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Pharma Insight Briefings

Exploring Trends in Contract Manufacturing
10:30 - 11:40 120G43
ICSE Theatre
xCell Strategic Consulting
President & CSO
Pharmatech Associates
Executive Director
Patheon, part of Thermo Fischer Scientific
Founder & Former President
Editor in Chief
PharmSource – a GlobalData Product
Vice President, Operations, Early Phase Development, Oral Drug Delivery
Head of Business Development
Dr. Reddy’s Custom Pharma Services

As Pharma evolves towards more complex therapies with specific manufacturing needs, the role of the CDMO has never been so important. With efficiency, cost, flexibility and quality all essential components of outsourcing, how are CDMOs evolving to remain competitive? Which technologies and strategies will provide the biggest returns?
• Is the One Stop Shop concept dead?
• Continuous manufacturing – application & development factors
• Scalable facilities for flexible manufacture
• M&A and industry consolidation -how is this shaping the industry?

Manufacturing of Complex Formulations in 1-50 mL Pre-Filled Syringes
11:50 - 12:20 120G43
ICSE Theatre
Vice President, Global Contract Manufacturing,
Fresenius Kabi

Sponsored by:

Fresenius KabiContract Manufacturing offers contract manufacturing services for sterile liquid injectable drugs from more than 20 manufacturing sites worldwide. Here, we introduce two of our FDA-approved sites and their fill/finish capabilities for pre-filled syringes for third party manufacturing. The Fresenius Kabi sites in Wilson/USA and Graz/Austria can accompany our partners during process development and scale-up through clinical and commercial batch manufacturefor world-wide supply. Our experience with different pre-filled syringe suppliers and scales enables us to offer drug product manufacture from standard solutions to complex formulations.In particular, our expertise spans from the standard small volumes up to large volume pre-filled syringes, such as the 10, 20 and 50 mL syringe formats.We also invested in state-of-the-art equipment to handle high-potent APIs down to an OEL of 0.1 μg/m3. Our decades of experience with disperse systems allows us to process various formulation technologies, such as liposomes and emulsionsthat we can combine with our pre-filled syringe technology

Freeflex®: Fill & Finish Service in innovative IV-bag for global supply
12:30 - 13:00 120G43
ICSE Theatre
Business Development Manager Global Manufacturing Sterile Pharmaceuticals
Fresenius Kabi

Sponsored by:

Highest quality PVC-free Freeflexbags are the leading-edge container technology of today for IV bag pharmaceuticals. Convenient and safe for use in a broad field of application from standard infusion to drug reconstitution.Fresenius Kabi offers its proprietary bag technology as well asfill and finish services for all markets around the world. Supporting our customers from product development to commercial manufacturing is our duty and pleasure.

SimpliFiH™ Solutions – Integrated approach to First-in-Human for bioavailability challenged molecules
13:10 - 13:40 120G43
ICSE Theatre
Director, Commercial Development, Dosage Forms & Delivery Systems

Sponsored by:

Oral administration of small molecules has become increasingly difficult due to a majority of new candidates demonstrating poor aqueous solubility. The bioavailability hurdle is made more challenging with the accelerated timelines, limited drug substance availability and financial restrictions associated with many of today’s drug programs. This presentation discusses a proven model-based technology selection methodology for poorly soluble molecules and an integrated formulation approach to minimize first-in-human timelines. The role of API development and supply, solid state characterization, micro-dosing and encapsulation best practices for FIH studies will also be discussed along with representative case studies.

HPAPIs and ADCs – a journey through high potency
13:50 - 14:20 120G43
ICSE Theatre
Senior Director, Head of Commercial Development, API

Sponsored by:

Drug development based on potent compounds can be quite challenging.Complications on the interface between operations in drug substance and drug product can lead to increased program complexity and cost.Crossing the boundary from small molecule to biologics into ADC territory is typically adding the next level of complexity.In this presentation, we will elaborate on best practices and infrastructure requirements that facilitate accelerated timelines to clinic and market:-CASE STUDY: the development, rapid scaling and commercial production of HPAPI drug substance-Integrated containment requirements for particle engineering and drug products-Advantages of seamless integration of HPAPI and ADC operations

The Importance of Terminal Sterilization in the Pharmaceutical Industry
14:30 - 15:00 120G43
ICSE Theatre
Technical Director - EO Pharma

Sponsored by:

A lack of sterility and sterility assurance continue to be a significant reason for drug recalls and regulatory citations and can pose a very real risk to patient safety and public health. Sterilization is therefore a pivotal step in the pharmaceutical drug development process to help ensure overall safety is maintained. In this presentation we will:
- Examine the goal and science of sterilization
- Introduce and contrast Terminal Sterilization and Aseptic Processing of drug products through a regulatory lens as well as that of a manufacturer
- Provide guidance for the assessment and selection of the optimal Terminal Sterilization technology (eg Gamma, E-Beam, ETO) for drug products

CDMO with Dedicated Solutions: Lyophilized Freeze Drying Technology - LyoDis® (ODT), High Potent Products, Sachets..and more!
15:10 - 15:40 120G43
ICSE Theatre

Sponsored by:

Galien+, CDMO with Dedicated Solutions

Discover our expertise for Complex Oral Solid dosages forms with special deep-down insite on ODTs LyoDis® (lyophilized freeze drying tablets technology), Sachets and High Potent FDF manufacturing.

Our know-how at your service !

Analysis from the Tufts Center for the Study of Drug Development (CSDD) to Assess the Financial Benefits from Translational Pharmaceutics®: A Platform for Accelerating Product Development
15:50 - 16:20 120G43
ICSE Theatre
Executive Director and Head, Drug Development Solutions (EMEA)
Quotient Sciences

Sponsored by:

The drug development process has been demonstrated to be highly costly and lengthy, with significant rates of molecule attrition and development risk. Despite long-standing efforts by drug developers to operate more efficiently, traditional drug development programs have become costlier on average. To inform drug developers of the potential financial impacts ofalternative drug development processes and outsourcing models, the Tufts CSDD conducted a study comparing the traditional drug development paradigm with Quotient Sciences’ signature drug development platform, referred to as Translational Pharmaceutics, which has been widely used by pharmaceutical and biotech companies to accelerate product development. Key applications of Translational Pharmaceutics include the transition of molecules from First in Human (FIH) to proof of concept (POC), and in the development and optimization of clinical formulations. This presentation will provide a summary of the key findings of the Tufts CSDD research, with respect to the impact on development cycle times and their derivative effects on development economics and financial gains.