Agenda

All times displayed for Europe/Amsterdam timezone.

CPhI Theatre

Analysing complex data in the Pharmaceutical Industry: The case for multivariate analysis
10:30 - 11:00 CPhI Theatre
Keynote
Research Fellow
Bristol-Myers Squibb
Quality by Design
11:10 - 11:40 CPhI Theatre
Keynote
Executive Board Member
International Pharmaceutical Excipients Council - Europe
Innovative gelatine product to manufacture enteric soft capsules in one step
11:50 - 12:20 CPhI Theatre
Pharma Insight Briefings
Product Manager Pharma Gelatine
Gelita

Sponsored by:

GELITA® EC is a new developed gelatine product that is resistant to gastric juices and dissolves in the intestine. With GELITA® EC enteric soft capsules can be manufactured very efficient in one step with standard equipment. Enteric capsules protect acid sensitive ingredients and avoid unpleasant belching (e. g. fish or Omega-3 oil) from the stomach. GELITA® EC perfectly fits into GELITA´s controlled release portfolio covering all aspects from slow to fast fill release.

A novel method for deliveringhygroscopic pharmaceutical drugs
12:30 - 13:00 CPhI Theatre
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 ofcapsule 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.

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13:10 - 15:40 CPhI Theatre
Pharma Insight Briefings

Sponsored by:

Shaken not stirred? How will USP661.1 and ICH Q3D impact your packaging materials cocktail?
13:50 - 14:20 CPhI Theatre
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’?

What´s next for sterile contract manufacturing in emerging markets?
14:30 - 15:00 CPhI Theatre
Pharma Insight Briefings
Business Development Manager Product Partnering Sterile Pharmaceuticals Region Europe, LAM, Africa & Asia
Fresenius Kabi

Sponsored by:

Fresenius Kabi operates a global network of more than 20 manufacturing sites worldwide focusing on sterile pharmaceuticals including in emerging markets such as Latin America and Asia. Manufacturing locally in specific countries becomes increasingly important not only for price considerations, but also due to governmental regulations and requirements for having access to the market. Here, we introduce two of our sites located in Indonesia and Brazil highlighting our capabilities to fill in vials and ampoules of IV drugs on a large commercial scale. The customized approach and flexibility provides the opportunity to offer tailored solutions for unique, specialized requirements. Once the development work is complete, we can formulate, fill/finish, label, and package our partners´ products according to their specifications.
In summary, Fresenius Kabi Product Partnering offers the assets to overcome barriers to emerging markets, allowing our partners to have access to trained and professional people, state-of-the-art production facilities and capabilities in Asia and Latin America. Our strategy simplifies the product´s path to the market while meeting partner´s manufacturing needs.

Speciality Containers: PVC-free freeflex® bags and pre-filled syringes for sterile drug products
15:10 - 16:20 CPhI Theatre
Pharma Insight Briefings
Key Accounts & Business Development Manager Product Partnering Sterile Pharmaceuticals Central Europe
Fresenius Kabi

Sponsored by:

The administration of sterile drug products including infusion therapy is becoming increasingly complex and challenging areas of modern medicine. Safety considerations and ease of handling in daily hospital life have encouraged the development of innovative containers for sterile drug products and infusion, particularly for new drugs with complex handling protocols and stability issues requirements. The features of the right container play an important role in fulfilling these requirements.
The PVC-free freeflex® bag technology is Fresenius Kabi’s innovative and flexible container concept . The bag benefits from the significant improvements made in infusion container technology. It achieves the high ecological and drug-compatibility standard of glass and retains the well accepted characteristics of an infusion bag: Clarity, flexibility, low weight and full collapsibility.
Another safe and comfortable possibility of supplying i.v. solutions are pre-filled syringes (PFS). PFS make application of the drug product safer and more convenient for physicians as well as self-administration. PFS are the system of choice for cost-intensive drugs by optimizing product yield.

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15:50 - 16:20 CPhI Theatre
Pharma Insight Briefings
Vice Corporate Quality Director
Indena

Sponsored by:

ICSE Theatre

“What ifs” in the 5-year CDMO plan
10:30 - 11:00 ICSE Theatre
Keynote
Former President
PharmSource
Are there learnings between bio processing and small molecule production?
11:10 - 11:40 ICSE Theatre
Keynote
Division President Drug Product & Pharma Development Service North America
Patheon, part of Thermo Fisher Scientific
The vast opportunities in the Emerging Markets for OTC & Pharma players. How to enter best and what to avoid. Practical case studies for Market Entry!
11:50 - 12:20 ICSE Theatre
Pharma Insight Briefings

Sponsored by:

Systematic Product and Country Analysis, Systematic local Partner identification, Gap Analysis, Systematic Market Entry Strategies, Regulatory guidance

The Journey of revealing unknowns and impurities by material knowledge. The Origin of Species.
12:30 - 13:00 ICSE Theatre
Pharma Insight Briefings
Department Head of Microbiology and Pharmaceutical Services
Nelson Labs

Sponsored by:

Passports, ID cards, fingerprints, metal detectors, iris recognition, camera’s… we are trying to reveal the journey of “unknowns” to ensure safety and to avoid disaster. How is this different from an unknown in your drug product? Unknowns can pop-up during release testing, stability testing and leachable testing. These impurities are often related to the material or interaction of the material with the drug. Different case studies will be presented to demonstrate that material knowledge will allow you to reveal the journey of most of these unknowns and impurities. So you will gain control by knowing the origin of species.

Is your product sterile or sterilized? Comparison between Aseptic Processing and Terminal Sterilization. Screening approach of terminal sterilization methods suitable for Pharma applications.
13:10 - 13:40 ICSE Theatre
Pharma Insight Briefings
Annick Gillet
Sterigenics

Sponsored by:

Standards like Ph.Eur/USP are clear and specific that, whenever possible, products intended to be sterile should be terminally sterilized in their final container. If terminal sterilization is not possible, only then should filtration or aseptic assembly be applied. The draft revision of the GMP Eudralex, Annex 1 emphasizes the importance of the choice of the sterilization method based on risk analysis approach. Understanding the fundamental differences between aseptic assembly and terminal sterilization is crucial to take the best decision with regard to patient safety.
Dry heat is the most commonly-used terminal sterilization method used by the pharmaceutical industry and, in cases of formulation instability at high temperature; alternative methods of terminal sterilization must be considered by the manufacturer.
This presentation aims to present a structured approach for the assessment and selection of the optimal terminal sterilization method for your Pharma Product

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13:50 - 14:20 ICSE Theatre
Pharma Insight Briefings
Technology selection methodologies for addressing bioavailability challenges
15:10 - 15:40 ICSE Theatre
Pharma Insight Briefings
Pharmaceutical Development Manager - Lonza Ploermel
Lonza

Sponsored by:

Compounds that require bioavailability enhancement to achieve target absorption are increasingly common in current pipelines. This presentation focuses on the rationale for selecting technologies that enable progression of such compounds, based on compound’s physical properties (e.g. melt and glass-transition temperatures, Log P) and product specifications (e.g., dose, pharmacokinetics, permeability). Predictive modelling and rapid screening best practices will also be discussed along with representative case studies.

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15:50 - 16:20 ICSE Theatre
Pharma Insight Briefings

Sponsored by:

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16:30 - 17:00 ICSE Theatre
Pharma Insight Briefings

Sponsored by:

Innopack & P-MEC Theatre

Latest Consumer trends in Packaging – the Pharmaceutical perspective
10:30 - 11:00 Innopack & P-MEC Theatre
Keynote
Global Ambassador
World Packaging Organisation
A personal approach to Pharma packaging: shifting from large volumes to personalised solutions
11:10 - 11:40 Innopack & P-MEC Theatre
Keynote
Debunking the Leachable Myths of Gamma Sterilization: A Migration Study of Steam Vs. Gamma
11:50 - 12:20 Innopack & P-MEC Theatre
Pharma Insight Briefings
President, Next Breath
Aptar

Sponsored by:

The Pharmaceutical Industry now receives millions of sterile elastomer components for direct introduction into filling lines. Aptar Pharma has been supplying ready-to-use components available in both gamma and steam sterilized formats for many years. Sterilization techniques eliminate bioburden. However, some literature suggests that gamma sterilization processes affect the functional and chemical properties of the elastomer. Julie D. Suman, R.Ph., Ph.D., President of Next Breath, will present a migration study commissioned by Aptar Pharma to assess the impact of sterilization on leachable profiles. Ready-To-Use (RTU) Uncoated Stoppers and PremiumCoat™ Fluorinated (ETFE) stoppers were evaluated with three levels of both steam sterilization and gamma sterilization. During this Pharma Insight Briefing, Dr. Suman will discuss the pros and cons of sterilization techniques. In addition, results from an accelerated leachable study representing real-life scenarios for both non-coated and coated stoppers will be presented.

Portable care for your respiratory tract: Exploring new technology platforms
12:30 - 13:00 Innopack & P-MEC Theatre
Pharma Insight Briefings
Director Business Development
Aptar

Sponsored by:

Besides typical cough & cold symptoms, allergies, air pollution and other factors have led to a tremendous increase in upper respiratory tract conditions. As such, caring for the respiratory tract is becoming more essential for many people who are using both OTC medications and natural remedies, like saline solutions. Although these market solutions are proven and effective, they sometimes might not fulfill the need of today’s population for portable, easy lifestyle treatments. For decades, Aptar Pharma has been one of the leading drug delivery companies for the development of dispensing solutions for upper and lower respiratory applications. Among these, their proven drug delivery systems like nasal and throat spray solutions have become the standard for cough & cold treatments. Aptar Pharma’s solutions have helped customers serve evolving market directions and capture incremental business opportunities to meet the needs of patients and consumers. During his talk at CPHI worldwide, Guenter Nadler, Director Business Development at Aptar Pharma, will discuss new trends in treating upper respiratory tract issues naturally, including new respiratory technology platforms that will meet new market needs.

Primary packaging solutions for wearable injectors
13:10 - 13:50 Innopack & P-MEC Theatre
Pharma Insight Briefings
Head of Business Development
Schott

Sponsored by:

Administration of biologic drugs > 2ml is typically done in hospital or clinics which increase the healthcare costs and may not be patient friendly. Pharmaceutical companies are evaluating new drug delivery systems like wearable devices, large volume injectors or bolus injectors as an option for self-administration of high volume and high viscous biological drugs at home.Until now, the primary focus was on the device design and features. One critical component in these devices is primary packaging which did not get the right focus till now. The primary packaging container in wearable injectors needs special attention to ensure drug stability, device compatibility, accurate dosing and easy manufacturing. Cartridges as primary packaging containers paved the way for self-injection of diabetes drugs since 1980s and this proven solution can also be used for next generation drug delivery devices. In this presentation, we will provide insights on how RTU cartridges can address the above-mentioned issues and share experiences on how pharma companies can manage risk for innovative drug delivery devices.

The Best Plastic Vial & Syringe for Biologics
13:50 - 15:20 Innopack & P-MEC Theatre
Pharma Insight Briefings
Researcher
Mitsubishi Gas and Chemical Inc.

Sponsored by:

We are happy to introduce Glass-Alternative multilayer plastic vial & syringe having excellent oxygen barrier. Glass is well-known as a good material for its high oxygen and water vapor barrier, but its breakage, protein aggregation and pH shift are often pointed out. As an alternative material to glass, COP and COC, which are known for their high water vapor barrier and low protein aggregation, are tried to use for parenteral drug containers recently. But glass hasn’t been replaced with plastic so much due to its insufficient oxygen barrier. We will share some data such as oxygen barrier, extractables, protein aggregation and UV barrier to verify the products are the best candidate for biologics.

An optimized packaging solution designed around biologic drug products key attributes
14:30 - 15:00 Innopack & P-MEC Theatre
Pharma Insight Briefings
OMPI Pharmaceutical Systems EZ-Fill
OMPI

Sponsored by:

With a rapid increase in the number of biologics coming to market and with reports that biologics could soon represent 50% of the world’s top selling drugs, it is mandatory for suppliers of glass Prefilled syringes and Auto Injectors [AI] to better cooperate in order to improve compatibility for the final combination product. This paper illustrates the process development of a prefillable syringe designed and manufactured since the beginning for DDS for injectables and biosimilars.
In 2014 Ompi, a Stevanato Group Brand, launched Nexa, a biotech PFS that is now well recognized as a robust choice for pharmaceutical companies with several adoptions in the market. In the recent years the strong cooperation between the Pharmaceutical Systems and Engineering Systems divisions of Stevanato Group generated a new state-of-the-art manufacturing process which is completely automatized with 100% controls on silicone distribution, dimensional, cosmetic featuring also X-Ray.

Key takeaways:

- Biotech challenges and Tungsten issues
- Visible and sub-visible particles: a plan to reduce and control them
- Viscosity issues and auto-injectors: mechanical resistance and optimized performances
- Compatibility with modern drug delivery systems: critical parameters, designing consideration and new options

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15:10 - 15:40 Innopack & P-MEC Theatre
Pharma Insight Briefings

Sponsored by:

Safe products from the factory floor to your patients’ hands
15:50 - 16:10 Innopack & P-MEC Theatre
Pharma Insight Briefings
Vice President of Sales, Systech Europe
Systech

Sponsored by:

Fake drugs pose a serious threat to consumers. Pharmaceutical counterfeiting ($200B globally) has resulted in varying legislation worldwide to secure global supply chains. Economic impact to businesses and consumers is escalating. When fraudulent products enter the market, consumer safety also is jeopardized and people lose confidence in the brands they trust. Brands have proactively increased their spending on anti-counterfeit packaging—adding layers of protection to solve these growing problems. Even with complex technologies in place, counterfeiting and product diversion continue at an alarming rate. What if you could change everything without changing anything about your current packaging? Learn how in this seminar.

High performance, solvent free heat seal coating for pharmaceutical blister packaging
16:30 - 17:00 Innopack & P-MEC Theatre
Pharma Insight Briefings
Director, Overseas Business Development Dep. MCI
Mitsui Chemicals Inc.

Sponsored by:

At present Solvent based heat seal coating is used for pharmaceutical blister packaging throughout the world which is a source of VOC emission to the environment. As the VOC related reglations are becoming stricter AI foil converting companies are looking for environment friendly VOC free heat seal coatings. Apart from that Pharmaceutical companies are also looking for high performance heat seal coatings which can seal at lower temperatures. Mitsui chemical has answered both the needs by its water based heat seal technology. This seminar provides the introduction of this technology.

Pharma Forum Theater

Panel discussion: Pricing and Affordability – Creating a Sustainable Market
10:30 - 11:40 Pharma Forum Theater
Keynote
Head of Policy & Market Access – Europe
Mylan GmbH
Market Access Director
Medicines for Europe
Head of Regulatory Affairs & Quality Assurance& Quality Compliance
Boehringer Ingelheim