Alaknanda Mishra, Ph.D.

Led the GMP analytical suite and directly interfaced with clients for project-based technical and bio/analytical related requirements. Managed and oversaw the analytical assay development, qualification validation strategies for pDNA, mRNA, and LNP-mRNA manufacturing. Acted as project manager for Vernal platform analytical projects and collaborated with various departments for timely completion of research activities and client-related projects in a high-paced work environment. Defined QC strategies in accordance to GMP compliance, authored/ reviewed technical documents, reports, technology transfer plan, phase-appropriate ICH, USP and FDA regulatory requirements for DS/DP release testing, authoring, and reviewing pre-IND, DS/DP specifications, raw material, reference standard and stability programs. Established and defined LIMS and ELN workflows and data trending program for analytical assays. Trained and mentored in analytical method development, qualification and validation. Coordinated research activities and testing with third-party stakeholders (KOLs, CROs, and academic labs). Audited and qualified third party labs as SME. Worked in collaboration with Commercial team and reviewed and contributed to technical docs, SOW and costing sheets for client projects. Worked with the R&D, Quality, MSAT, Supply Chain, Operations and Regulatory teams to develop and implement an appropriate strategic plan for end to end operations. Defined analytical method control strategies through life cycle management of analytical methods at collaborator sites such as CROs, academic partners, or internal functions. Conducted and documented risk assessments, and developed appropriate mitigation strategies and partnership opportunities. Built strategic plan for resources management and acquisition, budget, and organizational design of the analytical systems. Assisted with all CMC and Quality activities for GMP manufacturing plan of DS/DP.

Responsible for designing, implementing, and troubleshooting discovery programs and assay developments for Chameleon’s EVADER immunomodulation (Exosome and AAV) platform and products. Led novel opportunities to develop processes, immunoassays and analytical methods for the characterization of Exosome encapsulated AAV products. Subject matter expert for the understanding of Chameleon’s EVADER™platform that evades immune response in gene therapy and allows redosing (disease models: Hemophilia).

Responsibilities: • Equip the vivarium to perform in vivo studies focusing in the Ophthalmologic disease area. • Lead, design, execute and analyze data of in vivo studies to evaluate efficacy, biodistribution, PK/PD, and safety of our therapeutic candidates in rodent models • Hands-on work to establishing different disease ophthalmology animal models and perform therapeutic analysis of test articles by various routes of administration (IVT, SR, IV, IP, topical, etc) • Perform downstream PK analysis. • Establish SOPs leading to the development of protocols for therapeutic safety and efficacy analysis. • Perform ex vivo analyses to examine drug pharmacodynamics and support biomarker discovery • Design and develop cell based assays to examine target binding and downstream pathway modulation for different candidates • Author IACUC, SOPs, study protocols and study reports to ensure GLP-like studies are performed. • Complete accurate documentation of all work performed in a database and electronic lab notebook (ELN) • Interact with contract research organizations to perform in vivo studies and relevant analytical assays as required • Champion in vitro and in vivo testing in the validation of our different candidates • Work very closely with scientists from other teams to coordinate tasks and ensure that projects milestones are completed • Analyze and process data to generate presentations for internal and external company meetings, supporting company leadership in patent filing and scientific publications • Work closely with Senior Director of Preclinical Development to communicate strategy, methodology, progress and challenges to drive the team and projects forward • Provide training, guidance and mentorship to junior staff on the preclinical team

Learned to identify strategic business opportunities for translational research by exploring the commercial potential of biologic and drug products through market research, facilitate effective and strategic alliance or partnership with firms, network and negotiate with different third parties, such as vendors, agencies, government authorities, and regulators for licensing, sponsorship and collaboration

• Independently developed and studied biomedical, and health-related research programs or initiatives, under minimal supervision during my Ph.D. and postdoctoral research • Supervised multiple projects as a postdoctoral fellow and assisted or trained other workers in multiple facets of research • Conducted programmatic analyses and served as a consultant to provide advice on issues related to scientific research programs in lab. • Conducted scientific reviews of research activities such as peer reviewed multiple manuscripts in prestigious Elsevier and Springer Nature journals. • Conducted administrative reviews of research activities such as lab safety and GLP/GMP compliance, technology transfer and material transfer regulatory documents, SOP writing and implementation. • Implemented time and cost-effective research operations, and biosafety/ chemical safety related corrective measures to progress research activities in a safe work environment. • Performed health hazard risk and assessment in lab space and common workplace environments. • Skilled in computer based softwares for database and inventory management and analysis. • Reviewed and presented research progress in form of publications, summaries, manuscripts or reports. • Performed quality control and safety analysis in development of gene and cell based therapeutic studies. • Presented scientific and technical information, analyses, and proposals to various scientific and non-scientific audiences. • Facilitated and assisted in organization of scientific workshops and trainings. • Coordinated research activities in collaboration with third party stakeholders like contract research organizations. • Developed several research methodologies and troubleshooting referrals for scientific projects for efficient and accurate results. • Prepared summary statements for lab research projects, lab safety reviews, animal protocol committee findings and recommendations

Training towards developing technology transfer knowledge and skills including patent drafting, patentability assessments, ROI, NCD drafting, Market research and litigation analysis.

Worked on development of a chronic unpredictable mild stress mouse model of depression and analysis of Estrogen receptor alpha in the brain of mouse models developing chronic depression.