Welcome, ISPE Canada Affiliate

In-person Education and Product Symposium

May 6–7, 2024

Plan to join our diverse and exciting pharma and biopharma community at the ISPE Canada Affiliate’s Education and Product Symposium (EPS) on May 06 – 07, 2024 at the Marriott in downtown Toronto.

Why participate?

You will have access to a variety of educational sessions addressing relevant manufacturing challenges, delicious food throughout the event, product show access including a chance to win great prizes, networking opportunities, and lots of fun!

The theme of the EPS 2024 is Age of Transformation: Innovative Solutions to Proactive Changes in the Canadian Pharma and Biopharma Industry.

The biopharmaceutical and pharmaceutical industries are undergoing dramatic changes that will affect the design and operation of facilities. A rapidly changing market environment has also affected CMO and CDMO operations, where customer demands increasingly require the manufacture of drugs in smaller volumes. We believe that a multidisciplinary approach is essential for designing an end-to-end program that addresses all operations from the selection of raw materials through to the distribution of final products.

Ensuring product quality and supply chain safety and improving manufacturing efficiency are key initiatives for ISPE while always putting the patient first. Our industry makes products that are life-changing and life-sustaining and impact hundreds of millions of people worldwide.

After Dinner Party at Par Bar on Monday Night

Elevate your EPS experience at an after dinner party at Marriott’s Par Bar, located adjacent to the symposium hotel venue. After an enriching day of industry insights, unwind and connect with your peers at our exclusive after-dinner party and take advantage of the lounge setting with virtual games, bar bites, drinks, and a dance floor. This event is opened to attendees registered for the EPS at an additional cost of $10 and is limited to 100 people. To register, click on the following link https://ispecanada.org/product/par-bar-after-dinner-party/.

Leadership Workshop Tuesday Afternoon

The leadership workshop is aimed to enhance leadership skills among participants through a tailored training session and interactive exercises addressing industry-specific challenges and leadership competencies. The facilitators, Shervin Hebbi, General Manager, Thermo Fisher and George Karatigin, Director of Production, Thermo Fisher will provide practical insights and tools to become more effective leaders in our dynamic and highly regulated environment. This 2 hour session is opened to attendees registered for the EPS at an additional cost of $50.00 (lunch included). To register, click on the following link https://ispecanada.org/product/leadership-workshop/.

Monday, May 06, 2024

7:00 - 8:45

Registration

7:30 - 8:30

Continental Breakfast & Product Show

8:30 - 9:00

Opening Ceremony

9:00 - 10:30

Keynote Session

ISPE Drug Shortages Initiative – Where we have been and where we are going.

Health Canada’s Efforts to Mitigate Drug Shortages.

10:30 - 11:00

Break & Product Show

10:30 - 12:15

Concurrent Session – Pharma 4.0

Digital Advantage – Bridging Pharma 4.0 and Operational Excellence

Session Description
Session Description

Digital Advantage – Bridging Pharma 4.0 and Operational Excellence

An overview on the Digital Advantage program, aimed at equipping the organization with a framework for tackling digital transformation in manufacturing and key business units. The presentation will cover the approach to strategic roadmap development, complex use case definition, and the adoption and implementation of digital technologies for enhancing business operations, improving customer experiences, and driving sustainable growth.

Concurrent Session – New Modalities

Points to Consider for the Manufacturing of ATMPs, Annex 1 Implementation based on the QRM and CCS

Session Description
Session Description

Points to Consider for the Manufacturing of ATMPs, Annex 1 Implementation based on the QRM and CCS

The commercial Manufacturing and the design of the facility are often challenging to the industry. Should Annex 1 be Applied for Cell and Gene?. What to consider to build a multi purpose facility. How to work in a safe way with viral vectors.? Where does single use have it’s Limitation will be covered in the presentation.

Important Consideration for Facility Design of Cell and Gene Therapy facilities

14:45 - 15:00

Break

15:00 - 16:00

Concurrent Sessions – Sustainability

Decarbonizing Biopharmaceutical Manufacturing and Supply: A closer look at the differences between Scope 1, 2 and 3 Carbon emissions and the strategies to address them

Session Description
Session Description

Decarbonizing Biopharmaceutical Manufacturing and Supply: A closer look at the differences between Scope 1, 2 and 3 Carbon emissions and the strategies to address them

As the urgency to address climate change becomes more and more apparent to the world, companies are stepping up, setting targets and implementing strategies to achieve decarbonization. Many (including Sanofi) have committed to both carbon neutrality and net zero goals, but how can we get there. In this presentation, we will break down the differences between Scope 1, Scope 2 and Scope 3 carbon emissions and we will talk about some of the strategies that Sanofi is leveraging to achieve our decarbonization goals. We will also talk about the challenges and opportunities that remain and what must be addressed over the coming years to meet and exceed our goals, for the sake of our planet. Agenda: Why are carbon emissions a problem and why should Pharma be interested? What is the difference between Scope 1, 2 and 3

Concurrent Sessions – Validation & Quality and Sustainability

Implementing Phase-Appropriate Good Manufacturing Practices (GMP) for Developmental Drugs: Navigating Regulatory Requirements

Session Description
Session Description

Implementing Phase-Appropriate Good Manufacturing Practices (GMP) for Developmental Drugs: Navigating Regulatory Requirements

This discussion explores the critical aspects of adhering to phase-appropriate Good Manufacturing Practices (GMP) for drugs in different developmental stages. Understanding and adapting GMP principles in alignment with the distinct needs of drug developmental phases are crucial for ensuring safety, quality, regulatory compliance, along with management of resources and timelines. The discussion will explore the tailored strategies and challenges in implementing GMP protocols in development, addressing the nuanced considerations from preclinical stages to clinical trials and eventual commercialization. Emphasis will be placed on regulatory expectations of both facilities and equipment, risk-based approaches, cost-efficiency, and flexibility in manufacturing processes. Case studies and practical insights will be shared to aid pharmaceutical professionals in navigating the dynamic landscape of GMP compliance throughout the drug development continuum.

Achieving Waste Reduction through Dry Vacuum Solutions

16:00 - 16:15

Break

16:15 - 17:30

Leadership Panel

Cultivating Human Capital: Unleashing Latent Talent in Pharma and Biopharma Manufacturing

Session Description
Session Description

Cultivating Human Capital: Unleashing Latent Talent in Pharma and Biopharma Manufacturing

This panel discussion will illuminate the critical aspects of effective leadership within the fast-paced and intricate field of pharmaceutical manufacturing operations. We will delve into the art of empowering and inspiring large, cross-functional, and highly specialized teams in a science-focused environment, thereby fostering a culture of performance and excellence. Our exploration will span the strategies for managing organizational dynamics that encourage a self-sustaining culture of excellence, along with methods to identify, nurture, and build the next generation of industry leaders and high-performance teams. Additionally, we will tackle the complexities of navigating today's diverse workplace dynamics, aiming to uncover actionable strategies that harmonize a multigenerational workforce and enhance operational efficiency. The objective is to equip current and aspiring leaders with the knowledge and tools to drive innovation, ensure sustained excellence, and prepare for the future in the ever-evolving pharmaceutical industry. Highlight leadership essentials in pharmaceutical operations.

17:30 - 19:00

Cocktails

19:00 - 21:00

Dinner

21:00 ON

Sponsored After Dinner Party (Separate Tickets Required)

Tuesday, May 07, 2024

7:00 - 8:15

Continental Breakfast & Product Show

8:15 - 9:30

Concurrent Sessions – Facilities & Operations

Advantages of Continuous Manufacturing

Session Description
Session Description

Advantages of Continuous Manufacturing

Thermo Fisher Scientific, is one of the few pharmaceutical companies that have Continuous Manufacturing (CM) capabilities. With Continuous Manufacturing, in theory, there is no batch size specific by weight. The "batch" is defined by time as the process keeps running, so long as active ingredient and excipients are supplied into the manufacturing process. Traditional batch processes are typically scaled from the scale at which clinical material is manufactured up to an acceptable manufacturing scale. The scale-able nature of the CM process means the process does not need to be scaled, which can lead to material savings in the millions of dollars for clients and in turn provides better access for drugs to reach patients. CM development programs with aggressive clinical timelines, high annual volumes, high forecast variability due to launch or generic competition, and supply chain risks are great candidates. A detailed overview will provide a summary and lessons learned on; the facility layout and design, technology and equipment process, dynamic real-time process modeling, process analytical technology (PAT), along with real time quality release and continued process verification.

Concurrent Sessions – Sustainability

Machine Learning for Water Facility Sustainability

Session Description
Session Description

Machine Learning for Water Facility Sustainability

Today's machines are more and more connected. All the data are available and can be easily provided to the user. With the data Analytics, the data can be translated into information and can be very useful as a support to the decisions. Who has a long experience, doesn't have any problem and is normally used to decide quickly. The problem arises when the experience is not enough to decide or when we are flooded by so many information that is getting us confused. To take all these data, to cluster them, to correlate them and to learn from the history of previous events, it's the only way to avoid to repeat mistakes from the past. Artificial Intelligence and Machine Learning are contributing hugely and within the Water Facilities we have identified three main directions: to predict failures or problems timely, to suggest new ways to operate the plants, identifying the most sustainable operation profiles, reducing wastes of water, optimizing the energy consumption, providing increased efficiency over the entire lifecycle of the water facilities in the Lifescience industry.

Sustainable Approaches to the Design, Construction and Operation of Cleanrooms and Critical Environments

Session Description
Session Description

Sustainable Approaches to the Design, Construction and Operation of Cleanrooms and Critical Environments

Today, more than ever, it is becoming increasingly apparent that there is a need for a more sustainable future. The pharmaceutical industry has recognized this need and has begun to introduce minimal waste and energy conservation practices. While great progress has been made, it is necessary to continuously review the latest research and technological advancements in order to realize the benefits they make possible. Cleanrooms are inherently challenging when it comes to sustainability. They demand strict environmental controls and procedures to maintain cleanliness often leading to excess energy consumption and resource utilization. Design and operation well above the necessary thresholds is a common practice and a popular risk mitigating strategy. Despite this, there exist design philosophies and material choices that can be pursued to realize meaningful energy savings and significantly reduce the environmental footprint of these critical spaces. This presentation discusses a variety of areas where design, construction materials and operational control strategies can be implemented to achieve energy efficiencies, reductions in waste and lifecycle cost savings. Examining the latest data, studies, and example installations we will discuss how a variety of these approaches can be combined to bring us closer to a net zero future for cleanrooms and critical environments. The presentation will focus primarily on two key aspects of sustainable cleanroom design: 1. Energy Efficiency: We will examine how advanced HVAC systems design, LED lighting and smart controls can minimize energy consumption without compromising operational integrity. 2. Resource Optimization: We will discuss how the selection of re-usable, re-configurable and recyclable eco-friendly materials can not only reduce waste, increasing the long-term viability of cleanroom facilities, but also provide a greater degree of operational flexibility. By the end of this presentation, attendees will have gained a deeper understanding of how these sustainable design practices can be seamlessly integrated into future designs. While by no means an exhaustive list, these practices will arm designers with several new tools to help reduce the environmental impact of facilities, both existing and planned.

09:30 - 09:45

Break & Product Show

09:45 - 11:00

Concurrent Sessions – Validation & Quality

Digital CPV implementation – real use case

Session Description
Session Description

Digital CPV implementation – real use case

A customer use case presented on a digital Continued Process Verification (CPV) program implementation, from data integration to program set up and routine activities. In this presentation the main challenges before implementing a digital CPV solution are highlighted.Attendee Takeaways: By attending this session, attendees will gain insights on how to build a digital Continued Process Verification (CPV) program as also what are the main business impacts after this implementation. A special highlight is going to be made on the current challenges in having a digital continues verification program.

From Concept to Reality: Establishing and Scaling Digital QRM Programs

Session Description
Session Description

From Concept to Reality: Establishing and Scaling Digital QRM Programs

In this session, we will present real-life examples of implementation use cases of a digital Quality Risk Management program, using Industry 4.0 technologies. We will cover the goals, approaches, and outcomes of the implementation, as well as the key benefits gained from it.

Concurrent Sessions – Pharma 4.0

Machine Learning Models Lifecycle and Validation Approach in Drug Manufacturing Use Cases

Session Description
Session Description

Machine Learning Models Lifecycle and Validation Approach in Drug Manufacturing Use Cases

New areas of research based on artificial intelligence (AI) technologies are evolving, including machine learning (ML) and natural language processing (NLP) techniques, and are now being adopted to support Pharma processes. The uses of Artificial Intelligence (AI) extend across the enterprise and include GxP regulated processes. Data analytics solutions have potential to automate routine work and balance resource use across quality risk management and other GxP activities. Intelligent automation will contribute to the quality and consistency of data processing. These novel technology solutions are implemented to assist in processing GMP data. Health Authority regulations require pharmaceutical companies to validate this software. While the underlying validation requirements remain unchanged (e.g., such as conformity with user specifications, traceability of decision points with an audit trail, and reliability of algorithm output), additional software development activities tailored to intelligent automation are needed to document evidence that the system is fit for purpose. This presentation proposed classification of automation systems for Pharma, the Machine Learning lifecycle, along with validation considerations for emerging technologies to support whether existing validation frameworks can be used or should be extended to constitute a reasonable, risk-based validation strategy as has been done for computerized systems elsewhere within the industry.

11:00 - 11:15

Break

11:15 - 12:45

Closing Keynote Panel

Navigating Biomanufacturing: Cells as the Drug vs. the Drug Factory

12:45 - 13:15

Closing Ceremony & Passport Prize Draw

13:30 15:00

Leadership Workshop

Authoring Ambition: Crafting Your Leadership Story

Session Description
Session Description

Authoring Ambition: Crafting Your Leadership Story

In the vast landscape of leadership, our stories are not merely tales; they are the very foundation upon which we build ourselves. Every leader crafts a narrative, a simple, true account of who they are, where they aim to go, and the obstacles overcome along the way. This act of storytelling isn’t just about speaking—it’s about listening to the echo of one's own experiences and values, and shaping them into a clear, resonant voice that guides and inspires. For in the clarity of our stories, we find the essence of leadership: the power to move others and ourselves forward with purpose. Join us for an exhilarating workshop, “Authoring Ambition: Crafting Your Leadership Story”, where you will embark on a profound journey of self-discovery and reflection to shape your future as an influential leader. This immersive experience is designed to guide you through a comprehensive self-assessment, helping you identify and align your core values, strengths, and mindsets with your personal vision for leadership. Throughout this workshop, you will explore the power of storytelling as a tool not only for personal growth but also as a means to inspire and lead others effectively. We'll delve into the essential elements that make a compelling leadership story—your unique experiences, the challenges you've overcome, the values that guide you, and the goals you aspire to achieve. Workshop Key Highlights:

  • Self-Assessment: Uncover your core values and strengths, and recognize areas for personal growth and development.
  • Vision Crafting: Define a clear and impactful vision for your leadership journey, tailored to your aspirations and aligned with your strengths.
  • Storytelling Mastery: Learn the art of storytelling to effectively communicate your vision and influence those around you.
  • Interactive Exercises: Participate in engaging activities designed to draw out your natural leadership style and refine your storytelling skills.
  • Personalized Feedback: Receive constructive feedback on your leadership story in a supportive, collaborative setting.

Whether you're an emerging leader or looking to enhance your existing leadership capabilities, this workshop will equip you with the tools and confidence to articulate your vision and lead with authenticity. Prepare to transform your insights into action as you craft a leadership narrative that resonates and motivates, paving the way for a future of success and fulfillment. Join us to forge your path as a visionary leader who inspires change and drives impact.

Attendee Registration

Attendee passes include access to exhibits, educational sessions and all meals including Monday evening dinner

Registration Category Fee
Members $700.00
Non-members $850.00
Group (5+) at $675 each (membership not required) $3,375.00
Young Professionals (ISPE Membership Required) $350.00
Students (ISPE Membership Required) $50
Leadership Workshop $50
Par Bar After Dinner Party $10

Register now to attend this event

Attendee Registration Leadership Workshop Par Bar After Dinner Party

Exhibitors Opportunities

Exhibition Level Fee
10 × 10 Booth Exhibitor ( two attendees ) $3,500
TableTop Exhibitor ( one attendee ) $2,000

Additional charges will apply for passport program and power-drop

Program Fee
Passport Program (unique opportunity to interact with attendees) $300
Power-drop (standard power cord included with exhibit package) Contact Dina Iezzi at info@ispecanada.org

Symposium Exhibitor Registration Is Now Open

Tabletop Exhibitor Registration Booth (10×10) Exhibitor Registration Passport Program Registration

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Product Symposium – Sponsors

ISPE Canada Affiliate sincerely thanks the ongoing support of our sponsors and exhibitors. This support helps to make our events possible at a reasonable cost to the attendees.

Silver





Bronze




Par Bar After Dinner Party




Registration for this event is now open.

Par Bar After Dinner Party
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ISPE CANADA AFFILIATE IN-PERSON EDUCATION AND PRODUCT SYMPOSIUM

Par Bar After Dinner Party

$10.00
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Leadership Workshop
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ISPE CANADA AFFILIATE IN-PERSON EDUCATION AND PRODUCT SYMPOSIUM

Leadership Workshop

$50.00
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Ispe Canada Affiliate In-person Attendee Registration - Education and Product Symposium 2024

ISPE CANADA AFFILIATE IN-PERSON EDUCATION AND PRODUCT SYMPOSIUM

Ispe Canada Affiliate In-person Attendee Registration – Education and Product Symposium 2024

$850.00
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Tabletop Exhibitor Registration

ISPE CANADA AFFILIATE IN-PERSON EDUCATION AND PRODUCT SYMPOSIUM

Tabletop Exhibitor Registration

$2,000.00
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Booth (10×10) Exhibitor Registration
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ISPE CANADA AFFILIATE IN-PERSON EDUCATION AND PRODUCT SYMPOSIUM

Booth (10×10) Exhibitor Registration

$3,500.00
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Passport Program Registration
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ISPE CANADA AFFILIATE IN-PERSON EDUCATION AND PRODUCT SYMPOSIUM

Passport Program Registration

$300.00
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Platinum Sponsor Registration
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ISPE CANADA AFFILIATE IN-PERSON EDUCATION AND PRODUCT SYMPOSIUM

Platinum Sponsor Registration

$3,000.00
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Gold Sponsor Registration
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ISPE CANADA AFFILIATE IN-PERSON EDUCATION AND PRODUCT SYMPOSIUM

Gold Sponsor Registration

$2,000.00
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Silver Sponsor Registration
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ISPE CANADA AFFILIATE IN-PERSON EDUCATION AND PRODUCT SYMPOSIUM

Silver Sponsor Registration

$1,500.00
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ISPE CANADA AFFILIATE IN-PERSON EDUCATION AND PRODUCT SYMPOSIUM

Bronze Sponsor Registration

$1,000.00
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Emerging Leader Sponsor Registration
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ISPE CANADA AFFILIATE IN-PERSON EDUCATION AND PRODUCT SYMPOSIUM

Emerging Leader Sponsor Registration

$500.00
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ISPE CANADA AFFILIATE IN-PERSON EDUCATION AND PRODUCT SYMPOSIUM

Par Bar After Dinner Party Sponsor Registration

$2,500.00
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