Room D Seminars

9:30 am - 10:00 am

Increasing Product and Process Understanding to Deliver Quality

Speaker

10:00 am - 10:30 am

Applying Advanced Concepts to Formulation Design

The pharmaceutical oral products which are being generated now are more complex than the small white immediate release tablets that have been historically created.  Present-day drugs are a lot more complex and demanding, both in terms of their physicochemical properties and in terms of their biopharmaceutical requirements.   This presentation will show how data can be readily generated to optimise oral solid dose formulation design.

Speakers

11:30 am - 11:50 am

Development At The Interface of Engineering And Molecules

Speaker

11:50 am - 12:10 pm

Magnetic Electrospun Micro-fibre Scaffold Assemblies: Examples of Their Use for 3-Dimensional Cell-Based Screening Applications

After gaining his Ph.D. from Edinburgh University in 1990, Gary joined Hoffmann La Roche (USA) to investigate retinoid pharmacology and the role of nuclear hormone receptors in foetal development. He then worked for GSK (UK) in 1995, gaining expertise in the development of cell-based assays within the CNS disease area as well as novel drug discovery assay technologies. Thereafter, Gary spent over 10 years at AstraZeneca (UK), developing novel cell-culture robotics and evaluating and implementing new assay technologies for respiratory and inflammatory diseases, before founding Aurelia Bioscience, a UK based Contract Research Organisation specialising in bioassay development and compound screening.

Speaker

12:10 pm - 12:30 pm

Marketing Lifesciences; Successes and Learnings

 

 

3:45 pm - 4:15 pm

Pharma 4.0

Nick plans to bring a short update on the Pharma 4.0 SIG team discussions, development of operating models and guidelines as well as some practical opportunities for us to start developing our future facilities and the traditionalist potential barriers to progress.

Speaker

  • View full profile for Nick KestertonNick Kesterton Head of Automation, Control and Instrumentation PM Group - PM Group
4:15 pm - 4:35 pm

Managing Millennials

Speaker

9:15 am - 9:35 am

Use of Recombinant Human Albumin in Advanced Therapy Medicinal Products

Speaker

9:35 am - 9:55 am

Bridging The Gap Between Discovery and Development – DMPK Influence

Speaker

  • View full profile for Dr Richard WeaverDr Richard Weaver Senior Vice President - Pre-Clinical Development - Sygnature Discovery
9:55 am - 10:15 am

QbD is not Just DoE

Speaker

11:15 am - 11:35 am

Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities

11:35 am - 11:55 am

Pharmaceutical Packaging in the Digital Age

11:55 am - 12:15 pm

Serialisation in 2021 – Delivery and Challenges

12:15 pm - 12:35 pm

Making Pharmaceutical Packaging that is Easy for Elderly People to Open

12:35 pm - 2:00 pm

Break

2:20 pm - 2:40 pm

Nitrosamines Issue: Is Your Company Impacted?

- A background on the nitrosamine contaminants

- Impacted products

- Regulatory requirements with reference guidelines

- Timelines on actions that need to be taken by MA holders

2:50 pm - 3:00 pm

Tablet Defects: Can They Be Predicted?

Common tablet defects include chipping, picking & sticking, cracking, lamination & capping to name a few. Lamination & capping often occur during scale-up and are main issues in our industry. It is a common hurdle in tableting which is not generally observed during the R&D development phase. One of the reasons lie in the high production speeds on industrial rotary presses, speeds that are not generally seen on conventional R&D tablet presses. This explains why capping or lamination is sometimes only discovered during scale-up. It is essential to try to identify those issues at the very early stage of development.

3:00 pm - 4:00 pm

Break & Exhibition

9:30 am - 9:50 am

A Guide to Outsourced Stability Storage

Manufacturers conduct Stability Studies to establish shelf life. Shelf life of a product is ascertained under controlled environmental conditions such as humidity, temperature or light.

Stability studies are an evaluation of the risk of product degrading in different markets within different climatic zones.

Stability studies are important as the manufacturer has responsibility for the product from formulation to consumption and must ensure that the formulation does not lose its potency or result in degradation by-products that can do more harm than good to the consumer. The shelf life of a product is typically assessed either by real-time or accelerated stability trials.

The stability programme should also examine factors that influence its quality, for example, interaction of API with excipients, container closure systems and packaging materials.

Join Wendy to find out more about Stability Storage.

 

Speaker

  • Wendy Cullen Head of UK Sales - Stability Storage - Source Bioscience
9:50 am - 10:10 am

Particle Engineering to Optimise the Performance of Inhaled Therapeutics

The ability to access the large surface area of the lung makes pulmonary delivery an increasingly attractive option, not only for treating respiratory diseases but also to target rapid systemic uptake. To maximise delivery to the lung, however, particles must have tight size distributions and be easy to aerosolise. Traditional approaches to achieving the necessary requirements for inhalation (e.g. micronisation) often lead to undesirable properties which negatively impact stability and lung deposition, as well as introducing formulation complexity. This presentation will describe alternative strategies that facilitate the rapid development of optimised inhaled therapies, including the application of supercritical fluid technologies.

Speaker

10:10 am - 10:30 am

How to Accelerate Drug Product Development of Sensitive APIs with a Novel Ready-to-fill Capsule

Nina Hauschildt as explains how  novel ready-to-fill capsules optimize a drug’s release profile, protect active ingredients, and reduce clinical risk.

Key takeaways

  • Offers a solution to  challenges in targeted drug delivery
  • Case studies the use of more active ingredients which are sensitive to heat, moisture or gastric acid
  • Reduces risk and speeds up time to market for early stage drug development
  • Provides a flexible range of custom options such as choice of size, colour and release profiles

 

Speaker

10:30 am - 11:30 am

Break

11:30 am - 12:00 pm

Biopharma’s Growth Story: Ten Key Themes

Speaker

  • Dr Duncan Emerton Executive Director, Custom Intelligence & Analytics - Informa Pharma Intelligence
12:00 pm - 12:40 pm

How to Effectively Manage a Remediation Programme and Sustain Quality Improvements’

Speaker

1:00 pm - 2:00 pm

Break

2:00 pm - 3:00 pm

KEYNOTE in ROOM A: Pharma – Balancing Compliance and Charitable Efforts

A former MHRA inspector's experience showing different expectations of the UK Pharmaceutical industry. On the one hand, the licence holder has a desire to respond to humanitarian need. On the other hand, they meet many challenges and must still achieve compliance and exercise due diligence. Can we resolve this dilemma?

 

Speaker

3:00 pm - 3:30 pm

Break

3:45 pm - 4:05 pm

IP Protection in the Life Sciences – AI, 5G, AM and Beyond

Speaker

4:05 pm - 4:25 pm

Formulating Pharmacokinetics

Speaker

4:25 pm - 4:45 pm

Marketing LifeSciences; Successes and Learnings

Speaker

9:15 am - 9:35 am

How to Approve EXCiPACT as a 3rd Part Audit Provider

Speaker

9:35 am - 9:55 am

Application of EXCiPACT GMP to Excipient-like Materials Used in Pharmaceutical Drug Product Manufacture

Speaker

10:45 am - 11:30 am

Break

12:00 pm - 12:30 pm

GAMP 5 and Data Integrity – Trends for Manufacturing Systems

In recent years there has been concern about the integrity of the data used to release pharmaceuticals from the manufacturing stage to the market. This presentation takes a look at the current guidance on how to identify threats to this data, and how to ensure the data is not compromised.

The presentation explains

  • ‘Data Integrity’,
  • What is meant by a computerised ‘Manufacturing System’,
  • the sorts of data being collected,
  • how to define what is critical,
  • the data lifecycle
  • the risks associated with the data,
  • how the risks are controlled

 

Speaker

  • Hilary Mills-Baker European Quality and Validation Manager - Emerson Automation Solutions
12:30 pm - 2:00 pm

Break

2:00 pm - 2:20 pm

Dessicants and Sustainability in Active Packaging

Speaker

2:20 pm - 2:40 pm

Driving GDP Compliance for Outsourced Logistics Activities

Speaker

2:40 pm - 3:00 pm

Why the Future is Flexible in CDMOs

For pharmaceutical contract drug manufacturing operations (CDMOs), flexibility is key. An informed specification plays a big part in CDMOs being able to adapt to new projects. Using modular and bespoke furniture provides manufacturers with the ability to rapidly reconfigure their cleanrooms and production spaces to allow for each different contractual requirement.
The ability to maintain contamination control between projects is integral to this flexible approach.
This presentation looks at how, by thinking flexibly, you can specify adaptable and therefore cost effective furniture, whilst maintaining exemplary risk management and without compromising on hygiene standards.

Speaker