NanoViricides Inc. (NNVC)

[changes_iv]

On Mar 31, 2015 - We are now progressing to a 1kg scale-up of FluCide(TM), and enabling in-process control instrumentation--- CMC studies to enable further scale-up from the current multi-100g scale of production to kg-scale production. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch.

Drug substance is a pure material which exerts a pharmacological action while Drug product is a finished end product which may contain one or more drug substances in combination with excipients meant for use by humans and animals ~ posted by meghana

CMC Development Strategies for Small Pharma

by James Bernstein Ph.D.

A significant trend in the pharmaceutical industry is the increasing proportion of early drug development carried out in smaller organizations, as opposed to the large vertically-integrated pharmaceutical companies. Most of these small organizations use contract development and manufacturing organizations (CDMOs) for the Chemistry, Manufacturing and Controls (CMC) aspects of development. In this model of drug development, a small innovator organization works in partnership with contract organizations for the early non-clinical, clinical, and CMC aspects of drug development.

With their small size (often less than 50 persons), small innovator organizations seldom have a sizable CMC group within their organization. It is common for all CMC activities from pre-clinical through Phase 2 to be coordinated by one or two individuals, often simultaneously with other responsibilities. Given the typical background of personnel in small innovator organizations, the responsible individual often has limited direct experience in cGMP or CMC development activities. In any event, covering the whole range of outsourced CMC activities for even a single New Chemical Entity (NCE) is a challenging task for a single individual. As a result of these factors, small organizations often fail to take advantage of phase-appropriate CMC development strategies that can reduce costs while building asset value. The result is that scarce resources are spent on CMC activities that do not contribute significantly to early-phase asset value.
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http://www.pharmoutsourcing.com/Featured-Articles/133695-CMC-Development-Strategies-for-Small-Pharma/

NanoViricides Accelerates its Herpes Drug Development Program

SHELTON, CONNECTICUT -- Monday, August 17, 2015 -- NanoViricides, Inc. (NYSE MKT: NNVC) (the "Company") a nanomedicine company developing anti-viral drugs, reports that it is accelerating its HerpeCide™ drug development program.

The Company will continue to develop its anti-herpesvirus franchise in parallel with the development of FluCide™, its anti-influenza drug candidate. The Company believes that drug development of the external treatments for the different herpes virus infections, such as topical skin creams or lotions for the treatment of herpes lesions, or shingles rash, as well as eye drops or gels for the treatment of herpes keratitis, are likely to require significantly less development work compared to the development of an injectable drug.

Biologics Consulting Group, Inc., a leading FDA regulatory consultant, is advising the Company on drug approval pathways and regulatory strategy.
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http://www.nanoviricides.com/press%20releases/2015/NanoViricides%20Accelerates%20its%20Herpes%20Drug%20Development%20Program.html

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About Nanda Subbarao, Ph.D. joined Biologics Consulting Group, Inc. as a Senior Consultant in June 2007.

Prior to BCG, worked for Sandoz (Novartis) in Dayton, NJ as Stability Manager where she led a group of chemists and sample coordinators/stability administrators for the Research and Commercial Stability Program. She was also responsible for stability storage and testing, sample flow, controlled drug substances and Reference Standards. She authored CMC analytical sections for more than 20 products. Some of her key achievements at Sandoz included the improvement of the Stability program cGMP compliance to current standards and the set-up of the sample flow system.

Prior to Sandoz, Nanda worked at Pfizer in St Louis. She participated on the team to set up cGMP systems for the new Biologics QC Laboratory. Nanda was responsible for the design and implementation of the worksheet system, and validated spreadsheets for lab raw data and the upgrade of the laboratory GMP systems from R&D to Commercial GMP level. When the laboratory became operational, she headed the QC lab responsible for electrophoresis and other methods. She eventually became responsible for the Biologics Stability program and led the new cGMP Stability Facility construction and validation teams. She set up the cGMP compliant systems for the Stability Program. Her role also included management of stability studies in contract facilities, preparation and review of CMC Stability sections for Biologics Regulatory submissions from the IND to the Commercial stage.

Nanda has co-authored numerous scientific publications and frequently an invited speaker at Industry Meetings. As a Senior Consultant with Biologics Consulting Group, Nanda utilizes her strong technical skills and expertise in Analytical cGMP systems for both biologics and conventional drugs to assist clients in the following aspects of drug development:

· Set up of cGMP laboratory systems

· Implementation and management of stability programs

· Technical and GMP evaluation of a wide variety of analytical methods at all stages of product life cycle

· Provide technical guidance on method validation for a wide variety of products such as characterized proteins including biosimilars, vaccines, gene therapy products, stem cell products

· Writing and evaluation of method validation protocols and reports

· Specification setting

· CMC analytical sections preparation and review against current regulatory expectations
http://www.biologicsconsulting.com/staff-detail/nanda-subbarao/