Innovative Drug Delivery : Design, Profiling and Potential of Novel Therapeutics

Dr. Neelesh Kumar Mehra is working in the Department of Pharmaceutics, National Institute of Pharmaceutical Education & Research (NIPER), Hyderabad, India. He earned PhD from Dr. H.S. Gour University, Sagar and PostDoc from Irma Lerma Rangel College of Pharmacy, Texas A & M Health Science Centre, Kingsville, TX, USA. He served as Manager in Product Development, Sentiss Research Centre, Sentiss Pharma Pvt Ltd. Gurgaon for development, scale-up and technology transfer of complex ophthalmic, inhalation and optic pharmaceutical products. He received ‘TEAM AWARD’ for successful commercialisation of Ophthalmic Suspension product.  He also received the “Shakuntala Amir Chand Award” in the clinical sciences from Indian Council of Medical Research (ICMR), New Delhi.

He has authored more than 130 peer-reviewed publications in high repute International Journals, and >50 international book chapter contributions.

Dr. Mehra has h-index 44 with i10index 88 and total cumulative impact factor around 600 with more than 5000 citation. He has 04 granted and 04 filed patent on manufacturing process and composition to improved therapeutic efficacy for topical delivery. He has supervised 05 PhD and 10 PhD are currently working. He has guided 36 Master Students for their dissertations/research projects. He has received numerous outstanding awards including Young Scientist and Team Awards for their research output. He is a peer reviewer of various international Journals and publishers.

He recently published edited book on Multifunctional nanocarriers, Biopharmaceutical and nanotechnology. He has rich research and teaching experience in the formulation and development of complex, innovative ophthalmic and injectable biopharmaceutical products including micro- and nanotechnologies for regulated market and so on.

He is the member of the various government and institutional bodies to contribute in the science and technology. He is also a peer-reviewer for the various international journals and government agencies. He is the editorial board of the Scientific Report Journal being publish by the Nature Sciences.

According to announcement by the Stanford University Scientists based on the database and basis of standardized citation indicators, Dr. Mehra name is included in top 2% scientists in the world in the area of Pharmacology and Pharmacy, consecutively for 3 years.  

Dr. Neelesh Kumar Mehra is working in the Department of Pharmaceutics, National Institute of Pharmaceutical Education & Research (NIPER), Hyderabad, India. He earned PhD from Dr. H.S. Gour University, Sagar and PostDoc from Irma Lerma Rangel College of Pharmacy, Texas A & M Health Science Centre, Kingsville, TX, USA. He served as Manager in Product Development, Sentiss Research Centre, Sentiss Pharma Pvt Ltd. Gurgaon for development, scale-up and technology transfer of complex ophthalmic, inhalation and optic pharmaceutical products. He received ‘TEAM AWARD’ for successful commercialisation of Ophthalmic Suspension product.  He also received the “Shakuntala Amir Chand Award” in the clinical sciences from Indian Council of Medical Research (ICMR), New Delhi.

He has authored more than 130 peer-reviewed publications in high repute International Journals, and >50 international book chapter contributions.

Dr. Mehra has h-index 44 with i10index 88 and total cumulative impact factor around 600 with more than 5000 citation. He has 04 granted and 04 filed patent on manufacturing process and composition to improved therapeutic efficacy for topical delivery. He has supervised 05 PhD and 10 PhD are currently working. He has guided 36 Master Students for their dissertations/research projects. He has received numerous outstanding awards including Young Scientist and Team Awards for their research output. He is a peer reviewer of various international Journals and publishers.

He recently published edited book on Multifunctional nanocarriers, Biopharmaceutical and nanotechnology. He has rich research and teaching experience in the formulation and development of complex, innovative ophthalmic and injectable biopharmaceutical products including micro- and nanotechnologies for regulated market and so on.

He is the member of the various government and institutional bodies to contribute in the science and technology. 

2018-2023 Supervisor: Dr. Amit Nargotra, PhD scholar Principal Scientist, Discovery Informatics lab Natural Product and Medicinal Chemistry Division CSIR–Indian Institute of Integrative Medicine, Jammu Research focus: Application of computational studies for identification and elucidation of the mode of inhibition of potential inhibitors of Escherichia coli UDP-N-acetylglucosamine enolpyruvyl transferase (MurA) enzyme. 2013–2015 M.S. (Pharmacoinformatics) National Institute of Pharmaceutical Education and Research, Kolkata. CGPA 8.84/10 2008-2012 Bachelor of Pharmacy Department of Pharmaceutical Sciences (Kumaun University) Percentage 72.6% Research Experience  Computational Research Scientist (Part time) Oct 2022-July 2023; (Full time) July 2023-Present Drug Chemistry Research Centre (DCRC labs), Indore, Madhya Pradesh, India.

Areas of Expertise • Molecular Docking (The Schrödinger Drug Discovery Suite, FlexX, GOLD and PyRx) • Molecular Dynamics Simulation (Desmond, Gromax) • Pharmacophore and QSAR modeling (Phase, OChem) • Similarity Search (ChemAxon) • Python (Numpy, Pandas, Matplotlib) • Machine Learning (RDKIT, DeepChem, Scikit learn, Keras, Tensorflow) • Data analysis

Ph.D. Department of Pharmaceutical Sciences, MLSU Udaipur Period Mohan Lal Sukhadia University, Udaipur (Raj.)

M. Pharm School of Pharmaceuticals Sciences ,UTDs RGPV, Bhopal 2013-2019 Rajiv Gandhi Proudyogiki Vishwavidyalaya, Bhopal

B. Pharm Mahrishi Arvind College of Pharmacy, Jaipur University of Rajasthan, Jaipur 2008-10 2001-06

Senior JNV Tilwasni, Jodhpur C.B.S.C.(AISSCE) Secondary JNV Tilwasni , Jodhpur 1998-99

C.B.S.C. (AISSE) Awards & Achievement’s 1996-97

Awarded with fellowship for training of young scientist of MP council of science & technology in 29 MP Young Scientist Congress 2014.

❖ Postgraduate scholarship by Ministry of Human Resources and Development, Govt. of India

❖ GPAT -2020 2012, 2011, 2010, 2008 2007 qualified

15 year teaching experience

32 Research Publication

06 Patents

Managing the filing and approval processes for marketing applications and post-approval modifications is related to having 3 years of experience in regulatory affairs and a degree in pharmaceutical science. extremely well-organized, meticulous, and able to prioritize things and schedule them so that they are completed ahead of schedule. Good verbal, written, and interpersonal communication skills in addition to sound judgment.

Review, compilation & submission of the dossier and query responses for New Marketing Authorization (MA) application for EU & UK market for different dosage form like: Solid, Oral liquid and Topical.

❖ Review, compile & submission of dossier by international recognition procedure (IRP) in UK market. ❖ Examine & evaluate the safety evaluation of new product excipients using the IIG (USFDA), EFSA, and JECFA databases and also based on public literature.

❖ Examine and draft the scientific recommendations based on scientific literature regarding the product's new strength or formulation for the UK and EU markets.

❖ Review and assess the premarket requirement for new product launching like; requirement of BE on lower or higher strength and product can be bio-waive or not via referring scientific (PAR) and public literature.

❖ Compilation, review & submission of post approval changes (Type IA, IAIN, IB & II variation), Article 61 (3) notification, sunset clause and change of ownership.

❖ Compilation and review of administrative and CMC documents for EU & UK market

❖ Compilation and review of labeling documents (SmPC, PIL & other labelling documents) in-line with QRD & review of Artwork/Mock-ups

❖ Review of plant documents: Analytical method validation (report & protocol) and Analytical method transfer, Batch records (BMR & BPR), Specification, Analytical procedure, Certificate of Analysis (COA), Stability study protocol & Report, Process validation protocol & report, Hold time & In-use stability study Protocol & report, Registered Product Detail (RPD), Risk assessment for Elemental impurities & Nitrosamine impurities for EU & UK market.

❖ Tracking Certificate of suitability (CEP) through EDQM certification database.

❖ Coordination with clients to collect the documents/information regulatory submission.

❖ Coordination with QA team to collect the documents/information for regulatory submission and support in compiling PQR reports.

❖ Evaluation and review of change controls and support to implement the changes proposed in change control.

❖ Experience in submission of MA application, variation application through CESP & MHRA portal, Regulatory publishing software – Educe Management

Industrial Experience 

❖ Working as Regulatory Associate, in Wave Pharma Regulatory Services Ltd. (Eiman/Ursceal Pharma Pvt Ltd.) Noida, India [November 2022 – Till]

❖ 1-month Industrial Training as QA executive from Innova Captab Pvt, Ltd, Baddi, Himachal Pradesh.

❖ 1-month QC, R & D training as QC executive from Pious Laboratory Ltd, Indore, Madhya Pradesh.

Research Project Work M. Pharm.:

Synthesis & Pharmacological Evaluation of Short Peptides as Anticancer Agents.

17+ year of Work experience in IPQA, Validation, CSV, QMS, Audit and Compliance, Documentation etc. in formulation of Injectable, MDI and OSD.

➢ Strong leader & team player; Leading a team of 20+ employees, driving total continues improvement to improve the plant capacity and sustainability

➢ From last 6 years in lead position for Validation and QMS and Compliance System (Audit and Compliance, Quality Management System, Training Management).

➢ Conducted many training sessions to train the 100% employees (including contract workers) involved in CGMP activities. The topic covered as Data Integrity, Quality Culture and Mindset, Failure Investigation and Root Cause Analysis (with examples and case study of 483 and Warning letters), Risk Assessment, CSV GDP, CGMP, GLP etc. to prepare the team for All Time Audit Readiness’.

➢ Demonstrated communication and relationship management skills with the ability to lead and work in cross-functional teams in a cross-cultural environment.

➢ Imparted training on investigation, validation, RCA and CAPA to other Cipla location.

➢ Active member of USFDA WL remediation (against the commitment for QMS and CSV, etc.) and ensured implementation of identified CAPAs at site.

➢ Worked in Trackwise project validation and Qualification for Cipla and implemented the Trackwise module for Complaint, Deviation, CAPA, OOS, OOT, Inv, Incidence.

➢ Leaded and guided the Quality Assurance team for routine challenges, output and compliance mindset throughout the product lifecycle

Lachman training on INVESTIGATION, RCA AND CAPA by Mr. P flower, Ms. Deborah

2. PDA training on ‘Audit and compliance.

3. Training on ‘GOOD AUDITING SKILL’ by ex-USFDA inspector Dr. Massoud Motamed.

4. Training on ‘Improving CAPA and Investigation’ by ex-USFDA inspector Dr. Ademola..

5. Training on ‘Quality Management Maturity’ by USFDA.

6. Training on ‘How to respond FDA 483 observations and warning letter’ by P&A consultant..

7. Training on ‘Data Integrity, Cleaning Validation, Failure Investigation and Root Cause Analysis’ by external agency.

8. Training on ‘CSV by third party navitas

Work Experience :

➢ Working as Sr. Manager -Audit and Compliance, (Remediation) and Validation - in Felix Generics, Indore from June 2024 to till date

➢ Working as Manager - QMS, CSV and Audit & compliance (Section Head) - Quality Assurance in Cipla Ltd. Indore from Sept 2011 to June 2024.

➢ Working as a Jr. Manager (IPQA and QMS)– Quality Assurance (IPQA) in Dr. Reddy’s Lab, Hyderabad from Feb 2010 to Sept. 2011 (1 Year 7 months).

➢ Worked as an IPQA Officer – Quality Assurance in ICPA Ltd, Ankleshwar from Jan 2009 to Jan 2010 (1 Year).

➢ Worked as Management Staff – Production Packing in Jupiter Remedies Pvt. Ltd. Daman from July’ 2006 to May’ 2007 (11 Months).

working with esteemed organizations such as TCS and syneous Healthcare, where she have gained invaluable experience in the pharmaceutical industry. These experiences have shaped a passionate and driven individual dedicated to making adifference in the feild.

All India rank of 320 in GPAT

He is Currently working as a Senior Officer at TACC Limited (a subsidiary of HEG Limited), located in Mandideep, Bhopal, Madhya Pradesh. I specialize in synthesizing graphene and its derivatives through various techniques for commercial applications. At this stage of my career, I possess interdisciplinary expertise at the interface of Material science and Electrochemistry, with a strong focus on the synthesis of carbon-based nanomaterials for electrochemical studies in biomedical applications. I also have in-depth knowledge of graphene quantum dot (GQD) preparation from graphite rods via electrochemical exfoliation methods, along with experience in fabricating electrodes for biosensors. I have been awarded a Ph.D. degree in Chemical Sciences entitled “Investigation on Carbon Nanomaterials-based Composites for Electrochemical Biosensor Applications”. My background in carbon nanomaterials-based composites for biosensor applications, combined with my passion for synthesizing carbon nanomaterials for fluorescence and biomedical applications. Since August 2018, I have been awarded the prestigious CSIR/UGC NET-JRF national-level fellowship through a competitive selection process conducted by UGC. This fellowship supported my tenure as a Junior and subsequently Senior Research Fellow (JRF/SRF). During this period, I carried out independent research on carbon nanomaterials-based composites for biosensor applications under the supervision of Dr. Raju Khan at CSIR-AMPRI

Industry & Teaching Experience

➢ Industry Experience at TACC Limited, Mandideep, Bhopal. From 10 May 2024 to continue.

➢ Teaching Experience at S.R. Mahavidyalaya, Orai, Jalaun, U.P. From 1 September 2023 to 29 April 2024 (8 Months) . ➢ Freelance independent contractor in Chegg India Pvt. Ltd. From 18 October 2019 to 28 November 2022 (3 Years) .

➢ Teaching Experience at Sun Rise Inter Collage, Orai. Jalaun, U.P. From 1 July 2016 to 30 June 2018 (2 Years)

Additional Qualifications

➢ CSIR/UGC-JRF with AIR-61 (June -2018)

➢ CSIR/UGC-JRF with AIR-82 (June -2017)

➢ GATE examination two times (Gate- 2019 with AIR-4499 and GATE-2018 with AIR 3808)

Industry & Teaching Experience

➢ Industry Experience at TACC Limited, Mandideep, Bhopal. From 10 May 2024 to continue.

➢ Teaching Experience at S.R. Mahavidyalaya, Orai, Jalaun, U.P. From 1 September 2023 to 29 April 2024 (8 Months) . ➢ Freelance independent contractor in Chegg India Pvt. Ltd. From 18 October 2019 to 28 November 2022 (3 Years) .

➢ Teaching Experience at Sun Rise Inter Collage, Orai. Jalaun, U.P. From 1 July 2016 to 30 June 2018 (2 Years)

He is director & CEO of Molmet Biotech Pvt Ltd, Bhopal

Master of Science, Biotechnology, Chitransh A.D.P.G College Barkatullah University, Bhopal in 2009 Bachelor of Science, Biotechnology Chitransh A.D.P.G College Barkatullah University, Bhopal in 2007 H.S.S.in Biology, Shanti Niketan M.E.M.H.S School, Hoshangabad, M.P. India in 2001.

Member of Institutional Ethical Committee at Indian Institute Science Education and Research (IISER), Bhopal for successive 9 years since 28th October 2014 till date ▪ Member of Institutional Ethical Committee at SRK University, Bhopal, since July 2018 till date ▪ Member of Board of Education, for Dept. of Botany & Industrial Microbiology at Govt. MLB.PG (Autonomous) College, Bhopal from July 2015 till date ▪ Life time member of NGO, as President of “Vibhav Jankalyan Swayamsevi Sanstha, Hoshangabad, (M.P) India

Scientific Officer; Chromogen Biotech Lab, Research and Training Center, A Division of Chitransh A.D.P.G College Bhopal from May2009 to January2010. ▪ President of NGO: President of “Vibhav Jankalyan Swayamsevi Sanstha, Hoshangabad, (M.P) India from July 2016 till Date • Founder Director and Scientist; Vibhav Institute for Research & Application of Biotech, Bhopal from August 2010 to October 2014. • Managing Editor: Science Secure Journals from 2013. • Editor: International Journal of Microbiology & Biotechnology from 2021. • Director and Scientist; Lenience Biotech Lab from October 2014 to May 2022. • Director & CEO; Molmet Biotech Research Pvt Ltd. from June 2022 till date.

Total 12 yearsofexperience from2010 ▪ ExperienceintrainingforMicrobiologicalToolsandTechniques ▪ ExperienceintrainingforPhytochemicalExtractionandAnalysis ▪ Experience in training for Use of SDS-PAGE analysis of plant seed coat protein for investigation of genetic diversity and variations. ▪ DNA Isolation from Bacteria and Plant Samples and Genomic Profiling by RAPD, RFLP technique and other studies.