Chandralal (Lal) Weerasinghe

Chandralal (Lal) Weerasinghe Email and Phone Number

Independent Pharmaceuticals Professional @ Freelance
Groton, CT, US
Chandralal (Lal) Weerasinghe's Location
Groton, Connecticut, United States, United States
Chandralal (Lal) Weerasinghe's Contact Details

Chandralal (Lal) Weerasinghe work email

Chandralal (Lal) Weerasinghe personal email

Chandralal (Lal) Weerasinghe phone numbers

About Chandralal (Lal) Weerasinghe

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

Chandralal (Lal) Weerasinghe's Current Company Details
Freelance

Freelance

View
Independent Pharmaceuticals Professional
Groton, CT, US
Chandralal (Lal) Weerasinghe Work Experience Details
  • Freelance
    Independent Pharmaceuticals Professional
    Freelance
    Groton, Ct, Us
  • Vets Equity Group, Llc.
    A Member Of The Board Of Directors Of Vets-Plus Inc, A Subsidiary Of Dw Healthcare Partners.
    Vets Equity Group, Llc. Dec 2021 - Present
    Menomonie, Wisconsin, United States
    Provide product development strategies for approval by FDA, expand manufacturing capabilities, accelerate new product commercialization, and scale up operations.
  • Freelance
    Independent Pharmaceuticals Professional
    Freelance Aug 2014 - Present
    Vetsplus Inc. Wisconsin
    Provided 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..
  • Vets Plus, Inc.
    Consultant
    Vets Plus, Inc. Jun 2014 - Present
    Providing regulatory guidance on developing veterinary drugs minor and major species.
  • Isoplexis
    Independent Consultant
    Isoplexis Mar 2015 - Jun 2015
    New Haven, Connecticut
    Provided guidance on implementing FDA's Good Laboratory Practices, prepared a guidance document, and advice on developing SOPs.
  • Pfizer Inc
    Director, Intellectual Property Strategy Management Group-Legal Division
    Pfizer 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.
  • Pfizer Inc
    Assistant Director, Intellectual Property Strategic Management Group-Legal Division
    Pfizer 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.
  • Pfizer Inc
    Senior Technical Advisor, Contract Research Activities, Veterinary Medicine Safety And Metabolism
    Pfizer 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
  • Pfizer Inc
    Manager, Contract Research Activities, Animal Health Safety And Metabolism
    Pfizer 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.
  • Pfizer Inc
    Manager, Envirornmental Safety
    Pfizer 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).
  • Smithkline Beecham Animal Health (Sbah), West Chester, Pa
    Manager, Environmental Safety And Mass Spectrometry
    Smithkline 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).
  • Smithkline Beckman Animal Health Products, West Chester, Pa
    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.
  • Midwest Center For Mass Spectrometry, U Of Nebraska, Lincoln, Ne
    Senior Research Associate (Group Leader)
    Midwest Center For Mass Spectrometry, U Of Nebraska, Lincoln, Ne 1983 - 1986
    Managed 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

Pharmaceutical Industry Mass Spectrometry Sop Intellectual Property Glp Regulatory Submissions Bioanalysis Cro Hplc Analytical Techniques Chemistry Drug Development Clinical Trials Fda Biotechnology Validation Regulatory Affairs Technology Transfer Life Sciences Clinical Development Oncology Biopharmaceuticals Drug Discovery Quality Assurance

Chandralal (Lal) Weerasinghe Education Details

Frequently Asked Questions about Chandralal (Lal) Weerasinghe

What company does Chandralal (Lal) Weerasinghe work for?

Chandralal (Lal) Weerasinghe works for Freelance

What is Chandralal (Lal) Weerasinghe's role at the current company?

Chandralal (Lal) Weerasinghe's current role is Independent Pharmaceuticals Professional.

What is Chandralal (Lal) Weerasinghe's email address?

Chandralal (Lal) Weerasinghe's email address is cw****@****ape.net

What is Chandralal (Lal) Weerasinghe's direct phone number?

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.

What are some of Chandralal (Lal) Weerasinghe's interests?

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.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.