Milind Deore Email and Phone Number

Head of Global Toxicology group for safety assessment of Consumer Products worldwideCurrently leading and managing a group of Toxicologists across different regions/R&D sites globally , to support launches of consumer products in different regions as per respective regulatory/industry standards (US-FDA, EU Commission, ANVISA in LATAM, Chinese FDA (SFDA), Pacific -TGA and different countries in Asia). The support for launch of consumer products globally and regionally is through safety/risk assessment of ingredients, preservatives, fragrances and assessments of final products. These products belong to different need states in JnJ viz., adult and baby skin care cosmetics, color cosmetics, sun care products, cosmetic devices and Feminine care/wound care products. For OTC drug products, impurity qualifications as per ICH requirements to support launches in various regulatory domains, is the major focus apart for excipient qualification. Finalization of white papers, regulatory dossiers is a routine part of the profile. Identifying data gaps, planning studies in a cost-efficient manner is in scope. Currently the scope of activity has expanded to clinical skin safety to encompass integrated product safety. The efficiency in execution of preclinical support is achieved through innovative approaches, and talent development and adapting cost efficient steps. People management and talent development has been an integral part and has developed close to 50-60 Toxicologists to support consumer products risk assessment in India. The job profile also includes establishing collaborations within and outside organizations with local and regional industry associations (IBHA in India, ACA-SAT in ASEAN region), plus interactions with health authorities for product safety support

Safety assessment of ingredients- chemicals and botanicals and product safety evaluation for consumer products

Job profile included oversight of drug discovery programs in Pharma sector from identification of lead candidates to launch of drug products. It involved leading a team of 30 Toxicologists to monitor safety evaluation of NCEs, OTC compounds and bio-generics to support drug discovery and drug development through various phases viz., screening, identifying hits, IND directed studies, IND submission, non-clinical studies up to POC. The development was carried out by planning, conduct, monitoring pre-IND and NDA GLP studies and interpretation of their results. The studies included in-vivo (rodent and non-rodent) systemic toxicity studies- Acute, repeat dose, MTD studies by various routes.; complete battery of in-vitro and in-vivo genotox studies; Reproduction toxicity studies – Seg I, II III and male fertility studies; Safety pharmacology studies- Core battery and supplementary studies and discovery in-vitro toxicity studies.The planning, direction and execution of studies, budgeting, and logistics was an integral part of the job profile. It further included review of all study protocols, reports, IND write ups and submissions. Moreover the experience involved conduct of studies with SPF animals and in a GLP compliant facility. The job also involved devising strategies for impurity qualification and planning studies thereof. The development of generics was planned for qualification of products by various routes.