Agenda

ICSE

Pharma & OTC: Entering the most prosperous emerging markets
10:30 - 11:00 G1A1
Pharma Insight Briefings
CEO
Chameleon Pharma Consulting

Sponsored by:

With the ever increasing global competition that Pharma & OTC companies are facing, more and more firms are turning to the Emerging Markets where growth rates are significantly higher than those in the mature markets. The growth potential of these regions offer attractive internationalization opportunities for foreign Pharma & OTC companies. Countries in Asia, Middle East, Latin America and the CIS region are particularly interesting for foreign Pharma & OTC companies looking to geographically expand. One example is Mexico, which has the second largest pharmaceutical market in Latin America. Internationalizing into the Emerging Markets is not a straight forward process. With the example of Mexico, the registration process can be lengthy and complex. We find that applying a systematic approach to internationalization improves the efficiency and success rate of the process.Throughout this session, the opportunities for Pharma & OTC companies in the Emerging Markets will be discussed and strategies for approaching new markets will be explained. Additionally, a case study will be presented on the Mexican cough & cold market.

 

Serialisation – the vital role of the CDMO
11:10 - 11:40 G1A1
Pharma Insight Briefings
Vice President, Manufacturing Services
Recipharm

Sponsored by:

Serialisation represents the single biggest challenge currently faced by the pharmaceutical sector and the role of the CDMO is critical in ensuring industry-wide compliance. As drug developers look ahead to the European Falsified Medicines Directive (FMD), due to be enforced from February 2019, they must review a complex web of supply chain partners to ensure readiness for the deadline. CMOs, CPOs and 3PLs must be equipped to deliver an FMD-compliant service and those that fail to prepare risk loss of business in key markets. Erik Haeffler, Vice President, Manufacturing Services at Recipharm reviews current levels of preparedness in the industry, discusses the challenges and opportunities serialisation presents to contract partners and offers guidance on what pharmaceutical companies must consider when reviewing and assessing their supply networks. 

How do I standardise & accelerate serialisation onboarding of my CMOs?
11:50 - 12:20 G1A1
Pharma Insight Briefings
Senior Vice President - Global Innovation and Technology Services
Sharp

Sponsored by:

Serialisation readiness: Establishing the right strategy and partnerships for success
12:30 - 13:00 G1A1
Pharma Insight Briefings
Operations Director
AESICA

Sponsored by:

Model-based technology selection for bioavailability enhancement
13:10 - 13:40 G1A1
Pharma Insight Briefings
Director Research
Capsugel

Sponsored by:

It is reported that 60-90% of new chemical entities exhibit poor solubility or dissolution rate. Effectively addressing these issues is essential for the development of drugs with adequate bioavailability, which is crucial to provide the desired therapeutic benefit to patients. Rather than relying on trial and error, a fundamental, model-based approach has been developed to select the best technology according to the active principle profile. The presentation will look at models and other tools supporting the design process, resulting in accelerated and optimized product performance, while minimizing program cost and complexity.  Incorporation of Quality-by-Design (QbD) principles early in the product design phase ensures ultimate manufacturability of the formulation design.

Development manufacture of HPAPI drug products throughout the clinical phases
14:30 - 15:00 G1A1
Pharma Insight Briefings
Director Pharmaceutical Development
PCi Pharma Services

Sponsored by:

An Innovative Bioreactor System for enhancing Vero Cell growth
15:10 - 15:50 G1A1
Pharma Insight Briefings
Director Biomanufacturing Education & Training Center and Research Professor at Worcester Polytechnic Institute, MA, USA
Eppendorf

Sponsored by:

Microbial fermentation
15:50 - 16:20 G1A1
Pharma Insight Briefings
Director - Sales & Marketing
Capua Bioservices

Sponsored by:

Centralising stability studies – managing risks
16:30 - 17:00 G1A1
Pharma Insight Briefings
Business Development Director
Recipharm

Sponsored by:

Stability studies play an essential role across the lifecycle of pharmaceutical products. While on the surface they could be viewed as a routine service, this stage in drug development can be both time and labour intensive, bringing a number of challenges that have potential to delay time to market. As a result, there are multiple factors to consider when selecting a contract partner for stability studies, including infrastructure, manpower, technical competence and quality. In this seminar, Karan Bagaria, Business Development Director at Recipharm explores key challenges and considerations, the process of selecting and working with a contract laboratory and the critical factors in mitigating risk during stability testing. 

FDF - InnoPack

Setting new standard for coated stoppers
10:30 - 11:00 G1A3
Pharma Insight Briefings
Business Support Manager Injectables
Aptar Pharma

Sponsored by:

Successfully activating positive behaviors of stakeholders involved in vaccine purchasing and usage through technological advances
11:10 - 11:40 G1A3
Pharma Insight Briefings
Senior Advisor to the CEO
Pharmapan

Sponsored by:

Plastic vials and syringes with an excellent oxygen barrier
11:50 - 12:20 G1A3
Pharma Insight Briefings
Researcher
Mitsubishi Gas Chemical

Sponsored by:

Preventing falsified medicines from entering the EU supply chain
12:30 - 13:00 G1A3
Pharma Insight Briefings
Business Development Manager, Pharma
UPM Raflatac

Sponsored by:

Michael is a solution provider for pharmaceutical packaging and labelling. He has a long experience and strong expertise in the pharmaceutical market, having held different positions within the value chain including pharmaceutical manufacturer, label converter and label stock manufacturer.

3 bullet points concerning the presentation topic:

  • Falsified Medicine Directive current status
  • How to secure your products against counterfeits
  • Key learnings
How plastic materials can help protect your product and your patients
13:10 - 13:40 G1A3
Pharma Insight Briefings
Global Head of Healthcare Polymer Solutions
Clariant

Sponsored by:

Delivery of safe treatments is the mission of all pharmaceutical and device companies through risk management. The industry faces challenges of protecting its products from moisture and oxygen and a growing threat of counterfeits. Plastics play a vital role in protecting pharmaceuticals and creating innovative devices, and Clariant will describe how its products contribute to countering these challenges. In particular, we will show how PLASTIWARD in-plastic real-time authentication and monitoring system complements and supplements your actions against fakes.

How to deliver sterile eye drops with a safer alternative to preservatives
13:50 - 14:20 G1A3
Pharma Insight Briefings
Global Category Manager for Ophthalmic
Nemera

Sponsored by:

  1. Overview of the ophthalmic market and trends
  2. Patients’ needs
  3. Solutions
  4. Case study

 

 

Oral thin films: innovative dosage form for improving patient compliance
14:30 - 15:00 G1A3
Pharma Insight Briefings
Principal Research Co-ordinator
Zim

Sponsored by:

Over the last two decades, the global pharma market has been facing declining R&D productivity, increasing genericization and fewer New Chemical Entities. During this period pharma companies globally have moved towards developing Novel Drug Delivery Systems to Extend the Life Cycle of patented drugs (Life Cycle Management) and to Build a competitive advantage in the crowded Generics market. Zim is a maverick pharma company providing drug delivery solutions by developing and manufacturing innovative, differentiated pharmaceutical products targeting patient convenience and adherence through its indigenously developed proprietary technology platforms.

Conventional oral solid dosage forms like tablets and capsules in spite of their several advantages and resultant popularity suffer from one great disadvantage, i.e., they have to be swallowed preferably with water or any other liquid.  A need for non-obstructive dosage form possessing the other advantages of tablet has been felt constantly by the physicians and patients for many years. 
Thin films as drug delivering dosage forms evolved from this need. These are ideal for delivery to pediatric, geriatric, dysphagic, mentally challenged and other special needs patient populations. The seminar will cover the technical aspects involved in product development, manufacturing, analysis and regulatory approvals of this novel dosage form. Case studies will also be presented illustrating complexities of products based on thin film technology platform.

Future pharma manufacturing: RTU packaging solutions to increase flexibility & increase efficiency
15:10 - 15:40 G1A3
Pharma Insight Briefings
Global Product Manager, Cartridges
Schott

Sponsored by:

Driving better patient outcomes with connectivity
15:50 - 16:20 G1A3
Pharma Insight Briefings
Associate Director Business Development
Aptar Pharma
Business Development Director for Connected Devices
Aptar Pharma

Sponsored by:

CPhI - BioPh

Applications of plant cell cultures - from bench to commercial scale
11:10 - 11:40 G1A2
Pharma Insight Briefings
Chief Scientific Officer
Phyton Biotech

Sponsored by:

Novel oxidant NaOCl • 5H2O for organic reactions
11:50 - 12:20 G1A2
Pharma Insight Briefings

Sponsored by:

Solving the insoluable: innovative solutions for solubility enhancement
12:30 - 13:00 G1A2
Pharma Insight Briefings
Senior TS&D Scientist
Dow

Sponsored by:

Functional capsule technologies based on advanced polymer science
13:10 - 13:40 G1A2
Pharma Insight Briefings
Director, Pharmaceutical Business Development Manager EMEA & India
Capsugel

Sponsored by:

New developments in polymer science are broadening the role capsules play in drug delivery, medical research and pharmaceutical development. Today, options exist to achieve immediate, delayed, and controlled site-specific release. Specialized capsules embed new levels of complexity and can now play a functional role meeting the clinical needs for specific plasma time-course profiles, avoiding site-specific degradation in the GI tract, and overall improving drug efficacy for patients. The seminar will look into new HPMC-based capsules (including the recently launched intrinsically enteric capsule technologies), which offer a means of addressing some of the above challenges as well as the requirement for rapid product development. The expanding range and application of capsules are meeting the demand for both increasingly specialized and patient-centric dosage forms.

QbD applied to lipid-based pharmaceutical products
14:30 - 15:00 G1A2
Pharma Insight Briefings
Technical Director
Capsugel

Sponsored by:

Lipid-based formulations (LBF) have become a well-established strategy to improve bioavailability and reduce food effect or variability of poorly soluble compounds. Although awareness of LBF technologies is widespread, systematic science-based formulation approaches are not common.QbD applied through scientific approaches to the development and finalisation of LBF commercial processes can shorten project timelines while reducing risks and gaining valuable product knowledge. The presentation will look at case studies demonstrating the application of QbD principles to complex product development and process transfer projects utilising both liquid-filled hard capsule (LFHC) and soft gelatin capsule technology.

Sterility solutions for silicone tubing in critical biopharma applications
15:10 - 15:40 G1A2
Pharma Insight Briefings
Dow Food, Pharma & Medical Solutions
Dow

Sponsored by:

An approach to process risk mitigation by FMEA
15:50 - 16:20 G1A2
Pharma Insight Briefings
Business Development Manager
BACHEM

Sponsored by: