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Formulating the Future
Addressing formulation challenges for the therapies of the future
Types
Track sponsor
Oct 24th - Room 4.4
Oct 24th 11:00 - 11:15 (CET) Room: 4.4, Conference Centre 4
Setting the scene for drug formulation
Speaker: Ferenc Marofka, Policy Officer – Health - Medicines, European Commission
Oct 24th 11:15 - 11:35 (CET) Room: 4.4, Conference Centre 4
Many promising drug candidates face abandonment in the development pipeline, often due to difficulties encountered during formulation phase or API delivery. Overcoming these challenges is crucial for successful drug development and commercialization. In this talk, Camille Dumont, Manager, Customer Applications at Lonza Capsules & Health Ingredients will highlight:
- Actionable insights on how to overcome challenges around your future drug developments including your formulation and API delivery
- The advantages offered by Capsugel® Enprotect® capsules and Launch with Lonza™ Application Lab Services
- How Lonza can help with your next development project
Speaker: Camille Dumont, Manager, Customer Applications – Application Lab, Lonza Capsules and Health Ingredients
Oct 24th 11:40 - 12:00 (CET) Room: 4.4, Conference Centre 4
Acceptability of the pharmaceutical product is an essential part of patient centric drug delivery systems and formulation. Join to understand the importance of involving patients to achieve real “innovation” in drug product design, and how this can be implemented in future drug product development.
• Acceptability in the context of regulatory science
• The importance of patient involvement in drug product development and therapeutic outcomes
• Acceptability in the context of reimbursement
Speaker: Sven Stegemann, CEO, Leibniz JointLab
Oct 24th 12:05 - 12:25 (CET) Room: 4.4, Conference Centre 4
The FDA’s Center for Drug Evaluation and Research’s (CDER)’s Office of Pharmaceutical Quality (OPQ), in collaboration with other stakeholders, is currently engaged in operationalizing a voluntary QMM rating program for domestic and foreign pharmaceutical manufacturers (2). Since first formally proposed in 2020, the QMM initiative has steadily gained momentum. This session will discuss:
The basic tenets of this new program
Responsibilities for drug sponsors, CDMOs and API manufacturers as a result of the new program
CDER’s lessons learned from their pilot program
What to expect as this program continues to roll out
Speaker: Sireesha Yadlapalli, CEO, Pharmatech Associates
Oct 24th 12:30 - 12:50 (CET) Room: 4.4, Conference Centre 4
For this session, we will invite representatives of the European Commission to join industry stakeholders for a discussion on the competitiveness of EU manufacturers, compared to their international counterparts.
• Understanding current constraints of API manufacturing in the EU market
• Why global collaboration is essential for the evolution of current manufacturing practices
Speaker: Markus Sieger, CEO, Polpharma and Vice President, Medicines for Europe
Oct 24th 12:55 - 13:40 (CET) Room: 4.4, Conference Centre 4
• Market outlook – what's next for generics?
• Tackling shortages with fresh formulation approaches
• Driving quality improvements through process control optimisation
Moderator:
Camille Dumont, Manager, Customer Applications – Application Lab, Lonza Capsules and Health Ingredients
Panellists:
Sven Stegemann, CEO, Leibniz JointLab
Markus Sieger, CEO, Polpharma and Vice President, Medicines for Europe
Sireesha Yadlapalli, CEO, Pharmatech Associates
Online
1st Nov 10:30 - 10:55 Stand 30J20, Hall 3.1- Keynote
More than 75 % of new chemical entities are poorly soluble and require bioavailability-enhancing excipients. The application of excipients in advanced pharmaceutical processes, such as hot melt extrusion and 3D-printing, aligned with advanced approaches towards personalized medicine, requires special features. Lipid-based excipients (LBEs) are “natural contenders” for these tasks. However, until now, it has not been possible to fully exploit the potential of LBEs.
The main challenge is the unstable solid state of current LBEs, e.g. polymorphism, leading to instability of the final dosage form. Compared to polymers, the low melting temperature of lipids, combined with highly crystalline arrangement, limits their application in advanced pharmaceutical processes such as hot melt extrusion and 3D-printing.
1st Nov 11:00- 11:25 Stand 30J20, Hall 3.1
In recent years, the standardization of biologics manufacturing processes has given product developers multiple viable options for producing biologics. These options include building an in-house production system or partnering with a contract biologics manufacturer. Although building in-house does offer the advantage of direct control; the time, labor, and spend required to implement this often makes it the inefficient choice. On the other hand, working with an experienced contract manufacturer can help you save time and costs by leveraging a deep pool of industry experience. However, the process of selecting the right CDMO partner needs to be performed after careful analysis of many factors: any of which, if overlooked, can create risk of delay or cost overrun. In this session, we will discuss the key parameters that you can easily assess when choosing the right innovative CDMO partner that will keep you competitive in a rapidly evolving market.
Talk Sponsor
1st Nov 11:30- 11:55 Stand 30J20, Hall 3.1
Container closure integrity (CCI) testing is determined by evaluating whether a given container maintains its sterile barrier. It is a mandatory step in the design verification phase of a drug – device combination product development. Several methods exist with different advantages and limitations.
During this session, we will address the following points:
- Probabilistic vs deterministic CCI Testing
- Presentation of the different deterministic CCI testing methods with applications and limitations
- What to consider when selecting CCI testing method.
At the end of the session, attendees should better understand the influence of the drug specificities to select the most suitable technical option for Container Closure Integrity testing activities based on the advantages and limitations of different techniques available on the market.
Talk Sponsor
In person
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