Sangita Ghosh

• Provide strategic direction as a member of the Senior Management team • Built a high functioning Technical Operations team of consisting of Pharmaceutics, drug substance and drug product development, process and analytical development, manufacturing, Quality, end to end supply chain, CMC lifecycle management and program management • Successfully advanced Tavneos for ANCA Vasculitis to global regulatory approvals (U.S., Japan, EU, Canada); Successfully led the commercial manufacturing team to launch and commercial distribution; Advanced avacopan for Phase 3 trials in Lupus Nephritis and Hydradenitis Suppurativa • Advanced clinical candidates (CCX507, CCX111 and CCX559) into various phases of clinical development

• Reporting to the CEO, responsible for all aspects of Technical Operations to support clinical development of Tildacerfont for rare disorders including Congenital Adrenal Hyperplasia • Lead and oversee global network of drug substance, drug product, & Packaging CMO’s. Functional responsibilities include Development, Manufacturing, QA, Supply Chain, Process Development, Technology Transfer, QC, Contract Negotiation, Project Management and Project Budgeting. • Advanced Tildacerfont development through Phase 2 trials • Implemented Phase appropriate Quality System with Quality Manual, Directives and SOP to ensure compliance with relevant GxP requirements. • Executive Team Member helping shape the growth of the company; standing participant at Board of Directors meetings. • Completed strategic review of existing manufacturing and supply chain network against future requirements.

• Provide strategic direction, tactical oversight and technical expertise to CMC department consisting of formulation development, process development, analytical development, bio-analytical sciences, contract manufacturing, clinical supplies, commercial scale development and manufacturing and packaging • Development of Gocovri®, Namzaric® and other pipeline programs at outsourced manufacturers including vendor selection, technology transfer, formulation development, commercial scale manufacturing, analytical and bioanalytical methods and stability for drug substance (API) and drug product • Collaborate with Regulatory Affairs, Clinical Development, Nonclinical Development and Commercial groups to define and execute appropriate CMC strategies to support Adamas’ small molecule development pipeline • CMC discussions with FDA, Forest Laboratories and Actavis • Budgeting and financial planning for pharmaceutical development activities ( $15 MM)

• Responsible for Formulation Development, Process Development, Commercial Scale-Up, Analytical Development, Bioanalytical Development and Contract Manufacturing. Responsible for Clinical Manufacturing, Supply Chain, Packaging and Distribution,

Responsibility of all CMC activities and global clinical supply chain management for Varespladib methyl program for Acute Coronary Syndrome (ACS) Led drug substance and drug product manufacturing, formulation development, process development, analytical sciences and validation capabilities for Varespladib methyl program. Commercial scale manufacturing of Varespladib drug substance (US and Asia) and drug product for Phase 3 study (VISTA-16) Extensively managed contract manufacturers worldwide, contract research organizations, drug substance manufacturers, packaging and labeling vendors, excipient suppliers Represented Anthera as the CMC liaison to the FDA at the end of Phase 2 meeting Responsible for global clinical supply chain for VISTA-16 trial (phase 3, 16 countries, 6 depots) for ACS Resolved tough technical challenges in drug product manufacturing leading to a robust, commercially viable manufacturing process for Varespladib tablet (250 mg) Led formulation development for second generation Varespladib methyl tablet (500 mg tablet) Negotiated supply agreements and quality agreements with drug substance and drug product manufacturers Led life cycle planning, intellectual property strategy and launch presentation Partnered with Clinical Operations, Regulatory, Quality and Corporate development groups

Leadership role in technical projects; Formulation development of novel solid oral dosage forms, extended release oral suspension formulation, lead optimization, technology transfer to CMO Build Transcept intellectual property through creative ideas in product formulation and by developing new product concepts

Author CMC sections of IMPD for Intermezzo® and IND for pipeline products (TO-2061) Responsible for the manufacture of Ph I and II clinical trial material (CTM) for insomnia studies; Formulation development and Ph I CTM for Obsessive Compulsive Disorder. Clinical operations responsibilities including packaging and labeling for two complex double blind, double dummy cross-over studies in US and Europe. Import/export/release of CTM (controlled substance) in Europe. Work with senior management on FDA submission strategies and long-term strategic planning

Author CMC sections in Intermezzo® NDA (eCTD format) and IND for pipeline candidate for obsessive compulsive disorder. Responsible in a cross company development of process, production and DMF of non-compendial excipient critical to Intermezzo® formulation. Management of the project, technology transfer between vendors, method and process validation activities Ideation and animal studies as proof-of-concept for an anticholinergic drug for the treatment of depression Novel controlled release formulation for pipeline program for treatment of obsessive compulsive disorder

Project leader for an injectable product for the treatment of major depressive disorder successfully taking it under tight timelines from ideation to formulation selection. Responsibilities include ideation, overall project plan including cost, timelines, acquire management approval, lab set up for parenteral work with cytotoxic API, preformulation, lead selection, optimization and stability under ICH Lead several in-house development studies that were part of the product development sections of Intermezzo® NDA Development of alternate formulation of Intermezzo®