Boston BioDiligence LLC
San Francisco Bay Area
T. 415.317.1174
info@bostonbd.com
www.bostonbd.com
"...excellent at bringing abstract concepts to the forefront, and suggesting ways in which to apply them to real-world clinical settings." -President & CEO, OUS medical device company
Background
Client was a newly capitalized company developing platform-technology to treat multiple diseases.
Client needed to differentiate itself in a crowded field and attract investment from corporate partners capable of completing disease-specific products and sponsoring clinical trials.
Key questions were:
- Where does the intellectual property stand relative to the landscape?
- What is the status of preclinical feasibility?
- Which therapeutic applications are the best candidates for clinical trials?
- Does the regulatory strategy fit the goals?
- Who are potential corporate partners and how will partnership enhance their position?
Boston BioDiligence’s approach
- Worked with the management team, investors and patent counsel to focus on the key questions
- Aligned client’s website and corporate presentation with new partnering objectives
- Identified thought-leaders in disease-specific research and had them execute feasibility studies to evaluate the technology.
- Contacted potential corporate partners and began the cycle of confidential presentations and follow-on diligence
- Updated progress of preclinical research, regulatory strategy and patent portfolio.
Outcome
Early requirement to partner was a challenge and client responded by executing key deliverables.
Background
Client’s company pioneered a therapy used to treat over one million patients annually. Despite growing utilization, this therapy failed in one-third to one-half of patients. Ten years of research did not improve outcomes. The client faced a constant stream of innovators “knocking” on their door with potential solutions.
Client needed an independent analysis of the science in this field and a proactive strategy for investing in emerging technology. Key questions were:
- What are the most promising directions in new research?
- Where is it heading?
- What opportunities are available for investment?
- Which opportunities can be engaged with minimal investment?
Boston BioDiligence's approach
- Focused on science fundamentals; determined how the research was done, what it meant and what its shortcomings were.
- Identified key elements in the client’s proprietary position.
- Matched client’s intellectual property with potential therapies and fit the matches to an opportunity grid that considered time to market and cost.
- Developed recommendations and validated them with thought leaders.
- Worked with the client’s team of business, R&D and clinical personnel to target attractive acquisitions.
Outcome
By understanding what from their past was valuable and where they needed to go in the future, client was prepared to conduct rational R&D venturing to acquire the missing pieces.
Background
Client was a division of a multinational company. Potential licensor built a prototype of a new technology and demonstrated feasibility with funding from a small business innovation grant. The inventor was a university professor.
Client needed to determine whether to license the product concept which if successful could change the therapeutic landscape in its franchise. Key questions were:
- What does the potential licensor have?
- Is it feasible?
- Does the product concept offer a clinical advantage?
- Would it be prescribed routinely, on what patients and in what setting?
Boston BioDiligence’s approach
- Developed a technology backgrounder for the product concept by working with the client’s R&D team, academic experts and scientific literature.
- Using this information asked medical specialists to review their treatment decisions in light of the product concept.
- Supported the client’s patent counsel in examining prior art and patent validity.
- Reviewed progress with the client’s team of business, R&D and medical personnel.
- Facilitated a discovery meeting with the licensor, academic inventor and client’s team.
- Debriefed client and developed scenarios.
Outcome
Shortcomings in the licensor’s patent opened the door for the client to act independently. Boston BioDiligence’s ability to work with the client’s whole team provided the basis for a quick decision.
Background
Client provided a therapeutic option used to treat over 800,000 patients. Encouraged by accelerating adoption, client wanted to reduce side-effects. An inventor in the client’s R&D group proposed modifications that involved new technologies and management wanted an extended review of options before funding development.
Client needed assurance that the proposed modifications represented improvements. Key questions were:
- What are the facts and lessons learned from clinical experience?
- What biological endpoints are surrogates for pre-clinical testing?
- Is it possible to outline a modular development plan so improvements are iterative and leverage approved entities?
- How does the adoption of new technologies impact patent, regulatory and partnering options?
Boston BioDiligence's approach
- Performed an independent review of basic science, clinical and patent literature.
- Examined the inventor’s hypotheses and patent filings against this background.
- Identified approved entities for prototypes and outlined a pre-clinical plan.
- Enhanced scope of patent claims.
Outcome
Starting with the insight of a single inventor, client became more confident investing in new technologies and had a better understanding of the resources needed to execute the development path.
