Martin Brena

Associate Director - Global Process Development - Business Strategy & Operations

2024

Senior Manager - Global Process Development - Business Strategy & Operations

2023 - 2024

Scientific Diligence

2021 - 2023

•Scientific Assessment: Conducted multiple simultaneous scientific diligence projects focused primarily on oncology drug development. Analyzed large volumes of published and unpublished data to assess an asset’s likelihood of success in clinical studies as it advanced through the drug development process. •Scientific Collaboration: Worked closely with principal investigators, subject matter experts, and key opinion leaders to assess preclinical assets’ scientific potential and to determine clinical development risk. Routinely presented detailed diligence reports to Kairos Ventures’ Executive Investment Committee. •Alliance Management: Partnered with key stakeholders to set milestones. Delineated joint responsibilities to successfully achieve partnership objectives within agreed timelines. Reviewed partner contracts and advised on the execution of the contract negotiation strategy. •Portfolio Governance: Performed Board-level oversight of portfolio companies. Developed short and long term growth strategies by prioritizing assets based on pipeline maturity and guided asset funding allocation. •Clinical Study Design & Oversight: Reprioritized R&D activities and adapted execution plans to account for novel data or unexpected developments that could impact the initiation or continuation of Phase I studies. Participated in clinical study review meetings to assess asset development progress, identify challenges and propose solutions to ensure clinical study progress in accordance with pre-approved budgets and timelines. Developed and presented progress reports for senior leadership at Kairos Ventures. •Vendor Qualification & Risk Assessment: Proposed strategies to assess the effectiveness of vendor processes to ensure adherence to GLP and GCP practices. Reviewed standard operating procedures, FDA audit findings, and internal audit plans to determine a vendor’s execution risk for Phase I and Phase II clinical studies.

Board of Directors

2021 - 2023

Board of Directors

2021 - 2023

Pharma Life Sciences R&D

2017 - 2020

•R&D Integration, Process Development, & Program Management: Developed and implemented 9 end-to-end processes in the Nonclinical Development Function of a global pharmaceutical company. Led weekly meetings which included the Heads of Global Quality, Nonclinical Development, Clinical Operations, and Technical Operations. Adapted the initiative’s execution strategy to accommodate changing stakeholder needs and to achieve the initiative’s goals on time and on budget. Implemented a change management plan and updated the Nonclinical Development Function’s training matrix, reducing training time by over 25%. •Operating Model Assessment & Outcomes Reporting: Evaluated the operating model of 4 multinational CROs on behalf of a global pharmaceutical company via sponsor document reviews, CRO process audits, and on-site interviews at 7 CRO sites in Asia, Europe, South America, and North America. Identified areas of operational risk, developed procedures for their early identification and implemented mitigation strategies, which were approved by the sponsor's Global Head of R&D. •Vendor Qualification, Risk Assessment, Audit, & Governance: Assessed the qualification strategy for Clinical Operations vendors of a global pharmaceutical company, which encompassed 30 vendors that provided primary clinical data inputs. The qualification strategy included assessing resource allocation, metrics reporting, CAPA processes, and mitigation strategies for key areas of operational and regulatory compliance risk. Evaluated the sponsor’s internal and external audit strategy and audit plans for these vendors. •Quality Management System Compliance: Assessed the QMS of a foreign medical supply manufacturer for adherence to 21 CFR 820 guidelines to determine its operational readiness to produce COVID-19 test kits in the US. The assessment included the review of operational procedures covered by the regulation and the creation of procedural documents to address compliance gaps.

Pharma & Biotech R&D

2016 - 2017

•Preclinical Data Integration: Delivered a strategy to visualize genomics data from open source, current, and closed clinical studies. The strategy maximized the data’s utility for hypothesis generation, lead compound selection, and accelerated clinical study design. Identified risks in clinical data information flow and defined mitigation strategies. •Protocol Development: Developed a protocol for the performance and inclusion of liquid biopsies in new clinical studies. The protocol detailed sample extraction, processing, and storage, as well as quality control steps to test analyte integrity and attain consistent quality across samples collected from clinical sites worldwide.

Pharma & Biotech Innovation - R&D

2013 - 2015

•Process Development: Developed and implemented a process to streamline the adoption of analytical methods leveraged from closed clinical studies to analyze data from ongoing clinical studies. The process streamlined study design and lowered operational cost by reducing time to initiation of Phase I studies. •R&D Process Implementation: Implemented the adoption of Model‐Based Drug Development in the Biostatistics Division of a global biotechnology company. The implementation required cross-functional collaboration among various Clinical Operations functions. The initiative was projected to realize significant in savings over 7 years through the expedited initiation of Phase I studies by implementing novel clinical study designs that resulted in more rapid identification of effectiveness signals, leading to the earlier termination of studies for compounds unlikely to show efficacy.

Postdocotoral Fellow

2008 - 2011

•Susan G. Komen Foundation Fellow (top 3% of applicants). •Project Management & Data Aggregation Method Design: Coordinated U.S. arm of the International Stem Cell Initiative, a multinational venture involving 35 countries and 150 scientists. Designed and implemented an innovative data collection system and monitored compliance with data generation and adherence to protocol execution. Performed qualitative, quantitative, and statistical analyses of large datasets, and prepared periodic progress reports for the Steering Committee. •Program Development, Project Management, & Administration: Initiated a collaboration with Agency for Science, Technology & Research in Singapore (A*STAR) to share research and complementary technology capabilities between USC and A*STAR. Managed cross-functional teams and developed protocols to ensure quality compliance and data reliability. •Research Activities: Investigated the etiology of human breast cancer and studied the genesis of epigenetic alterations derived from maintaining human embryonic stem cells in distinct types of in-vitro culture media.

Postdoctoral Fellow

2007 - 2008

•International Association for the Study of Lung Cancer Fellow (top 5% of applicants). •Scientific Discovery: Identified OLIG1 as a predictive survival factor in human non-small cell lung cancer and published the results in PLoS Medicine. •Process Improvement & Innovation: Successfully redesigned two laboratory protocols (bisulfite conversion of human DNA and DNA methylation-specific PCR) and reduced their costs by 35%, without increasing system complexity or compromising assay quality. •Technology Innovation: Developed Bio-COBRA, an assay for absolute quantification of DNA methylation. Bio-COBRA has been applied in 200+ research studies and cited in 140+ peer-reviewed articles. •Publication Record: Published 22 manuscripts and 5 book chapters with 2,200+ citations worldwide. •Public Speaking: Gave over 600 presentations to audiences ranging from 10 to over 500 attendees.