Speaker: Peter Pekos, Dalton Pharma Services. Part of the MaRS Best Practices Series.This session, led by seasoned industry experts, will explore how to effectively set up your pre-clinical POC studies, address pre-clinical safety requirements and issues, and give you an overview of the manufacturing standards required for Phase I studies
More information: http://www.marsdd.com/Events/Event-Calendar/Best-Practices-Series/ind-05132008.html
Presentation by NEPAD Agency on the African Medicines Regulatory Harmonisation made at the Euro-Africa Health Investment Conference, March 26 - 27, 2013, London, United Kingdom.
Speaker: Peter Pekos, Dalton Pharma Services. Part of the MaRS Best Practices Series.This session, led by seasoned industry experts, will explore how to effectively set up your pre-clinical POC studies, address pre-clinical safety requirements and issues, and give you an overview of the manufacturing standards required for Phase I studies
More information: http://www.marsdd.com/Events/Event-Calendar/Best-Practices-Series/ind-05132008.html
Presentation by NEPAD Agency on the African Medicines Regulatory Harmonisation made at the Euro-Africa Health Investment Conference, March 26 - 27, 2013, London, United Kingdom.
Safety Data Exchange Agreements (Brief)
An integral part of enterprise risk management systems
Strategic management framework
Governance model
Standards, mechanisms, and metrics for management oversight
Roles and responsibilities
Stakeholder collaboration
Procedural documents and SDEA templates
CAPA management processes
Supporting systems
Document repositories
Introduction to ICSR Narrative Writing in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Implementing a Global Unique Device Identification (UDI) Solution: Regional U...Greenlight Guru
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as global health authorities publish mandates.
This session will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Unique Device Identification —aka UDI— is about more than barcodes and regulatory red tape. This global system for identifying medical devices is a chance to radically improve the quality of life for patients, providers, and producers of medical devices. However, implementing UDI into your product lifecycle means navigating differing requirements in both the United States and the European Union. If you’re looking to go global, we’ve brought together three industry leaders on the subject to make sure you know the difference.
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Nutritional Labeling And Clinical Investigation And Evaluation Of Medical Dev...gauravpatil327512
Regulatory Aspects of Food and Nutraceuticals : "Nutritional Labeling And Clinical Investigation And Evaluation Of Medical Devices And IVDs Recommended Dietary Allowances in Europe "
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Ann Rockley — Managing the Complexities of the Core Data Sheet (CDS)Ann Rockley
The Core Data Sheet (CDS) is a critical component of the effective creation of Labeling content for different regulatory regions and outputs (Prescribing Information/Package Insert, Package Leaflet, etc.). The content is typically managed in email, complex MS Word documents, or Excel spreadsheets. It is difficult to track content relationships and ensure accuracy as the content moves out of the CDS to the desired deliverables. It is a painstaking and error-prone process.
Learn how you can use intelligent content best practices to design a structured component-based CDS. You will learn how to identify a reuse strategy to ensure content is correctly reused and tracked wherever it appears; manage the content using a structured content management system; automatically track content relationships; and manage claims and associated references throughout the content lifecycle.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Are electronically enabled delivery devices (EEDDs) the future?Team Consulting Ltd
Team's Andy Fry looks at the role that electronically enabled drug delivery devices could play. This presentation was delivered at Management Forum's Injectable Drug Delivery conference in London in March 2012.
Safety Data Exchange Agreements (Brief)
An integral part of enterprise risk management systems
Strategic management framework
Governance model
Standards, mechanisms, and metrics for management oversight
Roles and responsibilities
Stakeholder collaboration
Procedural documents and SDEA templates
CAPA management processes
Supporting systems
Document repositories
Introduction to ICSR Narrative Writing in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Implementing a Global Unique Device Identification (UDI) Solution: Regional U...Greenlight Guru
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as global health authorities publish mandates.
This session will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Unique Device Identification —aka UDI— is about more than barcodes and regulatory red tape. This global system for identifying medical devices is a chance to radically improve the quality of life for patients, providers, and producers of medical devices. However, implementing UDI into your product lifecycle means navigating differing requirements in both the United States and the European Union. If you’re looking to go global, we’ve brought together three industry leaders on the subject to make sure you know the difference.
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Nutritional Labeling And Clinical Investigation And Evaluation Of Medical Dev...gauravpatil327512
Regulatory Aspects of Food and Nutraceuticals : "Nutritional Labeling And Clinical Investigation And Evaluation Of Medical Devices And IVDs Recommended Dietary Allowances in Europe "
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Ann Rockley — Managing the Complexities of the Core Data Sheet (CDS)Ann Rockley
The Core Data Sheet (CDS) is a critical component of the effective creation of Labeling content for different regulatory regions and outputs (Prescribing Information/Package Insert, Package Leaflet, etc.). The content is typically managed in email, complex MS Word documents, or Excel spreadsheets. It is difficult to track content relationships and ensure accuracy as the content moves out of the CDS to the desired deliverables. It is a painstaking and error-prone process.
Learn how you can use intelligent content best practices to design a structured component-based CDS. You will learn how to identify a reuse strategy to ensure content is correctly reused and tracked wherever it appears; manage the content using a structured content management system; automatically track content relationships; and manage claims and associated references throughout the content lifecycle.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Are electronically enabled delivery devices (EEDDs) the future?Team Consulting Ltd
Team's Andy Fry looks at the role that electronically enabled drug delivery devices could play. This presentation was delivered at Management Forum's Injectable Drug Delivery conference in London in March 2012.
Appealing to users: developing usable & desirable devicesTeam Consulting Ltd
Julian Dixon, Team's Director of Human Factors, delivered this presentation at the 2nd World Pre-filled Syringes Summit in Washington in September 2012
Thinking Human by Julian Dixon, PMPS Inhalation Technology SupplementTeam Consulting Ltd
As medical device companies strive to make their products more user-friendly, it becomes clear that listening to the end user is an important part of the process. Through small-scale studies and human factor analysis, inhalers can be developed that are simple and easy to use.
Device Usability and Compliance: The Implications, Opportunities and Requirem...Team Consulting Ltd
Andy Fry and Julian Dixon presented during the Parenteral Drug Association's (PDA) Prefilled Syringes SIG in March 2011 on the hot topic of device usability and compliance.
Appealing to Users: Designing Inhalers to Maximize Compliance and Minimize Mi...Team Consulting Ltd
Team Consulting's head of human factors and usability, Julian Dixon, presented on the subject of designing inhalers to maximise compliance and minimise misuse.
Please note: Image quality has been degraded by Slideshare during upload.
David Harris, principal consultant at Team Consulting, was invited by the DDL organising comittee to present the case for DPIs at the Drug Delivery to the Lung (DDL) conference in December 2011
FDA Design Controls: What Medical Device Makers Need to KnowGreenlight Guru
FDA Design Control regulations defined in 21 CFR 820.30 have been in place for 20 years now, yet year after year they continue to be one of the top issues cited during inspections.
This does not, and should not, be the case for your medical device company.
Join us for this free, two-part webinar series presented by two of the world's leading experts on the topic to learn how to implement a design control process that will not only ensure compliance but will actually benefit your product development efforts.
(You can view both webinars here: http://www.greenlight.guru/webinar/medical-device-design-controls)
In Part 1, you'll learn about Intended Use, User Needs, Design Inputs, Design Reviews, Design History File (DHF) and Risk Management.
Specifically:
-The importance of getting your intended use right up front
-The difference between a user need and a design input that's verifiable
-What stakeholders need to be involved in the process and why
-When and how many design reviews you should hold
-Why FMEA alone is NOT risk management and how to integrate risk into the design and development process
In Part 2, you'll learn about Design Outputs, Device Master Record (DMR), Design Verification and Validation (V&V), Design Transfer and Regulatory Submissions.
Specifically:
-Why your design outputs need to be more than a drawing and their relationship to your DMR
-How usability and human factors fits into the overall product development
-Making sure you build the correct device and build it correctly with design V&V
-Common mistakes people make during design transfer to production and how to avoid them
-When you can and should make your regulatory submission
Evaluating the cost to benefit ratio of a Drug Delivery platformBhaswat Chakraborty
This talk calls for a tall order of understanding of the patient needs, techno-innovative and economic aspects of drug delivery platform technologies and in turn making sound decisions in research & development, administration and policy making. In general, therapeutic effect of a drug is determined by its potency as well as by the efficiency of its delivery to the site of action. Thus, therapeutic effects of many drugs are improved and controlled through the use of appropriate new drug delivery systems (NDDS). Often this advantage is associated with the added benefit of improved side effects and patient compliance for most NDDS. NDDS cover a wide range of technologies and routes of administration, such as oral, buccal-mucosal, ophthalmic, transdermal, pulmonary and colonic – to name a few.
Understanding the key patient needs and the resolve of devising the best delivery formulations have revolutionized the platform technologies. For example, in oral modified release (MR) technology, the key need is to optimize bioavailability with much fewer dosing frequency, whereas in ophthalmic MRs, the principal requirements are absence of local toxicity, tolerance, ease of dispensing, sterility, and osmolarity, etc. In this context, therapeutic categories are very relevant (e.g., the challenges and accuracy in technology development in ophthalmic preparation are steeper than oral preparations). For pulmonary delivery systems, the release of the drug in pulmonary tract is more important and beneficial for the patients than controlling the delivery. Similarly, achieving high local concentrations is the main goal in colonic and vaginal technologies.
Economic values or improvement in benefit-cost ratio in NDDS come not only from better addressing patient needs (efficacy enhancement, reduced dosing and side effects etc.) and compliance. Economic benefits are explicit in patent extension, increased market share and decreased costs). These benefits are obvious. Subtle and non-obvious benefits become apparent upon thorough cost effectiveness and cost utility analysis of many NDDS technologies. The speaker will give a few examples of substantial gains in quality adjusted life years when a drug was delivered through a delivery technology.
luxe research presentation at InnoCos Europe, ParisKGS Global
TARGETING EMERGING DELIVERY TECHNOLOGIES ACROSS THE VALUE CHAIN Delivery systems can differentiate products in a crowded market place. Learn how partnering with innovative start-ups can help keep your company ahead of the competition.
What are the innovative delivery technologies relevant to the cos- metics industry? Best practices for partnering in the delivery space with specific examples from the cosmetics industry
How delivery technology developers stack up against each other on the Lux Innovation Grid and how the grid can be used in partner selection process
Chananit Sintuu, Ph.D, Research Associate, Lux Research Inc
Sandor Szalma (Janssen) gives an overview of this potential Pistoia Alliance working group during the "Dragons' Den" session of the Pistoia Alliance Conference in Boston, MA, on April 24, 2012.
The lesson outcomes are to describe the product life cycle, identify the life cycle assessment framework and importance of LCA, identify the strict liability concept, define ergonomics, and describe the importance of ergonomics applications.
Usability Validation Testing of Medical Devices and SoftwareUXPA Boston
The U.S. FDA and international regulatory bodies require usability testing of medical devices, products, software, and systems as part of their overall validation. Manufacturers must demonstrate that all potential use-related hazards have been identified, prioritized, and mitigated. The method for demonstrating this is human factors/usability engineering (HF/UE) validation testing. However, the way we conduct these studies is in many ways different from the way we conduct studies of non-medical products and systems.
This topic is relevant to the Boston UX community given the convergence of consumer and medical devices, as well as the rise of wearable technologies and the apps that interact with them. This presentation will cover the key aspects of HF/UE validation (a.k.a. ‘summative’) testing and what the FDA expects in the final HF/UE summary report.
Importantly, this session will consist of half presentation and half Q&A, with the audience driving the discussion toward current issues, questions, and challenges that are relevant to them.
mHealth Israel_Human Factors for MedTech Ergonomics and Usability_Rebecca MosesLevi Shapiro
Presentation by Rebecca Moses, Human Factors for MedTech Ergonomics and Usability, for the mHealth Israel community: Human Factors for MedTech Ergonomics and Usability
The advantages of a connected device can be explored through the different categories of needs, by trialling a range of solutions and considering a framework of manageable steps.
ONdrugDelivery - The advantages of designing high-resistance swirl chambers f...Team Consulting Ltd
In this article, David Harris, Head of Respiratory Drug Delivery, Team Consulting, taps into a powerful combination of detailed anatomical and functional understanding of the human respiratory system, pulmonary drug delivery technology and formulation expertise, and mathematical modelling techniques, in order to put forward the case for high-resistance swirl chambers in dry-powder inhalers, and a rational strategy for optimising the design and thus maximising therapeutic efficacy.
We think it is important to think ahead and to consider what issues the medical industry will be facing in the future.
As we near 2015 we’ve decided to use this as a half-way point. In this infographic we’ve reflected on significant global changes over the last 15 years and looked at the forecasts for the next 15. The result is a glimpse of what challenges healthcare will face in 2030. Can we do anything today to change the future? Or if we accept this vision of the future what do we need to do now to best prepare?
In an issue of IPT (Innovations in Pharmaceutical Technology) magazine, Team Consulting's David Harris explores the benefits of dry powder inhalers for a range of new therapeutic areas, outside of traditional asthma and COPD treatments.
If you were to tell some people that one of the most frustrating aspects of the development of a drug delivery device would be the little clicks that it makes as part of its operation, they would probably think you had lost your sense of priority.
Device developers know this - whether human factors experts or industrial designers, mechanical engineers, or risk analysis teams - yet this aspect of device design, like many others, is frequently not given the attention it deserves. So why is a click so important?
Designing for battery-powered and battery-packed medical devices, EPD&T, Dec ...Team Consulting Ltd
Team's Jonathan Oakley writes about designing the 'graceful shutdown'. When power starts to run out in a medical device it is important to think about which parts of the system are affected and at what stage.
First published in EPD&T in December 2013 http://www.epdtonthenet.net/
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
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Hot Selling Organic intermediates
Lowering the Hurdles in Device Selection for Biologics
1. Lowering the Hurdles in
PDA: A Global
Device Selection for
Biologics
Association
Andy Pocock – Team Consulting
7th November 2012
2. Who are Team Consulting?
Focus on medical devices to meet the needs of patients and healthcare
professionals worldwide for over 25 years
Drug delivery Surgical devices Critical care Regenerative
medicine
Over 40 parenteral device projects & developments including:
• autoinjectors, injector pens
• needle free devices
• wearable/large volume devices
• safety needles/safety syringes
• vaccine delivery systems
• dual chamber devices
3. Lowering hurdles?
Understand
the challenges
Awareness of
the process
What are the
requirements
Don’t get caught out by the wrong device choice…
4. Agenda
1. Some background and drivers to the biologics sector
– Market pull & delivery challenges
1. Selection process and key criteria
– What to consider during selection
1. Attributes for a successful delivery device for biologics
– ‘Ideal’ vs. ‘Essential’ characteristics
5. 1. Device Selection for Biologics
Some background:
Market Pull / Delivery Challenges
6. The drug delivery device ‘system’
Drug Delivery Primary
Device Container Drug Patient
• The primary container and delivery device are the ‘drug to patient interface’
• This is the key interface in the system, as there is limited control over the patient /
user actions
• The device choice (and design) is the opportunity to get it ‘right’ for the patient
and reduce the occurrence of use-related errors
7. Why adopt new drug delivery technology?
Survey of industry experts, small/medium sized drug companies, drug delivery specialists:
– User compliance – convenience and ease of use may help
– Differentiation – competition for market share driving product positioning via
delivery means (i.e. device type and design)
– Life Cycle Management – using device characteristics to extend product life
Shand.B – University of Cambridge / Simpson.I - Team Consulting.
2007
8. Biologics – Market Pull
• Increasing numbers of biologically derived
therapeutics in development
— monoclonal antibodies (mAbs) aimed at
the treatment of chronic illnesses –
Cancer, RA, MS Emerging
Vs.
• Global biologic sales expected to reach Developed?
US$166 billion by 2015*
— $64 billion from off-patented drugs
• Growth in Biosimilars following patent
expiry of many biologics e.g.
— Herceptin, Roche
— Enbrel, Amgen
— Humira, Abbott
*IMS Health 2007 & 2009, Evaluate Pharma, Sandoz analysis 2010
9. Biologics – Implications for injection devices 1
*in-Pharma Technologist.com –
February 2012
• Increasing competition within Biologics
market requires differentiation by delivery
means
— Diversification of device type/design to
meet particular user requirements
FDA - Guidance for Industry on
• Significant market drive toward self- Biosimilars
administration •Q.I.4. Can a proposed biosimilar product
— To contain costs and improve convenience
have a delivery device or container
closure system that is different from its
• Subcutaneous delivery is easily accessible reference product?
by patient and can accommodate
infrequent, regular regimens (e.g. weekly - •“Yes, some design differences in the
monthly) delivery device or container closure system
used with the proposed biosimilar product
may be acceptable”
10. Biologics – Implications for injection devices 2
• Heightened safety demands due to ‘home Dosing regime
use’ leading to more sophisticated, simple
to use, safer devices
— Single use, disposable (combination)
— Needle protection (needle retraction /
shielding) Formulation factors
• Focus on compliance - convenience,
usability etc.
Administration
• Minimise patient anxiety & pain
— Finer needles, concealed needles and/or
automatic insertion
— Needle-free devices
— Larger volume, slow release ‘wearable’
devices
11. Biologics – Implications for injection devices 3
Higher payloads of active biologic to achieve
the required therapeutic dose, leading to
(potentially):
•Larger volumes (1ml+ )
— Additional challenges of pain associated
with larger injected volumes, rate of
delivery etc.
•Higher viscosities (≈30cP)
— Stretching the ‘power’ budget required
— Challenging the robustness of primary • “The results show that increasing the volume from
0.5 to 1.0 mL increases the pain significantly.”
container and delivery mechanism • “Pain is subjective and highly variable, trending up
even in small volumes”
• “The volume should generally be less than 1.0 mL if
injected into thigh (SC)”
Source: Jorgensen et al, The Annals of
Pharmacotherapy: Vol. 30, No. 7, pp. 729-732, 1996
12. Self-Injection Spectrum
Pre-filled & Safety Auto injectors Wearable / electronically
Syringe & vial dual chamber syringes & Pen injectors enabled devices
More complex user task? Increased technical sophistication
Why the interest in anything more complex than a ‘standard’
prefilled syringe?
14. Selection as part of a development process?
Define Assess Options Implement Design Launch
Requirements
Contract Negotiation
Review landscape
TPP
TPP
Receive proposals
User
Needs Assess evidence Design Control Process
URS
URS and samples
Review capability
TPP
TPP
User
Needs URS
URS Review
Design
PRS
PRS
Input
Device Selected Design
Process
Design
Design
Verification Output DDS
DDS
Design Medical
Validation Device
15. Broad Commercial & Technical Criteria
Implementable?
Implementable?
Can technical,
Can technical,
industrialisation and
industrialisation and
regulatory issues be
regulatory issues be
overcome?
overcome?
Adaptable?
Adaptable?
Available?
Available? Can the device be adapted
Can the device be adapted
Is ititthe right device at the
Is the right device at the to suit delivery
to suit delivery
right price?
right price? requirements?
requirements?
Protectable?
Protectable? Acceptable?
Acceptable?
Can the device provide
Can the device provide Will the device be
Will the device be
sustained competitive
sustained competitive acceptable? (by patients,
acceptable? (by patients,
advantage?
advantage? HCP’s, payers etc.)
HCP’s, payers etc.)
Simpson.I – Team Consulting
16. Consideration during selection
8. Regulatory 1. Medical Condition (patient)
7. Technical Status 2. Treatment
6. Human Factors 3. Primary Drug Pack
Engineering (HFE)
5. Commercial and Operational 4. Marketing
17. Consideration during selection
1. Medical Condition (Patient)
• What do you know about the patient condition that might influence acceptance?
• What is the dexterity and cognitive ability of the target population?
• What is the dose frequency? Single or multi dose / Fixed or variable dose?
• What is the period of treatment i.e. chronic disease vs. short term treatment?
• Who will administer? Self (Home) or HCP (Hospital) administration?
• Are there specific safety requirements that need to be considered e.g. timer
lockouts?
2. Treatment (Drug)
• Will the device cope with the drug/treatment characteristics?
• What is the dose volume?
— An auto-injector is typically <1ml
• What is the drug viscosity?
• Is reconstitution required?
• Is injection time important for the therapy?
• What is the delivery depth?
18. Consideration during selection
3. Primary Packaging
•Which type of primary container will be used? Is it defined?
•Who will undertake filling and final device assembly?
•What are the challenges associated with the primary pack that
might influence device choice? E.g. for a PFS
— Removal force of needle shield
— Dimensional tolerances
— Break loose force and glide force variance
— Accommodation of PFS during auto-injection
— Use of a rigid needle shield or soft needle shield
•Does stability data exists for a primary container?
4. Marketing
• Will the delivery characteristics offer competitive advantage?
How adventurous do you need to be?
— What is expected the patient experience?
— What will be the perceived value of the device - ‘Me too’ or
unique design?
• How will the treatment be offered?
— Multiple devices to meet differing user requirements
— Device platform used for other treatments.
19. Consideration during selection
5. Commercial and Operational
• What type of commercial agreement is preferred ?
— Who owns what IP? What is being for license?
— Who owns the component tools?
— Who will undertake final fill and assembly?
• What are the timelines for clinical trials and product launch?
• What is the launch and scale up strategy?
• What is the cost per device / cost per dose?
6. Human Factors Engineering (HFE)
• Will the device be safe and effective to use by the intended user
FDA guidance
groups with a realistic level of training? ISO/IEC 62366 (incl. ANSI/AAMI HE74)
ANSI/AAMI HE75:2009
•FDA guidance on applying HFE in medical device design should influence
the process of device selection
— Regulatory submissions must show a sensible programme of HFE in identifying
and mitigating risk associated with use error
• Separate exploratory and summative studies will be required for each
medication and associated user group(s).
20. Consideration during selection
7. Technical status
•What stage of development is the technology?
— Prototype?
— Proven for other drug products and partners?
•What evidence of development analysis and testing Is available?
•What is known of the delivery window characterisation – viscosities,
delivery time, volume etc.
•Evidence of formative HF studies / experience with intended patient
groups?
8. Regulatory
•For biosimilars… how close does delivery method need to be to the
reference product?
•How will the device be regulated? A medical device or a combination
product?
•The route for submission will affect the level of complexity and risk
21. 3. Device Selection for Biologics
Attributes for a successful delivery
device for biologics
23. Selection – Develop or License?
Develop Benefits
•Secure IP to maintain competitive advantage
1.Create own device (‘ground up’ development)
•No ‘fuss’ tailored development to meet your
based on new or expired IP own specific requirements
•Freedom to select the right manufacturing
process capabilities
License Benefits
2.Develop a device with licensed IP for a specific •More predictable / manageable technical risk,
combination of technical feature(s) from a device cost and timescale
supplier •Reduced time to market - partially developed
already
3.Licence and customise an existing device core •Known (sometimes proven) technology with
technology to meet particular user / delivery access to manufacturing capability
requirements •Early development costs spread across other
non-competing sectors
4.Licence use of an existing device with no •Allows pharma/biotech to retain focus on core
changes to device other than branding / colour competence
•Reduced risk of IP infringement
24. The ‘IDEAL’ device for Biologics...
Creating a positive user
An injector people are WILLING experience
to use
Co
o ry
mm
lat
gu
erc
Re
Appealing
ial
An injector people CAN use An injector that can be MANUFACTURED
to FUNCTION as intended
Safe and intuitive or ‘learnable’ Ensuring robustness and
in the hands of the user Technical reliability
25. Essential Attributes - Functionality
• Invite input from all stakeholders – the functional specification represents
all needs and expectations – there should be no surprises
• Even for an ‘off the shelf’ injector, understand how and why the device
design works and where its limits are
— Stress test functional samples - in labs and in user’s hands. Face up to
likely realities as early as possible
— Model, simulate, test and iterate mathematical and physical models
— Expect convergence within 10% after 3 iterative loops between the
empirical and theoretical
— For multi-feature, multi function components – identify critical
features/dimensions based on in-depth understanding of the design
• Beware - Simulation and functional prototypes provide guidance only
— Production versions represent reality
— Manufacturability and usability must be built in from project start
26. Essential Attributes - Manufacturability
• Begin dialogue early – involve a manufacturing partner at design layout level
and must be shared by ALL
• A sound tolerance allocation methodology enables predictable production
— it must reflect the manufacturing processes involved and their
capabilities
— it must support the high levels of functionality and performance
required
— dialogue between designer and manufacturer should prevent
misunderstandings
• Consider high volume component assembly and feeding constraints early
– Top-tip; If you can assemble it automatically you can do it manually but this
seldom applies vice-versa!
27. Essential Attributes - Usability
• Reduce physical and cognitive ‘delivery task’ burden by eliminating the
negatives:
— Avoid significant use-related risks
— Maximise ease of use
— Minimise delivery pain / anxiety
— i.e. some users want to be in ‘control’, others want ‘distance’
• Reduce the cognitive and emotional treatment ‘self management’
burden
— Add functionality to deal with forgetfulness, incomprehension
and/or fear
— Balance dose size, dose discomfort and dosing frequency
28. Conclusions
• Delivery of biologics represent a significant and growing demand for safe,
effective, patient centred injection devices
• Expectations and challenges for delivery performance is rapidly evolving
• Suppliers are responding with a vast choice of novel and sophisticated
technologies
• A rigorous selection process can help avoid downstream headaches and
significantly enhance the chance of market success
— Consider the device early in the process... even during development of the drug.
29. Acknowledgements
• Ben Turner
Thank you for your attention
• Mark DiCioccio
Andy Pocock
Head of Parenteral Drug Delivery
andrew.pocock@team-consulting.com
• Andy Fry www.team-consulting.com
30. Lowering the Hurdles in
PDA: A Global
Device Selection for
Biologics
Association
Andy Pocock – Team Consulting
7th November 2012