company presentation. Development of the prostate cancer diagnostic test and in-vitro diagnostic device for the point-of-care diagnosis of prostate cancer
SMi Group's 6th annual Pre-Filled Syringes conference & exhibition is already Europe's leading event. This year it will be better than ever. Check out the programme.
SMi Group's 6th annual Pre-Filled Syringes conference & exhibition is already Europe's leading event. This year it will be better than ever. Check out the programme.
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Medicilon is an integrated contract research organization (CRO), providing comprehensive one-stop R&D services for pharmaceutical enterprises and scientific research institutions around the world. https://www.medicilon.com/
This 3-day event is the meeting place for international and domestic scientists to share case studies and project updates, showcase new techniques and form collaborations that pave the way towards the future of China’s biopharmaceutical industry.
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Join Dr. Danyi Wen as she describes a novel drug efficacy test using Patient Derived Xenograft (PDX) samples to measure drug efficacy and identify therapeutic candidates in personalized oncology treatments.
LIDE’s novel MiniPDX is a 7-day, in vivo drug efficacy test for oncology therapeutics. It is the in vivo version of a 3D organoid assay and correlates with traditional PDX by 92%, and with clinical end point at 82%. These high correlations make MiniPDX an effective option to test targeted drugs, chemotherapies, angiogenesis drugs, and more, while demonstrating superior testing times and cost-effectiveness versus traditional PDX. In a clinical setting, MiniPDX, together with next-generation sequencing (NGS), is playing an emerging role in personalized oncology.
The process starts with a freshly prepared cell suspension from either a clinical sample or PDX (Patient Derived Xenograft) model. This sample is sealed into a mini capsule with 500 KD cut-off pores. Capsules are implanted into SCID mice subcutaneously, and a test compound is given systemically for 7 days. The efficacy of the test compound is then evaluated by measuring ATP of the cancer cells in the capsule.
The MiniPDX mouse trial can also be coupled with “K-Cell Omic” analysis (DNA, RNA, and Protein), presenting a powerful tool for the identification of drug candidates and the discovery of companion diagnostic markers.
Key Topics Include:
Understand how MiniPDX + Omics analysis empowers precision medicine
Pros and cons of functional diagnosis assays (CR, Organoid, MiniPDX, PDX)
How to leverage MiniPDX + Omics for the identification of drug candidates
Role of K Cell RNAseq + FGI (Functional Genomic Imaging)
LIDE’s PMed Trial database for AI aided drug discovery
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Taking place on the 20th and 21st January 2016, London UK, Pharmaceutical Microbiology event will provide essential insights in to the latest advancements in practice and technology, developments in regulation and harmonisation of international practice and evolving methods and the latest technology.
Join us as we explore key issues in data review and analysis, contamination control strategies, strategies for low endotoxin recovery and best practice in sterile and non-sterile manufacture. Gain an in-depth insight into endotoxin testing, validation and LER. Understand the threats posed by VBNCs and how to detect them.
For more information or to register for this conference please visit:
www.pharma-microbiology.com/lin
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Book by 30th November and save £100!
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Join Dr. Danyi Wen as she describes a novel drug efficacy test using Patient Derived Xenograft (PDX) samples to measure drug efficacy and identify therapeutic candidates in personalized oncology treatments.
LIDE’s novel MiniPDX is a 7-day, in vivo drug efficacy test for oncology therapeutics. It is the in vivo version of a 3D organoid assay and correlates with traditional PDX by 92%, and with clinical end point at 82%. These high correlations make MiniPDX an effective option to test targeted drugs, chemotherapies, angiogenesis drugs, and more, while demonstrating superior testing times and cost-effectiveness versus traditional PDX. In a clinical setting, MiniPDX, together with next-generation sequencing (NGS), is playing an emerging role in personalized oncology.
The process starts with a freshly prepared cell suspension from either a clinical sample or PDX (Patient Derived Xenograft) model. This sample is sealed into a mini capsule with 500 KD cut-off pores. Capsules are implanted into SCID mice subcutaneously, and a test compound is given systemically for 7 days. The efficacy of the test compound is then evaluated by measuring ATP of the cancer cells in the capsule.
The MiniPDX mouse trial can also be coupled with “K-Cell Omic” analysis (DNA, RNA, and Protein), presenting a powerful tool for the identification of drug candidates and the discovery of companion diagnostic markers.
Key Topics Include:
Understand how MiniPDX + Omics analysis empowers precision medicine
Pros and cons of functional diagnosis assays (CR, Organoid, MiniPDX, PDX)
How to leverage MiniPDX + Omics for the identification of drug candidates
Role of K Cell RNAseq + FGI (Functional Genomic Imaging)
LIDE’s PMed Trial database for AI aided drug discovery
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Taking place on the 20th and 21st January 2016, London UK, Pharmaceutical Microbiology event will provide essential insights in to the latest advancements in practice and technology, developments in regulation and harmonisation of international practice and evolving methods and the latest technology.
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For more information or to register for this conference please visit:
www.pharma-microbiology.com/lin
Book by 30th October and save £200!
Book by 30th November and save £100!
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Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
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CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
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The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
2. A low-cost
non-invasive TEST
for early DETECTION
of prostate cancer
and prostate health
MONITORING
Mission
2
Bostwick et al., 1992
Age-specific prevalence of disease
3. Poor performance of current prostate cancer diagnostics
Problem
Current diagnostic pathway:
Referral to hospital
PSA
Suspected
prostate cancer clinic
Prostate specialist
MRI
ral to hospital
Suspected
ostate cancer clinic
Prostate specialist
MRI Prostate biopsy
Main problem:
Low accuracy of the PSA test results in up to 75% negative or inconclusive biopsies
3
4. Need
1
2
AN ACCURATE PRE-BIOPSY TEST
A TEST SUITABLE FOR REGULAR
MONITORING
Negative biopsies
>1 million
USA, 2012
4.7 million PSA tests
~1.3 million biopsies
Cancer
241 K
4
5. Novel test based on chemical elements as biomarkers
Solution
Levels of
microelemens
in seminal and
prostatic fluids
Diagnostic test
for home and
professional use
Significant
reduction of
unnecessary
biopsies
Prostate
function self-
monitoring
Off-the-shelf
third party
analytical
instrument
available
Non-
degradable
easy-to-
measure
biomarkers
5
Non-invasive
rapid
low-cost
test
6. Total addressable market size
Market
Assumptions:
10% - market penetration
£20 - home test price
£50 - professional test price
Home test market:
750 million men over 50 need regular
testing =
£1.5 Billion / year
Professional test market:
Global PSA testing market size is
45 million tests annually =
£225 million / year
6
7. Customers and benefits
Value proposition
Patients Medical Professionals
NHS Medical Insurers,
Private Trusts
- Reduced anxiety
- Improved quality of life
- Improved survival rate
Cost reduction by:
- early detection of cancer
- reduced number of biopsies
- reduced costs of active surveillance
- Accurate diagnosis
- Non-invasive diagnostic tool
- Additional revenue
7
8. National phase of the PCT application
Intellectual Property
8
PCT application on 45 biomarkers of prostate cancer
• filed 19.05.2015
• titled “Method of diagnosing prostate cancer by detecting
chemical elements”;
• publication number WO2015/177536 A1;
• entered into national phase in US, UK and EU in
November 2016
9. PSA test is no longer recommended for prostate cancer screening
Competition: Why Now
PSA biomarker is used in all currently available prostate cancer tests.
Recently developed tests 4K, SelectMDx and ExoDX are costly.
Cambridge Oncometrix diagnostic algorithm is affordable, accurate and
independent of the PSA biomarker.
Test Price FDA approval NICE approval
PSA £20 yes yes
PHI £80 yes no
PCA3 £350 yes no
4K £800 no no
ExoDX £475 no no
SelectMDx £400 no no
Cambridge
Oncometrix
£20 (home test)
£50 (laboratory test)
9
10. OUR VISION - three instruments to be developed
Products
Laboratory device
Point-of-Care device
Home test
10
11. Diagnostic Score based on 6 Microelements measured in sperm
Diagnostic Technology
11Healthy BPH PCa
0.00001
0.0001
0.001
0.01
0.1
1
10
100
1000
CambridgeOncometrixScore
Cut-off level
SPERM - results on
Cambridge Oncometrix
multiple marker score.
P=0.0011
n=14
n=21
n=18
12. Affordable personalized continuous surveillance pathway to detect cancer
Novel Diagnostic Concept
Panel of markers
is (self)-monitored
regularly
Age
40 80
Visit a urologist
BENIGN PROSTATE
ENLARGEMENT
HEALTHY
12
Marker
level
CANCER
13. Traction
13
50%
Total: 400K
Time:2 years
Deadline: 12/04/2017
Innovate UK
Innovation in Health
and Life Sciences
Leeds + DEC
- XRF
- Data analysis
50%
-80% FEC-
- Sample collection
- ICP-MS
- Data analysis
14. Potential Role of the test in NHS
14
PLiS
Figure 1. Current and proposed diagnostic pathway for prostate
cancer
Current pathway Proposed pathway
Pa#ents for whom
valua#on is
recommended
Pa#ents for whom
valua#on is
recommended
MP-MRI
CHEC
MP-MRI
BIOPSY
Cancer Cancer
Selec#on of pa#ents
who will benefit
from imaging and
biopsy
BIOPSY
Figure 1. Current and proposed diagnostic pathway for prostat
Current pathway Proposed pathway
Pa#ents for whom
valua#on is
recommended
Pa#ents for whom
valua#on is
recommended
MP-MRI
CHEC
MP-MRI
BIOPSY
Cancer Cancer
Selec#on of pa#ents
who will benefit
from imaging and
biopsy
BIOPSY
Pre-imaging and pre-biopsy triage
15. Important accomplishments to date
Track Record
Company was founded to develop
a diagnostic test based on
biomarkers (microelements)
present in prostatic tissue and
expressed prostatic secretions.
Russian subsidiary «ООО
Онкометрикс» was founded to
facilitate proof-of-concept clinical
trial.
Initiated a proof-of-concept
clinical trial in St. Petersburg,
Russia.
Developed a cloud based
clinical trial database.
Filed a patent application on
45 microelements as prostate
cancer biomarkers.
Successfully validated XRF
method and an analytical
device for use in centralized
diagnostic service or clinical
laboratory.
Initiated negotiations with
several XRF device
manufacturers.
Demonstrated high diagnostic
potential of the biomarkers in
semen.
2016201520142012 2013
Developed analytical
method.
Prizes and Awards
16. Multidisciplinary expertise
Team
CEO
M. Rossmann, Ph.D. Biochemistry
Biochemist with 12 years experience in
biochemistry, biophysics, cell biology and expertise
in microelement analysis by X-ray fluorescence.
Co-founder
CFO
Mrs I. Soltamova, M.Sc. Economics
Chartered auditor with over 20 years experience
in financial business consulting and due diligence.
CEO Oncometrix LLC, Russia
Co-founder
Principal
Scientist
Dr. D. Soloviev, Ph.D. Chemistry, MRSC
Chemist with over 25 years experience in
development of cancer diagnostic
radiopharmaceuticals for PET imaging.
Cancer Research UK
Co-founder
Principal
Investigator
Dr. D. Lebedev, MD
Consultant urologist with over 16 years
experience in clinical urology.
CEO Oncometrix LLC, Russia
Co-founder
IP protection,
regulatory affairs
Dr. I. Boros, Ph.D. Chemistry, MRSC
Organic chemist with over 8 years experience in
patent offices, for governmental and pharmaceutical
companies, quality assurance in GMP manufacture
of radiopharmaceuticals.
University of Cambridge
Co-founder
Engineering
Manager
Dr. D. Grigoriev, Ph.D., CEng MIET
Engineer with multi-disciplinary technical
expertise in sensors, instrument and test
development, test automation, electronics and IC
validation, Quality Control and Quality Assurance.
Product life cycle management and project
management experience.
Systems Characterisation Manager, Cambridge
CMOS Sensors
16
17. Experienced co-founders and advisors
Team
Honorary Head of
Advisory Board
Sir M. Snyder D.Sc., FRSA, MSI, FlnstD
Financial and business consulting.
Consultant and former Managing and Senior
Partner of Kingston Smith LLP.
Chairman of GLE Loan Finance Ltd.
Non-Executive Director of Metro Bank.
Advisor
Medicinal Physics
Prof. V. Zaichick, Ph.D., FRSC, D.Sc., C.Chem
Physicist with over 50 years experience in
medicinal physics and diagnostic method
development. World expert in micro-elemental
and chemical composition of human organs. 19
patents and over 500 publications.
Medical Radiological Research Centre, Obninsk,
Russia
Advisor
Diagnostic tests
Dr. A. Fini, Ph.D.
Renowned radiochemist and expert in the
diagnostic test development.
Founder of the Italian Group of
Radiopharmaceutical Chemistry (Gruppo
Interdisciplinare Chimica dei Radiofarmaci).
Advisor
Endocrinology
Prof. L. Schomburg, Ph.D. Biochemistry
Biochemist with over 20 years experience in
endocrinology, development and validation of novel
In-Vitro Diagnostic Assays and XRF.
Vice Director Institute for Experimental
Endocrinology, Charité - Universitätsmedizin Berlin.
Co-founder
Advisor
Business
Development
Dr. P. Shashkov, Ph.D. Physics
Physicist with 20 years experience in high-tech
business development. Successful serial
entrepreneur.
Founder of Keronite International, Cambridge
Nanotherm and Cambridge Nanolitic Ltd.
Co-founder
Sample processing
and Metrology
Dr. M. Vonsky, Ph.D. Physics and Maths.
Biophysicist, expert in clinical sample processing and
analysis, metrology in biochemical measurements.
Biomedical Technologies Institute of Cytology,
Russian Academy of Science.
Co-founder
17
18. Business development timeline
Milestones
18
2018
Analytical methods developed.
IP developed and protected.
Prototypes developed.
Laboratory instrument
approved. Clinical trials
Preparation finished.
POC device and Home test
development started.
2019 2021
Home test and POC devices
developed.
Validation Clinical trials started.
IP protected.
Home test and POC
devices approved and
certified.
Exit by
trade
sale.
2022
Value, M
Analytical
method
development
Prototype device
development
Clinical trials
Regulatory approvals and
exit
1.5
5
15
50
0.2M
0.7M
3M
19. Investment Needs
Financial Aspects
Phase 1a: completed
2014-2016
Proof-of-concept, IP development and protection.
Phase 1b: £200 K
2017-2018
Analytical method development, IP protection.
Phase 2: £700 K
2018-2019
Device prototype development, clinical trial preparation, IP protection.
Phase 3: £3 M
2019-2021
Clinical trials and regulatory approvals of tests and devices, IP protection.
19
Public
Funding,
30%
Venture
Capital, 40%
Private
funding,
30%
20. Current status – finalising proof-of-concept
Track Record
Referees
Sir David Neal - Professor of
surgical oncology
at the Nuffield Department
of Surgical Sciences
(University of Oxford)
Funding
Team Members’ Investment £30 K
Prizes & vouchers £8 K
Family & Friends Investors £31 K
Director’s Loan (Cash & expenses) £14 K
Donation-Based Crowdfunding £18 K
____________________________________________
Total £101 K
Academic partners and supporters
20
22. Appendix 1
1 million PSA tests
200.000 biopsies
150.000
negative biopsies
50.000
positive
biopsies
1 million PSA tests
125.000 biopsies
75.000
negative
biopsies
200.000 men offered a
biopsy
200.000 men offered
to consider a biopsy
£10 M
test costs
(£50 / test)
£75 M
savings due to
50% less negative
biopsies (£1,000 each)
50.000
positive
biopsies
Current diagnostic pathway in the U.K. New pathway
Economical Utility for NHS
24. Appendix 3
Concentration
24
Biomarker levels in seminal fluid – data from the clinical study
1 2
N
a
K
C
a
M
g
Zn
R
b
1
10
100
1000
10000
100000
SPERM
Marker
ppm
Healthy
BPH
PCa