Vinodkumar Indure
Mumbai
Summary
Dynamic Result-driven Pharmaceutical Research and Development Director with over 23 years of experience with Global Pharmaceutical Research and Development Organizations. My passion is to Develop Innovative yet Cost-effective Formulations in Niche Therapeutic segments for Treating Diseases with High Unmet Medical Needs e.g. AD, PD, IPF, COPD etc. My strengths are in Developing New Drug Products with Patent Non-Infringing Platform Technology and securing Intellectual Properties for the organization.
Overview
24
24
years of professional experience
2
2
Certification
Work History
Director Pharmaceutical Research and Development
Korea Health Industry Development Institute
08.2018 - Current
- Conceptualized several New Formulation Ideas and Platform Technologies and validated these concepts for their Scientific, Medical, Regulatory and Commercial feasibility
- Executed Turn-key Pharmaceutical Product Development in Niche Therapeutic Indications e.g. CNS, Respiratory, Cardiology, Pain, Fibrosis, Oncology etc.
- Evaluated company documentation to verify alignment with regulatory requirements.
- Increased company revenue by streamlining processes and implementing cost-saving measures.
- Secured key partnerships that contributed to company's overall growth strategy and market reach.
- Improved project efficiency with strategic planning, resource allocation, and time management practices.
- Identified and engaged accredited CRO, CDMO, CRAMS facilities and coordinated Product Development well within timelines and budgetary framework
- Negotiated price and service with customers and vendors to decrease expenses and increase profit.
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Drove business expansion by identifying new markets, conducting research, and developing targeted marketing campaigns.
- Assisted in recruiting, hiring and training of Technical team members.
- Worked closely with organizational leadership and board of directors to guide operational strategy.
- Self-motivated, with strong sense of personal responsibility.
- Evaluated employee performance objectively using established metrics, leading to fair compensation adjustments based on meritocracy principles.
- Demonstrated strong organizational and time management skills while managing multiple projects.
Assistant Director, Drug Discovery and Development
Bioxcel Therapeutics Inc
07.2015 - 07.2018
- Conceptualized several Disruptive New Product Ideas for treating Diseases with High Unmet Medical Needs especially in Therapeutic Areas such as Neuropsychiatry, Neuro-degenerative, Oncology, Immunology, Respiratory, Pain Management, and Orphan Disease Indications
- Developed Patentable Novel Drug Delivery Systems (NDDS) such as Controlled Release Transdermal Patches, Intra-Muscular and Subcutaneous Long-Acting Injections, Oral Thin Films (OTF), and Extended Drug Release Wound Healing Weatherproof Scaffolds, etc
- Prepared Top-level Drug Formulation Development Plans, Regulatory Roadmap, Clinical Development Plans, and budgetary requirements for New Clinical Programs
- Re-Innovated and Re-Purposed several Abandoned Clinical Assets of major Biopharmaceuticals and transformed these "Dead-Assets" into High-Value De-risked Clinical Assets by logically applying new Formulation Technologies and DMPK approaches
- Lead Innovator and Clinical Program Director of BXCL501, BXCL-502, BXCL602, BXCL-702, BXCL-703
- Directed and coordinated Several First in Human Clinical trials and USFDA fast Track Approvals
- Evaluated employee performance and conveyed constructive feedback to improve skills.
- Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement.
- Cultivated positive rapport with fellow employees to boost company morale and promote employee retention.
- Leveraged data and analytics to make informed decisions and drive business improvements.
- Managed department budget to ensure adequate resources for staff development and instructional materials.
- Trained and mentored new employees on industry practices and business operations.
Senior General Manager Innovative Formulations
Getz Pharma Research
11.2012 - 08.2015
- Spearheaded all aspects of Formulation Development including Non-clinical & Clinical Developments, proof-of-concept (POC) studies, Scale-up, Process Validations, CMC Development, Technology Transfer, and managing Client and Team engagements
- Developed New Drug Products (NPD) with Patent Non-Infringing Strategies and Devised High Barrier Patentable proprietary Drug Products
- Developed several First-to-File products, Paragraph-IV 505 (B)(2) products, and Novel Drug Delivery Systems
- Planned and coordinated Clinical Supplies, POC studies, Clinical Trials, and Protocol Development and executed BA-BE Studies in USFAD-approved facilities
- Reviewed CMC, Product Development Reports (PDR) and Clinical Protocols and reverted to Technical Queries from Drug Regulatory Bodies
- Prepared New Formulation Strategies, Top-level Development Plans, and Budgetary requirements and Presenting to the Board of Directors (BOD) and Scientific Advisory Board (SAB) for their buy-in.
- Assisted in recruiting, hiring and training of team members.
- Negotiated price and service with customers and vendors to decrease expenses and increase profit.
- Enhanced team productivity by implementing strategic management practices and fostering a collaborative work environment.
- Identified and qualified customer needs and negotiated and closed profitable projects with high success rate.
- Planned and assigned workload by delegating tasks and directing team members.
- Oversaw the successful execution of large-scale projects from inception through completion, ensuring timely delivery within budget constraints.
- Optimized supply chain operations by identifying inefficiencies in existing processes, implementing corrective measures to streamline workflows.
Vice President Research and Development
Cheminnova Remedies
02.2009 - 10.2012
- Spearheaded Formulation Development, Analytical Method Development and Validations, Scale-up and
- Technology Transfer, Regulatory-Affairs and managed Client and Team engagements for smooth delivery of projects as per agreed timelines and well within budgetary obligations
- Implemented EHS, LIMS, QMS, cGMP, cGLP, ICH Guidelines, SOPs, and Training Programmed for Technical Staff
- Developed and Reviewed CMC, Product Development Reports (PDR), Product Dossiers, Process Validation Protocols, Clinical Study Protocols and reverted to technical queries from drug regulatory bodies
- Identified and troubleshooted Technical Problems during Product Development, Scale-up,Technology Transfer and commercialization of Oral Solid Dosage Forms(OSD), Oral Liquids, Ophthalmic, Injectables, and Lyophilized formulations
- Developed Intellectual Property with Patent Non-infringing Processes Development strategies and applied new formulation technologies to improve the efficacy, safety, and stability of existing products
- Obtained Government of India grants from the Department of Science and Technology for indigenously developed 'Extended Release Oral Liquid' (EROL) drug delivery platform technology.
- Led cross-functional teams for the successful completion of major projects, resulting in increased efficiency and client satisfaction.
- Achieved significant cost savings through supply chain optimization efforts such as strategic sourcing initiatives and logistics improvements.
- Ensured regulatory compliance at all times by implementing robust internal controls systems coupled with proactive monitoring mechanisms.
- Built high-performance teams through effective recruitment practices focused on competency alignment coupled with ongoing performance management processes.
- Launched new products or services in various markets by conducting comprehensive market research studies and tailoring offerings based on customer needs analysis.
Senior Scientist
SK Life Science, Inc., (SK Chemicals Corporation)
09.2007 - 02.2009
- Identified and Implemented New Clinical Programs, Product Life Cycle Management, Regulatory Filing Strategies and Clinical Development Path
- I have a proven track record of success in developing IMPD, IND, NDA 505(b) (2), ANDA, and NDD formulations for Korean, US, CA, AU, NZ & EU markets
- Devised New Formulation strategies, Top-level Development plans, and Budgetary requirements and presented them to the Board of Directors (BOD) and Scientific Advisory Board (SAB)
- Built Product Pipelines, Managed Product Developments, and Complete Project Management from Ideation to Commercialization
- Conducted training program on the SOPs and the regulatory guidelines for pharmaceutical product development
- Identified and engaged accredited CROs and coordinated for timely execution of projects under development.
- Authored and co-authored numerous high-impact scientific publications, showcasing the company''s cutting-edge research.
- Improved research efficiency by streamlining laboratory processes and implementing advanced technologies.
- Participated in strategic planning efforts, helping to set both short-term and long-term goals for the organization.
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
- Advised or assisted in obtaining patents or meeting other legal requirements.
- Conducted experiments in laboratory environment for product development purposes.
- Championed interdisciplinary collaboration across departments, fostering innovation and creative problem-solving among colleagues.
- Worked well in a team setting, providing support and guidance.
Senior Scientist
Aurobindo Pharma Ltd
03.2006 - 09.2007
- Worked as Group Leader in Formulation Research and Development Department for ANDA (Generic) and NDA formulations Development for US, CA, EU and AU markets.
- Planned and executed Pre-formulation Studies, Prototype formulation development, formula optimization, process optimization and Stability Studies.
- Identified and troubleshooted critical problems during formulation developments.
- Developed patent non-infringing strategies to circumvent the existing formulation patents.
- Developed Expertise in First-to-File (FTF), Paragraph- 4 filing of formulations and managed complete formulation portfolio.
- Complete Project Management, Reviewing & Approval of Product Development Reports and Regulatory Submission Dossiers.
- Coordinated with multi-disciplinary teams for timely execution of projects under development and undertaken Training programs on the SOPs and the regulatory updates for Formulation Development Team.
- Involved insetting up a State-of-Art, Brand New Formulation R&D Center and raised CAPEX for Laboratory Equipments and did proper installations as per IQ, OQ & PQ protocols.
- Participated in strategic planning efforts, helping to set both short-term and long-term goals for the organization.
- Mentored junior scientists and provided guidance on project management, resulting in increased productivity and professional growth.
- Improved research efficiency by streamlining laboratory processes and implementing advanced technologies.
- Authored and co-authored numerous high-impact scientific publications, showcasing the company''s cutting-edge research.
- Developed innovative solutions to complex scientific problems, enhancing the company''s intellectual property portfolio.
Senior Research Associate
Pfizer, Orchid Healthcare Ltd
01.2003 - 03.2006
- Responsible for Generic Formulation Development (ANDAs) for USA & EU markets and related activities match the timelines given for product launch
- Undertaken Scale-up and Technology transfer to Commercial Production Site for over two dozen offormulations which includes OSD, Injectables, Topical Formulations and Lyophilized formulations
- Undertaken Formula Optimization, Process Optimization and Validation batches and prepared validation
- Protocols
- Prepared Cost-Effective & Quality Formulations and filed Patents on Innovative formulations
- Worked in World-class WHO, cGMP and USFDA, UKMHRA, TGA and MCC-approved facilities.
Senior Executive, Product Development Lab
Mylan Laboratories (Orchid Healthcare)
10.1999 - 01.2003
- Prototype Formulation Development, Scale-up of OSD and Liquid Orals and Optimization of Formulation and Process
- Pre-formulation and Stress-Studies for choosing proper excipient Stability Testing and self-life assessment for formulations as per ICH Guidelines
- Innovator's Product Physico-chemical Characterization and reverse engineering for elucidation of probable excipient, chemical content and impurities profile to arrive at target Formulation Profile and
- Product Packaging Development and trade dress development
- Preparation of in-process specifications, in-house specifications and finished product specifications
- Enhanced product quality and reduced time-to-market by streamlining processes and optimizing resources.
- Launched successful products by identifying customer needs and translating them into product features.
- Implemented robust quality assurance measures to minimize defects and enhance end-user satisfaction.
- Conducted market research to identify new opportunities and target markets.
- Developed innovative products by collaborating with cross-functional teams and conducting thorough market research.
Education
PhD, Honorary - Pharmaceutical Sciences
Westbrook University
USA02.2009
Master of Pharmacy - Pharmaceutics
Rajiv Gandhi University of Health Sciences
Bengaluru, India03.2000
Bachelor of Pharmacy - Pharmacy
Dr. Babasaheb Ambedkar Marathwada University
Aurangabad, India05.1997
Skills
- Ideation and New Product Development
- Platform Technology Development
- Scale-up and Technology Transfer
- R&D Team Leadership
- Drug Delivery System Development
- Process Development, Optimization and Validation
- Project Management
- Product Life-cycle Management
- Clinical Trials
- Team Management
- Formulation Development and Commercialization
Languages
English
Hindi
Marathi
Kannada
PHARMACEUTICAL RESEARCH AND DEVELOPMENT EXPERTISE
- Expertise in the development of Oral Solid Dosage Forms (OSD), Oral Liquids, Injectables, Transdermal Patches, Pre-filled Syringes, Long Acting Injectables, Controlled Release Formulations and NDDS
- Innovative Patentable Formulations and Platform Technology Development
- CMC Development, Formulation Lifecycle and Product Portfolio Management
- Conceptualizing New Formulation Ideas and Commercial Feasibility Assessment
- Complete Project Management, Regulatory Strategies and Team Management
- Re-formulation and Re-Purposing opportunities for Clinical Assets
- Proto-type Development, Formula and Process Optimization, Scale-up, Method Validation, Stability Studies, POC, Preclinical and Clinical Studies, Technology Transfer and Commercialization
- WHO, cGMP, ICH Guidelines, Regulatory requirements of USFDA, EMA, QMS, SOPs and EHS training
- CRO, CDMO, CRAMS Identification and KOL engagement
- Top-level Development Plans, Budgetary Requirements and Proposals for Grants
- National and International and multicultural work experience
Accomplishments
- (IN2016/11031612) ”An Oral Modified Release Formulation Of Dopamine Agonists And Method Of Use”
- (IN2017-1103-6678) “weekly once, Electro-spunned Transdermal Composite Patch Of Dopamine Agonist For Treating Parkinson's Disease (PD) And Rest-less Leg Syndrome”
- (IN2017-1103-1032) “A Novel Modified Release Oral Suspension Of Ropinirole With Biphasic Release Profile To Treat RLS & Pd Symptoms
- (WO2014108791A1) “Ready-To-Use Injectable Formulation Of Chlorothiazide”
- (US20150320680A1)“Injectable Composition Containing Chlorothiazide”
- (257/Che/2004) “Stable Ready To Use Injectable Composition Of Selective Cox-2 Inhibitory Drugs”
- (US2008/0206338) “Controlled Release Formulations Of An Alpha- Adrenergic Receptor Antagonist”
Certification
- Big Data Analytics Certified
- Project Management Certified
Affiliations
- American Association of Pharmaceutical Scientists (AAPS)
- Indian Pharmaceutical Association (IPA)
- Drug Information Association (DIA)
- Controlled Release Society (CRS)
- Nanotechnology World Network (NWN)
- Society for Clinical Data Management (SCDM)
- American Association of Indian Pharmaceutical Scientists (AAIPS)
- International Association for Pharmaceutical Technology, Germany (APV)
Timeline
Director Pharmaceutical Research and Development
Korea Health Industry Development Institute
08.2018 - Current
Assistant Director, Drug Discovery and Development
Bioxcel Therapeutics Inc
07.2015 - 07.2018
Senior General Manager Innovative Formulations
Getz Pharma Research
11.2012 - 08.2015
Vice President Research and Development
Cheminnova Remedies
02.2009 - 10.2012
Senior Scientist
SK Life Science, Inc., (SK Chemicals Corporation)
09.2007 - 02.2009
Senior Scientist
Aurobindo Pharma Ltd
03.2006 - 09.2007
Senior Research Associate
Pfizer, Orchid Healthcare Ltd
01.2003 - 03.2006
Senior Executive, Product Development Lab
Mylan Laboratories (Orchid Healthcare)
10.1999 - 01.2003
PhD, Honorary - Pharmaceutical Sciences
Westbrook University
Master of Pharmacy - Pharmaceutics
Rajiv Gandhi University of Health Sciences
Bachelor of Pharmacy - Pharmacy
Dr. Babasaheb Ambedkar Marathwada University
- Big Data Analytics Certified
- Project Management Certified
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