Chandralal (Lal) Weerasinghe Email and Phone Number
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Chandralal Weerasinghe, LLC offers consulting services in the following areas:PREPARATION OF SUITABILITY PETITIONS TO OBTAIN PERMISSIONS FROM FDA TO SUBMIT ANDA/ANADASINTELLECTUAL PROPERTY STRATEGY MANAGEMENTFREEDOM TO OPERATE (FTO) ANALYSISREGULATORY GUIDANCE ON SUBMITTING ANADAs TO US FDA-From JINAD to ApprovalENVIRONMENTAL IMPACT ASSESSMENT (EIA)REGULATORY/COMPLIANCE RELATED TO HUMAN/VETERINARY DRUG DEVELOPMENT:EXPERIENCE AND EXPERTISEChandralal Weerasinghe, Ph.D., has over 24 years in leadership and technical positions at Pfizer, Inc. and SmithKline Beecham Animal Health. Prior to that he managed the trace organic Analysis Group at Midwest Center for Mass Spectrometry attached to University of Nebraska. His expertise spans a diverse area in the pharmaceutical industry starting from molecular profiling, biotransformation, environmental impact assessment, and human food safety to intellectual property strategy management. He held positions with increasing responsibility in both technical and management. He is a strategic thinker with good leadership skills and his cross-functional expertise will help him to provide valuable and customized solutions to a variety of clients who can benefit from his expertise.Specialties: Life cycle management of pharmaceuticals Intellectual property strategy managementMarket exclusivity of drugs and patent term extensionsPatent portfolio management Environmental impact assessment of pharmaceuticalsHuman food safety of animal health drugs. Product defense activities at regulatory agencies, USA and EuropeTrace organic analysis of persistent organochlorines by HRGC/HRMSBioanalytical methods; HPLC, GC, HPLC/MS and GC/MS including wet chemistry
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Independent Pharmaceuticals ProfessionalFreelanceGroton, Ct, Us
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A Member Of The Board Of Directors Of Vets-Plus Inc, A Subsidiary Of Dw Healthcare Partners.Vets Equity Group, Llc. Dec 2021 - PresentMenomonie, Wisconsin, United StatesProvide product development strategies for approval by FDA, expand manufacturing capabilities, accelerate new product commercialization, and scale up operations.
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Independent Pharmaceuticals ProfessionalFreelance Aug 2014 - PresentVetsplus Inc. WisconsinProvided advice on intellectual property strategies for drug candidates under development, on market assessment for parasiticides in Emerging Markets, and guidance related to submission of regulatory dossiers under NADA and ANADA pathways to US FDA..
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ConsultantVets Plus, Inc. Jun 2014 - PresentProviding regulatory guidance on developing veterinary drugs minor and major species. -
Independent ConsultantIsoplexis Mar 2015 - Jun 2015New Haven, ConnecticutProvided guidance on implementing FDA's Good Laboratory Practices, prepared a guidance document, and advice on developing SOPs.
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Director, Intellectual Property Strategy Management Group-Legal DivisionPfizer Inc Jan 2005 - Dec 2010• Conducted Life cycle management of in-line products and advanced phase (after POC) candidates.• Responsible for estimating loss of exclusivity (LOE) for products / candidates (in-line and competitors) globally; instrumental in developing the LOE database for Pfizer, developing guidelines to assess LOE and responsible for managing the LOE database• Provided Loss of Exclusivity estimates of products and candidates for Investor Relations Group at Pfizer• Led the legal department efforts in candidate portfolio prioritization related to business development • Served as the CNS, Oncology and Urology and Sexual Health TA Lead for the group.• Developed IP life cycle plans for products under CNS and Urology and Sexual Health areas.• Led the assembly of LOE information (globally) for products / candidates under CNS and Urology and Sexual health areas.• In partnership with Patent TA Leads, provide IP related input to development and commercial teams. -
Assistant Director, Intellectual Property Strategic Management Group-Legal DivisionPfizer Inc 2001 - 2005• Conducted Life cycle management of in-line products and advanced phase (Phase III onwards) candidates.• Worked with project teams to improve awareness of intellectual property and to formulate action plans to capture IP around candidates and in-line products to enhance the value of the products.• Worked in partnership with attorneys assigned to various therapeutic areas to develop IP related strategies/action plans to bring value to products and candidates under development.• Worked with information management to keep abreast of the competitor landscape to ensure freedom to operate and to help gain maximum exclusivity for the products and candidates. -
Senior Technical Advisor, Contract Research Activities, Veterinary Medicine Safety And MetabolismPfizer Inc 1999 - 2001• Managed ADME and Environmental Fate and Effects studies of drug candidates conducted at Contract Research Organizations (CROs) including study/program design, contract negotiations, monitoring, technical reviews, report writing, and coordination of QA audits. • Conducted sponsor-monitored method trials in collaboration with US FDA for post-market surveillance of dug residues in edible tissues.• Developed global drug development strategies for regulatory submissions.• Helped setting up strategic goals in the drug development area for the department.• Prepared residue chemistry/analytical method validation sections (expert reports) for regulatory submissions.• Responded to queries and participated in product defense (in person) at regulatory agencies in the USA and Europe.• Maintained departmental SOPs and Guidelines (GLP and cGMP).• Served on Global Development Teams and Full development Teams for drug development.• Served on QA Advisory Panel and coordinated GLP activities.• Led the department’s effort on compliance with 21CFR part 11(E-Sig Rule).• Supervised and trained technical staff -
Manager, Contract Research Activities, Animal Health Safety And MetabolismPfizer Inc 1997 - 1999• Managed ADME and Environmental Fate and Effects studies conducted for AHSM at Contract Research Organizations (CROs) including study / program design, contract negotiations, monitoring, technical reviews, coordination of QA audits.• Developed global drug development strategies.• Helped setting strategic goals for the department.• Prepared residue chemistry / analytical method validation sections (expert reports) for regulatory submissions and respond to queries.• Responded to queries and participated in product defense at regulatory agencies globally.• Maintained (including revisions) departmental SOPs and Guidelines.• Served on Global Development Teams and Full development Teams.• Served on QA Advisory Panel and coordinate GLP activities for AHSM.• Served on Strategic Resourcing Initiative for Central Research.• Supervised and trained technical staff. -
Manager, Envirornmental SafetyPfizer Inc 1995 - 1997• Managed projects to assess environmental impact of drugs, participated in project team activities for drug development, trained and supervised staff.• Planned strategies for environmental impact assessment of drugs. Prepared technical reports for regulatory (US and EU) submissions.• Evaluated contract laboratories for outsourcing of studies. Designed and monitored environmental fate and effect studies. Prepared the environmental impact assessment document of products under development for regulatory submission globally.• Responded to queries on submissions and participated in product defense at FDA and VMD (UK), CNEVA (France) and BMAS (Germany) (heavily involved in the area of environmental risk assessment). -
Manager, Environmental Safety And Mass SpectrometrySmithkline Beecham Animal Health (Sbah), West Chester, Pa 1990 - 1995• Managed projects in environmental safety and drug metabolism for drug candidates, played a leading role in drug development strategies, working with regulatory groups to develop submission strategies for regulatory agencies, trained and supervised staff, prepared budgets for capital expenditure.• Conducted studies to characterize drugs produced by fermentation (e.g. glycopeptides), degradation products (for CMC section) and drug metabolites by mass spectrometry. Developed and validated tissue/milk residue methods for regulatory surveillance of products registered globally. Developed stability indicating assays. Prepared technical reports for regulatory (US, EU, Australian) submissions.• Evaluated contract laboratories for outsourcing of studies. Planned strategies for environmental impact assessment of drugs. Designed and monitored environmental fate and effect studies. Prepared the environmental impact assessment document of products under development for regulatory submission globally.• Responded to queries on submissions and Participated in product defense at FDA and VMD (UK), CNEVA (France) and BMAS (Germany) (heavily involved in the area of environmental risk assessment and product impurity characterization).
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Associate Senior Investigator (Bioanalytical)Smithkline Beckman Animal Health Products, West Chester, Pa 1986 - 1990• Directed studies in drug metabolism, residue depletion, pharmacokinetics, and environmental fate and effects studies related to the development of new animal drugs. The activities included designing protocols, conducting (or monitoring fate and effects studies), writing technical reports for NADA and European regulatory dossier (ERD). Discussed developmental strategies of drugs with the CVM of the U.S. FDA. Maintained the mass spectrometry resource.• Developed methods (e.g. wet chemistry, GC, HPLC, mass spectrometric, radioassay) for the isolation and characterization of drugs and their metabolites from tissues and fluids, and for drug impurities / degradation products.
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Senior Research Associate (Group Leader)Midwest Center For Mass Spectrometry, U Of Nebraska, Lincoln, Ne 1983 - 1986Managed the organic trace analysis program by fulfilling research needs of outside scientists by providing analytical services to U.S. EPA, U.S.Veterans Administration, Department of Natural Resources, Fish and Wild Life and the private sector. Supervised and trained technical staff. Participated in research proposal writing for funding of the facility. Prepared study protocols. Developed analytical methods for high resolution GC / MS analysis of dioxins and furans at trace level (ppt to ppq) from a variety of matrices. Participated in interlaboratory studies of method validations (EPA, industry and Universities). Wrote technical reports. Published results. Presented results at scientific meetings.
Chandralal (Lal) Weerasinghe Skills
Chandralal (Lal) Weerasinghe Education Details
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University Of Wales, CardiffAnalytical Chemistry -
Chemistry -
Chemistry, Biology And Mathematics
Frequently Asked Questions about Chandralal (Lal) Weerasinghe
What company does Chandralal (Lal) Weerasinghe work for?
Chandralal (Lal) Weerasinghe works for Freelance
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Chandralal (Lal) Weerasinghe's current role is Independent Pharmaceuticals Professional.
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Chandralal (Lal) Weerasinghe's direct phone number is +186073*****
What schools did Chandralal (Lal) Weerasinghe attend?
Chandralal (Lal) Weerasinghe attended University Of Wales, Cardiff, University Of Sri Jayewardenepura, University Of Sri Jayewardenepura.
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Chandralal (Lal) Weerasinghe has interest in Aerobics, Exercise, Home Improvement, Reading, Gourmet Cooking, Sports, Home Decoration, Health, Children, Cooking.
What skills is Chandralal (Lal) Weerasinghe known for?
Chandralal (Lal) Weerasinghe has skills like Pharmaceutical Industry, Mass Spectrometry, Sop, Intellectual Property, Glp, Regulatory Submissions, Bioanalysis, Cro, Hplc, Analytical Techniques, Chemistry, Drug Development.
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