Agenda

All times displayed for Europe/Madrid timezone.

Room S100E

In collaboration with SCI – Where Science meets Business
08:30 - 10:30 Room S100E
C-Suite Roundtable

A closed-door Roundtable event, gathering CEOs and members of executive leadership teams from across Pharma to discuss key challenges regarding policy, regulation, industry growth, new markets and global challenges.

This is a rare opportunity for Senior Pharma Leaders to come together on the first day of the world’s leading Pharma exhibition, to share ideas and challenges, develop strategies and network with senior peers.

This event will deliver key insights into the pain points and opportunities that Pharma leaders are trying to solve, and a write-up will be produced post-event detailing key discussion points and the solutions needed to overcome challenges and create change in Pharma.

Executives confirmed from:

Piramal
Chematek
IDT Biologika
Nemera
Dr. Reddy’s
BD Medical
Samsung Biologics
Archinova

This is an invite-only event. If a member of your leadership team would like to join, please contact [email protected] for more details.
A closed-door Roundtable event, gathering CEOs and members of executive leadership teams from across Pharma to discuss key challenges regarding policy, regulation, industry growth, new markets and global challenges.

This is a rare opportunity for Senior Pharma Leaders to come together on the first day of the world’s leading Pharma exhibition, to share ideas and challenges, develop strategies and network with senior peers.

This event will deliver key insights into the pain points and opportunities that Pharma leaders are trying to solve, and a write-up will be produced post-event detailing key discussion points and the solutions needed to overcome challenges and create change in Pharma.

Executives confirmed from:

Piramal
Chematek
IDT Biologika
Nemera
Dr. Reddy’s
BD Medical
Samsung Biologics
Archinova

This is an invite-only event. If a member of your leadership team would like to join, please contact [email protected] for more details.

CPhI Theatre

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.

ICSE Theatre

“What ifs” in the 5-year CDMO plan
10:30 - 11:00 ICSE Theatre, Hall 1 stand 1G90
Keynote
Former President
PharmSource
Are there learnings between bio processing and small molecule production?
11:10 - 11:40 ICSE Theatre, Hall 1 stand 1G90
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, Hall 1 stand 1G90
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, Hall 1 stand 1G90
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, Hall 1 stand 1G90
Pharma Insight Briefings
Director SteriPro Consulting Pharma Services
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

Engaging The Patient: The Opportunities & Challenges Of A Fully Serialization-Enabled Supply Chain
13:50 - 14:20 ICSE Theatre, Hall 1 stand 1G90
Pharma Insight Briefings
Sharp VP of Technology & Innovation
Sharp Packaging Solutions

Sponsored by:

What´s next for sterile contract manufacturing in emerging markets?
14:30 - 15:00 ICSE Theatre, Hall 1 stand 1G90
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.

Technology selection methodologies for addressing bioavailability challenges
15:10 - 15:40 ICSE Theatre, Hall 1 stand 1G90
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.

Navigating the pathway from formulation to clinical trial: A case study.
15:50 - 16:20 ICSE Theatre, Hall 1 stand 1G90
Pharma Insight Briefings
Sales Director Development Services
Recipharm AB

Sponsored by:

Added Value for Biotech Companies using CDMOs
16:30 - 17:00 ICSE Theatre, Hall 1 stand 1G90
Pharma Insight Briefings
Vice President Global Sales and Marketing
IDT Biologika

Sponsored by:

Innopack & P-MEC Theatre

Latest Consumer trends in Packaging – the Pharmaceutical perspective
10:30 - 11:00 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
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, Hall 4 stand 4F121
Keynote
Debunking the Leachable Myths of Gamma Sterilization: A Migration Study of Steam Vs. Gamma
11:50 - 12:20 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
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, Hall 4 stand 4F121
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, Hall 4 stand 4F121
Pharma Insight Briefings
Head of Business Development
SCHOTT Pharmaceutical Systems

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, Hall 4 stand 4F121
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, Hall 4 stand 4F121
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

Best in Class Sealing solutions for Parenteral Drug Packaging
15:10 - 15:40 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
Pharma Insight Briefings
Manager Materials and Surface Treatments
Datwyler Sealing Solutions

Sponsored by:

With the advent of biological and sensitive drugs, rubber components have improved over the years to deliver compounds with less and less leachables. The composition of the rubber can be further adapted in order to make them resistant to gamma irradiation in order to provide drug manufacturer with Ready-To-Use components for aseptic filling.
Several parameters in the rubber composition can have an influence on the resistance against gamma sterilization. Among them, we will discuss the chemical composition of the elastomer. The effect of gamma sterilization on functional and chemical properties of rubber will be presented as well the next generation rubber compound.

Authentic, Safe, Connected: Securing Your Supply Chain from the Factory Floor to your Patient’s Hands
15:50 - 16:20 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
Pharma Insight Briefings
Chief Executive Officer
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 is jeopardized and people lose confidence in the brands they trust.

Many pharmaceutical companies have serialized products based on compliance mandates. However, serialization is not enough. Some pharmas 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? Systech is the global technology leader in product safety, and consumer and brand protection. Systech pioneered pharmaceutical serialization and is defining the future of true product authentication. Systech unifies and optimizes enterprise serialization, track and trace, and authentication technologies to mitigate counterfeiting and diversion risk across the supply chain, and drive efficiency and profitability. Learn how we are solving these industry challenges and the unique innovations leading the way.

High performance, solvent free heat seal coating for pharmaceutical blister packaging
16:30 - 17:00 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
Pharma Insight Briefings
Vice president, R&D and new technology Bilcare
Mitsui Chemicals Inc.
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 Theatre

Panel discussion: Pricing and Affordability – Creating a Sustainable Market
10:30 - 11:40 Pharma Forum Theatre, Avenida outside Halls 5 &6
Keynote
Senior Consultant
IQVIA
Head of Policy & Market Access – Europe
Mylan GmbH
Market Access Director
Medicines for Europe
Challenging Products to Manufacture in Emerging Markets
11:50 - 12:20 Pharma Forum Theatre, Avenida outside Halls 5 &6
Pharma Insight Briefings
President
Velit Biopharmaceuticals
Serving global growth in clinical MAb demand from China
13:10 - 13:40 Pharma Forum Theatre, Avenida outside Halls 5 &6
Pharma Insight Briefings
VP Facilities
CMAB Biopharma

Sponsored by:

The biotechnology development and custom manufacturing environment within China continues to expand at a rapid rate. In 2017, China accounted for the second largest pharmaceutical industry valued at approximately USD122.6 billion and is second in the world for number of active clinical trials. With a new national directive to open up the industry 90% of China’s biopharma companies expect to serve both domestic as well as export markets at GMP levels within ten years. Please join our VP of Facilities Nick Kotlarski who will address the market opportunities within China and focus on the CMAB Biopharma approach to designing a custom-built CDMO facility to meet this expanding need for biotechnology production and custom manufacturing.

Adding value to strategic partnerships in the microbial CDMO space
14:30 - 15:00 Pharma Forum Theatre, Avenida outside Halls 5 &6
Pharma Insight Briefings
Director Sales & Marketing / Business Development
Capua BioServices S.p.A

Sponsored by:

Capua BioServices has been executing fermentation processes for over 50 years, and, thanks to our highly experienced staff, the company has been able to develop into a contract development and manufacturing organization with a strong reputation that enables the rapid development and scale-up of optimized manufacturing solutions. While typical CDMO projects flow from technology transfer through scale-up, at Capua we recognize that true value is added by developing a tailored process designed to fit the specific needs of each client, and creating customized solutions within a standard framework maximizes the likelihood of success.

Advancing nanomedicines into the clinic: analytical and manufacturing challenges
15:10 - 15:40 Pharma Forum Theatre, Avenida outside Halls 5 &6
Pharma Insight Briefings
Senior Scientist (MvE)
Ardena
Head of Formulation (MVS)
Ardena

Nanomedicine involves the use of nanoscale or nanostructured materials to impart unique pharmacokinetic and therapeutic effects such as enhanced dissolution rate and bioavailability, controlled release, enhanced efficacy and reduced toxicity. The control of materials in the nanometer size range requires scientifically demanding chemistry, analytical and manufacturing techniques. This presentation will address some of the challenges that may be encountered during development of nanomedicine products for preclinical and early clinical use. The talk will subsequently provide a case study addressing the clinical translation of an antibody conjugated iron oxide nanoparticle.

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15:30 - 16:00 Pharma Forum Theatre, Avenida outside Halls 5 &6
Pharma Insight Workshops
Phyton Biotech
15:50 - 16:20 Pharma Forum Theatre, Avenida outside Halls 5 &6
Pharma Insight Briefings

Sponsored by:

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16:10 - 16:40 Pharma Forum Theatre, Avenida outside Halls 5 &6
Pharma Insight Workshops