Case Scope

 
 

Dear Client,

Following our discussions, Fourth River Solutions (4RS) has prepared a proposal to assist the Client in assessing alternative market spaces for their novel drug delivery technology. Based on this analysis, 4RS will make recommendations and provide insights on an appropriate market for the Client to pursue. This document provides a) the suggested Fourth River Solution consultant team compositions b) a proposed meeting schedule, c) the deliverables to be expected by the Fourth River Solutions consultant teams, and d) our cost agreement. 

We propose a 6-week timeline, starting in February. Meetings will include:

  • A project kickoff with Client leadership to introduce the team, review the scope, and discuss relevant background material related to the project.

  • Weekly updates from the project manager. Format (email updates or virtual meetings) to be decided at project kickoff.

  • A midpoint meeting with the Client team after the 3rd week to discuss the consultant team’s progress and next steps.

  • A final meeting during the 6th week to present a summary of final deliverables.

To complete this project, we will employ a five-member team composed of an engagement manager (EM), a project manager (PM), and three student consultants. The role of the EM is an experienced 4RS PM who serves as an internal advisor to the project manager and assists in interpreting and defining client needs. The PM coordinates the consultant's effort, and curates the research results, while also providing high-quality deliverables that are in line with the client's needs and expectations. The consultants are responsible for performing research and collecting data. The consultants and project manager will contribute 10 hours per consultant per week for a total of 240 hours.

4RS team members are students and postdocs with daytime jobs. Therefore, 4RS team members are not required to be available for more than 1 business hour per week (Monday to Friday, 9 am-5 pm), unless agreed upon in writing by the 4RS team. Outside of phone and/or in-person meetings, work will be done at a time and location of their choosing. The 4RS team will be assembled and introduced via email after the Scope of Work is signed. 

Deliverables for this project will include the following sets of analyses to determine the best market space for Client to pursue:

1. Market Analysis: Consultants will perform Market Analysis using a two-step approach to determine the best market space for the Client to pursue:

A. Market Discovery: Each consultant will identify one (1) disease/health condition that affects superficial tissues (ex. lungs, heart, eye), would benefit from a targeted drug approach, and does not currently have successful, minimally-invasive treatment options (e.g. The technology requires intravenous administration, thus would be considered more invasive than current treatment options for a majority of relevant dermatological conditions)

      1. Relevant diseases/health conditions should be identified through a variety of methods including but not limited to: 

        1. Approved drugs that have failed trials due to high toxicity, but would benefit from a targeted approach (FDA drug trials website)

        2. Orphan diseases with a high amount of non-diluted funding (i.e. low amount of competition)

        3. Literature searches of diseases focused on precision medicine

      2. Consultants will collect the following information (whenever relevant) in a documented table:

        1. Name of Disease/Health Condition with a short description

        2. Include information on how Client’s technology would benefit this disease

        3. Drug name with information on the group attempting the trial (names and contact info, if available)

        4. Current treatment options including name and cost

        5. Current funding groups (i.e. foundations) and total amount available

        6. Ongoing clinical trials

        7. Key difficulties of the space (i.e. why are there no successful treatments)

      3. While cancer is a popular disease focus for precision medicine; due to the high dilution of this market, focus should be limited to only specific areas that are not highly saturated

B. Market Deep-Dive: Consultants will pursue a deeper analysis of the market for the diseases/drugs identified in [1a]. The following information will be collected and documented in a table (as well as any additional information deemed relevant by the consultants): 

  1. Size of the market space: Total Addressable Market and Total Attainable Market

    • A bottom-up approach should be performed whenever possible and can be completed through a literature search to determine disease prevalence

  2. Trends in the market space, including any major horizon technology, relevant funding initiatives, rising market subdivisions/needs, or major impacting issues

  3. Key competitors - this will be a starting point for [2] below

  4. Key funding groups

  5. Customer/client demographics

  6. Industry growth forecast over the next 5 – 10 years

For the remainder of deliverables, each consultant will perform a separate analysis to build the client a strong business model strategy from the best market space identified by the market deep-dive [1b]:

2. Competitive Analysis: 4RS will identify a minimum of ten (10) companies that have a platform technology of a similar FDA classification (Class III) and assess their go-to-market strategies, focused on understanding the characteristics of a beachhead market for biotech platform technologies. Consultants should focus on well-established companies that have successfully produced market sales. The technology functions do not need to align with Client’s technology but should have utility for a wide variety of diseases. For each competitor, the following information will be collected and documented in a table format:

  1. Name of the competitor

  2. Name of platform technology and a short description of the technology function

  3. Description of their initial disease/drug focus

  4. Description of any additional targeted diseases/drugs

  5. Timeline of funding

    • Include source (diluted and non-diluted funding, pitch or other competition or accelerator programs participated)

  6. Timeline of publications/clinical trial successes

  7. Revenue, specify source and amount if possible (begin the search in press releases or articles)

  8. IP footprint (if applicable using Pitchbook)

  9. Company size 

  10. Partnerships or research collaborations

    •  If available, provide a list of publications

  11. Business Model (i.e. licensing, direct sales, etc)

  12. Advertising Model (i.e. who is their primary resource for product recommendations?)

  13. Board of Advisors

    • Name of person(s)

    • Area(s) of expertise (i.e. What do they bring to the table for the specific product)

3. Regulatory Analysis of Comparable Class III Software: 4RS consultants will identify and compare two existing class III medical devices that have already obtained FDA clearance, and have a targeted drug delivery approach. 

    1. Consultants will investigate each company for details relating to the burden of proof. Relevant devices should be based on the following criteria:

      • Class III medical device

      • Targeted drug delivery

    2. Whenever possible, information for each identified company should be collected using the products’ FDA clearance letters, research articles, and FDA guidelines. The following information will be collected for each device:

      1.  The burden of proof collected to receive clearance

      2. If available:

        • What was the study design (prospective or retrospective?)

        • What was the study population size?

        • Summary of sensitive variables and logic behind choice of variables

        • (i.e. gender, education, income, etc)

        • If provided, a summary of reasoning for the use of retrospective or prospective data

    3. Selection of Sensitive Variables: Using the information collected from [i] and [iii], the consultant will identify and select a list of sensitive/protected variables to be included in the study population for the Client. These variables will be grouped into two categories: high-risk and low-risk. Once variables have been selected, geographical area(s) will be identified for the pilot study. Variables will be listed in an Excel spreadsheet with the following information:

      1. Reference study leading to identification

      2. Why was this study important?

      3. Is this study generalizable for at-risk populations?

      4. Justification for consideration in Client Study

      5. A list of geographic areas that should be covered in Client pilot sites

      6. Which areas would provide populations most representative of the country?

4. Stakeholder Analysis: 4RS Consultants will assess the current need for the Client’s technology in the market space determined in [1] using the following analysis:

  1. Compile a list of any and all potential stakeholders 

  2. Compile a list of current solutions/standards of care for the target disease

  3. Compile a list of relevant online groups that might detail the patient experience such as:

    1. Patient advocacy and support groups

    2. Online patient blogs

    3. Professional societies

    4. Review discussions of patient outcomes from primary literature

  4. From these analyses, the consultant will complete a statement of need for this disease state, relating to the Client’s technology

5. Reimbursement Assessment: *ONLY NECESSARY WITH TEAMS OF 4 CONSULTANTS

  1. Assessment of the reimbursement structure(s) for drug delivery technologies. Consultants will employ a two-pronged approach, consisting of:

  2. Assessment of existing reimbursement structures for competitors (if possible), which should include a dollar amount of reimbursement per approach. 

  3. Medical insurance-specific approach to assess policies for reimbursement and pricing. 

    1. Consultants will assess policies for a minimum of 5 (if possible) medical/prescription insurance plans, aiming for a representative example from PA for reimbursing drug delivery technologies

  4. In both cases, reimbursement analysis will detail, to the fullest extent possible, the entire reimbursement process, including the type of reimbursement strategy, the workflow of the reimbursement, all parties involved, and any and all pricing and fee information that is available. Whenever possible, consultants will record the monetary values involved at the dollar amount.

6. Final Recommendation: Based on the information found above, 4RS will provide recommendations to the Client on the most appropriate alternative market space to pursue.

  1. All final recommendations will be detailed in a white paper report and delivered in a PowerPoint presentation at the final meeting. 

4RS is not responsible for assessing competitors or markets outside those detailed above. Information on each competitor will be collected to the fullest extent possible, based on information available to consultants. Analyses beyond what is outlined above may be pursued in future engagements.

All deliverables collected throughout the engagement will be submitted and available by the end of the sixth week for your review. If revisions to these documents are desired, they must be requested within 48 hours of receipt. Revisions may also be incorporated into subsequent engagements at the discretion of Client and the 4RS Business Development team.