Abstract:
Artificial intelligence and machine learning is a upcoming technology in
medical device discovery and development for
diagnostics, personalized medicine, drug discovery and development,
robotic surgery, predictive analytics, manufacturing and
quality control, verification and validation, patient monitoring. Drug
device combination for medical devices are therapeutic or
diagnostic products biologics and pharmaceuticals that involve a drug
component of dose optimization, pharmacokinetics (PK)
and pharmacodynamics (PD) modelling individualized dosing and regulatory
submissions. Beyond combination products
modelling and simulation can be applied to quantitative systems
pharmacology, clinical trial design, and risk benefit assessment
and dosing algorithms for devices. Medical devices integrated with drug
eluting stents, digital therapeutics also integration with
biologics and pharmaceuticals understanding the GMP and cGMP
requirements of each component. AI based medical devices
applications and benefits can be improved efficacy, enhanced safety,
better patient outcomes and increased convenience,
personalized and smart devices, predictive maintenance, improved
functionality and adherence. AI based empowered medical
device innovator will fulfil the regulatory demands of FDA, EU-MDR and
ISO 13485 to GDPR and beyond to meet the highest
standards. AI based in medical device development meet the requirements
of both drug cGMP , GLP and device QS regulations.
Biosketch:
Currently working as a Chief Scientific Officer at Wexford Laboratories
Pvt Ltd, Tumkur-Bangalore, also working as a Scientific
Advisor to Indian Patent Office, New Delhi, India, also worked as an
Chief Technnical Officer at MRHM Pharma Pvt Ltd, Bangalore,
also worked as a General Manager-Production and Operations at Search
Foundation Rajajinagar, Bengaluru, also worked as a
PMT Head at MRHM Pharma Pvt Ltd, Bengaluru, Also worked as Assistant
Vice President and Plant Head at KJD Pharmaceuticals
Pvt Ltd, Bidar in Production, QA, QC Regulatory Affairs, IPR and R&D, I
have over 25 years of rich experience in pharmaceutical
industry and Pharmaceutical Education and Research Project
identification, initiation, development, production and
commercialisation. I have developed 170 products (26 Nutraceuticals, 10
Veterinary, 07 Equine, 05 Fishery, 07 Poultry, 40
Pharmaceuticals, 02 Biopharmaceuticals, 30 Cosmetics, 07 Homeopathic 06
Probiotics, 07 Prebiotics, 03 Dental, 05 Ophthalmic
and 15 Ayurvedic) for Domestic and International market. Developed
formulations and transferred successfully of tablets,
capsules, liquids, ointment, cream, gel, dry powder and Injections of
CNS, CVS, and Diabetic Class API. Formulation of Immediate
and other release tablets, Capsules and Liquids, developing prototype
formulations successfully for sublingual drops and
formulation and development of Nutraceutical and Ayurvedic products are
of my current interest. To secure a challenging
position with full dedication and commitment in the field of
Pharmaceutical Formulation R&D, Nutraceuticals, and
Cosmeceuticals and to work successfully in an innovative and competitive
world by applying my technical and organizational
skills. I am very good in quick & rapid Literature survey (US-FDA, FOI,
Orange Book, EMA, Formulation Patents, Dailymed, EMC,
etc) Pre-formulation study of new projects. Responsible for Development
of Solid Oral Products for highly regulated markets. I
could develop products along with relevant documentation within the time
frame set by management. I use to present scientific
data in conferences and meetings with collaborators of the project. I
have good experience in going through the Patents, SBOA,
SPC, SPL, for the extraction of newer knowledge and information. I am
involved in gathering useful information by reviewing
research articles and review articles and by reviewing various sites on
internet and patents. Technical competency: Solid Lipid
Nanotechnology; Micro emulsion formulation; Extrusion-Spheronization
Technology; Hot Melt Extrusion Technology; Bilayer, SR,
CR Tablet, MUPS, Generic and complex generics.
Business Development: I have a good experience right from brain Storming
techniques, product identification, product selection,
product development, scale up, production, QA & QC, co-ordinating with
Clinical development of the new products. I also have
experience in organising and conducting small business conferences with
doctors in promoting the new products
(Pharmaceuticals and Nutraceuticals). I always use to prepare product
promotion literatures for preparing Leaflets and other
product promotion materials. I have special interest in designing novel
packaging concepts like pillow packs (Unit dosage forms)
and newer delivery systems for all type of dosage forms.