Agenda

Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.

Featured Sessions

 

FDA Oversight of Drug Quality - Compliance
Oct 14, 2024 | 1630 - 1700
Presenter: FDA
Explore how the reconfigured quality assessment offices and research divisions are creating a more streamlined, agile, and flexible organization, reinforcing connections between assessment, inspection, surveillance, research, and policy operations. Delve into the reorganization of the Office of Regulatory Affairs into the Office of Inspectional and Investigations, aimed at reducing duplication and streamlining actions for greater clarity and promptness in enforcement. 
Unpacking Recent ICH Guidelines
Oct 15, 2024 | 1530 - 1700
Presenters: Multiple
Join us at the Global Implementation Strategies Forum to engage with industry experts and regulators on the Global Adoption Status and Implementation Strategies for ICH Q2(R2)/Q14 and Q12 guidelines. Discover how these science- and risk-based approaches to lifecycle management are ensuring the continued quality of drug substances and drug products worldwide. Explore how ICH Q12 provides tools for effective post-approval change management and regulatory reporting, while ICH Q2(R2)/Q14 focuses on the development, validation, and lifecycle of analytical procedures. 
ISPE Regulatory
Town Hall
Oct 16, 2024 | 0950 - 1120
Presenters: Multiple
Join us at the Regulatory Town Hall where you can engage with International Regulators and Industry thought leaders on topics including progress on Mutual Reliance, new methodologies on information sharing between industry and regulators, new product development paradigms, the use of mechanistic models to support physiologically based pharmacokinetics useful in product development and evaluations of medicines and vaccines. 

All session times are listed in Eastern Time (ET). Find your personal viewing time on the World Clock.

Tracks

Selected filters:

  • General Session
Mon, 14 Oct
Tue, 15 Oct
Wed, 16 Oct
0815 – 0840
General Session
Theresa Mullin, FDA
Ensuring the Availability of Medicines for Patients Recent advances in biomedical science, technology, and treatment modalities offer the promise of delivering safe and effective treatments for patients. A patient-centered approach to product quality also means seeing beyond product manufacturing, to the patient who needs the product, addressing quality through innovations to develop new medicines and the ensuring availability of already-approved medicines addressing vital needs. This requires effective pharmaceutical quality management, updating and innovating throughout the life cycle and applying knowledge gained during commercial operations to continually improve process and product. Regulators are working to better enable industry quality management, through coordinated efforts in ICMRA, ICH, PIC/S and IPRP, to build a global regulatory reliance capability. The resulting capability is expected to enable more agile quality management, improve operational resilience for both regulators and industry, and increase reliability in the supply of needed medicines for patients.
0840 – 0900
General Session
Jill Black, CTI Clinical Trial and Consulting Services
Emma Black’s inspiring journey living with a rare neurological condition called Rett Syndrome.  Mrs. Jill Black, Emma’s mother, will share six-year-old Emma’s story including the diagnosis, her day-to-day life, therapies and treatments, and what brings her hope for Emma's future. Individuals with Rett syndrome may not lead a “typical” life, but they can lead an incredible one
0900 – 0910
General Session
Renetta Mosley, Acadia
Magnolia’s Guide to Adventuring is a documentary video series created by AJ and Jenny Tesler and supported by Acadia Pharmaceuticals Inc. The series is inspired by their 13-year-old daughter Magnolia ("Maggie") who is living with Rett syndrome. Individuals with Rett syndrome may not lead a "typical" life, but they can lead an incredible one. Follow Maggie and her family as they head out on adventures across the United States with others living with Rett syndrome.
www.rettrevealed.com/adventuring-with-magnolia/
0810 – 0815
General Session
Norman Goldschmidt, Genesis AEC
0815 – 0840
General Session
Syed Abbas Yar-Khan, Eli Lilly and Company
In a world where millions of patients await, Lilly stands at the forefront of a transformative era. With a dynamic strategy, Lilly's commitment to innovation in pipeline, workforce, technology, safety, and quality is unwavering.
Discover the art of navigating these tides with Abbas Yar-Khan, Lilly's Group Vice President of Global Parenteral Products and Devices.  Dive into an inspiring session where agility meets urgency and learn how Lilly's accelerated efforts are shaping a healthier future for patients across the globe.
0840 – 0905
General Session
Chris Stevens, Spark Therapeutics, Inc.
Gene therapy offers tremendous potential and is continually evolving. Today the industry is tackling incurable diseases, providing durable cures and modifying diseases for relatively small patient populations. In the not-too-distant future gene therapy will provide permanent cures for much larger patient populations, enhancing existing treatments with precision medicine and preventing disease altogether. Almost by definition, the evolving nature of gene therapy drives the need for continual changes in technology, talent, platforms and development – all with the requirement for inherent flexibility.

Spark Therapeutics developed and launched the very first gene therapy for a genetic disease approved in both the US and EU. As a leader and driving force in gene therapy, Spark is continually evolving ahead of the industry and working to achieve its vision of a world where no life is limited by disease. Join Chris Stevens, Spark’s Chief Patient Supply Officer, for an in-depth conversation on how Spark is:
- Developing emerging technology and platforms with inherent adaptability; - Building capability and the talent Spark needs for today and tomorrow; - Investing and innovating in Philadelphia; and - Bringing their new Gene Therapy Innovation Center to life in West Philadelphia in the heart of University City.

Spark is on a mission to unlock the power of gene therapy to accelerate healthcare transformation. Chris will share how he and Spark’s Patient Supply Organization are making that mission a reality via (e)merging tech and talent, innovation and investment in the city of Philadelphia.
0910 – 0920
General Session
Sarah Pope Miksinski, Gilead Sciences, Inc.
ISPE Regulatory Groups: Driving Harmonization and Quality to Benefit Patients

Join us as the ISPE Regulatory Steering Committee (RSC) provides an update on ISPE’s current regulatory activities and initiatives. Gain valuable insights into the groups that are bringing visibility and solutions to challenges faced by the industry with regard to regulatory/quality aspects and facilitating the flow of information between ISPE members and global Health Authorities. Don't miss this opportunity to stay informed and engaged in the latest developments within ISPE's regulatory landscape.
0920 – 0950
General Session
Ciby Abraham, PhD, AstraZeneca
Emer Cooke, EMA
Sarah Pope Miksinski, Gilead Sciences, Inc.
In this engaging session, Ms. Cooke will share insights and perspectives on crucial topics shaping the pharmaceutical industry, including EU regulatory initiatives, ICMRA collaborations, and outcomes from the EU-US MRA.
Explore the integration of innovation into pharma operations, updates on Pharma Legislation for 2025, and the transformative potential of AI/ML in Pharma Operations. Gain valuable insights into the EU harmonized approach to Drug shortages, including outcomes from HERA and related activities from EMA, as well as international collaboration efforts between EMA/FDA and EMA/Industry.
0950 – 1120
General Session
Peter Marks, CBER/FDA
Megan Zoschg Canniere, Spark Therapeutics, Inc.
Anabela Marcal, EMA
Roger Nosal, NGT Biopharma
Timothy Watson, Gilead Sciences
Hugo Hamel, Health Canada
Andrew McKillop, Pfizer, Inc
Yasuhiro Kishioka, PhD, PMDA

A Regulatory Town Hall Meeting focused on the challenges and opportunities to expand innovation, improve product quality assurance and patient access to medicines relies on global regulatory harmonization and collaborative approaches in establishing effective policies.  This paradigm shift is predicated on transformation that only a future-looking workforce can deliver.

The pharmaceutical industry is advancing through an unprecedented innovative transformation, driven by the development of new product modalities, the emergence of innovative technologies, the evolution of alternative and adaptive regulatory frameworks, and the expeditious approaches introduced and leveraged in response to the COVID-19 pandemic experience. 

The Regulatory Town Hall will cultivate a compelling discussion among several panelists on the merits, opportunities and challenges associated with the introduction of innovative technologies, the use of modelling, artificial intelligence, and digital platforms that are shaping the future of pharmaceutical development and commercialization.  The key messages from this event will provide a template for the attributes and qualities necessary to enlist and engage a skilled and competent workforce capable of adapting to  the fluid demands and expectations of patients and health care providers globally.

The panel will include six representatives from industry and regulatory authorities who will address the following evolving topics:

1. Mutual reliance: How can the industry and regulators leverage the existing frameworks and initiatives, such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the Mutual Recognition Agreement (MRA), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), to enhance the mutual recognition and reliance of inspections, assessments, and standards across different jurisdictions?
2. Information sharing: How can the industry and regulators enhance the information sharing and communication between and among themselves, as well as with other stakeholders, such as patients, health care professionals, and the public, using the available and emerging digital platforms and tools?
3. Modelling: How can the industry and regulators increase the global acceptability and use of modelling and simulation techniques, such as mechanistic models, physiologically based pharmacokinetic (PBPK) models to support the design, development, and evaluation of medicines and vaccines?
4. AI algorithms: How can the industry and regulators ensure the quality, reliability, and validity of the artificial intelligence (AI) algorithms and systems that are increasingly used in the pharmaceutical sector, such as for drug discovery, clinical trials, pharmacovigilance, and manufacturing?
5. Inspection harmonization: How can the industry and regulators harmonize the implementation and interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (GMP), especially the Annex 1 on the manufacture of sterile medicinal products?
6. Supply chain management: How can the industry and regulators improve the resilience, transparency, and security of the global pharmaceutical supply chain, especially in the post-pandemic context, where the demand and supply of medicines and vaccines are subject to unprecedented fluctuations and disruptions?
7. Structuring the data: How to address the terminology when submitting data to different regulatory agencies? How to harmonize the data? What kind of standard should be used?
 
We invite all the participants to share their questions on these topics and engage in a constructive and productive dialogue on charting the direction for innovation in the industry to embrace the future that is now!

1120 – 1150
General Session
Gunter Baumgartner, Takeda Pharmaceuticals International AG
Unlocking the Future of Pharma 4.0 and a Global Digital Transformation Era The pharmaceutical industry is facing a multitude of external challenges, including cost pressures from healthcare systems, such as the Inflation Reduction Act (IRA), patent cliffs, and changes in the global political landscape, exemplified by the BioSecure Act. Amidst these challenges, Pharma 4.0 is emerging has one of the path to sustainably bring innovation to patients. The ISPE's frameworks have supported and encouraged steps towards digitalization and outlined benefits and use case. However, the pharma industry has been slow to change compared to other sectors. Already in 2021, the FDA was stating that "some industries are now well into Industry 3.0, but in many ways the pharmaceutical industry is still very much transitioning into it." With two-thirds of drug shortages historically still attributed to quality-related issues, the opportunities to continue the digitalization journey are plentiful. Exploring the root causes, many companies are lost on the journey, either organizationally or technologically, with some unsure of where to start, others pursuing multiple pilot projects, and some finding that the technology journey is just the beginning of the transformation journey. Additionally, the industry faces a tension between decentralized, democratic, and duplicative organizing principles versus centralized, cumbersome kingdoms.  Takeda has been on this journey for many years and taken the challenges head on. From the Facility of the Year (FOYA) awards for Singen and Linz awards in 2022 and 2024 to public commitments to sustainability Pharma 4.0, Takeda's approach has enabled the implementation of numerous technologies and new ways of working.   As the industry faces an increasingly diverse portfolio and an ever-complex manufacturing landscape, Pharma 4.0 will be a key driver of growth to meet patients’ demand.  We would like to explore some of the good practices we learnt on our digital transformation journey.

Hear From Top Industry Thought Leaders and Regulators on the Challenges and Solutions Impacting the Pharmaceutical Industry

Speaker Qualifications

Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.

Agenda Changes

Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.