The document discusses how to build effective partnerships between internal teams and external vendors for drug development. It emphasizes establishing clear expectations through quality agreements, defining oversight metrics, and fostering collaboration and communication. Risk management is also important, with risk assessment and identification of issues that could impact project execution. Building trust, respect, and rapport between sponsors and vendors helps ensure successful relationships.
2018 11-14 generating ideas on how to manage cro'seyalsron
Deconstructing challenges faced with working with CROs and effective processes to overcome them
Managing the process of relationship development with the right CRO to reduce unnecessary consumption of time
Unveiling mistakes and understanding the best way to work with CRO’s to strengthen relationships with your current and new vendors
Emphasizing the importance of coordination and communication and how that benefits your work load and organization of preclinical trials
A New Partnering Alliance Approach At Otsukavillahill
This presentation describes a state-of-the-art partnership alliance between Otsuka and Covance. It also describes a staffing forecasting model that will be used in the partnership.
EDR Webinar
Presented by June Jewell, CPA, President AEC Business Solutions
November 18, 2015
Project Managers (PMs) are the key to a professional services firm’s success. Yet many firms promote technical people into roles they are not prepared or ready for. As a result, project profitability suffers and there is frustration at every level of the organization. By enabling project managers, through financial and systems training, automation, and accountability measures, the firm’s profit margins can increase substantially.
In this webinar, attendees will be able to:
-Evaluate the challenges that cause many Project Managers to struggle with project profitability
-Understand the reasons that projects go over budget
-Review the financial aspects of project management that Project Managers need to know to be successful
-Learn how technology can help Project Managers deliver more profitable projects
-Develop some best practices to help Project Managers succeed
Speaker
June R. Jewell, CPA, President AEC Business Solutions
Jewell, a thought leader and expert in AEC firm profitability, has more than 28 years of business management consulting experience, and unsurpassed knowledge of the AEC industry. In addition to this role, she is the original founder and current strategic advisor of Acuity Business Solutions, a Deltek Premier Partner and consulting firm that works with AEC firms to support business profitability through web-based enterprise management technology.
She is the Amazon best-selling author of the book “Find The Lost Dollars: 6 Steps to Increase Profits in Architecture, Engineering and Environmental Firms.” Jewell has built and run a successful consulting practice, and is a highly sought after speaker at industry events and conferences. Her past speaking engagements include AIA, ACEC, SMPS, Design and Construction Network (DCN), Society for Design Administration (SDA), Zweig Group (formerly ZweigWhite), PSMJ, ROG Growth and Ownership Conference, Project Management Institute (PMI), Deltek Insight and Business of Architecture (BOA).
An exhaustive primer on Due Diligence for Mergers & Acquisitions, using examples from my career in law as well as a Corporate Development leader at Microsoft & Samsung Electronics. Covers prep, leveraging external vendors and focus on interaction and engagement with the target.
Ping me with questions and let me know what you thought!
https://www.linkedin.com/in/danny-b
2018 11-14 generating ideas on how to manage cro'seyalsron
Deconstructing challenges faced with working with CROs and effective processes to overcome them
Managing the process of relationship development with the right CRO to reduce unnecessary consumption of time
Unveiling mistakes and understanding the best way to work with CRO’s to strengthen relationships with your current and new vendors
Emphasizing the importance of coordination and communication and how that benefits your work load and organization of preclinical trials
A New Partnering Alliance Approach At Otsukavillahill
This presentation describes a state-of-the-art partnership alliance between Otsuka and Covance. It also describes a staffing forecasting model that will be used in the partnership.
EDR Webinar
Presented by June Jewell, CPA, President AEC Business Solutions
November 18, 2015
Project Managers (PMs) are the key to a professional services firm’s success. Yet many firms promote technical people into roles they are not prepared or ready for. As a result, project profitability suffers and there is frustration at every level of the organization. By enabling project managers, through financial and systems training, automation, and accountability measures, the firm’s profit margins can increase substantially.
In this webinar, attendees will be able to:
-Evaluate the challenges that cause many Project Managers to struggle with project profitability
-Understand the reasons that projects go over budget
-Review the financial aspects of project management that Project Managers need to know to be successful
-Learn how technology can help Project Managers deliver more profitable projects
-Develop some best practices to help Project Managers succeed
Speaker
June R. Jewell, CPA, President AEC Business Solutions
Jewell, a thought leader and expert in AEC firm profitability, has more than 28 years of business management consulting experience, and unsurpassed knowledge of the AEC industry. In addition to this role, she is the original founder and current strategic advisor of Acuity Business Solutions, a Deltek Premier Partner and consulting firm that works with AEC firms to support business profitability through web-based enterprise management technology.
She is the Amazon best-selling author of the book “Find The Lost Dollars: 6 Steps to Increase Profits in Architecture, Engineering and Environmental Firms.” Jewell has built and run a successful consulting practice, and is a highly sought after speaker at industry events and conferences. Her past speaking engagements include AIA, ACEC, SMPS, Design and Construction Network (DCN), Society for Design Administration (SDA), Zweig Group (formerly ZweigWhite), PSMJ, ROG Growth and Ownership Conference, Project Management Institute (PMI), Deltek Insight and Business of Architecture (BOA).
An exhaustive primer on Due Diligence for Mergers & Acquisitions, using examples from my career in law as well as a Corporate Development leader at Microsoft & Samsung Electronics. Covers prep, leveraging external vendors and focus on interaction and engagement with the target.
Ping me with questions and let me know what you thought!
https://www.linkedin.com/in/danny-b
Want to learn how to jump-start your SMMP?
You’ve got the go-ahead from procurement to implement a Strategic Meetings Management Program (SMMP). Fantastic! Now what? Knowing where to start, which stakeholders to involve and what steps to take to drive a successful strategy can be unfamiliar territory to meeting and event professionals of all levels.
This free webinar will help guide you through a high-level “getting started” process in which you will learn:
Typical components to SMMP
Pre-planning to get started
Key steps for implementation
Common pitfalls to avoid
Vendor Alliance: Cultivating the Most Beneficial Vendor Relationshipseyalsron
My Presentation at the Arena International, Clinical Trial Supply NE, 2018-03-07. The full presentation could be found here: https://www.slideshare.net/eyalsron/cultivating-the-most-beneficial-vendor-relationships
The Government Technology & Services Coalition (GTSC) and its Emerging Small Business Group on December 16 hosted a session for small companies to learn about business development in the Federal sector. Our presenter, Tony Sacco was Vice President of SAIC and has over 40 years of experience in business development, IT systems development, integration and operations. Topics included:
>>Introduction to the BD lifecycle from a small business perspective
>>Challenges and opportunities in each phase
>>Strategies and techniques to be successful at BD
About the GTSC Emerging Small Business Group
The Emerging Small Business Group is open to GTSC members with revenue <$2.5 million. It will focus on understanding the numerous challenges of starting/growing a small business in the Federal space and marshaling GTSC’s vast resources of peers, owners, mentors, subject matter experts and online virtual tools to provide our emerging small business members the knowledge and techniques they need to meet the challenges of growing a business.
Chair: Elaine Kapetanakis, CEO, Kapstone Technologies
As competition grows, written business proposals are getting more and more complicated and become critical to small and mid sized business. However, they don't want to spend on a professional Bid & Proposal Management structure.
This document highlights the main Bid & Proposal Management challenges for SMEs, as well as showing how a mature process helps companies winning more bids and more profitable business.
Driving Key Account Growth: Planning and Execution to Access the White SpaceRichardson
Decreasing customer loyalty, higher expectations, and constant competitive threats are making forecasted business from your best customers anything but a certainty. The presentation will cover the following:
1. The guiding principles for excellence in strategic account planning
2. Quantitative and qualitative factors to consider in choosing accounts for strategic account planning
3. How to align to the customer’s strategy
Account plan execution
A practical learning to help create an efficient and targeted approach towards clinical supply. TA exciting event and one particularly captivating presentation came from Gelesis's Chief Technology Officer, Eyal Ron. The vastly experienced Dr. Ron succinctly showcased manufacturing management strategies and examined selection processes to help provide the ideal manufacturing partner for your company.
Want to learn how to jump-start your SMMP?
You’ve got the go-ahead from procurement to implement a Strategic Meetings Management Program (SMMP). Fantastic! Now what? Knowing where to start, which stakeholders to involve and what steps to take to drive a successful strategy can be unfamiliar territory to meeting and event professionals of all levels.
This free webinar will help guide you through a high-level “getting started” process in which you will learn:
Typical components to SMMP
Pre-planning to get started
Key steps for implementation
Common pitfalls to avoid
Vendor Alliance: Cultivating the Most Beneficial Vendor Relationshipseyalsron
My Presentation at the Arena International, Clinical Trial Supply NE, 2018-03-07. The full presentation could be found here: https://www.slideshare.net/eyalsron/cultivating-the-most-beneficial-vendor-relationships
The Government Technology & Services Coalition (GTSC) and its Emerging Small Business Group on December 16 hosted a session for small companies to learn about business development in the Federal sector. Our presenter, Tony Sacco was Vice President of SAIC and has over 40 years of experience in business development, IT systems development, integration and operations. Topics included:
>>Introduction to the BD lifecycle from a small business perspective
>>Challenges and opportunities in each phase
>>Strategies and techniques to be successful at BD
About the GTSC Emerging Small Business Group
The Emerging Small Business Group is open to GTSC members with revenue <$2.5 million. It will focus on understanding the numerous challenges of starting/growing a small business in the Federal space and marshaling GTSC’s vast resources of peers, owners, mentors, subject matter experts and online virtual tools to provide our emerging small business members the knowledge and techniques they need to meet the challenges of growing a business.
Chair: Elaine Kapetanakis, CEO, Kapstone Technologies
As competition grows, written business proposals are getting more and more complicated and become critical to small and mid sized business. However, they don't want to spend on a professional Bid & Proposal Management structure.
This document highlights the main Bid & Proposal Management challenges for SMEs, as well as showing how a mature process helps companies winning more bids and more profitable business.
Driving Key Account Growth: Planning and Execution to Access the White SpaceRichardson
Decreasing customer loyalty, higher expectations, and constant competitive threats are making forecasted business from your best customers anything but a certainty. The presentation will cover the following:
1. The guiding principles for excellence in strategic account planning
2. Quantitative and qualitative factors to consider in choosing accounts for strategic account planning
3. How to align to the customer’s strategy
Account plan execution
A practical learning to help create an efficient and targeted approach towards clinical supply. TA exciting event and one particularly captivating presentation came from Gelesis's Chief Technology Officer, Eyal Ron. The vastly experienced Dr. Ron succinctly showcased manufacturing management strategies and examined selection processes to help provide the ideal manufacturing partner for your company.
The agency-client relationship can be difficult to establish and grow. These are the things I've learned over the years as both a consultant as well as operations leader, hiring consultants and agencies.
Is Doing a Business Plan Worth the Time?ventureneer
When starting a small business, developing a business plan can save you time and aggravation. Learn what type of plan is right for your company and how to write.
HR Outsourcing - A Primer (And Look Back)Mark Stelzner
Many in the HR community view outsourcing as a threat. But some companies' strategic implementation of outsourcing has freed HR from transactional obligations and allowed for focus on more strategic and high-value activities. In this SHRM presentation, Mark Stelzner of Inflexion Advisors discusses the ever-changing state of HR outsourcing and the strong business case for outsourcing recruiting, payroll, benefits and more. He'll also describe steps organizations can take to launch an outsourcing initiative, assess their current outsourcing partners and create an effective request for proposal.
Corporate and Personal Strategic Planning is a Process for Reaching Professional or Personal Goals. It can be used in coaching sessions for individuals, small businesses corporate teams or corportae planning to strategize action plans
This presentation was originally made at the 2016 Association of American University Presses Annual Meeting, 17 June 2016. It discusses both why and how to effectively hire consultants. The slides were developed by my colleague Pam Harley who originally was scheduled to give this talk.
This alliance lifecycle framework presentation was created as a tool to foster conversation and provide context on some of the questions to consider as you assess the importance and structure of a formal alliance lifecycle framework. I created this for a friend working with one of the leading Canadian consulting firms without a current formal strategy, framework or program in place for the development and management of IT channel business partner programs and relationships.
Procurement challenges may seem daunting, but there is hope. Here we have discussed ten common procurement challenges for businesses & tips for overcoming them.
Similar to The human side of drug development - building relations (20)
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
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
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.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Ocular injury ppt Upendra pal optometrist upums saifai etawah
The human side of drug development - building relations
1. The Human Side of Drug
Development - Building
Relations
Advancing Drug Development Forum
San Francisco, CA
Thursday, June 14, 2018
Eyal S. Ron, Ph.D.
Eyal@MADASH.com
MADASH, LLC.
1
2. Outline
How to form a perfect partnerships
Model relationships in clinical trial supply outsourcing
Identifying methods to find your ideal vendor to improve results
It’s a team effort
MADASH, LLC.
2
3. The Challenge
Creating a team that will work together interdependently and
cooperatively to meet the needs by accomplishing their
purpose and goals
Internal and external team
Finding a high quality collaborators that is suited to the needs of your
organization (technically, culturally, size, etc.)
Soliciting the a proposal (external)
Managing the relationship & oversight (internal / external)
Opportunity to interview key stakeholders and bridge the gap between the
vague aspirations that launch a project and the concrete, measurable
requirements that guide it to successful conclusion
MADASH, LLC.
3
4. Internal Relationship
Team building – “the process of turning
a group of individual contributing
employees into a cohesive team”
▪ A “forced” process (such as using
external facilitation)
▪ An organic “creation” (such as
setting a budget, goals, timeline,
positive employee recognition, etc.)
4 MADASH, LLC.
5. External Relationship: Through a
Request for Proposal (RfP)
A request for proposal (RfP) is a solicitation, often made through a
bidding process, by an agency or company interested in procurement
of a commodity, service or valuable asset, to potential suppliers to
submit business proposals. It is submitted early in the procurement
cycle, either at the preliminary study, or procurement stage
https://en.wikipedia.org/wiki/Request_for_proposal
MADASH, LLC.
5
6. Steps - the Request for Proposal Process
Internally:
▪ Establish the project's boundaries
▪ Identify key stakeholders and advisors
▪ Define your project needs
▪ Draft the RFP
o Create a draft of the scoring criteria
o Review with the team (stakeholders and advisors)
Externally:
▪ Select 3 – 5 vendors
▪ Circulate the RfP
▪ Review proposals
MADASH, LLC.
6
7. What Information Should be Included
in the RfP?
Organizational background
Project Description / objectives
Timeline (create a reasonable timeline)
Milestones
Deadlines
Questions and required information
A “Killer” criteria
Questions based on past experiences
Technical items: QC methods, synthesis pathways, etc.
Payments’ structure
Contact information and deadline for submission
MADASH, LLC.
7
8. RfP Specifications
The RFP Should Make Introductions. The RFP should provide basic introductions to
the company (who is requesting the proposal)
The RFP Should Present the Need. The RFP should provide a brief project overview,
stating the business case for the project and the need to be filled.
The RFP Should State Requirements. The RFP should state the service and
technical requirements and specifications upon which the proposed solution
must be based. Every requirements statement should include a "definitions"
section to ensure that all parties share a common understanding of all business
and technical needs.
The RFP Should Set Terms and Conditions. The RFP should state the expected
terms and conditions for solutions acceptance, including delivery requirements,
payment terms, and regulatory requirements.
The RFP Should Set Expectations. The RFP should describe the overall RFP bidding
process, including response submission requirements, "winning" evaluation and
selection criteria, process deadlines, and related technical procedures (response
format, submission mechanisms and how to submit questions and feedback).
MADASH, LLC.
8
9. What Information Should NOT be
Included in the RfP Process?
Misleading information
Different verbal and written communication
Request for “Freebies”
Champion receiving lowest prices
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10. Evaluate RfP - Do not Judge a Vendor
Solely by the Cover of the Proposal
Meet the vendor
▪ Management
▪ Team
▪ Project leader
▪ Communication style
Optionally, audit the vendor
Ask for references
Does the vendor really wants
to win the proposal
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Quality
Timeline
Cost
▪ Quality of communication
▪ Project leader
▪ Do they “get us”?
Cost True Cost
Quality Due Diligence / References
Delivery Lead time
Innovati
on
Number of ideas / improvements by the
vendor
12. The Proposal’s Challenges
Not all vendors with the appropriate capabilities will be interested in the
amount of business that are offered
Forecasts of future needs are uncertain, but they set the foundation for
credibility with the vendor
Rushing through the outsourcing process can lead to costs inaccuracies
and mistakes (→ amendments are costly)
Product’s quality must be of the highest possible level
Changes will require a single point of communication
Managing the end of a relationship is often viewed as adversarial and
therefore not addressed until a crisis occurs
The vendor’s team that wins often isn’t the team that services the business
relationships
Ensuring compliance with regulatory directives
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14. The Agreement
Responsibilities
Term and Termination
Payment / Reimbursement of
costs
Intellectual Property
Confidentiality
Publications
Indemnification
Insurance
Governing Laws
Arbitration
Notices
Assignments
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15. Quality Agreement and CRO Oversight
& Collaboration Plans
Draft a Quality Agreement that prescribed standards, expectations, and
responsibilities
Do not forget to include:
▪ Transfer of Responsibilities (TOR)
▪ Scope of Work (SOW)
▪ Audits
16. Oversight Metrics / Benchmarks
Is the vendor doing what we hired it to do?
Is the vendor adhering to the plan?
Is vendor performance meeting or exceeding expectations?
What issues should be escalated?
Why are we behind schedule?
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17. Define Quality Agreement and Vendor
Oversight & Collaboration Plans
Draft a Quality Agreement that prescribed standards, expectations,
and responsibilities
Do not forget to include:
▪ Transfer of Responsibilities (TOR)
▪ Scope of Work (SOW)
▪ Audits
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18. Risk Management Beneficial Vendor
Relationships
Risk assessment consists of the identification of hazards and the analysis and
evaluation of risks associated with exposure to those hazards. Quality risk
assessments begin with a well-defined problem description or risk question.
When the risk in question is well defined, an appropriate risk management tool
and the types of information needed to address the risk question will be more
readily identifiable. As an aid to clearly defining the risk(s) for risk assessment
purposes, three fundamental questions are often helpful:
What might go wrong?
What is the likelihood (probability) it will go wrong?
What are the consequences (severity)?
• Regulatory
• Processes
• Culture
• Communication
September 2015 EMA/CHMP/ICH/24235/2006 Committee for Human Medicinal Products
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19. Risk Management & Oversight
Risk assessment
Risk identification
Risk analysis
Risk control that includes decision making to reduce
and/or accept risks
“Not everything that can be counted counts, and not
everything that counts can be counted.”
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20. It’s a Team Effort
Empower teams through collaboration and workflow
Avoid micromanagement but perform the oversight
Measure the process not the people
If the vendor has weakness or lacking, how are these issues
impacting the program execution?
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21. Key Factors in Sponsor – Vendor Relationship
Trust
Respect
Rapport
Diversity
Communication
• Method (Telecon / meetings)
• Format (styles)
• Frequency
• Outcomes
Information sharing
Single point of Contact
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22. Motivation
Bonuses for achieving milestones / targets
Agreement for a continued work / revenue stream in exchange for
commitments
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23. Beneficial Vendor Relationships
Establish a written Quality Agreement to record the respective
responsibilities:
▪ Purpose/Scope
▪ Terms (including effective date and termination clause)
▪ Dispute Resolution
▪ Responsibilities, including communication mechanisms & contacts
▪ Change control and revision
▪ Formal agreement that delineates cGMP responsibilities (including
quality measures)
Evaluate contractors for quality and if needed for their cGMP compliance
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The Ultimately the Responsibility is on the Sponsor!
FDA Guidance for Industry Contract Manufacturing
Arrangements for Drugs: Quality Agreements