Anubhav Arora

Director, CMC | Key Contributions

• Led critical elements of the CMC function across multiple preclinical and clinical programs within a highly matrixed organization, overseeing drug substance and drug product formulation and development across all stages.
• Directed end‑to‑end execution of multiple concurrent CMC projects, managing program budgets exceeding $10M and aligning technical, regulatory, and operational deliverables.
• Built, onboarded, and managed a global external manufacturing and analytical network, partnering closely with Program Leads, Regulatory, Quality, Supply Chain, and Clinical teams.

Immunology – Empaveli® (pegylated peptide, subcutaneous infusion; approved for PNH, C3G, and IC‑MPGN)

• Directed pharmaceutical development, formulation, and device compatibility studies supporting successful NDA, sNDA, and MAA submissions.
• Authored and supported CMC Module 3 sections and led responses to regulatory questions under aggressive timelines.

Immunology – Gene‑Edited FcRn Therapy

• Led overall CMC strategy and execution for external manufacturing of gRNA, mRNA, and LNP drug product from preclinical through Phase 1.
• Executed RFPs, onboarded and qualified CDMOs and CROs for drug substance, drug product, and analytical testing.
• Led CMC regulatory strategy, authoring, and filing support for early‑phase submissions.

Ophthalmology – Syfovre® (pegylated peptide, intravitreal injection; approved for Geographic Atrophy)

• Directed pharmaceutical development and device compatibility studies supporting NDA approval.
• Led CMC Module 3 pharmaceutical development sections for NDA submission.
• Served as subject matter expert for post‑launch investigations related to adverse events.

• Led R&D strategy and innovation for a novel combination drug–device transdermal delivery platform, advancing smoking‑cessation technology and resulting in five provisional patent filings as named inventor.
• Built and scaled a cross‑functional R&D organization (engineers, scientists, consultants, CROs), managing 4 direct reports and $2M annual budgets, with direct reporting to the CEO.
• Established new laboratory infrastructure and experimental capabilities, enabling rapid ideation, prototyping, and data generation from concept through clinical proof‑of‑concept.
• Drove end‑to‑end platform development, integrating device engineering, formulation science, and translational strategy to achieve target pharmacokinetic profiles supporting Phase 2 clinical trials.
• Led development of next‑generation wearable drug delivery technologies, including sensor selection, fluidics design, formulation development, and device prototyping.
• Expanded platform applicability by identifying and advancing new therapeutic indications, including Parkinson’s disease (progressed from preclinical to Phase 2 and enabled clinical data licensing) and opioid cessation (API selection, feasibility, abuse studies, and market assessment).
• Led scientific due diligence and technical evaluation of APIs and platform fit, informing portfolio strategy, indication prioritization, and business development decisions.
• Established research governance, safety, and compliance frameworks, preparing labs for DEA Schedule II–IV and ISO standards; served as Company Safety Officer and represented the organization in DEA audits.

• Hired into New Technologies R&D and promoted to Senior Research Scientist, driving innovation in combination drug delivery systems (transdermal, oral, buccal) for peptides and small molecules.
• Expanded organizational technology capabilities through formulation development, preclinical studies, data analysis, and evaluation of emerging delivery platforms.
• Led strategic R&D operations, including relocation of laboratory facilities across states, delivering the project on time with ~60% cost savings.
• Selected as technical SME for a microneedle platform initiative, defining API selection criteria and building a curated API database through extensive literature and feasibility analysis.
• Demonstrated internal capability sufficiency vs in-licensing external technologies, resulting in cost savings of multi‑million‑dollars; filed two provisional patents, authored technical reports, mentored junior scientists, and established new SOPs.

• Led industry‑sponsored, application‑driven drug delivery research, translating academic innovation into commercially relevant technologies for pharmaceutical partners.
• Advanced needle‑free and transdermal delivery platforms, generating in vitro and in vivo proof‑of‑concept data that supported $16M Series B financing, issued patents, and licensing to a major pharma partner (Allergan).
• Authored multiple peer‑reviewed publications and patent applications, expanded platform applicability into vaccination and infectious disease prevention, and delivered high‑visibility outcomes including invited presentations and national media coverage.

• Established and led a protein biophysics research program, developing spectroscopic assays to quantify amyloid formation kinetics and evaluate small‑molecule inhibitors under stress conditions.
• Built a fully functional protein research laboratory from the ground up and published findings in two peer‑reviewed scientific journals.