Ravinder Sudini Email & Phone Number

• Sudini Pharma Consulting, LLC provides consulting services in chemical development to clients from candidate selection to commercial launch with cost effective solutions.• Help clients in route identification and development for rapid scale-up, the identification and development of final manufacturing routes with QbD principles, the transfer of manufacturing processes to the manufacturing sites, and the submission of regulatory dossiers. • Provide services in manufacturing and Supply sourcing strategies, and contract manufacturing partner selection for raw materials, impurities, starting materials, advanced intermediates & APIs. • Provide services in managing the internal and external projects (CROs/CMOs) and phase appropriate analytical methods and specifications to projects from phase 1 to commercial launch.Current Consulting CRO Clients: • AV Square Chem, Inc. New Jersey, USA• Ceyone Life Sciences (P) Ltd, Hyderabad, India• Nosch Labs Private Limited, Hyderabad, India.• ImOnco Therapeutics, Inc. New Jersey, USA• GlobeX API Services, New Jersey, USA

• Identify API manufacturers to support Nobias Development programme.• Provide technical support & RFPs for indentifying alternative materials suppliers to fund Nobias projects.• Support reference standards synthesis, storage and coordinate extension of shelf life for APIs.• Review Drug substance synthesis and provide assessment to Nobias Therapeutics CMC for selecting the manufacturers.• Review manufactureres DMFs, gaps and suitability for purchasing the APIs for Nobias DP manufacture.• Review and Support IND & IMPD filings.

South San Francisco, California, Us

● Providing technical deliverables for drug substance projects (API process development, technical reports, tech transfer and cGMP production, process characterization consistent with QbD principles, and process validation).● Serving as a technical resource to guide in VistaGen's strategic decisions and conducts analysis of technical and conceptual risk; identifies and champions operational processes and mitigation strategies.● Monitor industry trends and recommend and implement new technologies and innovations to deliver upon process chemistry goals as appropriate.● Work with CROs for drug substance deliverables and work in technology transfer activities to manufacturing site.

• Designing the synthesis of potential biomarkers and therapeutic drugs for Pancreatic Adeno Carcinoma and other solid tumors.• Utilizing external and internal resources to develop safe, cost efficient syntheses, well characterized, and fit for purpose scaffolds, linkers and with highly potent payload molecules.

● Providing technical deliverables for drug substance synthesis for commericial launch. Review risk assessment conducted for synthetic route, starting materials, impurities, genotoxins and provide mitigation plans. Help Reneo/CRO for process characterization consistent with QbD principles, design experiments and develop control strategy.

San Diego, Ca, Us

• Providing technical support as part of novel polymer excipient contract manufacturing.Responsibilities include supporting CMO business relationships, providing technical support & RFPs for indentifying alternative materials suppliers to Heron products.• Identify unknown impurities formation in ploymer excipient synthesis and understad mechanism pathway.• Write SOPs for qualifying the new suppliers to Heron Therapeutics

South San Francisco, California, Us

• Worked with client “Assembly Biosciences” on oncology assets i.e. ABI-H2158, ABI-H0731 and ABI-H3733 for new routes, process development, and manufacturing activities including managing vendors, providing progress reports, and final development reports. Provided guidance to improve processes and numerous new routes for API synthesis across Assembly bioscience's projects.

Tel-Aviv, Il

• Provided consulting services to risk evaluations, DMFs provided by CROs for APIs manufacture (>550 APIs) to Teva and developed guidance, worked with suppliers to mitigate/eliminate impurities formation in their APIs manufacture and meet quality of API materials to fund for Teva’s drug products manufacture (wide range of therapeutic areas) and to comply with regulatory bodies around the world.

San Diego, California, Us

• Worked with client “Oncternal Therapeutics” in advancing Phase 1 oncology asset TK216 for drug substance manufacture to late phase and to commercial launch.• Developed RFP (request for proposal) for API TK216 process optimization and Technical transfer to new CMOs.• Proposed TK216 API Design selection and control strategy & development steps to commercial launch for TK216 synthesis.

Brentford, Middlesex, Gb

Project Leader/Lead Chemist ǀ Tapinarof (2012 – 2019) • Invented commercial manufacturing process to Tapinarof synthesis (~ 90% cost reduction over early route A).• Lead & supervised 13 plant campaigns employing routes from B, C and E to produce drug substance (>1 MT) to fund tox, developmental, stability, and clinical studies (phase 1, 2, 3) & registration stability studies.• Developed impurity map, control strategy, application of QbD principles, genotoxin control plan, specifications settings for SMs, intermediates & reagents, TRA and Tech transfer to commercial site Cork, Ireland etc.• Contributed/ authored to INDs, CTAs, IMPD.• Worked with CROs/CMOs (Wuxi, Devi’s) for intermediates, impurities, markers synthesis for the project needs.• Coordinated & ensured the project knowledge transferred in the form of reports to the divestment partner “Dermavant”, and TT to Cork manufacturing site for upcoming validation and launch. Project Leader/Lead chemist for Sirtuin (2016 – 2017) • Lead outsourced project activities to the supply of 520g of API from GVK and Sundia to manufacture 624A intermediate (32kg) to deliver at Aptuit (UK) to manufacture 10kg API. Brought CRO Wuxi on board to supply 4kg of API to fund for 28-day tox to keep project plans on track. Project Leader for FORTENIB (2010 – 2011) • Assumed responsibilities for the knowledge transfer from RTP to UM site, updated GRA with additional impurities to discharge the risk for the manufactured API and updated the IND. Project Leader for BRAF back-UP ( 2009 – 2011) • As a Project Leader for Braf Bu (GSK2366297) compound, delivered the API for Early Phase and FTIH studies on time and on budget. Conduct meetings to review the progress project, campaigns planning, outsourced activities, genotoxin control strategy and provide updates to SA, PD on drug substance availability.

Brentford, Middlesex, Gb

Principal Chemist/ Lead chemist ǀ Pazopanib (Votrient) (December 2004 – October 2009) • Lead and executed conditions which resulted in approximately 90% cost reduction (vs previous route A5) for final pazopanib hydrochloride (Votrient) manufacturing route A6, tech transfer to the chemical production plants in Jurong, Singapore, and approval of the compound around the world by regulatory agencies. • Developed and carried out a Quality by Design approach to developing Votrient which was successfully filed with the FDA, EMEA, and numerous authorities around the world. Became experts in tools such as FMEA, BRITEST and impurity fate mapping. • Worked extensively with CROs/CMOs (Devi’s, Suven life sciences, Dottikon, Piramal, Sumitomo) in liaison with R&D and PSC and visited suppliers’ sites to ensure the quality of the materials supplied to align with GSK quality systems/agreements. Visited suppliers in Switzerland, and India to solve problems when they arose. • Developed a control strategy for Votrient which allows for upstream testing of genotoxins. This saved a great deal of time and money ($100,000’s) in releasing the drug substance. • Developed the impurity fate map, pazopanib reaction mapping, risk assessed impurity map, genotoxin control strategy and spiking and purging studies which allowed the pazopanib team to propose a simple control strategy for pazopanib synthesis toward regulatory filings with QbD principles (NDA, MAA & ROW filings). • Contributed heavily to the INDs, NDA and MAA.

Brentford, Middlesex, Gb

• As a chemist worked in lab and invented new synthetic routes for Calcium receptor, NK1 back up, BTI, vetronectin, macrolides. The invented routes were demonstrated on scale (grams to kilograms) from lab to pilot plant. • Proposed numerous new synthetic routes on projects (Calcium receptor, NK1, BTI & macrolides) in the department for successful demonstration at bench.• Managed and conducted group meetings, coordinated pilot plant campaigns, coached new chemists in developing the processes.

Post-Doctoral Studies, Organic Chemistry

Jst Research Associate, Organic Chemistry

Post-Doctoral Research Associate, Organic Chemistry

Doctor Of Philosophy - Phd, Organic Chemistry

Master'S Degree, Organic Chemistry