Staff at Siva Microbiological Solutions are highly qualified and experienced scientists in the fields of microbiology, molecular biology, analytical and organic chemistry
Lakshmi Sadasivan Ph.D Founder and Director
Dr. Lakshmi Sadasivan is a founder of Siva Microbiological Solutions, LLC. A consulting and contract laboratory company aimed at serving primarily the coatings and building products industry. SMS offers expert and cost effective solutions for any microbial problems in the industry. Lakshmi is a self motivated technical sales microbiologist in the area of biocides, antimicrobials and biodeterioration of materials. Worked on research and development projects for successful introduction of products for antibacterial, anti-fungal and anti-algal properties. Number of technical training and web seminars conducted on the subjects of plant hygiene, mold and mildew problems, and test methods. Expertise in the preservative efficacy testing, antimicrobial evaluations for dry surfaces and coatings, bacterial, fungal and algal identifications. Provided many technical value propositions, worked and written over twenty technical research reports for the business and published several articles in trade and peer reviewed journals.
Prior to founding SMS, Lakshmi was a Senior Scientist (Group Leader) in the Coatings Biocides Group in Rohm and Haas Company and managed groups of technicians and scientist for successful completion of projects resulting in significant business, sales and recognition for Rohm and Haas. Supported product stewardship and regulatory team foe successful registration of products with EPA and in California. Played a key technical role in obtaining EPA registration of approximately 10 products. Lakshmi has represented Rohm and Haas in several professional and industrial societies and associations like ASTM, IBRG, and nominated in the Organization of Economic Co-operation and Development (OECD) for the sub- group on the efficacy of biocides and antimicrobials to treat articles.
Dr. Sadasivan’s prior assignment was at Huls America’s Biocides Division (now Ashland Chemicals) Sr. Microbiologist where she conducted research in the discovery and screening of biocides for paints and coatings application. Promoted products to customers and trained sales and marketing forces.
Easwara Sadasivan Ph.D Vice President and Managing Partner
Prior to retiring, Dr. Easwara I. Sadasivan has been at St. Lukes-Roosevelt Hospital (NY) for 10 years as an American Society for Clinical Pathology (ASCP) certified and New York State licensed Molecular Pathologist. He holds strong expertise in molecular technologies such as Polymerase Chain Reaction (PCR)-Amplicor viral load quantification for human immunodeficiency virus (HIV) (Roche Diagnostics), branch DNA (bDNA) System 440 (Siemens Diagnostics) viral load for HIV and Hepatitis C Virus (HCV). Expert in troubleshooting and maintenance work of laboratory equipments, daily quality control (QC) monitoring, half-yearly testing of College of American Pathologists (CAP) and New York State Surveys for Laboratory Accreditation as required for Center for Medicare and Medicaid Services. He also performed PACE2C (GENPROBE) molecular screening and confirmation tests for intracellular obligate bacterial ribosomal RNA detection in sexually transmitted diseases (STD) such as Chlamydia Trachomatis and Neisseria Gonorrhoea.
In addition, Easwara holds significant responsibility and experience in serological diagnostics, which includes STD Syphilis for Treponima Pallidum spirochete bacterium tests by Rapid Plasma Reagin (RPR), Venereal Disease Antigen Test (VDRL), Immuno florescence test FTA , Cr. Neoformans (Fungus) identification by Cryptococcal Antigen latex bead test both for Serum and Cerebal Spinal Fluid, serum test Infectious Mononucleosis, Enzyme-linked Immunoassay (EIA or ElISA) for detection of both IgG antibodies for H.pylori, Measles, Mums, Rubella, Varicella, Toxoplasma Gondii (IgG. and IgM.), Cytomegalo virus (IgG. and IgM.) , Epstein-Barr Virus (IgG. and IgM.), Lyme disease (IgG.) and autoimmune IgG. SSA, SSB, Smith, smith RNP and Treponima Pallidum spirochete bacteria (IgG).
Previously, Easwara was an Assistant Professor at the State University of New York Health Science Center at Brooklyn for 16 years, a Research Associate and recipient of the National Research service Award winner from National Institute of Health (NIH) (for 4 Years), and held supervisory experience of training Technicians, Medical Students, Residents and Fellows at Hematology and Oncology at Veterans Administration Medical Center and at University Hospital. The research work focused on Molecular Cloning of complimentary DNA (cDNA), multifamily gene characterization, regulation, expression and purification of human folate receptors. He is a Technical expert in guiding in others on going projects in the Medicine Department. This research work was reported in 16 publications in peer-reviewed journal. Easwara developed Epoxy activated affinity matrix , purification, setting up of the molecular cloning, DNA sequencing, gene expression, nucleic acid hybridization such as southern and Northern Blots, Gene Array Technology for folate receptor.
Dr. Easwara I. Sadasivan obtained his Ph.D from the University of Massachusetts at Amherst. He has a post graduate Masters degree in Molecular Biology from Tata Institute of Fundamental Research (TIFR) [affiliated to the University of Bombay] and B.Sc degree in Chemistry from the St. Alberts College affiliated wit the Kerala University.
Jeffery Hinkle Ph.D, MBA Senior Technology and Business Consultant
Dr. Jeffery S. Hinkle is a founding partner of the Sigfreit Group, a senior level consulting and business representation firm, and an independent board member of a small pharmaceutical contract research organization (CRO). Dr. Hinkle rejoined a past colleague Lakshmi Sadasivan helping develop and grow the contract research and testing business at Siva Microbiological Solutions (SivaMS) as a senior consultant. Jeff's long experience and expertise in both the technical and business aspects of various biocides and antimicrobials application areas, including paints and coatings, lubricants, inks, ink-jet, plastics, cosmetics, and even pharmaceuticals, provides an excellent compliment with SivaMS to enable the team to offer broader solutions to the market.
Jeff was previously a Senior Director at Merck Research Laboratories (MRL) responsible for the creation and optimization of the global basic and pre-clinical development outsourcing efforts including both small molecule chemistry and biologics, development of the partner relationship management (PRM) system, and the Merck partner relationship executive for WuXi (a Shanghai-based global CRO). After leaving Merck, Dr. Hinkle has provided consultation roles in business development and customer relationship management at WuXi, Navin Fluorine, Bunge, and a number of other companies.
Dr. Hinkle's prior accomplishments at Degussa (now Evonik) over nearly 20 years included the development, growth and ultimate divestiture (to ISP, now Ashland) of a very successful biocides business, including a unique, patented no-VOC product range from lab invention to registration and commercialization. His global business management included leading a bankruptcy acquisition, integration and turnaround of a niche competitive business, partically involving an expatriate assignment in the Netherlands. In addition to leading the antimicrobial, colorant, and ink jet businesses, GLP compliance efforts, and other projects, he also worked in support of the pharmaceutical and Biotech contract research and contract manufacturing groups.
Jeff's functional area expertise includes marketing, business development, key account management, customer support, technical service, product research and development, process support and scale-up, strategic sourcing, P&L responsibility, and M&A (and divestiture) leadership. He is a lean six sigma black belt, and has identified, developed and completed projects generating cost savings ranging from $1.8 to over $10 million each.
Dr. Hinkle obtained his B.S. in chemistry from Ursinus College, and his Ph.D. in organic chemistry from Princeton University under Ted Taylor working with aza-beta-lactam analogs of antibiotics, and supporting chemistry for a project which is now the Lilly marketed oncology drug Alimta. He completed his MBA at Rutgers University School of Business in 2002 with a dual Marketing and Finance major. He is a member of ChemPharma, the Marketing Executives Networking Group (MENG), the American Chemical Society (ACS), Sigma Xi, the American Society for Testing and Materials (ASTM, past biodeterioration subcommittee chair), the National Paint and Coatings Association (past Federation of Societies for Coatings Technology Publications Committee), the Professional Services Group of Central NJ (PSGCNJ), and the Million Dollar Round Table (MDRT).
Pushpa D. Singh, Ph. D. Senior Quality Assurance Consultant
Dr. Singh is a Principal at CMC Consulting LLC which provides technical and regulatory compliance consulting services to meet current challenges in developing and gaining timely regulatory approval of new drugs.
She is a Pharmaceutical R&D executive with over 30 years of experience in all phases of product development including discovery, development, technology transfer, and product life-cycle management. As a Vice President, Quality Operations & CMC Regulatory at Keryx Biopharmaceuticals, she was responsible for the overall strategic and operational activities in ensuring quality and regulatory compliance in the production and analysis of clinical trial materials. She was also responsible for all aspects of CMC documentation and regulatory activities in support of investigational and registrational submissions.
As an Executive Director at Bristol-Myers Squibb, she successfully led a diverse organization requiring detailed and thorough review of technical information for Quality and GMP Compliance, CMC Technical Documentation, and Environment, Health & Safety. She provided strategic thinking and long range planning for groups involved in strategic planning and development portfolio analysis.
Dr. Singh has extensive experience in leading the creation, operation and improvement of a business area or process in the Chemistry, Manufacturing, and Controls (CMC) arena. She has vast experience in the preparation of CMC section of global investigational (IND/CTA), registrational (NDA/MAA/BLA) and LCM submissions for small molecules and biologics. She has proven record of successful regulatory agency interactions such as end-of-phase 2 and pre-NDA meetings with the FDA, and regulatory agency inspections. She possesses an in-depth knowledge of drug development processes, cGMP regulations, and CMC related FDA and international regulations. She has proven record of disciplined and logical approaches to problem solving, and the ability to build new groups and capability.
Dr. Singh received her Ph.D. in Organic Chemistry from Massachusetts Institute of Technology, and subsequently did postdoctoral work at Oxford University. She has published 17 papers and holds 5 patents.