Pharma Expert Forum – Repurposing Existing Drugs Through Novel Product Development Approaches
Overview
Pharma Expert Forum is a technical discussion group comprising of Senior Pharmaceutical Team Leaders and/or R & D Heads. The forum envisages bringing together the International Pharmaceutical Experts and Industry Scientists at a platform to discuss the hottest technical issues and topics for achieving research and business objectives. The forum is designed on the concept of “H2L -Honing to Lead”.
Looking back at an old, in-use or withdrawn drug molecule and turning it into a successful novel proposition is what every research oriented pharmaceutical company is looking at. This concept of Drug Repurposing or Rediscovery is certainly not only about giving a new life to an otherwise shelved or even rejected or dropped drug molecule, but it is looking at an existing molecule in an entirely different way. This is also not only for business objectives but also with an underlying objective of providing affordable alternative to the healthcare armamentarium.
Despite the advantages and regulatory provisions, drug rediscovery is not free from challenges and hurdles. Moreover, several propositions may require lengthy clinical and developmental studies before being considered eligible for approval as reproposed new drug under 505(b)(2) pathways with FDA or a hybrid drug application with EMA, which certainly means higher discovery cost. On top of it the dilemma for pharmaceutical scientists is where to begin from, which approach to follow, is there any time-tested pathway, will the new product be able to change the way it is currently being used and so on.
Objective: This Pharma Expert Forum will look for and deliberate upon the possible solutions in the field of Novel Product Development Approaches and will try to explore different viewpoints and school of thoughts in this method of drug repurposing. This forum is essentially a discussion group to ask questions, discuss, present viewpoints, raise issues, suggest solutions and not a conference or a training course.
The H2L Concept- The H2L or Honing to Lead is a novel concept and means honing or refining skills of the team leaders who have the responsibility to steer their team towards achieving the organizational goals. The H2L concept is about refining specifically the technical skills of the team leaders through higher level experts who have vast first-hand experience in the respective areas so that the leader gets an extremely focused conceptual insight into the problem area. This essentially involves bringing together the leaders who share a common platform with the Experts and where the Experts develop an atmosphere conducive to open discussion rather than a regular speaking-listening session.
Who should Join
Pharma R & D Heads i.e., Presidents, Vice Presidents, Heads and Directors from Formulation Development R & D and Product Lifecycle Management from Pharmaceutical companies. Participation is by invitation only. This is a limited participation forum and participation will be by invitation only. We expect not more than 1 login per R & D or per location.
Registration Closes - June 25, 2021
Contacts
Program and Technical Query: Ms. Pooja Sharma, M: 7696325050, Email: p.sharma@glostem.com
Registration and Participation Query: Ms. Swati Kanwar, M: 8289015050, Email: s.kanwar@glostem.com
Joining Link and and Test Run: Ms Ankita Kanwar, M: 7696425050, Email: ankita@glostem.com
Conference Dates
01-07-2021 to 02-07-2021
Wantanee Phuapradit's Biography
Wantanee Phuapradit
Senior Drug Product Consultant
DS InPharmatics
Dr. Wantanee Phuapradit has been confidently leading, directing, and making decisions on a large drug development portfolio in an entrepreneurial setting through all phases including early-stage product selection, product development, technology transfer, regulatory submission, FDA approval and commercialization. Leader of high-performing scientific and technical cross functional teams of pharmaceutical development scientists and other related CMC functions. Provides committed and inspiring leadership, stewardship and advocacy, striving for compound and manufacturing process knowledge development, continuous improvement, acceleration, risk assessment and mitigation, resource allocation and support. Ensures an effective Target Product Profile is in place which defines product characteristics and performance expectations to inform pharmaceutical development success.
Dr. Phuapradit has been serving as a scientific advisor and consultant in pharmaceutical R&D organizations. She previously served multiple R&D leadership roles with increasing responsibility including:
- Chief Scientific Officer at Tulex Pharmaceuticals
- Former Senior Vice President and Head of the Formulation Research and Development Group at Kashiv Pharma
- Former Senior Director of Barr/Teva
- 18 years with Hoffmann La Roche, including Senior Research Leader position
She holds a Ph.D. in Pharmaceutics from St. John’s University in New York City with over 30 years of experience in pharmaceutical oral dosage development, scale-up, technology transfer of generics, 505b2, and new chemical entities. Accolades include over 20 patents, 10 publications, and over 20 presentations/speaker events all specializing in pharmaceutical excellence.
Hashim Ahmed's Biography
Hashim Ahmed
Head, Formulation and Manufacturing
Avomeen
Dr Ahmed brings more than 25 years of experience from the biopharmaceutical and CDMO industries. Most recently, he held a Managing Director position at QLife Pharma. Prior to this, he has held leadership positions at Dr. Reddy’s Laboratories, GSK-Stiefel, and Hoffmann-La Roche Inc. Ahmed has also served as a consultant for various biopharmaceutical companies on effective risk assessment (RA) control strategy, specification, and chemistry, manufacturing and control (CMC) modules, including CMC-Quality for various dosage forms development; investigational new drug, abbreviated new drug application, new drug application, 505b2, RA, and quality by design (QbD) filings; and both conventional and QbD-based tech-transfer across global sites.
Throughout his career, Dr Ahmed has served as a pharmaceutical product development and regulatory expert and has worked on a diverse portfolio of APIs and dosage forms. His in-depth experience extends to both small and large molecules (proteins and peptides), orals (tablets and capsules), controlled-modified release formulations, and parenteral dosages. He holds 21 patents on drug formulation and process in the United States and globally and has more than 30 presentations and publications of his work in various symposiums and conferences.
Dr Ahmed is a World Health Organization Fellow and member of a number of professional organizations. He holds a doctorate degree in pharmaceutical sciences from the University of Bath-England-UK and a bachelor’s degree in pharmacy from the University of Khartoum.
Poonam Raghuvanshi's Biography
Poonam Raghuvanshi
Founder
iP Essentia Intellectual Property Firm
Dr Poonam has 21+ years leading the Intellectual Property and Patent teams of multinational Pharma companies (Dr. Reddy’s, Ranbaxy, Dabur) & International research institutes (ICGEB). She has 7+ years in Product Development and Research with leading Pharma research organizations and 1+ year of entrepreneurship
She has Led a large tribe of IP experts responsible for API, Formulation & NCE. She has Built high performance teams and instilled a winning culture. Was a team member for 3 Iconic patent infringement/invalidation cases in Generic product history Atorvastatin, Esomeprazole and Valganciclovir.
Dr Poonam has aligned structure and optimized resources to enhance efficiency & productivity. She contributed to build multi-Billion-dollar global product portfolio. Ensured no unknown 3rd Party IP risk to the Product portfolio. Conceptualized effective IP risk mitigation strategy across the globe. Designed & Led IP litigation in Branded markets to drive double digit growth.
• Led & built a collaborative culture to encourage idea sharing and creativity. Devised invention review board to effectively manage the Patent Portfolio. Provided Strategic partnership to management on people issues.
Her education qualification is M. Pharm, Ph.D. in Pharmaceutical Chemistry.
Moshe Rogosnitzky's Biography
Moshe Rogosnitzky
Founder and CEO
Drug Rediscovery Group Limited
Mr Moshe Rogosnitzky is Founder and CEO at Drug Rediscovery Group Ltd. An innovator in drug repurposing, he is a named inventor on numerous patents in many therapeutic fields. As a scientist, serial inventor, innovator, thought leader, and researcher, his mission is to create sustainable, self-empowering healthcare solutions and to champion accessible healthcare worldwide. Based in Israel, he helps people to live better lives by discovering new applications for established drugs, through personalized medicine.
As the Founder of Israel’s first personalized medicine consultancy, Adjuvant Medical Solutions, he used highly specific diagnostics to develop patient-centered treatment strategies for those for whom standard treatment protocols had failed.
In 2006 he co-founded the US non-profit organization, MedInsight® Research Institute, which is focused on delivering affordable and effective medical solutions to people everywhere, by sharing research and reviews about off-label drug uses. At MedInsight, he founded LDNscience.org - the largest global educational platform for Low Dose Naltrexone (LDN), which was key in taking a drug from obscurity to over 500,000 users globally, with published research now covering more than 60 chronic diseases.
He is one of the numerous expert physicians, scientists, government agency officials, and nonprofit leaders around the world who believe that solutions to chronic and life-endangering medical problems lie in the rediscovery and repurposing of widely used, low-cost, and clinically proven safe medicines. Real-world drug repurposing is the only sustainable option to prevent and treat current and future health crises such as the COVID-19 epidemic.
As an expert in drug repurposing, he has had the opportunity to share his unique approach at the Israel Ministry of Health, Massachusetts Institute of Technology, and at the Charité Health Summit in Berlin.
Girish Jain's Biography
Girish Jain
Pharmaceutical Consultant
Cochlea Pharma
Dr Girish Kumar Jain, currently a Pharmaceutical Consultant at Cochlea Pharma. He has vast experience in the development of niche and difficult to develop products as oral dosage form, sterile dosage forms, topical and transdermal delivery systems. Previously, he was Head, Global R&D at Slayback Pharma, President-Research & Development at Alkem Laboratories Ltd, Senior Vice President at Wockhardt Ltd. He has numerous patents to his credit. He received an undergraduate degree, a graduate degree and a doctorate from the University of Delhi.
Debasis Pore's Biography
Debasis Pore
Senior Scientific Manager
Excelra
Dr. Debasis Pore has experience in Research and Development, Data Analysis, and Team management. His Scientific expertise is in the areas of Immunology, Oncology, Autoimmunity, Inflammation, and Vaccine Development. Development of diverse in vivo mouse model. His Current Experience at Excelra is at Providing scientific solution in Drug Repurposing and Immuno-Oncology Projects, Led Microbiome curation project, Experienced in projects related to target ID, target prioritization, and target safety. His Post Doctoral Research Experience is in Lymphoma, Autoimmunity, and Inflammation from Cleveland Clinic Foundation, Cleveland, USA
Skill sets - Research & Development, Data Analysis, Tumor Immunology, Biomarkers Discovery, Microscopy, Generation of knockout mice, In Vivo Mouse Models, Gene knock-out or knock-in, Retroviral reconstitution/transduction, Stable cell lines, Analysis of microarray, proteomics, and phosphoproteomics data, Team Management
He has Scientific publications to his credit.
His has Received Gold medal (1st class 1st) for first rank in Microbiology (M.Sc.) in 2004, Young Scientist Award for the year 2009-2010 by Indian Science Congress Association
Best Speaker Award by Asian Journal of Experimental Sciences in 2010
F. Merlin Bumpus Junior Investigator Award in Basic Science by Cleveland Clinic in 2013, USA
Best Poster Award in Case Comprehensive Cancer Retreat in 2014, USA
Manish Grover's Biography
Manish Grover
Former Sr Director
Procter & Gamble
Dr Manish Grover has been in top leadership positions in his industry assignments for more than a decade. He is a proficient leader, adept at building highly engaged and productive teams, leveraging his knowledge and experience to efficiently solve problems. He has managed large global teams across functions. Previously, he has worked in Cadila Pharmaceuticals, Ajanta PHarma Ltd, Dabur Research Foundaion, Zydus Cadila, Piramal Helathcare Ltd, Abbott Healthcare Private Ltd, Merck Group and Procter and Gamble.
Dr Grover holds a PhD degree in Drug Design, followed by diverse industry experiences that include setting up a production plant, product development labs and pilot plants, and developing various dosage forms for diverse markets.
He has added more than 300 products in the Indian market and more than 50 products in the global market. Was awarded twice with CEO’s award for positively impacting the business.
Rajeev Raghuvanshi's Biography
Rajeev Raghuvanshi
Secretary-cum-Scientific Director
Indian Pharmacopoeia Commission (IPC)
Dr Raghuvanshi is currently a Secretary-cum-Scientific Director of the Indian Pharmacopoeia Commission (IPC).
Dr Raghuvanshi’s expertise lies in dosage form design and development, majorly in pharma innovation. He has been involved in the development of different kind of products like Oral Solids, Oral liquids, Topicals, Injections, Nasal Sprays, Auto-injectors, Sublingual, Mouth Dissolve, Extended Release and Delayed Release for global markets. Dr Raghuvanshi has 14 granted US patents along with more than 250 published PCTs and Indian Patents. He has more than 25 publications in peer-reviewed journals and has co-authored six chapters in books. He has been visiting faculty at NIPER – Hyderabad and IIT-BHU and has taught students of NIPER-Mohali.
He has been working at Dr Reddy’s Laboratories since 2010. In his 11 years of stay with Dr Reddy’s Labs, the initial eight years was in development of 505b(2) NDA products for the US market. Last three years at Dr Reddy’s has been in a different role of establishing an R&D team for markets like India, China, Russia and other Emerging Markets in the space of Pharmaceutical Product Innovation/ Differentiation, registration and launches.
He has completed his Bachelors and Masters from IIT-BHU (Formerly IT-BHU), Varanasi and PhD from National Institute of Immunology, New Delhi. His PhD work is in the area of extended-release formulation of vaccines, a project conceptualised to help reduce the number of injections required to be given for complete immunisation.
V Venkateshwarlu's Biography
V Venkateshwarlu
Managing Director
Neuheit Pharma Technologies Pvt Ltd
Dr. V. Venkateswarlu is a highly motivated scientist with in depth knowledge in pharmaceutical sciences, dedicated researcher and co-founder of NEUHEIT Pharma technologies PVT Ltd in 2013. The company is engaged in the development of complex generic and differentiated products from ideation to commercialization. It also offers consultancy services in all disciplines of pharmaceutical product development including Bioequivalence studies.
A post-doc in pharmaceutical sciences with 16 years of teaching and research experience at University College of Pharmaceutical Sciences, Kakatiya University, warangal, India and Head, Formulations, Biostudies and Packaging for 8 years in Dr.Reddy\\\\\\\\\\\\\\\'s Laboratories Ltd, Hyderabad as Vice President.
Dr. Venkateswarlu is involved in the development of ANDAs for USA, dossiers for regulated and RoW markets, developed differentiated products and created platform technology in microspheres. Project selection, design around strategy development, smooth execution of strategy with DoE and QbD principles, Scale up, technology transfer, exhibit batches execution, bio-relevant media development for biosuccess, QBR and QbD based PDR, and flawless dossier compilation are the critical steps handled by Dr. Venkateswarlu effectively. In addition, applications of critical chain project management principles, theory of constraints and six sigma principles.
Dr. Venkateswarlu established bio-relevant dissolution methods for bio-success of products and well versed with various dissolution methodologies for controlled release and complex solid orals. He is an expert in Biowaiver approach and changed guidance from clinical/ bioequivalence to in-vitro equivalence.
Conference Agenda
- Revisiting the Importance of Drug Repurposing
- Repurposing Drugs through Advanced Drug Delivery Technologies
- Fixed Dose Combinations for Reprofiling Existing Drugs
- Repositioning Drugs by Altering Dosages
Agenda Topics for Repurposing Existing Drugs Through Novel Product Development Approaches
- Revisiting the Importance of Drug Repurposing
- Repurposing Drugs through Advanced Drug Delivery Technologies
- Fixed Dose Combinations for Reprofiling Existing Drugs
- Repositioning Drugs by Altering Dosages
Speakers & Panelists
Wantanee Phuapradit's Biography
Wantanee Phuapradit
Senior Drug Product Consultant
DS InPharmatics
Dr. Wantanee Phuapradit has been confidently leading, directing, and making decisions on a large drug development portfolio in an entrepreneurial setting through all phases including early-stage product selection, product development, technology transfer, regulatory submission, FDA approval and commercialization. Leader of high-performing scientific and technical cross functional teams of pharmaceutical development scientists and other related CMC functions. Provides committed and inspiring leadership, stewardship and advocacy, striving for compound and manufacturing process knowledge development, continuous improvement, acceleration, risk assessment and mitigation, resource allocation and support. Ensures an effective Target Product Profile is in place which defines product characteristics and performance expectations to inform pharmaceutical development success.
Dr. Phuapradit has been serving as a scientific advisor and consultant in pharmaceutical R&D organizations. She previously served multiple R&D leadership roles with increasing responsibility including:
- Chief Scientific Officer at Tulex Pharmaceuticals
- Former Senior Vice President and Head of the Formulation Research and Development Group at Kashiv Pharma
- Former Senior Director of Barr/Teva
- 18 years with Hoffmann La Roche, including Senior Research Leader position
She holds a Ph.D. in Pharmaceutics from St. John’s University in New York City with over 30 years of experience in pharmaceutical oral dosage development, scale-up, technology transfer of generics, 505b2, and new chemical entities. Accolades include over 20 patents, 10 publications, and over 20 presentations/speaker events all specializing in pharmaceutical excellence.
Senior Drug Product Consultant,
DS InPharmatics,
USA
Hashim Ahmed's Biography
Hashim Ahmed
Head, Formulation and Manufacturing
Avomeen
Dr Ahmed brings more than 25 years of experience from the biopharmaceutical and CDMO industries. Most recently, he held a Managing Director position at QLife Pharma. Prior to this, he has held leadership positions at Dr. Reddy’s Laboratories, GSK-Stiefel, and Hoffmann-La Roche Inc. Ahmed has also served as a consultant for various biopharmaceutical companies on effective risk assessment (RA) control strategy, specification, and chemistry, manufacturing and control (CMC) modules, including CMC-Quality for various dosage forms development; investigational new drug, abbreviated new drug application, new drug application, 505b2, RA, and quality by design (QbD) filings; and both conventional and QbD-based tech-transfer across global sites.
Throughout his career, Dr Ahmed has served as a pharmaceutical product development and regulatory expert and has worked on a diverse portfolio of APIs and dosage forms. His in-depth experience extends to both small and large molecules (proteins and peptides), orals (tablets and capsules), controlled-modified release formulations, and parenteral dosages. He holds 21 patents on drug formulation and process in the United States and globally and has more than 30 presentations and publications of his work in various symposiums and conferences.
Dr Ahmed is a World Health Organization Fellow and member of a number of professional organizations. He holds a doctorate degree in pharmaceutical sciences from the University of Bath-England-UK and a bachelor’s degree in pharmacy from the University of Khartoum.
Head, Formulation and Manufacturing,
Avomeen,
USA
Poonam Raghuvanshi's Biography
Poonam Raghuvanshi
Founder
iP Essentia Intellectual Property Firm
Dr Poonam has 21+ years leading the Intellectual Property and Patent teams of multinational Pharma companies (Dr. Reddy’s, Ranbaxy, Dabur) & International research institutes (ICGEB). She has 7+ years in Product Development and Research with leading Pharma research organizations and 1+ year of entrepreneurship
She has Led a large tribe of IP experts responsible for API, Formulation & NCE. She has Built high performance teams and instilled a winning culture. Was a team member for 3 Iconic patent infringement/invalidation cases in Generic product history Atorvastatin, Esomeprazole and Valganciclovir.
Dr Poonam has aligned structure and optimized resources to enhance efficiency & productivity. She contributed to build multi-Billion-dollar global product portfolio. Ensured no unknown 3rd Party IP risk to the Product portfolio. Conceptualized effective IP risk mitigation strategy across the globe. Designed & Led IP litigation in Branded markets to drive double digit growth.
• Led & built a collaborative culture to encourage idea sharing and creativity. Devised invention review board to effectively manage the Patent Portfolio. Provided Strategic partnership to management on people issues.
Her education qualification is M. Pharm, Ph.D. in Pharmaceutical Chemistry.
Founder,
iP Essentia Intellectual Property Firm,
India
Moshe Rogosnitzky's Biography
Moshe Rogosnitzky
Founder and CEO
Drug Rediscovery Group Limited
Mr Moshe Rogosnitzky is Founder and CEO at Drug Rediscovery Group Ltd. An innovator in drug repurposing, he is a named inventor on numerous patents in many therapeutic fields. As a scientist, serial inventor, innovator, thought leader, and researcher, his mission is to create sustainable, self-empowering healthcare solutions and to champion accessible healthcare worldwide. Based in Israel, he helps people to live better lives by discovering new applications for established drugs, through personalized medicine.
As the Founder of Israel’s first personalized medicine consultancy, Adjuvant Medical Solutions, he used highly specific diagnostics to develop patient-centered treatment strategies for those for whom standard treatment protocols had failed.
In 2006 he co-founded the US non-profit organization, MedInsight® Research Institute, which is focused on delivering affordable and effective medical solutions to people everywhere, by sharing research and reviews about off-label drug uses. At MedInsight, he founded LDNscience.org - the largest global educational platform for Low Dose Naltrexone (LDN), which was key in taking a drug from obscurity to over 500,000 users globally, with published research now covering more than 60 chronic diseases.
He is one of the numerous expert physicians, scientists, government agency officials, and nonprofit leaders around the world who believe that solutions to chronic and life-endangering medical problems lie in the rediscovery and repurposing of widely used, low-cost, and clinically proven safe medicines. Real-world drug repurposing is the only sustainable option to prevent and treat current and future health crises such as the COVID-19 epidemic.
As an expert in drug repurposing, he has had the opportunity to share his unique approach at the Israel Ministry of Health, Massachusetts Institute of Technology, and at the Charité Health Summit in Berlin.
Founder and CEO,
Drug Rediscovery Group Limited,
Israel
Girish Jain's Biography
Girish Jain
Pharmaceutical Consultant
Cochlea Pharma
Dr Girish Kumar Jain, currently a Pharmaceutical Consultant at Cochlea Pharma. He has vast experience in the development of niche and difficult to develop products as oral dosage form, sterile dosage forms, topical and transdermal delivery systems. Previously, he was Head, Global R&D at Slayback Pharma, President-Research & Development at Alkem Laboratories Ltd, Senior Vice President at Wockhardt Ltd. He has numerous patents to his credit. He received an undergraduate degree, a graduate degree and a doctorate from the University of Delhi.
Pharmaceutical Consultant,
Cochlea Pharma,
India
Debasis Pore's Biography
Debasis Pore
Senior Scientific Manager
Excelra
Dr. Debasis Pore has experience in Research and Development, Data Analysis, and Team management. His Scientific expertise is in the areas of Immunology, Oncology, Autoimmunity, Inflammation, and Vaccine Development. Development of diverse in vivo mouse model. His Current Experience at Excelra is at Providing scientific solution in Drug Repurposing and Immuno-Oncology Projects, Led Microbiome curation project, Experienced in projects related to target ID, target prioritization, and target safety. His Post Doctoral Research Experience is in Lymphoma, Autoimmunity, and Inflammation from Cleveland Clinic Foundation, Cleveland, USA
Skill sets - Research & Development, Data Analysis, Tumor Immunology, Biomarkers Discovery, Microscopy, Generation of knockout mice, In Vivo Mouse Models, Gene knock-out or knock-in, Retroviral reconstitution/transduction, Stable cell lines, Analysis of microarray, proteomics, and phosphoproteomics data, Team Management
He has Scientific publications to his credit.
His has Received Gold medal (1st class 1st) for first rank in Microbiology (M.Sc.) in 2004, Young Scientist Award for the year 2009-2010 by Indian Science Congress Association
Best Speaker Award by Asian Journal of Experimental Sciences in 2010
F. Merlin Bumpus Junior Investigator Award in Basic Science by Cleveland Clinic in 2013, USA
Best Poster Award in Case Comprehensive Cancer Retreat in 2014, USA
Senior Scientific Manager,
Excelra,
India
Manish Grover's Biography
Manish Grover
Former Sr Director
Procter & Gamble
Dr Manish Grover has been in top leadership positions in his industry assignments for more than a decade. He is a proficient leader, adept at building highly engaged and productive teams, leveraging his knowledge and experience to efficiently solve problems. He has managed large global teams across functions. Previously, he has worked in Cadila Pharmaceuticals, Ajanta PHarma Ltd, Dabur Research Foundaion, Zydus Cadila, Piramal Helathcare Ltd, Abbott Healthcare Private Ltd, Merck Group and Procter and Gamble.
Dr Grover holds a PhD degree in Drug Design, followed by diverse industry experiences that include setting up a production plant, product development labs and pilot plants, and developing various dosage forms for diverse markets.
He has added more than 300 products in the Indian market and more than 50 products in the global market. Was awarded twice with CEO’s award for positively impacting the business.
Former Sr Director,
Procter & Gamble,
India
Rajeev Raghuvanshi's Biography
Rajeev Raghuvanshi
Secretary-cum-Scientific Director
Indian Pharmacopoeia Commission (IPC)
Dr Raghuvanshi is currently a Secretary-cum-Scientific Director of the Indian Pharmacopoeia Commission (IPC).
Dr Raghuvanshi’s expertise lies in dosage form design and development, majorly in pharma innovation. He has been involved in the development of different kind of products like Oral Solids, Oral liquids, Topicals, Injections, Nasal Sprays, Auto-injectors, Sublingual, Mouth Dissolve, Extended Release and Delayed Release for global markets. Dr Raghuvanshi has 14 granted US patents along with more than 250 published PCTs and Indian Patents. He has more than 25 publications in peer-reviewed journals and has co-authored six chapters in books. He has been visiting faculty at NIPER – Hyderabad and IIT-BHU and has taught students of NIPER-Mohali.
He has been working at Dr Reddy’s Laboratories since 2010. In his 11 years of stay with Dr Reddy’s Labs, the initial eight years was in development of 505b(2) NDA products for the US market. Last three years at Dr Reddy’s has been in a different role of establishing an R&D team for markets like India, China, Russia and other Emerging Markets in the space of Pharmaceutical Product Innovation/ Differentiation, registration and launches.
He has completed his Bachelors and Masters from IIT-BHU (Formerly IT-BHU), Varanasi and PhD from National Institute of Immunology, New Delhi. His PhD work is in the area of extended-release formulation of vaccines, a project conceptualised to help reduce the number of injections required to be given for complete immunisation.
Secretary-cum-Scientific Director,
Indian Pharmacopoeia Commission (IPC),
India
V Venkateshwarlu's Biography
V Venkateshwarlu
Managing Director
Neuheit Pharma Technologies Pvt Ltd
Dr. V. Venkateswarlu is a highly motivated scientist with in depth knowledge in pharmaceutical sciences, dedicated researcher and co-founder of NEUHEIT Pharma technologies PVT Ltd in 2013. The company is engaged in the development of complex generic and differentiated products from ideation to commercialization. It also offers consultancy services in all disciplines of pharmaceutical product development including Bioequivalence studies.
A post-doc in pharmaceutical sciences with 16 years of teaching and research experience at University College of Pharmaceutical Sciences, Kakatiya University, warangal, India and Head, Formulations, Biostudies and Packaging for 8 years in Dr.Reddy\\\\\\\\\\\\\\\'s Laboratories Ltd, Hyderabad as Vice President.
Dr. Venkateswarlu is involved in the development of ANDAs for USA, dossiers for regulated and RoW markets, developed differentiated products and created platform technology in microspheres. Project selection, design around strategy development, smooth execution of strategy with DoE and QbD principles, Scale up, technology transfer, exhibit batches execution, bio-relevant media development for biosuccess, QBR and QbD based PDR, and flawless dossier compilation are the critical steps handled by Dr. Venkateswarlu effectively. In addition, applications of critical chain project management principles, theory of constraints and six sigma principles.
Dr. Venkateswarlu established bio-relevant dissolution methods for bio-success of products and well versed with various dissolution methodologies for controlled release and complex solid orals. He is an expert in Biowaiver approach and changed guidance from clinical/ bioequivalence to in-vitro equivalence.
Managing Director,
Neuheit Pharma Technologies Pvt Ltd,
India
Repurposing Existing Drugs Through Novel Product Development Approaches
Download Programme PDFThursday, 1st July 2021
| 13:30 |
Test Run and Web Checks
|
| 14:30 |
Inauguration and Welcome Address
|
| 14:40 |
Session 1: Revisiting the Importance of Drug Repurposing
|
| 14:40 |
Drug Repurposing - Why, What and How? Rajeev Raghuvanshi, Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission (IPC), India |
| 15:10 |
Field Based Discoveries – A Treasure Trove of Repurposing Opportunities Moshe Rogosnitzky, Founder and CEO, Drug Rediscovery Group Limited, Israel |
| 15:40 |
Repurposed Drugs: The IP Opportunity and The Challenges Poonam Raghuvanshi, Founder, iP Essentia Intellectual Property Firm, India |
| 16:10 |
Session 2: Formulation Development Strategies for Repositioning Drugs (Moderator: V Venkateswarlu)
|
| 16:10 |
Presentation of Issues and Challenges by Participants - Dosage Form Design |
| 16:30 |
Dosage Form Design - Oral, Parenterals and Fixed Dose Combinations with and without Dose Alteration Hashim Ahmed, Head, Formulation and Manufacturing, Avomeen, USA |
| 17:00 |
Rap Session: (Lead Experts: Hashim Ahmed and Manish Grover) |
| 17:30 |
End of First Day of meeting |
Friday, 2nd July 2021
| 13:30 |
Pre-session Workshop - Portfolio Enhancement & Product Rationalization Workshop
|
| 14:30 |
Recap and Introduction of Day 2 Experts Rajeev Raghuvanshi, Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission (IPC), India |
| 14:35 |
Session 3: Repurposing Drugs through Advanced Drug Delivery Technologies (Moderator: Rajeev Raghuvanshi)
|
| 14:35 |
Redefining the Drug Value through Repurposing Debasis Pore, Debasis Pore, Senior Scientific Manager, Excelra, India |
| 15:05 |
Drug Repurposing - Are you Thinking \'out-of-the-Box\' ? Manish Grover, Former Sr Director, Procter & Gamble, India |
| 15:30 |
Presentation of Issues and Queries by Participants - Drug Delivery |
| 15:40 |
Complex Generics – An Insight - Formulation Development & Drug Delivery Girish Jain, Pharmaceutical Consultant, Cochlea Pharma, India |
| 16:10 |
Novel Oral Product Development Strategies for Repositioning Drugs Wantanee Phuapradit, Senior Drug Product Consultant, DS InPharmatics, USA |
| 16:40 |
Rap Session (Lead Experts: Wantanee Phuapradit and Girish Jain) |
| 17:10 |
Closing Remarks and End of the meeting |
| 17:20 |
Networking in Lounge (Available only after the end of session) |