CHRISTINA LAVNIK

Programmatic Initiatives and Scientific Review

• Support TRP OD in planning and implementing programmatic initiatives to achieve program objectives. Apply scientific knowledge to assess proposed research projects in relation to the current state of research and TRP’s priorities.
• Summarize the scientific merit for various clinical trial reviews and grant applications to support informed decision-making.
• Coordinate with Branch Chiefs and TRP OD to update network and non-network trial trackers quarterly, providing analysis and evaluating assigned program portfolios to identify new concepts, programs, or initiatives that align with organizational priorities.
• Coordinate clinical review activities and meetings for the TRP portfolio, including supporting the Clinical Science Review Committee (CSRC) and completing pre-review tasks for NIAID Data Safety and Monitoring Boards (DSMB). Ensure adherence to TRP program standards and timelines for grant applications, contract proposals, and research project applications.

Audit Preparation and Quality Management

• Participate in preparations for internal TRP audits and responses, ensuring effective communication within TRP and with other DAIDS scientific programs and offices.
• Conduct internal evaluations of program training for the TRP Quality Management System, ensuring compliance with TRP standards and best practices.

Policy Development and Protocol Oversight

• Stay informed about TRP program-level or protocol-related issues, collect TRP staff input, and participate in the development or update of TRP policies and procedures to align with regulatory requirements and industry standards.
• Provide expert reviews of protocols, ensuring scientific rigor in the evaluation process.

Data Management and Risk Mitigation

• Provide centralized storage support, acting as the TRP point of contact for uploading network and non-network trial files to DAIDS systems, including DAIDS eDR, TMF, BOX, and SharePoint.
• Participate in the formulation of risk management plans and strategies to mitigate identified risks in the TRP portfolio.

Special Projects and Knowledge Sharing

• Coordinate ad hoc special projects, including organizing and conducting workshops and forums to foster communication among researchers and advance the TRP program.
• Coordinate and organize teaching activities to share TRP's advancements and best practices.

Clinical Program Management

• Managed four accounts from top 10 pharmaceutical companies, supporting their clinical trials with dedicated teams and separate budgets for each project.
• Utilized scientific and business knowledge to shape clinical trial evaluations, ensuring adherence to standards, and addressing issues related to specific aspects of clinical trials.
• Conducted comprehensive risk and safety assessments for over 50 clinical study protocols, participating in daily triage meetings to guide go/no-go decisions in collaboration with pharmaceutical clients.
• Applied scientific knowledge to place proposed research projects in relation to the current state of research and the organization’s priorities.

Proposal and Contract Development

• Participated in the development of proposals and contracts, collaborating with Legal, Finance, and Recruitment teams to secure contracts worth $2.5 million.
• Orchestrated cross-functional team efforts, providing guidance on program issues and aligning contract terms with both client and organizational goals.

Document Review and Regulatory Compliance

• Led scientific and administrative reviews of clinical trial protocols and proposals, ensuring adherence to regulatory standards and alignment with client priorities through comprehensive analyses and evaluations.
• Summarized the results of scientific/technical merit reviews of protocols and proposals, supporting informed decision-making.
• Reviewed and approved patient-facing and technical documents using the Veeva Vault platform, ensuring precision and compliance with industry standards.
• Provided training to managers in the team how to utilize Veeva Vault platform for various documents review.
• Provided policy direction for the planning and execution of scientific and technical reviews, ensuring alignment with client priorities and regulatory standards.

Client Relations and Communication

• Managed client communications, organizing and leading meetings to track progress and align clinical trial conduct with recruitment strategies.
• Advised clients during the development and execution of clinical trial proposals, providing strategic guidance on project objectives, regulatory compliance, and adherence to industry standards.
• Engaged with pharmaceutical companies, research institutions, and government bodies (e.g., FDA) to promote clinical trial programs and facilitate external partnerships.

Data Analysis and Recruitment Strategy

• Developed and implemented patient data analysis strategies using the CVS database (100M individuals), driving improvements in patient funnel optimization and clinical trial recruitment strategies for pharmaceutical companies.
• Assessed the scientific and technical progress of clinical trials within HealthHubs and Minute Clinics, evaluating recruitment strategies to meet clinical and organizational objectives.

Process Improvement and Market Evaluation

• Increased team productivity by implementing streamlined processes and integrating Salesforce tools to optimize workflow and enhance collaboration.
• Evaluated pharmaceutical market program portfolios to identify new lucrative markets aligned with CVS Health organizational priorities.

National and Diversity Initiatives

• Participated in the development and launch of the Super Soul Sunday Brunch & Learn event with CVS Health and Biogen, focusing on recruiting a higher percentage of underrepresented populations in clinical trials.
• Coordinated client meetings at the DIA (Drug Information Association) Conference, contributing to national-level discussions on clinical trial management, patient recruitment strategies, and best practices.

Laboratory Operations and Process Development

• Fully managed and coordinated VaxArray platform operations, contributing to faster drug development through programmatic efforts.
• Played a key role in establishing laboratory processes and procedures for the NanoFlu vaccine research project.
• Supported the development of SOPs, test methods, and protocols, ensuring compliance with regulatory guidelines across projects.

Team Management and Training

• Supervised and trained multidisciplinary teams, including scientists and technicians, on performing the VaxArray method.
• Led efforts in conducting Combo ELISA and PicoGreen methods to assess NanoFlu vaccine potency and purity, mentoring junior staff to ensure precise execution of laboratory methods for scientific research.

Collaboration and Issue Resolution

• Attended in-person meetings with the VaxArray manufacturer to troubleshoot testing issues. Facilitated communication between internal teams and external vendors to address project challenges and ensure programmatic success.

Data Management and Reporting

• Analyzed and presented scientific data in internal and external meetings, contributing to strategic decision-making and fostering collaboration.
• Ensured laboratory equipment was calibrated, standardized, and regularly monitored to maintain precision in testing and results.

Safety and Compliance

• Participated in risk assessments, incident investigations, and Safety Committee inspections, ensuring compliance with safety standards.
• Regularly attended Safety Committee meetings, communicated important updates, and helped maintain a strong safety culture within the lab.

Programmatic and Strategic Contributions

• Administered the development of new testing protocols for project consistency and contributed to the review of laboratory methodologies, making necessary adjustments for accuracy and program enhancement.
• Contributed to program evaluations, ensuring that NanoFlu projects met both research and safety program standards.

Laboratory Operations and Research Development

• Led significant aspects of laboratory operations within the neurotrauma research unit, including establishing processes and procedures for traumatic brain injury (TBI) studies.
• Supervised and trained technicians on conducting surgeries, post-operative care and biochemical assays, ensuring adherence to research protocols and safety regulations.
• Participated in Penetrating Ballistic-Like Brain Injury (PBBI) surgeries and coordinated post-operative care, maintaining accurate health data for internal review processes.
• Maintained detailed records and analyzed surgical, medication, and health data using statistical tools, contributing to comprehensive project evaluations.

MRI Imaging and Data Analysis

• Administered MRI imaging protocols and analyzed complex MRI images using advanced software, supporting TBI research evaluations.
• Conducted biochemical assays to support TBI studies and contributed to risk assessments and scientific reviews to ensure accurate conclusions on brain trauma outcomes.

Research Projects

Evaluation of the Safety, Anticoagulation Efficacy, and Neuroprotective Properties of Prophylactic Enoxaparin in a Rat (Sprague-Dawley) Model of Penetrating Ballistic-Like Brain Injury (PBBI)

Scientific Advisors: Dr. Anke H. Scultetus, Dr. Zachary S. Bailey

· Led and coordinated PBBI surgeries and sham procedures (craniotomy only), administering enoxaparin and 0.9% sodium chloride (vehicle control) subcutaneously post-injury, continuing the program for seven days. Monitored and recorded neurological deficits and pain scores daily for project evaluation.

· Administered and analyzed MRI images using the 7 Tesla Bruker BioSpec 70/20 USR system to evaluate the size of intracerebral hemorrhage and edema. Managed MRI segmentation in ITK-SNAP 3.8, ensuring the scientific accuracy of machine learning algorithms. Manually reviewed and defined ipsilateral and contralateral hemispheres in ImageJ after hematoxylin and eosin (H&E) brain tissue staining, contributing to the scientific review of the project.

· Managed and maintained detailed study logs, documenting PBBI date, enoxaparin volume, administration times, perfusion time, neurological deficits, and body weight for comprehensive program tracking.

· Utilized advanced statistical software to conduct scientific data analysis, contributing to the scientific understanding and review of enoxaparin’s neuroprotective properties in traumatic brain injury models.

Evaluation of the Timing of Aeromedical Evacuation in a Rat (Rattus norvegicus) Model of Traumatic Brain Injury (TBI)

Scientific Advisor: Dr. Francoise Arnaud

· Conducted the homogenization of brain, heart, lungs, gastrointestinal tract, kidneys, and liver samples post-TBI and post-flight under normobaric and hypobaric conditions for scientific evaluation of project safety.

· Performed bicinchoninic acid (BCA) protein assays to calculate protein concentration, using SoftMax Pro to measure absorbance and Excel to prepare standard curves.

· ELISA to determine HIF-1 alpha levels and performed ANOVA testing using GraphPad Prism to analyze group differences, ensuring comprehensive evaluation of aeromedical evacuation timing’s impact on TBI outcomes.

· Processed and analyzed study data, summarizing findings in scientific research applications and program proposals, advancing understanding of traumatic brain injury in relation to evacuation timing.

Clinical Care and Patient Management

• Improved patient outcomes by conducting thorough clinical assessments, developing individualized care plans, and participating in multidisciplinary team collaborations for various research projects.
• Streamlined patient admission processes by efficiently gathering medical histories, performing physical exams, and ordering diagnostic tests, contributing to evaluation reports for patient health programs.
• Optimized treatment plans through evidence-based research and staying updated on advancements in dermatology, ensuring the best patient care.

Supervision and Mentorship

• Supervised medical students and junior residents, providing mentorship in clinical procedures and patient management across multiple projects.

Research and Program Evaluation

• Served as a reviewer on peer-reviewed panels for research publications, assessing scientific merit and offering expert guidance in dermatology.
• Participated in scientific program evaluations, ensuring compliance with the healthcare guidelines and contributing to the advancement of dermatology programs.Clinical Care and Patient Management
• Improved patient outcomes by conducting thorough clinical assessments, developing individualized care plans, and participating in multidisciplinary team collaborations for various research projects
• Streamlined patient admission processes by efficiently gathering medical histories, performing physical exams, and ordering diagnostic tests, contributing to evaluation reports for patient health programs
• Optimized treatment plans through evidence-based research and staying updated on advancements in dermatology, ensuring the best patient care
• Supervision and Mentorship
• Supervised medical students and junior residents, providing mentorship in clinical procedures and patient management across multiple projects
• Research and Program Evaluation
• Served as a reviewer on peer-reviewed panels for research publications, assessing scientific merit and offering expert guidance in dermatology
• Participated in scientific program evaluations, ensuring compliance with the healthcare guidelines and contributing to the advancement of dermatology programs.