PHARMA & BIOTECH LICENSING & PARTNERING:
Filling the Pipeline & Growing Market Share Through Strategic Deal-Making-- March 2-3- San Diego California
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS ...Pristyn Research Solutions
THESE ARE SOME COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
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Lifecycle Management in the Pharmaceutical IndustryAnthony Russell
Presented to students in the Drug Development and Product Management program at UC San Diego. Covers the rationale for lifecycle management is important. Includes case studies of successful implementation of lifecycle management. Presentation date: 2/5/2019.
Financial Disclosure – Duties and Strategies for Clinical StudiesMichael Swit
Financial disclosure requirements for clinical studies are explored with a particular emphasis on how the requirement for tracking "Significant Payments of Other Sorts" -- or SPOOS -- present challenges in clinical study compliance.
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS ...Pristyn Research Solutions
THESE ARE SOME COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW
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
Lifecycle Management in the Pharmaceutical IndustryAnthony Russell
Presented to students in the Drug Development and Product Management program at UC San Diego. Covers the rationale for lifecycle management is important. Includes case studies of successful implementation of lifecycle management. Presentation date: 2/5/2019.
Financial Disclosure – Duties and Strategies for Clinical StudiesMichael Swit
Financial disclosure requirements for clinical studies are explored with a particular emphasis on how the requirement for tracking "Significant Payments of Other Sorts" -- or SPOOS -- present challenges in clinical study compliance.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
The Food Safety Modernization Act (FSMA), signed into law on Jan. 4, 2011, expands the power of the Food and Drug Administration (FDA) to oversee food safety with a focus on prevention. Each year, about 48 million people get sick, 128,000 are hospitalized and 3,000 die—all from foodborne diseases that are preventable.
The FSMA is designed to reduce those numbers by radically updating industry practices to ensure food safety and defense in an evolving global economy. Because of how vast and interconnected food supply has become, these regulations will impact a number of industries.
Advances and investment in digital health is growing at an incredible rate and Contract Manufacturing Organizations and Contract Development and Manufacturing Organizations are becoming an essential part of the new pharma value chain. From wearables, to apps, to digital platforms, the data and efficiencies generated by these innovations are opening up important avenues across the pharma ecosystem. As pressure on improving drug development heats up, data, digital and technological innovations are critical to delivering the desired business and patient outcomes, promoting significantly more networking and outsourcing strategies. CMOs are evolving from service providers to strategic partners. CMOs now cover the entire value chain of pharma production, including specialized services such as R&D.
Please share these slides with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● A discussion on how new treatments are reviewed and approved for sale in this country, with a particular emphasis on Health Canada’s regulatory modernization initiative
● Explanation of patient involvement in Health Canada reviews as well as the special access program.
View the video:
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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,
Regulatory Due Diligence, Using Regulatory Affairs to Maximize the Value of a...SGS
Developing a new drug is a costly undertaking, which can cost several hundreds of millions. Except for the largest Pharma companies, any other company will need external funding at some stage in the development of a drug. A solid regulatory strategy in early phase clinical research is essential to convince your investors to further fund the clinical development of your compound. Depending on your compound (chemical, biotech product, advanced therapy) and the type of investors (private investors, government funding bodies or a larger pharmaceutical company), different aspects of the regulatory strategy need to be more developed.
The main aspects of such an early phase regulatory strategy will be discussed and illustrated with a number of case studies such as the development of a regulatory strategy for a bacteriophage and discussions with Health Authorities.
Contact Us: clinicalresearch@sgs.com
Visit our Website: http://www.sgs.com/cro
Follow Us on LinkedIn: http://bit.ly/SGSLifeSciences
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Disclaimer:
I have created this document with inputs from various sources. Some are taken right from slideshare. I just try to make this topic little compact and lucid, so that everybody can understand it easily
I am very much thankful to the original authors also, don't think I am just doing plagarism.
The Food Safety Modernization Act (FSMA), signed into law on Jan. 4, 2011, expands the power of the Food and Drug Administration (FDA) to oversee food safety with a focus on prevention. Each year, about 48 million people get sick, 128,000 are hospitalized and 3,000 die—all from foodborne diseases that are preventable.
The FSMA is designed to reduce those numbers by radically updating industry practices to ensure food safety and defense in an evolving global economy. Because of how vast and interconnected food supply has become, these regulations will impact a number of industries.
Advances and investment in digital health is growing at an incredible rate and Contract Manufacturing Organizations and Contract Development and Manufacturing Organizations are becoming an essential part of the new pharma value chain. From wearables, to apps, to digital platforms, the data and efficiencies generated by these innovations are opening up important avenues across the pharma ecosystem. As pressure on improving drug development heats up, data, digital and technological innovations are critical to delivering the desired business and patient outcomes, promoting significantly more networking and outsourcing strategies. CMOs are evolving from service providers to strategic partners. CMOs now cover the entire value chain of pharma production, including specialized services such as R&D.
Please share these slides with anyone who may be interested!
Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR
In this webinar:
● A discussion on how new treatments are reviewed and approved for sale in this country, with a particular emphasis on Health Canada’s regulatory modernization initiative
● Explanation of patient involvement in Health Canada reviews as well as the special access program.
View the video:
Follow our social media accounts:
Twitter - https://twitter.com/survivornetca
Facebook - https://www.facebook.com/CanadianSurvivorNet
Pinterest - https://www.pinterest.com/survivornetwork
YouTube - https://www.youtube.com/user/Survivornetca
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,
Regulatory Due Diligence, Using Regulatory Affairs to Maximize the Value of a...SGS
Developing a new drug is a costly undertaking, which can cost several hundreds of millions. Except for the largest Pharma companies, any other company will need external funding at some stage in the development of a drug. A solid regulatory strategy in early phase clinical research is essential to convince your investors to further fund the clinical development of your compound. Depending on your compound (chemical, biotech product, advanced therapy) and the type of investors (private investors, government funding bodies or a larger pharmaceutical company), different aspects of the regulatory strategy need to be more developed.
The main aspects of such an early phase regulatory strategy will be discussed and illustrated with a number of case studies such as the development of a regulatory strategy for a bacteriophage and discussions with Health Authorities.
Contact Us: clinicalresearch@sgs.com
Visit our Website: http://www.sgs.com/cro
Follow Us on LinkedIn: http://bit.ly/SGSLifeSciences
Taking a Commercial Approach To Drug DevelopmentPharmacision LLC
Explore Target Product Profile development and commercially driven drug development strategies for early stage pharmas and drug development companies. See how to develop commercially compelling new drug candidates and increase future licensing opportunities.
CambridgeIP Fact-based Strategy Development: Accelerating your out-licensingCambridgeIP Ltd
Quentin Tannock (Chairman, CambridgeIP) presented at BIO 2010 in Chicago on the topic 'Fact-based strategy development: Accelerating your out-licensing'. The presentation includes our thoughts on the key directions of innovation in the inhaler device space, together with examples of our work in auto-injectors and other spaces.
The animal health care market in the world has grown remarkably over the past few years due to the growth in the emerging markets such as China, India, Indonesia, Thailand, Malaysia and Taiwan followed by US and Europe. The animal health industry’s SWOT analysis provides animal health solutions to society depends on its in-depth knowledge of both cutting-edge technologies and classical veterinary science to innovate and keep up with the animal and human health challenges of new and emerging diseases. The main finding of this project indicates India is one of the important markets and can be seen as a key growth area in global animal health care industry.
- The Indian animal healthcare industry is responsible for maintaining the health and productivity of the over 640 million livestock and 2 billion poultry in India and ensuring the wholesomeness and abundance of the food they produce. Apart from, the industry must also cater to the health and well being of companion animals. Despite this, the global animal healthcare market is 50 times larger than the Indian animal healthcare combined market for all nonhuman species. In spite of this India’s largest milk and 3rd largest meat producer, and blessed with largest cattle population 20% of the world population, and largest buffalo more than 50% of the world. Veterinary Pharmaceutical is yet not considered as big industry as compared to Human Pharmaceutical. The reality is that the global animal health market is very complex, operating under stringent and increasingly strict regulations similar to those for human health, yet the market opportunities are considerably smaller. In an increasingly risky environment for new product development and innovation, the difference between success and failure in the future usually lies in successfully identifying the next growth segment, developing the right product candidates and being the first to market. The situation in developing countries like India is varied and economic and institutional framework of the live stock is often quite different in several respects to that encounter in developed world.
A challenging aspect of the overall market is within the animal food industry as consumers continue to express concern about the conditions under which their daily food is produced. Indian consumers are becoming more health conscious, willing to pay any amount and demanding healthy and balanced diets. By implementing a feeding plan that provides vitamins and supplements, consumers enjoy additional nutritional benefits. Additionally, healthy feeding results in minimized impact on the environment.
This presentation gives an in-depth look at the comprehensive due diligence process. It covers the framework for due diligence, its purpose, and types. This presentation is incrediably valuable for anyone doing or looking to do transactional work.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
How to Work Effectively with Research Teams in New Product PlanningAnthony Russell
Presented at the 3rd New Product Planning Summit. The presentation was designed to help professionals in New Product Planning to present a case for why commercial strategy input is needed early in the process of developing new therapeutics. The presentation also includes suggested approaches and tools to help with effective engagement with Research teams.
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.
5th Biosimilars Congregation 2014
10th September 2014, Kohinoor Continental Hotel, Mumbai, India
“Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars”
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
Investor presentation for Critical Outcome Technologies Inc. (TSX-V: COT; OTC: COTQF). This presentation provides the latest overview of the company's lead cancer drug, COTI-2, as well as other revenue opportunities being pursued by Critical Outcome Technologies.
Similar to How does the licensing process differ for in-licensing and out-licensing companies? (20)
How does the licensing process differ for in-licensing and out-licensing companies?
1. Panel Gary C. Cupit, Pharm D, CEO and Director Somnus Therapeutics, Inc Jones W. Bryan, Ph.D. ,Vice President Business Development and Licensing Supernus Pharmaceuticals Daisy Rivera- Muzzio R. Ph., M.S, MBA, Business Development Consultant PHARMA & BIOTECH LICENSING & PARTNERING: Filling the Pipeline & Growing Market Share Through Strategic Deal-Making .
8. Components to assess the value of the opportunity Licensor (Specialty) Licensee (Small or Large) Early stage development Perform only critical testing for advancement of agent (if discovery based) Novel target or highly differentiated is important and magnified if large pharma Late Stage Development Totally de-risk the asset if known entity or small market The larger the company the more premium placed on de-risked asset and differentiation Commercial analysis Detailed product profile and micro-analysis Input from prescribers, providers and payors with competitive agents – CGS estimates Probability of Technical and Regulatory Success Very High! Preclinical – 5% , Phase I – 10%, Phase II – 20%, Phase III – 50%, NDA File – 80% or wait until ready to commercialize IP assessment Freedom to operate and individual product protection in US/EU Multi country position if large pharma or regional as company size gets smaller (PLCM strategy) Regulatory Strategy Aggressive path with targeted line to approval Clear path with competitive positioning and data Roles/responsibilities at commercialization stage Minimal to full rights to co-promote Pay royalties and milestones to licensor or becomes M&A opportunity
9. Components to assess the value of the opportunity Licensor (Mid to Large BioPharma) Licensee (Small) Early stage development Perform broad based testing across multiple targets and define MOA Key development signals for efficacy Late Stage Development First in class or differentiation within class (Efficacy, safety or administration route/schedule) Target indication with single dosage form Commercial analysis Multiple points of original research at key time points of development/ Packaging/ Dosage design, Reimbursement Status Minimal original research Probability of Technical and Regulatory Success Preclinical – 5% , Phase I – 10%, Phase II – 20%, Phase III – 50%, NDA File – 80% Bullish outlook IP/Trademark assessment Coverage of product, field, dosage forms, future indications and broad geography Freedom to operate and individual product protection in US/EU Regulatory Strategy Broad efficacy/safety studies, biomarkers subpopulations, genomic footprint, REMS Aggressive path with targeted line to approval Roles/responsibilities at commercialization stage Pay royalties and milestones to licensee or M&A opportunity Maintain either specialist calls or future co-promote
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