Dr. Jules Mitchel, President of Target Health Inc., presents "How Creative Can One Be When Working with the FDA to Optimize the Drug and Device Development Process?" at the October 29 iCAN-Global Entrepreneur's Breakfast Forum.
Fast track Designation is a designation for accelerated approval of drugs and medicines in US. Presentation contains brief view of this expedite program.
Understanding the Drug Development ProcessEMMAIntl
The FDA’s process for drug development can be a lengthy, and often expensive, commitment. If you are developing a new drug product from the beginning, it is critical that you understand the phases of the development process and the deliverables for each. Beginning with R&D, you will have to ensure that your product corresponds with the FDA’s definition of a drug product. Next, it is advised that you conduct sufficient testing to get a baseline understanding of how your product works, what its intended use is, and other product specifications. Once you have completed this first step, you are ready to embark on the drug development journey...
The challenges of our time require a strategic approach to build the drugs and devices of the future. Our broad knowledge and long-term experience allow us to provide our customers with Innovative solutions and risk management.
Investigational new drug application must be submitted after discovering a new drug and before beginning of clinical trials. Here given a brief note on the topic.The topics included are types of IND, criteria for application, Information in IND application, resources for IND application, laws.regulations, policies and procedures, IND forms and instructions, IND content requirements and review of IND
Fast track Designation is a designation for accelerated approval of drugs and medicines in US. Presentation contains brief view of this expedite program.
Understanding the Drug Development ProcessEMMAIntl
The FDA’s process for drug development can be a lengthy, and often expensive, commitment. If you are developing a new drug product from the beginning, it is critical that you understand the phases of the development process and the deliverables for each. Beginning with R&D, you will have to ensure that your product corresponds with the FDA’s definition of a drug product. Next, it is advised that you conduct sufficient testing to get a baseline understanding of how your product works, what its intended use is, and other product specifications. Once you have completed this first step, you are ready to embark on the drug development journey...
The challenges of our time require a strategic approach to build the drugs and devices of the future. Our broad knowledge and long-term experience allow us to provide our customers with Innovative solutions and risk management.
Investigational new drug application must be submitted after discovering a new drug and before beginning of clinical trials. Here given a brief note on the topic.The topics included are types of IND, criteria for application, Information in IND application, resources for IND application, laws.regulations, policies and procedures, IND forms and instructions, IND content requirements and review of IND
Keynote presentation at the Drug Delivery Conference, sponsored by Pharmaceutical Education Associates, in June 2007, in San Diego. Talk focused on new drug regulatory issues, especially those arising under draft legislation that would eventually lead to the 2007 Food and Drug Administration Amendments Act (FDAAA).
Outsourcing is a Cost-effective strategy when used properly and at present is gaining more and more importance. Here's a short presentation about the importance of outsourcing in Clinical research.
Is your product or medical device FDA-friendly? Learn about how to get a safe and effective product into the market, confronting risk management, complaints, and remediation services.
ExL Pharma Clinical Trials Phase I and Phase IIa Conference Brochure: Phase 1...bryonmain
There is a pill or treatment for almost everything, or at least, that is how it seems. However, the amount of effort that goes into a pill or treatment before it is launched is extensive, expensive and often inefficient.
Efficiency and innovation go hand-in-hand with R&D and the development of clinical trials, however, FDA regulations and clinical trial standardization end up stifling these two key factors. This leads to drawn out processes that cost companies hundreds of millions of dollars before the drugs hit the market. Efforts have been made to increase efficiency in phase I/IIA with some companies changing their clinical trial manifestos to suit the available patient population at clinical sites, but more emphasis should be placed on creating more efficient processes for first in human studies by optimizing pharmacokinetics/pharmacodynamics, dosage selection, technological advancements to improve efficacy and structured patient mapping to increase successful trial and patient recruitment opportunities.
This program will give delegates the opportunity to share proven strategies between companies to help increase efficiency in this space and streamline processes to cut down costs. This event will bring together large and small companies and experts in this space to share best practices to decrease the financial drain theses phases have on the overall clinical trial budget. Life science corporations need the most up-to-date tools and practices to increase success by streamlining processes, sharing successful biomarker strategies, anticipating dosing quantities, and optimizing healthy or specialty patient recruitment and retention. Current strategies include patient mapping before organizing and setting up a clinical space, tailoring early phase clinical trials to patient populations, purchasing biological samples from collection companies, and trying to accelerate the process by submitting for breakthrough therapy designation.
Top Reasons To Attend
Identify Compound Development Strategies to Optimize Success in Clinical Trials
Learn Best Practices for Early Decision-Making Through Analysis of Biomarker Utility in Drug Development
Utilize Analytical Technology to Evaluate Multiple Configurations of a Small Molecule to Increase the Feasibility of Drug in Clinical Trials
Implement Adaptive Design in Proof of Concept Studies to Increase Efficiency, Decrease Time and Decrease Overall Cost
Explore the Seamless Development of Phase I to Phase II in Clinical Trials
NINE Case Studies and a Panel Session on Early Phase Clinical Trial Strategies
PAREXEL Principal Consultant Angela McGillivary discusses commercial considerations, clinical development, regulatory requirements, submission and post approval strategies in emerging markets
Keynote presentation at the Drug Delivery Conference, sponsored by Pharmaceutical Education Associates, in June 2007, in San Diego. Talk focused on new drug regulatory issues, especially those arising under draft legislation that would eventually lead to the 2007 Food and Drug Administration Amendments Act (FDAAA).
Outsourcing is a Cost-effective strategy when used properly and at present is gaining more and more importance. Here's a short presentation about the importance of outsourcing in Clinical research.
Is your product or medical device FDA-friendly? Learn about how to get a safe and effective product into the market, confronting risk management, complaints, and remediation services.
ExL Pharma Clinical Trials Phase I and Phase IIa Conference Brochure: Phase 1...bryonmain
There is a pill or treatment for almost everything, or at least, that is how it seems. However, the amount of effort that goes into a pill or treatment before it is launched is extensive, expensive and often inefficient.
Efficiency and innovation go hand-in-hand with R&D and the development of clinical trials, however, FDA regulations and clinical trial standardization end up stifling these two key factors. This leads to drawn out processes that cost companies hundreds of millions of dollars before the drugs hit the market. Efforts have been made to increase efficiency in phase I/IIA with some companies changing their clinical trial manifestos to suit the available patient population at clinical sites, but more emphasis should be placed on creating more efficient processes for first in human studies by optimizing pharmacokinetics/pharmacodynamics, dosage selection, technological advancements to improve efficacy and structured patient mapping to increase successful trial and patient recruitment opportunities.
This program will give delegates the opportunity to share proven strategies between companies to help increase efficiency in this space and streamline processes to cut down costs. This event will bring together large and small companies and experts in this space to share best practices to decrease the financial drain theses phases have on the overall clinical trial budget. Life science corporations need the most up-to-date tools and practices to increase success by streamlining processes, sharing successful biomarker strategies, anticipating dosing quantities, and optimizing healthy or specialty patient recruitment and retention. Current strategies include patient mapping before organizing and setting up a clinical space, tailoring early phase clinical trials to patient populations, purchasing biological samples from collection companies, and trying to accelerate the process by submitting for breakthrough therapy designation.
Top Reasons To Attend
Identify Compound Development Strategies to Optimize Success in Clinical Trials
Learn Best Practices for Early Decision-Making Through Analysis of Biomarker Utility in Drug Development
Utilize Analytical Technology to Evaluate Multiple Configurations of a Small Molecule to Increase the Feasibility of Drug in Clinical Trials
Implement Adaptive Design in Proof of Concept Studies to Increase Efficiency, Decrease Time and Decrease Overall Cost
Explore the Seamless Development of Phase I to Phase II in Clinical Trials
NINE Case Studies and a Panel Session on Early Phase Clinical Trial Strategies
PAREXEL Principal Consultant Angela McGillivary discusses commercial considerations, clinical development, regulatory requirements, submission and post approval strategies in emerging markets
National Forum Update on Professional Development FrameworkEloise Tan
An update from the National Forum for the Enhancement of Teaching and Learning in Higher Education regarding the emerging National Professional Development Framework for Teachers in Higher Education. December 16, 2014.
Regulatory Compliance in Clinical Research: Navigating the FDA and Other Agen...ClinosolIndia
Regulatory compliance is a crucial aspect of conducting clinical research, ensuring that studies meet the requirements and standards set by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and other relevant bodies. Here are some key points to navigate regulatory compliance in clinical research:
Familiarize Yourself with Applicable Regulations: Stay updated on the relevant regulations and guidelines that govern clinical research, including FDA regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, and local regulatory requirements. Understand the specific regulations that apply to your study, such as those related to investigational new drugs (IND) or investigational device exemptions (IDE).
Obtain Institutional Review Board (IRB) Approval: IRBs play a crucial role in ensuring the protection of human subjects in research. Before initiating a clinical trial, obtain IRB approval by submitting a detailed study protocol, informed consent documents, and other required materials. IRBs review the study's scientific merit, ethical considerations, and compliance with regulations.
Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application: If your clinical research involves the use of investigational drugs or devices, you may need to submit an IND or IDE application to the FDA. These applications provide detailed information on the investigational product, its safety, efficacy, manufacturing processes, and proposed study design.
Good Clinical Practice (GCP) Guidelines: GCP guidelines provide a framework for the conduct of clinical research to ensure data integrity and participant protection. Adhere to GCP principles, including informed consent, protocol adherence, accurate documentation, and appropriate monitoring and reporting of adverse events.
Adverse Event Reporting: Monitor and report adverse events occurring during the study promptly. Follow the FDA's requirements for safety reporting, including expedited reporting of serious and unexpected adverse events. Maintain accurate and complete records of adverse events and their follow-up actions.
Data Integrity and Documentation: Ensure the integrity, accuracy, and traceability of study data. Implement robust data management practices, including proper documentation, source data verification, and secure storage of study documents. Follow regulatory requirements for data retention, including archiving study records for the required period.
Audits and Inspections: Be prepared for audits and inspections by regulatory agencies. Maintain organized and easily accessible study documentation, including study protocols, informed consent forms, case report forms, and correspondence with IRBs and regulatory agencies. Cooperate with auditors or inspectors and address any identified deficiencies or findings promptly.
While the world is going through pandemic turmoil and regulatory agencies are under immense stress to approve newer pharmaceutical therapies to market. However, the classical/regular clinical trial is a hefty process hence alternative provisions like speed trials were explored for the early entry of drugs for emergency usage.
Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Suc...Michael Swit
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.
IN THIS SUMMARY
The United States Food and Drug Administration (FDA) has significant reach in the American economy, ranging from medicines and medical devices to items on the grocery store shelves. Since its inception in 1906, the agency has faced a variety of technical and political challenges. Looking ahead, the FDA faces many new demands that could enlarge the agency’s already expansive mandate. New responsibilities may include the cost of medicine, consumers’ pursuit of perfection through drugs, consumer lifestyles, tobacco, and counterterrorism. As the nature of public health changes over time, it is inevitable that the FDA’s scope and responsibilities will change as well. In Inside the FDA, Fran Hawthorne explains the history of the FDA, how its processes work, and what the future may hold for this government agency.
SUBSCRIBE TODAY
http://www.bizsum.com/summaries/inside-fda
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.
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...Yavuz Silay
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
Dr. Craig Kenesky, a patent attorney with the life science practice at WSGR in New York, delivers a presentation on "IP and the Biopharma Startup" at the October 29 iCAN-Global Entrepreneur's Breakfast Forum.
Stephen Young, principal at iCAN-Global, LLC and the founder of Mentor Business Group LLC discusses how to make your business more attractive to investors.
In this presentation, you are given an overview of Windstream Communications, provider of voice and data network communications, and managed services, to businesses in the United States.
Matthew Medney, CEO & Founder of DOG MEDIA LLC, discusses how regularly engaging with company followers on social media protects against negative comments. When combating negative social media, the best defense is a good offense. Creating engagement based pages that bring communities together around your brand creates a heavy wall of trust.
Broadstrokes, Inc. President & CTO Adam Hocek and VP of Business Development Donald Steinaker introduce one key service called Twexxt provides organizations with near real-time responsive text analytics based responses received from end-users.
Broadstokes, Inc. is a communication service provider of SMS text and voice messaging services for polling, surveys, critical notifications, and other applications. These services address the needs of many vertical markets and can scale to support small to very large numbers of end-users.
Jeffrey Domanski, Mid-Hudson Regional Outreach Contractor for the NYSERDA EDGE Program at Courtney Strong, Inc., discusses NYSERDA's Economic Development Growth Extension (EDGE) Program. The EDGE Program serves as a portal and catalyst for use of NYSERDA's energy efficiency, R&D, jobs creation, and clean-tech business incubation programs.
In this presentation Roxanne Hawkins, Co-Founder of International Directions reviews important steps to take before or as you begin your global journey.
This is the corporate presentation for iCAN-Global, a global company committed to providing digitally delivered education, business and technology advisory, acceleration and commercialization services to early, emerging and mature businesses.
Lars Ling is Founder and CEO of CleanTech Region Solutions, the leading sales and marketing accelerator of green innovative solutions from Sweden. He provides an overview of his organization and the global market for cleantech and sustainability.
Ethan Mayers is a founding partner of Synthenai, a New York City-based management consulting firm. In "Shepherding Success: How Good Operations Sustains Growth, Unleashes Innovation and Wins in the Marketplace" Ethan shares best practices he learned from working with startups.
GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
Key Trends Shaping the Future of Infrastructure.pdfCheryl Hung
Keynote at DIGIT West Expo, Glasgow on 29 May 2024.
Cheryl Hung, ochery.com
Sr Director, Infrastructure Ecosystem, Arm.
The key trends across hardware, cloud and open-source; exploring how these areas are likely to mature and develop over the short and long-term, and then considering how organisations can position themselves to adapt and thrive.
Accelerate your Kubernetes clusters with Varnish CachingThijs Feryn
A presentation about the usage and availability of Varnish on Kubernetes. This talk explores the capabilities of Varnish caching and shows how to use the Varnish Helm chart to deploy it to Kubernetes.
This presentation was delivered at K8SUG Singapore. See https://feryn.eu/presentations/accelerate-your-kubernetes-clusters-with-varnish-caching-k8sug-singapore-28-2024 for more details.
The Art of the Pitch: WordPress Relationships and SalesLaura Byrne
Clients don’t know what they don’t know. What web solutions are right for them? How does WordPress come into the picture? How do you make sure you understand scope and timeline? What do you do if sometime changes?
All these questions and more will be explored as we talk about matching clients’ needs with what your agency offers without pulling teeth or pulling your hair out. Practical tips, and strategies for successful relationship building that leads to closing the deal.
A tale of scale & speed: How the US Navy is enabling software delivery from l...sonjaschweigert1
Rapid and secure feature delivery is a goal across every application team and every branch of the DoD. The Navy’s DevSecOps platform, Party Barge, has achieved:
- Reduction in onboarding time from 5 weeks to 1 day
- Improved developer experience and productivity through actionable findings and reduction of false positives
- Maintenance of superior security standards and inherent policy enforcement with Authorization to Operate (ATO)
Development teams can ship efficiently and ensure applications are cyber ready for Navy Authorizing Officials (AOs). In this webinar, Sigma Defense and Anchore will give attendees a look behind the scenes and demo secure pipeline automation and security artifacts that speed up application ATO and time to production.
We will cover:
- How to remove silos in DevSecOps
- How to build efficient development pipeline roles and component templates
- How to deliver security artifacts that matter for ATO’s (SBOMs, vulnerability reports, and policy evidence)
- How to streamline operations with automated policy checks on container images
LF Energy Webinar: Electrical Grid Modelling and Simulation Through PowSyBl -...DanBrown980551
Do you want to learn how to model and simulate an electrical network from scratch in under an hour?
Then welcome to this PowSyBl workshop, hosted by Rte, the French Transmission System Operator (TSO)!
During the webinar, you will discover the PowSyBl ecosystem as well as handle and study an electrical network through an interactive Python notebook.
PowSyBl is an open source project hosted by LF Energy, which offers a comprehensive set of features for electrical grid modelling and simulation. Among other advanced features, PowSyBl provides:
- A fully editable and extendable library for grid component modelling;
- Visualization tools to display your network;
- Grid simulation tools, such as power flows, security analyses (with or without remedial actions) and sensitivity analyses;
The framework is mostly written in Java, with a Python binding so that Python developers can access PowSyBl functionalities as well.
What you will learn during the webinar:
- For beginners: discover PowSyBl's functionalities through a quick general presentation and the notebook, without needing any expert coding skills;
- For advanced developers: master the skills to efficiently apply PowSyBl functionalities to your real-world scenarios.
DevOps and Testing slides at DASA ConnectKari Kakkonen
My and Rik Marselis slides at 30.5.2024 DASA Connect conference. We discuss about what is testing, then what is agile testing and finally what is Testing in DevOps. Finally we had lovely workshop with the participants trying to find out different ways to think about quality and testing in different parts of the DevOps infinity loop.
Elevating Tactical DDD Patterns Through Object CalisthenicsDorra BARTAGUIZ
After immersing yourself in the blue book and its red counterpart, attending DDD-focused conferences, and applying tactical patterns, you're left with a crucial question: How do I ensure my design is effective? Tactical patterns within Domain-Driven Design (DDD) serve as guiding principles for creating clear and manageable domain models. However, achieving success with these patterns requires additional guidance. Interestingly, we've observed that a set of constraints initially designed for training purposes remarkably aligns with effective pattern implementation, offering a more ‘mechanical’ approach. Let's explore together how Object Calisthenics can elevate the design of your tactical DDD patterns, offering concrete help for those venturing into DDD for the first time!
UiPath Test Automation using UiPath Test Suite series, part 3DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 3. In this session, we will cover desktop automation along with UI automation.
Topics covered:
UI automation Introduction,
UI automation Sample
Desktop automation flow
Pradeep Chinnala, Senior Consultant Automation Developer @WonderBotz and UiPath MVP
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
GraphRAG is All You need? LLM & Knowledge GraphGuy Korland
Guy Korland, CEO and Co-founder of FalkorDB, will review two articles on the integration of language models with knowledge graphs.
1. Unifying Large Language Models and Knowledge Graphs: A Roadmap.
https://arxiv.org/abs/2306.08302
2. Microsoft Research's GraphRAG paper and a review paper on various uses of knowledge graphs:
https://www.microsoft.com/en-us/research/blog/graphrag-unlocking-llm-discovery-on-narrative-private-data/
UiPath Test Automation using UiPath Test Suite series, part 4DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 4. In this session, we will cover Test Manager overview along with SAP heatmap.
The UiPath Test Manager overview with SAP heatmap webinar offers a concise yet comprehensive exploration of the role of a Test Manager within SAP environments, coupled with the utilization of heatmaps for effective testing strategies.
Participants will gain insights into the responsibilities, challenges, and best practices associated with test management in SAP projects. Additionally, the webinar delves into the significance of heatmaps as a visual aid for identifying testing priorities, areas of risk, and resource allocation within SAP landscapes. Through this session, attendees can expect to enhance their understanding of test management principles while learning practical approaches to optimize testing processes in SAP environments using heatmap visualization techniques
What will you get from this session?
1. Insights into SAP testing best practices
2. Heatmap utilization for testing
3. Optimization of testing processes
4. Demo
Topics covered:
Execution from the test manager
Orchestrator execution result
Defect reporting
SAP heatmap example with demo
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
Encryption in Microsoft 365 - ExpertsLive Netherlands 2024Albert Hoitingh
In this session I delve into the encryption technology used in Microsoft 365 and Microsoft Purview. Including the concepts of Customer Key and Double Key Encryption.
Welocme to ViralQR, your best QR code generator.ViralQR
Welcome to ViralQR, your best QR code generator available on the market!
At ViralQR, we design static and dynamic QR codes. Our mission is to make business operations easier and customer engagement more powerful through the use of QR technology. Be it a small-scale business or a huge enterprise, our easy-to-use platform provides multiple choices that can be tailored according to your company's branding and marketing strategies.
Our Vision
We are here to make the process of creating QR codes easy and smooth, thus enhancing customer interaction and making business more fluid. We very strongly believe in the ability of QR codes to change the world for businesses in their interaction with customers and are set on making that technology accessible and usable far and wide.
Our Achievements
Ever since its inception, we have successfully served many clients by offering QR codes in their marketing, service delivery, and collection of feedback across various industries. Our platform has been recognized for its ease of use and amazing features, which helped a business to make QR codes.
Our Services
At ViralQR, here is a comprehensive suite of services that caters to your very needs:
Static QR Codes: Create free static QR codes. These QR codes are able to store significant information such as URLs, vCards, plain text, emails and SMS, Wi-Fi credentials, and Bitcoin addresses.
Dynamic QR codes: These also have all the advanced features but are subscription-based. They can directly link to PDF files, images, micro-landing pages, social accounts, review forms, business pages, and applications. In addition, they can be branded with CTAs, frames, patterns, colors, and logos to enhance your branding.
Pricing and Packages
Additionally, there is a 14-day free offer to ViralQR, which is an exceptional opportunity for new users to take a feel of this platform. One can easily subscribe from there and experience the full dynamic of using QR codes. The subscription plans are not only meant for business; they are priced very flexibly so that literally every business could afford to benefit from our service.
Why choose us?
ViralQR will provide services for marketing, advertising, catering, retail, and the like. The QR codes can be posted on fliers, packaging, merchandise, and banners, as well as to substitute for cash and cards in a restaurant or coffee shop. With QR codes integrated into your business, improve customer engagement and streamline operations.
Comprehensive Analytics
Subscribers of ViralQR receive detailed analytics and tracking tools in light of having a view of the core values of QR code performance. Our analytics dashboard shows aggregate views and unique views, as well as detailed information about each impression, including time, device, browser, and estimated location by city and country.
So, thank you for choosing ViralQR; we have an offer of nothing but the best in terms of QR code services to meet business diversity!
Assuring Contact Center Experiences for Your Customers With ThousandEyes
Working with the FDA
1. WORKING WITH FDA
How Creative Can One Be When Working with
the FDA to Optimize the Drug and Device
Development Process?
Jules T. Mitchel, MBA, PhD
President, Target Health Inc.
2. Target Health Inc.
TARGET HEALTH INC., founded in 1993, is a
private, New York City-based, full-service eCRO,
engaged in all aspects of Drug and Device
Development, including Regulatory Affairs
Strategic Planning, Clinical Research, Data
Management, Biostatistics, Medical Writing and
the Paperless Clinical Trial.
2
3. GENERAL APPROACH
Have Good Medicine
Have Good Science
Have Good Regulations
Have Pride in Your Product
3
4. THE TEAM
Discovery/Development
Marketing
Clinical
Legal
Toxicology
Regulatory
FDA
4
5. DEVELOPMENT PHILOSOPHY
Don’t Waste Time, Time is Money
Plan Carefully
Execute Meticulously
Re-plan When Necessary
Do Only What is Needed
Hire People Who Want to Get the Job Done
And it will cost more than you think and it will take longer
than you think
5
6. AVAILABLE SERVICES
FREEDOM OF INFORMATION - FDA
FOI SERVICES
FDA SMALL BUSINESS HELP LINE
DATABASES
6
8. FDA STRUCTURE
Center for Drug Evaluation and Research
(CDER)
Center for Biologics Evaluation and Research
(CBER)
Center for Devices and Radiologic Health
(CDRH)
Center for Food Science and Applied Nutrition
(CFSAN)
8
9. DEFINITIONS
IND - INVESTIGATIONAL NEW DRUG APPLICATION
NDA - NEW DRUG APPLICATION
IDE - INVESTIGATIONAL DEVICE EXEMPTION
PMA - PREMARKET APPROVAL APPLICATION
DMF - DRUG MASTER FILE
GMP - GOOD MANUFACTURING PRACTICES
GLP - GOOD LABORATORY PRACTICES
GCP - GOOD CLINIAL PRACTICES
9
11. Innovation at FDA
Driving Biomedical Innovation
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM274464.pdf
Innovation at CDER
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/default.htm
Innovation and Regulatory Science
http://www.fda.gov/BiologicsBloodVaccines/ScienceResearch/ucm234680.htm
CDRH Medical Device Innovation Initiative
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHI
nnovation/default.htm
11
12. Innovation at FDA
Fast Track
Accelerated Approval
Priority Review
Breakthrough Therapy
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformatio
n/Guidances/UCM358301.pdf
12
13. FAST TRACK
Fast track emphasizes the critical nature of close
early communication between the FDA and
sponsors.
Fast track adds to existing programs, such as
accelerated approval, the possibility of a "rolling
review" for an application.
An applicant must submit a request with supporting
documentation for designation and FDA must
respond within 60 days.
13
14. Accelerated Approval
This program allows for earlier approval of drugs
that treat serious conditions, and fill an unmet
medical need based on a surrogate endpoint; a
marker that is thought to predict clinical benefit, but
is not itself a measure of clinical benefit.
Drug companies are still required to conduct studies
to confirm the anticipated clinical benefit. If the
confirmatory trial shows that the drug actually
provides a clinical benefit, then the FDA grants
traditional approval for the drug. If not…...
14
15. PRIORITY REVIEW
A Priority Review designation means FDA’s goal is to take
action on an application within 6 months (compared to 10
months) if the drug could provide significant advantages such
as:
evidence of increased effectiveness in treatment, prevention,
or diagnosis of condition;
elimination or substantial reduction of a treatment-limiting
drug reaction
documented enhancement of patient compliance
evidence of safety and effectiveness in a new subpopulation.
15
16. BREAKTHROUGH THERAPY
A breakthrough therapy is a drug:
intended alone or in combination with one or more
other drugs to treat a serious or life threatening
disease or condition.
preliminary clinical evidence indicates that the drug
may demonstrate substantial improvement over
existing therapies on one or more clinically
significant endpoints, such as substantial treatment
effects observed early in clinical development.
16
17. HOW DO WE DETERMINE WHERE OUR
PRODUCT BELONGS?
What center and what group within that center will have
primary review of our product?
Sometimes its obvious
Call the FDA and find someone who is helpful
Submit a request for designation
Submit IND or IDE and find out
17
18. HOW TO WORK WITH FDA
What should be our initial contact with the FDA and
how should we do it?
Preparation for the initial FDA meeting.
How should we conduct an FDA meeting?
Should we view the FDA as part of our development
team?
18
19. HOW DO WE DETERMINE
REGULATORY REQUIREMENTS?
Hire a regulatory professional
Full-time employee
Consultant
Lawyer
Other types of experts
19
20. HOW DO WE DETERMINE CLINICAL
REQUIREMENTS?
Summary Basis of Approval
FDA Guidances
Find someone who’s done it already
20
21. WHAT SHOULD BE OUR INITIAL CONTACT
WITH FDA AND HOW SHOULD WE DO IT?
First, do your homework
You could call the division of interest at FDA and
briefly introduce yourself
Discuss the project and its status
Discuss option of an initial meeting
Establish action items
Plan a meeting
Do initial filing and then meet
21
22. PREPARATION FOR THE FDA MEETING
Assign one person to organize and champion the
meeting
Prepare a solid document providing
rationale
chemistry issues
non-clinical pharmacology issues and data
clinical data, if available
clinical protocol
reprints
table of contents
22
23. MEETING MATERIALS
Paginate, check quality of photocopying
Find out how many copies
Put in proposed meeting dates and blackout
dates
Let FDA know when the briefing document is
sent
Confirm receipt over the phone
23
24. HOW SHOULD WE CONDUCT AN FDA
MEETING?
Be prepared
Identify one experienced scientific and one
experienced clinical expert as participants
Bring in the president and a marketing person
Make sure each person knows his/her role
Make no formal presentation
24
25. CONDUCTING THE MEETING
Take complete minutes
Make sure that all of your issues are addressed
Chat informally after the meeting
25
26. SHOULD WE VIEW THE FDA AS PART
OF OUR DEVELOPMENT TEAM?
Share ideas
Set milestones
Send data
Maintain dialogue
No secrets
FDA is part of your team whether you like
it or not
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27. TARGET HEALTH INC.
Dr. Jules T. Mitchel, President
261 Madison Avenue, 24th Floor
New York, NY 10016
Tel: (212) 681-2100 ext 0
JMitchel@TargetHealth.com
www.TargetHealth.com
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