Dr. Gopinath Ramakrishnan

Sr. Pharmaceutical Researcher

esearcher

Career Objective:

Internationally recognized and accomplished Pharmaceutical Research Professional with 19Years+ of experience in the Research and Development. Committed to lead the design, strategy and implementation of Quality Operations ensuring compliance with all relevant regulations.

Seeking an opportunity to join an established team of professionals as suitable Leadership role and utilize my knowledge & expertise of Research and Development expertise and procedure.

A pragmatic leader with more than nineteen years of experience in pharmaceutical research and development field in UAE, GCC, and India, inclusive of bioequivalence studies, PK/PD studies, DMPK, Dissolution, IVRT studies, Toxicology, Bioanalysis, and regulatory affairs.

• Expertise in Bioequivalence studies for simple and complex generics, PD and Clinical endpoint studies, Biosimilar development, NCE development, Pharmacokinetics, Regulatory Affairs, preclinical development, In-vitro testing and in-vitro in-vivo correlation (IVIVC) etc.

• More than 200 bioequivalence studies were coordinated by me, right from selection of CRO, quote negotiation, study design, review of BE protocol, monitoring of the studies and review of BE report. I have also coordinated Toxicological studies NCEs and Biosimilars.

• Published more than 20 original research papers in international and national peer review journals with a good impact factor.

• High level negotiation experience with CROs, analytical laboratories, scientific research organizations and Regulatory experts from CDSCO, USFDA, SFDA. JFDA & MOHs. Experienced in dealing with multicultural teams from diverse backgrounds across different geographies.

• Currently heading Bioequivalence and Clinical Research function at Julphar and responsible for Dissolution study, IVRT study and bioequivalence study. Besides this I am also responsible for resource allocations, prioritizations and planning of projects, managing clinical development/IVRT study budgets and decision making based on regulatory guidance, scientific facts and figures and providing response to regulatory queries.

• Excellent organizational and time management skills with great ability to lead and manage multiple complex projects.

• Ability to develop strategic plans, recommended course of action and implement, and ability to work effectively in cross functional teams and successfully leverage internal and external partnerships.

• Ability to effectively synthesize, interpret and present scientific information to both internal stakeholders and external medical community.

• Ability to work proactively and effectively, with creative problem-solving skills, thorough knowledge and understanding of FDA, GCP, and ICH regulations and guidance.

• Doctor of Philosophy (PhD)

Vinayaka Mission’s Research Foundation, India. Passing 2022

• Master of Pharmacy

Tamil Nadu Dr. M.G.R. Medical University, Chennai, India. Passing 2004

• Bachelor of Pharmacy

Tamil Nadu Dr. M.G.R. Medical University, Chennai, India. Passing Year 2000 Contact Details

English

Tamil

Malayalam

adyalj@r.postjobfree.com

+971-**-***-**** (UAE)

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LinkedIn Profile

Ras al-Khaimah, UAE

Clinical Research

Research & Development

Bioequivalence & Bioavailability

IVRT/IVPT Studies

Bioanalysis

Generic Product Development

In-vitro in-vivo correlation (IVIVC)

Regulatory Compliance

Drug Metabolism & Pharmacokinetics

Good Operation Skills

Customer Relationships CRM

Ability to Work with Functional Team

Ability to Work Independently

GLP/GCP/GMP Guidelines

Phoenix WinNonlin IVIVC kit & NCA

Business Communication

Languages

Areas of Expertise

Summary of Experience

Educational Qualifications

Qualifications

+91-915-***-**** (India)

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Indian Citizen

Manager – Research and Development, (Bioequivalence, Clinical & Invitro Studies) Gulf Pharmaceutical Industries (Julphar), Ras Al Khaimah, UAE. Nov 2014 – Present Responsibilities;

• Design BE/clinical studies according to current standards and guidance applicable to conduct of BE studies/clinical studies.

• Review & approve the clinical protocol and to review and approve Informed Consent Forms (IFCs) and Case Report Form (CRFs) for BE studies/clinical studies.

• Responsible for Budget Assessment; Study Feasibility; Study Designing; Medical Writing; CRO/Vendor Selection; System Audit and CRO/Site Qualification Visits; Project Management

• Work with the CRO to ensure that all deliverables are received as per the agreed upon timelines.

• Evaluation of RLD based on literature/experimental data and identify critical bioavailability attributes.

• IVIVC assessment in support of formulation/Process change

• Preparation of Bio waivers report based on modeling and simulation approach for regulatory submission.

• Assist in the response to deficiency letters from authorities and audit comments.

• Design / utilize state-of-art invitro methodology and interpret results, especially novel dissolution, bio relevant, discriminatory, and multimedia, towards oral solid drug development.

• Manages IVRT/IVPT studies for topical products.

• Manages clinical trial budget.

• IVIVC modeling in support of dissolution method development and setting up clinically relevant specifications.

• Calculation of PK parameters using WinNonlin

• Provide direction, support, and policy development recommendations to bioequivalence and dissolution team.

• Evaluate statistical analysis for the outcome of the pilot and pivotal BE studies. Lab Manager in Bioequivalence Center

First Gulf Pharmaceuticals Center, UAE. Jan 2014 to Sept 2014 Responsibilities:

• Developed and established bioanalytical testing facility.

• Coordinated with sponsors and cross functional departments for bioequivalence study actives. Group Leader in Bioanalytical Lab

Ethics Bio Lab Private Limited (Known as PAR Bio science), Chennai, India. Aug 2012 to Jan 2014 Responsibilities:

• Spearhead a team of 20+ bioanalytical scientists to develop and validate bioanalytical methods to support Bioequivalence/Bioavailability study sample analysis by LC-MS/MS

• Oversee bioanalytical activities and projects to meet strategic and project goals.

• Assisted to setup state of the art bioanalytical facility and clinical facility for conducting BE studies.

• Established operational systems to meet regulatory requirements. Research Associate in Biology

Orchid Chemicals & Pharmaceuticals Limited, Chennai, India. Aug 2009 - July 2012 Responsibilities:

• Develop and validate bioanalytical methods to support Preclinical studies in new drug discovery by Q- trap LC-MS/MS

• Developed an established system for metabolite identification and profiling to support NCE screening.

• Calculated pharmacokinetic parameters using WinNonlin.

• Worked closely with synthetic chemistry team for lead identification and screening.

• Functioned as a study director for bioanalytical phase of OECD GLP Toxicity studies. Professional Work Experience

• Helped to build a state of the art bioanalytical and drug metabolism facility to support in house activities.

Group Leader in Bioanalytical Department

Huclin Research Ltd, Chennai, India. Nov 2005 to July 2009 Responsibilities:

• Developed and validated bioanalytical methods to support bioequivalence studies.

• Involved in bioequivalence study samples processing and analysis.

• Supervises technical staff, including work assessment and performance monitoring. Research Associate

Center for Advance Drug Research & Testing (CADRAT), Ooty, India. April 2004 to Oct 2005 RECENT PUBLICATIONS

1. Gopinath R, Narenderan ST, Kumar M, Babu B. A sensitive liquid chromatography–tandem mass spectrometry method for quantitative bioanalysis of fingolimod in human blood: Application to pharmacokinetic study. Biomedical Chromatography. 2020 ;e4822. https://doi. org/10.1002/bmc.4822.

2. Gopinath et al. Development and validation of a liquid chromatography-tandem mass spectrometric method for the determination of lenalidomide in human plasma and its application on bioequivalence studies, Journal of Analytical Science and Technology (2019) 10:33 3. R.Gopinath and M. Kumar Development and Validation of an LC-MS/MS Method for Estimation of Rivaroxaban in Human Plasma, Indian Journal of Natural Sciences, Vol.12 / Issue 69 / December / 2021

Abstracts:

1. F. A. Ahamed, S. Chandrasekaran, R. Gopinath, A. A. Khan, B. Kannan, S. Rajagopal, V. Kachhadia, S. Narayanan, B. Gopalan and N. Surendran, Pre-clinical development of OCID 4681-S-01: A Novel HDAC inhibitor for oncology indications, FIP Pharmaceutical Sciences 2010 World Congress in Association with the AAPS Annual Meeting and Exposition in New Orleans. References are available on request!

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