDevelopment in focus

The four step path

Regulatory trials& approval

Reimbursementapproval

Medicine isprescribed

Patients takethe medicine


The design of efficient, effective and differentiated strategies and products – pharmaceutical development, clinical development, regulatory development and medical affairs – based upon data, facts, observations and customer insight.

We are creating an environment that is fit for the future. Putting science first allows creativity and ideas to flourish, teams to collaborate effectively and our people to be bold in their decision-making and take smart risks.

What science can do

We expect a lot from our people. They share a passion for science and putting the patient first. And they play to win, setting high standards and living up to them every day, making courageous choices and speaking the truth, even if that means giving hard feedback.

Above all, it’s an entrepreneurial environment. The challenges we face demand this. We have to be nimble, agile. And we have to continually question and push ourselves to be better for the benefit of millions of patients.

The capability and discipline to select only the right molecules and technology in which to invest.

To brilliantly deliver on our strategies and thereby delight our customers.

In GMD, we want to be perfect in three critical areas:

Transforming patients’ lives 7


Our global reachWe have made big strides to becoming a more agile, collaborative organisation. Our GMD team is around 5,000 people and our critical, core expertise sits at the heart of our vibrant scientific centres in the UK, Sweden and the US. It means we’re working even more closely with colleagues in our biotechs and commercial groups, driving faster decision-making and enabling the smoother transition of projects.

Global Medicines Development key locations

Boston Infection Oncology Neuroscience

Mölndal Respiratory Inflammation, NS & Autoimmunity CVMD

Alderley Park1 Oncology Inflammation, NS & Autoimmunity

Shanghai GMD China Clinical Operations

1.! Until end of 2016

1

CambridgeOncology

Inflammation NS & Autoimmunity

GMD locations

Gaithersburg Oncology

Respiratory Inflammation, NS & Autoimmunity

CVMD Infection

San Diego Ardea Biosciences Pearl Therapeutics

MacclesfieldPharm Dev

Regulatory Affairs & Patient Safety

Poland Clinical Operations

Osaka & Tokyo R&D Japan

Global Medicines Development key locations

Gothenburg

Cambridge

GaithersburgSan Diego

Boston

Macclesfield

Shanghai

Osaka & Tokyo

Alderley Park Poland

Our network of support sites in key locations enables us to remain focused on activities where co-location is less critical, for example, Pharmaceutical Development and Clinical Operations.

We also have a presence in Japan and China, ensuring a deep understanding of patients and local healthcare professionals in those locations, further enhancing our ability to do drug development in Asia for Asia.

uK – cambridgeIn 2013, AstraZeneca announced plans to move our uK research activities from our current home in Alderley Park, Cheshire to a new $500m facility in the centre of Cambridge. Our new facility at the Cambridge biomedical Campus will become the company’s largest centre for oncology research and a centre of excellence for pre-clinical research, medicinal chemistry and high-throughput screening.

Sweden – MölndalLocated just south of gothenburg, our strategic R&D centre in Mölndal is designed to inspire innovation. It’s the centre of our research for two of our iMed units – the therapy areas of cardiovascular/metabolic diseases and respiratory/inflammation/autoimmunity and the home to a large number of our scientists from our early phase discovery sciences unit and our drug safety and metabolism team.

uSA – Bostonboston is home to AstraZeneca’s small-molecule research in north America, with state-of-the-art laboratories in Waltham, just west of the city centre, and our neuroscience team in the heart of the city’s Technology square. Our boston-based scientists focus on the discovery and development of new medicines for the treatment of cancers, infectious disease and neurological disorders.

china – ShanghaiOur small-molecule research facility in China is located at the Zhangjiang high Tech Park in the Pudong area of shanghai. Our research teams here focus on discovering new drugs that meet the unique needs of patients in Asia. This includes cancers with a high prevalence in this part of the world, such as lung, liver and gastric cancer. We also have a dedicated translational science team, which works across therapy areas in support of global projects.

Our science centres

We are creating thriving, vibrant science centres at four locations around the world.

InTrODucIng IMED | PushIng ThE bOunDARIEs Of sCIEnCE

10





Our science centres



10





Our science centres



10

We’re working more closely with colleagues, driving faster decision-making and smoother transition of projects.

Clinical Operations Site Management and Monitoring

Argentina

Australia

Belgium

Brazil

Bulgaria

Canada

Chile

China

Colombia

Czech Republic

France

Germany

Hungary

India

Israel

Italy

Japan

Mexico

Netherlands

Peru

Philippines

Poland

Republic of Korea

Romania

Russia

Saudi Arabia

Slovakia

South Africa

Spain

Sweden

Taiwan

Thailand

Turkey

UK

Ukraine

United States of America

Vietnam

10 ©AstraZeneca 2015

Our operating model is focused on achieving this. We work closely with IMED and MedImmune to shape our therapy area strategies, operating as disease area franchises to deliver the right medicines. And we have joined forces with the Global Portfolio and Product Strategy (GPPS) organisation to further enhance this.

Our Global Medicine Leaders are responsible for ensuring the successful development and commercialisation of each of our drug projects, and through them we are focused on making a difference in how we approach increasingly competitive and challenging markets. They lead our Global Product Teams who work cross functionally

to gather expertise and knowledge that informs our drug development programmes. They are ultimately responsible for ensuring the pieces fit together to deliver for patients and physicians.

Our governance framework features three formal product committees that make major investment and progression decisions:

Late Stage Product Committee is responsible for late development and lifecycle governance. The committee is co-chaired by the EVP Global Medicines Development and Chief Medical Officer, and the EVP for Global Portfolio and Product Strategy

(GPPS). The Chief Executive Officer and the Chief Financial Officer are both core members of the LSPC.

MedImmune Early Stage Product Committee is chaired by the EVP MedImmune, and responsible for large molecules governance to Proof of Concept (POC).

Innovative Medicines and Early Development (IMED) Early Stage Product Committee is chaired by the EVP Innovative Medicines & Early Development and responsible for small molecules governance to POC.

With the transformation of our late stage pipeline, we have an incredible number of opportunities. Now, more than ever, it’s critical that we deliver exceptional performance and drive the best and most transformative programmes for every drug project.

Our operatingmodel

GLOBAL MEDICINE LEADER

Medical Science Director

Commercial Lead

Payer Lead

Legal, Finance & IP Leads

CMCSub-team

Lead

Regulatory Lead

Global Products Manager

Director Clinical

Development

Clinical S

ub-team

Sub-

team

s

Commercial Sub-team

Pay

er S

ub-t

eam

Regulatory Sub-team

CMC

TranslationalSub-team

Sub-team



Our Global Medicines Development Units (GMeds) design, develop and deliver clinical trial programmes designed to answer the right questions.

There are six:

• Cardiovascular & Metabolic Diseases

• Respiratory

• Oncology

• Immuno-Oncology

• Inflammation, Autoimmunity& Neuroscience

• Infection

GMeds in focus

Each GMed steers the successful development of their products through the Global Product Teams. Working closely with IMED, MedImmune and the Global Portfolio and Product Strategy (GPPS) organisation, they drive a robust long-term strategy for respective therapy areas and portfolios.

Each GMed is home to a wealth of medical, scientific and technical expertise. We are committed to creating an environment that is driven by science, enabling our people to forge connections across GMD and AstraZeneca that drives a world-class pipeline to benefit patients everywhere.

Our six GMeds drive our drug projects:

Cardiovascular & Metabolic Disease

InfectionOncology

Our Global Medicines Development Units (GMeds) design, develop and deliver clinical trial programmes designed to answer the right questions.

Global Medicines Development Units (GMeds)

Inflammation, Autoimmunity and

Neuroscience

Immuno-OncologyRespiratory

CVMD GMed

TA ClinicalGlobal Products

Medical Science DirectorsStrategy & Operations

Respiratory GMed TA Clinical

Global ProductsMedical Communications

ScienceStrategy & Operations

Oncology & New Opps GMed


GMD ChinaStrategy & Operations

Inflammation, Autoimmunity and

Neuroscience TA Clinical

Global ProductsMedical Communications

ScienceStrategy & Operations

Infection GMed



GLOBAL MEDICINES DEVELOPMENT UNITS (GMEDS)

Immuno-Oncology GMed





StrategicEnablement

Site Management & Monitoring

EMEAAsia

Americas

Study Management & Operations Hubs

ShanghaiWarsawMölndal

Clinical Operations Therapy Areas

CVMDOncology / Infection

Inflammation / Neuroscience /

Respiratory

DataManagement

GLOBAL CLINICAL

OPERATIONS

GMD Clinical Operations

We deliver global clinical trials for late-stage projects recruiting many thousands of patients every year in countries across the world, using our expertise and partnering with external Contract Research Organisations. We are focused on continuous improvement, striving to produce high-quality data as quickly as possible.

What we do

Working across therapy areas, we focus on driving quality in clinical programme delivery through world-class programme management, high-quality clinical strategy development and therapy area knowledge.

Our central clinical trials are managed from Sweden, China, and Poland. In addition, we have a small US hub.

Our Site Management and Monitoring team (SM&M) organisation work across about 40 countries, managing and monitoring activities to protect patients, support investigators and ensure high-quality data is delivered.

Strategic enablement drives the delivery of Business Process Excellence and Technology, owning and providing industry leading process, standards and technology on behalf of Clinical Operations and our partners.

Data management (DM) provides industry leading DM capability to ensure the effective, timely delivery of quality data from our trials.

We focus on driving quality in clinical programme delivery.



GLOBAL REGULATORY AFFAIRS, PATIENT SAFETY

& QUALITY ASSURANCE

Regulatory Therapy Areas

Respiratory & Inflammation

Infection/VaccinesOncologyCVMD &

Neuroscience

Patient Safety Therapy Areas

Respiratory & Inflammation

Infection/VaccinesOncologyCVMD &

Neuroscience

Regions

US Europe & Emerging Markets Regulatory

Chemistry, Manufacturing

& Controls(CMC)

Delivery & Enablement

QualityAssurance

We are structured around our key capabilities:

• Regulatory Therapy Areas, Regions and RegulatoryChemistry, Manufacturing and Controls (CMC)

• Delivery and Enablement

• Patient Safety Therapy Areas

• Quality Assurance

How we work

We provide all these services across AstraZeneca and MedImmune, offering:

• Global strategic regulatory input tosupport our regulatory submissionsto secure approvals in countriesaround the world for our medicinesin development

• Pharmacovigilance expertise,processes and tools to ensure thewell-being of patients involved inclinical trials and in ensuring the on-going safety of our medicines oncethey are approved

• Strategic safety and QA (Good Clinical Practice, GCP) and Good Laboratory Practice, GLP) support to inform disease area and programme design and prioritisation

• Integrated, ongoing assessment andcommunication of emerging productsafety profile

• Guidance on global regulations andbrokering proactive policy discussionswith relevant regulatory authorities

• Electrocardiogram Centresupport of Early ClinicalDevelopment organisation

• Advisory Committee planningand logistics

• Activities to ensure we maintainregulatory compliance by interactingwith health authorities and supportingregulatory inspections

• Maintenance of our proceduralframework across all science units,so everyone is clear on how we goabout our clinical, regulatory andpharmacovigilance activities

We are focused on making a meaningful difference to patient health through the development, quality assurance, registration and safety surveillance of our medicines across their life-cycle.

Global Regulatory Affairs, Patient Safety and Quality Assurance



How we work

What we do

• All CMC (Chemistry, Manufacturing,Control) activities required to delivera rapid evaluation to achieve asafe test in man and building thefoundation for medicines development

• Portfolio and Project Management

• Design and development of drugsubstance route & processes fornew molecular entities (NMEs)

• Efficient and timely supply of materialsfor toxicology and clinical studies

• Design and delivery of formulations,devices, packaging, analyticalmethods and specifications forNMEs and line extensions

• Partner with Biotech units to identifyopportunities and facilitate thenomination of high quality CandidateDrugs (CDs)

• Deliver documentation that supportsour product submissions and meetscustomer needs

• Provide technical oversight tosupport our products when theyare out in the market

• Demand management, planningand managing the delivery of drugsubstance, drug product, packaging,distribution and comparators toclinical trials

• Management of internal productioncapability and external sourcing

• Intelligent Pharmaceuticals –the integration of medicines withintelligent devices and IT to deliverthe knowledge that will help patientsand physicians manage disease

• Predictive Science with the long-termvision to be fully embedded in alldrug projects

• Protecting innovation by securingIntellectual Property

PharmaceuticalDevelopment

We’re the bridge that turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.

PHARMACEUTICAL DEVELOPMENT

Product Development

Chemical Development

R&D Supply Chain

PharmaceuticalInnovation

Projects & Portfolio

Management

Quality Assurance & Compliance



To help patients, healthcare professionals need knowledge and confidence that the medicines they prescribe will make a real difference. We deliver evidence to payers, regulators, healthcare providers, policy makers and patients that demonstrate the value of our medicines.

What we do

GPEP drive worldwide patient access to AstraZeneca medicines through pricing and payer evidence strategies that deliver value, and by being indispensable strategic partners, market access solutions providers, portfolio optimisers and payer evidence leaders.

We deliver payer and evidence strategies from early phase development through commercialisation and are responsible for generating market access solutions that support our Marketing Companies in achieving market access and reimbursement for our products.

Through the Payer Excellence (PEX) Academy we help our Marketing Companies achieve excellence in their work with payers. Payer “How-to-Guides” in key areas such as pricing and localising value stories, coupled with checklists and on-line learning are available to everyone in AstraZeneca, and we work directly with Marketing Companies to respond to live market access challenges.

Payer analytics and quantitative analysis are critical to our ability to secure reimbursement and pricing. Our Health Economists and Patient Reported Outcomes (PRO) experts help payers understand the value demonstrated in our clinical trial programmes such as cost of care, patient experience and health outcomes.

Our skill sets and capabilities include

• Leading cross functional Payer Teamsto shape commercial strategy anddeliver strategic pricing

• Portfolio optimisers: ensuring thatpayer needs are fully understoodand considered when investmentdecisions are made – be they indevelopment or acquisitions

• Payer evidence leaders: influencingthe development of evidence, ensuringthe needs of payers are discussed,considered and addressed

• Payer insight providers: via primaryand secondary research as well aspayer advisory boards

• Market Access Launch ExcellenceLeads delivering MA Launch

strategies, Global Reimbursement Dossiers, Global Value Packs, Global Pricing Strategies and contracting toolboxes

• Development and implementationof clinical outcome assessments,including PROs in clinical programmes

• Expert advisors, including economicand PRO representation to payer andregulatory authorities, plus modellingand predictive reimbursement analysis

Health Economics

& Outcomes Research

GPEP Operations

Global Price & Reimbursement

CVMDRespiratory & Inflammation

OncologyAutoimmune/

Neuroscience & Infection

Strategic Pricing Unit

GLOBAL PAYER EVIDENCE

AND PRICING

Global Payer Evidence and Pricing



What we do

We’re champions of excellence in clinical trial design and interpretation. We use expertise in model-based drug development, real world evidence, health technology assessment, safety science and personalised healthcare and biomarkers with high quality analytics to deliver objective design and decision-making criteria, spelling out any uncertainty.

We are driving the adoption of clinical information standards across our drug programmes to enhance our ability to exploit information – both practically and creatively – across studies, projects and therapy areas.

We champion the standardisation of information, quality and integrity in everything we do.

Our skill sets and capabilities:

• Statistics

• Design and Interpretation (D&I)

• Programming/analytics

• Informatics

• Standardisation expertise

• Information expertise

• Visualisation, structured dataexploration and modelling

Biometrics and Information Sciences is a key contributor to several capability build and improvement projects:

• Design and Interpretation

• Clinical Information Infrastructure(iCare)

• An New Global Electronic Library(ANGEL)

• Analysis and Reporting Technology

• Model Based Drug Development

• Real World Evidence

We’re focused on getting results for patients. Our statistical, programming and information experts seek to answer drug development objectives and reduce uncertainty in product development, driving better decisions for AstraZeneca.

Biometrics and Information Sciences

BIOMETRICS AND INFORMATION

SCIENCE

B&I Therapy Areas

InfectionOncology

Inflammation, Neuroscience & Respiratory

CVMD

Programming

Clinical Transparency

Task Force

InformationPractice

Alliance and

Business Office

Advanced Analytics Centre



Global Medical Affairs

In Global Medical Affairs, we’re focused on generating and sharing evidence that inspires confidence in the use of our medicines amongst healthcare professionals and patients.

We operate in a complex environment which requires a bold way of thinking. There are three elements at the heart of how we operate:

1. As we strive for scientificleadership, medical affairs-led external collaborations,engagement and scientificinteractions across the AstraZenecamedical network worldwide arecritical. The insight we bring backinto the organisation providesfocus, empowers decision-makingand enables us to better supporthealthcare professionals and thepatients they care for.

2. Patients influence everything wedo. Listening to them and using theinsight we gain shapes decision-making across our business.

3. To deliver for patients, we needthe best people. We invest in ourmedical infrastructure and trainingto ensure our medical knowledgeremains ahead of the curve.

Global Therapy Area Medical AffairsThe Global Therapy Area Medical Affairs Team is made up of Therapy Area VPs (TAVPs), Medical Affairs Leads (MALs) and other supporting roles, who together are accountable for delivering iMAPs – the Integrated Medical Affairs Plans that summarise medical strategies and plans for each product across the global medical network.

Evidence Generation Group (EvGen)The EvGen Group leads the development of all additional evidence that supports the use of our products and addresses the needs of healthcare professionals. The Group’s remit includes non-indication seeking interventional trials, observational research, real world evidence and Externally Sponsored Research (ESR), as well as having oversight for Patient Support Programmes, Expanded Access and Compassionate Use.

Medical ExcellenceIn addition to core medical platforms and training initiatives such as the Medical Academy and Global Medical Information Platform, we’ve further built on our offering to incorporate the centralised Publications Team and a new Medical Standards Team. We are also enhancing medical capabilities, infrastructure and training for our global Medical Network.

Patient Centricity (PaCe)Our new PaCe Team reflects our ambition to put the patient at the heart of everything we do. This cross-functional approach includes a long-term collaboration with PatientsLikeMe. This enables us to partner with a network of patients to gain insight and generate evidence that positively impacts our research and development decision-making. Our PaCe work will also include building a simplified patient-centric infrastructure within GMD, and connecting our organisation cross-functionally to share patient-centric best practice.

Medical Affairs Council (MAC)We are actively focused on building strong connections between our global and local capabilities. The MAC unites Medical Directors from key markets and regions with the GMA Lead Team and provides leadership for medical strategy, governance, talent management, resource prioritisation and best practices across the world.

Evidence Generation

Externally Sponsored Scientific Research Operations

Real World EvidencePhase IIIb/IV

Clinical Trial and Compassionate

UseGlobal

Medical Affairs Therapy Areas

OncologyCVMDBrilinta

Respiratory/Inflammation/Autoimmune

Infection/Neuroscience/ GI

Strategy & Planning

Medical ExcellencePublications

Global Medical PlatformsMedical AcademyMSL Excellence

Medical/Business CapabilityQSCR / Nominated

Signatories

GLOBAL MEDICAL AFFAIRS

Patient Centricity



R&DJAPAN

Therapy AreasCVMD (GI)Oncology

Immuno-oncologyRespiratory & InflammationNeuroscience & Infection

(New Opps)

Clinical Science

Project & Business

Management

ClinicalOperations

Regulatory

R&D JapanR&D Japan delivers AstraZeneca’s pipeline in Japan with speed and quality and ensures lifecycle management and growth of our already-launched brands to maximise the value of our medicines for patients in Japan and to our business.

What we do

We cover drug development at all stages from early clinical development through to lifecycle management in collaboration with our global Science Units by ensuring that Japan’s medical, regulatory and business needs and insights are incorporated in the development strategies and programmes early on.

We drive drug development across biologics and small molecules across therapeutic areas.

We support AstraZeneca’s external alliances and partnering activities in Japan to help access innovative science and potential assets in Japan for our global organisation.

We work in alignment with the Japan commercial organisation (AZKK) business to maximise brands by co-developing brand strategies and to make AstraZeneca the most attractive partner for other companies.

R&D Japan is also the base for some of the team members working in our first global GPT in Asia – Iressa – so we can benefit from the insights of Asian patients and healthcare professionals in driving forward Iressa’s development strategy.

Our skill sets and capabilities:

Five Therapeutic Area (TA) Leads Oncology, Immuno-oncology, Cardiovascular & Metabolic Diseases (GI), Respiratory & Inflammation, and Neuroscience & Infection (New Opportunities)

Project & Business Management Project Managers/Directors, Business Management Office (Capacity Management, Opal Team, KPIs, Internal Communications)

Clinical ScienceTA Physicians (Clinical Science Directors), Project/Study Physicians, Clinical Research Scientists, Statisticians, Programmers, Medical Communications Scientists, Publication Managers, Toxicologists, Pharmacologists, Pharmacokineticists, Pharmacometricians, Externalisation, Translational Science/Personalised Healthcare & Biomarkers

Clinical OperationsTA Clinical Development Directors, Clinical Development Leaders, Study Leaders, Clinical Development Associates, Site Management & Monitoring (Clinical Research Monitors), Strategic Enablement (Process/Vendor/System Management, Training)

RegulatoryTA Regulatory Affairs Directors, Japan Regulatory Leads, Regulatory External Relations, Regulatory CMC (Development, Maintenance, Investigational Product), Regulatory Compliance, Regulatory Policy &Intelligence, Translation/Interpreting, Patient Safety (Safety Science, Case Handling, Process Management, Safety Physicians)


We can benefit from the insights of Asian patients and healthcare professionals.


GMD China GMD OperationsGMD China’s vision is to become a centre of excellence with end-to-end development capability to lead and drive new medicine development in China for China, the region, and globally to serve patients in need.

We provide best-in-class, cost effective enabling support to all teams within Global Medicines Development (GMD), and in many cases the wider Science Units.

What we do

We unite unique development capabilities and talents to support the realisation of AstraZeneca’s mission and ambition in China.

We are accountable to China and global governance bodies to deliver AstraZeneca’s portfolio value with quality and speed in China, including small molecules, biologics and lifecycle management of AstraZeneca assets.

Our Value proposition

We will speed up medicine development in China and reduce the time gap between first market approval and approval in China. We are building acapability to lead and drive medicine development, in China for China, Asia Pacific and for global. We will be a lynchpin and a catalyst uniting all functions in China to lead and drive the medicine development in China. We will be a key force to enhance AstraZeneca’s scientific leadership in China.

Our skill sets and capabilities

• Three strategic Clinical Science TAs(Cardiovascular/Metabolic Diseases,Oncology, Respiratory/Inflammation+ Others)

• Biometrics and Information Sciences

• Portfolio Project Management andOperation & Planning

Cardiovascular and Metabolic Disease

Oncology

Business Support OfficeProvides regular business maintenance activities including administrative services, information management and communications support.

Business Management OfficeAccountable for the Business Management processes across GMD, driving effective business decision-making. It includes Capacity Planning, GMD Strategy facilitation and performance monitoring; benefit case tracking, and change management. The GMD Business Information Analysis group sits in this Office.

External Interface OrganisationResponsible for the interface with external parties and protecting corporate integrity under relevant external legislation. Includes Chief Medical Office, Science Unit Transparency & Reporting group (SUTAR) and the Global Conference Team.

OPAL OfficeProject Management Analysts and other OPAL experts comprise the OPAL office, that we use to support our forecasting and resource planning, with the vision to make the system and tools easier and simpler to use for the business

user community across GMD and the Science Units we support.

Education & LearningWork in partnership with GMD to define strategic capability needs and implement effective education and learning solutions to achieve business goals.

We have five centres of excellence

Three strategic Clinical Science therapy areas

Respiratory/Inflammation

Others

GMDOPERATIONS

External Interface

Office

Business Management

Office

Business Management

Support

Education & Learning

Opal

Lead and drive medical development in China, for China.


Across our business, we’re focused on turning ground-breaking science into life-changing medicines for our patients. To do that we need the best people operating in an environment that is agile and driven by a relentless focus on improvement.

This is Global Medicines Development

GMD Business Partners

HRFinance

CommunicationsLegal / IP

RDI ComplianceProcurementExecutive Vice President

Global Medicines Development

Chief Medical Officer AstraZeneca and

MedImmune

Global Payer Evidence &

Pricing

Immuno-Oncology

GMed

RespiratoryGMed

IA&NS GMed

CVMDGMed

GMD China

GMD Operations

R&DJapan

Pharmaceutical Development

Biometrics & Information Sciences

GMD Clinical Operations

Global Medical Affairs

GRAPSQA

Oncology GMed

Infection GMed


www.astrazeneca.com

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Global Medicines Development Transforming patients' lives