Product Development & Strategy Committee
Product Development & Strategy Committee Charter
Purpose
The Product Development and Strategy Committee (the “Committee”) has been established by the Board of Directors (the “Board”) to assist in fulfilling its oversight responsibilities at BioPorto A/S (the “Company”).
The Committee provides strategic oversight of product development, including clinical evaluation, regulatory strategy, and commercial planning. Its role is to provide guidance to help ensure that the product pipeline and commercialization efforts remain aligned with the Company’s overall development strategy. As an advisory body, the Committee evaluates whether activities such as, but not limited to, assay design, bench testing, clinical studies, performance validation and regulatory submissions appropriately reflect market needs, strategic partnerships, and customer adoption. The Committee advises on whether development priorities are directionally consistent with the Company’s mission, scientific focus, and commercial goals, particularly in vitro diagnostics and its expertise in antibodies and assay development. The flagship products are based on the NGAL biomarker and designed to aid in risk assessment and diagnosis of Acute Kidney Injury (AKI).
Committee Members
- Donna Haire, Committee Chairman
- Jens Due Olsen
All members possess the required qualifications in finance and relevant competencies within the business sector and therefore meet the requirements set forth in Danish law and Danish corporate governance recommendations.
Members
The Committee consists of a Committee Chair and Committee member(s).
Meetings
The Committee shall meet as needed according to the Company’s Annual Plan and as deemed necessary or appropriate in relation to the Company’s needs or development priorities. A quorum for any meeting shall be a majority of the members. The Chair of the Committee shall have the casting vote. Minutes of each meeting shall be prepared and distributed to the Board.
Committee meetings shall include input from key functional areas such as R&D, Clinical, Regulatory, and Commercial to support effective strategic oversight. Materials and presentations must reflect cross-functional perspectives, and subject matter experts may be invited as needed to provide a complete view of risks, timelines, and interdependencies.
Reporting
The Committee shall report regularly to the Board on its activities and recommendations. The Committee shall review its charter annually and recommend any necessary changes to the Board.
Remuneration
The Committee members may be remunerated with a fee proposed by the Board of Directors and decided by the Annual General Meeting.
Main Activities
Evaluate Product Development Strategy
- Review and provide input on the Company’s overall diagnostic development roadmap and strategy, including the prioritization of programs based on meaningful clinical needs, market opportunity, and competitive differentiation. Assess whether the strategy is appropriately aligned with the Company’s long-term growth strategy, scientific vision, commercial objectives, and core competencies.
- Advise on product platform expansion and new indications.
- Evaluate the feasibility of proposed development plans by considering technical readiness, resource requirements, timeline assumptions, and potential external dependencies.
- Monitor key development milestones and associated risks, advise the Board on strategic implications.
Clinical and Analytical Validation Oversight
- Provide oversight of the Company’s clinical and analytical validation strategy, including high-level evaluation of study design, intended use, and applicable regulatory requirements and industry standards.
- Provide strategic oversight of validation activities, including those involving bench testing, clinical studies, and performance testing on third-party analyzers.
- Monitor the Company’s approach to generating and communicating clinical evidence to ensure scientific rigor and alignment with strategic objectives.
REGULATORY STRATEGY OVERSIGHT
- Provide oversight on the Company’s global regulatory strategy, including planned submissions and key interactions with health authorities.
- Review significant regulatory risks and evaluate whether appropriate mitigation strategies are in place.
- Evaluate alignment between regulatory pathways and broader product development and commercialization goals.
EVALUATE DEVELOPMENT RISKS
- Monitor risks associated with clinical validation and regulatory activities and assess the adequacy of management’s mitigation plans.
- Evaluate the effectiveness of internal governance structures, including quality systems and compliance frameworks relevant to development and validation.
- Advise the Board on any significant risks or issues that could impact on the Company’s ability to advance its product pipeline.