31 May 2022

Formulating the Future: Accelerating Oral Drug Development and Manufacturing

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One Nucleus is collaborating with Catalent to bring you a complimentary full day event on 31 May at Burlington House, London.

Oral solid dosage forms remain a preferred option for many pharmaceutical drug developers. However, their successful development and manufacture still presents several unique challenges and opportunities.

This event is primarily focused on bringing together experts, thought leaders, and key decision-makers in formulation and manufacturing sciences to learn about:

• Overcoming challenges and advanced solutions including improving bioavailabilty, optimising manufacturing and scaling supply

• Key elements to consider when creating patient-centric dosage forms

• How to accelerate progression to the clinic and on to market success

Those working in Preclinical & Formulation Development, CMC, Drug Product Development, Project Management, Manufacturing and Operations Management, and Consultants within the biopharma industry are all welcome and encouraged to attend.

PROGRAMME

9:00 am – 9: 45 am – Registration and Networking Breakfast

9:45 am – 9: 50 am – Welcome Note

9:50 am – 10:00 am – Introductions

10:00 am – 10:30 am – Sustaining Accelerated Product Development

• Ways of accelerating product development and new approaches to the development and approval of drug products

• The continuum of product development, post pandemic

10:30 am – 11:00 am – Physiologically-based Pharmacokinetic Modelling to Support Drug Development

• Characterizing drug exposure and predicting how a drug will behave in vivo

• Assessing changes in dosage requirements

11:00 am – 11:30 am – Small-Molecule Manufacturing Options for Expedited Programs

• Optimizing drug performance using conventional and advanced formulation technologies

• Flexible drug product manufacturing for adaptive clinical trial – Choosing formulations that are best suited to this approach?

11:30 am – 12:00 pm – A Fast-Track Roadmap from Concept to
Clinical Batch of HME-Based Drug Products

• Integrated product development and process screening

• Process setup and scale-up via advanced modelling

• Transfer of the process to any GMP-certified manufacturing site

12:00 pm – 1:30 pm – Networking Lunch

1:30 pm – 2:00 pm – Transfer and Scale Up Process Steps for Spray Drying

• Key challenges faced during transfer scale up

• Techniques for determining operating conditions at large scale

2:00 pm – 2:30 pm – Optimizing Late-Stage Manufacturing Efficiency

• Key considerations of transitioning an early-stage project to late stage and technology transfer

• Understanding the relationship between critical material attributes and critical process parameters

2:30 pm – 3:00 pm – Recent Advances in Softgel Dosage Form as a Delivery System

• Advances in softgel capsule shell materials for modified release applications

• Lipid-based delivery of peptide therapeuticss

3:00 pm – 3:30 pm – Improving Clinical & Patient Adherence Outcomes with Orally Disintegrating Tablets (ODTs)

• Opportunities for ODTs as a patient-centric drug delivery tool

• Optimizing ODTs for enhanced dissolution and rapid absorption from the oral cavity

3:30 pm – 3:40 pm – Concluding Remarks

3:40 pm – 5:00 pm – Drinks Reception & Meet the Experts

PLEASE SEE FULL PROGRAMME HERE – INCLUDING SPEAKERS

Registration is Complimentary, please see note above for additional terms

Register Here

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