Abhi Kathuria

I played a pivotal role in advancing formulation development and manufacturing at Viking Therapeutics, Inc. • Led cross-functional teams to develop innovative drug delivery systems for peptides and small molecules. • Ensured seamless transition of drug products from early development to phase 3 trials, maintaining high standards. • Managed critical labeling and distribution processes to support clinical trial operations effectively.

• Executed technical DS and DP development strategies in support of IND filings and Phase 2/3 clinical studies. Led the product development work on multiple immunotherapy, enzyme based oral drug products. • Provided technical oversight of all the GMP activities associated with the development and manufacturing of drug substances and drug products. • Managed drug product activities at external CDMOs. Successfully manage multiple external teams to meet deliverables. Coordinate meetings, review technical data, and provide scientific input to help partners and drive projects. • Prepared regulatory filings INDs, CTAs, IMPDs and NDAs/BLA/MAA as required for the programs. • Set up the product development department at Aimmune/Nestle to manage development of multiple complex oral delivery products. • Identified, hired, mentored/develop direct reports in drug product development function.

• Led formulation development from initial compound development at IND stage through the life cycle into phase 2/3 and corresponding regulatory filings. • Co-ordinated and led development activities at CMOs leading to filing of Nuplazid® 34mg capsules and multiple phase 1 to 3 solid oral and long-acting injectable products. • Developed formulation and process for the product from formulation optimization to validation. Authored development sections for the NDA filing leading to the product approval.

- Led formulation and process development and scale up for oral solid, softgel products at third party sites across US. - Identified and recommend CROs and CMOs for new products. - Managed regulatory aspects including CMC tech writing, technical (R&D, scale up), process engineering (equipment procurement, qualifications), project management (managing timelines, deliverables) for all projects that I led. - Projects undertaken vary from 250k to 10M USD in scope of project work.

- Evaluate and remediate manufacturing issues for solid and liquid oral dosage forms and shampoo products at third party and internal manufacturing sites per the consent decree plan - Assisted with remediation plan development for two McNeil sites including manufacturing validation and material management plans. - Worked on re-validation of three commercial solid dose and liquid oral products, developing re-validation from R&D evaluation to commercial manufacture.

- Assist brand and generics companies across US in product/formulation development, process development, process troubleshooting, manufacturing/validation. - Give technical seminars/conduct technical courses on polymer applications in pharmaceutical formulation development and process development. - Hands on contract product development and manufacturing work.

- Manage locations and negotiate contracts for monthly meetings with various social locations across Fort Washington, PA area. - Identify potential value added speakers for the group. - Attend AAPS leadership meetings. - Work with 8 member local board to co-ordinate all chapter activities.

• Manage clinical manufacture for solid-dosage FTIH and Phase II projects ranging in scale from small R&D batches to manufacturing scale. Develop manufacturing process from scratch and make clinical supplies. • Manage, optimize and execute third party manufacturing.

- Scale up, optimize and transfer solid dosage and liquids projects from research scale to manufacturing. - Design blending, compression, coating processes for contract projects for the Outsourcing division of Mallinckrodt. Lead projects from design phase to exhibit and validation filings. - Perform engineering design, qualification and optimization of blenders, granulators, encapsulators, tablet presses, liquid transfer, mixing and piping systems to efficiently transfer products across sites.