In this section of the coronavirus pandemic series, we discuss the current capacity of local healthcare systems and the need for effective treatment options as well as the pathogenesis of the coronavirus. Current treatment options include RNA, monoclonal antibodies (mAb), antibodies, convalescent plasma, and others. Critical stage implications such as cytokine storm and the need for immunomodulatory agents would also be discussed. Therapeutic pathways would are also compared.
In this section of the coronavirus pandemic series, we discuss the current capacity of local healthcare systems and the need for effective treatment options as well as the pathogenesis of the coronavirus. Current treatment options include RNA, monoclonal antibodies (mAb), antibodies, convalescent plasma, and others. Critical stage implications such as cytokine storm and the need for immunomodulatory agents would also be discussed. Therapeutic pathways would are also compared.
In this webinar, you will learn:
Trends in vaccine manufacturing
Innovative solutions in facility design
Case studies and proposals for future vaccine factories
Considerations while setting up Quality Management Systems (QMSs)
How validation helps accelerate regulatory approval
Detailed description:
How we see vaccine manufacturing evolving due to the COVID-19 pandemic, how could it further transform, and what are some solutions we can incorporate to prepare ourselves for next-generation facilities?
The unprecedented COVID-19 pandemic has driven significant tech acceleration around the world, including methods of vaccine manufacturing. Together with the concept of Bioprocessing 4.0, digital biomanufacturing enables centralized orchestration of production process and data management, and a "Facility of the Future" characterized by intensified, continuous, predictive, and autonomous operations. In this presentation, we will explore trends in vaccine manufacturing, including fully single-use processes, closed processing, modular facilities, and platform manufacturing. We will also discuss some key considerations when setting up Quality Management Systems for novel facilities, and how to speed up regulatory approval through best practices in facility validation.
This SlideShare gives an overview on how a drug is discovered, researched, developed, tested and reviewed for approval. It follows the current standard of approval set by the Food and Drug Administration (FDA), a federal agency of the United States Department of Health and Human Services. The process is generally divided into 4 Stages: Pre-Clinical, Clinical, New Drug Application (NDA) Review & Post-Marketing.
These slides talk about the top few candidates in the COVID-19 vaccine race. There are currently around 200 candidates in R&D, a handful of which has entered clinical trials. The top runners are AstraZeneca, Pfizer, & Moderna.
The COVID-19 vaccine race is progressing rapidly, with a handful of candidates already entering Phase 3 clinical trials in Q3 2020. Deals are being struck between developed nations and the top vaccine developers to secure doses even before FDA approval. Coalitions & alliances are also being set up to ensure vaccine access for lower-income countries.
Global cancer tyrosine kinase inhibitors market & clinical pipeline outlo...KuicK Research
“Global Cancer Tyrosine Kinase Inhibitors Market & Clinical Pipeline Outlook 2020” Report Highlights:
Introduction to Cancer Tyrosine Kinase Inhibitors
Signaling Pathway of Receptor Tyrosine Kinase
Advantage of Tyrosine Kinase Inhibitors for Treatment of Cancer
Applications of Tyrosine Kinase Inhibitor in Cancer Therapy
Global Tyrosine Kinase Inhibitors Market Overview
Global Cancer Tyrosine Kinase Inhibitors Clinical Pipeline by Company, Indication & Phase
Global Cancer Tyrosine Kinase Inhibitors Clinical Pipeline: 411 Drugs
Majority of Cancer Tyrosine Kinase Inhibitors in Preclinical Phase: 164 Drugs
Marketed Cancer Tyrosine Kinase Inhibitors: 32 Drugs
Webinar: Re-imagining vaccine manufacturing to address global health challengesMilliporeSigma
Participate in the interactive on demand webinar: http://bit.ly/ReimaginingVaccinesWebinar
In this webinar, you will learn:
- The evolution of vaccine production in response to pandemics and outbreaks
- Key considerations and perspectives on how vaccine processing and facilities could change to address future global health challenges
"Global HIV Vaccine Market Future Outlook" Report Highlights:
Introduction to HIV Vaccines
Issues Related to the Development of HIV Vaccines
Parameters for Successful Commercialization of HIV Vaccines
Global HIV Vaccines Market Opportunity Analysis
Global HIV Vaccine Clinical Pipeline by Company & Phase
Global HIV Vaccine Clinical Pipeline: 100 Vaccines
Majority Vaccine in Preclinical Phase: 42 Vaccines
In this webinar, you will learn:
Trends in vaccine manufacturing
Innovative solutions in facility design
Case studies and proposals for future vaccine factories
Considerations while setting up Quality Management Systems (QMSs)
How validation helps accelerate regulatory approval
Detailed description:
How we see vaccine manufacturing evolving due to the COVID-19 pandemic, how could it further transform, and what are some solutions we can incorporate to prepare ourselves for next-generation facilities?
The unprecedented COVID-19 pandemic has driven significant tech acceleration around the world, including methods of vaccine manufacturing. Together with the concept of Bioprocessing 4.0, digital biomanufacturing enables centralized orchestration of production process and data management, and a "Facility of the Future" characterized by intensified, continuous, predictive, and autonomous operations. In this presentation, we will explore trends in vaccine manufacturing, including fully single-use processes, closed processing, modular facilities, and platform manufacturing. We will also discuss some key considerations when setting up Quality Management Systems for novel facilities, and how to speed up regulatory approval through best practices in facility validation.
This SlideShare gives an overview on how a drug is discovered, researched, developed, tested and reviewed for approval. It follows the current standard of approval set by the Food and Drug Administration (FDA), a federal agency of the United States Department of Health and Human Services. The process is generally divided into 4 Stages: Pre-Clinical, Clinical, New Drug Application (NDA) Review & Post-Marketing.
These slides talk about the top few candidates in the COVID-19 vaccine race. There are currently around 200 candidates in R&D, a handful of which has entered clinical trials. The top runners are AstraZeneca, Pfizer, & Moderna.
The COVID-19 vaccine race is progressing rapidly, with a handful of candidates already entering Phase 3 clinical trials in Q3 2020. Deals are being struck between developed nations and the top vaccine developers to secure doses even before FDA approval. Coalitions & alliances are also being set up to ensure vaccine access for lower-income countries.
Global cancer tyrosine kinase inhibitors market & clinical pipeline outlo...KuicK Research
“Global Cancer Tyrosine Kinase Inhibitors Market & Clinical Pipeline Outlook 2020” Report Highlights:
Introduction to Cancer Tyrosine Kinase Inhibitors
Signaling Pathway of Receptor Tyrosine Kinase
Advantage of Tyrosine Kinase Inhibitors for Treatment of Cancer
Applications of Tyrosine Kinase Inhibitor in Cancer Therapy
Global Tyrosine Kinase Inhibitors Market Overview
Global Cancer Tyrosine Kinase Inhibitors Clinical Pipeline by Company, Indication & Phase
Global Cancer Tyrosine Kinase Inhibitors Clinical Pipeline: 411 Drugs
Majority of Cancer Tyrosine Kinase Inhibitors in Preclinical Phase: 164 Drugs
Marketed Cancer Tyrosine Kinase Inhibitors: 32 Drugs
Webinar: Re-imagining vaccine manufacturing to address global health challengesMilliporeSigma
Participate in the interactive on demand webinar: http://bit.ly/ReimaginingVaccinesWebinar
In this webinar, you will learn:
- The evolution of vaccine production in response to pandemics and outbreaks
- Key considerations and perspectives on how vaccine processing and facilities could change to address future global health challenges
"Global HIV Vaccine Market Future Outlook" Report Highlights:
Introduction to HIV Vaccines
Issues Related to the Development of HIV Vaccines
Parameters for Successful Commercialization of HIV Vaccines
Global HIV Vaccines Market Opportunity Analysis
Global HIV Vaccine Clinical Pipeline by Company & Phase
Global HIV Vaccine Clinical Pipeline: 100 Vaccines
Majority Vaccine in Preclinical Phase: 42 Vaccines
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All about flipcart, Marketing mIx, strategy of flipcart, 1) introduction of flipcart. 2) 4Ps of Marketing (flipcart.com) 3) The marketing strategies of Producer (flipcart.com) 4)SWOT analysis (flipcart.com) 5)Input of marketing strategies and output of it. (flipcart.com)
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Business Valuation Principles for EntrepreneursBen Wann
This insightful presentation is designed to equip entrepreneurs with the essential knowledge and tools needed to accurately value their businesses. Understanding business valuation is crucial for making informed decisions, whether you're seeking investment, planning to sell, or simply want to gauge your company's worth.
Taurus Zodiac Sign_ Personality Traits and Sign Dates.pptxmy Pandit
Explore the world of the Taurus zodiac sign. Learn about their stability, determination, and appreciation for beauty. Discover how Taureans' grounded nature and hardworking mindset define their unique personality.
India Orthopedic Devices Market: Unlocking Growth Secrets, Trends and Develop...Kumar Satyam
According to TechSci Research report, “India Orthopedic Devices Market -Industry Size, Share, Trends, Competition Forecast & Opportunities, 2030”, the India Orthopedic Devices Market stood at USD 1,280.54 Million in 2024 and is anticipated to grow with a CAGR of 7.84% in the forecast period, 2026-2030F. The India Orthopedic Devices Market is being driven by several factors. The most prominent ones include an increase in the elderly population, who are more prone to orthopedic conditions such as osteoporosis and arthritis. Moreover, the rise in sports injuries and road accidents are also contributing to the demand for orthopedic devices. Advances in technology and the introduction of innovative implants and prosthetics have further propelled the market growth. Additionally, government initiatives aimed at improving healthcare infrastructure and the increasing prevalence of lifestyle diseases have led to an upward trend in orthopedic surgeries, thereby fueling the market demand for these devices.
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.
"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬"
𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
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Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
⭐ 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐩𝐫𝐨𝐣𝐞𝐜𝐭𝐬:
➢ 2024 BAEKHYUN [Lonsdaleite] IN HO CHI MINH
➢ SUPER JUNIOR-L.S.S. THE SHOW : Th3ee Guys in HO CHI MINH
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➢CHILDREN ART EXHIBITION 2024: BEYOND BARRIERS
➢ WOW K-Music Festival 2023
➢ Winner [CROSS] Tour in HCM
➢ Super Show 9 in HCM with Super Junior
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➢ Korean Vietnam Partnership - Fair with LG
➢ Korean President visits Samsung Electronics R&D Center
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"𝐄𝐯𝐞𝐫𝐲 𝐞𝐯𝐞𝐧𝐭 𝐢𝐬 𝐚 𝐬𝐭𝐨𝐫𝐲, 𝐚 𝐬𝐩𝐞𝐜𝐢𝐚𝐥 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐖𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐛𝐞𝐥𝐢𝐞𝐯𝐞 𝐭𝐡𝐚𝐭 𝐬𝐡𝐨𝐫𝐭𝐥𝐲 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐚 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐬𝐭𝐨𝐫𝐢𝐞𝐬."
What is the TDS Return Filing Due Date for FY 2024-25.pdfseoforlegalpillers
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Putting the SPARK into Virtual Training.pptxCynthia Clay
This 60-minute webinar, sponsored by Adobe, was delivered for the Training Mag Network. It explored the five elements of SPARK: Storytelling, Purpose, Action, Relationships, and Kudos. Knowing how to tell a well-structured story is key to building long-term memory. Stating a clear purpose that doesn't take away from the discovery learning process is critical. Ensuring that people move from theory to practical application is imperative. Creating strong social learning is the key to commitment and engagement. Validating and affirming participants' comments is the way to create a positive learning environment.
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.
[Note: This is a partial preview. To download this presentation, visit:
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Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
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CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
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2. Forward Looking Statement
Our commentary and responses to your questions may contain
forward-looking statements, including comments concerning
clinical trials and product development programs, evaluation of
potential opportunities, the level of corporate expenditures,
the assessment of Inovio’s technology by potential corporate
partners, capital market conditions, timing of events, cash
consumption and other subjects. Information concerning
factors that could cause actual results to differ materially from
those set forth in our Annual Report on Form 10-K for the year
ended December 31, 2012, our Form 10-Q for the quarter
ended September 30, 2013 and other regulatory filings from
time to time.
2
3. Roche Partnership
• Collaborating with a global leader in innovative cancer drugs
• Develop and commercialize Inovio’s prostate cancer (INO5150) and hepatitis B (INO-1800) immunotherapies
• $10 million up-front payment
• $412.5 million milestone payments for development and
commercial events
• Roche may pay other development milestone payments if it
pursues other indications with INO-5150 or INO-1800
• Roche to fund all ongoing development costs
• Up to double-digit royalties on sales of a marketed product
3
4. T cells: Inovio Commands the Body’s SWAT Team
Infected
cell
• Are safe and tolerable
• Requires a directive
to attack
T cell
Cytotoxic T lymphocyte
4
Provided by Dr. Philip Greenberg
Hutchinson Cancer Research Center
6. The Basis For How We Stimulate T-cells
Antigen Y
Select important
common antigen(s),
which body recognizes
as foreign and relates
to a cancer or infected
cell
Antigen Y
Strain 2
Antigen Y
Strain X
6
Strain 1
Choose important
strains/variants of
target virus/cancer
7. The Basis For How We Stimulate T-cells
Antigen Y
Antigen Y
Antigen Y
Strain 2
Strain X
Identify gene sequence
of selected antigen(s) from
chosen strains/variants of
the virus/cancer
Strain 1
Synthetically create optimal
consensus gene sequence for
the selected antigen
7
8. The Basis For How We Stimulate T-cells
Insert SynCon® gene
sequence for selected
antigen into DNA plasmid
Antigen
consensus
sequence
SYNCON®
DNA
SynCon DNA plasmid ready
to manufacture
8
DNA
Plasmid
9. The Basis For How We Stimulate T-cells
DNA vaccine delivered
into muscle or skin
Antibodies or killer T-cells that can eliminate
cancerous or infected cells are produced
9
Electroporation: millisecond
electrical fields applied
Antigen-presenting cells
engulf the antigens and carry
them to lymph nodes
Temporary pores in cell
membrane; significant cellular
uptake of vaccine
Cell membrane reseals. Cellular machinery uses
the DNA code to produce one or more of the
targeted disease antigens
11. #1 in Accelerating and Driving T Cell Responses
“Immunotherapy against
HPV 16/18 generates
potent TH1 and cytotoxic
cellular immune responses”
October 10, 2012
“Safety and comparative
immunogenicity of an HIV-1
DNA vaccine in combination
with plasmid Interleukin 12
and impact of intramuscular
electroporation for delivery”
July 8, 2013
11
12. Broad Medical and Market Opportunities
Product Name
Indication
Preclinical
Vgx-3100
Cervical dysplasia
Therapeutic
INO-3112
Cervical Cancer
Therapeutic
INO-3112
Head & Neck Cancer
Phase I
Therapeutic
Ino-5150
Prostate cancer
Ino-1400
Breast/lung cancers
pennvax®
hiv
Preventive/Therapeutic
Ino-3510
influenza
Preventive
Ino-8000
Hepatitis C
Therapeutic
ino-1800
Hepatitis B
Therapeutic
MaV-12
malaria
Preventive
12
INTERNALLY FUNDED
Therapeutic
Therapeutic
EXTERNALLY FUNDED
Phase II
Phase III
13. Inovio’s Lead Program
VGX 3100:
• Capitalizes on Inovio’s ability to generate T cells
• Immunotherapy for pre-cancers and cancers
caused by human papillomavirus (HPV)
• Phase II on-going: high grade cervical precancers (CIN 2/3 dysplasia)
• Projected efficacy data: mid-2014
13
15. VGX-3100: Phase I Study Data
Inovio’s Lead Program
• Strong T-cell response in 14 of
18 (78%) vaccinated subjects at
month 4
• 83% response rate in highest
dose group
15
*Immunotherapy against HPV16/18 generates potent TH1 and cytotoxic cellular immune responses.
Sci Transl Med. 2012 Oct; 4:155ra13. dOI:10.1126/scitranslmed.3004414
16. Inovio’s Lead Program
Phase I trial results for vgx-3100
•
•
16
9 month durability of
robust T cell response
in 12/14 responders
• 10/11 responders
showed killing effect against
target cells
Safe & well tolerated
Source: Science Translational Medicine Oct. 2012
18. Broad Medical and Market Opportunities
HPV product
franchise planning
• CIN 2/3 Phase III
• Other HPV-related indications: initiate Phase IIs
• Orphan designation potential
18
19. Strategy
• Build on proof-ofconcept studies with
phase I/II clinical trials
• Spread cost/risk with:
o Non-dilutive
partner funding
o R&D grants
o “Sponsored”
clinical trials
• May partner or license
out products for
further development
and commercialization
19
20. Broad Base of Support for Inovio
•
•
•
•
Universities
Government
Foundations
Corporate partnerships
Almost $60M in funding since 2009
20
23. Management
J.Joseph Kim, PhD
President & CEO
• Decades of biotechnology/pharma
management
• Merck: hepatitis A and B vaccines
manufacturing; HIV vaccine (Ad5) R&D
Niranjan Y. Sardesai, PhD
COO
• Extensive biotech management and product
development experience
• Led development of diagnostics for
mesothelioma, bladder cancer, and ovarian
cancer for Fujirebio Diagnostics
23
Peter Kies
CFO
• Ernst & Young
• Experience with growth companies
anthrax
Louis Pasteur
Mark L. Bagarazzi, MD
CMO
• Clinical research experience incl. Merck
• Led clinical/regulatory for shingles and
rotavirus vaccines; DNA vaccine expert
24. Board of Directors
Morton Collins, PhD
Avtar Dhillon, MD
• General Partner, Battelle Ventures and
Innovations Valley Partners
Chairman, BOD
• Former President & CEO,
Inovio Biomedical
Simon X. Benito
• Former Senior Vice President,
Merck Vaccine Division
Angel Cabrera, PhD
• President, George Mason University
• Former President, Thunderbird School of
Global Management
24
anthrax
Louis Pasteur
J.Joseph Kim, PhD
• President & CEO, Inovio
Adel Mahmoud, PhD
• Professor, Princeton University
• Former President, Merck Vaccines
• Responsible for Gardasil®, Zostavax®,
Proquad® and Rotateq®
25. Scientific Advisory Board
Philip Greenberg, MD
David B. Weiner, PhD
• Expert in T-cell immunology
• Head, Immunology Program, Fred
Hutchinson Cancer Research Center
Chairman
•“Father of DNA vaccines”
• Dept. of Pathology & Laboratory Medicine,
University of Pennsylvania
Thomas S. Edgington, MD
• Founded multiple biotech companies;
extensively published
• Emeritus Professor, Scripps
Research Institute
Anthony W. Ford-Hutchinson, PhD
• Former SVP, Vaccines R&D, Merck
• Oversaw development: Singulair®, Januvia®,
Gardasil®, Zostavax®, Proquad® and Rotateq®
25
anthrax
Louis Pasteur
Stanley A. Plotkin, MD
• Developed rubella and rabies vaccines
• Oversaw Sanofi flu vaccine
• Emeritus Professor, Wistar Institute &
University of Pennsylvania
31. The Opportunity
Investor Highlights
• Break-through immune therapy with the power
to save lives and maximize shareholder value
• Targeting broad range of diseases and
billion dollar markets
• Best-in-class T cells to prevent, treat & cure
cancers and infectious diseases
• Phase II efficacy data coming
• Validating partnership with Roche
31