Statement of Work (SOW)
I. Scope of Work: Use technology to reduce R&D expense and to help foster the growth of innovation within J&J and the Health Care Industry
II. Location of Work: The project team will meet at Pennsylvania State University. Any testing that needs to be done will be handled at a J&J facility.
III. Period of Performance: The work load is expected to start on 23 Jan. 2012.
IV. Deliverables Schedule: Initiating- Project Charter, Proposed Personnel, Letter of Intent, Work Breakdown Structure; 2 Feb. 2012
Planning Phase- Project Management Plan, Team Contract, Stakeholder Register and Management Plan, Define Requirements/Resources, Collect Requirements; 16 Feb. 2012
Execution Phase-Survey Users, Develop New System, Check New System, Meet with Stakeholders, Testin ; 1 May 2012
Closing- Final Report, Executive Signoff; 15 May 2012
V. Applicable Standards: Specify any company or industry-specific standard
Consumer
The consumer R&D process varies depending on the product being researched and/or developed but you can reference the high-level process below in an effort to broadly understand the process cycle.
1) Market research partners are engaged to determine the need and/or wants of the consumer.
2) Customer needs/wants are identified and prioritized based on the company’s goals.
3) The Business and Research & Development Departments coordinate to create mock designs
4) Prototypes are created.
5) Prototypes are taken to a subset of consumers for feedback.
(Steps 1-5 are repeated until the consumers are satisfied)
6) Developed product goes through stability testing to ensure safety.
7) Product is transferred to Technology Engineering for additional testing and design analysis.
8) Product is transferred to Manufacturing for mass production.
Pharmaceuticals
1) The Drug Discovery phase
a. The scientists analyze patterns in the disease process to find abnormal events occurring at the cellular and molecular level, and determine what they should target to “fix
b. After choosing a specific target, they perform a number of tests and simulations to determine which molecular compounds act on that target and which ones are the most viable
c. The process takes about 5 years, on average, and starts at over 10,000 compounds. Going into the Pre-Clinical phase, they have narrowed it down to 250 “lead” compounds which warrant further testing
2) The Pre-Clinical Phase
a. In this phase, the scientists perform intensive, high-compute analysis on each of the “lead” compounds.
b. Once specific models are computed / determined, they are developed in labs and tested. (This process takes approximately 5 years and whittles the 250 compounds down to about 5)
3) The Clinical Phase
a. Phase 1 – uses 20-100 healthy human volunteers to determine the safety of the drug and appropriate dosages
i. Patients receive drug for less than 1 month
ii. Phase takes 6 months – 1 year
b. Phase 2 – uses 100-300 patient volunteers to determine efficacy and side effects of affected patients
i. The reasoning to test healthy patients first is that affected patients may be taking other medications or have difficulty absorbing or metabolizing the drug due to their underlying disease
ii. Takes about 1-2 years
iii. Only about 1/3 of potential drugs successfully complete both phases 1 and 2
c. Phase 3 – uses 1000-5000+ patient volunteers to monitor long-term adverse reactions
i. This phase really determines whether mass-production is feasible
ii. It lasts 2-4 years
iii. The important thing to remember is that no drug is completely safe and without side effects. We have to continually monitor throughout this phase for any indication of adverse reactions
d. Each phase ends in with a “Go / No-Go” decision to continue the tests
4) The Approval Phase
a. Need to submit a New Drug Application to the FDA and go through the approval process
b. The FDA requires all documentation throughout the entire multi-year process that it took to develop the drug
c. Once approved, the drug can be manufactured
Medical Device & Diagnostics
The MD&D R&D process varies depending on the product being researched and/or developed but you can reference the process below in order to broadly understand the flow.
1) The two primary drivers for new product development are
a. What have the competition launching or have they launched?
b. What do the patients want / need?
2) Competitor products/features and patient needs/wants are identified and prioritized based on the company’s goals.
3) The Business and Research & Development Departments coordinate to create mock designs (this is reiterated until a solution is agreed upon).
4) Prototypes are created.
5) Prototypes are taken to a subset of patients to conduct human factor studies. Human factor studies are expensive and are sometimes condensed.
6) Prototypes are used in clinical studies. This can be done in parallel with Step 5. Clinical studies look at ensuring the safety of the product.
(Steps 1-6 are repeated until the safety of the product and the patients are satisfied)
7) Product is submitted to the FDA for approval.
8) In parallel Marketing, Sales and Operations ensure that the product is ready for launch. Once FDA approves the product, it is launched.
VI. Acceptance Criteria: All project requirements are completed to their respective requirements definition. Quality is checked throughout the life of the project. Final approval by the project stakeholders is required.
VII. Special Requirements: Follow the J&J credo and standards.
I. Scope of Work: Use technology to reduce R&D expense and to help foster the growth of innovation within J&J and the Health Care Industry
II. Location of Work: The project team will meet at Pennsylvania State University. Any testing that needs to be done will be handled at a J&J facility.
III. Period of Performance: The work load is expected to start on 23 Jan. 2012.
IV. Deliverables Schedule: Initiating- Project Charter, Proposed Personnel, Letter of Intent, Work Breakdown Structure; 2 Feb. 2012
Planning Phase- Project Management Plan, Team Contract, Stakeholder Register and Management Plan, Define Requirements/Resources, Collect Requirements; 16 Feb. 2012
Execution Phase-Survey Users, Develop New System, Check New System, Meet with Stakeholders, Testin ; 1 May 2012
Closing- Final Report, Executive Signoff; 15 May 2012
V. Applicable Standards: Specify any company or industry-specific standard
Consumer
The consumer R&D process varies depending on the product being researched and/or developed but you can reference the high-level process below in an effort to broadly understand the process cycle.
1) Market research partners are engaged to determine the need and/or wants of the consumer.
2) Customer needs/wants are identified and prioritized based on the company’s goals.
3) The Business and Research & Development Departments coordinate to create mock designs
4) Prototypes are created.
5) Prototypes are taken to a subset of consumers for feedback.
(Steps 1-5 are repeated until the consumers are satisfied)
6) Developed product goes through stability testing to ensure safety.
7) Product is transferred to Technology Engineering for additional testing and design analysis.
8) Product is transferred to Manufacturing for mass production.
Pharmaceuticals
1) The Drug Discovery phase
a. The scientists analyze patterns in the disease process to find abnormal events occurring at the cellular and molecular level, and determine what they should target to “fix
b. After choosing a specific target, they perform a number of tests and simulations to determine which molecular compounds act on that target and which ones are the most viable
c. The process takes about 5 years, on average, and starts at over 10,000 compounds. Going into the Pre-Clinical phase, they have narrowed it down to 250 “lead” compounds which warrant further testing
2) The Pre-Clinical Phase
a. In this phase, the scientists perform intensive, high-compute analysis on each of the “lead” compounds.
b. Once specific models are computed / determined, they are developed in labs and tested. (This process takes approximately 5 years and whittles the 250 compounds down to about 5)
3) The Clinical Phase
a. Phase 1 – uses 20-100 healthy human volunteers to determine the safety of the drug and appropriate dosages
i. Patients receive drug for less than 1 month
ii. Phase takes 6 months – 1 year
b. Phase 2 – uses 100-300 patient volunteers to determine efficacy and side effects of affected patients
i. The reasoning to test healthy patients first is that affected patients may be taking other medications or have difficulty absorbing or metabolizing the drug due to their underlying disease
ii. Takes about 1-2 years
iii. Only about 1/3 of potential drugs successfully complete both phases 1 and 2
c. Phase 3 – uses 1000-5000+ patient volunteers to monitor long-term adverse reactions
i. This phase really determines whether mass-production is feasible
ii. It lasts 2-4 years
iii. The important thing to remember is that no drug is completely safe and without side effects. We have to continually monitor throughout this phase for any indication of adverse reactions
d. Each phase ends in with a “Go / No-Go” decision to continue the tests
4) The Approval Phase
a. Need to submit a New Drug Application to the FDA and go through the approval process
b. The FDA requires all documentation throughout the entire multi-year process that it took to develop the drug
c. Once approved, the drug can be manufactured
Medical Device & Diagnostics
The MD&D R&D process varies depending on the product being researched and/or developed but you can reference the process below in order to broadly understand the flow.
1) The two primary drivers for new product development are
a. What have the competition launching or have they launched?
b. What do the patients want / need?
2) Competitor products/features and patient needs/wants are identified and prioritized based on the company’s goals.
3) The Business and Research & Development Departments coordinate to create mock designs (this is reiterated until a solution is agreed upon).
4) Prototypes are created.
5) Prototypes are taken to a subset of patients to conduct human factor studies. Human factor studies are expensive and are sometimes condensed.
6) Prototypes are used in clinical studies. This can be done in parallel with Step 5. Clinical studies look at ensuring the safety of the product.
(Steps 1-6 are repeated until the safety of the product and the patients are satisfied)
7) Product is submitted to the FDA for approval.
8) In parallel Marketing, Sales and Operations ensure that the product is ready for launch. Once FDA approves the product, it is launched.
VI. Acceptance Criteria: All project requirements are completed to their respective requirements definition. Quality is checked throughout the life of the project. Final approval by the project stakeholders is required.
VII. Special Requirements: Follow the J&J credo and standards.
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