Gene Therapy and FDA Regulations
•Download as DOCX, PDF•
0 likes•16 views
How does gene therapy fit into the FDA? Is it a medical device, a drug, or a combination product? What if gene therapy can cure a life-threatening disease? There are a lot of questions that can pop into your mind when you first hear “gene therapy”, but EMMA International is here to answer them...
Report
Share
Report
Share
Recommended
Surya Singh: "From Development to Delivery in the US"
Surya Singh: "From Development to Delivery in the US"The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics
PLEASE NOTE: THESE SLIDES MAY NOT DISPLAY PROPERLY ONLINE, BUT THEY ARE READABLE IF DOWNLOADED.
October 28, 2018
This one-day conference explored the current pharmaceutical pricing landscape by bringing together leaders from the pharmaceutical industry, policymakers, legal practitioners, and scholars to engage in novel, interdisciplinary discussions to better understand current challenges and articulate best practices to address these issues. Participants assessed the current challenges presented in drug pricing policy, from development to delivery, in both the United States and international context. We also explored and articulated best practices to expand access to medicines and worked toward developing a plan for disseminating these practices more widely.GPhA Labeling Rule
The FDA has delayed finalizing a proposed rule requiring generic drug companies to unilaterally update labels when new safety information emerges from December 2014 to September 2015. This delay provides more time for the generic drug industry, represented by the Generic Pharmaceutical Association (GPhA), to continue fighting the rule, which they allege would impose huge costs. However, public health advocates view the rule as important for drug safety and informing consumers. The debate around the economic impact of the rule on the generic drug industry versus the improved safety it could provide is expected to continue into next year.
Avoiding Off-Label Promotion
This presentation covers the essential concept of ensuring all promotional communications are on label and the safe harbors established by FDA for disseminating off-label information compliantly.
EncepHeal Pitch deck
A Biotechnology company with a mission to accelerate the early development of substance abuse treatments.
Arm q2 2015_web%20version_final
The Alliance for Regenerative Medicine (ARM) is the leading global advocate for regenerative and advanced therapies. It fosters research, development, investment, and commercialization of transformative treatments and cures. ARM leverages the expertise of its members to promote legislative, regulatory, and public support for this expanding field of medicine.
Presentation__Reimbursement Overview
This document provides an overview of the US healthcare reimbursement model and strategic reimbursement planning. It outlines four main steps to developing a reimbursement plan: 1) identifying who influences product use, 2) defining the market model by finding existing codes, 3) identifying any coding gaps, and 4) determining any regulatory issues. Key tactics include training opinion leaders, collaborating with medical societies, and publishing clinical data. FDA registration involves establishment, product listing, and approval processes which can take up to a year and cost over $60,000 for monoclonal antibodies. Consultants can help navigate the FDA process.
Group4padgett&becoatm6a1
The document discusses the need for the FDA to better regulate the dietary supplements industry in order to protect public safety. It notes that the billion dollar industry is currently under less stringent regulation than the pharmaceutical industry since supplements are classified as foods rather than drugs. This could allow unsafe products to reach consumers without proper testing or oversight. The authors propose several steps for the FDA to take including implementing pre-market regulations to review products for safety, educating consumers, and increasing independent case studies to hold manufacturers accountable. The goal is to ensure supplements are reliable and consumers can make informed choices to avoid potential health issues like mortality from overuse or contaminated products.
Group4 padgett&becoatm6a1
The document discusses the need for the FDA to better regulate the dietary supplements industry in order to protect public safety. It notes that the billion dollar industry is currently under less stringent regulation than the pharmaceutical industry, despite supplements sometimes having detrimental health effects. The authors propose that the FDA implement pre-market regulations and testing of supplements, educate consumers, and conduct more case studies to hold manufacturers accountable and remove unsafe products from the market. This would help ensure that supplements are reliable and that consumers are informed of benefits and risks.
Recommended
Surya Singh: "From Development to Delivery in the US"
Surya Singh: "From Development to Delivery in the US"The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics
PLEASE NOTE: THESE SLIDES MAY NOT DISPLAY PROPERLY ONLINE, BUT THEY ARE READABLE IF DOWNLOADED.
October 28, 2018
This one-day conference explored the current pharmaceutical pricing landscape by bringing together leaders from the pharmaceutical industry, policymakers, legal practitioners, and scholars to engage in novel, interdisciplinary discussions to better understand current challenges and articulate best practices to address these issues. Participants assessed the current challenges presented in drug pricing policy, from development to delivery, in both the United States and international context. We also explored and articulated best practices to expand access to medicines and worked toward developing a plan for disseminating these practices more widely.GPhA Labeling Rule
The FDA has delayed finalizing a proposed rule requiring generic drug companies to unilaterally update labels when new safety information emerges from December 2014 to September 2015. This delay provides more time for the generic drug industry, represented by the Generic Pharmaceutical Association (GPhA), to continue fighting the rule, which they allege would impose huge costs. However, public health advocates view the rule as important for drug safety and informing consumers. The debate around the economic impact of the rule on the generic drug industry versus the improved safety it could provide is expected to continue into next year.
Avoiding Off-Label Promotion
This presentation covers the essential concept of ensuring all promotional communications are on label and the safe harbors established by FDA for disseminating off-label information compliantly.
EncepHeal Pitch deck
A Biotechnology company with a mission to accelerate the early development of substance abuse treatments.
Arm q2 2015_web%20version_final
The Alliance for Regenerative Medicine (ARM) is the leading global advocate for regenerative and advanced therapies. It fosters research, development, investment, and commercialization of transformative treatments and cures. ARM leverages the expertise of its members to promote legislative, regulatory, and public support for this expanding field of medicine.
Presentation__Reimbursement Overview
This document provides an overview of the US healthcare reimbursement model and strategic reimbursement planning. It outlines four main steps to developing a reimbursement plan: 1) identifying who influences product use, 2) defining the market model by finding existing codes, 3) identifying any coding gaps, and 4) determining any regulatory issues. Key tactics include training opinion leaders, collaborating with medical societies, and publishing clinical data. FDA registration involves establishment, product listing, and approval processes which can take up to a year and cost over $60,000 for monoclonal antibodies. Consultants can help navigate the FDA process.
Group4padgett&becoatm6a1
The document discusses the need for the FDA to better regulate the dietary supplements industry in order to protect public safety. It notes that the billion dollar industry is currently under less stringent regulation than the pharmaceutical industry since supplements are classified as foods rather than drugs. This could allow unsafe products to reach consumers without proper testing or oversight. The authors propose several steps for the FDA to take including implementing pre-market regulations to review products for safety, educating consumers, and increasing independent case studies to hold manufacturers accountable. The goal is to ensure supplements are reliable and consumers can make informed choices to avoid potential health issues like mortality from overuse or contaminated products.
Group4 padgett&becoatm6a1
The document discusses the need for the FDA to better regulate the dietary supplements industry in order to protect public safety. It notes that the billion dollar industry is currently under less stringent regulation than the pharmaceutical industry, despite supplements sometimes having detrimental health effects. The authors propose that the FDA implement pre-market regulations and testing of supplements, educate consumers, and conduct more case studies to hold manufacturers accountable and remove unsafe products from the market. This would help ensure that supplements are reliable and that consumers are informed of benefits and risks.
Ethical Behaviour
This document discusses ethical issues with the pricing of drugs by US pharmaceutical companies. It provides examples of Valeant Pharmaceuticals and Turing Pharmaceuticals dramatically increasing prices of older drugs. While legal, these actions seem unethical given lack of investment in research. Congress is investigating if drugmakers are price gouging. There is debate around government regulation of drug prices to balance innovation and accessibility.
Compliant Promotion in an On-demand World
The Internet is now the premier source of healthcare information for physicians and consumers alike. Consequently, FDA-regulated companies have been leveraging it in various ways, but compliance has proven challenging and confusing for companies not accustomed to digital tactics.
* Recent FDA enforcement actions that command the attention of anyone considering digital communication tactics
* Trends in digital media consumption and their impact on advertising effectiveness
* FDA’s 2009 Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion
* FDA’s 2011 Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications
*Some red flags guaranteed to draw FDA’s ire
* The latest on FDA social media guidance
What Do Doctors Think About Biosimilars?
As the global biosimilars market opens up, what do physicians faced with choosing between prescribing a brand-name biologic or biosimilar think – and know?
Merck Keytruda and Eisai Lenvima Achieve Triple Approval In Oncology And Wome...
Merck Keytruda and Eisai Lenvima Achieve Triple Approval In Oncology And Wome...Bare Sky Marketing Healthcare Content Writing Services
Oncology initiatives in Women’s Healthcare have gained another valuable therapy to improve patient care and outcomes…
Merck & Co.’s ( NYSE: MRK )Keytruda and combination partner therapy Eisai’s ( OTCMKTS: ESALY ) Lenvima will keep their respective marketing and sales units very busy in the upcoming months. Regulatory agencies in the United States, Canada and Australia have concurrently approval to the Keytruda-Lenvima tandem for women with certain advanced endometrial carcinoma. It represents a significant accomplishment by Merck and Eisai and for government regulatory agencies working together to accelerate the process of advancing medicine whether it’s for completely new products or clinically strategic new indications.
Project Orbis: Improve accuracy and accelerate new drug and indication approvals across multiple nation government agencies...
The parallel decisions are the first made through Project Orbis ;a collaborative initiative of the Food And Drug Administration ( FDA ), the Australian Therapeutic Goods Administration ( TGA ) and Health Canada that seeks to reduce new oncology therapy review turnaround between nations. It champions concurrent submissions by drug manufacturers and collaborative assessments by each of the three government regulatory agencies, sponsors and collaborative reviews by all three agencies.
Project Orbis: A winning initiative for patients and clinicians
New drug approvals and the process of approving additional indications is a detail heavy exercise necessary to qualify performance and safety of medications. By improving the processes within nations and cultivating collaboration between them, patients and clinicians benefit from having access to approved therapies sooner. For advanced medication, payers are often reluctant to cover their costs without specific regulatory approval of precise indications. Project Orbis initiatives helps to overcome this hurdle.
Read the article for complete details and contact John Baresky for further information...Could Generic Insulin Soon Hit the U.S. Market?
Diabetes blogger Scott Strumello (sstrumello.blogspot.com) investigates whether follow-on (generic) insulin formulation will soon emerge in accordance with U.S. patent law.
Publish Date: January 1, 2007
Current State of Paid Search Marketing
This presentation is no longer accurate. Google search has changed in ways that are not addressed in this presentation.
Shivai Gupta - POSTER
Orphan drugs are pharmaceutical agents that treat rare diseases or conditions affecting less than 200,000 people in the United States. The Orphan Drug Act provides incentives for developing these drugs, including 7 years of market exclusivity and tax credits. Since its passage, over 3,600 orphan drugs have been designated. By 2020, orphan drugs are projected to make up 20.2% of worldwide prescription drug sales due to their high prices and lack of alternatives for patients.
The Dark Side of Pharma Globalization
U.S. dependency on foreign pharmaceutical production imposes vulnerability to failure
Authors: Veronika Valdova, D.V.M. and Ronald L Sheckler
Affiliation: Arete-Zoe, LLC
ABSTRACT
Pharmaceutical supply chains have become increasingly complex due to the shift of manufacturing and critical operations to Asia. U.S. pharmaceutical dependency on foreign sole-source production of essential materials imposes vulnerability affecting the entire industry and national health systems from interruption by exposure to natural events and man-made threats, both accidental and criminal as well as political. Sector vulnerabilities stem from complex regulatory landscape, difficulties for enforcement of quality standards at foreign facilities, single-source supply chain resulting from limited sourcing options, increasing shipping distance exposure to both natural events and complicated by maritime chokepoints. Periodic and chronic shortages of many essential products across therapeutic categories have been significant for more than a decade. The Covid-19 crisis aggravated some of these long-standing issues and made the systemic vulnerabilities publicly evident. The combination of limited capacity to exercise control over essential commodities, the long-term trend of outsourcing, with the politicization of business relationships causes the entire pharmaceutical industrial sector to be internationally dependent, creating numerous potentials for systemic failure.
Generic Medicine and its Future Prospects in India
Its is one of the project assigned to us in Rural Marketing!!! Mine topic was Generic Medicine and its future prospects in India keeping in mind the High Expenditure an average Indian has capacity to bear.
Hope its liked and appreciated by people. I will be also sharing a slide with a small online survey I did in this context which will provide a bit more insight in this aspect to everyone.
Hope people will find this useful and informative..
The Other Agency: An introduction to Pharma Marketing
This presentation helps people understand FDA's regulation of the marketing and promotion of prescription products. Included are the most prominent regulations that promotion of prescription products must meet.
PAYING FOR BREAKTHROUGH EYE THERAPIES (BIOLOGICS, BIOSIMILARS & GENE THERAPIE...
Presentation by AGTC at OIS@ASRS 2016.
Participant:
Stephen Potter, Chief Business Officer - AGTC
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
Taking Health on the Road
I delivered this presentation at the DTC National Conference in Washington DC. The presentation highlights the importance of mobile for people making decisions about their health and discusses how to present information about FDA-regulated products in this important channel.
Infographic: The World of Drug Development Trends
Trends in the pharmaceutical industry include increased use of adaptive trials, focus on orphan drugs, and outsourcing of drug development. Adaptive trials allow sponsors to react to data in real time to improve decision making. As blockbuster drugs lose patent protection, companies are turning to orphan drugs for new products. Growing costs are also driving outsourcing and use of multiple countries for clinical trials to reduce expenses.
Antibody drug conjugate market opportunity analysis
“Antibody Drug Conjugate Market Opportunity Analysis” Report Highlights:
Global ADC Market Insight
ADC Patent Analysis
Orphan Status & ADC
Favorable Market Drivers & Key Issues to be Discussed
ADC Clinical Trial Insight by Phase & Target Indications
ADC Profiles in Report: 201
Majority of ADC in Preclinical Phase: 83
Marketed ADC Clinical Profiles
Meet today's health care consumer
Imagine a future in which more consumers engage with the health care system – a future that holds the promise of more effective, efficient, and satisfying care experiences and better health outcomes for those individuals and the accountable care populations to which they belong. Findings from Deloitte’s 2015 Survey of US Health Care Consumers suggest we are moving closer to that future as consumer engagement increases in three important areas. Explore trends in consumers’ use of online resources and health technologies: http://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/health-care-consumer-engagement.html.
DIA Webinar Regulating a Social World
With the explosion of social media and its growing importance, it’s critical for those in the pharmaceutical industry to understand how to leverage social networks compliantly to see positive results and minimize risk. If, and when, the FDA guidance on social media is final, questions will remain. This presentation helps the audience incorporate the latest social media technologies into acceptable and successful communications and marketing plans. Focus is given to regulatory requirements, types of communications, responsiveness, and dealing with adverse events.
Global cell therapy market outlook 2020
" Global Cell Therapy Market Outlook 2020" Report Highlight:
Introduction & Classification of Cell Therapy
Role of Stem Cells in Cell Therapy
Global Cell Therapy Market Analysis
Global Cell Therapy Clinical Pipeline by Country, Indication & Phase
Marketed Cell Therapy Clinical Insight by Brand Name, Company & Indication
Global Cell Therapy Clinical Pipeline: 262 Cell Therapies Drugs
Marketed Cell Therapies: 13
Becton-Dickinson
The document discusses Becton, Dickinson & Co.'s (BD) acquisition of CareFusion Corporation and how it will increase BD's position in the medication management industry. The acquisition will boost BD's revenues through increased presence in emerging markets and the US healthcare sector. The implementation of the Affordable Care Act and an aging population will increase demand for healthcare products. BD focuses on developing current products and new products planned through 2017 to ensure growth across all business segments.
Be Careful What You Ask For
This presentation was delivered to a webinar sponsored by Zinc Ahead on May 21, 2015, and provided an update about the current state of guidance from the FDA on the appropriate use of social media by prescription product manufacturers.
Big Pharma Ethical Issues
This document discusses several ethical issues facing the pharmaceutical industry. It examines cases involving Martin Shkreli sharply increasing drug prices, Mylan acquiring EpiPen and significantly raising its price, and the role of government patent protections and lobbying contributing to pharmaceutical monopolies in the US market. It poses the question of whether it is justified or ethical for drug companies to set extremely high prices that make life-saving treatments unaffordable for most consumers.
SAC360 Chapter 24 safe food and drugs
The document discusses government regulation of food and drug safety in the United States. It notes that responsibility is divided between multiple agencies, including the Department of Agriculture (USDA) which regulates meat and poultry, and the Food and Drug Administration (FDA) which regulates all other foods. However, the FDA has a smaller budget and less regulatory authority than the USDA despite regulating most foods. The document also outlines various food and drug safety measures, controversies around clinical drug trials and dietary supplements, and politics around the FDA approval process.
PGx.pptx
Direct-to-consumer personal genome testing allows customers to order genetic testing kits online, swab their cheek for a DNA sample, send it to a lab for analysis, and access their results online. While this provides information about disease risks and ancestry, there are also ethical concerns like inaccurate results, lack of counseling, and potential for genetic discrimination. Regulators in the US face challenges overseeing these tests, as some laboratories develop their own tests which escape FDA review, and tests may be used for purposes other than their intended use. The solution may lie in expanding post-market surveillance and regulation as is done for drug approval.
More Related Content
What's hot
Ethical Behaviour
This document discusses ethical issues with the pricing of drugs by US pharmaceutical companies. It provides examples of Valeant Pharmaceuticals and Turing Pharmaceuticals dramatically increasing prices of older drugs. While legal, these actions seem unethical given lack of investment in research. Congress is investigating if drugmakers are price gouging. There is debate around government regulation of drug prices to balance innovation and accessibility.
Compliant Promotion in an On-demand World
The Internet is now the premier source of healthcare information for physicians and consumers alike. Consequently, FDA-regulated companies have been leveraging it in various ways, but compliance has proven challenging and confusing for companies not accustomed to digital tactics.
* Recent FDA enforcement actions that command the attention of anyone considering digital communication tactics
* Trends in digital media consumption and their impact on advertising effectiveness
* FDA’s 2009 Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion
* FDA’s 2011 Draft Guidance for Industry and Food and Drug Administration Staff: Mobile Medical Applications
*Some red flags guaranteed to draw FDA’s ire
* The latest on FDA social media guidance
What Do Doctors Think About Biosimilars?
As the global biosimilars market opens up, what do physicians faced with choosing between prescribing a brand-name biologic or biosimilar think – and know?
Merck Keytruda and Eisai Lenvima Achieve Triple Approval In Oncology And Wome...
Merck Keytruda and Eisai Lenvima Achieve Triple Approval In Oncology And Wome...Bare Sky Marketing Healthcare Content Writing Services
Oncology initiatives in Women’s Healthcare have gained another valuable therapy to improve patient care and outcomes…
Merck & Co.’s ( NYSE: MRK )Keytruda and combination partner therapy Eisai’s ( OTCMKTS: ESALY ) Lenvima will keep their respective marketing and sales units very busy in the upcoming months. Regulatory agencies in the United States, Canada and Australia have concurrently approval to the Keytruda-Lenvima tandem for women with certain advanced endometrial carcinoma. It represents a significant accomplishment by Merck and Eisai and for government regulatory agencies working together to accelerate the process of advancing medicine whether it’s for completely new products or clinically strategic new indications.
Project Orbis: Improve accuracy and accelerate new drug and indication approvals across multiple nation government agencies...
The parallel decisions are the first made through Project Orbis ;a collaborative initiative of the Food And Drug Administration ( FDA ), the Australian Therapeutic Goods Administration ( TGA ) and Health Canada that seeks to reduce new oncology therapy review turnaround between nations. It champions concurrent submissions by drug manufacturers and collaborative assessments by each of the three government regulatory agencies, sponsors and collaborative reviews by all three agencies.
Project Orbis: A winning initiative for patients and clinicians
New drug approvals and the process of approving additional indications is a detail heavy exercise necessary to qualify performance and safety of medications. By improving the processes within nations and cultivating collaboration between them, patients and clinicians benefit from having access to approved therapies sooner. For advanced medication, payers are often reluctant to cover their costs without specific regulatory approval of precise indications. Project Orbis initiatives helps to overcome this hurdle.
Read the article for complete details and contact John Baresky for further information...Could Generic Insulin Soon Hit the U.S. Market?
Diabetes blogger Scott Strumello (sstrumello.blogspot.com) investigates whether follow-on (generic) insulin formulation will soon emerge in accordance with U.S. patent law.
Publish Date: January 1, 2007
Current State of Paid Search Marketing
This presentation is no longer accurate. Google search has changed in ways that are not addressed in this presentation.
Shivai Gupta - POSTER
Orphan drugs are pharmaceutical agents that treat rare diseases or conditions affecting less than 200,000 people in the United States. The Orphan Drug Act provides incentives for developing these drugs, including 7 years of market exclusivity and tax credits. Since its passage, over 3,600 orphan drugs have been designated. By 2020, orphan drugs are projected to make up 20.2% of worldwide prescription drug sales due to their high prices and lack of alternatives for patients.
The Dark Side of Pharma Globalization
U.S. dependency on foreign pharmaceutical production imposes vulnerability to failure
Authors: Veronika Valdova, D.V.M. and Ronald L Sheckler
Affiliation: Arete-Zoe, LLC
ABSTRACT
Pharmaceutical supply chains have become increasingly complex due to the shift of manufacturing and critical operations to Asia. U.S. pharmaceutical dependency on foreign sole-source production of essential materials imposes vulnerability affecting the entire industry and national health systems from interruption by exposure to natural events and man-made threats, both accidental and criminal as well as political. Sector vulnerabilities stem from complex regulatory landscape, difficulties for enforcement of quality standards at foreign facilities, single-source supply chain resulting from limited sourcing options, increasing shipping distance exposure to both natural events and complicated by maritime chokepoints. Periodic and chronic shortages of many essential products across therapeutic categories have been significant for more than a decade. The Covid-19 crisis aggravated some of these long-standing issues and made the systemic vulnerabilities publicly evident. The combination of limited capacity to exercise control over essential commodities, the long-term trend of outsourcing, with the politicization of business relationships causes the entire pharmaceutical industrial sector to be internationally dependent, creating numerous potentials for systemic failure.
Generic Medicine and its Future Prospects in India
Its is one of the project assigned to us in Rural Marketing!!! Mine topic was Generic Medicine and its future prospects in India keeping in mind the High Expenditure an average Indian has capacity to bear.
Hope its liked and appreciated by people. I will be also sharing a slide with a small online survey I did in this context which will provide a bit more insight in this aspect to everyone.
Hope people will find this useful and informative..
The Other Agency: An introduction to Pharma Marketing
This presentation helps people understand FDA's regulation of the marketing and promotion of prescription products. Included are the most prominent regulations that promotion of prescription products must meet.
PAYING FOR BREAKTHROUGH EYE THERAPIES (BIOLOGICS, BIOSIMILARS & GENE THERAPIE...
Presentation by AGTC at OIS@ASRS 2016.
Participant:
Stephen Potter, Chief Business Officer - AGTC
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
Taking Health on the Road
I delivered this presentation at the DTC National Conference in Washington DC. The presentation highlights the importance of mobile for people making decisions about their health and discusses how to present information about FDA-regulated products in this important channel.
Infographic: The World of Drug Development Trends
Trends in the pharmaceutical industry include increased use of adaptive trials, focus on orphan drugs, and outsourcing of drug development. Adaptive trials allow sponsors to react to data in real time to improve decision making. As blockbuster drugs lose patent protection, companies are turning to orphan drugs for new products. Growing costs are also driving outsourcing and use of multiple countries for clinical trials to reduce expenses.
Antibody drug conjugate market opportunity analysis
“Antibody Drug Conjugate Market Opportunity Analysis” Report Highlights:
Global ADC Market Insight
ADC Patent Analysis
Orphan Status & ADC
Favorable Market Drivers & Key Issues to be Discussed
ADC Clinical Trial Insight by Phase & Target Indications
ADC Profiles in Report: 201
Majority of ADC in Preclinical Phase: 83
Marketed ADC Clinical Profiles
Meet today's health care consumer
Imagine a future in which more consumers engage with the health care system – a future that holds the promise of more effective, efficient, and satisfying care experiences and better health outcomes for those individuals and the accountable care populations to which they belong. Findings from Deloitte’s 2015 Survey of US Health Care Consumers suggest we are moving closer to that future as consumer engagement increases in three important areas. Explore trends in consumers’ use of online resources and health technologies: http://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/health-care-consumer-engagement.html.
DIA Webinar Regulating a Social World
With the explosion of social media and its growing importance, it’s critical for those in the pharmaceutical industry to understand how to leverage social networks compliantly to see positive results and minimize risk. If, and when, the FDA guidance on social media is final, questions will remain. This presentation helps the audience incorporate the latest social media technologies into acceptable and successful communications and marketing plans. Focus is given to regulatory requirements, types of communications, responsiveness, and dealing with adverse events.
Global cell therapy market outlook 2020
" Global Cell Therapy Market Outlook 2020" Report Highlight:
Introduction & Classification of Cell Therapy
Role of Stem Cells in Cell Therapy
Global Cell Therapy Market Analysis
Global Cell Therapy Clinical Pipeline by Country, Indication & Phase
Marketed Cell Therapy Clinical Insight by Brand Name, Company & Indication
Global Cell Therapy Clinical Pipeline: 262 Cell Therapies Drugs
Marketed Cell Therapies: 13
Becton-Dickinson
The document discusses Becton, Dickinson & Co.'s (BD) acquisition of CareFusion Corporation and how it will increase BD's position in the medication management industry. The acquisition will boost BD's revenues through increased presence in emerging markets and the US healthcare sector. The implementation of the Affordable Care Act and an aging population will increase demand for healthcare products. BD focuses on developing current products and new products planned through 2017 to ensure growth across all business segments.
Be Careful What You Ask For
This presentation was delivered to a webinar sponsored by Zinc Ahead on May 21, 2015, and provided an update about the current state of guidance from the FDA on the appropriate use of social media by prescription product manufacturers.
Big Pharma Ethical Issues
This document discusses several ethical issues facing the pharmaceutical industry. It examines cases involving Martin Shkreli sharply increasing drug prices, Mylan acquiring EpiPen and significantly raising its price, and the role of government patent protections and lobbying contributing to pharmaceutical monopolies in the US market. It poses the question of whether it is justified or ethical for drug companies to set extremely high prices that make life-saving treatments unaffordable for most consumers.
What's hot (20)
Merck Keytruda and Eisai Lenvima Achieve Triple Approval In Oncology And Wome...
Merck Keytruda and Eisai Lenvima Achieve Triple Approval In Oncology And Wome...
Generic Medicine and its Future Prospects in India
Generic Medicine and its Future Prospects in India
The Other Agency: An introduction to Pharma Marketing
The Other Agency: An introduction to Pharma Marketing
PAYING FOR BREAKTHROUGH EYE THERAPIES (BIOLOGICS, BIOSIMILARS & GENE THERAPIE...
PAYING FOR BREAKTHROUGH EYE THERAPIES (BIOLOGICS, BIOSIMILARS & GENE THERAPIE...
Antibody drug conjugate market opportunity analysis
Antibody drug conjugate market opportunity analysis
Similar to Gene Therapy and FDA Regulations
SAC360 Chapter 24 safe food and drugs
The document discusses government regulation of food and drug safety in the United States. It notes that responsibility is divided between multiple agencies, including the Department of Agriculture (USDA) which regulates meat and poultry, and the Food and Drug Administration (FDA) which regulates all other foods. However, the FDA has a smaller budget and less regulatory authority than the USDA despite regulating most foods. The document also outlines various food and drug safety measures, controversies around clinical drug trials and dietary supplements, and politics around the FDA approval process.
PGx.pptx
Direct-to-consumer personal genome testing allows customers to order genetic testing kits online, swab their cheek for a DNA sample, send it to a lab for analysis, and access their results online. While this provides information about disease risks and ancestry, there are also ethical concerns like inaccurate results, lack of counseling, and potential for genetic discrimination. Regulators in the US face challenges overseeing these tests, as some laboratories develop their own tests which escape FDA review, and tests may be used for purposes other than their intended use. The solution may lie in expanding post-market surveillance and regulation as is done for drug approval.
Regulatory requirements for the product
This document discusses the regulatory process for biologics in the United States and Europe. It provides information on the sources and types of biologics, as well as the differences between biologics and chemical drugs. It also describes the regulatory authorities, approval processes, and requirements for a Biological License Application in the US. Finally, it compares the US and European guidelines regarding preclinical studies and requirements for approval of biologics.
BetterCells Investor Presentation
The problem is that we have a health industry that is not concerned with food…
…and a food industry that is not concerned with health.
For further information on how to invest please contact:
Andrew Haythorpe
Founder, Managing Director
Mobile: +61407 737 973
Email: a@bettercells.com
Skype: andrewhaythorpe
Jubilant Therapeutics Corporate Deck_Non-Con_May2022.pdf
The document provides an overview of Jubilant Therapeutics, a clinical stage precision therapeutics company developing novel therapies for cancer and autoimmune diseases. Jubilant has a differentiated pipeline including a dual LSD1/HDAC6 inhibitor (JBI-802) in Phase I/II trials for various cancers, as well as preclinical programs targeting PRMT5, PD-L1, and PAD4. The company utilizes a structure-based drug discovery platform called TIBEO to rapidly design and optimize first-in-class and best-in-class small molecule therapies.
What Your Saliva Reveals About You: Direct-to-Consumer Genetic Tests
Direct-to-consumer (DTC) tests, such as those marketed by 23andMe, are changing the classic paradigm of health professionals ordering and interpreting genetic testing for a patient. In this article, we provide an overview of the DTC landscape and regulatory pathways...
Genetic Testing Reduces Specialty Drug Spend
An award-winning WellDyneRx study, recognized by the Academy of Managed Care Pharmacy, found that pharmacogenomics screening saved self-funded employers 5 percent in specialty drug claim costs.
What is biologic, biosimilar, and biobetter
Biologics (eg, vaccines, blood and blood components, somatic cells, gene therapy, tissues, therapeutic proteins) are regulated by the US Food and Drug Administration (FDA). Biologics/Biosimilars/Biobetters are widely used to diagnose, prevent, treat, and cure diseases and medical conditions.
Naveen Kumar Singh received his B.Sc. in Biotechnology (2007) at University of Pune (Pune, India), M.Sc. in Biotechnology (2009) at Jaipur National University (Jaipur, India), and Ph.D. in Biochemical Engineering (2016) at Jacobs University Bremen (Bremen, Germany).
During his Ph.D., Naveen worked under the supervision of Prof. Marcelo Fernández-Lahore. His research dealt with designing experiments for developing fiber-based and cryogel-based adsorbents for capturing large therapeutic biomolecules (proteins, plasmids, and monoclonal antibodies). He had successfully evaluated the in-house fiber- and cryogel-based chromatographic adsorbents with the commercially available adsorbents and the in-house adsorbents had shown similar or higher productivities compared to the commercial adsorbents.
In February 2017, Naveen joined the group of Prof. Merlin L. Bruening in the Department of Chemical and Biomolecular Engineering at the University of Notre Dame as a Postdoctoral Research Associate. His current research focuses on developing novel bioseparation processes by introducing polyelectrolyte multilayer films onto membranes/monoliths for the purification of biotherapeutics like monoclonal antibodies.
Publications:
N. K. Singh, et al, “Preparation and Characterization of Grafted Cellulosic Fibers and their Applications in Protein Purification“, Sep. Purif. Technol., 143 (2015) pp. 177–183. https://www.sciencedirect.com/science/article/pii/S1383586615000714
N. K. Singh, et al, “Direct Capture of His6-tagged Proteins Using Megaporous Cryogels Developed for Metal-ion Affinity Chromatography“, inAffinity Chromatography (Ed.: S. Reichelt), Spinger, New York, USA, Methods in Molecular Biology, 1286 (2015) pp. 201–212. http://link.springer.com/protocol/10.1007/978-1-4939-2447-9_16
N. K. Singh, et al, “Gamma ray mediated functionalization of monolithic cryogels for macro-biomolecule purification“, N. Biotechnol., 31, Supplement (2014) pp. S127. http://www.sciencedirect.com/science/article/pii/S1871678414019906
N. K. Singh, et al, “High capacity cryogel-type adsorbents for protein purification“, J. Chromatogr. A, 1355 (2014) pp. 143–148. https://www.sciencedirect.com/science/article/pii/S0021967314008899
N. S. Bibi, N. K. Singh, et al, “Synthesis and performance of megaporous immobilized metal-ion affinity cryogels for recombinant protein capture and purification“, J. Chromatogr. A, 1272 (2013) pp. 145–149. https://www.sciencedirect.com/science/article/pii/S0021967312017670
Blog articles:
What are cryogels? https://www.biochemadda.com/cryogels-monolith-ion-exchange-affinity-chromatography/
BioEntrepreneurship: The Business of Biotech
This is part of the MaRS BioEntrepreneurship series.
Speaker: Lynne Zydowsky, Ph.D., Managing Principal Zydowsky Consultants
* Explore the development of regulated drugs and devices
* Understand where and how value is generated in the pharmaceuticals industry
* Appreciate the interplay between science and business in a biotech company
To download a copy of the audio for this presentation, please go to:
http://www.marsdd.com/bioent/oct16
For the event blog and Q+A, please see:
http://blog.marsdd.com/2006/10/17/bringing-together-art-and-science/
DTC Testing
Direct to consumer genetic testing provides ancestry and health risk information directly to consumers but has significant limitations. While it may promote health awareness, unexpected results can be stressful and consumers may make important medical decisions based on inaccurate or incomplete information from unregulated tests. The high rate of false positives seen in confirmatory testing suggests many consumers are receiving incorrect information from these tests. Regulatory bodies have concerns about oversight, accuracy, and inappropriate use of genetic data that could impact consumers.
Pharmacovigilance Risk Management for Biosimilars
This paper focuses on pharmacovigilance (PV) and risk management for biosimilars, the issues and challenges faced in monitoring their safety and possible solutions.
Need Of Regulatory Affairs In Biotechnology
The document discusses the need for regulatory affairs professionals in the biotechnology industry. It explains that biotechnology uses techniques like cell culture and recombinant DNA to develop new products for medicine, agriculture, and the environment. Regulatory affairs ensures biotechnology products meet regulations before commercial use through tasks like tracking legal changes, reviewing safety data, and interacting with agencies like the FDA. For new, complex biotechnology medicines and therapies, regulatory oversight is especially important given the high research costs and risks.
Chap2 CTPMR, 2nd Ed. 2016
This document discusses the FDA's perspective on regulating cellular therapies. It provides the following key points:
1. The FDA regulates cellular therapies as drugs, biological products, and human cells/tissues under various regulations including cGMP, biological product regulations, labeling regulations, and HCT/P regulations.
2. Cellular therapies present challenges for development and regulation due to their complex nature involving living cells.
3. The document provides tips for navigating FDA regulations during development, including being data-driven, providing complete documentation, being informed of FDA resources, communicating with the FDA, and planning ahead.
Genetic Technologies Presentation - January 2021
Genetic Technologies Limited is a diversified molecular diagnostics
company developing tools for the prediction and assessment of cancer
risk to help physicians proactively manage patient health. The
Company’s lead products, ‘GeneType for Breast Cancer’ and
‘GeneType for Colorectal Cancer’, are clinically validated risk
assessment tests that are first in their class. The Company’s
development pipeline includes new tests for COVID-19, Type 2
diabetes, cardiovascular disease, prostate cancer, and melanoma.
Listed on the ASX in 2000 and NASDAQ in 2005, Genetic
Technologies has been a leader in the development and
commercialization of genetic risk assessment technology for 20 years.
Go life pres 2018-11-09
The document discusses Go-Life's strategy to expand from producing nutritional supplements to providing a more holistic approach to healthcare. It plans to do this through developing digital health platforms, medical devices, stem cell therapy, and partnerships in areas like frail care, clinics, and pharmacies. The goal is to shift from reactive disease management to preventative wellness and participate across the spectrum of changing healthcare focus areas.
Biologics ppt
The document discusses the regulatory requirements for approval of biologics. It defines biologics as complex molecules produced through biotechnology from biological sources. The regulatory authority for biologics is the Center for Biologics Evaluation and Research (CBER) within the FDA. The approval process involves an Investigational New Drug Application, Biologics License Application, and approval or refusal. Key differences between biologics and chemical drugs are outlined regarding size, structure, stability and manufacturing. Regulatory guidelines in the US and EU are compared.
PMRG 2008 Presentation
The pharmaceutical industry is facing many challenges today including declining drug approvals, rising generics competition, increased regulatory scrutiny, and a broken R&D process. Proposed changes like high-throughput screening and biomarkers have failed to significantly improve R&D productivity. Outsourcing drug development and focusing on commercialization may be a solution. Healthcare is also transitioning to personalized and preventative care focused on diagnosis over acute treatment, making patients more proactive consumers. Pharmaceutical companies will need new business models that integrate with changing healthcare systems.
Biotechnology 1
The document provides an overview of the pharmaceutical and biotechnology industries. It discusses how pharmaceutical companies produce drugs and other products, and how biotechnology companies use genetic research to develop products. It outlines trends in industry consolidation and partnerships between large pharmaceutical companies and smaller biotech firms. It also describes various career opportunities and paths within these industries.
Lessons Learned from the Ethical Challenges of Marketing in Healthcare
Lessons Learned from the Ethical Challenges of Marketing in HealthcareSandeepkumar Balabbigari, PharmD, RPh
This document discusses the ethical challenges of marketing in the healthcare industry, particularly in the pharmaceutical sector. It examines cases involving Eli Lilly, GlaxoSmithKline, 23andMe, and Par Pharmaceuticals to illustrate tensions between informing patients and the FDA's role in ensuring safety. Pharmaceutical companies aim to educate through marketing, while the FDA controls information dissemination and prohibits off-label promotion to protect public health based on rigorous testing. The document urges understanding both perspectives to balance business and patient interests.Genentech
A presentation of Genentech strategic growth options vis-a-vis the current economic and structural challenges the biotech industry is facing.
Team project, December 2008.
Similar to Gene Therapy and FDA Regulations (20)
Jubilant Therapeutics Corporate Deck_Non-Con_May2022.pdf
Jubilant Therapeutics Corporate Deck_Non-Con_May2022.pdf
What Your Saliva Reveals About You: Direct-to-Consumer Genetic Tests
What Your Saliva Reveals About You: Direct-to-Consumer Genetic Tests
Lessons Learned from the Ethical Challenges of Marketing in Healthcare
Lessons Learned from the Ethical Challenges of Marketing in Healthcare
More from EMMAIntl
Cartilage Regeneration Techniques
Two cartilage regeneration techniques are briefly covered: Autologous Chondrocyte Implantation (ACI) and Autologous Matrix-Induced Chondrogenesis (AMIC). ACI involves taking cartilage cells from a non-load bearing area, multiplying them in a lab, and re-injecting them into damaged cartilage in two surgeries. AMIC requires only one surgery - the damaged cartilage is removed, the area is stimulated with microfractures, and a collagen membrane placed over the site promotes new cartilage growth from stem cells. These techniques and bio-scaffold technologies offer potential long-term solutions for cartilage conditions and regeneration of original cartilage properties.
Stability Testing of Pharmaceuticals and Supplements
Whether you are working on a prescription drug, over-the-counter (OTC) drug, or even a dietary supplement, stability testing is required depending on the location of registration and agencies involved in its approval. Stability testing is the method of testing a product's safety, efficacy, and chemical composition after a set period...
Intolerance vs. Allergy
Millions in the United States alone have an allergic condition, with many of these allergies being related to food. According to the Food Allergy Research & Education organization (FARE) 32 million Americans have food allergies. Of those 32 million, 200,000 require emergency medical care for allergic reactions from those foods. A common misconception is that food intolerance is a food allergy when in actuality that is its own unique category...
Material Science in MedTech
The field of biomedical engineering is a new, widely researched, and well-funded industry that aims to tackle problems in medicine and health by providing engineered solutions. These solutions might be delivered in the form of electrical hardware, chemicals, or even software. Given the extensive range of applications that exist in the medical device industry, the field is continuously accelerating its innovations in technology via an abundance of research and innovation outlets in countless interrelated fields. One of the many fields that are fundamentally fueling the growth of the biomedical industry is material science...
Investigating Ketamine for Parkinson’s Disease
In May 2021, the FDA approved an Investigational New Drug (IND) application from PharmaTher Holdings Ltd., to proceed with a Phase Two clinical trial. PharmaTher Holdings Ltd. is a psychedelics biotech organization that focuses on research and development, and commercialization of psychedelics to treat pain and neurological disorders, and mental illnesses. This company is headquartered in Vancouver, Canada...
Aduhelm, an Accelerated Approval for Alzheimer’s
Alzheimer’s disease is the most common cause of dementia, especially in patients aged 65 and older1. Alzheimer’s disease is a neurodegenerative disease that has a direct correlation to age: as age increases, the likelihood of developing Alzheimer’s increases as well. Alzheimer’s has long been a subject of discussion in the pharmaceutical industries and, until the FDA’s recent accelerated approval of Aduhelm earlier this month, the most recent treatment approved for Alzheimer’s was in 2003, almost two decades ago. The FDA’s approval of Aduhelm represents the first-of-its-kind treatment and is the first therapy that aims to interrupt the underlying physiological pathway of Alzheimer’s, rather than simply attempt to treat its symptoms...
World Blood Donor Day 2021
Every June 14th, the World Health Organization (WHO) hosts World Blood Donor Day to raise awareness all over the globe for how crucial the need for safe blood is in the healthcare industry. In the US and Canada alone, 43,000 pints of blood are used each day for life-saving procedures and treatments...
New COVID-19 Vaccine
Starting in Summer 2021, a new type of COVID vaccine could be available. Known as a protein subunit vaccine, this vaccine contains a spike protein that the other three vaccines are missing. The other vaccines, Pfizer, Moderna, and Johnson & Johnson, contain instructions for the spike protein but do not actually include the spike protein in the vaccination. The three vaccines allow our cell bodies to make the protein up for itself...
Men’s Health Week: Depression
June 14th through the 20th is Men’s Health Week, which is a great opportunity to heighten awareness for men’s depression. There is a theme in society applicable to most men as they tend to internalize depressive thoughts, not allowing for a proper diagnosis. There are four major reasons men do not reach out for help with their depression: failure to recognize the depression consuming them, downplaying signs and symptoms, reluctance to converse about their feelings with others, and resisting mental health treatment...
Celebrating Pride Month at EMMA International
June 1 started the celebration of Pride Month, which commemorates Lesbian, Gay, Bisexual, and Transgender members. Celebrating Pride Month is also more than celebrating members of the LGBTQIA+, this month is also about recognizing that diversity fuels innovation and collaboration among a variety of industries, including the life sciences...
Growth and Integration of ML/AI in Biotech
The biotechnology and pharmaceutical industries are heavily reliant on collecting, storing, and analyzing data for both R&D as well as production purposes. The large, countless, and rapidly growing sets of data are critical for researchers and scientists to accelerate progress in the medical industry. As our technologies advance and our capacity to store data continue to increase, we must continue to find new ways to efficiently analyze data. Researchers at the European Bioinformatics Institute (EMBL-EBI) have determined that nucleotide and proteomics data is growing at an exponential rate, with the amount of data stored on their servers doubling each year...
Using QFD for Medical Device Development
Quality Function Deployment, or QFD, is a decades-old methodology focused on the voice of the customer. It was initially developed in Japan in the 1960s but was popularized in the US by the automotive industry in the 1980s . QFD is a tool often leveraged by Total Quality Management (TQM), which is a quality principle that customers define quality and subsequently should be prioritized at all stages of the product, both pre-and post-production...
The Appeal and Fears of Digital Health
New digital health technology is coming out every day and is changing the course of the MedTech industry as we know it. Many physicians are making the transition to using these digital health devices and technologies to improve patient care and outcomes. Some of this increase can be attributed to COVID-19 of course as it enabled them to provide care for patients remotely. However, many of these digital health devices and technologies have been around for a bit, so what caused the hesitation in adapting them sooner and what are some of the great perks of this new wave of medical care?
Immune Systems After the COVID-19 Pandemic
Everyone has heard that immune systems weaken when they are sheltered, but is that really the case? As we are now over one year into lockdowns and social distancing, many are becoming concerned that after the pandemic immune systems are going to falter after being isolated for such a long period, and many adults are concerned to resume a “normal” life due to this...
Stability Testing Requirements for Pharmaceuticals
Deciding how and when to conduct stability tests on your new drug can be challenging. Stability tests provide evidence data on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors. It also establishes a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions...
Staying Healthy During COVID-19
EMMA International is continuing to celebrate Women’s Health Week! While there are so many reasons Women’s Health Week is important, one of the best things to come out of this week is the attention it brings and the reminders that we should all consider our health and take steps to ensure a healthy future...
A History of Reproductive Health
Happy National Women’s Health Week! In honor of this week bringing light to important women’s health issues, I wanted to walk through a brief history of innovations that shaped one of the largest facets of women’s health – reproductive health...
Electronic Signatures Under 21CFR§11
Electronic signatures have become increasingly important with the shift to remote work during the pandemic. 21CFR§11 provides regulations for electronic signatures and documentation in FDA-regulated industries to ensure validation and compliance. The regulations require that each electronic signature be unique to an individual and that their identity is authenticated, often with a password or pin. Software used must also maintain traceability of electronic signatures. While there are pre-validated software options, manufacturers are responsible for additionally validating software for their intended use and 21CFR§11 compliance. EMMA International offers assistance with software validation to support compliance with regulatory requirements.
Considerations for Biocompatibility Evaluation
Biocompatibility is one of the most critical performance studies that manufacturers need to perform as part of their product development process. ISO 10993-5 and ISO 10993-10 are FDA-recognized standards for biocompatibility. Whether you perform these studies in-house or send out samples to a third-party lab the protocol for biocompatibility assessment must be conducted in accordance with ISO 10993...
Restoring the Earth for a Healthier Future
Today marks the 52nd anniversary of the birth of the true modern environmental movement, however, you probably know it as Earth Day. Early in the pandemic, many hoped that the lockdowns would help the Earth heal as people began to stay home, stopped commuting, and some factories even had paused production. Unfortunately, as things are beginning to open back up emissions are on the rise again and we need to continue to think about the future consequences...
More from EMMAIntl (20)
Stability Testing of Pharmaceuticals and Supplements
Stability Testing of Pharmaceuticals and Supplements
Stability Testing Requirements for Pharmaceuticals
Stability Testing Requirements for Pharmaceuticals
Recently uploaded
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...rightmanforbloodline
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.Pediatric Emergency Care for Children | Apollo Hospital
Pediatric Emergency Care for Children | Apollo HospitalApollo 24/7 Adult & Paediatric Emergency Services
At Apollo Hospital, Lucknow, U.P., we provide specialized care for children experiencing dehydration and other symptoms. We also offer NICU & PICU Ambulance Facility Services. Consult our expert today for the best pediatric emergency care.
For More Details:
Map: https://cutt.ly/BwCeflYo
Name: Apollo Hospital
Address: Singar Nagar, LDA Colony, Lucknow, Uttar Pradesh 226012
Phone: 08429021957
Opening Hours: 24X7DR SHAMIN EABENSON - JOURNAL CLUB - NEEDLE STICK INJURY
JOURNAL CLUB - NEEDLE STICK INJURY - TOPIC PRESENTED BY DR SHAMIN
Gemma Wean- Nutritional solution for Artemia
GEMMA Wean is a high end larval co-feeding and weaning diet aimed at Artemia optimisation and is fortified with a high level of proteins and phospholipids. GEMMA Wean provides the early weaned juveniles with dedicated fish nutrition and is an ideal follow on from GEMMA Micro or Artemia.
GEMMA Wean has an optimised nutritional balance and physical quality so that it flows more freely and spreads readily on the water surface. The balance of phospholipid classes to- gether with the production technology based on a low temperature extrusion process improve the physical aspect of the pellets while still retaining the high phospholipid content.
GEMMA Wean is available in 0.1mm, 0.2mm and 0.3mm. There is also a 0.5mm micro-pellet, GEMMA Wean Diamond, which covers the early nursery stage from post-weaning to pre-growing.
CCSN_June_06 2024_jones. Cancer Rehabpptx
About this webinar: This talk will introduce what cancer rehabilitation is, where it fits into the cancer trajectory, and who can benefit from it. In addition, the current landscape of cancer rehabilitation in Canada will be discussed and the need for advocacy to increase access to this essential component of cancer care.
The Power of Superfoods and Exercise.pdf
Healthy Eating Habits:
Understanding Nutrition Labels: Teaches how to read and interpret food labels, focusing on serving sizes, calorie intake, and nutrients to limit or include.
Tips for Healthy Eating: Offers practical advice such as incorporating a variety of foods, practicing moderation, staying hydrated, and eating mindfully.
Benefits of Regular Exercise:
Physical Benefits: Discusses how exercise aids in weight management, muscle and bone health, cardiovascular health, and flexibility.
Mental Benefits: Explains the psychological advantages, including stress reduction, improved mood, and better sleep.
Tips for Staying Active:
Encourages consistency, variety in exercises, setting realistic goals, and finding enjoyable activities to maintain motivation.
Maintaining a Balanced Lifestyle:
Integrating Nutrition and Exercise: Suggests meal planning and incorporating physical activity into daily routines.
Monitoring Progress: Recommends tracking food intake and exercise, regular health check-ups, and provides tips for achieving balance, such as getting sufficient sleep, managing stress, and staying socially active.
Pneumothorax and role of Physiotherapy in it.
This particular slides consist of- what is Pneumothorax,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is a summary of Pneumothorax:
Pneumothorax, also known as a collapsed lung, is a condition that occurs when air leaks into the space between the lung and chest wall. This air buildup puts pressure on the lung, preventing it from expanding fully when you breathe. A pneumothorax can cause a complete or partial collapse of the lung.
Unlocking the Secrets to Safe Patient Handling.pdf
Furthermore, the time constraints and workload in healthcare settings can make it challenging for caregivers to prioritise safe patient handling Australia practices, leading to shortcuts and increased risks.
Champions of Health Spotlight On Leaders Shaping Germany's Healthcare.pdf
This edition features a handful of Champions of Health: Spotlight On Leaders Shaping Germany's Healthcare that are leading us into a better future.
U Part Wigs_ A Natural Look with Minimal Effort Jokerwigs.in.pdf
Joker Wigs has been a one-stop-shop for hair products for over 26 years. We provide high-quality hair wigs, hair extensions, hair toppers, hair patch, and more for both men and women.
Hypertension and it's role of physiotherapy in it.
This particular slides consist of- what is hypertension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is summary of hypertension -
Hypertension, also known as high blood pressure, is a serious medical condition that occurs when blood pressure in the body's arteries is consistently too high. Blood pressure is the force of blood pushing against the walls of blood vessels as the heart pumps it. Hypertension can increase the risk of heart disease, brain disease, kidney disease, and premature death.
PET CT beginners Guide covers some of the underrepresented topics in PET CT
This lecture briefly covers some of the underrepresented topics in Molecular imaging with cases , such as:
- Primary pleural tumors and pleural metastases.
- Distinguishing between MPM and Talc Pleurodesis.
- Urological tumors.
- The role of FDG PET in NET.
Tips for Pet Care in winters How to take care of pets.
Tips for Pet Care in winters How to take care of pets.
Hypotension and role of physiotherapy in it
This particular slides consist of- what is hypotension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is the summary of hypotension:
Hypotension, or low blood pressure, is when the pressure of blood circulating in the body is lower than normal or expected. It's only a problem if it negatively impacts the body and causes symptoms. Normal blood pressure is usually between 90/60 mmHg and 120/80 mmHg, but pressures below 90/60 are generally considered hypotensive.
Let's Talk About It: Breast Cancer (What is Mindset and Does it Really Matter?)
Your mindset is the way you make sense of the world around you. This lens influences the way you think, the way you feel, and how you might behave in certain situations. Let's talk about mindset myths that can get us into trouble and ways to cultivate a mindset to support your cancer survivorship in authentic ways. Let’s Talk About It!
2024 HIPAA Compliance Training Guide to the Compliance Officers
Join us for a comprehensive 90-minute lesson designed specifically for Compliance Officers and Practice/Business Managers. This 2024 HIPAA Training session will guide you through the critical steps needed to ensure your practice is fully prepared for upcoming audits. Key updates and significant changes under the Omnibus Rule will be covered, along with the latest applicable updates for 2024.
Key Areas Covered:
Texting and Email Communication: Understand the compliance requirements for electronic communication.
Encryption Standards: Learn what is necessary and what is overhyped.
Medical Messaging and Voice Data: Ensure secure handling of sensitive information.
IT Risk Factors: Identify and mitigate risks related to your IT infrastructure.
Why Attend:
Expert Instructor: Brian Tuttle, with over 20 years in Health IT and Compliance Consulting, brings invaluable experience and knowledge, including insights from over 1000 risk assessments and direct dealings with Office of Civil Rights HIPAA auditors.
Actionable Insights: Receive practical advice on preparing for audits and avoiding common mistakes.
Clarity on Compliance: Clear up misconceptions and understand the reality of HIPAA regulations.
Ensure your compliance strategy is up-to-date and effective. Enroll now and be prepared for the 2024 HIPAA audits.
Enroll Now to secure your spot in this crucial training session and ensure your HIPAA compliance is robust and audit-ready.
https://conferencepanel.com/conference/hipaa-training-for-the-compliance-officer-2024-updates
Recently uploaded (20)
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...
Pediatric Emergency Care for Children | Apollo Hospital
Pediatric Emergency Care for Children | Apollo Hospital
DR SHAMIN EABENSON - JOURNAL CLUB - NEEDLE STICK INJURY
DR SHAMIN EABENSON - JOURNAL CLUB - NEEDLE STICK INJURY
Unlocking the Secrets to Safe Patient Handling.pdf
Unlocking the Secrets to Safe Patient Handling.pdf
Champions of Health Spotlight On Leaders Shaping Germany's Healthcare.pdf
Champions of Health Spotlight On Leaders Shaping Germany's Healthcare.pdf
U Part Wigs_ A Natural Look with Minimal Effort Jokerwigs.in.pdf
U Part Wigs_ A Natural Look with Minimal Effort Jokerwigs.in.pdf
Hypertension and it's role of physiotherapy in it.
Hypertension and it's role of physiotherapy in it.
PET CT beginners Guide covers some of the underrepresented topics in PET CT
PET CT beginners Guide covers some of the underrepresented topics in PET CT
Tips for Pet Care in winters How to take care of pets.
Tips for Pet Care in winters How to take care of pets.
Bringing AI into a Mid-Sized Company: A structured Approach
Bringing AI into a Mid-Sized Company: A structured Approach
Let's Talk About It: Breast Cancer (What is Mindset and Does it Really Matter?)
Let's Talk About It: Breast Cancer (What is Mindset and Does it Really Matter?)
2024 HIPAA Compliance Training Guide to the Compliance Officers
2024 HIPAA Compliance Training Guide to the Compliance Officers
chatgptfornlp-230314021506-2f03f614.pdf. 21506-2f03f614.pdf
chatgptfornlp-230314021506-2f03f614.pdf. 21506-2f03f614.pdf
Gene Therapy and FDA Regulations
- 1. Gene Therapy and FDA Regulations By: Haley Fenn How does gene therapy fit into the FDA? Is it a medical device, a drug, or a combination product? What if gene therapy can cure a life-threatening disease? There are a lot of questions that can pop into your mind when you first hear “gene therapy”, but EMMA International is here to answer them. Gene therapy is a field that is expected to rise in the near future. With the ability to treat or prevent diseases, gene therapy has finally caught the eyes of the FDA in a significant way. The Center for Biologics Evaluation and Research (CBER) has approved both cellular and gene therapy products; however, the FDA just recently finalized a set of policies for the development and assessment of gene therapies. This clarified its views as it prepares for a coming surge of new treatments in diseases. By 2025, the FDA expects it will be reviewing and approving between 10 and 20 cell and gene therapy requests each year, which will also help advance the science. i Gene therapy is classified as a biological product that needs to be licensed through one of the two Biologics License Application pathways (BLA). BLA 351(a) is for a stand-alone biological product and BLA 351(k) is for “biosimilar” or “interchangeable” biological products. Both applications demonstrate that the biological product is manufactured, processed, packed, or held to meet standards designed to ensure that it continues to be safe, pure, and potent.ii The FDA offers expedited programs for regenerative medicine therapies for serious conditions or life-threatening diseases. Your gene therapy technique could be eligible for fast track designation, breakthrough therapy designation, RMAT (Regenerative Medicine Advanced Therapies) designation, accelerated approval, and priority review designation if it meets the correct criteria.iii The addition of effective gene therapy in the market creates a beneficial competition amongst other developers. This is helpful to the overall community in the result of potentially treating rare and serious diseases. EMMA International can help you with all your gene therapy questions and FDA needs. Contact us at 248-987-4497 or email info@emmainternational.com to see how we can help you and your business!
- 2. Page 2 of 2 i BioPharmDive (01/28/2020) FDA,expecting a genetherapy boom,firms up policies retrieved on (01/29/2020) from https://www.biopharmadive.com/news/fda-gene-therapy-guidance-sameness-durability/571225/ ii FDA (February 2019)Principles of Premarket Pathways for Com bination Products – Guidancefor Industry and FDA Staff retrievedon (01/29/2020)from https://www.fda.gov/media/119958/download iii FDA (February 2019)Expedited Programs for Regenerative Medicine Therapies for Serios Conditions – Guidance for Industry retrieved on (01/29/2020)from https://www.fda.gov/media/120267/download