Welcome to Sapala Organics Private Limited Confidential Sapala Organics Pvt. Ltd. “Offering Expertise in Organic Synthesis for Cost-Effective Research and Production, since 2007” Quality Deliverables with Speed Confidential Content 1. Introduction 2. Business Model 3. Capabilities and Expertise 4. Chemistry Services offering 5. Advantage Sapala Confidential Introduction Founders and Promoters: Technical leaders from industries and academia across the globe Confidential Location Hyderabad Population: 7.5 million Elevation: 536 m Capital City of the Indian State of Andhra Pradesh 5th Largest Metropolis Emerging IT and Biotech hub of India Excellent pool of chemistry graduates Centrally located with direct flights to international destinations Confidential Mission and Vision Vision: To be a Respected Contract Research Organisation (CRO) contributing to the society Mission: To be an organization skilled in organic synthesis and a partner of choice for diverse customers Confidential Business Models Fee for services : • • • • Predefined Deliverables. Flexible option’s: Client may choose any Literature precedent for the preparation. that’s suitable. Mutually agreeable timelines. Agreed cost (Resources + Raw Material Cost) Full Time Equivalents (FTEs) Services: • • • • • • Dedicated resources and laboratory infrastructure at Sapala Flexibility of work plans (WPs) and deliverables to client. Client can change priority of WPs as per internal development. Dedicated Project Manager – One point contact at Sapala. Agreed FTE cost per annum inclusive of solvents, routine chemicals and disposable items for daily operations ( upto 10 g level). Special reagents specific for the project charged separately. Confidential Team Sapala - Staff Breakup Department R&D QC&A Admin Regular Staff - Designation Group Leader Research Scientist Senior Scientific officer Scientific officer Sr. Chemist Chemist Trainee Chemist R&D Total Head QC&A Senior scientific officer Sr. Chemist Chemist Trainee Chemist QC&A Total General Manager Manager (Finance & Accounts) Accounts Executive Executive HR Building & Facility Supervisor Supervisor-cum-Purchase Executive Stores Assistant General & House Keeping Supervisor Office Assistant Admin Total Grand Total Male Female Total 1 4 2 5 2 8 4 26 1 0 2 2 0 5 1 1 2 1 1 1 1 1 1 10 41 0 2 0 0 2 4 0 8 0 1 0 0 1 2 0 0 0 0 0 0 0 0 0 0 10 1 6 2 5 4 12 4 34 1 1 2 2 1 7 1 1 2 1 1 1 1 1 1 10 51 Contract Grand Male Female Total Employees Total Student Trainees Guest Researcher 5 1 0 2 7 1 8 1 0 1 1 0 1 Consultants 4 0 4 House Keeping 15 6 21 Security 7 0 7 26 34 6 7 32 41 Confidential Female % 42 79 21 8 75 25 42 88 14 92 82 18 6 2 Student Trainees Male % Team Sapala Total Strength: 51 • • • • Technical Administrators : 2 Synthesis Lab – 34 Analytical – 07 Support Functions – 10 (HR, F&A, Purchase, Stores and Admin) Min Qualification Research Experience No Ph. D > 20 Yrs 2 Ph. D > 10 Yrs 1 Ph. D > 5 Yrs 6 Sr. Scientific Officer MS > 10 Yrs 2 Scientific Officer MS > 4 Yrs 5 Research Associate MS > 2 Yrs 20 Designation Technical Administrators Group Head Research Scientist Confidential Chemistry Capabilities Synthetic and Medicinal Chemistry Support • Hit identification enabling libraries • Focused libraries for supporting Hit to Lead campaign • Drug standards and reference compounds with ultra high purity • Synthesis of building blocks and scaffolds enabling IP positioning • Supply of hetero cyclic and natural product like scaffolds • Synthesis of premium priced reagents and intermediates for med-chem support Material Chemistry Support • Synthesis of Dyes for photo-functional applications. • Synthesis of organic compounds for their application as nano tubes and electro / photochemical switches. Confidential Chemistry Capabilities Process Research and Scale up: • Route scouting. • Optimization of reaction and unit processes. • Optimization of processes for scale up from gm to Kg. • Run single campaign based on Tech Pack (quick and dirty). Analytical Chemistry : • Analytical Method development and Validation. • Spectroscopic analysis. • Purification of high value material to achieve purity levels > 99.5%. Confidential Proven Experience • • • • • • • • • Library synthesis Intermediates for drug candidates Reference compounds and Pharmaceutical Standards Drug metabolites, or degradation products Fluoro-, Alkylated-, carbohydrate synthesis Nucleoside chemistry, including synthesis of phosphoamidate Preparation of boronate reagents not described in literatures Bio-Organic transformations Multi step synthesis on large scale (15 steps 100 gm delivery) Confidential Analytical Chemistry Support Analytical Laboratory: • • • • • • • • • FT NMR spectra for multi-nuclei (1H, 11C, 13C, 17O, 19F & 31P) 2D NMR Experiments (COSY, HETCOR, HMQC, NOESY) HPLC– 2 Nos (Jasco) LCMS – 1 No (Jasco) FTIR (JASCO) Gas Chromatography Specific Optical Rotation Chemical Methods of analysis Determination of physical properties. Confidential Infrastructure Synthesis Laboratory: • • • • • • • • • Modular Laboratories with standard equipments and instruments Fume hoods Walk in fume hoods Rotary evaporators Prep HPLC purification system Flash chromatographic purification Humidity controlled facility Reaction performance temp range -78 to +200 °C Analytical instruments (NMR, HPLC, LCMS-MS and GC). Confidential Good Practices and SHE • All scientist follow guidelines for Good Laboratory Practices. • Project leaders regularly audit and correct deviations from good laboratory practices. • • Strict compliance to Environment, Health and Safety. Safety committee representing all laboratory unit monitors compliance. • Regular audits by internal representatives and external experts. Confidential Good Practices and SHE • Awareness programs and Training on various laboratory safety aspects conducted routinely. • Documentation of all unsafe incidents and learning from the same shared with all employees. • • PPE with high safety standards are provided to all scientist. All employees are covered under hospitalization and accident insurance. Confidential Project Management • Dedicated Project Manager : o One point contact - Qualified Scientist (Ph D with Experience) o Proactive Communication Daily / Weekly o Responsible for all execution of scientific and technical guidelines o Problem solving and knowledge input. o Controls access to tech pack by team (need to know basis). • • • • • Receptive to change of work plan priority as per the clients need. Weekly update / bi weekly report - teleconference. Quarterly evaluation of the FTE program for productivity and efficiency. Video conference. Site visit by client as well as by Sapala PM – yearly once. Confidential Documentation • • • Laboratory note books (LNBs) issued for all FFS and FTE project. SOP for writing LNBs – Compliance is mandatory. Orderly upkeep of supporting information (Spectroscopic data and literature) in separate folder with appropriate identification. • LNBs and supporting folder are audited regularly by QA / QC department for their compliance. • • • Weekly / fortnightly updates to track progress. Structured QA / QC reports Project report is submitted upon completion – details goals and suggested path, if any alteration and modifications in the same to complete the project. Highlights if any additional information or knowledge is generated. Confidential Advantage Sapala • • Rich experiences in drug discovery research and development Key managers have extensive research experience in Japan and other developed countries. • • • Japanese project management coupled to Indian research teams. Full analytical capabilities for synthesis on site Customers’ satisfaction: o Quality Custom Synthesis / On-time delivery o Timely communication in English (or Japanese) o High information-security o Affordable Cost o Highest environmental and safety standards o International ethical standards Confidential Project Life Cycle • • • • • • • • Sign Confidentiality Disclosure Agreement. Evaluate RFQ / RFP. Propose details of the approaches to the deliverables including quotation. Sign research / production agreement with clearly defined terms and conditions. Appoint a dedicated scientific project manager. Update weekly and biweekly to client after the initiation of the project. Communicate with regular teleconference or video conference. Deliver on time the deliverables to client. All IPR generated during the project execution is owned by the client. Confidential Contacts USA Japan Dr. Yogesh S. Sanghvi Dr. Masami Nakane 2802 Crystal Ridge Road Encinitas, CA 92024 U.S.A. 124-1 Miyukiyama Tenpaku Phone: 760.944.1541 Fax: 760.944.1543 cell: 7603107539 Phone and Fax: 81-52-836-6945 Nagoya Aichi 468-0075 Email: masami.nakane@sapalaorganics.com Email: yogeshss@sapalaorganics.com EU India Dr. Md. K. Nazeeruddin G. Sanjay Station 6 Plot # 146B & 147, Phase-II, Laboratory of Photonics and Interfaces (LPI) IDA Mallapur, Uppal Mandal, Institute of Chemical Science and Engineering Kapra Muncipality, Hyderabad-500076 Faculty of Basic Science (A.P), India. Mobile: +91-9963111463 Ecole Polytechnique Federale de Lausanne Fax : + 91-40-27150601 CH-1015 Lausanne Email:sanjayg@sapalaorganics.com Switzerland Tel +41 21 693 6124 Fax +41 21 693 4111 Email: s.nazeeruddin@heliochemicals.ch Confidential Thank you. Confidential