Agenda

Plant cell culture as a controllable and scalable supply solution
10:00 - 10:25 2C70
CPhI Showcase
Chief Scientific Officer Research & Development
Phyton Biotech, LLC

Secondary metabolites from plants or derivatives thereof are utilized in numerous medical applications. In the pharmaceutical industry the ability to provide sufficient amounts of high quality product is the inevitable requirement for the supply chain. Whereas the chemical complexity of secondary metabolites precludes chemical synthesis on a reasonable commercial basis, plant cells provide a natural chemical factory for a given compound, just by its biosynthetic pathways. Thus plant cell culture might provide a favourable supply solution. Here, the most prominent example of production by plant cell fermentation (PCF®) - the process for the anticancer compound paclitaxel – will be presented as one case study. Since 2000 paclitaxel is produced at Phyton Biotech (Stand 4C47) according to cGMP standard at 75,000 l fermentor scale.

As a second case study the successful development of Thapsigargin expressing plant suspension cultures will be described. Thapsigargin is a powerful cytotoxin – a SERCA inhibitor – and the precursor for the derivative ADT, the key ingredient of Mipsagargin (G-202) which is in several clinical trials at Inspyr, Inc.1. 

1The authors gratefully acknowledge Inspyr for funding

 

Innovative application systems for precise and hygienic application of topical drugs
10:30 - 10:55 2A70
InnoPack Showcase
Project Manager
Neopac The Tube + GEKA Healthcare
Head of Sales & Marketing Pharma
Neopac The Tube + GEKA Healthcare

Neopac (Stand 2K51) and GEKA (Stand 2P66) provide a perfect match for innovative pharmaceutical packaging. The Twist’n’brush™ packaging uniquely combines Neopac’s proven Twist’n’use™ system for single dose applications with the extremely soft micro-bristles from GEKA. Twist’n’brush™ enables a precise,and hygienic single topical application of e.g. oral fluids or dermatological lotions etc. The micro-bristle applicator is protected with a transparent cap. 

The Stylo Bristle Polyfoil® tube – a multi-dose device equipped with an open/close system to preventleakage – is the ideal packaging for a multi-dose product. The Stylo Bristle is equipped as well with a micro-bristle applicator from GEKA.
Together Neopac and GEKA have developed a new generation of precise and hygienic pharmaceutical packaging.

Secure your supply chain with Protect Your Brand™: A plan for dual/backup drug substance and drug product supply
10:30 - 10:55
CPhI Showcase
Chief Commercial Officer
Alcami Corporation

Alcami (Stand 3H51) is offering Protect Your Brand™ as a unique service to support pharma-biotech companies looking to implement a dual sourcing strategy. Under this program, Alcami will support tech transfer and validation of products in advance of potential manufacturing needs without any long-term commitment or minimum annual volume – just validation. It’s that simple. This service can be used for drug substances and / or drug product and for clinical supplies, launch quantities, and / or commercial supply. Alcami can be ready on quick notice to bridge unexpected gaps in your critical supply needs.

Alcami is a world-class supplier of comprehensive pharmaceutical development and manufacturing services. With seven sites across the globe, our combined capabilities include API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (solid dose and parenteral), packaging, and stability services.

An activated Carbon Sample Kit to help Process Chemists quickly develop a synthetic scheme to manufacture compounds for clinical trials
11:00 - 11:25 2C70
CPhI Showcase
Global Market Segment Manager Pharmaceuticals
Cabot Norit Activated Carbon

Process Chemists in early drug development are chartered with a difficult task:  they must quickly develop synthetic schemes and pilot procedures to manufacture many promising lead compounds for clinical trials.  Their goal is to maximize yield of target compounds while also removing unwanted impurities, including colorants, metals and process impurities.  Process impurities are particularly challenging to remove given that they often look similar to the target compound ofinterest.  Metal impurities are ubiquitous in such samples as well, given that transition metal catalyzed processes areextensively employed in drug discovery for chemical library preparations and discovery compound syntheses.  

Activated carbon is a technology that has proven to be broadly effective at removing such impurities.  But with many activated carbon grades on the market (Cabot manufactures 300 unique grades), how does a scientist in Chemical R&D know which activated carbon to use?  Cabot has developed a 6-pack activated carbon sample kit as a tool to help process chemists quickly and efficiently optimize their purification methods, thereby enabling them to develop chemical processes that are safe, reproducible and cost-effective. 

Cabot Norit Activated Carbon (Stand 7K73)

H&T Presspart’s eMDI - Smart Inhaling Technology creating Patient Value through Increased Adherence
11:00 - 11:25 2A70
InnoPack Showcase
Business Development Manager, Programme Manager eMDI
H&T Presspart

Asthmatic patients being more compliant are significantly less likely to undergo exacerbation than their less-compliant counterparts. Studies demonstrate that patient adherence to long-term therapies is limited on the one side, on the other it can be significantly increased by smart inhaling technology.

Therefore H&T Presspart (Stand 2H74) – a division of the Heitkamp & Thumann Group and the market leader in respiratory drug delivery components – developed an eMDI: the first connected inhaler for tracking and improving medication adherence. The eMDI incorporates electronics into a medication inhaler to passively track and communicate medication utilization. The device incorporates a sensor to track the date and time when medication is actuated, which is then stored in onboard memory, as well as shared wirelessly via Bluetooth.

During the presentation the features of the current version will be introduced: Intuitive and non-intrusive (embedded) design, location and size of the electronic componentry, counting mechanism, connectivity functions etc. The participants will see a live presentation of the smart inhaler and a potential corresponding app from Cohero Health, a digital health company offering a connected health platform. 

Downstream processing in food and pharma using synthetic chromatographic resins: Challenges and applications of Chromalite® resins
11:30 - 11:55 2C70
CPhI Showcase
Lifetech Manager
Purolite Life Sciences

Purolite (Stand 6H11) Life Sciences offers the broadest range of products available today for biotech applications.

The Praesto® range of agarose resins is designed for protein separation under very mild conditions. The Chromalite® range of products includes different synthetic resins made of styrene, divinylbenzene or acrylic polymers. Chromalite products are designed to be robust, solvent tolerant, extremely robust to high pressures and easy to regenerate. Chromalite products can be applied from analytical HPLC through to industrial downstream processing, since they have a wide particle size range.

Here we present the new developments in terms of new acrylic chromatographic resins with more hydrophilic backbone, and our new line of products – PuroPhase™ - for Solid Phase Extraction applications

Innovation in High Quality Primary Packaging: Multilayer containers for solid formulations and Duma® Twist-Off Protect and closure solutions (senior friendly)
11:30 - 11:55 2A70
InnoPack Showcase
Product Management and Innovation (Plastic Packaging)
Gerresheimer

Gerresheimer (Stand 2H28) has recently developed a new generation of protective packaging for tablet containers.

Duma® Twist-Off Protect offers a new level of water vapour and oxygen barrier for sensitive solid dose formulations. Addressing the rising demand of the industry for high quality packaging components, Duma® Twist-Off Protect will provide improved stability for moisture and oxygen sensitive products and by this allow prolongation of shelf life. Duma® Twist-Off Protect offers with its improved barrier a passive protection of the content, an advantage which will in example avoid overdrying of the content by the desiccant.

A commercial benefit is that the elimination of desiccant or scavenger bags allow the reduction of the packaging size which will contribute to the over-all cost for the supply chain of the relevant product. Another benefit will be experienced by the patients using the new Duma® Twist-off Protect. The elimination of desiccant or scavenger bags will facilitate the withdrawal of the tablets and prevent that the bags will block the content.

Computer-aided synthesis design: an introduction to ChemPlanner
11:30 - 11:55
iCSE Showcase
Director, Lab Solutions
Wiley

The global pharmaceutical industry continually develops new drugs to cure or improve the treatment of disease. The drug creation process is extremely challenging; it takes an average of 12 years and billions of dollars of investment for one new drug to make it all the way from the lab bench to approval and into the clinic.

In this seminar, we will show how Wiley ChemPlanner combines state-of-the-art cheminformatics technology with high-quality data to speed up the early stages of the drug creation process, saving pharmaceutical corporations millions of dollars and getting drugs to patients faster. ChemPlanner lowers the barrier for synthesizing new molecules, thus accelerating the discovery process and allowing the exploration of an expanded region of chemical space. ChemPlanner also enables chemists to optimize synthetic routes, eliminating potentially harmful contaminating side products and reducing manufacturing costs.

 

 

 

Managing the challenging complexity of printed packaging material in the digital age
12:00 - 12:25 2A70
InnoPack Showcase
Managing Partner
August Faller GmbH & Co. KG

With the advent of orphan drugs and personalised medicine, combined with a truly globalised supply chain, the order sizes for printed packaging material are shrinking, while the number of orders are vastly growing, encompassing higher risks in the supply chain.The traditional way of managing the supply chain, such as planning, ordering, delivering and logistics handling will not meet the demanding business goals of short time-to-market, high flexibility and efficiency of the total cost.

The Faller Group (Stand 2H30), who is solely specialising on the needs of healthcare packaging for more than 20 years, is proposing to design a newly engineered process between supplier and customer, utilising state of the art technologies in our digital age.

Grow Your Presence in the Largest Pharma Market
12:30 - 12:55 2C70
CPhI Showcase
Event Director, CPhI North America
UBM
Ompi Nexa Product Portfolio: Best in class solutions for your most demanding injectable products
12:30 - 12:55 2A70
InnoPack Showcase
Bulk Vials & Cartridges Product Manager
OMPI

Ompi (Stand 2K20) boasts a unique expertise in providing superior pharmaceutical containers from glass-tubing.This expertise is the result of continuous research, enabling the development of innovative high quality parenteral glass packaging and service solutions specifically designed to meet the most stringent Customers’ requirements.

The request of very high cosmetic performances is no longer a nice-to-have but a must-have. The integration with medical devices or sophisticated auto-injectors is another important aspect to consider.

In order to respond to that, Ompi designed Ompi Nexa, a complete state-of-the-art portfolio of solutions, organized starting from its proven experience, to provide the highest level of quality, safety and technology even for the most demanding drugs.

These new solutions exploit the know-how and the synergies of Ompi with the Engineering Division of Stevanato Group to reach an optimized combination of containers’ process platform on forming, transporting and handling with leading edge technology for cosmetic defects detection systems for the automatic control of 100% of containers’ surface.

What are the benefits? Minimization of Customers’ T.C.O. enabled by lower cosmetic inspection rejects due to glass defects, optimized yield and manufacturing efficiency and increased patient safety.

Contamination Free Handling according to Annex 1
12:30 - 12:50 2G70
iCSE Showcase
Vice President
Ortner Reinraumtechnik GmbH

In the amendment to Annex 1, contamination-free handling is mandated EU and FDA-wide for the freeze-drying sector. With this act, Annex 1 not only catches up with international standards but also sends a strong signal towards higher quality and security standards in the pharmaceutical filling sector.

With the amendment to Annex 1, both producing companies and equipment and system manufacturers are challenged to come up with new ideas for affected production areas.

This presentation shows different options for contamination-free handling area especially for existing production lines. It also gives a short introduction to H2O2 decontamination in such areas.

 

Ortner Reinraumtechnik GmbH (Stand 2M10)

Tackling serialisation - a CDMO perspective
13:00 - 13:25 2G70
iCSE Showcase
Director Corporate Projects
Recipharm AB

Since 2013, Recipharm has made a strong commitment to invest in and fully implement the technical solutions needed to comply with global requirements for serialisation and track and trace (T&T).

Having developed our expertise working with customers in a wide range of markets to produce serialised products, we understand the process can be complex and time consuming, particularly without the right tools and expertise.

We have committed to leading the CDMO market in the area of serialisation. The challenge is firmly on our agenda. As such, Recipharm’s dedicated serialisation taskforce is investing €40 million into our serialisation capabilities to ensure our 75 production lines, across 14 European locations, are ready to meet evolving serialisation requirements.

Recipharm AB (Stand 3N30)

The Bachem approach to Quality By Design
13:30 - 13:55 2C70
CPhI Showcase
Business Development Manager Bachem
Bachem AG

Bachem (Stand 7H14)  is a listed technology-based company focused on peptide chemistry providing a full range of services to pharmaceutical and biotech industries. We specialize in the development of innovative and efficient manufacturing processes, and the reliable production of peptide-based active pharmaceutical ingredients. Headquartered in Switzerland with subsidiaries in Europe and the US, the group has a global reach with more experience and peptide know-how than any other company in the industry.

As a leader in the field, quality is central to all our manufacturing.  Through partnership with our customers webuild quality into every project stage through proactive, scientific and risk-based approaches to the development of processes. We follow the principles of deliberate and systematic design in the journey from initiation, through all clinical development phases to commercial supply, gaining full understanding of the relationship between process attributes and final product.  

Risks are identified and managed with customers, and Continuous ProcessVerification provides ultimate control. This presentation provides insight into Bachem’s knowledge base and customer focused QBD approach, and aims to provide further confidence in the core quality of our products.

Increasing the speed to clinical trials of potent molecules; an Xcelodose® case study
13:30 - 13:55 2G70
iCSE Showcase
Director, Pharmaceutical Development
PCI

PCI Pharma Services (Stand 3B16) will showcase their industry leadership in the safe contract development and manufacture of solid dosage forms containing potent molecules.

The presentation will explain how to increase the speed to market of early drug candidates using Xcelodose® technology. Early drug candidates often do not have the same level of toxicological information available and have to be deemed potentially potent drugs. With certain oncology products they are deemed potent through mode of action and similarity to other potent molecular structures and are evaluated and transferred into a multiple API facility to ensure operator and patient safety.

The importance of using robust toxicological assessments aligned with a strong focus on training, occupational hygiene and cleaning controls will be shown as some of the more important key factors in assuring safety and quality throughout the process.   

OXYCAPT™ multilayer plastic pre-filled syringe with glass-like gas barrier
13:30 - 13:55 2A70
InnoPack Showcase
Researcher
Mitsubishi Gas Chemical Co Inc

MITSUBISHI GAS CHEMICAL (MGC) (Stand 2F52) is a leading company in the field of oxygen barrier and absorbing technology. Based on the existing experiences, MGC has successfully developed multilayer plastic vial and syringe made of new oxygen absorbing polymer and COP.

They have the characteristics of glass-like oxygen barrier, extremely low water vapor permeability, extremely low extractables, low protein adsorption, high transparency, high break resistance, high pH tolerance and others.

MGC recommends using them for oxygen-sensitive bio drugs, vaccines or diagnostics as an alternative for glass containers.

Tailoring an auto-injector to the targeted patient and the formulation: SAFELIA®
14:00 - 14:25 2A70
InnoPack Showcase

Nemera (Stand 2M38) has developed an innovative autoinjector, SAFELIA, focusing on the unmet needs: tailoring the autoinjection. Benefits are to ease the self-injection experience for patients and ensure the best delivery of the formulation.

  • For the patients, adjust the design with the pain perception reduction in mind
    • with the ability to inject through thinner needles
    • with an integrated Human Factor approach to take into account specific populations needs
    • with the tailoring of the velocity of injection
    • with a delayed mechanism prior to automatic needle retraction to safety position

 

  • For the formulation, take into account biologics, sensitive formulations to shear effect and highly viscous drugs
    • with the possibility to inject several 100s Cps
    • with the tailoring of the force applied onto the plunger rod during the delivery course
    • with the option of minimizing the residual volume

 

Safelia 2-step autoinjectors (automatic needle insertion and automatic needle retraction) are available for customization on 1ml and 2.25ml platforms.

New approaches to customised manufacturing solutions that provide flexibility, scalability, and efficiency for pre/post market success
14:00 - 14:25
iCSE Showcase
Senior Vice President, Global Operations
Catalent Pharma Solutions

Pharmaceutical pipelines today require more flexibility in manufacturing than ever before. The demands for customised solutions are increasing as specialty products and targeted treatments play a larger role in new product approvals. 

The need to find a partner that can support the specific manufacturing requirements of complex new products is key. Not only do you need to think about how and where your product will be manufactured, you also may want to consider how you can improve the efficiency and reliability of the manufacturing process. 

Customised finished product manufacturing solutions provide scalability, flexibility, and efficiency. Through best practices and case study examples, we will illustrate how unique manufacturing capabilities can help ensure pre and post approval success.

Catalent Pharma Solutions (Stand 3J16)

Building a pre-eminent CRO/CDMO for Complex Science
14:00 - 14:25
CPhI Showcase
Executive VP, API
Albany Molecular Research Inc.

Building a premier supplier of contract research, development and manufacturing services organization requires an understanding of the marketplace, a long-term strategy for inorganic and organic growth and the ability to effectively integrate acquisitions.

Albany Molecular Research Inc.’s (AMRI) - Stand 3Q10 July 2016 acquisition of Prime European Therapeuticals S.p.A., also known as “Euticals”, positions AMRI as one of the largest independent developers and suppliers of API to the pharmaceutical industry and provides the company with an established custom synthesis presence in key European markets. As AMRI celebrates its 25th anniversary this year, this transaction is a timely achievement that positions AMRI for success over many years to come.

Euticals is a privately-held company headquartered in Lodi, Italy, specializing in custom synthesis and the manufacture of active pharmaceutical ingredients (APIs). The acquisition more than doubles AMRI’s contract revenue; significantly expands our portfolio of niche, high barrier to entry APIs; expands our global footprint; expands and diversifies our customer base; and affords customers new/expanded capabilities and technologies.

Sirio’s Vegetarian Soft Gel: a better way for delivering value for health
14:30 - 14:55
iCSE Showcase
perfeXion™ @ SCHOTT Tubing - The New Era of Quality Processing: Moving towards Zero Defects
14:30 - 14:55 2A70
InnoPack Showcase
Director Product Management & Scientific Services
Schott AG

Beside quality, patient safety is the most relevant and discussed topic in the pharmaceutical primary packaging industry. SCHOTT’s responsibility as the market leader is to continuously push the limits with its main products out of the FIOLAX® family.  

 

With our new holistic Zero Defect approach SCHOTT Pharmaceutical Tubing is following its tradition of consequently targeting the quality requirements of the entire value chain – from the pharmaceutical company via the converter down to the tubing manufacturer. Therefore, in our new TLB 2017/Technical Specifications “we speak pharma” by transforming our tubing specification limit values into ppm values based on container units.

With our advanced 100% inline measurement devices, including self-calibrating measurement chains for important parameters, we are ideally prepared to push the transition from AQL to Zero Defect, providing optimal solutions to the new challenges in the packaging business like i.e. self-injection devices.  

By collecting all relevant process and quality data in a FDA 21 CFR part 11 conform process information data base, we are now able to monitor and optimize selected quality criteria on Cp and Cpk level.

By fusing these two features together – 100% measurement and storing the data in an historical database – we present a worldwide unrivalled holistic approach: The perfeXion™ process. 

perfeXion™ now allows us to improve quality and patient safety through consequent track and trace possibilities – principally down to tube level, to stabilize processes and  thereby broaden our ability to customize tubing to customer specific needs.

SCHOTT AG (Stand 2H16)

Quality and customer focus at Cambrex – The experts you’ll enjoy working with
14:30 - 14:55 2C70
CPhI Showcase
Director of Sales and Business Development
Cambrex

Come and hear speaker Alexandra Pichard Nielsen, Director of Sales and Business Development from Cambrex (Stand 8F30) presenting highlights of our commitment to quality and strong focus on project delivery. We can demonstrate how we meet the demands of our customers, targeting a position as leading partner in small molecule API development and manufacturing as well as bringing products to market quickly and effectively. During this presentation we demonstrate the importance of close collaboration and open communication with our customers to ensure successful project delivery.

Preservative free multidose dispensing of eye care medications
15:00 - 15:25 2A70
InnoPack Showcase
Vice President Marketing
Aptar Pharma

 

Poor patient compliance with drug dosing regimens can be a major impediment to effective treatments. Eye Care diseases such as AMD and Glaucoma are potentially blinding chronic diseases, requiring life-long medical therapy. Failure to adhere to proper treatment may lead to disease progression and visual loss, not to speak of economic consequences. Even though the topical application of ophthalmic drugs is quite straightforward, it is common knowledge that poor compliance is widespread. It is often a cocktail of many ingredients, including stinging drops and the difficulty of applying drops accurately, in particular for older patients.

Taking into account that in terms of both efficacy and safety, topical delivery of drugs, especially for front-of-the-eye indications, is superior to all other options of administration, this presentation shows the available options and discusses future trends. Specific strategies to address the general issues of patient compliance and drug delivery optimization are discussed. Inaddition, limitations and regulatory hurdles associated with future methods are mentioned. Finally, the presentation looks atapproaches available now and in the near future that enhance efficacy by improving delivery of ophthalmic formulations.

Aptar Pharma (Stand 2M18)

Anticipating the formulation challenges of complex molecules
15:00 - 15:25 2G70
iCSE Showcase
Vice President of API Process Development Services
Patheon

Historically, medicinal chemists have been asked only to advance new molecular entities into clinical development with acceptable physical properties for formulation. But today, with approximately 40% of new molecules having complex APIs that require advanced formulation science, characterizing physical properties is no longer a straight-forward task for chemists.  What’s more, as the disciplines of characterizing chemical and physical properties tend to be separated along the development timeline between API chemists and formulators, there is often an imperfect understanding of each other’s problems and solutions.   

The future of molecule development will not become simpler. Formulation challenges will not get easier. And the costs of reworking processes or trials will not go down. Join Andreas Stolle, Vice President of API Process Development Services at Patheon (Stand 3L16), as he discusses challenges and solutions for the formulation of complex molecules in early phase development.  

Enzymatic synthesis of chiral intermediates and APIs
15:30 - 15:55 2C70
CPhI Showcase
Manager, International Business
MAPIC Europe N.V./S.A.

API Corporation, a subsidiary of Life Science Institute, Inc. and a member of Mitsubishi Chemical Holdings group, has been developing efficient enzymatic processes for the synthesis of pharmaceutical intermediates and APIs, such as chiralalcohols, carboxylic acids or unnatural amino acids.

The competence of API Corporation resides in its ability to design cost effective synthetic routes, including enzymatic reaction, for its target compounds, and also to develop original enzymes required for the reaction. API Corporation explores novel activities in nature and modifies their characteristics with long and successful experience in this field, ranging from fine to bulk chemicals, of Mitsubishi Chemical Holdings group.  

API Corporation is ready and willing to support your business with its state-of the-art technology.

Visit the exhibitor at stand 4C52

Insights into providing integrated drug delivery solutions to address the challenge of higher volume and high viscosity biologics
15:30 - 15:55 2G70
iCSE Showcase
Global Business Development Lead
Bespak Europe and Aesica Pharmaceuticals

An increasing number of biologics now need to be delivered as a higher volume injectables and several of these drugs are also quite viscous.  As a result, demand for drug delivery devices and fully integrated solutions have steadily risen. To overcome these challenges and to meet the needs of biopharmaceutical clients globally, Bespak in collaboration with Aesica are working together to provide a fresh approach to the market.  

During this talk, we will highlight Bespak’s newest auto injector line Syrina™ as well as the cutting edge powerpack system Vapoursoft™. This system can support viscosities of several hundred centipoise and injection volumes from <1ml to >10ml for handheld and wearable devices. Aesica has the capability and expertise to manage the fill finish ofproducts externally and provides in-house final assembly for devices such as auto injectors in smallbatches or in volumes of several million at their facilities in Europe.

There will be a Q&A session at the end of the talk and the opportunity to speak with our technical and commercial experts at our exhibition booth, stand 3J20.

Glass or Polymer for Parenteral Packaging
15:30 - 15:55 2A70
InnoPack Showcase
Director Strategic Marketing & Innovation
Schott AG

Picking a material for parenteral containers is tricky. When it comes to PFS, one recurring question is: which material is better – glass or polymer?

Glass dominates the market, but the use of polymer syringes is expected to grow in the next few years. Glass’s excellent barrier properties and regulatory ease make it the first choice for drug manufacturers, but polymer’s break resistance and inert properties, as well as its wide design options, make it an attractive choice as well.

As each material has its strengths and weaknesses, drug makers must take a holistic view when deciding on a prefilled syringe for a particular application.

SCHOTT AG (Stand 2H16)

Repsol: A new step forward. Polyolefins for pharmaceutical packaging and medical devices
16:00 - 16:25 2A70
InnoPack Showcase
Pharma Packaging Marketing Manager
Repsol

Building a new path on existing strengths that will allow Repsol to become an active player in the Healthcare segment with: Guarantee, Commitment and Service.

The result is a suitable range of polyolefins, comprising HDPE, LDPE, EVA and PP grades, an outstanding and differentiated level of service, a long-term commitment, willingness for continuous improvement based on our technical expertise and our sales team and a helping hand on technical matters to get the best performance from what we offer.

Identification of Surface Impurities and Particles by Means of Special Analysis Methods
16:00 - 16:25 2G70
iCSE Showcase

Analysis of surface contamination and of particles as foreign material is of outmost importance for product release, failure and damage analysis, and for product quality assurance.

The presentation will demonstrate the application, advantages and limits of special physical and chemical analysis methods such as Fourrier Transformed Infra-Red (FTIR) microscopy, Raman, Scanning Electron Microscopy (SEM) and Energy Dispersive X-ray Detection (SEM/EDX), X-ray photoelectron spectroscopy (XPS) and Auger electron spectroscopy (AES), Time-of-Flight Secondary Ion Mass Spectrometry (ToF-SIMS) and others.

All methods will be illustrated in the context of current application case studies and basic working principles. The case studies were performed as service projects for industrial partners. The resulting requirements for interactions with the customer (e.g. project definition, sample shipment, results reporting) will be outlined.

SGS Life Science Services (Stand 3D50)

Pharma Focus on Indonesia and South East Asia : Meeting the Challenges of Highest Growing Markets
16:30 - 18:30 Room 8.19 in CC8
Keynote

Pharma Focus on Indonesia and South East Asia : Meeting the Challenges of Highest Growing Markets

Exploring the pharma market in South East Asia? Join our Pharma Focus meeting for South East Asia at WW.

Meet the senior pharma professionals from Indonesian Pharmaceutical Association and the National Agency for Drug and Food Control right here at CPhI Worldwide! Ask them what you want to know about business opportunity awaits you in Indonesia and South East Asia. Learn about the pharma industry map, government policy supporting the industry and experience sharing from industry player.

See South East Asia through the best perspective in a good mix among regulatory body, trade association, manufacturers, distributors, importers and service providers, all in one time.

Where: Room 8.19 in CC8
When: October 4th  at 15.30 – 17.30

THEATRE ONE

Pharma Insight Briefings Day 1
10:30 - 18:30 Fira de Barcelona Gran Via, Barcelona, Spain
Pharma Insight Briefings
Vice President EMEA
TraceLink Europe Ltd.
Chief Commercial Officer
PaizaBio
Director of Business Development
Biocat
Managing Director
LODAAT Pharma
Commercial Accounts Lead
Pfizer CentreOne
Business Development and Contract Manufacturing Director
Polpharma Biologics
Sr. Vice President, Innovation and Technology Services
Sharp Packaging Services

BIOTECH
10:30 - 11:15 | The BioRegion: The Catalan life sciences and healthcare sector

  • Gain insight into one of the most dynamic bioregions in Europe with 734 companies and 89 research organizations
  • Understand and take advantage of the different regional assets and initiatives
  • What challenges and opportunities we will see emerging from this region in the coming years?

Jordi Fàbrega, Director of Business Development, Biocat

-----------------------------------------------------------------------------------------------------------

PHARMA PACKAGING
11:30 - 12:15 | ‘Optimizing your supply chain means optimizing your partners’

Have you assessed your outsource partners readiness for serialisation yet?

  • Timelines – urgency of developing and deploying a strategy
  • Leadership buy-in- clarity on strategy, capital allocation
  • Need for experience – technical and PM skills, implementation knowledge
  • Success through collaboration – consolidate with technology leaders
  • ​Risks: timelines, equipment ordering & validation, skills gap

Rick Seibert, Sr. Vice President, Innovation and Technology Services, Sharp Packaging Services

-----------------------------------------------------------------------------------------------------------

PHARMA PACKAGING
12:30 - 13:15 | Global Serialisation: 4 Key Success Factors For Achieving Compliance and Ensuring Supply

  • How to achieve global compliance with multiple country regulations
  • Managing the serialisation and data management challenges
  • How to orchestrate CMO network on-boarding
  • Ensuring line management readiness and integrations
  • The four critical success factors in serialisation

Jean Marie Aulnette, Vice President, EMEA, TraceLink

-----------------------------------------------------------------------------------------------------------

CONTRACT MANUFACTURING
13:30 - 14:15 | How to consolidate your CMO network – and why you should, whether you’re big or small biopharma

  • Strategies for consolidating your portfolio of CMOs and their web of suppliers
  • How to simplify your supply chain to reduce the transaction costs of working with a multitude of service providers
  • Small companies: How to manage your supply chain to increase your attractiveness to prospective partners

Moderator: Dorene Lynch, Commercial Accounts Lead, Drug Product Manufacturing Services, Pfizer CentreOne

Read our interview with Dorene Lynch via this link.

Panellists:

Joseph Akers, Senior Director, Global Sourcing, AbbVie, Inc.
James Lucie, Associate Director Supply Chain, AMAG Pharmaceuticals, Inc.
Gerri Mirkin, Senior Manager, Global Category, Third Party Operations Procurement, Teva Pharmaceuticals

-----------------------------------------------------------------------------------------------------------

REGULATORY
14:30 - 15:15 | Reformation of China’s Drug Regulatory Laws: Salvation for the Global Drug Industry

  • Overview of the Chinese healthcare system and steps taken to overhaul the system, with a view to lowering costs and optimizing value.    
  • Growth opportunities for multinational corporations.
  • The transition from low-cost export to high value-laden exports
  • An overview of recently implemented changes to drug regulatory laws
  • Policy changes which impact all phases of commercialization; i.e. pricing, distribution, promotional activities, etc.
  • Strategic repositioning of the Chinese market within the global pharmaceutical sector

David Deere, Chief Commercial Officer, PaizaBio, Inc.

Read our interview with David Deere, via this link.

-----------------------------------------------------------------------------------------------------------

INGREDIENTS
15:30 - 16:15 | Global Trends for Natural Medicine

  • Top botanical extracts for therapeutic categories including Immunity, Cognition, Sexual health, Cardiovascular support and Diabetes support.
  • Application, and profiling and product differentiation in customization for individual personalization.
  • Paradigm Shifts: Examination of synthetic alternatives , and how natural medicine can complement APIs
  • Discussion of latest manufacturing technologies and how to insure against adulteration.
  • Evolving Roles between RX pharma firms and their natural alternative counterparts.
  • What are Key lessons on and how best to capitalize and profit from Licensing, CMO, CRO and other partnerships

Rajiv Khatau, Managing Director, LODAAT Pharma

-----------------------------------------------------------------------------------------------------------

16:30 - 17:15 | How to set up state of the art biopharmaceutical production in cell culture?

  • High yield cell line development
  • From pilot scale to market demand
  • Forecasting and flexibility
  • Own developments and contract manufacturing under one roof

Federico Pollano, Business Development and Contract Manufacturing Director, Polpharma Biologics

-----------------------------------------------------------------------------------------------------------

THEATRE TWO

Pharma Insight Briefings Day 1
10:30 - 18:30 Fira de Barcelona Gran Via, Barcelona, Spain
Pharma Insight Briefings
President
xCell Strategic Consulting
Managing Director, Livingston site
Capsugel DFS
Senior Consultant
EAS Consulting
Partner and Pharmaceutical and Life Science Consulting Leader
PwC

REGULATORY
10:30 - 11:15 | FDA Insight: Responding to 483s & Warning Letters

  • What is an FDA-483, List of Observations?
  • What is a Warning Letter?
  • Importance of a timely response to FDA-483s and Warning Letters.
  • How to prepare effective responses to FDA-483s and Warning Letters.

Robert Fish, Senior Consultant, EAS Consulting

Read our interview with Robert Fish via this link.

-----------------------------------------------------------------------------------------------------------

REGIONAL UPDATE
11:30 - 13:15 | India-Spain Summit
India Brand Equity Foundation

-----------------------------------------------------------------------------------------------------------

DRUG DELIVERY
13:30 - 14:15 | Why high potency drugs require a specialized approach?

  • What is a high potency drug product?
  • Safety considerations: operator and environmental protection
  • Target Product Profile: Product characteristics and specialist dosage forms.
  • Facility, equipment and process design considerations

Dr. Stephen Brown, Managing Director, Livingston site, Capsugel DFS

-----------------------------------------------------------------------------------------------------------

STRATEGY
14:30 - 15:15 | mHealth: Business strategies for a digital world

A connected consumer has the potential to drive better outcomes in healthcare, and present significant opportunities for Pharma.  Pharma has the opportunity to learn from other industries such as consumer goods and financial services but will be open to competition form new entrants such as technology providers. This talk will cover: 

- The opportunity that digital presents to pharma
- Enablers and barriers that need to be considered
- How to assess the value of a digitally enabled business strategy

Jo Pisani, Partner, PwC Strategy

-----------------------------------------------------------------------------------------------------------

STRATEGY
15:30 - 16:15 | Assessing Risk & Building Supply Chain Reliability

  • What risk assessment tools are available?
  • Getting started with Drug Shortage Prevention
  • Putting a Supply Chain Reliability Plan in place
  • Documenting a plan

Peter Bigelow, President, Xcell Consulting

-----------------------------------------------------------------------------------------------------------

INGREDIENTS
16:30 - 17:15 | New Natural Plant-Based Technology for Supplements

This session will focus on the Overview of Catalent Softgel Technology and the Consumer Advantages & Benefits. We will highlight Catalent Vegicaps® Plant Based Technology as well as Product features and examples of new, differentiated Vegicaps opportunities as well as discussion on our Innovation Capabilities and our New Product Development Process.

Claudia Valla, Product Development Adviser, Catalent Pharma Solutions

-----------------------------------------------------------------------------------------------------------

17:15 - 18:30 Drinks Reception