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IP status – the partner’s view. Yael Weiss Medical Director MSD Israel. Rules of thumb. Strong IP (not use patents, ability to expand and maintain IP) Novelty Ability to incubate and mature project in house because of “The later the better” concept: mandatory – proof of concept in vivo

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Ip status the partner s view

IP status – the partner’s view

Yael Weiss

Medical Director

MSD Israel


Rules of thumb
Rules of thumb

  • Strong IP (not use patents, ability to expand and maintain IP)

  • Novelty

  • Ability to incubate and mature project in house because of “The later the better” concept: mandatory – proof of concept in vivo

  • Partnership for collaboration and further/future development (depending on type of deal)

  • Strategic fit (less relevant in case of VC’s)


Collaboration with emerging scientific markets
Collaboration with Emerging Scientific Markets

Objectives

Identify ex-U.S. markets with high potential for I.P assets, entities and technologies in pharma-related R&D:

  • NCEs: novel chemistry; known MOA (is highly preferred, but not essential); proof of concept; validated in vivo

  • NBEs: proof of concept; validated in vivo

  • Platforms: HTS; assays; informatics; drug delivery; molecular profiling

Source: MRL External Scientific Affairs - Strategy for Growth (Presentation by Dr. Lew Mandel)


Projects at mrl product types
Projects at MRL: Product Types

New Chemical Entity (NCE) – Small molecules:

  • Novel chemistry - single enantiomer with Mol. Wt. 200-800

  • Product patent (vs. use) & worldwide

  • Defined biochemical mechanism (potent & specific)

  • Proof-of-concept in at least one animal model (oral activity, low dose)

  • Favorable PK & few metabolites

  • First- in-class or best-in-class is ideal

    New Biological Entity (NBE) – Therapeutic proteins:

  • Characteristics (fully human, high binding affinity, low toxicity/immunogenicity)

  • Patent (composition and use)

  • Targets (ID, Cancer, Inflammation); or, where small molecules do not work

  • Flexibility (antagonist or agonist, single chain, may be bispecific)

  • Administration (IV or SC, minimal infusion reactions)

  • Manufacture (ease of production, reasonable cost of manufacture)

Source: MRL External Scientific Affairs - Strategy for Growth (Presentation by Dr. Lew Mandel)


Collaboration with emerging scientific markets1
Collaboration with Emerging Scientific Markets

Factors Considered Include:

  • Research centers with strongest scientific disciplines

  • Publications and patents

  • Number of scientists engaged in academia and industry

  • Level of government support & R&D incentives

  • Local on-the-ground support

    Potential Interactions Include:

  • Acquire new lab methodologies

  • Purchase sample collections

  • Establish basic research collaborations

  • Chemistry Outsourcing

  • Optimize an early lead compound

  • License-in a specific NCE or NBE

Source: MRL External Scientific Affairs - Strategy for Growth (Presentation by Dr. Lew Mandel)


Academic environment knowledge capital
Academic Environment: Knowledge Capital

Publications of Life Science Research in Leading Magazines* per 100, 000 Inhabitants (1999)

US Patents Granted in Biotechnology by Origin of Inventor per 100, 000 Inhabitants (1999)

Notes: * Leading magazines; Nature, Science, The Cell

Source: Monitor Report, PubMed/Medline Database, “Technology Profile Report, Patent Examining Technology Center Groups, 1630-1660, Biotechnology” US Patent & Trademark Office, 2001


Academic environment knowledge capital1
Academic Environment: Knowledge Capital

Applied Research Projects in the Academia & Hospitals Available for the Industry (2003)

  • 86% of the projects are in the academia

  • 14% of the projects are in the Hospitals

  • Yissum of the Hebrew University & Yeda of the Weizmann Institute hold almost 60% of all the available projects.

Total of 210 projects

  • In the Biotechnology industry in Israel, especially in the therapeutics and bioinformatics segments, almost 50% of all the companies and projects are based on knowledge created in the academia and transferred to the industry. The rest of the industry is mostly based on independent ideas of local and newly immigrating scientists

  • Alternative sources of knowledge can be found mainly in the medium/big companies, where some knowledge is created in-house or in-licensed from foreign companies

  • Companies created by spin-offs are very few

.

Source: Technology Transfer Companies web sites and company web sites


Government support many different initiatives
Government Support: Many Different Initiatives

Academia

  • “Nofar” Pre-Seed Grant for applied Bio-Research in Academia

  • Grant (without Royalties)

  • 90% up to $ 100 K over 1 year

  • “Magnet” Consortium for Developing Platform Technologies

  • Grant (without Royalties)

  • 66% over 3 years

  • “Tenufa” Pre-Seed Grant for Entrepreneurs

  • Grant (without Royalties)

  • 85% up to $ 50 K

Pre-Seed

  • “Privatized-Incubator” Grant & Infrastructure for Start-ups

  • Convertible Bonds

  • 85% up to $ 500 K over 2 Years

  • “Magneton” Technology Transfer from Academia to Industry

  • Grant (without Royalties)

  • 66% up to $ 0.5 M over 2 Years

  • “Incubator” Pre-Seed Grant & Infrastructure for Start-ups

  • Grant with Royalties reimburse

  • 85% up to $ 300 K over 2 year

Seed

  • “Bi-National” & “International” Funds for industrial collaboration

  • Grant with Royalties reimburse

  • 50% up to ~ $ 0.9 M (BIRD-F)

  • “Bio-Incubator” Seed Grant & Infrastructure for Biotech Start-ups

  • Convertible Bonds

  • 75% up to $ 1.35 M over 3 year

  • “Haznek” Seed Fund for Start-ups

  • Convertible Bonds…………………..with option to investor

  • 50% up to $ 1 M over 2 Years

Mature

  • Support for R&D based Companies

  • Grant with Royalties reimburse

  • 20-50%

  • Support for Long Term R&D Big-Companies (with manufacturing)

  • Grant (without Royalties)

  • 50% up to $ 15 M

  • Incentive for Approved Factory (in regular & preferred location)

  • Grants with Royalties reimburse

  • Tax exemptions

Industry

Source: Ministry of Industry & Trade (www.moit.gov.il)


How are we perceived
How are we perceived?

Upside Downside

(well recognized) (areas for improvement)

General Entrepreneurial Culture difference

Innovative Distance

Basic research High quality Mostly very early stage

Governmental funding IP (?)

Clinical trials Very high quality Costs increasing

Marketing Receptive to innovation Small and limited market

IP and data protection issues


Projects at mrl therapeutic areas
Projects at MRL: Therapeutic Areas

Top Priority includes:

  • Obesity

  • Alzheimer’s disease

  • Cancer

  • Biologics

    High Interest:

  • Neurological Disorders: anxiety, cognition, depression, schizophrenia, Parkinson's diseases

  • Metabolic Diseases: type II diabetes

  • Infectious Diseases: anti-bacterial, anti-fungal, anti-viral & vaccines

  • Cardiovascular Diseases: atherosclerosis, hypertension, atrial arrhythmia

  • Respiratory Diseases: asthma, chronic bronchitis & COPD

  • Immunological and Inflammatory Diseases: autoimmune diseases, chronic pain, osteoarthritis & rheumatoid arthritis

  • Ophthalmology

  • Osteoporosis

    Opportunistic:

  • Gastroenterology

    Also:

  • Imaging techniques to follow response to therapy, animal models of disease, platform technologies

Source: MRL External Scientific Affairs - Strategy for Growth (Presentation by Dr. Lew Mandel), phone conversation with GW



Merck research laboratories facts figures
Merck Research Laboratories: Facts & Figures

  • Merck Research Laboratories (MRL) is the R&D division of Merck operating at multi-locations world wide, with nearly 10,000 employees.

  • Merck had a research budget of $3.2 Billon in 2003.

  • The accomplishments include:

    • Over 1000 scientific papers published each year

    • About 250 new patent applications filed each year

    • 16 new drug applications (NDA) approved in past 7 years

  • Actively pursue of external relationships to complement internal research

Source: MRL External Scientific Affairs - Strategy for Growth (Presentation by Dr. Lew Mandel)


Merck research laboratories strategy
Merck Research Laboratories: Strategy

  • Select major medical targets

  • Select the right target by understanding the mechanism to improve existing therapies Focus on the new chemical entity (NCE)

  • Shorten length of R&D at the research & pre-clinical development

  • Discriminate between projects as they progress through development, with a rapid proof-of-concept tested clinically

  • Establish the best scientific program in the area by either internal research, external collaborations, or both

  • Partner & collaborate with top R&D organizations, to support future growth, by a wide range of relationships: from licensing through joint ventures

Source: MRL External Scientific Affairs - Strategy for Growth (Presentation by Dr. Lew Mandel)


The deterioration in israel s ip regime 1998 2005
The deterioration in Israel’s IP regime 1998 - 2005

  • 1998 – Amendment to the patent law to allow experiments on patent protected products.

  • 2000 – Israel does not adopt data exclusivity despite its commitment under TRIPs

  • 2004 – Government proposes a marketing exclusivity bill which falls far short of international standards.

  • 2005 – The Government proposes to amend the patent law and considerably shorten the patent extension period.


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