User:Nzfooty/sandbox

IP

 * IP Portfolio Manager
 * Patent Analysis (e.g., License-in Candidate, Potential Competitors)
 * Patentability Assessment (on R&D Results)
 * Filing Strategy Recommendation (on Global IP Protection)
 * Patent Specification Drafting and Editing
 * Patent Prosecution Recommendation (e.g., Office Actions)
 * Patent Management
 * Training Program on Basic Patent Law (for R&D staff)

Site Contracts

 * Site Contracts Analyst - as a study team member, Analyst provide support to the clinical team in the pricing, planning, execution, issue resolution and management related to site/investigator budgets and contracts and other documents as necessary
 * Site Contract Leader
 * Site Contracts Specialist
 * Contracts Associate - work with Contracts Team, Business Development and Operations

Business

 * Business Development Manager - developing and diversifying business so that income increases, and the future and growth of the organisation are guaranteed.. Specializations in In & Out Licensing, Co-development, and Distribution Collaborations:
 * Business approaches and partner introduction
 * Market research and analysis
 * Project-specific market forecast and valuation assessment
 * Business proposal and plan
 * Business lead and negotiations on terms (LOI, Agreements etc.)
 * Business recommendations and coaching
 * Training Program on Business Development & Management

Patent holders

 * Majority of DNA patent holders are (~80%):
 * Universities
 * Non-profit organizations


 * They apply for patents because:
 * to claim the recognition that comes with scientific discovery; and
 * to protect their research
 * there is risk of inhibited access to their research if a competing lab:
 * makes a similar discovery;
 * applies for a patent; and
 * exercise their rights as patent holders

That's how the Myriad case came about.

Myriad Case
Quoting:

"Myriad Genetics, a private firm, exercised its legal right as a patent holder. Myriad's charges about $3,000 for the cancer screening test and retained the exclusive right to the test until its patent expired in 2015. The issue was further complicated when one considers the back story. Myriad Genetics co-owns the patents for the BRCA1 and BRCA2 genes along with the University of Utah, which discovered the genes while financed by a National Institutes of Health (NIH) grant. As is common practice, the University of Utah licensed the technology to a private company for commercial development."

In-licensing and Out-licensing

 * giving another party permission to use your property
 * in the case of pharmaceuticals it’s generally intellectual property

Timing in the pharmaceutical sector
When a drug lead is produced but the company does not have the resources to continue with clinical trials, out-licensing the patents to a larger pharmaceutical firm for them to complete development is a common path.

Large companies tend to be execution-strong and lead-weak. As a result, they often in-license technologies from smaller firms, in the hopes of obtaining approval to market the resulting drugs.


 * Now happening at early phase II stage
 * A few years ago, after phase I
 * 10 years ago, at the preclinical stage

Co-development
This involves two parties collaborating to advance an asset to market where the two parties share the development risk and subsequently share in the commercialization rewards in the form of revenues either from direct marketing or licensing to a third party.