Agenda

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Women in Leadership Forum

Breakfast Reception & Icebreaker Introduction
08:00 AM - 08:30 AM Women in Leadership Forum
Women in Leadership Forum

Get to know your fellow attendees and start the conversation around our own experiences with bias.

Leadership Lessons: How empathy can inspire great leadership
08:00 AM - 11:00 AM Women in Leadership Forum
Women in Leadership Forum

As leaders we must constantly think about the big picture to ensure our workplaces are future proof by creating an environment where everybody can fulfil their full potential. Simon Sinek reminds us that as a leader it “is not about being in charge, but about being responsible for the people in our charge.”
Empathy is the ability to understand another person’s experiences and perspective, and without it you cannot predict how your actions will affect another person or begin to build & nurture a team. This year the Women in Leadership Forum will tackle this key leadership skill by asking you to look at your own biases and how they unconsciously effect your day-to-day perspective of others. Hear from senior leaders across the pharma supply chain as they share a defining moment from their own leadership journey that demonstrates the importance of being an empathic leader.

Opening remarks from the chair
08:30 AM - 08:45 AM Women in Leadership Forum
Women in Leadership Forum
Leadership Lessons
08:45 AM - 09:45 AM Women in Leadership Forum
Women in Leadership Forum

Pharma leaders share a defining moment in their leadership journey with empathy at its heart.

Speakers:
• Bonnie Bain, Global Head & Executive Vice President of Healthcare Operations & Strategy, GlobalData PLC
• Frances Zipp, President & CEO, Lachman Consultant Services

Campfire Session
09:45 AM - 10:25 AM Women in Leadership Forum
Women in Leadership Forum

Get to know our speakers as they delve deeper into their stories & ask questions about your own career challenges.

Dynamic Networking
10:25 AM - 11:00 AM Women in Leadership Forum
Women in Leadership Forum

Own your biases.

Drug Development & Delivery

The Digital Transformation of Drug Development
10:00 AM - 10:30 AM Drug Development & Delivery Theater
Drug Development & Delivery

Speaker: Aurelio Arias, Senior Consultant, IQVIA

Applying AI to Drug Development
10:30 AM - 11:30 AM Drug Development & Delivery Theater
Drug Development & Delivery

Speaker: Bibiana Campos Seijos, Editor-in-Chief and VP of C&EN Media Group

Overcoming formulation challenges: solutions for solubility, bioavailability and stability
11:30 AM - 01:00 PM Drug Development & Delivery Theater
Drug Development & Delivery

11:30-11:35: Introduction: Tackling the ongoing challenges of solubility, stability and bioavailability with new approaches – Rita Peters, Editorial Director, Pharmaceutical Technology

11:35-11:50: Nanoparticle Engineering

11:50-12:05: Spray drying – Dr David Lyon, Senior Research Fellow, Lonza

12:05-12:20: Co-Crystals – Aniruddh Singh, Ph.D. Founder & Director, Asha Pharma LLC

12:20-12:35: Hot Melt Extrusion – Dr Feng Zhang, Assistant Professor at University of Texas

12:35-12:50: Modified and Controlled Release Formulations

12:50-13:00: Q&A

The Role of Excipients: Advanced Functionality and Drug Development
01:00 PM - 01:30 PM Drug Development & Delivery Theater
Drug Development & Delivery

• Increased demand for advanced function excipients in development of advanced therapeutics
• the role of excipients in overcoming challenges associated with stability and solubility
• Regulatory challenges and perspectives of novel and co-processed excipients

Speaker: Dr Nigel Langley, Ph.D., Director - Technical Service and Scientific Affairs, Pharma Solutions, BASF

Lunch
01:30 PM - 02:00 PM Drug Development & Delivery Theater
Drug Development & Delivery
Identifying and Mitigating Errors in Organic Extractables & Leachables Screening
02:00 PM - 02:45 PM Drug Development & Delivery Theater
Drug Development & Delivery

Organic Chromatographic “Screening” to discover, identify and quantify organic compounds in an extract or drug product is a relatively new concept to both the Pharmaceutical and Medical Device Industries. While the Chromatographic Screening process is the best solution to cover the three functions is should serve, each function of the screening process is prone to errors that are inherent to the screening methodology.
• The risk of omission: omitting a compound in chromatographic screening as fatal error
• The risk of inexact identification: mis-identifying a compound as fatal error
• The risk of inaccurate and imprecise quantitation in chromatographic screening processes.
The presentation will explain these errors in detail and how to minimize the occurrence of these errors

Speaker: Piet Christiaens, Scientific Director at Nelson Labs Europe

Panel Discussion: Innovation in Oncology Development
03:30 PM - 04:30 PM Drug Development & Delivery Theater
Drug Development & Delivery

• Drug pipeline and approvals
• New approaches to drug development
• Nanotechnology, Immunotherapy

Moderator: Dustin Phan, Analyst, Informa Pharma Intelligence

Panel Discussion: Unlocking the potential of cannabinoid derived drugs
04:30 PM - 05:00 PM Drug Development & Delivery Theater
Drug Development & Delivery

• Current market overview – GW’s epilepsy drug
• Potential for application to other therapy areas
• Synthetic vs natural
• Development challenges
• Regulatory perspectives

Moderator: Scott Watson, Principal, The C-C Bond Group

Panellists:
• Jessica Rousset, Chief Operating Officer, CURE Pharmaceutical
• Joshua Hoerner, PhD, VP Global Innovation, Purisys
• Dr Brian Furmanski, Senior Director, Clinical Pharmacology & Regulatory Affairs, Nuventra Pharma

Drug Manufacturing

Panel Keynote
10:00 AM - 10:30 AM Drug Manufacturing Theater
Drug Manufacturing
Digitally Uniting the Health Care-Pharma Supply Chain System for Greater Good
10:30 AM - 11:00 AM Drug Manufacturing Theater
Drug Manufacturing

Today’s health care and pharma industries are under significant pressure to digitally transform in order to support advancements in medicine and patient safety. However, the health care system is both complex and constrained because it involves patients, their health and safety, and ever-evolving regulations. Health care providers and the pharma industry must refrain from working in silos and work together to provide one patient-centric ecosystem.

This session will present a unique and innovative approach to tackling the challenges of pharma supply chain regulations with the safety of patients at the core. This approach will show how digital solutions can be utilized to enable digital tracking and tracing of serialized medicines to ensure the safety of pharmaceutical products. Performed on one unified platform, pharma and health care partners will be able to leverage the valuable data within it to produce better patient outcomes. Examples within this session will highlight how this new data can be leveraged to:

• Enable greater visibility into medication availability
• Enable real-time collaboration to resolve critical business challenges
• Enable a safer and more efficiently regulated supply chain

Speaker: Roddy Martin, Chief Digital Strategist, TraceLink

Break
11:00 AM - 11:30 AM Drug Manufacturing Theater
Drug Manufacturing
Lunch
12:30 PM - 02:00 PM Drug Manufacturing Theater
Drug Manufacturing
Facing Integration Challenges with Smart Equipment
02:00 PM - 02:30 PM Drug Manufacturing Theater
Drug Manufacturing
From Documen-Based to Design-Focused: The Critical Paradigm Shift to Drive Digital Transformation
02:30 PM - 03:00 PM Drug Manufacturing Theater
Drug Manufacturing

Digital transformation, Pharma 4.0 and IIoT are not only buzzwords, but concepts that hold tremendous promise for pharma manufacturers. To realize that promise, however, the industry must move beyond today’s document-based approaches to key manufacturing activities—from initial tech transfer to ongoing process development.

This session will present an innovative yet proven approach centered on digital process design. Under this new paradigm, processes are digitally modeled and simulated, with the design environment tightly integrated with manufacturing and business management systems enterprise-wide. Real-world case studies will highlight how this design-based approach:

• Provides a powerful backbone for digital transformation
• Eliminates resource-intensive, error-prone manual processes
• Dramatically improves product quality and cost-efficiency

Speaker: Cathal Strain, CEO, NEO PLM

Best Practices for the Monitoring and Analysis of Smart Pharma Manufacturing
03:00 PM - 03:30 PM Drug Manufacturing Theater
Drug Manufacturing
Lightning Round: Technologies Advancing Plant Floor Production
03:30 PM - 04:00 PM Drug Manufacturing Theater
Drug Manufacturing

Bioprocessing & Manufacturing

Global Trends and Emerging Modalities
10:00 AM - 03:30 PM Bioprocessing & Manufacturing Theater
Bioprocessing & Manufacturing

10:00- 10:30: Market Outlook - Global Trends and Growth Opportunities in Biopharmaceutical Product Development and Manufacturing
10:30-11:00: Market Outlook - Opportunities and the Evolving Biopharma Landscape in Asia-Pacific
11:00-11:30: Global Outlook for Biosimilars
11:30-12:30: Panel Discussion: Adapting Manufacturing Strategies and Facilities for Next Generation Biotherapeutics and Emerging Therapies
12:30-13:00: Cell and Gene Therapies Opportunities
13:00-14:00: Lunch
14:00-14:45: Partner Presentation
14:45-15:30: Partner Presentation
15:30-16:30: Panel Discussion | Cell and Gene Therapies - Manufacturing, Supply Chain and Commercialisation Strategies