TAKE Solutions Ltd. (BSE: 532890), leaders in Life Sciences and Supply Chain Management (SCM) products, announced that the company has entered into strategic partnership with Reliance Life Sciences to supply its unique and innovative PharmaReady eCTD, SPL and PPM modules. The seamless integration of TAKE Solutions’ technologically advanced products will not only support Reliance Life Sciences in strengthening product development services; but these customized IT solutions will also add a cutting-edge finesse to the present line of business. With its strong background and industry knowledge, TAKE’s Warehousing & Clinical Systems Development and Integration tools will deliver a full spectrum of Information Management Services, leveraging on industry data standards to streamline the clinical information lifecycle. “We were looking out for a submission solution that can address our current and future requirement of our organization that enables our regulatory submissions. Also, in addition to software solutions, we wanted to partner with an organization that understands our business dynamics, and could work with Reliance Life Sciences to enhance the business process and solution set over the time to come. After a detailed market search, and understanding of the solutions available, TAKE Solutions emerged as a definite choice for us as the solution set offered us flexibility and options for customization, while meeting the core requirements. Also, TAKE Solutions as an organization has the right credentials, industry expertise and resource strength that we were looking for.” said Mr. Gopal Rangaraj, Vice President IT, Reliance Life Sciences Pvt. Ltd. “We are extremely pleased to partner with Reliance Life Sciences. Our engagement with such a credible and commended Life Sciences solution major is evidence of TAKE Solutions’ comprehensive understanding of the business, the challenges and proven track record of providing intelligent and innovative clinical regulatory solutions,” said, Mr. Ramesh L, Vice President – Sales, Life Sciences APAC, TAKE Solutions Ltd. Notes to EditorAbout Reliance Life Sciences Reliance Life Sciences, is a new millennium initiative of the Reliance Group. Reliance Group is the largest private sector enterprise in India, participating in businesses in the energy and materials value chain, with group revenues of USD 30 billion. The flagship company, Reliance Industries Limited, is a Fortune Global 500 company, and ranks 103rd amongst the world’s top companies in terms of revenues. Reliance Life Sciences is developing business opportunities in the domains of medical, plant and industrial biotechnology. From a domain perspective, these opportunities cover Biopharmaceuticals, Pharmaceuticals, Clinical Research Services, Regenerative Medicine, Molecular Medicine, Novel Therapeutics, BioFuels, Plant Tissue Culture, Plant Metabolic Engineering and Industrial Biotechnology. From an integration perspective, these opportunities encompass Repositories, Research, Process Development, Pre-clinical Studies, Clinica; Trials, Commercial-scale Manufacture and Marketing, all of which are carried out in-house. About TAKE Solutions TAKE Solutions is a leading software and services provider with domain expertise in Life Sciences (LS) and Supply Chain Management (SCM). With intellectual property assets embedded within its technology solutions, and with a set of best practices executed by skilled domain and technology professionals, TAKE is constantly looking at opportunities to drive efficiencies for its clients’ businesses. Headquartered in Chennai, TAKE primarily drives its SCM Domain Excellence Centre and Global Delivery Centre from India. Company has strong presence in the USA with Life Sciences Domain Excellence centres located in Princeton, New Jersey. The Company conducts business today with more than 390 customers worldwide. TAKE has been recognized as India’s 10th fastest growing technology company by Deloitte Technology Fast 50 India 2008 and has also been assessed at Level 5 of the Capability Maturity Model Integration (CMMI) & Level 3 of the People Capability Maturity Model, Software Engineering Institute, Carnegie Mellon University, USA. TAKE is also a Microsoft Gold Certified Partner, a Charter Member of the Microsoft BioIT Alliance, and along with its subsidiary (ACI), is a Registered CDISC Solution Provider, with recognized industry leadership in Microsoft-based Solutions, Regulated Life Sciences, and Supply Chain Management.

Source:http://news-views.in/reliance-life-sciences-and-take-solutions-enter-into-a-strategic-alliance/

Reliance Clinical Research Services has been set up by the Reliance Life Sciences Group to offer world-class clinical research services to pharmaceutical, biotechnology and medical device companies of the world. It has been established as a contract based research organization by the biotechnological subsidiary of Reliance Industries Limited. The headquarters of Reliance Clinical Research Services (RCRS) are situated in the Reliance Life Sciences facility in Navi Mumbai, India. RCRS also has business development offices in USA and UK. The services on offer by RCRS include Phase I-IV Clinical Trial Management and Monitoring, Pharmacovigilance, Biometrics, Pharmacokinetic & Pharmacodynamic studies, Cardiac Safety (thorough QTc) studies, Bioequivalence studies, Regulatory Affairs, Quality Assurance, Pre-clinical Development, Diagnostic Laboratory Services, Bioanalytical services, Medical Writing and Translation.

RCRS has a highly qualified staff to compliment the services offered which consists of Physicians, PhDs, and multi-disciplinary GCP trained staff. RCRS is the first Clinical Research Organization (CRO) in India to have its Central Pathology Laboratory accredited within the first two years of its inception by the College of American Pathologists (CAP). The Molecular Diagnostics Laboratory of RCRS has also been accredited by the National Accreditation Board for Calibration and Testing Laboratories (NABL) as well as the College of American Pathologists (CAP). RCRS utilizes its network of investigators from South East Asia, Eastern Europe and the Commonwealth of Independent States (CIS) countries to offer an array of services. RCRS has conducted studies in over 14 therapeutic domains including oncology, endocrinology, dermatology, hematology, gastroenterology, neurology, cardiovascular, vaccines, psychiatry, gynecology, infectious diseases, regenerative disorders, ophthalmology and nephrology.

Preclinical Services

The preclinical studies for RCRS are conducted at the Dhirubhai Ambani Life Sciences Centre in Navi Mumbai, India. Its preclinical services are essentially in-vivo efficacy and pre-clinical safety studies primarily for cell-based therapies, proteins and chemical entities. The studies are conducted in a state-of-the-art facility with an environmental monitoring system while ensuring compliance with OECD principles of Good Laboratory Practice. The preclinical services division of RCRS is capable of conducting general toxicology studies that include Acute Toxicology, Sub-Chronic Toxicity Studies and Chronic Toxicity Studies by Ooral and Parenteral Routes. Local tissue tolerance studies, mutagenicity studies and Bio efficacy studies of biotechnologically derived products are also part of the RIL preclinical services.

Phase I – IV Clinical Trials

RCRS has an over-60 bedded clinical facility in Navi Mumbai and an over-35 bedded facility at Bangalore for conducting Bioequivalence and Bioavailability studies. Along with using techniques like bar-coding for volunteers and biological samples RCRS also complies with regulatory requirements of US FDA, ANVISA (Brazil), MPA (Sweden), MoH (Turkey), MHRA (UK), MCC (South Africa), TGA (Australia) and DCG (India). For phase II to IV of clinical trials, RCRS offers services for project management, co-ordination of investigator meetings, clinical trial site qualification and monitoring, clinical trial monitoring and supplies management, pharmacovigilance, biometrics and quality assurance. The Biometrics Group encompasses the functions of Data Management, SAS Programming, and Statistics. The Quality Assurance team at RCRS offers Clinical Investigator Site Audits, Sponsor Audits, Systems Audits, Central Laboratory Audits, Clinical Trial Supply Audits, Adverse Event Reporting System Audits, Computer Systems Validation Audits, Database and Data Management audits and GLP Audits.

Diagnostic Laboratory Services

The diagnostic laboratory of RCRS is enrolled with CAP and Bio-Rad for external proficiency testing. RCRS provides a host of molecular diagnostic services in association with Reliance Life Sciences’ Molecular Diagnostics and Genetics testing laboratory which include DNA amplification of infectious diseases, HLA typing, Bcr/abl RT PCR along with Genetic testing, karyotyping, FISH and pre-implantation genetic diagnostics. The laboratory also offers facilities for testing flow cytometry, CD4 / CD8 / CD3 absolute, percentage, Oncology Leukemia, Lymphoma markers, Serology, HIV 1 & 2 Ab, HBsAg, HCV Ab, Syphillis Ab, CMV lgG / lgM Ab, HTLV 1 & 2 Ab (LlA), HIV Western Blot and Cytokine / chemokine levels.

Medical Writing

RCRS offers regulatory, marketing, clinical and educational document writing services including peer-review publications. SOPs, developing scientific posters and writing manuscripts are also on offer by RCRS. The RCRS team consists of physicians who hold expertise in developing documents in various therapeutic areas like oncology, cardiology, infectious diseases, ophthalmology, diabetes, neuropsychiatry and respiratory disorders. US/EU/ICH guidelines and regulations are followed by RCRS while preparing documents.

RCRS offers the Young Clinical Research Professionals Program (YCPP) and the Advance Diploma in Clinical Research as courses that focus on the responsibilities of sponsors, investigators, Ethics Committe personnel and other clinical trial players.

The Reliance Institute of Life Sciences is dedicated towards offering higher learning in various domains of life sciences and related technologies. The educational institute was established by the Dhirubhai Ambani Foundation which is registered under the Bombay Public Trust Act 1950. It is said to be the first ever effort in India that provides graduate, postgraduate, doctoral, research and continuing education programs in several emerging areas of science as well as technology. The institute offers training in specific areas of fundamental and applied research that include basic and applied sciences, computer science and engineering, biomedical science and engineering, pharmaceutical science and engineering, agriculture and environment sciences, process development and manufacturing science and clinical research.

The administration of Reliance Institute of Life Sciences is headed by Mukesh Ambani as the Chairman. K.V. Subramaniam is the vice-chairman while Dr. Arnab Kapat is the director. The executive members for the institute include Prof. Arvind Kudchadker, Dilip Kumar Ghosh and Vinay Ranade. The faculty comprises of a pool of eminent scientists working for Reliance Life Sciences. Faculty from reputed academic institutions and the life sciences industry are also invited in order to teach specific fundamental and applied topics. The Reliance Life Sciences campus also houses Reliance Institute of Life Sciences (RILS) that has state-of-the-art lecture halls, a library that comprises of a reference section, a regular text section and a computing facility that has Internet access. The diploma programs are conducted on a five-day week basis during class room training. The working hours have been affixed from 10.30 a.m. to 6.00 p.m.; however, during the project the work week is adjusted to a six-day week and work hours are rescheduled to 10.30 a.m. to 6.00 p.m.

The Competency Development Program

The competency development programs offered by RILS focus on training aspirants in the domain of life sciences by developing their competencies to cater to life sciences and allied areas. Classroom training is carried on for a period of three months which is then followed up by nine months of field training. During training candidates are assessed for learning and performing abilities. The Young Professionals’ Program includes the Young Engineers Program (YEP), Young Clinical Professionals’ Program (YCPP), Young Manufacturing Professionals’ Program (YMPP), Young Quality Management Professionals’ Program (YQMPP), Young Scientists’ Program (YSP), Young Medico-Marketing Professionals’ Program (YMMPP), Young Agri-Professionals Program (YAPP), ECG Readers’ Program (ERP) and the Young Laboratory Technicians Program (YLTP).

YEP trains enrollees on building competency for designing, engineering, implementing, installing, commissioning and validating highly automated biopharmaceuticals manufacturing plants while complying with the regulations of Indian FDA, USFDA and EMEA. YCPP trains participants in various aspects of clinical research, clinical trials, bio-equivalence and bioavailability studies as well as regulatory affairs. In YSP participants are trained on the basic fundamentals of biological sciences and good laboratory practices. The ECG Readers’ Program is a highly specialized program that trains medical doctors on ECG measurement, annotation and overall assessment to be at par with international standards.

Advanced Diploma Programs

Under the advanced diploma program in biotherapeutics students would be trained on modules like introduction to Embryonic stem cells, Ocular stem cells, Haematopoietic stem cells, Skin and tissue engineering, cell biology, plant engineering, cGMP manufacturing, quality management, clinical research as well as occupational health and safety. The three months of class room training will then be followed by project work a duration of nine months in areas like Cell biology, Molecular biology, Upstream process engineering, Downstream process engineering, cGMP manufacturing, Plant engineering and Quality management.

The advanced diploma in clinical research by RILS is a part time program for a time period of 52 weeks that focuses on conducting clinical trials for bioavailability/bio-equivalence studies of drug molecules and is designed to meet the need of Contract Research Organizations. A few of the modules offered by the program are Good Clinical Practices (GCP) & regulatory overview, Preclinical Studies and Pharmacology, Clinical study document preparation, Clinical trial initiation, Site initiation, Project management, Data Management, Biostatistics, Risk in clinical research and the Influence of technology.

RILS has conducted three international symposia till date in collaboration with Reliance Life Sciences which were focused on Preventive and Predictive Molecular Diagnostics and Stem Cells and Regenerative Medicine in 2006 and Evidence-Based Practices in Reproductive and Fetal Medicine in 2007. The international symposia are conducted with the aim of creating a knowledge-sharing platform for the entire scientific fraternity of the world. Specialized workshops are also conducted by RILS to impart training on the various aspects of genetically inherited diseases, testing and methodology and the psychological and social aspects of counseling.

History:
Founding –

Reliance Life Sciences was incorporated in the year 2001 and is an initiative of the Reliance Group of companies. Reliance Life Sciences was initiated in order to develop business opportunities on the medical, plant and industrial biotechnology front. RLS aspires to be the most diverse and integrated biotechnology initiative developed in the world. The main campus for Reliance Life Sciences is at the Dhirubhai Ambani Life Sciences Center which is located on a 20 acre plot in Navi Mumbai. The Clinical Research Services are situated in a facility in Bangalore. The Biofuels agronomy research is conducted at farms located in Kakinada, Nagothane and Gandhar. Taking forth its motto of diversity and depth of initiatives Reliance Life Sciences has a team of PH.Ds,  M.Ds, Engineers and post graduates in sciences. One-third of its employees are women.

Important past events –

Reliance GeneMedix Plc is a UK-based subsidiary of Reliance Life Sciences. It has emerged from the acquisition of the UK based biotech company Genemedix Plc in order to develop biosimilars for the European market. The manufacturing facility for Reliance GeneMedix Plc is situated in Ireland. The first product from this association is slated to be the biosimilar version of Erythropoietin which is used in kidney-related applications and in patients under chemotherapy.

Reliance Life Sciences has filed over 281 patents at both national and international levels that cover the entire spectrum of its research and development activities. Reliance Life Sciences is also working on the development of novel therapeutics that are aimed at the treatment of cancer, infectious diseases, inflammatory disorders, ocular disorders and neurodegenerative disorders. This discovery program is based on siRNA and monoclonal antibodies.

Reliance Life Sciences made an important contribution towards surgery of Hemophiliac patients in 2006. Total Knee replacement surgery was previously viewed as too risky and complex in Hemophiliac patients but is now possible with Anti-Hemophilic Factor VIII that was made available by Reliance Life Sciences.

Reliance Life Sciences also plans to foray into the global generic drug space with the introduction of its first generic drug in the international market in 2009. It will produce Active Pharmaceuticals Ingredients (APIs) and generic medicines for the international market including the US and Europe.

Products:

Reliance Life Sciences has a variety of medical and plant products to offer.
It offers the following through its medical products and services line:

Medical Products:
Biopharmaceuticals

Plasma Proteins –

• ReliSeal: It is a quick acting fibrin sealant derived from human blood plasma with hemostatic sealing and adhesive properties. It can be used in surgical procedures to curb bleeding, seal tissues and heal wounds by mimicking the final stage of the natural clotting mechanism.

• AlbuRel: It is human normal albumin and is used for the restoration and maintenance of circulating blood volume where there is volume deficiency and use of colloid oncotic pressure is required.

• ImmunoRel: It is derived from pooled human plasma. Its U.S. FDA approved indications are in primary immunodeficiency, ITP, Kawasaki disease, CLL, paediatric HIV infection, bone marrow transplantation. Its off-label uses are for GB syndrome, Multifocal Motor Neuropathy, CIDP, Lambert Eaton Myasthenic syndrome, Myasthenia Gravis, Neonatal Sepsis, Polymyositis and Dermatomyositis.

• HemoRel: It is an intermediate pure factor VII and is indicated for patients diagnosed with the clotting disorder of haemophilia A, who have a deficiency of factor VIII. It was successfully used in the total knee replacement of a haemophilia patient in 2006.

• ReliPlasma: It is pooled viral inactivated plasma which is used as a substitute of fresh frozen plasma and effectively eliminates enveloped viruses like HBV, HCV and HIV from plasma. Treatment of plasma with Reliplasma has shown a reduction of the frequency of both transfusion transmitted infections and non-infectious complications. It can be administered for treatment of various clotting disorders, TTP and bleeding related to use of drugs such as warfarin.

Biosimilars

• Reliferon: It assists the human immune response system by activating natural killer cells and macrophages, promoting antigen presentation to lymphocytes and thereby inducing resistance of host cells against foreign agents and also has direct anti-viral effects. It is used in the treatment of more than 14 malignancies and viral diseases which includes adjuvant therapy in metastatic melanoma, condyloma acuminata, Kaposi’s sarcoma and most significantly hepatitis B and C.

• ReliPoietin: It works as a growth hormone and also stimulates the production of red blood cells from the hematopoietic stem cells found in the bone marrow. It is solely produced by kidney cells, and therefore, any functional damage to the kidneys can result in the deficiency of EPO as well as reduction in the production of the RBC pool that eventually leads to anemia. It is used to reverse anemic conditions that arise due to the body’s inability to produce the required amount of erythropoietin, and thereby reduce the pool of red blood cells. It is used as support therapy to reduce the number of dialysis required by renal failure patients and better tolerance of chemotherapy and reduced number of blood transfusions in case of cancer patients.

• ReliGrast: It is a human recombinant Granulocyte Colony Stimulating Factor which is a specific growth factor that is known to stimulate the production of neutrophils that are a type of white blood cells in the body that are necessary for fighting infections. It is used to therapeutically reverse neutropenic conditions. It can be used in chemotherapy induced neutropenia, AIDS-associated neutropenia, congenital and cyclic idiopathic neutropenia.

Regenrative Medicine:

• Reli-Heal G: It is sterile gauze that provides a moist environment for wounds to heal. Its benefits are a decreased rate of infection, autolytic debridement of slough and necrotic tissue as well as minimal pain or trauma to the wound bed, whenever it is applied or removed.

Pharmaceuticals

• TemoRel: It is a chemotherapeutic agent that is indicated for the treatment of newly diagnosed glioblastoma multiforme (GBM) and refractory anaplastic astrocytoma. GBM and anaplastic astrocytoma are high grades of brain tumors or gliomas.

Medical Services -
Regenerative Medicine

• Relicord: Relicord S is a sibling donor program and Relicord A is an allogenic voluntary donor program that is offered to patients who suffer from blood related disorders and need transplantation. The Cord Blood Repository for Reliance Life Sciences holds a license from the Food and Drug Administration of the Government of India.

• ReliNethra: It is the first stem cell based therapy in India and is indicated for unilateral partial and total limbal stem cell deficiency conditions like chemical burns, thermal burns, mechanical injuries to cornea, contact lens-induced keratopathy and more.

Molecular Medicine

• Relix: It is a range of molecular diagnostic and genetic testing services used for diagnosing several infectious diseases and genetic disorders like tuberculosis, hepatitis B and C, dengue virus, typhoid, amniotic fluid karyotyping, cord blood karyotyping and more.

For its plant products and services line Reliance Life Sciences offers:

Plant Products -

• Tissue Cultured Plants: To cultivate a wide variety of plants for various uses in categories like horticulture, floriculture, ornamental plants, plantation, bio-diesel and medicinal and aromatic plants.

• ReliCare: It is Aloe Vera spray dried powder that can be useful in cosmetic applications and nutraceuticals applications.

• Rellure: It is Kesar Mango pulp made from the Kesar mangoes grown at the Reliance orchard in Jamnagar and is marketed for use as an ingredient in milk shakes, ice cream and mango juice preparations.

Plant Services -

• Cultivation Technology: Reliance Life Sciences uses a detailed package of practices for tissue cultured plant-based plantations as well as it has timely field inspections along with advice from qualified and experienced scientists.

• Contract Production & Research: Through this Reliance Life Sciences offers contract production of plants that uses either the protocol supplied by the client or the available in-house protocols. Reliance Life Sciences also initiates and micro-propagates cultures supplied by customers. It also develops commercially viable tissue culture production protocols on request.

Business Divisions

The Plant Tissue Culture Group is to provide micro-propagation of plants, mass multiplication of elite varieties and contract production of client-specific plant varieties.

ReGenesis is an assisted reproduction facility of Reliance Life Sciences which is situated in Worli, Mumbai. It is a centre for assisted reproduction, endoscopy and fetal medicine.

The Industrial Biotechnology initiative encompasses Biopolymers and Biochemicals and is involved in bioprocess innovation and development from process inception to industrial level production.

Reliance Life Sciences pursues research programs in Enzymology in Industrial Enzymes for Biofuels and Therapeutic Enzymes.

Reliance Institute of Life Sciences is a part of the initiative by Reliance Life Sciences. It is a not-for-profit organization that is sponsored by the Dhirubhai Ambani Foundation. The main focus of Reliance Institute of Life Sciences is to develop competent biotechnology that will be of use to the entire industry. The Institute has on offer a wide range of competency development programs and diploma programs in both biotherapeutics and clinical research.

Corporate Structure:
The company board of directors, important executives and other people instrumental to the success of the company

Stock : Listing and Performance over time – No separate listing on any stock exchange.

Slogans/Mission Statements -

Vision of attaining global leadership through innovative and cost-effective solutions for a better life.

Subsidiaries:

Reliance Biopharmaceuticals Private Limited: An initiative to research, develop and market products in categories of Blood Plasma Proteins, Biosimilars and Monoclonal Antibodies.

Reliance Pharmaceuticals Private Limited: To develop active pharmaceutical ingredients and formulations for global markets.

Reliance Clinical Research Services: To cater to drug development needs of pharmaceutical, biopharmaceutical, medical device and nutraceutical companies from USA, EU, Japan, India and other parts of the world. To offer CRO in domains like medical writing, biostatistics, clinical data management, etc.

Reliance Biofuels Private Limited: It is working towards developing an India-centric biofuels initiative that covers Biodiesel from Jatropha and other non-food oil seed crops, Bioethanol from cellulosic biomass and Biobutanol from cellulosic biomass.

Sponsorships: Only as part of the Reliance Group

ReliCord is an initiative by the Reliance Group in the field of biotechnological advancement. It is established as a part of the subsidiary of Reliance Industries, Reliance Life Sciences. ReliCord is the first to have a registered cord blood band and repository in India as well as the entire region of South East Asia. In terms of Biotechnology India is currently amongst the top five countries in the Asia Pacific region. Reliance Life Sciences and ReliCord are an endeavour by the Reliance Group to tap into this emerging market that has great potential.

ReliCord has already stored over 3,500 cord blood samples at its repository. It conforms to the AABB and USFDA guidelines and has an infrastructure to collect cord blood from any corner of the country through its collection centres. ReliCord offers public as well as private banking and is the only facility in India that offers stem cell research for current and future applications. The cord blood samples are stored at the Dhirubhai Ambani Life Sciences Centre (DALC) campus in Navi Mumbai. The repository is completely automated and uses the most advanced technology under the supervision of a host of experienced scientists.

ReliCord runs three programs for the collection of cord blood: ReliCord S, ReliCord A and ReliCord M. ReliCord S and ReliCord A offer stem cell enriched cord blood repository services as well as stem cell enriched cord blood for transplantation to address haematological disorders. ReliCord S is a program for sibling donors. This program is for a mother or a family that wants to process and bank the umbilical cord blood stem cells from the present pregnancy. Only family members waiting for transplantation can utilize this program. Under ReliCord S the stored cord blood stem cells can be used for haematopoetic stem cell transplantation for family members suffering from diseases such as Thalassemia or Leukemia. The ReliCord S and A program not only stores the stem cells but also tests and processes the same along with delivering the stem cells to the transplant site as per the direction received from the transplant physician.

ReliCord A is meant for patients who require transplants with grafts from the repository. Under this program a patient first has to obtain his HLA profile to facilitate the availability of the graft. HLA profiling is also offered by Reliance Life Sciences. ReliCord M offers umbilical cord banking and cord tissue derived mesenchymal stem cells banking services as a combined storage service for parents-to-be. The Relicord M program offers umbilical cord collection, processing of the cord, culturing of mesenchymal stem cells and storage of cord tissue with 15 million stem cells. Before storage the cord blood is tested for HIV, HBV, HCV and CMV. The blood is also typed for Human Leukocyte Antigens (HLA) Class 1 and 2 antigens before processing. The stem cell enriched cord blood is then cryo-preserved at the repository at a temperature of minus 196 degree Celcius. Stem cell enriched cord blood can be used as a therapy for the treatment of Thalassemia, Leukaemia, Brain Tumor, Neuroblastoma and Sickle Cell Anaemia and can be used as an adjunct therapy for chemotherapy.