The presentation proposes a new innovation model where universities partner with industry in translational research focused on moving discoveries from the lab into product development through proof of concept studies and clinical candidates, with a case study example of a collaboration between Purdue and Kylin Therapeutics to develop an RNA nanoparticle therapeutic for cancer. Challenges of traditional academic and industry research cultures are addressed through multi-disciplinary project teams managed by a virtual CRO to deliver translational research results.
This is a simple and general presentation about the health research which is prepared to present within staffs of Naulo Ghumti Nepal especially for EIHS staffs, objective if this presentation is to orient staffs about research.
This is a simple and general presentation about the health research which is prepared to present within staffs of Naulo Ghumti Nepal especially for EIHS staffs, objective if this presentation is to orient staffs about research.
Describes in detail definition, purpose, participants and goal of good clinical practices (GCP). Gives history of GCP staring form Nuremberg code in 1948 to implementation of GCP guidance via WHO handbook in 2005. Also describes Nuremberg's code, declaration of Helsinki and Thirteen principles of GCP.
Introduction to meta-analysis (1612_MA_workshop)Ahmed Negida
Chapter 1: Introduction to Meta-analysis
- From the 1612 MA Workshop that will be held on 11th, December, 2016 at Dokki, Giza, Egypt
- Workshop instructor: Mr. Ahmed Negida, MBBCh candidate
The dream of any physician and consequently every patient is to receive the right treatment in the right time with cost effectiveness. To achieve this goal, the 3 pillars: evidence based medicine, clinical research innovation & resources utilization should be integrated efficiently.
In this presentation, I'll try to comprehensively review the following:
1- How are we used to perform clinical trials in Oncology?
2- Does it fits in today’s needs?
3- Integration of biology knowledge in shaping drug development
4- New Clinical trial designs “Can they offer solution for accelerating drug development?”
5- The supporting infrastructure role in clinical trial execution
Presentation "Challenges in research ethics" by Milica Ševkušić, Re@WBC ERASMUS + Project, Training for trainers, April 5–7, 2017, University of Belgrade
Study designs, Epidemiological study design, Types of studiesDr Lipilekha Patnaik
Study design, Epidemiological study designA study design is a specific plan or protocol
for conducting the study, which allows the investigator to translate the conceptual hypothesis into an operational one.
ETHICS COMMITTEE
MEMBERS OF ETHICS COMMITTEE
SOME ETHICS COMMITTEE AROUND THE WORLD
What authority does EC/IRB have?
.
.
.
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
Critical appraisal is the process of carefully and systematically analyze the research paper to judge its trustworthiness, its value and relevance in a particular context. (Amanda Burls 2009)
A critical review must identify the strengths and limitations in a research paper and this should be carried out in a systematic manner.
The Critical Appraisal helps in developing the necessary skills to make sense of scientific evidence, based on validity, results and relevance.
June Lee, MD, Director of CTSI's Early Translational Research program, presents the goals and vision for the program. Learn more about June Lee at UCSF Profiles http://profiles.ucsf.edu/ProfileDetails.aspx?From=SE&Person=5208624
Describes in detail definition, purpose, participants and goal of good clinical practices (GCP). Gives history of GCP staring form Nuremberg code in 1948 to implementation of GCP guidance via WHO handbook in 2005. Also describes Nuremberg's code, declaration of Helsinki and Thirteen principles of GCP.
Introduction to meta-analysis (1612_MA_workshop)Ahmed Negida
Chapter 1: Introduction to Meta-analysis
- From the 1612 MA Workshop that will be held on 11th, December, 2016 at Dokki, Giza, Egypt
- Workshop instructor: Mr. Ahmed Negida, MBBCh candidate
The dream of any physician and consequently every patient is to receive the right treatment in the right time with cost effectiveness. To achieve this goal, the 3 pillars: evidence based medicine, clinical research innovation & resources utilization should be integrated efficiently.
In this presentation, I'll try to comprehensively review the following:
1- How are we used to perform clinical trials in Oncology?
2- Does it fits in today’s needs?
3- Integration of biology knowledge in shaping drug development
4- New Clinical trial designs “Can they offer solution for accelerating drug development?”
5- The supporting infrastructure role in clinical trial execution
Presentation "Challenges in research ethics" by Milica Ševkušić, Re@WBC ERASMUS + Project, Training for trainers, April 5–7, 2017, University of Belgrade
Study designs, Epidemiological study design, Types of studiesDr Lipilekha Patnaik
Study design, Epidemiological study designA study design is a specific plan or protocol
for conducting the study, which allows the investigator to translate the conceptual hypothesis into an operational one.
ETHICS COMMITTEE
MEMBERS OF ETHICS COMMITTEE
SOME ETHICS COMMITTEE AROUND THE WORLD
What authority does EC/IRB have?
.
.
.
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
Critical appraisal is the process of carefully and systematically analyze the research paper to judge its trustworthiness, its value and relevance in a particular context. (Amanda Burls 2009)
A critical review must identify the strengths and limitations in a research paper and this should be carried out in a systematic manner.
The Critical Appraisal helps in developing the necessary skills to make sense of scientific evidence, based on validity, results and relevance.
June Lee, MD, Director of CTSI's Early Translational Research program, presents the goals and vision for the program. Learn more about June Lee at UCSF Profiles http://profiles.ucsf.edu/ProfileDetails.aspx?From=SE&Person=5208624
Access the webinar: http://goo.gl/p08pTz
These slides were presented in a webinar by Denodo in collaboration with BioStorage Technologies and Indiana Clinical and Translational Sciences Institute and Regenstrief Institute.
BioStorage Technologies, Inc., Indiana Clinical and Translational Sciences Institute, and Regenstrief Institute (CTSI) have joined Denodo to talk about the important role of technological advancements, such as data virtualization, in advancing biospecimen research.
By watching this webinar, you can gain insight into best practices around the integration of biospecimen and research data as well as technology solutions that provide consolidated views and rapid conversions of this data into valuable business insights. You will also learn how data virtualization can assist with the integration of data residing in heterogeneous repositories and can securely deliver aggregated data in real-time.
Karen Arts is one of the founding members and chair of the board of directors of the Network of Networks, a not for profit organization, which aims to share best practices and establish national standards for clinical research conduct in Canada. For more info goto: http://n2canada.ca/
Science Exchange - Measuring Research Efficiency & QualityScience Exchange
Presentation by Science Exchange Founder & CEO Elizabeth Iorns, Ph.D. at the Altmetrics 2012 Workshop covering the company's plan to address problems with the efficiency and quality of scientific research.
https://www.facebook.com/handicorp
HandICorp contracts inventors across different fields and transforms their creations into new products for the industry based on global consumer opinions with the help of online and offline services to let:
- Consumers voice their pain points.
- Industries seek their future products.
- Inventors monetize their unique creations.
Research-for-development (R4D) has been viewed as generating evidence on the effectiveness of foreign aid, inventing new technologies that serve poor people, and strengthening research capabilities in poor countries. What determines which of these policy goals are pursued?
Public research funders adjust their approach based on past experience and on the expectations within their home governments. These dynamics influence how R4D is defined and funded, which carry implications for researchers at home and abroad.
Curlew Research Brussels 2014 Electronic Data & Knowledge ManagementNick Lynch
Life Science externalisation and collaboration overview and the challenges that Life Science companies face in delivering successful data sharing with their partners in either Open Innovation or pre-competitive workflows
This is a talk given to rising undergrad chemistry seniors attending a summer REU program at UMass Amherst funded by NSF in 2010. The talk is designed to make students aware of the impact they can have on the world by pursuing commercial translation opportunities.
Guiding researchers to the web tools they need: The rationale behind a Web to...ALISS
Guiding researchers to the web tools they need: The rationale behind a Web tools for researchers’ guide
Presentation by Miggie Pickton, University of Northampton
2. Innovator’s DNA
5 Skills that result in Innovation
Experiment
Network Question Observe
Associate
Dyer, H., Gregersen, H. & Christensen, C. (2009) The
Innovator’s DNA,. Harvard Business Review, 87 (12):
60-7, 128.
3. Question:
Is the “Business Model” of the
research University meeting the
needs of its stakeholders in today’s
environment?
6. Observation:
The University Environment
Focused on academic excellence
Research labs focused on basic research
and discovery
Systems in place to reward publishing
Intellectual property policies consistent
with Bayh-Dole Act
7. Observation:
Economic Development Mission
Purdue University: Promoting discovery with delivery by conducting field-defining
research with breakthrough outcomes and catalyzing research-based economic
development and entrepreneurship.
Indiana University: Indiana University is a partner in helping to transform the Hoosier
economy, and a key result of the [Strategic Plan] will be new innovations and transferable
research that together will help create the basis for economic transformation and growth in
Indiana.
The Ohio State University: Become a catalyst for the development of Ohio’s
technology-based economy. Increase collaborations with the private sector to enhance
research, successfully transfer University technology, and provide experiential learning
opportunities for students.
8. Observation:
Emerging Industry Support
Purdue GIT MIT U of M CMU
Industry Expend/Total 13% 8% 7% 4% 8%
License/FTE 8.5 7.2 2.8 2.7 3.1
Startups 10 9 18 10 8
Startups/Licenses 12% 14% 20% 53% 10%
9. Observation:
The U.S. Corporate Environment
Pressure to focus limited resources on
core strengths
Desire and pressure to outsource as
much as possible, including research,
discovery, and development activities
Desire to keep R & D in U.S.
14. Association:
Need for PublicPrivate Strategic
Partnerships with focus on Translational
Research
•University’s need to explore and expand
research funding sources
•Industry needs to add more “R” to its “D”
•Translational Research is common focus
15. Experiment:
Manage multi-disciplinary team to defined
“deliverable”
Major Challenges to resolve:
• Contracting and IP transfer very
complicated
• Individual Faculty utilize $$ for own
individual objectives
• Focus on publication not translation
• No project management or coordination
• Unfamiliarity with industry expectations
• Academic culture and industry culture
are very different
16. Experiment:
A test model for collaboration
Kylin Therapeutics
• Purdue Invention: pRNA – Self-assembling RNA
nanoparticle
• Goal: Develop therapeutic pRNA nanoparticle
for ovarian cancer
• Deliverable: Proof of principle data package and
clinical candidate
• Partnership: Kylin sponsors research effort in
the Bindley Bioscience center & Kylin scientists
and Purdue scientists work cooperatively to
common goal.
17. Experiment:
A test model for collaboration
Kylin Therapeutics
Concept Concept
Publish Funding
Publish Funding
Discovery Discovery
Delivery
Current Basic Research Model New Innovation Research Model
18. Experiment:
A test model for collaboration
Kylin Therapeutics
Experimental Observations since 2007
University Mission
• Average of 6 full-time staff (avg. $69k per year)
• $574K in sponsored research since 2007
• 3 publications
• 2 manuscripts in production
• Diverse research opportunities
• 1 post-doc
• 2 research internships
• 1 business internship
• Opportunity to Network with Industry experts
19. Experiment:
A test model for collaboration
Kylin Therapeutics
Experimental Observations since 2007
Industry Mission
• 3 patent applications
• 3 publications
• 2 Manuscripts in production
• Pharmacological characterization of pRNA
completed
• Novel pRNA chemical synthesis methods
developed
• Opportunity to Network with Academic experts
• $145K* per FTE
* Average - Includes general lab and reagent supplies
20. Experiment:
A test model for collaboration
• Focus on “Delivery”
Academic
Industry
Discovery • “Agile” project
Expertise
management
Joint
Research
Team
• Multi-disciplinary
Academic/Industry
research teams
Delivery
• Culture of
Entrepreneurship
•Diverse Networking
21. Experiment:
A test model for collaboration
•Tech Transfer,
Sponsored Research,
Tech
Transfer Research Team and
Business Offices need
Business
to be aligned to a
Office common mission
Sponsored
Program
Services • Common metrics
• “Service” oriented
• Business Friendly
22. New Innovation Model
Discovery through Validation
Large
Pharma and
Biotech
Animal
Clinical
Testing
Trials
Facility
Translational
Management
– a virtual
CRO
GMP Mfg. Research
Facility Staff
Multi-
disciplinary
Academic
Team
23. New Innovation Model
Discovery through Validation
Large Pharma Academic TeamUniv. Virtual CRO
• ProblemIP • ExpertiseIP • Project
• $ • Facilities Management
• Expertise • Multi-disciplinary • Manage to
approach “Deliverable”
• Contract Support
Negotiation
GMP Mfg. Research Staff Animal Testing Clinical Trials
• Outsourced • The “Hands” • Vivarium • Affiliated
Mfg (if • Animal Hospitals
required) Testing and • Clinical Trial
Analysis Management
24. New Innovation Model
Discovery through Validation
Large
Pharma
and
Biotech
Animal
Clinical
Testing
Trials
Facility
Translational
Management
GMP Mfg. Research
Facility Staff
Multi-
disciplinary
Academic
Team
Clinical Pipeline
25. New Innovation Model
Recent Examples
• Pfizer/UCSF: $85Million to fund biotherapeutic
discovery and development
•Johnson & Johnson/Vanderbilt: up to $100 Million
for Schizophrenia drug development
• AstraZeneca/Univ. College of London: Major stem
cell collaboration
•GenentechUCSF: $13 Million to fund discovery and
development of neurodegenerative diseases
26. Discovery through Validation
J. Eric Davis
edavis@in-vivoventures.com
650-260-8923
Value Proposition
• Identify and assemble world-class research teamsIP
• Negotiate and manage complex contracting process
• Manage IP protection and transfer - Licensing
• Manage research and development projects to Deliverable
• Proof of principle data package
• Problem resolution
• Clinical Candidate
• Average fully-loaded FTE cost $155K
•Provide contract research staff
Focus Areas
Cancer HIV
Infectious Disease Inflammation
DiabetesObesity Neurological Disorders