This document describes a new patented nanotechnology called Hybrid-NanoengineeringTM that can resolve solubility issues for over 60 drugs. Dr. Mewa Singh is offering a free proof-of-concept trial to collaborate with pharmaceutical companies. The technology involves using a new molecule that acts as both the active drug and part of the nanoparticle formulation. Experimental results show Hybrid-NanoengineeringTM increases drug potency and overcomes drug resistance compared to conventional formulations. The technology has potential to extend drug patents and beat generic competition.
Our fifth webinar in the MDC Connects Series 2021 | A Guide to Complex Medicines.
This slide deck takes a closer look at whether complex medicines raise different challenges from a safety perspective.
Richard Knight (Apconix)
Formulation Science
Main steps of formulating a Drug Product
The role of Formulation Science in different
stages of Drug Development
Trends and challenges in formulation
development
In our final webinar of the MDC Connects Series 2021 | A Guide to Complex Medicines.
This slide deck takes a closer look at overcoming the challenges of scaling up a complex medicine.
Graham Worrall and Emily Port, CPI
Our fifth webinar in the MDC Connects Series 2021 | A Guide to Complex Medicines.
This slide deck takes a closer look at whether complex medicines raise different challenges from a safety perspective.
Richard Knight (Apconix)
Formulation Science
Main steps of formulating a Drug Product
The role of Formulation Science in different
stages of Drug Development
Trends and challenges in formulation
development
In our final webinar of the MDC Connects Series 2021 | A Guide to Complex Medicines.
This slide deck takes a closer look at overcoming the challenges of scaling up a complex medicine.
Graham Worrall and Emily Port, CPI
In our final webinar of the MDC Connects Series 2021 | A Guide to Complex Medicines.
This slide deck takes a closer look at the advantages of good formulation.
Claire Patterson, Seda Pharmaceutical Development Services
A provider of contract pharma services in high potent manufacturing, Alkermes Contract Pharma Services, outlines here some of the elements that should be considered by a Sponsor/Donor Pharmaceutical company when outsourcing secondary processing (i.e. dosage form transfer, scale-up and commercial manufacture) of a highly potent product.
Webinar: Post Approval Changes in Biologics Manufacturing - A Practical Asses...MilliporeSigma
Participate in the interactive webinar: http://bit.ly/PACWebinar
Post-approval changes for biologics manufacturing processes are complicated and challenging with the current global diverse regulatory environment. Here, we will present approaches to make these changes more efficient using a risk-based approach.
Explore our webinar library: www.emdmillipore.com/webinars
New PDA/IPEC Technical Report on Excipient Risk Assessment - insights for dru...MilliporeSigma
Access the interactive recording: https://bit.ly/37HqbTK
Abstract:
Since March 2016 the EU Guideline to ascertain the appropriate GMP for pharmaceutical excipients is legally binding. Although the EU Guideline itself provides a high level description how to perform the risk assessment, the implementation can be challenging. In January 2018 PDA and IPEC formed a joint Task Force with the objective to develop a joint Technical Report to share best practices with industry. This Technical Report was published in December 2019. In this webinar you will be introduced to the new Technical Report, its objective, proposed approaches and examples shared by PDA/IPEC member companies.
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...MilliporeSigma
Register for the interactive, on-demand webinar now: https://bit.ly/USP665
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing
Risk-based Approach to evaluate Nitrosamines and Elemental Impurities from Si...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3usdjx7
Nitrosamines and elemental impurities are now a concern for regulatory agencies. A key issue related to plastic single-use systems (SUS) is potential leachables from contact materials. For SUS it’s essential to evaluate leachables as well as nitrosamines and elemental impurities risks.
Residual impurities can potentially be introduced into the biopharmaceutical manufacturing process at a variety of stages. Recently, nitrosamines and elemental impurities have been a concern for regulatory agencies. These impurities originate from various raw materials, process chemicals and manufacturing equipment. Single-use systems (SUS) incorporate a number of plastic components. A key concern related to plastic SUS is potential leachable compounds from contact materials. It’s essential to obtain information on leachables as well as nitrosamines and elemental impurities. This webinar looks into how to evaluate nitrosamine and elemental impurity risk related to SUS and filters.
In this webinar, you will:
• Understand of the potential of nitrosamine contamination
• Learn how to leverage industry, supplier, and scientific expertise to assess the risk of elemental impurities taking advantage of ICH Q3D guidance on biologic drug manufacturing
• See a case study using Emprove® Elemental Impurities to help you conduct an efficient elemental impurities safety evaluation D46
Presented by: Janmeet Anant
Senior Regulatory Consultant
General Investor and partnership presentation for the launch of a new pharmaceutical product. Specifically funds the initial clinical trial and market tests.
In our final webinar of the MDC Connects Series 2021 | A Guide to Complex Medicines.
This slide deck takes a closer look at the advantages of good formulation.
Claire Patterson, Seda Pharmaceutical Development Services
A provider of contract pharma services in high potent manufacturing, Alkermes Contract Pharma Services, outlines here some of the elements that should be considered by a Sponsor/Donor Pharmaceutical company when outsourcing secondary processing (i.e. dosage form transfer, scale-up and commercial manufacture) of a highly potent product.
Webinar: Post Approval Changes in Biologics Manufacturing - A Practical Asses...MilliporeSigma
Participate in the interactive webinar: http://bit.ly/PACWebinar
Post-approval changes for biologics manufacturing processes are complicated and challenging with the current global diverse regulatory environment. Here, we will present approaches to make these changes more efficient using a risk-based approach.
Explore our webinar library: www.emdmillipore.com/webinars
New PDA/IPEC Technical Report on Excipient Risk Assessment - insights for dru...MilliporeSigma
Access the interactive recording: https://bit.ly/37HqbTK
Abstract:
Since March 2016 the EU Guideline to ascertain the appropriate GMP for pharmaceutical excipients is legally binding. Although the EU Guideline itself provides a high level description how to perform the risk assessment, the implementation can be challenging. In January 2018 PDA and IPEC formed a joint Task Force with the objective to develop a joint Technical Report to share best practices with industry. This Technical Report was published in December 2019. In this webinar you will be introduced to the new Technical Report, its objective, proposed approaches and examples shared by PDA/IPEC member companies.
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...MilliporeSigma
Register for the interactive, on-demand webinar now: https://bit.ly/USP665
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing
Risk-based Approach to evaluate Nitrosamines and Elemental Impurities from Si...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3usdjx7
Nitrosamines and elemental impurities are now a concern for regulatory agencies. A key issue related to plastic single-use systems (SUS) is potential leachables from contact materials. For SUS it’s essential to evaluate leachables as well as nitrosamines and elemental impurities risks.
Residual impurities can potentially be introduced into the biopharmaceutical manufacturing process at a variety of stages. Recently, nitrosamines and elemental impurities have been a concern for regulatory agencies. These impurities originate from various raw materials, process chemicals and manufacturing equipment. Single-use systems (SUS) incorporate a number of plastic components. A key concern related to plastic SUS is potential leachable compounds from contact materials. It’s essential to obtain information on leachables as well as nitrosamines and elemental impurities. This webinar looks into how to evaluate nitrosamine and elemental impurity risk related to SUS and filters.
In this webinar, you will:
• Understand of the potential of nitrosamine contamination
• Learn how to leverage industry, supplier, and scientific expertise to assess the risk of elemental impurities taking advantage of ICH Q3D guidance on biologic drug manufacturing
• See a case study using Emprove® Elemental Impurities to help you conduct an efficient elemental impurities safety evaluation D46
Presented by: Janmeet Anant
Senior Regulatory Consultant
General Investor and partnership presentation for the launch of a new pharmaceutical product. Specifically funds the initial clinical trial and market tests.
Cellgen Diagnostics is an early stage venture that is developing a break through Companion Diagnostic platform that will enable Precision Medicine by determining whether a patients genetic profile is a match for the prescribed cancer therapeutic.
Clinical Trial Simulation training with simulo 20161124Ruben Faelens
In collaboration with the University of Lyon, we presented a 2-hour session in Clinical Trial Simulation. This session fitted nicely within the Master's program curated by Emilie Henin (Calvagone).
The 10 students managed to explore the PK model for Sunitinib. 4 students struck gold at the end, managing to create an efficient design that proved biosimilarity.
The company founder effectively life-hacked a $billion dollar OTC product and was awarded 6 patents for it. The funds raised were to prove efficacy and will probably be the only funding required before licensing.
We took a highly technical breifing and created a story that is both understandable and informative. We developed the brands, strategy, copy, graphics, and put together the deck and arranged key meetings with investors.
www.wildoutwest.com
OneMedForum New York 2010 - Company Presentation. Access Pharmaceuticals, Inc., a emerging biopharmaceutical company that focuses on adding value to exciting product concepts in research by advancing those products through clinical development.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
- 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
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
Contact us if you are interested:
Email / Skype : kefaya1771@gmail.com
Threema: PXHY5PDH
New BATCH Ku !!! MUCH IN DEMAND FAST SALE EVERY BATCH HAPPY GOOD EFFECT BIG BATCH !
Contact me on Threema or skype to start big business!!
Hot-sale products:
NEW HOT EUTYLONE WHITE CRYSTAL!!
5cl-adba precursor (semi finished )
5cl-adba raw materials
ADBB precursor (semi finished )
ADBB raw materials
APVP powder
5fadb/4f-adb
Jwh018 / Jwh210
Eutylone crystal
Protonitazene (hydrochloride) CAS: 119276-01-6
Flubrotizolam CAS: 57801-95-3
Metonitazene CAS: 14680-51-4
Payment terms: Western Union,MoneyGram,Bitcoin or USDT.
Deliver Time: Usually 7-15days
Shipping method: FedEx, TNT, DHL,UPS etc.Our deliveries are 100% safe, fast, reliable and discreet.
Samples will be sent for your evaluation!If you are interested in, please contact me, let's talk details.
We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
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
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...
Nanotechnology
1. Hybrid-Nanoengineering™
Opportunity
To beat Multi Billion Dollar
Patent Cliff Using A New
Patented Technology
Hybrid-Nanoengineering™
Concept to Bench to Clinic and
More…….
Dr. Mewa Singh
609-902-7128
mewasinghsandhu@hotmail.com
2. Simple to collaborate
• Since I know it is very hard for big pharmaceutical
to review and come up with a decision for
collaboration, so we have a very simple risk free
process at our end. We offer a free of cost one
drug proof-of-concept for our technology. Either
you select a drug from our list of solubility
resolved drugs or you provide us with your drug
to resolve the solubility issue using our Hybrid
Nanoengineering platform.
• We will just take three weeks to inform you
results.
3. What is new
• New concept and new approach
• There have never been used two active molecule in
nanomedicines
• There have never been developed a hybrid nanomedicine
• There have never been used an active molecule to
developed a water soluble drug formulation
• Two water insoluble drugs have never been used to
developed a water soluble formulation, at least without
changing the chemistry
• Chemistry of individual drugs remains unchanged
• IT IS NOT JUST SOLUBILITY BUT A BETTER
TREATMENT
4. What has been accomplished
or we have in our basket
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Drugs List (Resolved solubility problem)
5-aminosalicylic acid
Aspirin
Artemisinin
Aripiprazole, 99%
Azacitidine (Vidaza)
Azathioprine
Bexarotene, Free Acid (4)
Budesonide, 98%
Camptothecin
Capecitabine
Carbenicillin disodium salt
Celecoxib
Cisplatin
Clopidogrel Sulfate
Combrestastatin A4
Curcumin (2cc.) for injection
Cyclosporin A
Daunorubicin hydrochloride
Dexamethasone
Dihydroergotamine Mesylate
Digooxin
Docetaxel
Epothilone A
Erlotinib Monohydrochloride
β-Estradiol
Fexofenadine hcl
Griseofulvin
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Ibuprofen
Itraconazole
Ivermectin
Lenalidomide
Leucovorin Calcium
Loperamide HCL
Loratadine
Magestrol Acetate
Methotrexate
Mevastatin, Minimum 95% HPLC
Nystatin mycostatin
Nimodipine
Ofloxacin
Olanzapine
Paclitaxel from Taxus Brevifolia
Paliperidone
Pomalidomide
Pravastatin Sodium (2)
Prednisone
Quinine
Rapamycin
Resveratrol
Retinonic acid 97%
Rifampin
Rlaxifene hcl
Statine
Sidenafil Citrate >99%
Sulfasalazine
Tadalafil (Cialis) (2)
•
•
•
•
•
•
•
Telaprevir
Thalidomide
Valsartan 99%
Vardenafil hydrocholoride trihydrate
Variconazole
Zidovudine
Ziprasidone hydrocholoride
1. Provisional patent filed in
May, 2012 and final is on its
way this year.
2. There is no common
solubility which cover 63
drugs using one procedure.
3.A simple and inexpensive
technology to resolve
solubility problem of 63 drugs
should deserve some respect.
5. Practical progress
• 86 drugs have tested at lab. scale
• Five drugs have been tested at pilot scale
production
• Three drugs have been tested in dogs
• Two drugs have been tested in dogs and
humans.
The technology is not at early stages of
proof of concept or R&D
6. Technology
• Typical existing nanotechnology involved the
use of phosphophilipids, detergents,
surfactants, polymers and copolymers,
PEGylation and other multistep procedures to
manufacture a nanomedicine.
• We have discovered a new system and a new
molecules to manufacture nanomedicines or to
generate nano-particles.
7. New System and Molecule for
NanoTechnology
• The new molecule discovered is drug that has
its own mode of action to treat the disease.
• The new molecule has its own properties to be
a part of the process to make nanoparticles
• This new molecule of discovery is the
integral part of the whole formulation or
nanomedicine (Hybrid-Nanoengineering™)
8. Experimetal results-1 ( Paclitaxel)
Microscopy
Paclitaxel in water
Paclitaxel in water
Using Hybrid nanoengineering
10. Passive Targeting
Longer circulation by evading
scavenging by the mononuclear
phagocytic system
And
Bypassing inter-endothelial cells
600-800 nm
Size
Charge
Hydrophobicity
Enhanced Permeability
and Retention (EPR) Effect
12. Experimental Results-5
• In Mewtaxol ( Paclitaxel) Hypothesis is that
our Hybrid partner shut down the pumps ,
hence incremental in drug concentration leads
to overcome the drug resistance.
• Our Mewtaxol demonstrate the above
mentioned mechanism by killing the paclitaxel
drug resistance cell lines.
13. Mechanism of action
For our Cancer Hybrid formulations
• Control inflammation
• ABCG2 control
• While keeping the parent drug unaltered
14. Overall Summary
• Taxanes are a key first-line component of BC therapy
• The majority of patients treated with a taxane develop
resistance
• To date, most therapies developed to overcome
resistance are inadequate
• Epothilones have shown activity against taxaneresistant tumors
– Poor substrates for P-gp
– May be unaffected by taxane-resistant tubulin mutations
– Positive results in clinical trials
15. Limitations of Conventional,
Solvent-based Taxane Therapy
• Taxanes, like many cancer drugs, are
hydrophobic and require solvents
• Solvents cause hypersensitivity reactions that
necessitate
– Corticosteroid premedication
– Prolonged infusion
• Solvents leach plasticizers, requiring specialized
IV tubing
• Solvents alter the bioavailability of the active
drug
van Zuylen L, et al. Invest New Drugs. 2001;19:125-141; van Tellingen O, et al. Clin Cancer Res. 1999;5:2918-2924; Ellis AG, et al. Cancer
Chemother Pharmacol. 1996;38:81-87; LoRusso PM, Pilat MJ. ONS News. 2004;19:75-76.
16. Alternative Approaches to
Taxane Drug Development
Strategy
Example
Stage
Reference
HAS-Paclitaxel
Pre-clinical
Dosio (2001)
Emulsions
Tocosol paclitaxel
Clinical (Phase III)
Spigel (2002)
Liposomes
LEP-ETU
Clinical (Phase I/II)
Soepenberg
(2004)
Cyclodextrins
PTX-CYD
Pre-clinical
Alcaro (2002)
Nanoparticles
nab-paclitaxel
Approved
Gradishar (2005)
Microspheres
Paclimer
Clinical (Phase I)
Armstrong (2006)
Analogs
BMS-184476; RPR 109881
Clinical (Phase II)
Hildago (2001)
Prodrugs
DHA-Paclitaxel
Clinical (Phase II)
Harries (2004)
Prodrugs
Paclitaxel polyglumex
Clinical (Phase III)
Albain (2006)
Paclitaxel + cyclosporine
Clinical (Phase II)
Kruijtzer (2002)
Pharmaceutical
Co-solvents
Chemical
Biological
Oral
administration
Adapted from ten Tije AJ, et al. Clin Pharmacokinet. 2003;42:665-685.
There is no reported technology like our’s Hybrid-Nanoengineering™
17. Properties
For
Business
Success
Hybrid Nanoengineering™
One Platform fit
for more than
80 Drugs
No
No
Platform
Patent
Protection
Simplicity
and
Cost of
production
No
No
No need to change any
Existing manufacturing
Setup For Generic or new Drug
Need facility change
Simplicity
Synergistic
Or
Potentiating
Of Material used
No
No
No
No
No
No
?
?
Yes
Just filed in 2013
Old Technology
?
Fit for 87 Drugs
List is Growing
?
?
A new way to make use of Nanomedicine
One step
POC in 3-weeks
POC for your Drug
Free
20. Time to discover More
• Nanotechnology is used for pharmaceutical
products since many years
• It has solved many problems
• It will solve even more problems in the future:
mainly solubility and bioavailability
• Hybrid-Nanoengineering™ is the newest
invention in Nanotechnology. We need you
join us
21. Nanomedicine
~200 Companies are involved in nanomedicine R&D
• ~40 Nanomedicine products registered
•
–
Active US clinical trials using nano-based drug delivery
systems in september 2009
Emulsion 127
Liposomes 392
Micelle 5
Microemulsion 44
Hybrid-Nanoengineering™
Nanoemulsion 1
2013 IND
Nanoparticle 73
Nanocrystal 8
Nanosuspension 1
(www.clinicaltrials.gov)
–
–
–
–
–
–
–
–
22. To Beat Generic And Patent Cliff
• An inventory of 67 drugs covered by our
patent
• These drugs covered multi billion dollar
market
• Using our technology ,we can avoid the metoo concept in generic market
• Using our technology ,we can beat the
competition.
23. Example:
1.Lipitor
Cholesterol fighter Lipitor held the title "best-selling drug" for a few years, and had been a major source of income for the world's biggest drug company, Pfizer.
Lipitor (atorvastatin) was released in 1998, and by 2006 it had reached worldwide peak sales of $12.9 billion, accounting for 27% of the company's revenue.
In 2010, with $10.8 billion in sales, Lipitor still accounted for 15.8% of Pfizer’s total revenue. Unfortunately, Lipitor lost its patent protection and cut Pfizer's total
net income by 50%. Pfizer's CEO Ian Read stated on January 31, 2012, in USA TODAY: "Patent losses cost the company 5 Billion Dollars."
2.Paclitaxel and Docetaxel
The cumulative sales of paclitaxel have exceeded $ 20 billion so far since 1992. It is estimated that its total global sales were approximately $ 4.5 billion last
year.
Docetaxel is considered the largest oncology product ever developed with global market value at $3 billion in 2009.
Patent and generic cliff can be taken care with our technology.
Hybrid Nanoengineering™ can rejuvenate ageing pharmaceutical assets to counteract generic threats and preserve market share and income streams—it
could become one of the more successful specialty pharmaceutical companies in memory.
Pharmaceutical companies desperately need to protect their revenue streams especially towards the end of their patent life as this is when their products are
most profitable. For that reason, upfront and milestone payments should be significant and commensurate to the perceived value brought to the project by
adopting Hybrid Nanoengineering™ technology.
In addition to milestone payments, royalties would continue for the life of the newly patented product. For drug delivery companies, royalty rates are generally
accepted to be in the 7% to 12% range depending on the time and expense of adopting the extended release mechanism.
Crown’s Strong patent estate and low development costs for new formulations appears to provide for the least expensive and expedient method for preserving
patents and revenue streams.
We see a long term share price in the 30.00 to 40.00 range. Strong Buy.
Mewa Singh, PhD, Meda Biotech, measinghsandhu@hotmail.com, 609-902-7128,
www.nanomeda.com
24. Nano Companies
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Abraxis (USA)
The company's nab™ drug delivery technology uses albumin nanoparticles to deliver drugs into tumors.
Access Pharmaceuticals (USA)
Access' lead anticancer program is ProLindac™ applies the principals of nanoparticulate prodrugs to enhance the delivery of a platinum drug to tumors.
AcryMed (USA)
Manufacturer of SilvaGard, a silver nanoparticle antimicrobial surface treatment for medical devices.
ActiVery (Spain)
The basic technology platform of Activery™ is a nanoparticle production method using supercritical fluids (SCF). Based on SCF the company intends to create new medicines and modified active ingredients for pharmaceutical and cosmetic use.
Acusphere (USA)
The company has developed a proprietary formulation technology called HDDS that converts drugs that do not dissolve well in water, or hydrophobic drugs, into microparticles or nanoparticles of the drug embedded in small microspheres, such that
the drug can more rapidly dissolve in water.
AparnaBio (USA)
The company develops biomedical nanoparticle technology and products for research and treatment of human disease. They are developing NanoElectroPlex™, a proprietary tissue selective nanoparticle platform technology based on biodegradable
macromolecular carriers.
Aphios (USA)
The company has developed enabling nanotechnologies for the production of protein nanoparticles, polymer nanospheres and phospholipid nanosomes for the enhanced delivery of drugs
Aquanova (Germany)
Develops and manufactures micelle-like nanoparticulate encapsulation technology for applications in food, cosmetics, pharmaceuticals and biotechnology.
Asklepios BioPharmaceuticals (USA)
A biotechnology company engaged in the development and delivery of novel protein and cellular based therapies through design of proprietary Biological Nano Particles.
Azaya Therapeutics (USA)
A specialty pharmaceutical company with a novel drug delivery system. Its proprietary Protein Stabilized Liposomes nanotechnology platform addresses the significant problems associated with delivery of water insoluble drugs.
BIND Biosciences (USA)
BIND Biosciences, Inc. is a biopharmaceutical company developing therapeutic targeted nanoparticles.
Bio Delivery Sciences International (USA)
The company's he Bioral® drug delivery technology encapsulates the selected drug in a nanocrystalline structure termed a "cochleate" cylinder.
BioAlliance Pharma (France)
Manufactures a nanoparticle-based drug delivery platform.
BioCure (USA)
Develops amphiphilic self-assembling nanocapsules and planar membranes for drug delivery.
Bionostra (Spain)
The company's technology is based on the large scale production of nanometric particles known as VLPs (virus like particles). The most advanced application of this technology is the production of viral vector derived vaccines for human and animal
health.
Biophan Technologies (USA)
Develops nanotechnology drug delivery systems based on novel nanomaterials that provide precise control over location and timing of drug delivery.
Biosante Pharmaceuticals (USA)
The company is developing its proprietary calcium phosphate nanotechnology (CAP) for novel vaccines, including biodefense vaccines for toxins such as anthrax and ricin, and drug delivery systems.
BioSpectrum (South Korea)
A life sciences R&D company with a special focus on skin cell biology. The company has established proprietary technologies for nano-liposomal formulation techniques.
25. Nano companies
•
•
•
•
•
•
•
•
Capsulution (Germany)
Develops nanotechnology-based advanced drug delivery carriers, medical devices and diagnostic particles.
Celator Pharmaceuticals (USA)
The company develops new treatments for cancer based on a portfolio of delivery technologies including liposomes, polymers and nanotechnologies.
Cornerstone Pharmaceuticals (USA)
Develops the Emulsiphan™ nanoparticle tumor targeting technology.
Dabur Pharma (India)
One of the company's delivery systems in the most advanced stages of clinical development is a novel drug delivery system for Paclitaxel. Because of the better safety and pharmacokinetic profile, the polymeric
nanoparticle delivery system is seen as a potential super generic.
•
•
•
•
Debiopharm Group (Switzerland)
Debiopharm Group is a global biopharmaceutical development specialist that in-licenses promising biologics and small molecule drug candidates.
Delpor (USA)
Delpor develops the next generation Drug Delivery Systems that improve the clinical and commercial value of drugs and biopharmaceuticals. The company also has developed a microfabricated nanopore device
for the sustained release of therapeutic agents.
•
•
•
•
dermaCM (USA)
The company's NLP technology produces a generation of particles which retains the strength of the Dermazone Solutions' (SDMC) technologies, but includes the ability to produce particles of 60 nanometers to
150 nanometers which are optically clear. The use of this generation of lipid-based particle delivery system provides the ability to control the size of the final particle by controlling the number of NLPs used to
assemble the finished particle. This system maintains very high loading capacity of passenger molecules and uses only safe, all natural ingredients to form both the NLPs and the final delivery system.
Dune Sciences (USA)
Dune Sciences is an emerging technology company specializing in products and services that will facilitate the development and commercialization of nano-enabled products. The company employs several
patented and patent-pending technologies to engineer interfaces for the integration of new materials and devices in medicine, bionanotechnology, energy technologies, and nanoscience.
•
•
•
•
•
•
•
•
•
•
Elan (Ireland)
The company's proprietary NanoCrystal® technology can enable formulation and improve compound activity and final product characteristics for poorly water-soluble compounds.
Endor Nanotechnologies (Spain)
The company's mission is to develop and license R&D projects in Nanotechnology applied to Life Sciences. Endor is also developing pioneer in-house projects in novel Nanomaterials.
Eqalix (USA)
The company is in the Regenerative Medicine space. The backbone of Eqalix's technology resides in development of a plant-based protein nanofiber structure.
Eugene Science (South Korea)
Develops food additives with specially formulated nanoparticles which improve bioavailability.
Exilica (UK)
The company develops unique molecular delivery systems. Its spherical micrometer sizes polymer particles act like micro sponges and absorb molecules while the sub-micrometer sized Hollow silica shells have an
internal void space and act much like a standard container.
26. Nano Companies
•
•
GeneSegues (USA)
The company's targeted nanocapsule technology is designed using a flexible formulation process and can carry large or small molecules, custom target delivery to different organs,
tissues and cells, and be applied several ways including topically, intravenously, or via devices or tablets.
•
•
•
•
iCeutica (USA)
iCeutica has developed the Encapsulated Organic Nanoparticles (EON™) Platform to produce consistent nano-sized drug particles.
Intezyn Technologies (USA)
The foundation of the company's IVEC™ drug delivery platform is based on polymer micelle technology, spherical nanosized capsules formed by the assembly of block copolymers in
water.
•
•
•
•
Introgen Therapeutics (USA)
Develops and markets a nanoparticle vector technology that combines DNA with the lipids DOTAP and cholesterol to create a synthetic gene delivery vehicle.
Keystone Nano (USA)
Keystone Nano has an exclusive license to Penn State patented technology that allows the creation of stable, non-toxic, 5 to 50 nm-composite particles that they call Molecular Dots
(MDs). These Molecular Dots can encapsulate drugs and/or fluorescent molecules.
•
•
•
•
Labopharm (Canada)
Develops novel polymeric, nano-delivery systems for delivery of water-insoluble and poorly bio-available drugs.
LiPlasome Pharma (Denmark)
The combination of a protected blood transporting nanocarrier system and a tumor specific activation technology makes LiPlasome Pharma very competitive in a commercially attractive
and dynamic anticancer market, where drug delivery systems will gain increasing importance over the coming years.
•
•
Lipoxen (UK)
Lipoxen is a leading biopharmaceutical company operating from the UK that develops high-value, differentiated pharmaceutical products in the fields of protein drugs, vaccines and anticancer drugs.
•
•
Lumera (USA)
Develops proprietary nanoengineered polymer materials and products based on these materials for a broad range of applications.
27. Nano Companies
•
•
•
•
Magforce Nanotechnologies (Germany)
Provides integrated systems for nanotechnology-based cancer therapy
Mersana Therapeutics (USA)
The company utilizes its proprietary nanotechnology platform to transform existing and experimental anti-cancer agents into new, patentable drugs with superior pharmaceutical
properties.
•
•
•
•
•
•
•
•
•
•
•
•
Midatech Group (UK)
Design, synthesis and manufacture of biocompatible nanoparticles called nanocells.
NanoBio Corporation (USA)
A biopharmaceutical company focused on developing and commercializing anti-infective products and mucosal vaccines, based on its nanotechnology platform.
Nanocarrier (Japan)
Applies the manufacturing technology of ultrafine particles termed 'micellar nanoparticles' to use them as carriers for drugs, such as anticancer agents.
NanoMedica (USA)
The company's core technology includes a suite of proprietary drug discovery and drug delivery tools referred to as the NanoDiscovery™ platform.
Nanospectra Biosciences (USA)
Develops a therapeutic medical device which incorporates a new class of microparticles/nano-shells to selectively destroy solid tumors.
Nanotherapeutics (USA)
Uses nanotechnology to create novel drug delivery systems.
28. Nano companies
•
•
•
•
Oasmia (Sweden)
Oasmia Pharmaceutical AB develops next generation cancer drugs based on nanotechnology for human and veterinary use.
Particle Sciences (USA)
Particle Sciences is an integrated provider of both standard and nanotechnology approaches to drug development and delivery. The company originally pioneered use of encapsulated ingredients and
nanoparticles for sunscreens and personal care. In 1999 the company licensed a portion of its nanotechnology portfolio to BASF and focused its efforts on providing services to Life Sciences companies. Now,
through a full range of formulation, analytic, and manufacturing services, Particle Sciences provides pharmaceutical companies with a complete and seamless development solution designed to minimize the time
and risk between discovery and the clinic.
•
•
PDS Biotechnology (USA)
PDS Biotechnology Corporation is a biopharmaceutical company applying the company's platform Versamune nanotechnology to a new class of safe, simple, potent and targeted immunotherapies for the
treatment of cancer and infectious diseases.
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
PharmaIN (USA)
Develops a Protected Graft Copolymer (PGC™) nano-carrier drug delivery system.
PharmaNova (USA)
PharmaNova Inc. is a privately held, specialty drug development company founded on the re-purposing and enhancement of known drugs using our proprietary nanoparticle technology platform and other
complementary formulation and drug delivery technologies.
orthopaedics markets.
PolyMicrospheres (USA)
The company is specialized in developing cutting-edge nanoparticle technologies for the development of targeted drug delivery systems.
pSivida (Australia)
A nanobiotechnology company developing commercializing drug delivery products and new nanostructured biomaterials.
Rexahn Pharmaceuticals (USA)
Rexahn and the University of Maryland, Baltimore (UMB) Center for Nanomedicine & Cellular Delivery (CNCD), are jointly pursuing the development of water-soluble nano-polymers for targeted delivery of
anticancer drugs.
Starpharma (Australia)
Starpharma Holdings Limited is a world leader in the development of dendrimer nanotechnology products for pharmaceutical, life-science and other applications.
Tempo Pharmaceuticals (USA)
Tempo is focused on significantly improving the efficacy and safety profile of existing and new drugs employing advances in nanotechnology. The Company utilizes its proprietary Nanocell™ technology to develop
multi-compartmental, nanoparticle-based therapeutics in which two drugs with varied release rates are packaged within a single nanoparticle.
•
•
Uluru (USA)
Developed and manufactures a novel, biomaterial which utilizes hydrogel nanoparticles which aggregate to form a material of varying strength and elasticity which has extensive medical application including
wound management and burn care, tissue regeneration and drug delivery devices.
29. www.nanomeda.com
• None of the existing companies has any
technology close to our unique platform.
•
A recent report by Cientifica, a leading global emerging technology consulting firm predicts:
Nanotech-enabled drug delivery therapeutics is set to grow from a current value of $2.3 billion to $136 billion by the year
2021.
Nano
Nano
Nano
Nano
Nano
Nano
Nano
Nano
Nano
Hybrid-Nanoengineering™
Nano
Nano
Nano
Nano
Nano