Immuron Ltd (NASDAQ: IMRN) is an Australian biopharmaceutical company focused on immunotherapy using dairy-derived antibody products for humans. Immuron has a unique and versatile technology platform that is capable of generating a wide range of products, all with a high safety profile. The versatility of Immuron’s platform technology enables the development of medicines that target a large range of medical needs, including infectious diseases, immune mediated disorders, and cancers. The versatility is also a function of the dairy origin of Immuron’s antibodies, which enables Immuron to commercialize its platform derived products through a range of regulatory pathways, including prescription (Rx), medical foods, over-the-counter (OTC) medicines, and dietary supplements. The Company has received clearance from the FDA to commence a Phase IIb clinical trial for its NASH product (IMM-124E), a potential blockbuster, in less than three years from commencing its NASH R&D program. Additionally, Immuron has one marketed product (Travelan, for the prevention of travelers’ diarrhea) and a pipeline of products at various stages of clinical and earlier development. Visit RedChip.com for more information.
This document provides details about Priya Bhatavadekar's experience and credentials working in medico-marketing in the pharmaceutical industry over the past 15 years. She currently runs her own consultancy firm, Priomed Consultants, which provides various services to pharmaceutical companies such as product development, marketing strategies, and medical education. Priomed Consultants works with both large multinational companies and Indian pharmaceutical firms across multiple therapy areas.
(2286) World Orphan Drug Congress USA 2016 A4 32 Page Brochure 1.5 SCREEN SPREADPinky Fadullon
This document provides information about the 6th Annual Global Orphan Drug Conference and Expo taking place April 21-22, 2016 in Washington D.C. The conference will bring together stakeholders in the orphan drug industry including pharmaceutical companies, patient advocacy groups, regulators, payers, and investors. It will include keynote sessions, workshops on topics like market forecasting and commercialization, and networking opportunities. A pre-conference day of workshops is scheduled for April 20th.
This document provides information about the 9th Pharmacovigilance conference happening on September 2nd, 2015 in Mumbai, India. It lists the conference organizers, speakers, sponsors, and themes to be discussed. The conference will bring together pharmaceutical and biotech representatives to discuss drug safety, legislation, audits, signal detection and other pharmacovigilance topics. Attendees will include leaders in pharmacovigilance, drug safety, clinical research, and regulatory affairs from various companies. The goal of the event is to help professionals stay up-to-date on best practices and network with others in the industry.
CAREER OVERVIEW
I am a pharmaceutical management professional with experience of 8 years in the pharmaceutical sales and marketing, 1.5 years in administrative corporate management, 5 years in the research and development innovation project management, 1.5 years as a Medical Director, and one year as a CRO Managing Director. I have worked in multinational and Egyptian pharmaceutical companies with a proven track record of developing new business and motivating cross-functional teams to consistently achieve action plans. I've completed a Doctorate of Business Administration with distinction and looking for interesting opportunities in the pharmaceutical research field in which my skills set can add value to an organization with the goal of benefiting humanity. I am willing to relocate.
This document provides an outline for a report on the Indian pharmaceutical trade and distribution channels. It begins with an introduction to the large size and growth of the Indian pharma industry. Section 2 discusses the growth trends in pharma exports by region, country, and category. Section 3 covers favorable government policies supporting the industry. Section 4 notes declining imports. Sections 5-7 analyze the distribution channel in India and changes occurring. Sections 8-9 evaluate the distribution channel's effectiveness and efficiency. The document concludes with sections on potential improvements to the distribution model and an overview of emerging e-pharmacy models.
Bill Hatfield is a biotechnology executive with over 20 years of experience in oncology leadership, commercial development, and marketing. He has led the commercial development and US launches of 10 oncology products, including Velcade at Millennium Pharmaceuticals where he achieved $100 million in sales in the first year. Currently he is Senior Vice President of Commercial Development at Karyopharm Therapeutics, leading the commercialization of Selinexor as a potential therapy for hematological malignancies and solid tumors.
The document outlines regulatory guidelines for promotion of prescription drugs in India established by the Organization of Pharmaceutical Producers of India (OPPI). The guidelines set standards for ethical promotion of drugs to healthcare professionals and require all promotional materials to include key product information. The guidelines do not regulate direct-to-consumer advertising or promotion of over-the-counter drugs.
The document provides information about the 9th Pharmacovigilance Conference to be held on September 2nd, 2015 in Mumbai, India. It discusses key themes that will be covered including legislation, audits, signal detection, patient safety, and the developing regulatory framework. It outlines the agenda with topics such as PV for biologics, challenges in PV lifecycle management, and the necessary shift of sponsors and CROs from adversaries to partners. The conference aims to bring together representatives from the pharmaceutical industry and regulatory bodies to address issues in pharmacovigilance and risk management. It is intended to help attendees expand their knowledge and network with industry leaders.
This document provides details about Priya Bhatavadekar's experience and credentials working in medico-marketing in the pharmaceutical industry over the past 15 years. She currently runs her own consultancy firm, Priomed Consultants, which provides various services to pharmaceutical companies such as product development, marketing strategies, and medical education. Priomed Consultants works with both large multinational companies and Indian pharmaceutical firms across multiple therapy areas.
(2286) World Orphan Drug Congress USA 2016 A4 32 Page Brochure 1.5 SCREEN SPREADPinky Fadullon
This document provides information about the 6th Annual Global Orphan Drug Conference and Expo taking place April 21-22, 2016 in Washington D.C. The conference will bring together stakeholders in the orphan drug industry including pharmaceutical companies, patient advocacy groups, regulators, payers, and investors. It will include keynote sessions, workshops on topics like market forecasting and commercialization, and networking opportunities. A pre-conference day of workshops is scheduled for April 20th.
This document provides information about the 9th Pharmacovigilance conference happening on September 2nd, 2015 in Mumbai, India. It lists the conference organizers, speakers, sponsors, and themes to be discussed. The conference will bring together pharmaceutical and biotech representatives to discuss drug safety, legislation, audits, signal detection and other pharmacovigilance topics. Attendees will include leaders in pharmacovigilance, drug safety, clinical research, and regulatory affairs from various companies. The goal of the event is to help professionals stay up-to-date on best practices and network with others in the industry.
CAREER OVERVIEW
I am a pharmaceutical management professional with experience of 8 years in the pharmaceutical sales and marketing, 1.5 years in administrative corporate management, 5 years in the research and development innovation project management, 1.5 years as a Medical Director, and one year as a CRO Managing Director. I have worked in multinational and Egyptian pharmaceutical companies with a proven track record of developing new business and motivating cross-functional teams to consistently achieve action plans. I've completed a Doctorate of Business Administration with distinction and looking for interesting opportunities in the pharmaceutical research field in which my skills set can add value to an organization with the goal of benefiting humanity. I am willing to relocate.
This document provides an outline for a report on the Indian pharmaceutical trade and distribution channels. It begins with an introduction to the large size and growth of the Indian pharma industry. Section 2 discusses the growth trends in pharma exports by region, country, and category. Section 3 covers favorable government policies supporting the industry. Section 4 notes declining imports. Sections 5-7 analyze the distribution channel in India and changes occurring. Sections 8-9 evaluate the distribution channel's effectiveness and efficiency. The document concludes with sections on potential improvements to the distribution model and an overview of emerging e-pharmacy models.
Bill Hatfield is a biotechnology executive with over 20 years of experience in oncology leadership, commercial development, and marketing. He has led the commercial development and US launches of 10 oncology products, including Velcade at Millennium Pharmaceuticals where he achieved $100 million in sales in the first year. Currently he is Senior Vice President of Commercial Development at Karyopharm Therapeutics, leading the commercialization of Selinexor as a potential therapy for hematological malignancies and solid tumors.
The document outlines regulatory guidelines for promotion of prescription drugs in India established by the Organization of Pharmaceutical Producers of India (OPPI). The guidelines set standards for ethical promotion of drugs to healthcare professionals and require all promotional materials to include key product information. The guidelines do not regulate direct-to-consumer advertising or promotion of over-the-counter drugs.
The document provides information about the 9th Pharmacovigilance Conference to be held on September 2nd, 2015 in Mumbai, India. It discusses key themes that will be covered including legislation, audits, signal detection, patient safety, and the developing regulatory framework. It outlines the agenda with topics such as PV for biologics, challenges in PV lifecycle management, and the necessary shift of sponsors and CROs from adversaries to partners. The conference aims to bring together representatives from the pharmaceutical industry and regulatory bodies to address issues in pharmacovigilance and risk management. It is intended to help attendees expand their knowledge and network with industry leaders.
Immuron Ltd. (NASDAQ: IMRN; ASX: IMC), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases. Immuron’s technology platform utilizes highly specific vaccines for the generation of hyperimmune antibody-rich bovine colostrum, providing a means of antimicrobial therapy without the drawbacks of antibiotics to treat gut-mediated diseases. To learn more, visit IMRNinfo.com.
Immuron Ltd. (NASDAQ: IMRN; ASX: IMC), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases. Immuron’s technology platform utilizes highly specific vaccines for the generation of hyperimmune antibody-rich bovine colostrum, providing a means of antimicrobial therapy without the drawbacks of antibiotics to treat gut-mediated diseases. To learn more, visit IMRNinfo.com.
Immuron Ltd is an Australian biopharmaceutical company focused on immunotherapy using dairy-derived antibody products for humans. Immuron has a unique and versatile technology platform that is capable of generating a wide range of products, all with a high safety profile. The versatility of Immuron’s platform technology enables the development of medicines that target a large range of medical needs, including infectious diseases, immune mediated disorders, and cancers. The versatility is also a function of the dairy origin of Immuron’s antibodies, which enables Immuon to commercialize its platform derived products through a range of regulatory pathways, including prescription (Rx), medical foods, over-the-counter (OTC) medicines, and dietary supplements. The Company has received clearance from the FDA to commence a Phase IIb clinical trial for its NASH product (IMM-124E), a potential blockbuster, in less than three years from commencing its NASH R&D program. Additionally, Immuron has one marketed product (Travelan, for the prevention of travelers’ diarrhea) and a pipeline of products at various stages of clinical and earlier development.
Immuron is presenting an overview of their company and investment opportunities. They have a unique oral immunotherapy platform targeting the microbiome and inflammation with potential in various indications. Their lead program is in NASH (non-alcoholic steatohepatitis), where their drug IMM-124E has shown in preclinical and clinical trials to reduce liver inflammation and fibrosis by binding to LPS (bacterial endotoxin) and promoting regulatory T-cells. Phase 2 trials in NASH are ongoing with results expected in late 2016 to early 2017. Immuron is also developing a vaccine for C. difficile and generates revenues from their traveler's diarrhea drug Travelan. They highlight the significant commercial potential of NASH which is estimated
Immuron Limited (NASDAQ: IMRN; ASX: IMC), is an Australian biopharmaceutical
company focused on developing and commercializing orally delivered polyclonal antibodies
for the treatment of inflammatory mediated and infectious diseases. Immuron’s technology
platform utilizes highly specific vaccines for the generation of hyperimmune antibody-rich
bovine colostrum, providing a means of antimicrobial therapy without the drawbacks of
antibiotics to treat gut-mediated diseases. The Company currently markets Travelan®, which
is a listed medicine on the Australian Register for Therapeutic Goods, in Australia to reduce
the risk of travelers’ diarrhea (TD). In Canada, Travelan® is a licensed natural health
product and is indicated to reduce the risk of travelers’ diarrhea. In the U.S. Travelan® is
sold as a dietary supplement for digestive-tract protection. Immuron recently announced
plans to pursue clinical development of its lead drug candidate, IMM-124E, through a formal
FDA registration pathway as a drug to specifically prevent TD. Immuron’s second clinicalstage asset, IMM-529, targets Clostridium difficile infections (CDI), and is presently in a
clinical trial in CDI patients.
Immuron is presenting an overview of their company and investment opportunities. They have a unique oral immunotherapy platform targeting the microbiome and inflammation with potential in various indications. Their lead program is in NASH (non-alcoholic steatohepatitis), where their drug IMM-124E has shown potential in preclinical and clinical studies to reduce liver inflammation and fibrosis through its anti-LPS and regulatory T-cell promoting properties. They are also developing a vaccine against C. difficile and have an approved traveler's diarrhea drug called Travelan that is generating revenues. Immuron believes they are significantly undervalued given their pipeline, which includes programs targeting large markets like NASH estimated at $35-40 billion by
Immuron Ltd. (NASDAQ: IMRN; ASX: IMC), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases. Immuron’s technology platform utilizes highly specific vaccines for the generation of hyperimmune antibody-rich bovine colostrum, providing a means of antimicrobial therapy without the drawbacks of antibiotics to treat gut-mediated diseases. To learn more, visit IMRNinfo.com.
Immuron Ltd. (NASDAQ: IMRN; ASX: IMC), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases. Immuron’s technology platform utilizes highly specific vaccines for the generation of hyperimmune antibody-rich bovine colostrum, providing a means of antimicrobial therapy without the drawbacks of antibiotics to treat gut-mediated diseases.
This document provides a company presentation by Dan Peres, MD, Senior VP of Innovation at Immuron. It begins with a forward-looking statement noting that certain statements in the presentation are based on estimates and projections and are subject to risks. The presentation then discusses Immuron's oral immunotherapy approach, which aims to alter the systemic immune system using ingestible compounds to target the innate immune system of the gut and promote regulatory T cells to suppress inflammation. Key products in Immuron's pipeline include IMM-124E for fatty liver disease, diabetes, and Clostridium difficile, as well as IMM-529 specifically for Clostridium difficile. The presentation concludes with an overview of Immuron's corporate
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.
09 CeoMeeting- Session 4- Medicines for MalariaMLSCF
The document discusses product development partnerships (PDPs) that work to develop medicines and treatments for diseases that disproportionately impact developing countries and have limited commercial incentives. It provides Medicine for Malaria Venture (MMV) as a key example of a PDP focused on developing antimalarial drugs. MMV has developed over a dozen antimalarial candidates and products over its existence, including a pediatric-friendly version of Coartem through partnerships with Novartis. PDPs have grown substantially over the past decade and play a central role in driving neglected disease product pipelines.
This document provides a summary of a teleconference on the need for technology innovations for reaching target patients. It discusses:
- How pharmaceutical marketing is shifting from HCP-centric to patient-centric approaches. Technology provides new opportunities but also regulatory challenges.
- Case studies of initiatives by various pharmaceutical companies to engage patients directly through online communities, mobile technologies, and public awareness campaigns. These aim to educate patients while building trust.
- Recommendations for pharmaceutical marketing include taking participatory, collaborative, and category-building approaches while navigating regulatory guidelines and innovating with new technologies. Direct consumer outreach can help build disease awareness.
Immuron provided a company update for the first half of 2016. Key developments included reaching 50% recruitment milestones in its Phase 2 NASH trial, initiating a pediatric NASH study, and reporting highly successful pre-clinical data for IMM-529 in treating C. difficile that demonstrated efficacy without antibiotics. The company also started pre-clinical programs in colitis and collaborated with the US Army on a Shigella vaccine. In its OTC business, Immuron expanded its US customer and retail footprint and launched products in China through an e-commerce partnership. Upcoming milestones include reporting interim NASH results in 4Q2016 and initiating the Phase 1 C. difficile trial.
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
1. FDA's Medwatch program allows reporting of adverse events from medical products to help identify safety concerns, with reports on Zyvox and Levoxine/LANOXIN leading to label changes.
2. It is important to report serious adverse events, therapeutic failures, use errors, and product quality issues to the FDA to maintain the Medwatch system.
3. The iPLEDGE program imposed stricter controls on isotretinoin due to depression and suicide risks, requiring registration of prescribers, pharmacies, patients.
This document contains forward-looking statements about ChromaDex's expected sales, financial performance, products, and commercialization opportunities in various markets. It discusses ChromaDex's patented ingredient technologies including NIAGENTM, a nicotinamide riboside ingredient, and PURENERGYTM, a patented combination of pterostilbene and caffeine. The document notes recent regulatory scrutiny of energy drinks and how PURENERGYTM could help reduce caffeine content while maintaining energy benefits. It summarizes ChromaDex's commercialization progress for NIAGENTM including a large supply agreement and initial customer adoption.
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...Pristyn Research Solutions
Quick Job interview short guide For Pharma and all Life science jobseekers.All Medical | Biotech |Micro |B.Sc., M.Sc.
These are the commonly asked questions with their answers asked in job interviews. The file was updated in 2022.
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Sample Questions are:
What is Pharmacovigilance (PV)?
What are the objectives of PV?
What is MedDRA?
WHAT ARE THE Role of Drug Safety
Associate?
What should narratives consist of?
What are Data assessments in PV?
Which products are covered by PV?
Methods of signal detection?
Why PV is required after clinical
trial?
What is an Adverse Drug Event (ADE)?
What
is the minimum criterion required
for a valid case according to WHO?
When
do you consider an event to be
serious?
What do you mean by causality?
Types of
Unsolicited reports
Sources of Solicited Reports
Name the core regulatory bodies
What is Volume 9A
What do you know
about E2a, E2b and E2c guidelines?
When do you consider a case to be medically confirmed?
What is CemFlow?
What is the yellow card in PV?
What are Comorbid conditions?
What is a medication error?
What is a signal?
Rechallenge
Dechallenge
What are WHO ART, WHO DD and MedDRA and the difference between them?
What is SUSAR?
Adverse Drug Reaction (ADR)
Effectiveness/risk
harm
Essential medicines
Frequency of ADRs
Individual Case Safety Report
ADR Reporting process in PV
VigiFlow
VigiMed
ABBOTTS
COGNIZANT
I 3 GLOBAL DRUG
SAFETY
LAURUS LABS
PARAXEL
SRISTEK
ACCENTURE
CREST.
I GATE PATNI
COMPUTERS
MAHINDRA
SATYAMBSG
PIRAMAL
SUN
PHARMA
ALEMBIC
DIAGNOSEAR
CH
ICON
MAKROCARE
PPD
SYMOGEN
APC PHARMA.
DR REDDY’S
iMEDGlobal,
MANKIND
QUANTUM
SOLUTIONS
SYNOGEN
APCER
ECRON
ACUNOVA
IMS HEALTH
MEDHIMALAYAS
QUINTILES
TAKE
SOLUTIONS
APCER
EMCURE
INC RESEARCH
MEDPACE.
SCIFORMIX
RATIOPHARM
TCS
ASTRAZENECA
FDC
Infocorp
Soft
Solutions
MICRO LABS
RX MD
THOMSON
REUTERS
AUROBINDO
FORTIS
HEALTH CARE
INVENTIVE
MSD (MERCK)
SANTHA
BIOTECH
USV
LIMITED
BESTOCHEM
G7 INFOTECH
IPCA
LABORATORIES
NEKTAR
THERAPEUTICS
SCIFORMIX.
VIMTA LABS
BIOCAD
GENPACT
IPLEX
NORWICH
CLINICAL SERVICES
SHANTHA
BIOTECHNICS
WIPRO
BIOCON
GRANULES
JUBILIANT
BIOSYS NOVARTIS
SIRO
CLINPHARM
WNS
BIOLOGICAL E.
LTD
GVK
KINAPSE
NOVO NORDISK
SP softtech
WOCKHARD
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BLUEFISH
HCL
LAMBDA
OMNICARECLINICA
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SRI KRISHNA
PHARMA
4C
Pharma
Solutions
Disseminate Clinical Data Early to Support Payer Coverage DecisionsTodd Berner MD
This document summarizes Todd Berner's presentation on early dissemination of clinical data to support payer coverage decisions. The presentation discusses comparative effectiveness research standards and how cost, comparators, and ambiguous results should be handled. It also addresses tailoring drug development to patient heterogeneity and biomarkers. Developing an open dialogue with payers throughout drug development is emphasized to demonstrate clinical and economic value. Field teams can establish relationships, disseminate outcomes data, and conduct research to support products. The goal is for clinical programs to demonstrate value through meaningful endpoints and real-world evidence.
Global vaccine market Keyword Market PPT 2021-26 | Enhancing Huge Growth and ...IMARC Group
According to the latest report by IMARC Group the global vaccine market size reached a strong growth in 2020.One of the leading trends witnessed in the global vaccines market is the surging cases of the coronavirus disease (COVID-19), which has, till date, resulted in the loss of around half a million lives around the world Looking forward, the market value is projected to reach a strong growth during the forecast period (2021-2026).
- Pharmacists play an important role during public health emergencies like the COVID-19 pandemic. They provide services both in hospitals and communities. In hospitals, pharmacists' duties expand to focused care of COVID-19 patients and ensuring adequate drug supply. They are an important part of the medical team. In communities, pharmacists educate the public and promote preventive measures. Pharmacists are accessible healthcare professionals that can help reduce disease burden.
Based in Ann Arbor, Michigan, Zomedica is a veterinary health company creating diagnostic and therapeutic products for horses, dogs, and cats by focusing on the unmet needs of clinical veterinarians. With modest cash burn and a strong balance sheet, including $142.4 million cash and cash equivalents as of June 30, 2023, Zomedica is well-positioned to fund both organic growth and acquisitions.
Docola has developed a healthcare communication platform that utilizes asynchronous telehealth to deliver patient education and support. Their proprietary platform currently has over 55,000 patient users and over 1,100 clinician users. Docola seeks to raise up to $500,000 through a convertible note to fund working capital, research and development, and costs associated with an upcoming IPO.
Immuron Ltd. (NASDAQ: IMRN; ASX: IMC), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases. Immuron’s technology platform utilizes highly specific vaccines for the generation of hyperimmune antibody-rich bovine colostrum, providing a means of antimicrobial therapy without the drawbacks of antibiotics to treat gut-mediated diseases. To learn more, visit IMRNinfo.com.
Immuron Ltd. (NASDAQ: IMRN; ASX: IMC), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases. Immuron’s technology platform utilizes highly specific vaccines for the generation of hyperimmune antibody-rich bovine colostrum, providing a means of antimicrobial therapy without the drawbacks of antibiotics to treat gut-mediated diseases. To learn more, visit IMRNinfo.com.
Immuron Ltd is an Australian biopharmaceutical company focused on immunotherapy using dairy-derived antibody products for humans. Immuron has a unique and versatile technology platform that is capable of generating a wide range of products, all with a high safety profile. The versatility of Immuron’s platform technology enables the development of medicines that target a large range of medical needs, including infectious diseases, immune mediated disorders, and cancers. The versatility is also a function of the dairy origin of Immuron’s antibodies, which enables Immuon to commercialize its platform derived products through a range of regulatory pathways, including prescription (Rx), medical foods, over-the-counter (OTC) medicines, and dietary supplements. The Company has received clearance from the FDA to commence a Phase IIb clinical trial for its NASH product (IMM-124E), a potential blockbuster, in less than three years from commencing its NASH R&D program. Additionally, Immuron has one marketed product (Travelan, for the prevention of travelers’ diarrhea) and a pipeline of products at various stages of clinical and earlier development.
Immuron is presenting an overview of their company and investment opportunities. They have a unique oral immunotherapy platform targeting the microbiome and inflammation with potential in various indications. Their lead program is in NASH (non-alcoholic steatohepatitis), where their drug IMM-124E has shown in preclinical and clinical trials to reduce liver inflammation and fibrosis by binding to LPS (bacterial endotoxin) and promoting regulatory T-cells. Phase 2 trials in NASH are ongoing with results expected in late 2016 to early 2017. Immuron is also developing a vaccine for C. difficile and generates revenues from their traveler's diarrhea drug Travelan. They highlight the significant commercial potential of NASH which is estimated
Immuron Limited (NASDAQ: IMRN; ASX: IMC), is an Australian biopharmaceutical
company focused on developing and commercializing orally delivered polyclonal antibodies
for the treatment of inflammatory mediated and infectious diseases. Immuron’s technology
platform utilizes highly specific vaccines for the generation of hyperimmune antibody-rich
bovine colostrum, providing a means of antimicrobial therapy without the drawbacks of
antibiotics to treat gut-mediated diseases. The Company currently markets Travelan®, which
is a listed medicine on the Australian Register for Therapeutic Goods, in Australia to reduce
the risk of travelers’ diarrhea (TD). In Canada, Travelan® is a licensed natural health
product and is indicated to reduce the risk of travelers’ diarrhea. In the U.S. Travelan® is
sold as a dietary supplement for digestive-tract protection. Immuron recently announced
plans to pursue clinical development of its lead drug candidate, IMM-124E, through a formal
FDA registration pathway as a drug to specifically prevent TD. Immuron’s second clinicalstage asset, IMM-529, targets Clostridium difficile infections (CDI), and is presently in a
clinical trial in CDI patients.
Immuron is presenting an overview of their company and investment opportunities. They have a unique oral immunotherapy platform targeting the microbiome and inflammation with potential in various indications. Their lead program is in NASH (non-alcoholic steatohepatitis), where their drug IMM-124E has shown potential in preclinical and clinical studies to reduce liver inflammation and fibrosis through its anti-LPS and regulatory T-cell promoting properties. They are also developing a vaccine against C. difficile and have an approved traveler's diarrhea drug called Travelan that is generating revenues. Immuron believes they are significantly undervalued given their pipeline, which includes programs targeting large markets like NASH estimated at $35-40 billion by
Immuron Ltd. (NASDAQ: IMRN; ASX: IMC), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases. Immuron’s technology platform utilizes highly specific vaccines for the generation of hyperimmune antibody-rich bovine colostrum, providing a means of antimicrobial therapy without the drawbacks of antibiotics to treat gut-mediated diseases. To learn more, visit IMRNinfo.com.
Immuron Ltd. (NASDAQ: IMRN; ASX: IMC), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases. Immuron’s technology platform utilizes highly specific vaccines for the generation of hyperimmune antibody-rich bovine colostrum, providing a means of antimicrobial therapy without the drawbacks of antibiotics to treat gut-mediated diseases.
This document provides a company presentation by Dan Peres, MD, Senior VP of Innovation at Immuron. It begins with a forward-looking statement noting that certain statements in the presentation are based on estimates and projections and are subject to risks. The presentation then discusses Immuron's oral immunotherapy approach, which aims to alter the systemic immune system using ingestible compounds to target the innate immune system of the gut and promote regulatory T cells to suppress inflammation. Key products in Immuron's pipeline include IMM-124E for fatty liver disease, diabetes, and Clostridium difficile, as well as IMM-529 specifically for Clostridium difficile. The presentation concludes with an overview of Immuron's corporate
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.
09 CeoMeeting- Session 4- Medicines for MalariaMLSCF
The document discusses product development partnerships (PDPs) that work to develop medicines and treatments for diseases that disproportionately impact developing countries and have limited commercial incentives. It provides Medicine for Malaria Venture (MMV) as a key example of a PDP focused on developing antimalarial drugs. MMV has developed over a dozen antimalarial candidates and products over its existence, including a pediatric-friendly version of Coartem through partnerships with Novartis. PDPs have grown substantially over the past decade and play a central role in driving neglected disease product pipelines.
This document provides a summary of a teleconference on the need for technology innovations for reaching target patients. It discusses:
- How pharmaceutical marketing is shifting from HCP-centric to patient-centric approaches. Technology provides new opportunities but also regulatory challenges.
- Case studies of initiatives by various pharmaceutical companies to engage patients directly through online communities, mobile technologies, and public awareness campaigns. These aim to educate patients while building trust.
- Recommendations for pharmaceutical marketing include taking participatory, collaborative, and category-building approaches while navigating regulatory guidelines and innovating with new technologies. Direct consumer outreach can help build disease awareness.
Immuron provided a company update for the first half of 2016. Key developments included reaching 50% recruitment milestones in its Phase 2 NASH trial, initiating a pediatric NASH study, and reporting highly successful pre-clinical data for IMM-529 in treating C. difficile that demonstrated efficacy without antibiotics. The company also started pre-clinical programs in colitis and collaborated with the US Army on a Shigella vaccine. In its OTC business, Immuron expanded its US customer and retail footprint and launched products in China through an e-commerce partnership. Upcoming milestones include reporting interim NASH results in 4Q2016 and initiating the Phase 1 C. difficile trial.
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
1. FDA's Medwatch program allows reporting of adverse events from medical products to help identify safety concerns, with reports on Zyvox and Levoxine/LANOXIN leading to label changes.
2. It is important to report serious adverse events, therapeutic failures, use errors, and product quality issues to the FDA to maintain the Medwatch system.
3. The iPLEDGE program imposed stricter controls on isotretinoin due to depression and suicide risks, requiring registration of prescribers, pharmacies, patients.
This document contains forward-looking statements about ChromaDex's expected sales, financial performance, products, and commercialization opportunities in various markets. It discusses ChromaDex's patented ingredient technologies including NIAGENTM, a nicotinamide riboside ingredient, and PURENERGYTM, a patented combination of pterostilbene and caffeine. The document notes recent regulatory scrutiny of energy drinks and how PURENERGYTM could help reduce caffeine content while maintaining energy benefits. It summarizes ChromaDex's commercialization progress for NIAGENTM including a large supply agreement and initial customer adoption.
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...Pristyn Research Solutions
Quick Job interview short guide For Pharma and all Life science jobseekers.All Medical | Biotech |Micro |B.Sc., M.Sc.
These are the commonly asked questions with their answers asked in job interviews. The file was updated in 2022.
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Sample Questions are:
What is Pharmacovigilance (PV)?
What are the objectives of PV?
What is MedDRA?
WHAT ARE THE Role of Drug Safety
Associate?
What should narratives consist of?
What are Data assessments in PV?
Which products are covered by PV?
Methods of signal detection?
Why PV is required after clinical
trial?
What is an Adverse Drug Event (ADE)?
What
is the minimum criterion required
for a valid case according to WHO?
When
do you consider an event to be
serious?
What do you mean by causality?
Types of
Unsolicited reports
Sources of Solicited Reports
Name the core regulatory bodies
What is Volume 9A
What do you know
about E2a, E2b and E2c guidelines?
When do you consider a case to be medically confirmed?
What is CemFlow?
What is the yellow card in PV?
What are Comorbid conditions?
What is a medication error?
What is a signal?
Rechallenge
Dechallenge
What are WHO ART, WHO DD and MedDRA and the difference between them?
What is SUSAR?
Adverse Drug Reaction (ADR)
Effectiveness/risk
harm
Essential medicines
Frequency of ADRs
Individual Case Safety Report
ADR Reporting process in PV
VigiFlow
VigiMed
ABBOTTS
COGNIZANT
I 3 GLOBAL DRUG
SAFETY
LAURUS LABS
PARAXEL
SRISTEK
ACCENTURE
CREST.
I GATE PATNI
COMPUTERS
MAHINDRA
SATYAMBSG
PIRAMAL
SUN
PHARMA
ALEMBIC
DIAGNOSEAR
CH
ICON
MAKROCARE
PPD
SYMOGEN
APC PHARMA.
DR REDDY’S
iMEDGlobal,
MANKIND
QUANTUM
SOLUTIONS
SYNOGEN
APCER
ECRON
ACUNOVA
IMS HEALTH
MEDHIMALAYAS
QUINTILES
TAKE
SOLUTIONS
APCER
EMCURE
INC RESEARCH
MEDPACE.
SCIFORMIX
RATIOPHARM
TCS
ASTRAZENECA
FDC
Infocorp
Soft
Solutions
MICRO LABS
RX MD
THOMSON
REUTERS
AUROBINDO
FORTIS
HEALTH CARE
INVENTIVE
MSD (MERCK)
SANTHA
BIOTECH
USV
LIMITED
BESTOCHEM
G7 INFOTECH
IPCA
LABORATORIES
NEKTAR
THERAPEUTICS
SCIFORMIX.
VIMTA LABS
BIOCAD
GENPACT
IPLEX
NORWICH
CLINICAL SERVICES
SHANTHA
BIOTECHNICS
WIPRO
BIOCON
GRANULES
JUBILIANT
BIOSYS NOVARTIS
SIRO
CLINPHARM
WNS
BIOLOGICAL E.
LTD
GVK
KINAPSE
NOVO NORDISK
SP softtech
WOCKHARD
T
BLUEFISH
HCL
LAMBDA
OMNICARECLINICA
L RESEARCH
SRI KRISHNA
PHARMA
4C
Pharma
Solutions
Disseminate Clinical Data Early to Support Payer Coverage DecisionsTodd Berner MD
This document summarizes Todd Berner's presentation on early dissemination of clinical data to support payer coverage decisions. The presentation discusses comparative effectiveness research standards and how cost, comparators, and ambiguous results should be handled. It also addresses tailoring drug development to patient heterogeneity and biomarkers. Developing an open dialogue with payers throughout drug development is emphasized to demonstrate clinical and economic value. Field teams can establish relationships, disseminate outcomes data, and conduct research to support products. The goal is for clinical programs to demonstrate value through meaningful endpoints and real-world evidence.
Global vaccine market Keyword Market PPT 2021-26 | Enhancing Huge Growth and ...IMARC Group
According to the latest report by IMARC Group the global vaccine market size reached a strong growth in 2020.One of the leading trends witnessed in the global vaccines market is the surging cases of the coronavirus disease (COVID-19), which has, till date, resulted in the loss of around half a million lives around the world Looking forward, the market value is projected to reach a strong growth during the forecast period (2021-2026).
- Pharmacists play an important role during public health emergencies like the COVID-19 pandemic. They provide services both in hospitals and communities. In hospitals, pharmacists' duties expand to focused care of COVID-19 patients and ensuring adequate drug supply. They are an important part of the medical team. In communities, pharmacists educate the public and promote preventive measures. Pharmacists are accessible healthcare professionals that can help reduce disease burden.
Similar to Immuron Corp Presentation 5.05.2019 (20)
Based in Ann Arbor, Michigan, Zomedica is a veterinary health company creating diagnostic and therapeutic products for horses, dogs, and cats by focusing on the unmet needs of clinical veterinarians. With modest cash burn and a strong balance sheet, including $142.4 million cash and cash equivalents as of June 30, 2023, Zomedica is well-positioned to fund both organic growth and acquisitions.
Docola has developed a healthcare communication platform that utilizes asynchronous telehealth to deliver patient education and support. Their proprietary platform currently has over 55,000 patient users and over 1,100 clinician users. Docola seeks to raise up to $500,000 through a convertible note to fund working capital, research and development, and costs associated with an upcoming IPO.
- INNO Holdings is presenting an IPO investor presentation for an initial public offering on the NASDAQ Capital Market.
- The company manufactures prefabricated steel building components and systems using proprietary technology to reduce construction costs and environmental impact.
- INNO Holdings has four initial product lines - metal studs, prefabricated housing units, modular apartment buildings, and a mobile factory system. It aims to disrupt the construction industry through standardized, sustainable construction methods.
Everything Blockchain builds platforms of trust for the modern enterprise and is on a mission to ensure every organization has access to the tools and platforms that enable them to manage, store, and protect data without the cost and complexity that holds them back today. The Company’s patented advances in engineering deliver the essential elements needed for real-world business use: speed, security, and efficiency. Everything Blockchain’s current business lines include: EB Advise, Build DB and EB Control.
ASP Isotope is an isotope enrichment company utilizing technology developed in South Africa over the past 20 years to enrich isotopes of elements or molecules with low atomic masses. Many of these elements are unsuitable for enrichment using traditional methods such as centrifuges. The Company’s initial focus is on producing and commercializing highly enriched isotopes for the healthcare and technology industries.
MDNA Life Sciences is a pioneer in the science of mitochondrial DNA. It’s our mission to create an extensive portfolio of proprietary tests that dramatically improve diagnosis, treatment, prognosis and monitoring. Putting an end to the unnecessary surgical procedures, pain and uncertainty that affect patients across the world.
Digital Ally, Inc. is a diversified holding company with operations in video solution technology, human and animal health protection products, healthcare revenue cycle management, ticket brokering and marketing, and event production. The Company pursues an acquisition strategy that targets organizations with positive earnings, strong growth potential, innovation, and operational synergies. To maximize long-term shareholder value, Digital Ally intends to spin-off its ticketing and entertainment business lines into a separate public company in 2023. The spin-off will create two optimized, tech-driven public companies with strong growth opportunities and operating metrics.
Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 25 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The Company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and is on track to launch this new product line in Q4 2023. The Company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US.
Aditxt is a biotech company developing immune monitoring and immune modulation platforms. Its AditxtScore platform can provide comprehensive immune profiles to monitor responses to pathogens, vaccines, drugs and transplants. Its Adimune platform aims to modulate the immune system to treat conditions like psoriasis, type 1 diabetes, and increase skin allograft survival. The company is working to develop, operate and commercialize these platforms. It currently generates revenue from immune monitoring tests and expects revenue from licensing deals for immune modulation programs as they advance in clinical trials towards commercialization.
1847 Holdings LLC, a publicly traded diversified acquisition holding company, was founded by Ellery W. Roberts, a former partner of Parallel Investment Partners, Saunders Karp & Megrue and Principal of Lazard Freres Strategic Realty Investors. EFSH's investment thesis is that capital market inefficiencies have left the founders and/or stakeholders of many small business enterprises and lower-middle market businesses with limited exit options, despite the intrinsic value of their business. Given this dynamic, EFSH can consistently acquire "solid" businesses for reasonable multiples of cash flow and then deploy resources to strengthen the infrastructure and systems to improve operations. These improvements may lead to a sale or IPO of an operating subsidiary at considerably higher valuations than the purchase price (as successfully demonstrated with the mid-2020 IPO of 1847 Goedeker on the NYSE American) and/or alternatively, an operating subsidiary may be held in perpetuity and contribute to EFSH's ability to pay regular and special dividends to shareholders.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The Company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and is on track to launch this new product line in Q4 2023. The Company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US.
SPI Energy is a global renewable energy company and provider of solar storage and electric vehicle (EV) solutions that was founded in 2006 in Roseville, California and is headquartered in McClellan Park, California. The Company has three core divisions: SolarJuice which has solar wholesale distribution, as well as residential solar and roofing installation and solar module manufacturing (Solar4America & SEM Wafertech), SPI Solar and Orange Power which operates a commercial & utility solar division, and the EdisonFuture/Phoenix Motor EV division. SolarJuice is the leader in renewable energy system solutions for residential and small commercial markets and has extensive operations in the Asia Pacific and North America markets. The SPI Solar commercial & utility solar division provides a full spectrum of EPC services to third party project developers, and develops, owns and operates solar projects that sell electricity to the grid in multiple regions, including the U.S., U.K., and Europe. Phoenix Motor is a leader in medium-duty commercial electric vehicles, and is developing EV charger solutions, electric pickup trucks, electric forklifts, and other EV products. SPI maintains global operations in North America, Australia, Asia and Europe and is also targeting strategic investment opportunities in fast growing green energy industries such as battery storage, charging stations, and other EVs which leverage the Company's expertise and substantial solar cash flow.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
BioVie is a clinical-stage company developing what it believes will be transformative therapies to overcome unmet medical needs in neurodegeneration and liver disease. The Company is developing NE3107 for Alzheimer’s (AD) and Parkinson’s (PD) and BIV201 for refractory ascites and HRS-AKI.
Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 25 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Genetic Technologies is a diversified molecular diagnostics company. A global leader in genomics-based tests in health, wellness and serious disease through its geneType and EasyDNA brands. GENE offers cancer predictive testing and assessment tools to help physicians to improve health outcomes for people around the world. The Company has a proprietary risk stratification platform that has been developed over the past decade and integrates clinical and genetic risk to deliver actionable outcomes to physicians and individuals. Leading the world in risk prediction in oncology, cardiovascular and metabolic diseases, Genetic Technologies continues to develop risk assessment products.
Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wines by the glass, SALT naturally flavored tequilas, Pulpoloco Sangria, and TapouT performance hydration and recovery drinks and TapouT Cognitive Energy Drink. Splash’s strategy is to rapidly develop early-stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution.
Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wines by the glass, SALT naturally flavored tequilas, Pulpoloco Sangria, and TapouT performance hydration and recovery drinks and TapouT Cognitive Energy Drink. Splash’s strategy is to rapidly develop early-stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
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1. 11
FORGING COMMERCIAL
& CLINICAL PATHWAYS
TARGETING INFECTIOUS DISEASES WITH ORAL
IMMUNOTHERAPIES – APRIL 2019
NASDAQ: IMRN
ASX: IMC
GARY S. JACOB, Ph.D.
CEO
2. 22
Certain statements made in this presentation are forward-looking statements and are based on Immuron’s
current expectations, estimates and projections. Words such as “anticipates,” “expects,” “intends,” “plans,”
“believes,” “seeks,” “estimates,” “guidance” and similar expressions are intended to identify forward-looking
statements.
Although Immuron believes the forward-looking statements are based on reasonable assumptions, they are
subject to certain risks and uncertainties, some of which are beyond Immuron’s control, including those risks
or uncertainties inherent in the process of both developing and commercializing technology. As a result, actual
results could materially differ from those expressed or forecasted in the forward-looking statements.
The forward-looking statements made in this presentation relate only to events as of the date on which the
statements are made. Immuron will not undertake any obligation to release publicly any revisions or updates
to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after
the date of this presentation except as required by law or by any appropriate regulatory authority.
SAFE HARBOR STATEMENT
3. 33
MARKET INFORMATION
• Stock Price: $5.55
• Stock Symbol: NASDAQ: IMRN, ASX: IMC
• Fiscal Year: June
• Shares Outstanding: 3.58M ADS
• Market Cap: $19.8M
As of April 23, 2019
4. 44
MANAGEMENT
• Chief Executive Officer of Immuron Limited since November 16, 2018.
• Over 30 years of experience in pharmaceutical and biotechnology - including R&D, operations, business
development and capital financing.
• Co-founder and founding CEO of Synergy Pharmaceuticals.
• Co-inventor of TRULANCE® (plecanatide), an FDA approved drug to treat chronic GI disorders.
• Raised over USD $500 million of capital in the public markets to support Synergy from founding to
approval of TRULANCE® in 2017.
• Ph.D. in Biochemistry; University of Wisconsin-Madison and BS in Chemistry from the University of
Missouri.
• Former Acting CEO of Immuron Ltd. Over twenty years’ experience in pharmaceutical and
biotechnology industries.
• Former Chief Operating Officer of TransBio Ltd. Responsible for strategic identification, development
and maintenance of global commercial partnerships, along with development, management and IP
portfolio, R&D and technology transfer.
• Leadership roles in business development, project management, IP portfolio management, R&D,
senior management.
• Consultant to academic institutes, private and publicly listed companies and government
departments specializing in development and commercialization strategies.
• PhD in medicine from the University of Melbourne.
6. 66
COMPANY HIGHLIGHTS
We are a commercial and clinical-stage biopharmaceutical company focusing on
infectious diseases with oral immunoglobulin-based therapies.
Validated Technology Platform – with One Registered
Asset, Travelan® Generating Revenue
IMM-124E & IMM-529, in Phase 2 Development for
Treatment of Liver Disease and C. difficile Infections
Plan for Accelerated Regulatory Path to Approval for IMM-
124E (Travelan®) as Drug to Prevent Travelers’ Diarrhea in USA
7. 77
PLATFORM OVERVIEW: ORAL IMMUNOGLOBULINS
Development
of Highly
Specific
Vaccines
Isolation of
hyperimmune
antibody-rich
bovine
colostrum
Oral
Antimicrobial
therapeutics
without
drawbacks of
antibiotics
Toxin
Neutralization
+
Clearance of
targeted gut
pathogens
8. 88
US DOD R&D COLLABORATION AGREEMENTS
• Armed Forces Research Institute of Medical Sciences (AFRIMS) – June 2016
• Naval Medical Research Center (NMRC) – August 2016
• Walter Reed Army Institute of Research (WRAIR) – June 2016
• Travelan® binds 180 pathogenic strains of bacteria from infected personnel deployed in
Bhutan, Cambodia, Nepal and Thailand
Collaboration on Development of a Shigella-Specific Therapeutic
9. 99
DEVELOPMENT PIPELINE:TWO-PRONGED PLAN
DEVELOPMENT STAGE
HIGHLIGHTS
PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 MARKET
ANTI-INFLAMMATORY PROGRAMS
Travelan®
Commercial product - Australia
Commercial product - Canada
Commercial product - USA
IMM-124E (Travelan®)
PLAN TO DEVELOP AS DRUG TO
PREVENT TRAVELERS’ DIARRHEA
IN USA
IMM-529
TO PREVENT RECURRENCE IN
C. DIFFICILE PATIENTS
Dietary supplement (2015)
Health Canada NPN 80046016 (2015)
TGA ARTG Aust L106709 (2004)
10. 1010
BACKGROUND OFTRAVELAN®: PLANTO EXPAND USE
Marketed in Australia, USA
and Canada
Status with FDA:
IND open and active
COMMERCIAL PRODUCT DRUG CANDIDATE
IMM-124E
Plan to develop IMM-124E as an
approved drug to prevent Travelers’
Diarrhea
11. 1111
WHAT ISTRAVELERS’ DIARRHEA?
• Caused by consuming food or water infected
with pathogens. Three or more unformed stools
in 24 hours.
• Bacterial pathogens are the predominant risk1.
• Enterotoxigenic E. coli (ETEC) are the
predominant pathogens:
42% in Latin America
28% in Southeast Asia
• Up to 70% of travelers suffer from travelers’
diarrhea2.
1 - Steffen, R. 2017 Epidemiology of travelers’ diarrhea. Journal of Travel Medicine 24(1).
2 - CDC Yellow Book 2018, Chapter 2 Travelers’ Diarrhea.
12. 1212
TRAVELAN® COMMERCIAL PROFILE:
INCREASING SALES ADDRESSING LARGE MARKETS
Global market growing
At 7% CAGR from US$630M
in 2019 up to US$1B by 2025.
$1.38M
$2.01M
$2.68M
$0
$500,000
$1,000,000
$1,500,000
$2,000,000
$2,500,000
$3,000,000
FY17A FY18A FY19B
Immuron Sales
AUD
13. 1313
International Society of Travel Medicine, 2017 guidelines for treating Travelers’ Diarrhea included1:
• Antibiotics should NOT be used routinely, except patients at high risk of complications
• Rifaximin recommended when antibiotic prophylaxis is indicated
• Fluoroquinolones not recommended for prophylaxis2
• Insufficient evidence to recommend prebiotics or probiotics
1 Riddle et al. 2017. Guidelines for the prevention and treatment of travellers’ diarrhea: a graded expert panel report. Journal of Travel
Medicine 24(1).
2 Tribble, D. 2017 Resistant pathogens as causes of traveller’s diarrhea globally and impact(s) on treatment failure and recommendations.
Journal of Travel Medicine 24(1)
ANTIBIOTIC RESISTANCE: OPPORTUNITY FORTRAVELAN®
The opportunity: Travelan®, the alternative to antibiotic treatment of TD
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1
4
TRAVELAN® AS A DRUGTO PREVENTTRAVELERS’
DIARRHEA
Otto et al. 2011 Randomized Control Trials using a tablet formulation of hyperimmune bovine colostrum to
prevent diarrhea caused by ETEC in volunteers. Scandinavian Journal of Gastroenterology, 2011; 46: 862–868.
Oral challenge with O78
ETEC strain (H10407)
Diarrhea was defined as
passage of two or more
unformed stools during 48
hour period within 72 hours
of the challenge
•
RESULTS: Travelan® provided over 90% prophylactic
efficacy against diarrhea due to infection by the major
strain of E.coli that causes TD
PLACEBO
15
IMM-124E
400mg TID
15
STUDY 1: 30 participants• Travelan® evaluated in two
randomised, double-blind, placebo-
Controlled Human Infection Model
challenge clinical trials
• 90 healthy volunteers
• Published in Scandinavian Journal of
Gastroenterology
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“Travelan®” x 6 days
“Placebo” x 6 days
3 x109
S. flexneri
= last day of S. flexneri consecutive +ve stool culture
No Treatment x 8 days
RESULTS OFTRAVELAN® SHIGELLA CHALLENGE STUDY*
Travelan® group
Placebo control group
DAYS
1
1 2 3 4 5 6 7 8 9 10 11 12 13 14
*Collaboration with AFRIMS & WRAIR
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Revamp Travelan® for FDA approval as drug to prevent Travelers’ Diarrhea in
travelers to endemic areas:
IMM-124E DRUG DEVELOPMENT PLAN
Execute
Prevention Trial
and File
505(b)(2) BLA
File IND with
Single Double-
Blind & Placebo
Controlled Trial
for Prevention of
Travelers’
Diarrhea
Hold Pre-IND
Meeting to
Discuss Merits of
505(b)(2)
Application
Assimilate Data
to Support
Literature-Based
FDA Submission
17. 1717
US SALES FORECAST FORTRAVELAN®:
IF APPROVED AS DRUGTO PREVENTTD
MARKET POTENTIAL FOR TRAVELAN® SALES:
Market potential figure derived from:
2014 figures of US citizens traveling to high risk destinations for TD
(44.3 million)1 and obtaining pretravel advice (22.2 million)2. Sources
of pre-travel advice include primary care provider, travel medicine
specialist, company doctors, pharmacist, and travel agencies2. Our
forecast utilizes a very conservative estimate for % of US citizens
purchasing Travelan® after seeking pre-travel advice.
1. U.S. Department of Commerce, International Trade Administration, National Travel and Tourism Office. U.S. Citizen Traffic to Overseas Regions, Canada & Mexico 2014.
Monthly Statistics, U.S.Outbound Travel by World Regions. 2014. Available at: http://travel.trade.gov/view/m-2014-O-001/index.html. Accessed June 26, 2015.
2. Mathyas Wang , MD , Thomas D. Szucs , MD, MBA, MPH, LLM , and Robert Steffen , MD. Economic Aspects of Travelers ’ Diarrhea. Journal of Travel Medicine, Volume
15, Issue 2, 2008, 110–118
USD >$100 MILLION
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COMPETITOR MARKET ANALYSIS – ANTI-DIARRHEAL DRUGS
Drug Indication Dosing
Ave cost – 2
week trip
Revenue USD Millions (Year)
FDA APPROVED DRUG TREATMENTS FOR DIARRHEA
PEPTO BISMOL (BSS) Relief for heartburn, nausea, indigestion, upset
stomach and diarrhea.
2 tabs QID $14.56 97.8 (2018)
82.6 (2013)
IMMODIUM Decrease the frequency of diarrhea in TD,
gastroenteritis, inflammatory bowel disease, and
short bowel syndrome.
2 tabs (2 mg) $11.48
(48 caplets)
82.5 (2013)
CIPROFLOXACIN
(FLUOROQUINOLINE)
Bacterial infections. 500 mg $44.52 40.8 (2015)
RIFAXIMIN Treatment of Travellers’ Diarrhea. 3 caps (200 mg)
TID
$246.96 -
$493.92
PRESENTLY, THERE IS NO FDA APPROVED DRUG TO PREVENT TRAVELERS’ DIARRHEA
TRAVELAN® Dietary Supplement. 3 caps (200 mg)
TID
$30 – 30
caplets
0.77 (2018)
20. 2020
CLOSTRIDIUM DIFFICILE MARKET OPPORTUNITY
1. GlobalData, Decision Resources
2. K. Desai, BMC Infect. Dis., 2016,16:303
• Therapeutic market expected to grow from USD $360 million in 2014 to
over $1.7 billion by 2024 – CAGR 15%1
• Leading cause of gastroenteritis-associated mortality in U.S.
• Approx. 44,500 patients2 die each year from C. difficile infections (U.S.)
• Potential orphan disease (7 years market exclusivity and premium
pricing)
Clostridium difficile (C. difficile) is a bacterium that causes diarrhea and more
serious intestinal conditions such as colitis
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THE UNMET NEED
• Current standard of care for C. difficile includes vancomycin and metronidazole, accounting for 80% of
patient share (US)
• Therapies plagued by significant CDI recurrences (*1st relapse: 25%; 2nd: 40%; 3rd: 60%) underscoring
need for new treatments
• Growing resistance to vancomycin treatment
• Some treatments are administered intravenously rather than via the gut where C. difficile resides
*Isobel Ramsay, Nicholas Brown and David Enoch. Recent Progress for the Effective Prevention and Treatment of Recurrent
Clostridium difficile Infection. Infectious Diseases: Research and Treatment Volume 11: 1–4 (2018).
DOI: 10.1177/1178633718758023
22. 2222
Ingestion of
spores
Germination of spores
Colonisation by vegetative cells
Toxin B production
Infection
IMM-529 TARGETS
Due to unique character of C.
difficile bacterium, it is difficult
to reduce its recurrence with
antibiotics.
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Day -10 -1 0
Antibioticsin drinkingwaterto
induce susceptibilityto C. difficile
C. difficilechallenge
(103 spores)
C57BL/6mice 6–7 weeks
THE C. DIFFICILE PREVENTION OF RECURRENT CDI
MOUSE MODEL*
+8
Administration of vancomycin alone or
vancomycin + IMM-529 12 hour post infection
Administration of water
or IMM-529
Vancomycin treatment
ceases
Monitor:
• Weight loss
• Physiological appearance
• Activity
• Diarrhoea
*Collaboration with Prof. Dena Lyras, Monash University, Australia
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Percentsurvival
IMM-529 ANIMAL MODEL STUDY
All studies
statistically
significant
Demonstrated ~80%
survival rate (7/9) vs.
~10% survival rate in
control group (1/9)
Relapse Study
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Develop clinical protocol for FDA approval as drug to prevent recurrent Clostridium
difficle Infection:
IMM-529 DRUG DEVELOPMENT PLAN
Execute
recurrence
prevention trial
File IND with
plan for placebo
controlled trial
for prevention of
disease
recurrence
Hold pre-IND
meeting to
discuss clinical
protocol and
strategy
Develop clinical
registration
strategy for FDA
submission
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2
6
COMMERCIAL & PRODUCT DEVELOPMENT PIPELINE
PROGRAM INDICATIONS
DEVELOPMENT STAGE
PROGRAM HIGHLIGHTS
PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 MARKET
ANTI-INFLAMMATORY PROGRAMS
Travelan® Travelers’ Diarrhea
Commercial product Australia.
Travelan® Travelers’ Diarrhea
Commercial product Canada.
Travelan®
Commercial product USA.
Travelan®
(IMM-124E)
Travelers’ Diarrhea Plan for FDA submission.
Travelan®
(IMM-124E)
NASH Top Line Results Reported March 2018
IMM-124E ASH
NIH Funded U of Virginia.
Topline results expected 2Q 2019.
IMM-124E Pediatric NAFLD
NIH Funded; Emory University.
Topline results expected 1Q 2020.
IMM-529 C. Difficile
Developing to prevent recurrence in C.
difficile patients.
WRAIR Shigella Walter Reed Army Institute of Research.
Dietary supplement (2015)
Health Canada NPN 80046016 (2015)
TGA ARTG Aust L106709 (2004)
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IMM-124E: FATTY-LIVER PORTFOLIO
ASH
• NIH funded; sponsored by University of Virginia
• Lead Principal Investigator: Arun Sanyal; Former President of AASLD (American Association for the Study of Liver
Diseases) and current Chair of the Liver Study Section at the NIH (National Institute of Health)
• Fully recruited: 56 patients
• Endpoint: Serum endotoxin/ lipopolysaccharide (LPS) levels
• Timing: topline results in 2Q2019
PEDIATRIC NAFLD
• NIH funded; sponsored by Emory University
• Lead Principal Investigator: Miriam Vos;
• Current enrollment: 23/40 patients
• Endpoint: ALT; 3 months treatment
• Timing: topline results in 1Q 2020
Two ongoing NIH funded Phase 2 Programs currently underway: ASH and Pediatric NAFLD
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KEY MILESTONES EXPECTEDTO DRIVEVALUE
Results from US Army trials expected
2019/2020
2H
2019
1H
2020
2H
2020
1H
2021
• Pre-IND Meeting to
Discuss IMM-124E
Literature-Based
505(b)(2)
• IMM-124E ASH
Clinical Trial Top Line
Results
• Initiate Phase 3
Clinical Trial on
IMM-124E TD
prevention study
• Pre-IND Meeting
on IMM-529 C.
difficile program
• Pediatric NAFLD
Top Line Results
• Phase 3 IMM-
124E TD
Clinical Data
Available
• Initiate U.S.
Phase 2 trial
on IMM-529 to
treat recurrent
CDI
• File
505(b)(2) NDA
for IMM-124E
TD prevention
study