Clintech Research Llc Information

ClinTech Research, founded in 2005 in New Jersey, USA, has a team of advisors and consultants with substantial experience that includes technical project management and regulatory affairs in the pharmaceutical and CRO industries. Sri P Srivastava, PhD, PMP - Principal Consultant of ClinTech Research has technical experience related to the full range of pharmaceutical R&D activities. Furthermore, he has substantial project management experience in the pharmaceutical industry in the USA. The focus of ClinTech Research is on Integrated drug development management also draws on practical awareness of drug discovery, preclinical & clinical development meaning that Dr. Srivastava is uniquely qualified to operate as general manager of this process for client companies. The principle of integration is usually not addressed by small to mid-size biotechnology companies and start-ups due to resource constraint. ClinTech Research, as a strategic partner provides an experienced drug development implementation team and external know-how, saving significant time- and resources in the process. In addition, it is important to recognize the parallel priorities of Time, Cost, and Reliability that clients require. ClinTech Research believes that it is ideally placed to meet this need since the practical work is done by a network of pre-identified (and continually growing) appropriate CRO & CMO sites in the USA and offshore… With regards to offshore sites India is considered to be particularly important because of long standing historical awareness of FDA regulatory requirements, reasonable cost and the wide range of CRO & CMO contacts in that country by ClinTech Research. ClinTech Research has a number of differentiating characteristics namely:Provides access to a broad global choice of CRO/CMO collaborators and consultants that can be matched to clients special needs. Technical professionals with extensive experience in drug development project management in the pharmaceutical industry.Management of the interfaces between various biological and chemistry disciplines involved in preclinical drug development. An in depth knowledge of drug development processes and outsourcing management including lessons learned as a resultof working on other outsourced / offshore projects. Sri P Srivastava, PhD PMP: The management team is led by Sri P Srivastava, PhD, who has more than 20 years of experience in drug development including discovery, preclinical toxicology & clinical operations within the US industry. Prior to founding ClinTech Research, Dr. Srivastava has held positions with progressive management responsibilities at large to mid-size multinational pharmaceutical companies like Parke-Davis, Pfizer, Purdue Pharma, and Organon Pharmaceuticals. Before joining the pharmaceutical industry, Dr. Srivastava worked as a research scientist at Howard Hughes Medical Institute/ University of Michigan, Ann Arbor. He has published more than 20 publications in peer reviewed journals and has been invited as a speaker at various national and international symposiums. Dr. Srivastava has earned his Doctor of Philosophy (PhD) in Biochemistry and his Master of Science (MS) from Banaras Hindu University in India. Christopher Ball, PhD : Dr. Chris Ball is a senior advisor for ClinTech Research, and has a 40 year career in pharmaceutical research and development and corporate management. In Glaxo and Squibb he led research groups in drug discovery and process improvement. He published extensively and edited the book 'Genetics and Breeding of Industrial Microorganisms'. For 15 years Dr. Ball was Chairman and CEO of Panlabs - one of the first non-clinical CROs. The company grew substantially in profitable revenue driven by the introduction of new technologies in Genetics, Pharmacology, Chemistry and High Throughput Screening. He later founded the consulting company Creative Bioventures to advice life science organizations on business strategy. Dr. Tage Honore : Dr. Tage Honore is the senior advisor for ClinTech Research, and is the founder, president and CEO of Aestus Therapeutics, Inc, a biotechnology company. Dr. Honore has a distinguished career in pharmaceutical research, championing development of ideas to progress into early clinical studies. Previously, Vice President at Novartis, Novo Nordisk and Purdue Pharma, he has contributed to more than 35 new molecular entities entering clinical development. For ten years he was opinion leader in the Excitatory Amino Acid Receptor field and contributed considerably to the progress and understanding of this important neuronal pathway. His passion for and skill in interacting with people and with different cultures has enabled development of new organizational models to obtain record pipeline productivity in several companies. Dr. Honore earned his Doctor of Philosophy in Medicinal Chemistry and his Doctor of Science degree in Neurobiology from the Royal Danish School of Pharmacy in Denmark. He continued his training in business at both the Harvard Business School and the European Management Centre. Carl G Osborne : Carl G Osborne, D.V.M is the advisor and senior consultant for ClinTech Research, and is the founder and a principal officer of SciLucent, Inc. Mr. Osborne is an internationally recognized expert in drug development, business development, strategic planning and operational process improvement. He has undertaken or overseen numerous due diligence exercises for drug, biologics, and medical devices; helped define business, scientific, and regulatory strategies for development-stage companies; assisted clients in the planning and execution of numerous product development plans, prepared INDs, IDEs, NDAs, BLAs, CTAs, and MAAs; and worked to help companies develop better operational systems (e.g., Project/Program Management, Outsource Management, Compliance Management, etc.). He is a former FDA toxicologist and compliance officer with extensive experience in international regulatory affairs, and quality systems (cGMP, GLP, GCP, QSR,) design, implementation, management, and remediation. Carl's expertise includes monoclonal antibodies, oncology drugs, neurology drugs, antibiotics, cardiovascular drugs, pulmonary drugs, and gastrointestinal drugs.