1. We believe in thinking global and acting local

2. Asias business would be worth more than $400 million up to 2015http://www.bccresearch.com/report/BIO075A.html Report Code:BIO075APublished: March 2011 3. Worldwide estimated market size according to therapeutic areas Largest expansion in diseases of the central nervous system and cancer. Major markets for Skin and soft tissue repair & diabetes mellitus 4. There are almost 180 prominent stem cells companies in theworld.While adult stem cell therapy currently dominates the globalstem cells market with a share of almost 58 percent, the globalstem cell market is expected to touch the $20 billion mark by2010. Sushmi Dey Express Pharma. 5. INDIA STORYThe Stem Cell Global Foundation, a New Delhi-basedorganization promoting stem cell research, estimatesthe business to be growing at a compounded annualgrowth of 15 per cent and cross Rs 2,200 crore next year. Business India PB Jayakumar / MumbaiAccording to a report by the Stem Cell Research Forum ofIndia (SCRFI), the industry is expected to grow to $540million by 2010, with a growth rate of 15%.The reason is simple: Therapies using stem cells aregiving hope to millions of patients afflicted withchronic diseases. Globally, stem cells are used to treatover 130 diseases and it is estimated that more than500 clinical trials are being done to develop therapiesusing stem cells. Indian companies are becoming animportant part of this revolution, helping treatpatients with diseases ranging from eye problems toheart disorders. http://business.in.com/article/briefing/stem-cell-research-advantage- india/9892/1#ixzz1cGnQPzcdForbes India 6. Potential patient pool Alziemers &Burns Parkinsons0.3m Spinal cord injuries Birth defects 0.25m 0.15mCancers 5.5mOrtho 8.2m 5.5m10m 58 m CardiovascularDiabetes32 m Auto immune30 m Dr Vasantha Muthuswamy Senior Deputy Director General Indian Council of Medical Research 7. Clinical ResearchPatients were recruited under multi-centric phase-III clinical trials on acute myocardialinfarction using autologous bone marrow mononuclear cells implemented at six hospitalsin the country. About 80% recruitment was completed by all the centers. A CRO wasengaged for monitoring this study . Similarly, all the five sites were taken up for therecruitment of patients under phase-II clinical study on acute ischemic stroke. The patientsare also being recruited under critical limb ischemia after obtaining ethical clearances atfour centers. (as per DBT annual report 2010. latest available) Currently 23 trials with stem cells have been registered with CTRI with application invarious areas, How many are still unregistered ???? Even fake centers are established.Reliance life sciences conducting trials with different indications. With already 2 productscommercialized.Life cell to conduct trials. We have completed a pilot study of 60 patients and hope tocommercialize the product in three to four years. Stem cell-based cardio vascular therapieshave a potential of over Rs 3,000 crore in India, said Mayur Abhaya, executive director ofLifeCell.Cytori to conduct trials especially in cardiac. 8. Stem Cell Therapy Trials in Public & Private SectorNeutech Mediworld: Diabetes, spino-cerebellar degenerative disorder, spino-muscular atrophy etc.Ruby Hall Clinic: Parkinsons diseaseJIVS: Ischemic leg (3 cases)Asian Heart Institute & Research Centre: CADNiCRM: Limbal, melanocyte, MIAIIMS: Cardiovascular Diseases (40 cases),Diabetes (2), DMD, Cerebral Palsy,Stroke, SCI, Limbal etc.Global Healthcare Hospital: ESC therapy 9. As per DBT annual report 2010, The exciting developments in stem cell researchand the emerging therapeutic applications are many. The challenges that need to be addressed pertain to expertise,infrastructure, interdisciplinary networking of researchers and cliniciansfor well defined basic research leading to translational research andappropriate regulatory mechanisms. 10. CURRENT BUSINESS APPROCH3 1 Major CROs IndividualInvestigators4 Biotech & Stem cell companies Chain of Hospitals 2 Referrals andMarketing support 11. INVESTIGATOR / HOSPITAL ORIENTED Medical writing Documentation:1. Site master fileS2. IEC approval3. ICSCRT approvalE4. Source document5. Patient filesCQuality assuranceIMonitoringVPublication of resultsRLab oriented:1. GMP set up2. Quality assuranceE3. Procedure trainingStem cell providerS 12. Pre-Trial: During the TrialPost TrialIdentify sitesAssist in the ICF process, Coordinate close out visit screening & enrollment R V I C E SIdentify PisResolve data queriesBiotech & Stem cell companies Coordinate subject follow upIdentify and coordinate visits preventing lost to follow up Archival at sitetranslations of Essential& missed visitsdocuments Manage CTM accountability,Identify Couriers and other distribution & logisticssupport service vendors Coordinate Central Lab logisticsRegulatory submission & & sample flowapproval with rapid turn-aroundtime Coordinate Monitoring & Audit visitsIEC and ICSCRT submission &approval with rapid turn-aroundSubject reimbursementstime Maintain and update TrialSite set up Master FileDocument collection Coordinate SAE reporting on timeCreate source document EtemplatePrepare site for SIVSPre-screening, in case of chronicdisease trials 13. Current market playersStem cell global foundation. (Not in therapy but withallied services)Totipotent Rx. Tied up with Fortis hospitals for their stemcell setups. (Allied only for therapy purpose)International stem cell services. (Stem cell banking and ,therapy services)Stem one Biologics. (Banking and therapeutics)Stem cure (Ahmadabad) claims to be CRO. (Therapymarket only) 14. How do we Stand Out in these:Our business alliances : Life cell International(Harvest tech) & GMP service providers.Tie up with stem cell providers.ICSCRT set for the purpose of approvals.No SMO in the area of Biotech.Phd doctorate working with us.Medical scientist. 15. Future avenues for business Sell protocols.Start with owncentre. PublicationEstablished Join handsAllied servicewith Govt. protocolsproviderbodies for these (Patent those)and inculcatethem astherapeuticmeasures.BE A COMPLETE SERVICE PROVIDERBANKING , THERAPEUTICS , MEDICO MARKETING & ALLIED SERVICES BE A COMPLETE CRO