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TRANSCRIPT
Dono Widiatmoko
How Pharmaceutical Industries Contributes to Society
Our State of the World
Health Determinants
# World’s Population
Density – Distribution – Growth – Dynamics
http://www.worldometers.info
World’s Population, 7 November 2011
>7 Billion People
World’s most populous nation
Ageing Scottish Population Structure
The Health and Well-Being of Older People in Scotland, 2000
Population Adjusted World Map (2002)
Wealth (GDP) Adjusted World Map (2002)
# Ensuring survivability of the world’s population
13
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Global Health Problems (1)
Global population in 2050 estimated by
9.200.000.000 It is estimated more than 2 billion seniors in 2050
At least 80% of seniors have one or more chronic diseases (examples : COPD, Cancers, Diabetes, Alzheimers, Cardiovascular Disease, Stroke, etc)
Chronic diseases cause 60% of deaths & adding up to 75% of healthcare costs
Global Health Problems (2)
Nearly 1 in 5 child deaths is caused by diarrhea
Seasonal flu causes more than 250.000 death each year
Non communicable disease causes serious damage to global health status around the world
And socio-behavioural illness are emerging into one cautious phenomenon
While communicable diseases are still threatening in some developing countries
To live longer • Avoid preventable death • Increase life expectancy
To live Better • Living healthier life • Living more productively • Enjoy happier life
What We Do
Innovate Medical Progress
“biopharmaceutical innovation has led to accelerated progress in the fight against many diseases”
Advancing medical process through Innovation, that aims for :
• Increased Life Expectancy • Decreased Disability • Optimizing Quality of Life • Caring rare disorders • Best treatment with minimum impairment
Developing new medicines: a risky business
It takes 8–12 years of research and clinical development efforts
Investments of up to USD 2bn are needed to bring one new molecule to the market (including all the costs of the failed compounds)
Only one out of 10 000 originally synthesized compounds will become a commercially available drug
Out of 20 years of patent lifetime, usually only 8–12 years remain to recoup the investment
Less than 50% of drugs are profitable
Making a difference
Cataracts impaired Maria Lúcia Martins Moreira’s vision
Surgery, performed using advanced drug & equipment at a clinic in Sao Paulo, Brazil has since solved this eyesight problem
Special Olympian Ryan Groves from Michigan in the US, has tuberous sclerosis and suffers from kidney tumors and mild autism
He takes a drug that helps reduce tumors
Build Partnership in Leveraging Better Healthcare System
Biopharmaceutical Industries has started several Partnership with Government, Non-Government, Private, Medical Association, Patient Group, etc. to accommodate one another goals such as :
To Address health system infrastructure
Increasing availability of treatments
Preventing the spread of communicable diseases and non communicable diseases
Developing new treatments for diseases of the developing cuntries
Characteristics of Pharma Providers in Indonesia
Indonesian Manufacturers • Mainly produce out of patent / generic products, OTC,
Fitofarmaka
• Some companies have started their quest of developing R&D and new product compounds
MNCs • Mainly expand through research-based innovative medicines • Older, proven established medicines are still keeping some
market • Research are essential, although driven through global
initiative
The Role of MNCs in Indonesia Pharma Market
Provide innovative medicine solutions
Drive services to patients with rare and serious (specialty) diseases not adequately covered by older medicines
Continue to provide quality products through current established product portfolio
Drive higher integrity, compliance, and business ethics in commercial operations
How Pharma Companies acquire new product pipelines
In House R&D: • Expensive, but are focused on company’s target research area • Networked global research ensure collaboration and synergy
Products acquisition from other Pharma or BioTech Startups • Shortcut to enrich products portfolio, often driven by own
company strategy
Contracted out (Contract Research Organization) • More efficient, target oriented, and simpler to maintain
Clinical Research in Indonesia
Huge potential due to population size, characteristics, and diseases involved
Currently very limited to very few centers due to infrastructure, human resource, and lack of political drive limitations
Relies on government, and international organization budget support – less from commercial organization
Research is embedded into university education, but publication of research results are still low
Incentive to participate in global research
Contribute to global health improvement
Exchange of cutting edge information with global institutions and experts
Support local expertise in biotechnology research, avoid brain drain
Improving global perception to Indonesia’s education and R&D status
Improving quality standards for research sites in hospitals and academic institutions
Provide opportunities to increase academic sector involvement in R&D – multiplier effect, including quantity and quality of academic papers published.
Hurdles and challenges to Global Collaboration with Indonesia
MTA (Material Transfer Agreement) is perceived as a big barrier to do more clinical studies in Indonesia
The need for qualified clinical research associates to monitor the studies and trained investigators
Large gaps between academic centers in Indonesia
Perceived complications of regulatory and ethics committee review to compete with countries like Korea, Singapore
Transfer of Technology
Transferring advance technology is essential for economic development
Technology transfer has the potential to help improve health
It enables low to middle income countries can accelerate the acquisition of knowledges, experiences, and equipment related to advanced, innovative industrial products and processes
Also benefiting overall economy by increasing the reliability of supply, decrease reliance on imports, and increasing the competence of local workforce
Environment of the Pharma Industry
Pharmaceutical companies operates in a challenging environment as they interact with various stakeholder in a highly regulated market.
Employees Patients
Private Sector
Governments Organizations Physicians
Health Issues
Shareholders
Conclusion
Keep the Discovering & Innovating for new science
Change the way we diagnose and prevent diseases
Continuously Increase Disease Awareness
Thank you for your attention
Novartis Biocamp Roadshow Surabaya, 18th April 2016
Career in Biotechnology Industry
“Biotechnology, often referred to as “biotech,” is the application of biological research techniques to create new
processes and products while using biological systems, living organisms, and/or derivatives of organisms.”
Although biotech processes have been used for thousands of years, scientists began to use components of microorganisms to solve human problems within spheres such as agriculture, medicine/healthcare, food processing and industry in the 1970s
Consideration Questions Before Starting Career at Pharma/Biotech Industry
“Do I like thinking about living things?”
“What sectors of the economy can I see myself operating in?”
As you think about a career in biotechnology, it can be useful to identify the general areas where your aptitude and interests lie
Overview of Pharma/Biotech from Product Cycle Prespective
Communications Quality
Clinical Research Operations
Research & Development
Marketing Legal
Compliance
Finance
Regulatory
Government Affairs Human Resources Information Technology
Market Research
Account Management
Medical Affairs Business Development Health Economics Sales
Roles & Positions in Pharma/Biotech
RESEARCH POSITIONS
Research positions deal with the process of drug discovery and testing.
The entry-level job title in most pharmaceutical companies is lab technician. The work can be somewhat tedious, but a lab tech position can be an excellent way into the industry
Some examples of Research Positions Are :
LAB TECHNICIAN Lab techs perform the routine maintenance tasks- cleaning and maintaining glassware, working with animal colonies, operating lab equipment, and so on-that are needed to keep labs functioning
RESEARCH ASSOCIATE A degree in biochemistry or a related discipline and experience working in a lab are typically required to land this job. Associates work at the bench, conducting experiments under the guidance of scientists. If you're coming out of school with some lab experience but no PhD and you want to work in R&D, this is the job for you
RESEARCH SCIENTIST A scientist can get a job as a research scientist (sometimes the initial title is "associate scientist"), designing and conducting experiments and writing up results for publication when appropriate.
RESEARCH POSITIONS
CLINICAL DEVELOPMENT & MEDICAL
CLINICAL DEVELOPMENT AND MEDICAL
Clinical development offers several career options, A variety of medical and scientific specialists at pharma companies perform the numerous studies required to take clinical compounds from the lab bench to the pharmacy shelf and ends up into regulatory documents for Drug Approval
Some of Medical Function are responsible for building product's clinical development plan, creating that lays out & guidelines of the studies a company intends to perform.
also write or contribute to clinical trial protocols, the instructions for an investigator describing the objectives, design, and methodology of a clinical trial
If you work in clinical development within Big Pharma, interacting with CROs will be an important part of the job
CLINICAL RESEARCH Clinical Research develop and implement plans for ushering experimental drugs through preapproval clinical trials. They get involved in designing protocols, enlisting physician investigators, training clinic personnel, and evaluating data. The job can require travel, sometimes as much as 80 percent of the time
REGULATORY AFFAIRS Regulatory affairs specialists complete the paperwork required by regulatory agencies worldwide and communicate directly with the agencies to ask questions and resolve issues. Depending on their level of industry experience, they may also set regulatory strategy for a pharma company.
BIO STATISTICIAN Statisticians in clinical development prepare analysis plans for clinical studies, design tables and figures that display information clearly, interpret final study data, and write the statistical sections of clinical study reports.
CLINICAL DATA MANAGER Clinical data managers supervise all aspects of clinical data. They specify how metrics will be collected and assist in standardizing data management procedures for internal operations and external reporting
Examples of Roles
CLINICAL DEVELOPMENT AND MEDICAL
MEDICAL SCIENCE LIAISON Medical Science Liasons (MSLs) are field-based MDs, PhDs, or PharmDs with therapeutic area specialties. They interact with physicians and scientists in the health care community-especially those doing prominent academic research-to maximize the acceptance and proper use of company products
MEDICAL ADVISOR Medical Advisor are MDs and/or PhDs or PharmDs that responsible for drawing up a particular product's overall clinical development plan, which is a strategic and tactical document that lays out the studies a company intends to perform before it applies for marketing approval
Examples of Roles
CLINICAL DEVELOPMENT AND MEDICAL
MANUFACTURING & QUALITY ASSURANCE
MANUFACTURING AND QUALITY ASSURANCE
Roles include designing the manufacturing processes for drugs, ensuring the integrity of finished product, creating product packaging, and planning specialized workspaces
One area that gets a lot of attention in pharmaceuticals is called quality assurance and control, often shortened to QA/QC. Quality experts ensure that medicines are manufactured and studied in compliance with federal standards
Like scientists on the pure research side, many employees in manufacturing and QA/QC encounter a dual ladder in Big Pharma. Engineers and scientists can get promoted doing technical work or, if they have the aptitude and inclination, can shift over and become part of the management team that coordinates the work of the technical team
PROCESS ENGINEER In most cases, process engineers work on project teams with more senior engineers. Job responsibilities may include designing chemical or biological methods for mass-producing compounds, designing equipment, and designing and overseeing the construction of various elements of manufacturing plants from pilot to commercial scale
QUALITY CONTROL ANALYST Quality Control (QC) analysts are responsible for the biological and chemical evaluation of products, materials, and facilities. They perform assays and establish and write specifications and standard operating procedures
QUALITY ASSURANCE SPECIALIST Quality assurance (QA) specialists ensure that a company's testing, reporting, and manufacturing are in compliance with regulatory requirements. They conduct site audits and review and analyze data and documentation
MANUFACTURING AND QUALITY ASSURANCE
BUSINESS OPERATIONS
Business operations encompasses the diverse array of commercially oriented positions within a pharma company, plus the standard corporate positions in areas such as Finance, Legal, Compliances, HR, and purchasing
MARKET RESEARCH ANALYST Market research analysts collect and analyze data to support the marketing of medicines during every stage of the product life cycle, including pre-launch, launch, and when the products become established. They design and conduct market research studies, analyze accumulated data, and communicate findings to management to support business recommendations
BUSINESS OPERATIONS
ASSOCIATE PRODUCT MANAGER/PRODUCT EXECUTIVE primarily responsible for coordinating and implementing campaigns for specific drugs, audiences, or both. This involves a little strategy and a lot of execution-things like developing collateral pieces, working as a liaison to advertising agencies, and establishing a company presence at conventions
PRODUCT MANAGER This job requires managing a team of people and working to determine price, distribution, brand image, forecasting, and overall strategy for one or more drugs. On a micro level, the job can be claustrophobic:
Imagine spending 13 months of six-day weeks learning every aspect of a single drug, then having the company decide that it would be best simply to let the product die
STRATEGY DIRECTOR Strategy directors develop plans for maximizing the commercial potential of a particular product or therapeutic area. They perform quantitative and qualitative analyses of disease and treatments trends, as well as assess opportunities for expanding market share and competitive positioning. These individuals typically work closely with colleagues in marketing analytics, business development, and finance
BUSINESS OPERATIONS
BUSINESS DEVELOPMENT MANAGER Employees in business development evaluate new business opportunities aligned with a pharma company's therapeutic product divisions and strategic goals. They examine in- and out-licensing opportunities, collaborative development deals, and joint ventures.
SALES JOBS Sales reps are categorized according to the particular customer base they serve : primary care physicians (PCPs), specialty physicians, hospital physicians, and managed care companies. Some sales reps visit pharmacies as well. From their expertise & experiences, sales jobs can be defined into two main roles:
• Field reps service territories that are typically defined by specialty and geography, and operate under a prescribed call cycle that determines how often they visit doctors in their territory
• District/Area managers usually are in charge of 10 to 14 field reps, hiring, training, and supervising them; regional managers oversee the district managers. Some sales positions require extensive travel; others don't. Virtually all positions come with generous perks such as a company car, computer, and expense account, plus attractive bonuses based on sales.
BUSINESS OPERATIONS
HUMAN RESOURCES
INFORMATION TECHNOLOGY
PROCUREMENTS
FINANCE
TRAINING
LEGAL
SUPPLY & DISTRIBUTION
BUSINESS OPERATIONS
ADMINISTRATIVE FUNCTIONS
COMPLIANCES
GOVERNMENT AFFAIRS
COMMUNICATIONS
GENERAL MANAGEMENT
Thank you for your attention
Dono Widiatmoko Country Government Affairs, Market Access and Communication Head, Novartis Indonesia