CPhI Theatre

All times displayed for Europe/Madrid timezone.

Analysing complex data in the Pharmaceutical Industry: The case for multivariate analysis
10:30 - 11:00 CPhI Theatre, Hall 9 stand 9C80
Keynote
Research Fellow
Bristol-Myers Squibb
Quality by Design
11:10 - 11:40 CPhI Theatre, Hall 9 stand 9C80
Keynote
Senior T&D Scientist
Pharma Dow Pharma Solutions
Innovative gelatine product to manufacture enteric soft capsules in one step
11:50 - 12:20 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
Business Development Manager
Bachem

Sponsored by:

Wet AMD(Age-related Macular degeneration) is abnormal blood vessels grow under the retina.
Currently, periodic intravitreal injection of anti-VEGF mono-clonal is the most common clinical treatment for the disease.
The various forms of anti-VEGF injections include ranibizumab (Lucentis, made by Genentech/Novartis), bevacizumab (off label Avastin from Genentech)
and aflibercept (Eylea/VEGF Trap-Eye from Regeneron/Bayer).

Caregen has developed a novel peptide, a VEGF receptor antagonist, which efficiently down-regulated neovascularization in in vitro assay and in vivo laser induced CNV mouse model.
The innovative features of the research are:
- Eye drop application of the peptide with comparable efficacy to anti-VEGF injection drug.
- Very Low toxicity (Not reported toxicity at 2000 mg/kg)
- Efficient peptide delivery to retina

A novel capsule for delivering hygroscopic pharmaceutical drugs
12:30 - 13:00 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
Director of Scientific Business Development
Qualicaps

Sponsored by:

The stability, activity, and expiry date of certain active pharmaceutical ingredients (APIs) under certain environmental conditions depend on the moisture content towhich they are exposed. Also, determined hygroscopic compounds (e.g. polyethylene glycols, acid glycerol esters, acid triglycerides) widely used as excipients thanks to their outstanding solubility or absorption properties, cannot be used inside gelatin or standard cellulose capsules without reducing their resistance.Qualicaps®, the company responsible for several milestones in the history of hard capsule development within the pharmaceutical industry, continues to innovate by presenting an extra dry cellulose capsulethat will enable the development and productionof moisture-sensitivedrugs to dispense the formulation without any additional moisture elimination treatment.Qualicaps® is a long-term capsule partner on a global scale. With over 120 years of capsule manufacturing experience, as well as the introduction of several capsule innovations, we are uniquely positioned to provide an integral service through our growing global team of commercial, scientific, and technical experts.

Effect of empty capsule on drug dissolution test
13:10 - 15:40 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
Product Engineer
Lefancaps

Sponsored by:

Take gelatin hollow capsules as an example.From the raw material of capsules,the production process and compatibility with drugs and so on,to describe what will be effects drugs because of the different pharmaceutical quality.It will be also effect the quality and efficacy consistency evaluation between generic drugs and original drugs.

Shaken not stirred? How will USP661.1 and ICH Q3D impact your packaging materials cocktail?
13:50 - 14:20 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
Technical Manager
Clariant Plastics & Coatings

Sponsored by:

Just as when making a cocktail, regulators expect you to understand interactions between various components to avoid unpleasant surprises. The new plastic packaging regulation USP661.1, and ICHQ3D guideline on risk of elemental impurities, bring new requirements that could 'shake' the industry if not well prepared. The new USP661.1 standard for pharmaceutical packaging materials doesn't take full effect until May 2020, when it will impact all packaging of current and future drugs on the US market. Featuring new test methods, and a risk-based approach that destroys the well-worn ‘food contact declarations are enough’, the packaging supply chain will need evaluate what goes into their packaging materials cocktail well in advance. Clariant, one of the leaders suppliers plastics color and additive compounds and concentrates used in medical devices and pharmaceutical packaging will explain the impact of the new regulations, and how you might avoid to be ‘shaken’ into last-minute changes. Has your interest been ‘stirred’?

Cannabis as therapeutic solution, from traditional hemp to standardized API. What’s the next step after recent WHO declarations?
14:30 - 15:00 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
Director of the Center for Pain treatment, Santa Corona Hospital, Albenga and Pietra Ligure
Linnea
Commercial Manager
Linnea
Biologist at Stabilimento Chimico Farmaceutico Militare (SCFM)
Linnea

Sponsored by:

Starting from an overview of the WHO World Health Organization declarations, released in June 2018, we will analyze the potential of CBD and standardized extracts as powerful therapeutic solution in different application fields.
The Critical Review Report by ECDD 40th (Geneva, June 2018) is representing a milestone in the Cannabis scenario, since, for the first time, Cannabidiol has been declared safe and considered a drug substance with an efficacy profile and with a deep impact on the global accessibility of this compound for medical research.
Our clinical ambassador, Dr. Marco Bertolotto will report his own experience using medical Cannabis, giving a real and fact based view of the experienced therapeutic solutions.
Touch point of the discussion: the importance of the extract standardization and GMP certification, assuring high quality standards as unique possible drug approach, creating the perfect business environment to develop new opportunities.

Biological Assays: Responding to Increasing Demands in the Release of Peptide-Based APIs.
15:10 - 15:40 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
Business Development Manager
Bachem

Sponsored by:

Release testing of peptides as APIs relies currently on a barrage of physicochemical tests (e.g. for purity, identity) in alignment with the guidelines provided by ICH, FDA and other regulatory authorities. None of these, however, shows a measure of functional potency of the API. There is an apparent trend towards biological assays as release test for peptide APIs, driven by a greater number of peptide-based APIs being classed as Biologics, as well as customer requests. This is likely to increase further inthe future.Developing and validating a biological assay relies heavily on the application of that assay, with the breadth and diversity of drug targets providing a wide expanse of possible designs. A biological assay must be fit for purpose, and many such assays have some common ground, for example, an emphasis on rigorous statistical analysis is critical. This provides confidence that a robust identity or meaningful functional potency measure can be obtained systematically, despite the inherent variability of biology and biological systems.This presentation aims to discuss our experience with biological assays as regulatory requirements and/or customer requests, as well as looking at the inherent value such assays can bring to release testing in a synthetic peptide-manufacturing context.

Breakthrough Eye Drop application of novel peptide for Wet Age-Related Macualr Degeneration (Wet AMD) treatment
15:50 - 16:20 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings

Sponsored by:

Wet AMD(Age-related Macular degeneration) is abnormal blood vessels grow under the retina.
Currently, periodic intravitreal injection of anti-VEGF mono-clonal is the most common clinical treatment for the disease.
The various forms of anti-VEGF injections include ranibizumab (Lucentis, made by Genentech/Novartis), bevacizumab (off label Avastin from Genentech)
and aflibercept (Eylea/VEGF Trap-Eye from Regeneron/Bayer).

Caregen has developed a novel peptide, a VEGF receptor antagonist, which efficiently down-regulated neovascularization in in vitro assay and in vivo laser induced CNV mouse model.
The innovative features of the research are:
- Eye drop application of the peptide with comparable efficacy to anti-VEGF injection drug.
- Very Low toxicity (Not reported toxicity at 2000 mg/kg)
- Efficient peptide delivery to retina

Expertise in Drug Delivery and Formulations
16:30 - 17:00 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
Technical Service & Development, Formulation Specialist
Dow

Sponsored by:

Virginie Caprasse, technical specialist for Dow Silicones (DOW CORNING™ brands), will discuss expertise in drug delivery with silicone formulations and meeting formulator requirements. Discover how silicone excipients can meet the challenge of formulators working with sensitive actives with the efficiency of silicone polymers to improve aesthetics and patient compliance.