Shashi Ramaiah

Vice President. Discovery, Preclinical, Translational and Investigative Sciences. Pfizer
TransBioLine Project Leader

What is your/your company current role in TransBioLine?
  • As a Project Leader, I represent Pfizer and oversee the scientific and project governance by working closely with the incredible team which includes project coordinator (Sophia Samodelov) and the Executive Committee (Tanja Z, Guru A, Sara P, Sophia S, Estefania C and Shashi R). Specifically, I am tasked to ensure the industry in-kind commitments are fulfilled, leverage industry leadership in accomplishing scientific and project goals and be proactive where industry can implement near-ready qualification biomarkers within industry portfolio.
What is your overall vision of the Project?
  • Safety and tolerability of drug candidates and newly approved drugs are still a major concern. TransBioLine is a focused investment effort which is expected to mitigate clinical safety concerns and reduce safety attrition.

  • A Desirable outcome is after end of this project is that we would have made significant Progress towards preliminary or full qualification of novel biomarker(s) for 5 organ packages which includes kidney, liver, pancreas, vascular and neuro.

  • In the interim and after qualification, we want to implement these biomarkers during early drug development for limited/exploratory use to enable better informed, higher quality, decisions on advancing promising molecules.

What have you found the most challenging/interesting during the Project?
  • Collecting the right number of high-quality clinical samples across the work packages is key to the success of the consortium. To accomplish this significant process-related foundational work needed to be accomplished during the early stage of the project such as building data management solutions, training, SOPs, consent forms and analysis plans. In spite of these time-consuming tasks, teams never took shortcuts in building these sustainable solutions.

  • Compliance with ethical standards and regulation, intellectual property rules are all important challenges that occasionally resulted in huge burden to EFPIA and partners that included GDPR compliance, privacy agreements, transfer of samples and data. Complexity, legal and related jargons were carefully manoeuvred and expertise across the network were mobilized.

  • COVID-19 Pandemic resulted in some delays due to stoppage of clinical recruitment and laboratory work. In spite of these challenges and delays, the team has been able to leverage broader experiences across industry and academics to make significant progress in several fronts including assay development, biobanking, clinical recruitment, regulatory interactions, communications and publications.

What has been your/your company greatest achievement during the Project?
  • Huge support from Pfizer leadership to engage and deliver TransBioLine goals. Pfizer in-kind commitments fulfilled (and exceeded) which was critical considering previous ‘under delivery’ of industry commitments. Pfizer’s contributions (delivered 100% HV prospective clinical samples) complemented prospective diverse clinical sample collections and assay expertise from peer EFPIA companies and renowned European academic centers.
  • Maintaining engaging partnerships within the Executive Committee, WP leaders, Scientific and Ethical advisory board, and within the community of acad emic participants has enabled continuity and achieving milestones.

  • Personally, I am proud to have worked with incredibly talented and dedicated EFPIA and academic investigators to deliver important milestones and building long standing relationships. Above all, I am impressed with the open mindedness to change course and solve problems and the perseverance of the team.
What you consider will be the major impact of TransBioLine on the society / biomedical research area?
  • Understanding the art and science of biomarker research development as it applies to drug development. Huge development and learning opportunity to learn emerging biomarker sciences for academic and industry participants.

  • Ability to Access vast pools of innovation outside the walls of pharma companies and tap into the unique resources to accomplish biomarker research has enabled cross connection of expertise, build relationships across large network of SMEs.

  • Mutual academic and industry access to technical, scientific, regulatory and strategic expertise through this network.

What will you keep in your memories on TransBioLine?
  • Being engaged for >5 years with frequent virtual meeting and F2F interactions, I appreciated the diversity of personality and thoughts with creative and meaningful ideas to solve complex issues. Relationships built enabled discussing difficult topics and outcomes. Last few years has been a fantastic journey that achieved balance between productive milestones and some chaos through which I was able to build strong professional relationships. I noticed the consortium to be an exciting career development opportunity for both EFPIA and academic institutions and have seen participants gain immense knowledge in biomarker research.

  • To sum up—representing TransBioLine as a project leader and working with the project coordinator, executive committee, project leaders and broader members was exhilarating and made my engagement fun and easier. Strong leadership teams made a huge difference in ensuring productivity, planning ahead and prioritizing and moving ahead whenever they are asked which I will cherish. While we hit our goals in some areas and missed some, the purpose, focus and incremental progress made from the teams ensured significant progress in key areas that can lead to something spectacular in the future.