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Conference
PharmaLytica Conference 2024

The healthcare sector has significantly elevated its quality standards and is rapidly embracing digitalization.

PharmaLytica Conference 2024 will delve into pivotal themes such as the challenges and opportunities associated with digital transformation, strategies for ensuring a resilient global supply chain, and innovative analysis methods for optimizing laboratory processes, thereby fostering the evolution of smart technological labs.

This exclusive two-day conference is an invite-only event, where industry leaders will convene to strategize the next phase of growth in the pharmaceutical industry.

Agenda
Agenda At A Glance
Day 1

  1. CMO
  2. API
  3. Excipients
  4. Manufacturing
  5. Partnerships
  6. Development & Validation
  7. Lab & Analytical
  8. Telangana Life Sciences

Day 2

  1. Supply Chain
  2. OSD
  3. Digitalisation
  4. Quality & Risk Management
  5. RWE & RWD
  6. Packaging, Labelling, Serialization,Track & Trace
  7. Roadmap to 2024

Agenda
Agenda 2024
Time Topic
9:00 AM 10:00 AM Registration & Networking
10:00 AM 11:00 AM Welcome Address and Conference Inauguration
Technology Trends
11:00 AM - 11:50 AM
Panel Discussion -: Maximizing Pharma Productivity through Technological Advancement.
  • Optimizing formulation process by implementing process analytical technology (PAT) solutions, continuous manufacturing techniques and big data analytics.
  • Leveraging AI tools for accelerating drug discovery and development.
  • Integrating data analytics tools, advanced spectroscopic and chromatographic techniques for rapid raw material characterization and quality assurance, ensuring consistency and purity.
  • Leveraging predictive analytics and AI-driven demand forecasting to optimize inventory, mitigate stock outs, and prevent supply chain disruptions.
  • Deploying IoT sensors and blockchain technologies to offer real-time pharmaceutical raw material and finished product tracking and traceability.

Moderator :

  • Girish Kapur , Senior Vice President & Site Head, R&D,US Pharmacopeia - India.

Panelists:

  • Dr. Suresh Pathi , Head Operational Excellence-Formulation Cluster, Granules India.
  • Krishna Bhavanasi , Chief Scientific Officer, Extrovis Pharma.
  • Dr. Damodharan Muniyandi , Chief Quality Officer - Global Quality &Regulatory Affairs, Sai Lifesceinces.
  • Gopal Madabhushi , Senior Vice President Business Leader - South Asia, Veolia Water Technologies and Solutions.
11:50 AM - 12:20 PM
The Role of Indian Pharmacopoeia Commission in Setting Pharmacopoeial Standards.
  • Identifying the process for setting Indian Pharmacopoeia (IP) monograph standards.
  • Role in ensuring the quality of medicines.
  • Establishment of IP reference standards.
  • Harmonization of pharmacopoeia standards, and global recognition of the IP.

Speaker :

  • Dr. Gaurav Pratap Singh , Senior Principal Scientific Officer, Indian Pharmacopoeia Commission.
Technological Advancements
12:20 PM 12:40 PM
AI/ML Solution for API Manufacturing Process – The next gen prediction solution.
  • How to develop and train an AI/ML model in a sequential structure.
  • Convert unstructured data to structured data.
  • Create data lake.
  • Compare the data at one place.
  • Apply statistical tools.
  • Train the ML model.
  • Generate predictions.
  • How AI/ML model can predict the potential failures in manufacturing process. A practical case study.

Dr. Damodharan Muniyandi , Chief Quality Officer - Global Quality & Regulatory Affairs, Sai Lifesceinces.

Rajendra Lakshmi Prasad , Head Data Analytics, Sai LifeSciences.

12:40 PM - 01:00 PM
Technology evolution in Pharma Water/Wastewater management
  • Sustainable, low OPEX Cold WFI for injectables/vaccines.
  • Advanced biological treatment for micropollutant/AMR removal.
  • Power driven "Steam free" compact ZLDs.

Santhosh Hegde , Sales Leader - South Asia, Veolia Water Technologies and Solutions.

Biosimilar
01:00 PM - 01:15 PM
Regulatory and Quality Framework of Biosimilars Development.
  • Biosimilars play a vital role in increasing the accessibility of Biologics drugs.
  • Extensive analytical studies are essential to establish similarity with originator products.
  • Critical clinical studies are needed to establish safety and efficacy of Biosimilars.

Dr. Ranjan Chakrabarti , Consultant, Biopharma and Drug Discovery

01.15 PM – 02:00 Lunch & Networking
Drugs Repositioning Strategies
02:00 PM - 02:20 PM
Fireside Chat -: Maximizing Drug Repositioning -: India's Strategic Approach to Exploring New Therapeutic Applications
  • Insights from Case Studies like Remdesivir etc.
  • Benefits of drug repositioning and identifying potential drugs for repurpose.
  • Integrating AI into Drug Repositioning Strategies, approaches methods and consideration.
  • Identifying opportunities for cross-sector partnerships and data sharing.
  • Understanding regulatory frameworks to support and facilitate drug repositioning.

Moderator :

  • Nalam Madhusudhana Rao , CEO, Atal Incubation Centre -CCMB, Hyderabad.

Panelist :

  • Dr. Tathagata Dutta , Chief Technology Officer, JODAS EXPOIM Pharmaceuticals.
  • Dr. Srinivas Arutla , Chief Executive Officer, Zenara Pharma.
Quality Integration in Clinical Development
02:20 PM - 02:40 PM
Quality excellence in Clinical Trials
  • Quality centric approach in clinical trials- CRO, sponsor and ICH-GCP.
  • Audits and inspection readiness in clinical trials.
  • Automation in Clinical quality processes.

Dr. Shubhadeep D Sinha , Senior Vice President Development, Hetero Group of Companies (Hetero Labs).

Pharma Packaging
02:40 PM - 03:30 PM
Panel Discussion : Adapting to Evolving Pharmaceutical Packaging Standards
  • Understating revised chapters USP 661 and 671compliance and decoding revisions and Strategies to prepare for and adapt to the revised USP standards ahead of the 2025 deadline.
  • Overview on technology advancements and how it is facilitating compliance with evolving standards, such as tamper-evident features, serialization, and smart packaging solutions.
  • Importance of adapting packaging practices to ensure product safety and integrity, addressing concerns such as counterfeit drugs, contamination, and shelf-life extension.
  • Growing importance of sustainable packaging solutions in the pharmaceutical industry and how companies are integrating eco-friendly materials and practices to reduce environmental impact.
  • Insights into future trends and advancements in developing flexible and responsive packaging solutions to anticipate regulatory changes and market needs.

Moderator :

  • Ravipati Chandi Prasad , Head Packaging Development, Aurobindo Pharma Ltd.

Panelist :

  • Sekhar Babu Puli , Head - Packaging Development,MSN Laboratories.
  • Ram Gopal , DGM Packaging Development, Aurobindo Pharma.
03:30 PM - 04:00 PM Tea - Coffee and Networking Break
04:00 PM – 04:20 PM
Role of Incubators in Nurturing Bio-Pharma Startups to Scale-up.
  • Understating the need for Biopharma Startup Incubation.
  • Overview of Pilot or Scale-up avenues.
  • Understanding application processes and eligibility criteria for Government Grants and Subsidies and Overview of different funding opportunities.

Ramjee Pallela , Chief Operating Officer, Atal Incubation Centre-CCM.

Analytical Instrumentation
04:20 PM – 04:45 PM
Recent developments in ICH GCP E6 R2.
  • History of ICH GCP.
  • Evolution of GCP.
  • Need for new guidance post pandemic situation.
  • Way forward to ICH GCP.

Dr. Pankaj Thakur , General Manager, Hetero Labs.

End of Day 01
Time Topic
API
11:00 AM - 12:00 PM
Panel Discussion :- Shifting the Gear: Strategies for India's Transition from Generic Manufacturer to API Production Hub.
  • Analyzing the need for shifting focus to API manufacturing.
  • Identifying the innovative approaches and technologies to optimize API manufacturing processes and reduce production costs.
  • Role of emerging technologies such as continuous manufacturing, green chemistry, and process automation to improve efficiency, sustainability, and cost-effectiveness.
  • Outlining the regulatory hurdles and propose solutions for streamlining processes.
  • Exploring opportunities for global collaboration, partnerships, and market access agreements to promote India's API manufacturing capabilities globally.
  • Control strategies in complex API manufacturing.

Moderator :

  • Sivakumar V , Director, PharmQS Consulting (Former Quality Lead in Pfizer & Mylan).

Panelist :

  • Ramkumar Esakki , Senior Vice President, Suven Pharma.
  • Balaram Patro , CEO, GRK Research Laboratories.
  • Dr. Vasanthakumar Ramu , Head of Research and Development - Peptides & Complex, API's, Alembic Pharmaceuticals.
  • Himal P. Desai , Executive Vice President, Supply Chain Management & Information Technology, Sekhmet Pharmaventures.
  • Matruprasad P , Senior Director - Regions & Program Operations & General Manager - South Asia,US Pharmacopeia.
CRO and CMO
12:00 PM - 12:20 PM
Redefining Pharma Partnerships -: Maximizing Value through Strategic Collaborations with CMOs and CROs.
  • Understanding the dynamics of outsourcing in pharma.
  • The rise of sophisticated CMOs and CROs with focus on their core competencies of drug discovery and development.
  • Strategies for managing outsourcing relationships, mitigating potential challenges, and leveraging opportunities for growth.

Kiran Marthak , Director - Medical Affairs, Phase-1 and Regulatory Affairs, Veeda Clinical Research.

Pharma Manufacturing
12:20 PM - 12:40 PM
Empowering Pharma Manufacturing with Advanced Analytics
  • A data driven approach by Quality-by-Design (QbD) in continuous manufacturing.
  • Role of advanced analytics in meeting regulatory standards.
  • Optimizing ISA-88 Standards for batch control and leveraging advanced techniques for monitoring vital process parameters and detecting deviations.

Ramkumar Esakki , Senior Vice President, Suven Pharma.

Innovation
12:40 PM - 01:30 PM
Panel Discussion : Breaking Boundaries with Innovations in Pharmaceutical.
  • AI, Big Data and advanced analytics optimizing personalized medicine and patient-centric care and revolutionizing drug discovery.
  • Data analytics tool forecasting tomorrow's medicines today.
  • Analytics driving pharma efficiency streamlining regulatory processes, accelerate approvals, and bring life-saving therapies to market faster.
  • Blockchain & IoT paving the way for a future of unprecedented discovery and impact.
  • Need for robust collaboration catalysts from industry leaders, researchers, and regulatory agencies to foster innovation and drive collective progress.

Moderator :

Dr. Subhash Thuluva , Sr. Vice President & Head - Clinical Development, Biological E. Limited.

Panelist :

  • Dr. Shubhadeep D Sinha , Senior Vice President Development, Hetero Group of Companies (Hetero Labs).
  • Elayaraja Natarajan , Vice President - Research And Development, Lyrus Life Sciences.
  • Aman Agarwal , Head - Digital & Analytics for Manufacturing & Quality, Dr Reddy's Laboratories.
  • Praveen Kumar , Senior Director, Centralized Monitoring & Medical Data Review, Fortrea.
01:30 PM - 02:30 PM Lunch Networking Break
Green Chemistry
02:30 PM - 02:50 PM
Flowing Towards Greener Pharma : Sustainable Production with Flow Chemistry.
  • Significance of sustainability in the pharmaceutical industry and how flow chemistry differs from traditional batch processes.
  • Advancements and innovations in flow chemistry to address sustainability goal.
  • Call to action for continued research and collaboration to drive sustainable practices in the pharmaceutical industry.

Dr. Makarand Pimplapure , Managing Director, MakSpeed Technologies

02:50 PM - 03:10 PM
Lean & Agile Supply Chain: Risk & Challenges
  • Benefits of lean supply chain .
  • Challenges of Lean supply chain risk management .
  • Efficient supply chain Models.

Deepak Khurana , Vice President-Procurement & SCM, Suven Pharmaceutical

Analytical Instrumentation
03:10 PM - 03:30 PM
Exploring cutting-edge technologies revolutionizing drug discovery, formulation, and quality control.
  • Role of advanced analytics optimizing personalized medicine.
  • Leveraging analytics to streamline regulatory processes, accelerate approvals, and bring life-saving therapies to market faster.
  • Reducing the complexities of data governance, quality assurance, and regulatory standards with big data.

Kamaraj Abraham , Associate Vice President, Head Quality Assurance, Aurobindo Pharma.

03:30 PM - 04:00 PM Tea - Coffee and Networking Break
Supply Chain / Cold Chain
04:00 PM - 04:20 PM
Building Efficient Pharma Supply Chain and Cold Chain Enhancing Quality and Accessibility Across Production and Distribution.
  • Designing efficient sustainable transportation practices to reduce carbon emissions and environmental impact.
  • Developing robust uninterrupted cold chain quality management systems to monitor and maintain product integrity.
  • Risk mitigation strategies and contingency planning and building resilience through diversification, redundancy, and flexibility in supply chain operations.

Bharat Bhushan Rathi , Head Distribution and Logistics,Mankind Pharma.

Industry Outlook- Pharma Packaging, Labelling, Serialization and Track and Trace
04:20 PM - 04:40 PM
Ensuring Safety and Security: Pharma Packaging, Labeling, Serialization, and Traceability Solutions.
  • Advancements in pharmaceutical packaging design and its role in ensuring the integrity of products throughout the supply chain.
  • Importance of accurate and compliant labeling practices focusing on strategies to improve patient safety, regulatory adherence, and information transparency.
  • Enhancing Supply Chain Visibility Through Serialization and Track & Trace.

PV Raju , Senior Vice President - Procurement & SCM, Biological E.

04:40 PM - 05:00 PM Vote of Thanks
Topics
Key Agenda Topics 2024

  • Latest developments and trends in the Pharma API industry
  • Pharma Machines & Manufacturing - Latest developments towards quality improvement
  • Method Validation to Optimisation and Automation in Analytical and Microbiological Laboratories
  • QR codes on API's, medicines and all drug packs - From Jan 01st 2023 - What is to be done now to ensure that the deadline is met?
  • Challenges and opportunities in moving towards digitalisation - It's time to start your run towards your digital transformation
  • Latest trends and developments in your supply chain
  • Smart packaging for pharma industries - Making packaging and labelling truly intelligent

Speakers
Key Speakers

Dr. Shubhadeep D Sinha

Senior Vice President Development
Hetero Group of Companies (Hetero Labs)

Bharat Bhushan Rathi

Head Distribution and Logistics
Mankind Pharma

Dr. Tathagata Dutta

Chief Technology Officer
Jodas Expoim Pharmaceuticals

Ramkumar Esakki

Senior Vice President
Suven Pharma

Dr. Srinivas Arutla

Chief Executive Officer
Zenara Pharma Pvt. Ltd.

Elayaraja Natarajan

Vice President - Research And Development
Lyrus Life Sciences

Dr. Suresh Pathi

Head Operational Excellence-Formulation Cluster
Granules India

Dr. Balaram Patro

CEO
GRK Research Laboratories

Dr. Vasanthakumar Ramu

Head of Research and Development - Peptides & Complex, API's
Alembic Pharmaceuticals

Dr. Krishna Murthy Bhavanasi

Chief Scientific Officer
Extrovis Pharma

Dr. Gaurav Pratap Singh

Senior Principal Scientific Officer
Indian Pharmacopoeia Commission

Dr. Kiran Marthak

Director - Medical Affairs, Phase-1 and Regulatory Affairs
Veeda Clinical Research

Dr. Damodharan Muniyandi

Chief Quality Officer - Global Quality & Regulatory Affairs
Sai Lifesceinces

PV Raju

Senior Vice President - Procurement & SCM
Biological E.

Himal P. Desai

Executive Vice President, Supply Chain Management & Information Technology
Sekhmet Pharmaventures

Kamaraj Abraham

Associate Vice President, Head Quality Assurance
Aurobindo Pharma

Matruprasad Priyadarshi

Senior Director - Regions & Program Operations & General Manager - South Asia
US Pharmacopeia

Girish Kapur

Senior Vice President & Site Head, R&D
US Pharmacopeia - India

Aman Agarwal

Head - Digital & Analytics for Manufacturing & Quality
Dr. Reddy's Laboratories

Sekhar Babu Puli

Head - Packaging Development
MSN Laboratories

Dr. Subhash Thuluva

Senior VP & Head - Clinical Development & Pharmacovigilance
Biological E Ltd

Sivakumar V

Director
Quality Systems and Audits, PharmQS Consulting

Deepak Khurana

Vice President-Procurement & SCM
Suven Pharmaceuticals

Dr. Makarand Pimplapure

Managing Director
MakSpeed Technologies

Dr. Ranjan Chakrabarti

Consultant
Biopharma and Drug Discovery

Ravipati Chandi Prasad

Head Packaging Development
Aurobindo Pharma Ltd.

Nalam Madhusudhana Rao

CEO
Atal Incubation Centre

Gopala Krishna Madabhushi

Senior Vice President & Business Leader
Veolia Water Technologies & Solutions

Santhosh Hegde

Sales Leader
South Asia, Veolia Water Technologies and Solutions

Rajendra Lakshmi Prasad

Head Data Analytics
Sai Life Sciences Limited

Ram Gopal

DGM Packaging Development
Aurobindo Pharma

Dr. Pankaj Thakur

General Manager
Hetero Labs

Praveen Kumar

Senior Director
Centralized Monitoring & Medical Data Review, Fortrea

Ramjee Pallela

Chief Operating Officer
Atal Incubation Centre-CCM
Who Should Attend?

The conference is an exclusive invite only event for senior delegates from the pharma industry. The profile of the attendees is as below:

  1. Pharma Leaders & Top CEO
  2. Technical Heads & Plant Heads
  3. Medical Heads & Senior Scientist
  4. Marketing & Strategy Leaders
  5. Quality Control & Clinical Research
  6. R&D Heads and Technocrats
  7. Engineering & Production Professionals
  8. Purchase & Packaging Professionals
  9. Regulatory Affairs Professionals

Pharmalytica 2024