ACT is conducting three clinical trials for dry age-related macular degeneration (AMD) and Stargardt's disease (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells. The trials have shown no adverse events and persistence of the cells with measurable improvements in visual acuity for most patients. ACT has additional programs developing blood components like red blood cells and platelets from stem cells, as well as mesenchymal stem cells for treating autoimmune diseases. ACT has an experienced management team and scientific advisors to advance its pipeline of ophthalmology and regenerative medicine therapies.
Posterior Segment Company Showcase - AGTCHealthegy
Posterior Segment Company Showcase - AGTC at OIS@AAO 2016.
Presenter:
Sue Washer, President & CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
$ATHX @athersys Corporate Overview - Investor Presentation (dated 08-10-18 / 32 slides) - http://www.athersys.com/static-files/df957fcc-48c5-46aa-8ae4-c254e18e05ee As found by "imz72", with growing, insightful shareholder's comments at reddit - https://redd.it/98b693 #MultiStem #Stroke Company Website -http://www.athersys.com/ As posted at Twitter - https://twitter.com/twenty2John/status/1030883310082318337
9/11/2017 Revised Bocce Courts 4 HB (Huntington Beach). This report, given in book form, to each of the seven members of the HB City Council (including, Mayor), and two copies to David Dominguez - Facilities, Development & Concessions Manager (HB).
Special Note: All links should be CLICKABLE (Tap link twice), EXCEPT links on first (3) pages. Links, on first (3) pages of this report are not accessible.
Human embryonic stem cell-derived retinal pigment epithelium in patients with age-related macular degeneration and Stargardt's macular dystrophy: follow-up of two open-label phase 1/2 studies
Published Online: 15 October 2014
Including Comment By, Anthony Atala
Q2 2015 ARM - Alliance for Regenerative Medicine
Quarterly Data Report: Q2 2015 provides an in-depth look at regenerative medicine and advanced therapies sector trends and metrics compiled from more than 580 leading therapeutic companies worldwide.
Part 2 Of 2 Comment/Reply on ACT/Ocata Lancet Report (Oct. 2014)
Reply by, *Steven D Schwartz, Eddy Anglade, Robert Lanza, on behalf of the Ocata
Macular Disease Investigator Group
schwartz@jsei.ucla.edu
Jules Stein Eye Institute Retina Division, and David
Geffen School of Medicine, University of California,
Los Angeles, CA 90095, USA (SDS); and Ocata
Therapeutics Inc, Marlborough, MA, USA (EA, RL)
Source Material: http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(15)61203-X.pdf
March 23, 2015 Sheraton Silver Spring Hotel - Silver Spring, Maryland USA
Bioassays 2015: Scientific Approaches & Regulatory Strategies
Bioassay Development for Human Stem Cell-derived Retinal Pigment Epithelium: Progress and Challenges
Irina Klimanskaya, Ocata Therapeutics, Inc., Marlborough, MA USA
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
2. 2
Cautionary Statement Concerning Forward-Looking Statements
This presentation is intended to present a summary of ACT’s (“ACT”, or “Advanced
Cell Technology Inc”, or “the Company”) salient business characteristics.
The information herein contains “forward-looking statements” as defined under the
federal securities laws. Actual results could vary materially. Factors that could cause
actual results to vary materially are described in our filings with the Securities and
Exchange Commission.
You should pay particular attention to the “risk factors” contained in documents we
file from time to time with the Securities and Exchange Commission. The risks identified
therein, as well as others not identified by the Company, could cause the Company’s
actual results to differ materially from those expressed in any forward-looking
statements. Ropes Gray
3. 3
Three clinical trials aimed at very large unmet medical needs
• Dry Age related Macular Degeneration and Stargardt’s Disease affect nearly 30 million
people in the US and EU, expected to grow by 50% over next 10 years
World-class cell biology capabilities
• ACT scientific team continues to develop best-in-class, and only-in-class cell lines which
create several preclinical opportunities across many disease areas
Strong Intellectual Property Estate
• 190 patents filed, 37 issued which provide ACT with sustainable competitive advantage
for decades to come
Active partnering program to monetize non-core assets
• ACT management is dedicated to monetizing non-core pre-clinical assets and
continues to optimize portfolio of opportunities to fuel future clinical programs
Several Key Inflection Points Provide Near-term
and Long-term Growth Opportunities
4. 4
Pre-clinical/
in vitro
POC –
Animal Studies IND Approved Phase I Phase II Phase III Approval
Dry AMD
SMD
MMD
Photo-
receptors
Ganglion
Neurons
Cornea
Platelets
Mesenchymal
Stem Cells
Robust Development Pipeline Provides Multiple Opportunities to
Commercialize and Partner
Potential Gov’t Funding
First Priority Based
On Current
Funding
Advance into
Phase I and
Partner
Based on POC results,
pursue appropriate
funding and collaborations
OphthalmologyPrograms
5. The Retina the light-sensitive
tissue lining the inner surface of
the eye
Retina
Structure of the Retina
5
6. Provides nutrients and growth factors
• photoreceptors see no blood
Recycles Vitamin A
• maintains photoreceptor excitability
Detoxifies photoreceptor layer
Maintains Bruch’s Membrane
• natural antiangiogenic barrier
• immune privilege of retina
Absorbs stray light / protects from UV
RPE Layer has
multiple
critical roles
in the
health and
function
of photoreceptors and
the retina as a whole.
Life Support for Photoreceptors
6
7. Failure of RPE cells
results in many
degenerative diseases
Stargardt’s disease
Myopic Macular Dystrophy
Age-related macular degeneration (AMD)
Life Support for Photoreceptors
7
8. 8
Prevalence of AMD Increases Exponentially with Age
Data from http://www.nei.nih.gov/eyedata/ and
U.S. Census Bureau Publication “65+ in the United States”, P23-209
Exponential rise in prevalence and incidence
rates with age, with prevalence rates of late
AMD quadrupling per decade
133.7 142.2 173.4 202.7 207.4 205.5
37.4 52.9
64.8
81.9 105.3 121
80+
65-79
2000 2010 2020 2030 2040 2050
Developed Countries
“macular degeneration will soon
take on aspects of an epidemic”
- former Director of the National Eye Institute Dr Carl Kupfer
60%
50%
40%
30%
20%
10%
50-5940-49 60-69 70-79 80+
Age
Intermediate AMD
Late AMD
%Prevalence(U.S.)
9. 9
Prevalence of AMD Increases Exponentially with Age
Exponential rise in prevalence and incidence
rates with age, with prevalence rates of late
AMD quadrupling per decade
The currently 30 Million American and
European AMD patients are projected
to become 45 Million patients by 2025
10. RPE Therapy- Rationale
• Massive unmet medical need
• Small dosage size
– less than 200K cells
• Immune-privileged site
– minimal immunosuppression
• Ease of administration
– no separate device approval
• Unique measuring and observation environment
10
12. Jules Stein
(UCLA)
Mass
Eye & Ear
Infirmary
Wills Eye
Institute
Bascom
Palmer Eye
Institute
Moorfields
Eye
Hospital
Edinburgh
Royal
Infirmary
World renowned leadership to help us navigate the
clinical path and ultimately support market launch
Clinical Trials being led by World Leaders in Ophthalmology
12
13. • No Adverse Events
• Persistence of cells
• Impact on Acuity
Recorded functional visual
improvements in majority of patients.
• Increased letters on ETDRS
Charts
• Color perception
• Contrast
• Low light vision
Phase I Trials Exceeding Expectations – no adverse events and persistence of cells
13
14. IND
Approved
50% Patient
Enrollment
100% Patient
Enrollment
U.S. – Dry AMD
U.S. – SMD
U.K. – SMD
U.S. – MMD
12/16 patients treated
10/16 patients treated
7/12 patients treated
Enrolling – 12 patients total
2 years since the first patients were treated
Measurable Improvements in Visual
Acuity for Majority of Treated Patients
Active Clinical Programs in AMD and SMD Indicate Encouraging Results
14
15. January 2013: FDA approved additional 4 patient “better vision”
cohorts in each trial.
For Cohort 2a – can enroll patients with vision as
good as 20/100.
Cohort 1
50K Cells
Cohort 2
100K Cells
Cohort 3
150K Cells
Cohort 4
200K Cells
Cohort 2a
100K Cells
First Treatments informed a more aggressive strategy to treat “better vision” cohort, could
lead to broader label and/or earlier approval
15
16. Several Important clinical milestones 2H 2013, 1H 2014
150K 200K
Cohort 2a
100K
Jan 2014 Jan 2015
Dry AMD
& SMD Trials
Patient follow-up
PII design Patient TreatmentPhase II
Patient TreatmentMMD Trial
16
Sep 2013 July 2014
Phase I
Phase I
20. 20
Mesenchymal Stem Cells in Therapy
Self External
Autoimmune Diseases
Rheumatoid Arthritis, Psoriasis,
Multiple Sclerosis, Crohn’s disease,
Type I Diabetes, Lupus
Allergic Reaction
Asthma, eczema,
sinusitis
Immune Over-reaction
Balanced Immune System
Autoimmune Disease Prevalence
• At least 80 disease affecting every organ system
• Americans spend over $100B each year in total
healthcare costs associated with autoimmune disease
• In the U.S., 14.7-23.5M people (5%-8%)
(for comparison: heart disease (22M), Cancer (9M)
A rapidly growing
health issue (% growth)
21. 21
Suppressing Immune Responses gives rise to Therapy
Promising
therapeutic potential
for treating autoimmune
and inflammatory
diseases.
However,
adult-derived MSCs
are limited by
replicative capacity
Mesenchymal stem cells (MSCs)
suppress disease-causing immune responses
22. ACT Proprietary Process
• Manufacture MSC’s from hES and iPS Cell Banks
• Virtually inexhaustible source of starting material
• Use Single Master Cell Bank
• Less labor-intensive
A further differentiating feature…
Our MSC’s are substantially more potent
than current sources of cells
ACT’s Breakthrough – Inexhaustible Supply of Very Potent MSC’s
22
25. Platelets are key elements of
hemostasis and thrombosis as well as
tissue regeneration after injury or surgery.
• Wound repair and treatment of trauma
• Thrombocytopenia
• Reconstructive, plastic and joint replacement surgery
Platelets are the blood product most difficult
to maintain – cannot be refrigerated or frozen
The Case for Platelets
25
27. Gary Rabin – Chairman and CEO
Edward Myles – CFO and EVP of Corp Development
Dr. Matthew Vincent, Ph.D. – Director of Business
Development
Dr. Robert Lanza, MD – Chief Scientific Officer
Dr. Irina Klimanskaya, Ph.D. – Director of Stem Cell
Biology
Dr. Shi-Jiang (John) Lu, Ph.D. – Senior Director of
Research
Edmund Mickunas – Vice President of Regulatory
Affairs
Dr. Roger Gay, Ph.D. - Senior Director of Manufacturing
Proven business leaders who can
develop and implement corporate
strategy and monetize assets to
maximize shareholder value
World-renowned scientific thought
leaders pushing the cutting edge of
science to develop important
therapies
Deep experience navigating the
complex regulatory landscape from
development to market
GMP manufacturing to ensure the highest quality
products are delivered to our patients
An Experienced and Dedicated Management Team
27
28. Michael Heffernan CEO – Collegium Pharmaceuticals
Robert S. Langer, Sc.D. Institute Professor, MIT
Zohar Loshitzer
CEO – Presbia, Inc., & Principal in
Ochard Capital
Greg Perry EVP & CFO - Immunogen
Alan C. Shapiro
Finance Professor and Chairman of the
Department of Finance and Business
Economics (retired) – University of
Southern California
Gary Rabin
Chairman and CEO – Advanced Cell
Technology
A World-Class Board of Directors
28