In this video:
Valedictory Address: Dr Raj Suryanarayanan, Professor and William & Mildred Peters Endowed Chair, Department of Pharmaceutics, College of Pharmacy, University of Minnesota

Topic: Recent advances in the solid state drug product characterization

Key Highlights:
+ Change from amorphous to crystalline form of drugs leads to a loss in bioavailability
+ If we are not careful, the amorphous drugs will convert to crystalline, and the products might have to be recalled from the market
+ About 50% of all drug molecules are administered as salts
+ Dissolution rate, bioavailability and solubility are some of the advantages of salt formation
+ Factors causing disproportionation of drugs include excipients, humidity, temperature and mechanical activation/processing parameters

The post Valedictory Address: Dr Raj Suryanarayanan, Professor and William & Mildred Peters Endowed Chair, Department of Pharmaceutics, College of Pharmacy, University of Minnesota appeared first on Express Pharma.

Panelists in this video:
+ Sauri Gudlavalletti, Head R&D, Dr Reddy’s Laboratories (Moderator)
+ Dr Rupesh Kelaskar, AVP – Corporate Quality Control, FDC
+ Dr Kiran Marthak, Director – Medical and Regulatory Affairs, Veeda Clinical Research
+ Rajit Muraleedharan Nair, Director, Deloitte Touche Tohmatsu India LLP

Key Highlights:
+ It is important to capture data digitally to improve efficiency, the accuracy of R&D efforts and reduce human errors: Sauri Gudlavalletti, Head R&D, Dr Reddy’s Laboratories

+ Lab informatics is a growing industry due to rising R&D expenditure, emerging integrated solutions, and need for better documentation for regulatory compliance: Sauri Gudlavalletti, Head R&D, Dr Reddy’s Laboratories

+ Lab Informatics are not only transforming lab operations but also improving efficacy of clinical research: Dr Kiran Marthak, Director – Medical and Regulatory Affairs, Veeda Clinical Research

+ Lab Informatics is facilitating predictive maintenance of instruments and equipment which is very crucial in Pharma R&D and Manufacturing: Dr Rupesh Kelaskar, AVP – Corporate Quality Control, FDC

+ The entire lab is becoming more integrated, and thereby, more agile. Lab informatics is also enabling data standardisation, better data mining, improved R&D collaborations etc: Rajit Muraleedharan Nair, Director, Deloitte Touche Tohmatsu India LLP

The post Panel Discussion: Lab Informatics: Revolutionising Pharma R&D appeared first on Express Pharma.

Panelists in this video:
+ Vinod Arora, Principal Advisor, Institute of Good Manufacturing Practices India (IGMPI)
+ Naresh Narasimhan, Principal Architect & Managing Partner, Venkataramanan Associates
+ Archana Salil, Founder Director & Principal Architect, Arena Consultants
+ Dr Ajeet Kumar Agrawal, Assistant Director- Analytical Science Division-Biology (ASD-Bio), Shriram Institute for Industrial Research, New Delhi India
+ SM Mudda, Managing Director, Misom Labs

Key Highlights:
+ There is a need to shift from traditional labs to automated labs: Vinod Arora, Principal Advisor, Institute of Good Manufacturing Practices India (IGMPI)

+ Flexibility balanced with functionality to change the very nature of laboratory itself, indicating clever engineering is crucial while designing a lab: Naresh Narasimhan, Principal Architect & Managing Partner, Venkataramanan Associates

+ Digitisation of lab designing is the future. Lab infrastructure cost will rise with digitisation but things are going to change drastically and will move in the positive direction: Archana Salil, Founder Director & Principal Architect, Arena Consultants

+ Recruitment & retention of staff, purchase of capital equipment, laboratory facility upgrade & maintenance and management of changes are some of the current major challenges faced by laboratories: Dr Ajeet Kumar Agrawal, Assistant Director- Analytical Science Division-Biology (ASD-Bio), Shriram, Institute for Industrial Research, New Delhi

+ Focusing on the innovation and modern technology is the need of the hour. Smart labs are the future of lab design: SM Mudda, Managing Director, Misom Labs

The post Panel Discussion: Trends in Lab Design appeared first on Express Pharma.

In this video:
Session by Amit Ghate, Application Specialist – Lab Informatics, Agilent Technologies
Topic: An Integrated Laboratory Informatics System for Greater Efficiency and Data Integrity

Key Highlights:
+ Our customers don’t want products, but solutions for their challenges
+ To be efficient, every lab business needs speed, quality and lower cost
+ Pains in day-to-day lab operations include insufficient communication, incomplete knowledge, uneven workload, etc.
+ Principles for a digital lab are an integrated solution, interfaces enabling people and workflows and simple deployment, among others
+ Remaining connected is important and a dashboard can help see the real-time status of each and every instrument in a digital lab
+ Every organisation needs solutions and products are those solutions

The post Session by Amit Ghate, Application Specialist – Lab Informatics, Agilent Technologies appeared first on Express Pharma.

In this video:
Keynote Address: Dr Ajaz S Hussain, Independent Advisor – Life Sciences
Topic: Making Sense of Good Quality by Design in the 2020s

Key Highlights:
+ Quality by Design of Analytical Methods is a key area of focus today
+ Pre-Digital Plant, Digital Silos, Connected Plant, Predictive Plant and Adaptive Plant are the five maturity levels of a ‘Smart Factory’. Most Big Biopharma companies are at Level 3.
+ By 2030, there is an aim to remove humans from cGMP to reduce errors. We need to do this by leveraging sensemaking and investing in the right technologies
+ COVID-19 tragedy has broken our systems. We need to build back and go through a reset. Quality by Design will have a key role in this rebuilding process.

The post Keynote Address: Dr Ajaz S Hussain, Independent Advisor – Life Sciences appeared first on Express Pharma.

Panelists in this video:
+ Dr Vinay Nayak, Independent Director, Aarti Industries (Moderator)
+ Dr Pritesh Upadhyay, Senior VP-Analytical Research, Lupin
+ Dr Shitalkumar Pathak, VP- Head Analytical Research & Development (Formulations), Glenmark Pharmaceuticals
+ Vipul Yamdagni, Vice President & Head – Quality (Generics), Jubilant Generics
+ Dr Sandhya Shenoy, Associate VP, FDC

Key Highlights:
+ As R&D professionals, we need to support the organisation by being agile and adapting rapidly to evolving circumstances and technological advancements: Dr Sandhya Shenoy, Associate VP, FDC

+ Lab procedures, techniques are becoming more efficient and effective with advancements in technology and equipment: Sundara Kalyana Balaji, Head-Analytical, Alembic Pharma

+ Hybrid Pharma Labs that can operate both physically and virtually will improve efficiency, GLP and productivity: Dr Shitalkumar Pathak, VP – Head Analytical Research & Development (Formulations), Glenmark Pharmaceuticals

+ As the Pharma sector becomes more systems-oriented, automation and digitalisation is driving better decisions, reducing errors, improving productivity and enabling cost optimization: Dr Pritesh Upadhyay, Senior VP – Analytical Research, Lupin

+ Covid-19 has been a tough teacher. But India Pharma Inc will turn challenges into learnings and opportunities to produce good quality and affordable medicines for India and the world: Viveka Roychowdhury, Editor, Express Pharma & Express Healthcare

The post Panel Discussion: Next Gen Pharma Labs: Techniques, Technology and Adapting to rapid changes to Pharma Testings appeared first on Express Pharma.

In this video:
Session by Uday Koushik, Senior GM- Services- India & South Asia, PerkinElmer Inc
Topic: Latest trends in Laboratory Services for more operational efficiency

Key Highlights:
+ Service is taking action to create value for someone else
+ Service represents a working system, not a broken system
+ Customer education and training is fast becoming a norm these days which helps in enhancing knowledge and skillsets
+ Remote support helps in the quick virtual arrival of support staff, is cost-effective, safe and secure, as control is with the user, and has faster resolutions
+ The role of the service engineers is evolving from reactive to proactive. They act as fixers, trainers and consultants to discuss maintenance strategies

The post Session by Uday Koushik, Senior GM- Services- India & South Asia, PerkinElmer Inc appeared first on Express Pharma.

Panelists in this video:
+ Dr Ranjit Barshikar, CEO – QbD International; United Nations Adviser – Geneva
+ Dr Rajiv Desai, Executive VP – Corporate Quality, Lupin
+ Dr Sanjay Kumar Jain, President – India, Amneal Pharmaceuticals
+ Dr BM Rao, Head of Quality for Emerging Markets, ASAT & Corporate Quality Control, Dr Reddy’s Laboratories
+ Ranjith Ramakrishnan, Head Quality Control Biologics, Syngene International

Key Highlights:
+ Including digitalisation as a subject in pharma courses is the need of the hour: Dr Ranjit Barshikar, CEO – QbD International; United Nations Adviser – Geneva
+ More automation of documentation will mean less errors. We will be able to get better compliance in our systems with digitalisation. We should be able to integrate the information from various systems and vendors: Dr Rajiv Desai, Executive VP – Corporate Quality, Lupin
+ Technology in labs have increased the level of data integrity, reduced the manual and transcription error and enhanced the flexibility in tracking the sample and inventory management: Dr Sanjay Kumar Jain, President – India, Amneal Pharmaceuticals
+ We need a holistic approach if we want to achieve complete data integrity in labs while dealing with the technology: Dr BM Rao, Head of Quality for Emerging Markets, ASAT & Corporate Quality Control, Dr Reddy’s Laboratories
+ Automation, robotics, digitalisation will reduce errors due to human fatigue and this will add to the quality systems of the organisation: Ranjith Ramakrishnan, Head Quality Control Biologics, Syngene International

The post Panel Discussion: Pharma 4:0 – Digital and paperless laboratory: Need of the hour appeared first on Express Pharma.

In this video:
Session by Venkatesh Krishnamurthy, Compliance Product Specialist, Agilent Technologies
Topic: Digital Compliance solution for a Lab – Automated Instrument Qualification

Key Highlights:
+ Every lab is now aiming for a digital lab
+ More than the digitalisation, user experience is important
+ Increasing lab efficiency will help in avoiding the data integrity issues
+ Three of the biggest risks with manual and transcribed qualification process are human error, increased turn-around time and testing into compliance
+ Agilent has automated the Analytical Instrument Qualification (AIQ) of analytical instruments to enhance productivity and compliance
+ The two cornerstone documents that are the foundation of Agilent’s Qualification Services are the Equipment Qualification Plan (EQP) and Equipment Qualification Report (EQR)

The post Session by Venkatesh Krishnamurthy, Compliance Product Specialist, Agilent Technologies appeared first on Express Pharma.

In this video:
Keynote Address: Dr Rajeev Singh Raghuvanshi, Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Govt. of India
Topic: Indian Pharmacopoeia – The Contextual Relevance

Key Highlights:
+ Newer techniques are improving sensitivity, accuracy of data generation while digitalisation and modelling are making Data Analysis more efficient in Pharma R&D
+ Pharma companies have to plan for contingencies and build new capabilites to survive and thrive in a complex and volatile environment
+ The quality of our Pharma and Medicinal products created for the domestic market have to improve and match global standards
+ Manufacturers and regulators have to join hands to rebuild our Quality Management Systems for domestic production of Pharma Products
+ IPC has initiated changes in 5 areas – IP-online, impurity limits – harmonising with ICH, dissolution for SR Products, flexible monographs and increasing inventory of impurity standards

The post Keynote Address: Dr Rajeev Singh Raghuvanshi, Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Govt. of India appeared first on Express Pharma.