Agenda

All times displayed for Europe/Berlin timezone.

CPhI Theatre

Current trends in generics portfolio strategies
10:30 - 11:00 CPhI Theatre, Hall 9 stand 9C80
Keynote
Segment Lead – Generics
Clarivate Analytics
Brexit: The wider implications for the Pharmaceutical sector
11:10 - 11:40 CPhI Theatre, Hall 9 stand 9C80
Keynote
Managing Director
Pharma Synergies

Brexit is being considered as disruptive policy.
No-deal Brexit between EU & UK’ would mean disruption of the single potential market in terms of regulations, cross border movement of goods, intellectual property, supply chain, cost of regulatory compliance & marketing and comparative pricing.
There is no prospect of the EU & UK to a larger extent and also the global industry being able to fully manage additional resources required for any divergence, for transition in the time available.
There are concerns about its implications on the pharmaceutical industry in the EU, UK and also in ROW as the national & regional economies are linked to global economy and the pharmaceutical industry being a global one
For the first time, this interactive presentation attempts to address the wider implications, preliminary approach, interim options during implementation, short term strategies to manage the challenges and the long term plan of action.

Champagne taste for beer price? Metabolomic and isotopic fingerprint of commercial saw palmetto (Serenoa repens) extracts.
11:50 - 12:20 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
Professor
Università del Piemonte Orientale, Faculty of Pharmacy

Sponsored by:

Saw palmetto (Serenoa repens, SP) is the most expensive oil source of the pharmaceutical and healthfood market, and its high cost and recurrent shortages have made its adulteration rampant. The most common adulteration of SP extracts is their replacement, or dilution, with cheaper food-based oils (canola, coconut, olive, palm, sunflower), a procedure easily detected by evaluating the fatty acids profile and the concentration of specific fatty acids relative to lauric acid, the major fatty acid (> 20%) of SP. On the other hand, the growing price of SP berries has spurred the development of novel and more sophisticated adulterations, like designer blends of fatty acids that mimic the phytochemical profile of SP and fraudulently comply with the current authentication assays of the oil. To detect this adulteration, isotopic fingerprint and -omic analysis have been comparatively applied, using Principal Component Analysis (PCA) to handle the complex databases generated by these techniques and to identify the possible source of the adulterants. The presence of fatty acids of animal origin turned out to be widespread in commercial samples of the plant.

Capsule based Dry Powder Inhalation – Opportunities, Trends & Solutions
12:30 - 13:00 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
Scientific Business Development Manager – ACG Capsules
ACG Associated Capsules Pvt. Ltd

Sponsored by:

Capsule based Dry Powder Inhalation – Opportunities, Trends & Solutions

Best practices for Highly Potent API (HPAPI) development & manufacturing
13:10 - 13:40 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
senior Director, Head of Commercial Development for the Active Pharmaceutical Ingredient (API)
Lonza

Sponsored by:

Drug product development for highly potent APIs (HPAPIs) can be challenging. Complications with the interface between operations in drug substance and drug product handling can result in increased program complexity and cost. This presentation focuses on best practices for developing and manufacturing highly potent compounds, contained particle engineering, and overall infrastructure requirements to meet accelerated timelines to clinic and market. Case studies which illustrate efficient and rapid development, scaling and commercial production of HPAPI will be discussed.

Improve your Bioprocesses with innovative Salts - Novel scientific Data on Iron Salts
13:50 - 14:20 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
Project Manager Biopharma
Dr. Paul Lohmann

Sponsored by:

Biopharmaceutical upstream and downstream processes define highest standards on requirements for raw materials within production processes. These raw materials comprise culture media, buffer solutions and other process aids. Meeting these challenges Dr. Paul Lohmann®, with more than 130 years expertise in manufacturing, offers a wide range of process aids for biopharmaceutical applications ranging from cell nutrients and purification agents to excipients for final drug formulation. As part of upstream organic and inorganic salts contribute to the osmotic balance and are used as enzymatic co-factors in cell culture media. Particularly the cations iron, copper and manganese are critical and their management is essential for a suitable cell culture system. Based on our profound expertise in iron salts we will provide you with recent data on the role of various iron salts on cellular bioavailability. We will show improved cellular bioavailability with the appropriate iron salt selection. Moreover, the attendees will gain insights into innovative product modification for more efficient bioprocesses.

The Importance of Choosing the Right PSD for its Measurement and the Influence of Grinding/Milling/Micronisation on it
14:30 - 15:00 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
CEO
GfM Gesellschaft für Micronisierung mbH

Sponsored by:

A Groundbreaking Way to Go to Market Faster in Any Color You Choose
15:10 - 15:40 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
Business Development Manager
Capsugel

Sponsored by:

One major concern when developing a new drug is the ability to anticipate upfront interactions between fill and capsule. During this presentation, Dr. Nicolas Madit will introduce an innovative standalone R&D solution ideal for early stage capsule development. Capsugel®Colorista™ technology can provide a shorter development time for your product, while offering flexibility to progress with technical development before the final commercial color decision is taken. Capsugel® Colorista™ capsules are the perfect tool for pharmaceutical customers who are looking for flexible and time-efficient development of new products or generics.

Superba KrillTM oil supplementation improves skin hydration and elasticity in adults
15:50 - 16:20 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
Director Research & Development
Aker Biomarine

Sponsored by:

Polyunsaturated long-chain omega-3 fatty acids are vital to human health, yet average population levels are very low across several regions of the world. Superba KrillTM phospholipid omega-3s are a unique combination of docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and choline, and offers significant health benefits. Here we present preclinical data detailing skin incorporation of EPA and DHA as well as RCT data demonstrating improvements in skin hydration and elasticity following Superba KrillTM oil supplementation. Highlights • EPA and DHA are incorporated into skin following oral intake • Superba KrillTM oil improves skin elasticity • Superba KrillTM oil improves skin hydration

A quality mindset: continuous improvement and risk management through the value chain
16:30 - 17:00 CPhI Theatre, Hall 9 stand 9C80
Pharma Insight Briefings
Senior Director Global Quality
Capsugel

Sponsored by:

With changing regulations, high speed filling machines, more accurate dosing requirements and higher customer demands, there is a clear need for products with tighter specifications and higher quality levels. Through a comprehensive quality control and assurance program – from the purchase of key raw materials to manufacturing, packaging, release and delivery, product quality and safety is guaranteed. Continuous improvement and investment in new technologies and equipment, enable us to set new standards and support the need for customization.

ICSE Theatre

Panel Discussion: M&A Outlook for Pharma
10:30 - 11:40 ICSE Theatre, Hall 1 stand 1G90
Keynote
Director, Strategic Planning, Investments & Business Development – Industrial Affairs
Sanofi
Partner
Results International
VP Business Development Global Supply
Pfizer
EVP Corporate Development
Recipharm AB
Chairman & CEO
Avara Pharmaceutical Services
Compaction Simulation as a Powerful Quality by Design Tool: How we Optimize Prototyping, Scale-up and even Production Equipment Workload of Complex Oral Solid Dosage Forms.
11:50 - 12:20 ICSE Theatre, Hall 1 stand 1G90
Pharma Insight Briefings

Sponsored by:

Early Intermediate for increased supply security  
12:30 - 13:00 ICSE Theatre, Hall 1 stand 1G90
Pharma Insight Briefings
Director Business Development
Lonza

Sponsored by:

The API supply chain is increasingly challenging. The trend towards more specialized medicines can result in more raw material requirements and more complex supply chains. The challenge is compounded by the biopharmaceutical industry’s overdependence on regional supply of API as well as their precursors. Supply shortages, quality and regulatory issues have resulted and in some cases threatened the supply of critical medicines. Lonza, an established leader in API development and manufacturing, has utilized its extensive chemical facility in Visp, Switzerland to address this issue. ISO early intermediates and cGMP advanced intermediates are manufactured for its API production, reducing dependency on regional producers, and these capabilities are now made available to biopharma customers. Join us to learn how Early Intermediates supply from Lonza can meet your API supply chain challenges.

Manufacture of highly potent oral solid dosage forms
13:10 - 13:40 ICSE Theatre, Hall 1 stand 1G90
Pharma Insight Briefings
Vice President, Contract Manufacturing Operations
Pfizer Global Supply and Pfizer CentreOne Contract Manufacturing

Sponsored by:

As drugs in development become more potent, regulatory expectations keep changing. Manufacturing has to adapt. The head of operations for Pfizer’s contract manufacturing business, Tom Wilson, discusses best practices for meeting the challenges of compliance as requirements shift, using Pfizer’s Newbridge, Ireland, facility as a model.

ALCOA data integrity assessment
13:50 - 14:20 ICSE Theatre, Hall 1 stand 1G90
Pharma Insight Briefings
Vice President Business Development
PQE

Sponsored by:

ALCOA data integrity assessment: ALCOA data integrity assessment is a fundamental tool for successful regulatory and customer inspections.

Encapsulation best practices for early clinical studies  
14:30 - 15:00 ICSE Theatre, Hall 1 stand 1G90
Pharma Insight Briefings
Technology Transfer and Innovation Manager
Lonza

Sponsored by:

Encapsulation best practices for early clinical studies: Specialized encapsulation techniques can greatly simplify early studies, and play a critical role in meeting drug program timelines. Xcelodose® Precision Powder Micro-dosing Systems facilitate powder-in-capsule (PIC) / micro-dosing studies can eliminate the need for preformulation steps and excipient compatibility testing in early clinical evaluations. A set of best practices have been developed based on extensive PIC studies over a range of API characteristics to help accelerate feasibility studies and first-in-human (FIH). Representative case studies demonstrating PIC study extremes will be discussed.

Speciality Containers: PVC-free bags and pre-filled syringes for sterile drug products
15:10 - 15:40 ICSE Theatre, Hall 1 stand 1G90
Pharma Insight Briefings

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.

Managing the Pharmaceutical Supply Chain
15:50 - 16:20 ICSE Theatre, Hall 1 stand 1G90
Pharma Insight Briefings
Executive Director, pharma biotech
NSF International

Sponsored by:

Pharmaceutical supply chains within the pharmaceutical industry have become very complicated with many actors. In these increasingly complex supply chains, how can you identify and manage risks?. This presentation will cover: How to meet the EU regulatory how can you identify and manage risks?. This presentation will cover: How to meet the EU regulatory requirements for API supply chains - What needs to be included in the QP declaration - How you can use recent legislation to identify and manage risks - The potential impact of BREXIT on supply chains.

Accessing the European Market
16:30 - 17:00 ICSE Theatre, Hall 1 stand 1G90
Pharma Insight Briefings

Sponsored by:

In this seminar we will tackle the current situation for accessing to the European market. Our approach to this topic includes: new normatives and regulations, key factors involved and strategies recommended.

Innopack & P-MEC Theatre

Pharmaceutical packaging innovations: Collaboration from fundamental science to industrialisation
10:30 - 11:30 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
Keynote
Head PTS Pre-Competitive Activities
GSK
Head of Centre for International Manufacturing
Institute for Manufacturing, Department of Engineering, University of Cambridge
Antimicrobial protection by the matter’s power : application to the pharmaceutical products to replace preservatives and better protect the patients
11:50 - 12:20 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
Pharma Insight Briefings
Senior Product Manager Pharma
AMCOR
CEO
SAS Pylote

Sponsored by:

Pharmaceutical products containing an aqueous phase are susceptible to microbial contamination during use and require the addition of preservatives to limit the proliferation of pathogenic micro-organisms. However, some preservatives are allergens, irritants and/or suspected of being endocrine disruptors and cancer-causing agents in humans. Pylote develops, produces and markets innovative technology based on an exclusive manufacturing process for 100% mineral microspheres that transfer microbial properties to the materials into which they are integrated. Pylote technology has a significant impact on a wide variety of microorganisms, including bacteria expressing acquired antibiotic resistance, and viruses. Given that microspheres are listed as authorized additives in international Pharmacopoeas, do not contain nanoparticles and there is no migration from the host material, the technology is totally safe for consumers. Microspheres have been integrated successfully on the industrial production lines of many products such as eye-droppers, liquidsticks, wipes, cosmetic dispensers and applicators, without altering the manufacturing process. Pylote reduces the source
of microbial contamination during use in order to reduce or remove the use of preservatives while guaranteeing a “microbiologically clean” dosage to consumers.

Evolution of Raman into Preferred Method for Pharma QA/QC Analysis
12:30 - 13:00 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
Pharma Insight Briefings
Business Development
B&W Tek

Sponsored by:

Raman technology has evolved quickly over the past 10 years, going from novel lab-based technology to easy-to-use, on-the-spot handheld and portable analyzers that fulfill specific purposes. Handheld Raman is now considered one of the best choices for incoming raw material identification, allowing users to scan through secondary packaging and get results within seconds. Raman is also seeing uptake in pharmaceutical R&D and QC labs, with portable Raman being used for content and blend uniformity as well as in formulation development. During this seminar, Dr. Enrique Lozano Diz will describe several applications and how quality testing with Raman can save companies time and give great returns on investment.

Modern approaches to Pharma QC
13:10 - 13:40 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
Pharma Insight Briefings
Pharma Marketing Manager
Agilent

Sponsored by:

This seminar will describe the application of Raman and Infrared Spectroscopy for Quality Control in Pharma. This will include use of Raman for raw materials verification of incoming goods through unopened non-transparent Containers and the use of transmission Raman as an alternative to UPHPLC for content uniformity studies. Furthermore, use of a next generation IR instrument using a quantum cascade laser will be described for chemical imaging studies including analysis of tablet component distribution, polymorph distribution, salt exchange and stability studies.

Building a Connected Devices Eco-System for Digital Medicines
13:50 - 14:20 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
Pharma Insight Briefings
Business Development Director for Connected Devices
Aptar

Sponsored by:

At this Pharma Insight Briefing session, Sai Shankar, Director Business Development Connected Devices will discuss Aptar Pharma’s approach to building the Digital Medicine ecosystem for connected drug delivery devices across therapeutic areas. To deliver on the promise of digital medicine to improve patient outcomes, it is important to look at the building blocks of such an eco-system. This starts with understanding the challenges faced by patients while taking their medications, their interactions with the drug delivery systems and how design of connected devices can be seamlessly integrated to improve adherence. This patient-centric design approach will determine the type of data that should be generated from the connected devices, which in turn will drive the type of technology that should be adopted. These design decisions will also impact the electronics design architecture, stacking of different technology options and cross-platform interoperability. Complementing the device design should be a proven high quality manufacturing setup that has a secure supply chain for electronics and plastic components. The last mile of building the ecosystem is the successful pairing of the data from devices to the digital medicine platform.

Container Closure Integrity Testing of Sterile Pharmaceutical Product
14:30 - 15:00 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
Pharma Insight Briefings
Director Product Line
Lighthouse Instruments

Sponsored by:

The recently release draft Annex 1 Revision could result in significant changes to the requirements for container closure integrity (CCI) testing. In addition, FDA requirements for CCI testing are being influenced by the recently revised U.S. Pharmacopeia <1207> chapter on 'Package Integrity Evaluation - Sterile Products'. This presentation will discuss the proposed regulatory changes and present case study examples for industry best practices for CCI testing during the product life cycle. Examples include statistical CCI studies, validation of raised stopper limits, validation of CCI during transport, and CCI testing during shelf life.

Moulding the future? How moulded glass is supporting biotechs and OTC
15:10 - 15:40 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
Pharma Insight Briefings
Managing Director
FEVE
Public Affairs Manager
FEVE
Chief Commercial Officer
FEVE

Sponsored by:

The biopharmaceutical is a very important growing market – key insights on the characteristics of this market, the challenges it represents, and expectations customers have from the packaging supply chain will be outlined. OTC is not a new market and glass is already very much present in this sector. However, customers decision-making on packaging is more than often driven by other aspects than the product preservation and the total absence of interaction with the contained product. In this segment there is a need to redefine the role of molded glass as premium packaging material at very competitive market conditions. The glass industry is investing in both segments as major drivers for innovation of the packaging solutions, and for a redefinition of the industry business model from a glass container manufacturer to a value-added and high-quality solutions provider. This will add to the unique inherent properties of glass in terms of inertness and recyclability. How can glass flaconnage industry strengthen its position of key partner for the pharma industry? Is there space for more and better collaboration between the glass supplier and the pharma customer?

Tracking on primary packaging with anti-counterfeiting feature
15:50 - 16:20 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
Pharma Insight Briefings
CSO Pharma & Medical
Stoelzle-Oberglas GmbH

Sponsored by:

Tracking and Tracing is more and more important to all of us. We do want to know where, when, and who has produced the goods to chain back the distribution in the case of an information lack or any issue. Also with the Stölze solution " Track-back to the beginning of glass" we support on the primary packaging the requested information for logistic, quality and even for marketing.

Exploring the Advantages of Prefillable COP Polymer Syringes
16:30 - 17:00 InnoPack & P-MEC Theatre, Hall 4 stand 4F121
Pharma Insight Briefings
Manager Technical Support Medical Systems
Gerresheimer

Sponsored by:

Besides the traditional glass syringe, polymer syringes have established in the aesthetics as well as in the biotech and animal health sectors. There are some advantages of polymer syringes, especially high break resistance and freedom of design, as they are not produced from tubes like glass syringes. Especially for highly demanding drug formulations the features "glue free" and "tungsten free" are important. Particulate matter caused by the siliconization of the syringes are often an issue for sensitive drug formulations. Low particle loads are achieved by a special siliconization and there are silicone free options feasable. The presentation will give an insight into the new production facility for COP syringes called "Gx RTF Clearject" in Germany.

Pharma Forum Theatre

Impact of Generics, biosimilars and next-in-class biologics on access to the state-of-the-art treatment of oncology and autoimmune diseases.
10:30 - 11:00 Pharma Forum Theatre, Avenida outside Halls 5 &6
Keynote
Vice-president, R&D
BIOCAD
Russia: Market Outlook In Partnership with Association of the Russian Pharmaceutical Manufacturers
11:10 - 11:40 Pharma Forum Theatre, Avenida outside Halls 5 &6
Keynote
Director
Association of the Russian Pharmaceutical Manufacturers
Optimising Biopharmaceutical Processes using Hybrid Modelling and Evolutionary Computation Techniques
11:50 - 12:20 Pharma Forum Theatre, Avenida outside Halls 5 &6
Pharma Insight Briefings
Data Scientist
Boehringer Ingelheim

Fermentation processes are biotechnical process where Escherichia coli converts sugars to a mixture of products under certain conditions (process conditions). Identifying the optimal set of process parameters that maximizes product volume, quality, and minimize time inside a fermentation process is a challenging task for scientists. That is down to the complexity that underlies these processes, which comes into two folds, complexity of process behavior and cell behavior. Resorting to data-driven modelling and utilizing historical data generated from the process is an approach that Smart Process Design Team at Boehringer Ingelheim Digital Lab (BI X) is taking to address this optimization problem. The approach is developing a data driven model that can be used as a fitness function for a population based search technique to find the optimal set of process parameters that maximizes product volume inside the fermenter.

Using big data and AI to empower patients in healthcare through digital campaigns
12:30 - 13:00 Pharma Forum Theatre, Avenida outside Halls 5 &6
Pharma Insight Briefings
Marketing Manager Diabetes
AstraZeneca
Production of chemical specialties in the Czech Republic
13:20 - 13:40 Pharma Forum Theatre, Avenida outside Halls 5 &6
Pharma Insight Briefings

Sponsored by:

1. Characteristics of the Czech chemical industry and position of Specility Chemicals 2. Main players-producers in Speciality Chemicals on the Czech market 3. Focus on typical products originated from the Czech chemical specialities Producers

Doing Business amongst Evolving Dynamics: India - EU and UK
14:00 - 17:10 Pharma Forum Theatre, Avenida outside Halls 5 &6
Pharma Insight Workshops

This workshop will be led by Pharmexcil & IBEF.
FREE TO ATTEND, please register in advance here: https://ubm.cphi.com/workshop/doing-business-amongst-evolving-dynamics/i...

13:50-14:00: Registrations
14:00-14:05: Welcome Address | Dr Dinesh Dua, Chairman, Pharmexcil
14:05-14:10: Credible, Affordable and Sustainable: Indian Pharmaceuticals | Mr Uday Bhaskar, Director General, Pharmexcil
14:10-14:20: Key Note Address | Mr. Siddhartha Chattopadhyay, Chargé d'affaires, Embassy of India
14:30-15:00: Panel Discussion - Synergy between Regulatory Framework | Mr Richard Andrews, Inspectorate Operations Manager, UK-MHRA and Dr K Bangaru Rajan, Joint Drugs Controller(I), CDSCO
15:00-15:10: Q&A
15:10-15:40: Panel Discussion: Emerging Paradigms of Collaborations: India-EU and UK | Fruniz Olatz, Senior Director Business Marketing, IQVIA
15:40-15:50: Q&A
15:50-16:20: UK: Connect, Collaborate, Innovate | An interactive session with UK Pharma companies to explore potential partnership opportunities with India
16:20-16:30: Q&A and Concluding Remarks

This session will be followed by a meet and greet for Indian and UK companies at Pharmexcil's India Pavilion