Module 3 - Transfer of Technology

Technology Transfer

Technology Transfer

The systematic procedure that is followed in order to pass the documented knowledge and experience gained during development and/or commercialization to an appropriate, responsible, and authorized party.

Technology transfer

embodies both the transfer of documentation and the demonstrated ability of a Receiving Unit to effectively perform the critical elements of transferred technology, to the satisfaction of all parties and any, or all, applicable regulatory bodies.

Technology Transfer

New product transfers during development through manufacturing •

Technology Transfer

Transfers within or between manufacturing sites for marketed products

Drug discover -> Commercialization Small scalle -> Large scale production

In short Technology Transfer is from :

the need for additional capacity

the strategic requirement to relocate business units because of economic advantages in different regions of the world

the natural progression in a product development life cycle, from a discovery laboratory, through scale-up and clinical development, to commercialization

the by-product of corporate mergers and consolidations

The transfer of technologies, methods, processes, and/or products, occurs for a variety of reasons and may be based on a number of factors,

routinely reproduce the transferred product, process, or method against a predefined set of specifications as

Technology transfer can be considered successful if a Receiving Unit can _______ agreed with a Sending Unit and /or a Development Unit.

● GOVERNMENT LABS TO PRIVATE SECTORS ● BETWEEN PRIVATED SECTORS ● FROM ACADEMICS TO PRIVATE SECTORS ● BETWEEN ACADEMY, PRIVATE AND GOVERNEMENT SECTORS

Facets of Technology Transfer

2009

"Philippine Technology Transfer Act of _____"

RA 10055

"Philippine Technology Transfer Act of 2009" ----> RA _____

"Philippine Technology Transfer Act of 2009" / RA 10055

AN ACT PROVIDING THE FRAMEWORK AND SUPPORT SYSTEM FOR THE OWNERSHIP, MANAGEMENT, USE, AND COMMERCIALIZATION OF INTELLECTUAL PROPERTY GENERATED FROM RESEARCH AND DEVELOPMENT FUNDED BY GOVERNMENT AND FOR OTHER PURPOSES

"Philippine Technology Transfer Act of 2009" / RA 10055

This Act aims to promote and facilitate the transfer, dissemination, and effective use, management, and commercialization of intellectual property, technology and knowledge resulting from R&D funded by the government for the benefit of national economy and taxpayers

the transfer, dissemination, and effective use, management, and commercialization of intellectual property, technology and knowledge resulting from R&D funded by the government for the benefit of national economy and taxpayer

"Philippine Technology Transfer Act of 2009" / RA 10055 aims to promote and facilitate what?

"Government Funding Agency (GFA)"

refers to any government agency or instrumentality, or government-owned and/or controlled corporation that provides research grants and other technical and material support, from government appropriations and resources and those sourced from government-managed Official Development Assistance (ODA) funds.

"Parent Agency"

refers to the Department or agency, which exercises the power of control or supervision over the GFAS, RDIS or RDI acting as the GFA itself.

parent agency

In general, where multiple GFAS are involved, the department or agency, which has the largest financial contribution, shall be deemed as the _____ , except as may otherwise be specifically provided by "Philippine Technology Transfer Act of 2009"

"Research and Development Institute or Institution (RDI)"

refers to a public or association, private organization, partnership, joint venture, higher education institution or corporation that performs R&D activities and is duly registered andlor licensed to do business in the Philippines, or otherwise with legal personality in the Philippines.

Philippines 60%

In the case of private"Research and Development Institute or Institution (RDI)" , they shall be owned solely by the citizens of the _____ or corporations or associations at least percent (%) of the capital of which is owned by such citizens. This does not include RDIs covered by international bilateral or multilateral agreements.

"Spin off firm or company"

refers to a juridical entity that is an independent business technology taker with a separate legal personality from the GFA, RDI and researcher created through the initiative of the researcher employee who generated the technology.

startup firm or company

refers to a juridical entity that is an independent business technology recipient with a separate legal personality from the GFA, RDI and researcher, which is created independently of the researcher employee who generated the technology

1. Support for R&D

2.Niche Centers in the Regions For R&D (NICER) Program

3. Collaborative Research and Development to Leverage Philippine Economy (CRADLE)

4. Business Innovation thru S&T (BIST) Program

R&D Funding Program (DOST Councils) (1-4)

Promoting Research and Outstanding Milestones in Innovation and Science for Entrepreneurship

PROMISE meaning

Promoting Research and Outstanding Milestones in Innovation and Science for Entrepreneurship

the event which showcased DOST's market-ready technologies to investors, enterprises, and organizations.

April 27 2016

The 1st DOST TECHNOLOGY TRANSFER DAY

Lagundi Tablet, Lagundi Pediatric Syrup Sambong Tablet Akapulko Lotion

Technologies Licensed from UP Manila

November 1995

[Date] First licensed issued for Laagundi and Sambong Tablet

1999

[Date] First licensed issued Lagundi Pediatric Syrup

Ascof ReLeaf

Trademark for Lagundi is _____ for Sambong is ______

Strawberry Banana-flavored

Product Variants after Licensing of Lagundi Pediatric Syrup

UM NO. 2-1999-00164

UM NO. _____ of Lagundi Pediatric

PATENT NO. 1-1997-57575

PATENT NO. ___ of Sambong

diuretic and for kidney stone dissolution)

Sambong/Ngai Camphor (Blumea balsamifera) uses

Ulasimang bato (Peperomia pellucida)

Antihyperuricemic

On February 11, 2019 the National Integrated Research Program on Medicinal Plants (NIRPROMP), through the UP Manila Technology Transfer and Business Development Office (UPM TTBDO), and in partnership with the Philippine Institute of Traditional and Alternative Health Care (PITAHC), held the Technology Presentation of _____ as ______ Agent for various members of the private sector, to attract prospective licensees of the technology.

Documentation/Information:

Consistent and controlled procedures for Technology Transfer and for running your process

Documentation/Information:

Assurance of clear documentation of all process/product knowledge

Documentation/Information:

Understanding of prior knowledge from similar products

Personnel:

The integrated interdisciplinary team of cross functional experts: Operations, Tech Operations, CMC, Supply Chain, Analytical, Quality, R&D etc.

Personnel:

The integrated interdisciplinary team of cross functional experts: Operations, Tech Operations, CMC, Supply Chain, Analytical, Quality, R&D etc.

Personnel:

Roles and responsibilities of development group and the site are defined

Personnel:

Technology Evaluation/Development:

Personnel:

Assure have well understood, robust process, and corresponding analytical methods

Personnel:

Utilize principals in ICH Q8, Q9 QRM, and Q10

Personnel:

Well designed and well understood equipment train

Personnel:

Uni/Multivariant Design of experiments

Personnel:

Identification/verification of CPPs and CQAs and other important parameters.

Execution:

Successful manufacture of demonstration batches

Execution:

Note: This aids in site training and demonstrates that the receiving site has the ability to perform the process adequately and is the basis for Process Validation

Execution:

Understand validation requirements/strategy

Execution:

Understand validation requirements/strategy

Executable control strategy under site PQS

Pharmaceutical Quality System:

Utilize PQSs to help drive/control any changes, document learning’s during and post transfer