This document discusses Amgen's strategy of innovating beyond molecules in biopharma. It provides examples of Amgen innovating drug delivery systems and digital health tools to better meet patient needs. Specifically, it describes how Neulasta evolved from daily injections to an on-body injector and companion app. The document argues an ecosystem is needed where patients can access and adhere to therapies to achieve full benefits, and healthcare systems cover costs given confirmed outcomes.
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Ajaz Hussain
Design is to do good not just be and look good. "Design means being good, not just looking good." ~ Clement Mok. "A small change at the beginning of the design process defines an entirely different product at the end." ~ Jonathan Ive. "User-centered design means understanding what your users need, how they think, and how they behave - and incorporating that understanding into every aspect of your process." ~ Jesse James Garrett.
Compared to “one factor at a time” experiments, increased experimental efficiency, accounting interactions, multivariate predictive capability, minimization, maximization, optimization, graphical illustration for enhanced communication of complex topics.
"Design is intelligence made visible." -- Alina Wheeler
Equivalence Assessment and Maturity of Quality Management SystemsAjaz Hussain
Challenge: As a system or cohort, we can do more to adequately appreciate that “systems” proficiency is a stage in adult development that most struggle to achieve.
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004Ajaz Hussain
Each section within P2 can have an impact on the other P2 sections and similarly other sections of a submission and to CGMP’s By recognizing this as a complex design system that involves multiple attributes, goals, constraints, multidisciplinary design teams (subsystems), different degrees of uncertainty, risk tolerance, etc., we wish to find opportunities to identify robust designs and design space that provides a sound basis for risk assessment and mitigation
Repurposing in the Chaos of 2020 and Validity of Scientific EvidenceAjaz Hussain
Having been focused on manufacturing challenges for most of 2020, taking a time out to think about how best to garner "new prior knowledge" needed to facilitate development of evidence for repurposing option for the SARS-COV-2 cases and COVID-19 disease.
Strengthening the National System for Excipient Risk Mitigation Ajaz Hussain
Today the assurance of continual supply, authenticity, quality, and functionality of pharmaceutical materials active and so-called "inactive" excipients is at risk that needs to be mitigated. This presentation seeks to bring attention to the prevalent "inactive" mindset that is so difficult to change. At the precipice, we do change. Are we there yet?
Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...Ajaz Hussain
Self-authorship bridging the Academia to Industry (A2I) Gap. The challenge in our systems asking why signifies ignorance. Perhaps until a correction is needed. But after corrective and preventive actions (CAPA) often nothing changes. Errors reoccur and we acquire an “immunity to change.”
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Ajaz Hussain
Design is to do good not just be and look good. "Design means being good, not just looking good." ~ Clement Mok. "A small change at the beginning of the design process defines an entirely different product at the end." ~ Jonathan Ive. "User-centered design means understanding what your users need, how they think, and how they behave - and incorporating that understanding into every aspect of your process." ~ Jesse James Garrett.
Compared to “one factor at a time” experiments, increased experimental efficiency, accounting interactions, multivariate predictive capability, minimization, maximization, optimization, graphical illustration for enhanced communication of complex topics.
"Design is intelligence made visible." -- Alina Wheeler
Equivalence Assessment and Maturity of Quality Management SystemsAjaz Hussain
Challenge: As a system or cohort, we can do more to adequately appreciate that “systems” proficiency is a stage in adult development that most struggle to achieve.
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004Ajaz Hussain
Each section within P2 can have an impact on the other P2 sections and similarly other sections of a submission and to CGMP’s By recognizing this as a complex design system that involves multiple attributes, goals, constraints, multidisciplinary design teams (subsystems), different degrees of uncertainty, risk tolerance, etc., we wish to find opportunities to identify robust designs and design space that provides a sound basis for risk assessment and mitigation
Repurposing in the Chaos of 2020 and Validity of Scientific EvidenceAjaz Hussain
Having been focused on manufacturing challenges for most of 2020, taking a time out to think about how best to garner "new prior knowledge" needed to facilitate development of evidence for repurposing option for the SARS-COV-2 cases and COVID-19 disease.
Strengthening the National System for Excipient Risk Mitigation Ajaz Hussain
Today the assurance of continual supply, authenticity, quality, and functionality of pharmaceutical materials active and so-called "inactive" excipients is at risk that needs to be mitigated. This presentation seeks to bring attention to the prevalent "inactive" mindset that is so difficult to change. At the precipice, we do change. Are we there yet?
Sharpen your Unique Sensing Proclivity: Dissolution is a process in mind and ...Ajaz Hussain
Self-authorship bridging the Academia to Industry (A2I) Gap. The challenge in our systems asking why signifies ignorance. Perhaps until a correction is needed. But after corrective and preventive actions (CAPA) often nothing changes. Errors reoccur and we acquire an “immunity to change.”
Sustain and Build a Quality Culture in Today's RealitiesAjaz Hussain
What is quality, what is culture? Culture, quality, and assurance are just a few of the many abstract words in our lexicon. The meaning we make evolves with our development and maturity. Our education and training are necessary but insufficient for our development and maturity. Learning from experience is essential, and experiential learning is highly variable. Some continue to develop, but at different rates; others do not. In this presentation, I share why and how a connect-the-dots framework was developed and what it offers to individuals and organizations. Building refers to a process by which a source code guides software coding programs for a stand-alone computer or an enterprise-wide system. The context of this presentation is experiential. The content is derived from experiencing the real world via an intentional journey beginning in 2015 across the globe; since 2020, this journey has been searching for the source code to what is good. In my imagination and thought experiments, the building is a process, as in the context of software development. Coding for a stand-alone computer is similar but not interchangeable or automatically substitutable for writing and executing a personal or individualized continuous professional development plan. I speak about quality culture to ease the process of continuous learning, development, and maturity in professionals and management systems. To improve feedback and encourage backpropagation of errors of omission and commission to learn how to prevent mistakes and improve continually, I remind that it is increasingly relevant today to begin asking - how might we assess suitability, capability, and comparability of humans and AI in the context of CGMP compliance and maturity of a pQMS. I implicitly use the lexicon of biosimilars, interchangeable biosimilar products, and automatic generic substitution for brand products to help us make sense of our suitability and capability to know the difference in the maturity stages we call professional and good practitioners to appreciate the differences in the regulatory and social expectation of validation and assurance broadly and specifically as in the validation of computer and pharmaceutical systems.
Of the different patterns that have emerged in governments’ fight against coronavirus—crush and contain is the most effective. While many countries missed the initial opportunity to crush and contain, it is critical that governments prepare now to make sure they don’t miss the opportunity again.
Webinar: Discovering Small Molecule Protein-Protein Interaction Inhibitors th...Dr. Wolfgang Kissel
Small Molecule Protein-Protein-interaction inhibitors (smPPII) are an emerging drug class which recently has entered the discussion of drug discovery and R&D productivity. By targeting “hot spots” on the protein surface, small molecules have shown to be able to disrupt effectively protein-protein interactions. This approach seem to decrease risks for later drug development stages.
Computational methods applied for the discovery and design of appropriate smPPII compounds have proven to deliver better quality in significant shorter time and substantial lower cost.
In combination, computational discovery and design methods and smPPIIs provide a double de-risk strategy in drug development and create a quantum leap in R&D productivity.
The webinar discusses our experience in this field and the implications on the early drug discovery phase in particular. Here is the link to the webinar http://www.computistresearch.com/webinar.html
Behavioral Economics and Managment of Pharmaceutical QbD 25 August 2016Ajaz Hussain
Pharmaceutical knowledge pyramid can be toppled easily!
Serendipitous intersection of Behavioral Economics & CGMP.
Why attention to Behavioral Economics can improve management of QbD work-streams?
How? What (benefits)?
Between regulatory query and response there is Design Space. In that space is our comparability protocol…
How should nonprofit leaders adjust to the new reality of operating under COVID-19? This detailed checklist can help you understand the actions needed to protect team health, improve financial resilience, and continue executing on your mission with clarity and impact.
Equity research presentation and investment pitch on the viability of Invitae Corporation as a potential company to include in our portfolio. Analyzed the business model, strategic outlook, and competitive positioning of Invitae Corporation within the pre-natal genetic diagnostic testing industry. Includes DCF valuation of Invitae Corporation. My partner and I rated Invitae Corporation as a strong buy.
Managing Pharmaceutical Quality in Traditional Paradigm and in the Emerging “...Ajaz Hussain
The epistemic crisis has deepened; multiple systems are now chaotic, fear and anxiety unabated and as expected the dominant response to the crisis is procrustean. Scenarios to consider managing pharmaceutical quality design space in traditional paradigm and in the emerging “SMARTness”?
Genetic Technologies Limited is a diversified molecular diagnostics
company developing tools for the prediction and assessment of cancer
risk to help physicians proactively manage patient health. The
Company’s lead products, ‘GeneType for Breast Cancer’ and
‘GeneType for Colorectal Cancer’, are clinically validated risk
assessment tests that are first in their class. The Company’s
development pipeline includes new tests for COVID-19, Type 2
diabetes, cardiovascular disease, prostate cancer, and melanoma.
Listed on the ASX in 2000 and NASDAQ in 2005, Genetic
Technologies has been a leader in the development and
commercialization of genetic risk assessment technology for 20 years.
Sustain and Build a Quality Culture in Today's RealitiesAjaz Hussain
What is quality, what is culture? Culture, quality, and assurance are just a few of the many abstract words in our lexicon. The meaning we make evolves with our development and maturity. Our education and training are necessary but insufficient for our development and maturity. Learning from experience is essential, and experiential learning is highly variable. Some continue to develop, but at different rates; others do not. In this presentation, I share why and how a connect-the-dots framework was developed and what it offers to individuals and organizations. Building refers to a process by which a source code guides software coding programs for a stand-alone computer or an enterprise-wide system. The context of this presentation is experiential. The content is derived from experiencing the real world via an intentional journey beginning in 2015 across the globe; since 2020, this journey has been searching for the source code to what is good. In my imagination and thought experiments, the building is a process, as in the context of software development. Coding for a stand-alone computer is similar but not interchangeable or automatically substitutable for writing and executing a personal or individualized continuous professional development plan. I speak about quality culture to ease the process of continuous learning, development, and maturity in professionals and management systems. To improve feedback and encourage backpropagation of errors of omission and commission to learn how to prevent mistakes and improve continually, I remind that it is increasingly relevant today to begin asking - how might we assess suitability, capability, and comparability of humans and AI in the context of CGMP compliance and maturity of a pQMS. I implicitly use the lexicon of biosimilars, interchangeable biosimilar products, and automatic generic substitution for brand products to help us make sense of our suitability and capability to know the difference in the maturity stages we call professional and good practitioners to appreciate the differences in the regulatory and social expectation of validation and assurance broadly and specifically as in the validation of computer and pharmaceutical systems.
Of the different patterns that have emerged in governments’ fight against coronavirus—crush and contain is the most effective. While many countries missed the initial opportunity to crush and contain, it is critical that governments prepare now to make sure they don’t miss the opportunity again.
Webinar: Discovering Small Molecule Protein-Protein Interaction Inhibitors th...Dr. Wolfgang Kissel
Small Molecule Protein-Protein-interaction inhibitors (smPPII) are an emerging drug class which recently has entered the discussion of drug discovery and R&D productivity. By targeting “hot spots” on the protein surface, small molecules have shown to be able to disrupt effectively protein-protein interactions. This approach seem to decrease risks for later drug development stages.
Computational methods applied for the discovery and design of appropriate smPPII compounds have proven to deliver better quality in significant shorter time and substantial lower cost.
In combination, computational discovery and design methods and smPPIIs provide a double de-risk strategy in drug development and create a quantum leap in R&D productivity.
The webinar discusses our experience in this field and the implications on the early drug discovery phase in particular. Here is the link to the webinar http://www.computistresearch.com/webinar.html
Behavioral Economics and Managment of Pharmaceutical QbD 25 August 2016Ajaz Hussain
Pharmaceutical knowledge pyramid can be toppled easily!
Serendipitous intersection of Behavioral Economics & CGMP.
Why attention to Behavioral Economics can improve management of QbD work-streams?
How? What (benefits)?
Between regulatory query and response there is Design Space. In that space is our comparability protocol…
How should nonprofit leaders adjust to the new reality of operating under COVID-19? This detailed checklist can help you understand the actions needed to protect team health, improve financial resilience, and continue executing on your mission with clarity and impact.
Equity research presentation and investment pitch on the viability of Invitae Corporation as a potential company to include in our portfolio. Analyzed the business model, strategic outlook, and competitive positioning of Invitae Corporation within the pre-natal genetic diagnostic testing industry. Includes DCF valuation of Invitae Corporation. My partner and I rated Invitae Corporation as a strong buy.
Managing Pharmaceutical Quality in Traditional Paradigm and in the Emerging “...Ajaz Hussain
The epistemic crisis has deepened; multiple systems are now chaotic, fear and anxiety unabated and as expected the dominant response to the crisis is procrustean. Scenarios to consider managing pharmaceutical quality design space in traditional paradigm and in the emerging “SMARTness”?
Genetic Technologies Limited is a diversified molecular diagnostics
company developing tools for the prediction and assessment of cancer
risk to help physicians proactively manage patient health. The
Company’s lead products, ‘GeneType for Breast Cancer’ and
‘GeneType for Colorectal Cancer’, are clinically validated risk
assessment tests that are first in their class. The Company’s
development pipeline includes new tests for COVID-19, Type 2
diabetes, cardiovascular disease, prostate cancer, and melanoma.
Listed on the ASX in 2000 and NASDAQ in 2005, Genetic
Technologies has been a leader in the development and
commercialization of genetic risk assessment technology for 20 years.
Genetic Technologies is a diversified molecular diagnostics company. A global leader in genomics-based tests in health, wellness and serious disease through its geneType and EasyDNA brands. GENE offers cancer predictive testing and assessment tools to help physicians to improve health outcomes for people around the world. The Company has a proprietary risk stratification platform that has been developed over the past decade and integrates clinical and genetic risk to deliver actionable outcomes to physicians and individuals. Leading the world in risk prediction in oncology, cardiovascular and metabolic diseases, Genetic Technologies continues to develop risk assessment products.
Process Analytical Technology, Quality by Design & PharmacogenomicsAjaz Hussain
Keynote address at the 2013 Scientific Conference of the Nigerian Association of Pharmacists and Pharmaceutical Scientists in the Americas (NAPPSA). The lecture attempts to 'connect the dots' between PAT and QbD to Pharmacogenomics in the context of the authors experience at the US FDA and in industry.
Genetic Technologies Limited is a diversified molecular diagnostics company developing tools for the prediction and assessment of chronic disease risk to help physicians proactively manage patient health. The Company’s lead products, ‘GeneType for Breast Cancer’ and ‘GeneType for Colorectal Cancer’, are clinically validated risk assessment tests that are first in their class. The Company signed a multi-year distribution agreement for its COVID-19 Risk Test and remains on track to launch its revolutionary Multi-Test, covering up to 70% of mortalities and morbidities, including major oncological, metabolic, and degenerative diseases. Genetic Technologies recent acquisition of EasyDNA has significantly accelerated the Company’s commercialization strategy, providing established revenue streams and direct-to-consumer marketing channels that include 70 websites in 40 countries. Listed on the ASX in 2000 and NASDAQ in 2005, Genetic Technologies has been a leader in the development and commercialization of genetic risk assessment technology for 20 years.
Commercial considerations in early drug developmentSunil Ramkali
It is important in the drug development process that marketers and researchers collaborate early to ensure that products being developed are truly innovative and deliver brand value to the different end users in a way that the product and the subsequent brand messaging is relevant, compelling and differentiating compared to the competition. T
In the market place that is heavily cost constraint, innovation is no longer about a unique mode of action or a new formulation, but more about the incremental brand value offered by new pharmaceutical products over existing treatments (standard of care) and how much healthcare systems are prepared to pay for these incremental benefits. My lecture at the Department of Innovation, Lund University, Sweden explored the importance of R&D functions getter closer to external stakeholders to really understand their needs, how they define brand value and the importance of considering this early in the drug development process.
In recent years, the pharmaceutical industry has witnessed increased political interest and attention due to the increased recognition of the economic importance and financial impact of healthcare as a component of national budgets. Biologic drugs (biologics) have attracted the attention of politicians since biologics have moved out of the niche pharmaceutical arena to contribute 17% of global pharmaceutical sales, representing revenues of more than $120bn in 2009. The market for biologics is growing at twice the rate of pharmaceutical drugs, placing significant cost pressures on government, employers, insurers, and patients. Government and insurers are using several strategies to contain costs but must ensure that the financial burden placed on patients does not restrict access to the health care system. Establishing a regulatory pathway for ‘follow-on’ biologics (biosimilars) was therefore felt to be necessary by many stake holders to encourage competition and reduce prices. Many pharmacutical companies both large and small - are expecting their bottom line growth to be driven by biosimilars and are channeling their R&D budgets to compete in what – according to many - is going to be one of the hottest areas in a radically changing global pharmaceutical market.
Non invasive prenatal testing (nipt) marketAkshay Shinde
Non-invasive prenatal testing (NIPT) is an innovative way of screening pregnancies for fetal chromosomal aneuploidies by analyzing fetal cell-free DNA circulating in maternal blood. It involves the testing for particular diseases or birth defects in a fetus or embryo before it is born
Rising Importance of Health Economics & Outcomes ResearchCitiusTech
Health Economics & Outcomes Research (HE&OR) guides stakeholders to make informed decisions regarding patient access to drugs and services. This document highlights specific use cases for healthcare information technology that add value to HE&OR.
Clinical and Pharmacoeconomic analysis was extensivley done on Eylea for its placement on a hypothetical health plans formulary for Macular Degeneration. Information was presented to a panel of pharmacy professionals in managed care and industry
Statement of Inger Mollerup, VP Novo Nordisk A/S for Congressional Hearings o...sstrumello
Statement of Inger Mollerup, MSc
Vice President Novo Nordisk A/S
Before the Government Oversight and Reform Committee Hearing On "Safe and Affordable Biotech Drugs - The Need for a Generic Pathway"
March 26, 2007
Hannes Smarason: Progress & Prospects in GenomicsHannes Smárason
The annual American Society of Human Genetics Meeting (ASHG 2016) is an excellent time for the field of genomics to take stock of the past and clarify our perspectives for the future.
Similar to Shawn Davis, Director, Technical Strategy & Innovation, Amgen (20)
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Discover the innovative and creative projects that highlight my journey throu...dylandmeas
Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...BBPMedia1
Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.
Company Valuation webinar series - Tuesday, 4 June 2024FelixPerez547899
This session provided an update as to the latest valuation data in the UK and then delved into a discussion on the upcoming election and the impacts on valuation. We finished, as always with a Q&A
3.0 Project 2_ Developing My Brand Identity Kit.pptxtanyjahb
A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
Digital Transformation and IT Strategy Toolkit and TemplatesAurelien Domont, MBA
This Digital Transformation and IT Strategy Toolkit was created by ex-McKinsey, Deloitte and BCG Management Consultants, after more than 5,000 hours of work. It is considered the world's best & most comprehensive Digital Transformation and IT Strategy Toolkit. It includes all the Frameworks, Best Practices & Templates required to successfully undertake the Digital Transformation of your organization and define a robust IT Strategy.
Editable Toolkit to help you reuse our content: 700 Powerpoint slides | 35 Excel sheets | 84 minutes of Video training
This PowerPoint presentation is only a small preview of our Toolkits. For more details, visit www.domontconsulting.com
LA HUG - Video Testimonials with Chynna Morgan - June 2024Lital Barkan
Have you ever heard that user-generated content or video testimonials can take your brand to the next level? We will explore how you can effectively use video testimonials to leverage and boost your sales, content strategy, and increase your CRM data.🤯
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Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
Improving profitability for small businessBen Wann
In this comprehensive presentation, we will explore strategies and practical tips for enhancing profitability in small businesses. Tailored to meet the unique challenges faced by small enterprises, this session covers various aspects that directly impact the bottom line. Attendees will learn how to optimize operational efficiency, manage expenses, and increase revenue through innovative marketing and customer engagement techniques.
RMD24 | Debunking the non-endemic revenue myth Marvin Vacquier Droop | First ...BBPMedia1
Marvin neemt je in deze presentatie mee in de voordelen van non-endemic advertising op retail media netwerken. Hij brengt ook de uitdagingen in beeld die de markt op dit moment heeft op het gebied van retail media voor niet-leveranciers.
Retail media wordt gezien als het nieuwe advertising-medium en ook mediabureaus richten massaal retail media-afdelingen op. Merken die niet in de betreffende winkel liggen staan ook nog niet in de rij om op de retail media netwerken te adverteren. Marvin belicht de uitdagingen die er zijn om echt aansluiting te vinden op die markt van non-endemic advertising.
The key differences between the MDR and IVDR in the EUAllensmith572606
In the European Union (EU), two significant regulations have been introduced to enhance the safety and effectiveness of medical devices – the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR).
https://mavenprofserv.com/comparison-and-highlighting-of-the-key-differences-between-the-mdr-and-ivdr-in-the-eu/
1. SEPTEMBER 21, 2017
SHAWN P DAVIS, PHD
INNOVATING BEYOND THE MOLECULE
IN BIOPHARMA
Public Information
2. 2
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
INNOVATING BEYOND THE MOLECULE IN BIOPHARMA
Public Information
Amgen
Introduction
• Startup
success
story
• Molecular
Innovation
Beyond the
Molecule
• Shifts in the
landscape
• Value of an
ecosystem
Case Studies
• Memorial
Sloan
Kettering
• Neulasta®
OnProTM
Kit
3. 3
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
One of the world’s
leading
independent
biotechnology
companies
~ 100 countries
Reached millions
of patients
AMGEN TODAY
Public Information
4. 4
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
THOUSAND OAKS, CALIFORNIA, USA
Photo courtesy of Ed Lawrence
Public Information
5. 5
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
STARTUP
Public Information
6. 6
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
OUR MISSION TO SERVE PATIENTS
Public Information
7. 7
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
FIRST LAUNCHES
Public Information
8. 8
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
PRODUCTS
For additional information about Amgen products, including important safety information, please visit amgen.com
Public Information
9. 9
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
THERAPEUTIC AREAS
Oncology/
Hematology
Cardiovascular
Disease
Inflammation
Bone Health
Neuroscience
Nephrology
Public Information
10. 10
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
FULLY INTEGRATED BIOTECHNOLOGY COMPANY:
WORLD-CLASS CAPABILITIES
Investing in Innovation Protein Engineering
Global Clinical Trials Biologics Manufacturing Successful Launch
Track Record
Global Commercial
Infrastructure
Biology First AdvantageGenetic Validation
Public Information
11. 11
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
OUR STRATEGY
INNOVATIVE MEDICINES
TRANSFORMING AMGEN
FOR THE FUTURE
GLOBAL GEOGRAPHIC
REACH
IMPROVED DRUG
DELIVERY SYSTEMS
CAPITAL ALLOCATION
AND INVESTING FOR
LONG-TERM GROWTH
BRANDED BIOSIMILARS
NEXT-GENERATION
BIOMANUFACTURING
Public Information
12. 12
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
CHANGES IN STRATEGY ARE DRIVEN BY INTERNAL AND
EXTERNAL FORCES
Public Information
13. 13
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
• Randomized, controlled trial: 10 year study following 776 patients treated with
chemotherapy for metastatic cancers
• Patient Reported Outcomes and symptoms via a web portal versus standard of
care
• Five month survivability benefit of the PRO system relative to standard of care
CASE STUDY: ONLINE SYMPTOM-MONITORING TOOL
IMPROVES SURVIVAL FOR METASTATIC CANCER PATIENTS
Public Information
Basch EM, Deal AM, Dueck AC, et al. Overall survival results of a randomized trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. J
Clin Oncol. 2017;35(suppl; abst LBA2).
“Although symptom management is a cornerstone of high-
quality cancer care, prior research has shown that doctors
miss up to half of patients’ symptoms during cancer
treatment”-Ethan Basch, MD
14. 14
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
What kind of ecosystem is required to support this vision?
• Every patient that can benefit from Amgen’s therapies is
identified, prescribed, and remains adherent to achieve the
full therapeutic benefit of the product.
• The healthcare system fully covers the cost of this care
since the benefit and outcome is known a priori and
confirmed with real world data.
TO SET THE STRATEGY WE MUST HAVE A VISION
In a perfect world…
Public Information
15. 15
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
BEYOND THE MOLECULE INNOVATION
Public Information
“For so long as a company we
thought about innovation as
our molecules. But what we’ve
come to recognize is, that is
not enough. We have to be
innovative in everything we
do… [producing] innovation
beyond the molecule.”
–Amgen CEO Bob Bradway
16. 16
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
AMGEN’S WORLDWIDE INNOVATION NETWORK
Public Information
1. San Jose
2. Santa Monica
3. Cambridge
4. Berlin
5. Tel Aviv
6. Singapore
17. 17
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
The molecule was in the innovation
• NEUPOGEN® helps boost the production of
infection-fighting white blood cells (neutrophils)
• Injected once a day after chemotherapy until
neutrophils return to normal level
CASE STUDY: EVOLUTION OF NEUPOGEN® TO BETTER MEET
PATIENT’S NEEDS
Public Information
18. 18
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
The molecule was the innovation
• Neulasta® is an extended duration form of
NEUPOGEN® to minimize dosing frequency
• Injected once after chemotherapy (must be
administered 24 hours post therapy)
CASE STUDY: EVOLUTION OF NEUPOGEN® TO BETTER MEET
PATIENT’S NEEDS
Public Information
19. 19
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
Drug Delivery becomes the innovation
• The on-body injector for Neulasta® allows the
timing of delivery to eliminate need for patients
to return to the clinic the day after
chemotherapy
– Applied during chemotherapy visit (same day)
– Initiates the Neulasta® delivery 27 hours after
application
CASE STUDY: EVOLUTION OF NEULASTA® TO BETTER MEET
PATIENT’S NEEDS
Public Information
20. 20
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
Digital Health becomes the innovation
• OBI Digital Companion mobile app is an
optional, convenient resource for patients
prescribed Neulasta® OnPro™ Kit
– Provides optional notifications to patient or
caregiver
– Key features are patient education material and
one-touch support
CASE STUDY: EVOLUTION OF NEULASTA® TO BETTER MEET
PATIENT’S NEEDS
Public Information
21. 21
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
• Every patient that can benefit from Amgen’s therapies is
identified, prescribed, and remains adherent to achieve the full
therapeutic benefit of the product.
• The healthcare system fully covers the cost of this care since the
benefit and outcome is known a priori and confirmed with real
world data.
PROGRESS TO ACHIEVE THE VISION IS BEING MADE
In a perfect world…
Public Information
22. 22
Provided September 21, 2017, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
AMGEN’S MISSION IS TO SERVE PATIENTS
Public Information