Pharma Insight Briefings

All times displayed for Europe/Berlin timezone.

The Future of Medicine: What are the therapies of tomorrow?
10:30 - 11:40 61D61
CPhI Theatre
Senior Consultant
IQVIA
President & Co-Founder
Camargo Pharmaceutical Services
Managing Director & Partner
Strategy&
CEO
Crystec Pharma
Head of Oncology and Hematology
KSBL

Oncology, auto-immune, cardiovascular, pulmonary and mental health are all key therapy areas for Pharma companies to crack. This panel will examine emerging therapies for the future pharma toolkit – both developing the new and repurposing the old.
• Value added medicines - Innovation through repurposing, and reformulating.
• New-gen APIs
• Personalised therapies
• The shift from mass market to niche therapies
• Balancing the needs of patients and payers
• What does the future hold for generics?

Exploring Trends in Contract Manufacturing
10:30 - 11:40 120D40
ICSE Theatre
President
xCell Strategic Consulting
President & CSO
Pharmatech Associates
Executive Director
Patheon, part of Thermo Fischer Scientific
Founder & Former President
PharmSource
Editor in Chief
PharmSource – a GlobalData Product

As Pharma evolves towards more complex therapies with specific manufacturing needs, the role of the CDMO has never been so important. With efficiency, cost, flexibility and quality all essential components of outsourcing, how are CDMOs evolving to remain competitive? Which technologies and strategies will provide the biggest returns?
• Is the One Stop Shop concept dead?
• Continuous manufacturing – application & development factors
• Scalable facilities for flexible manufacture
• M&A and industry consolidation -how is this shaping the industry?

Trends in Sustainable pharma Packaging & Drug Delivery Devices
10:30 - 11:40 110D40
InnoPack & P-MEC Theatre
Managing Director
Pharmacentric Solutions
Sustainability and Strategic Innovation Director
Huhtamaki Flexible Packaging
Research & Innovation Manager
Berry Global
Eco-Design Manager
Adelphe

Sponsored by:

In collaboration with Pharmapack Europe

The vast opportunities in the Emerging Markets for OTC, Pharma and Medical Device companies. Effective market entry, how to avoid typical pitfalls in regulatory, commercial. Practical case studies on Market Entry!
11:50 - 12:20 61D61
CPhI Theatre

Sponsored by:

Manufacturing of Complex Formulations in 1-50 mL Pre-Filled Syringes
11:50 - 12:20 120G43
ICSE Theatre
Vice President, Global Contract Manufacturing,
Fresenius Kabi

Sponsored by:

Fresenius KabiContract Manufacturing offers contract manufacturing services for sterile liquid injectable drugs from more than 20 manufacturing sites worldwide. Here, we introduce two of our FDA-approved sites and their fill/finish capabilities for pre-filled syringes for third party manufacturing. The Fresenius Kabi sites in Wilson/USA and Graz/Austria can accompany our partners during process development and scale-up through clinical and commercial batch manufacturefor world-wide supply. Our experience with different pre-filled syringe suppliers and scales enables us to offer drug product manufacture from standard solutions to complex formulations.In particular, our expertise spans from the standard small volumes up to large volume pre-filled syringes, such as the 10, 20 and 50 mL syringe formats.We also invested in state-of-the-art equipment to handle high-potent APIs down to an OEL of 0.1 μg/m3. Our decades of experience with disperse systems allows us to process various formulation technologies, such as liposomes and emulsionsthat we can combine with our pre-filled syringe technology

Advances in Polymers for Container Closure Systems
11:50 - 12:20 110D50
InnoPack & P-MEC Theatre
Global Market Development Team Leader
Honeywell

Sponsored by:

Demand for polymer-based container closure systems for the drug delivery of both new chemical entities (NCEs) and new active substances (NASs) have been growing for more than 40 years. As Pharma continues to invest in new therapies whilst employing new mechanisms of actions it is today harder than ever before to demonstrate that a proposed packaging system is suitable for its intended use. Containers for drug products should be composed of materials that are considered safe for use with the dosage form and the route of administration. They should adequately protect the dosage form and should be compatible with it. This seminar highlights recent advances in polymer-based high barrier bottles, vials and bags. Special emphasis is made on Honeywell’s efforts to minimizing: 1. Permeation of gases and liquids through polymers; 2. Migration of additives and oligomers from packaging into the drug product; 3. Penetration and absorption of active and non-active substances into packaging and 4. Protein binding on surfaces. Highlighted are further efforts to develop new polymers that withstand gamma-sterilization and cryogenic temperatures below – 190 °C.

Session Title TBC
12:30 - 13:00 61D61
CPhI Theatre

Sponsored by:

Freeflex®: Fill & Finish Service in innovative IV-bag for global supply
12:30 - 13:00 120G43
ICSE Theatre
Business Development Manager Global Manufacturing Sterile Pharmaceuticals
Fresenius Kabi

Sponsored by:

Highest quality PVC-free Freeflexbags are the leading-edge container technology of today for IV bag pharmaceuticals. Convenient and safe for use in a broad field of application from standard infusion to drug reconstitution.Fresenius Kabi offers its proprietary bag technology as well asfill and finish services for all markets around the world. Supporting our customers from product development to commercial manufacturing is our duty and pleasure.

Session available for booking
12:30 - 13:00 110D50
InnoPack & P-MEC Theatre
Capsugel® Zephyr™ dry-powder inhalation (DPI) capsule portfolio
13:10 - 13:40 61D61
CPhI Theatre
Business Development, Manager Innovative Products
Capsugel - Lonza

Sponsored by:

Session Title TBC
13:10 - 13:40 120G43
ICSE Theatre

Sponsored by:

Session available for booking
13:10 - 13:40 110D50
InnoPack & P-MEC Theatre
Birds of a Different Feather: Natural, Semi-synthetic and transgenic cannabinoids do not flock together
13:50 - 14:20 61D61
CPhI Theatre
Professor
Università del Piemonte Orientale, Faculty of Pharmacy

Sponsored by:

Progress in organic synthesis and in techniques of cloning and heterologous expression have the potential to replace isolation as a source of bioactive natural products. On the other hand, natural-, synthetic-and biotechnological versions of an active principle can be significantly different not only in their14C contents and the overall isotopic profile, but also in terms of impurity profile. Therefore, their biological profile might not be completely overlapping, at leastwhen the therapeutic dosages arehigh and high-potency compounds are present as impurities. Cannabidiol (CBD) exemplifies this issue. The API version of the compound (Epidolex, an anti-epileptic drug) contains Delta-9-THC (Dronabinol) as an impurity. Given the high therapeutic dosages ofEpidiolex and thepotency of Delta-9-THC , treatment with Epidiolex is associated to the co-administration of clinical dosages of Dronabinol. This could have played a role in the clinical failure as anti-epileptic drug of a transdermal delivery system of CBD based on synthetic CBD(ZYN002), in contrast to the clinical efficacy of a syrup containing the natural product (Epidiolex).

Session available for booking
13:50 - 14:20 110D50
InnoPack & P-MEC Theatre
HPAPIs and ADCs – a journey through high potency
13:50 - 14:20 120G43
ICSE Theatre

Sponsored by:

Drug development based on potent compounds can be quite challenging.Complications on the interface between operations in drug substance and drug product can lead to increased program complexity and cost.Crossing the boundary from small molecule to biologics into ADC territory is typically adding the next level of complexity.In this presentation, we will elaborate on best practices and infrastructure requirements that facilitate accelerated timelines to clinic and market:-CASE STUDY: the development, rapid scaling and commercial production of HPAPI drug substance-Integrated containment requirements for particle engineering and drug products-Advantages of seamless integration of HPAPI and ADC operations

Session Title TBC
14:30 - 15:00 61D61
CPhI Theatre
The Importance of Terminal Sterilization in the Pharmaceutical Industry
14:30 - 15:00 120G43
ICSE Theatre
Technical Director
EO Pharma

Sponsored by:

A lack of sterility and sterility assurance continue to be a significant reason for drug recalls and regulatory citations and can pose a very real risk to patient safety and public health. Sterilization is therefore a pivotal step in the pharmaceutical drug development process to help ensure overall safety is maintained. In this presentation we will:
- Examine the goal and science of sterilization
- Introduce and contrast Terminal Sterilization and Aseptic Processing of drug products through a regulatory lens as well as that of a manufacturer
- Provide guidance for the assessment and selection of the optimal Terminal Sterilization technology (eg Gamma, E-Beam, ETO) for drug products

Latest Data of OXYCAPT Multilayer Plastic Vial & Syringe
14:30 - 15:00 110D50
InnoPack & P-MEC Theatre
Research Manager
Mitsubishi Gas Chemical Company

Sponsored by:

OXYCAPT is multilayer plastic vial & syringe. The three-layered structure achieves excellent oxygen barrier, water vapour barrier, ultraviolet barrier, very low extractables, low protein adsorption, high break resistance, etc. In addition to some basic data such as oxygen barrier, water vapour barrier, organic and inorganic extractables and ultraviolet barrier, we will show some latest data like oxidation of antibody, resistance to lyophilization, cold storage and liquid nitrogen storage, protein aggregation and container closure integrity.

Data governance driving data integrity in computerized system validation
15:10 - 15:40 61D61
CPhI Theatre
Global Head of Compliance Services
PerkinElmer

Sponsored by:

Having a data governance program in place is key to establish the foundation for ensuring data integrity in computerized system validation. In addition, understanding the regulations and how they are applied to particular environments (GMP, GLP, GCP) help drive compliance in Pharmaceutical laboratories.The FDA defines data integrity as all data being complete, consistent and accurate throughout the data life cycle regardless of data being paper or electronic. As technologies advance and companies partner to grow, there is an increase in the number of data integrity violations seen by the FDA and many of the violations stem from 21 CFR Part 11 which was put into the federal registry in 1997 and contains the regulations pertaining to electronic records and signatures. While the regulations on electronic signatures is well understood, regulations surrounding electronic records still leads to confusion when it comes to computerized systems since is not a one-time event for laboratories and validation must be complete to satisfy the regulators. By linking data integrity with computerized system validation (CSV) in the data governance program, the pharmaceutical laboratories can feel confidence on their path to compliance

CDMO with Dedicated Solutions: Lyophilized Freeze Drying Technology - LyoDis® (ODT), High Potent Products, Sachets..and more!
15:10 - 15:40 120G43
ICSE Theatre
Executive Director
galien +

Galien+, CDMO with Dedicated Solutions

Discover our expertise for Complex Oral Solid dosages forms with special deep-down insite on ODTs LyoDis® (lyophilized freeze drying tablets technology), Sachets and High Potent FDF manufacturing.

Our know-how at your service !

High viscosity/high volume drugs - Challenges and needs for shorter needles and integrated systems
15:10 - 15:40 110D50
InnoPack & P-MEC Theatre
Global Marketing Manager
Becton Dickinson & Co

There is an increasing trend of biologic drug pipeline development in the chronic disease space being formulated with high viscosity and/or higher volume. In order to dispense safer, more effective and less painful injections in the subcutaneous layer, needle solutions including shorter needles might become the ultimate solution to improve quality of life and delivery outcomes of chronic disease patients. To further improve chronic patient adherence to treatment, autoinjector solutions are proven to be a preferred choice. Therefore, a robust performing device is necessary to increase the chances of adherence and effective drug delivery by patients. To optimize system integration of combination products, it is necessary to master the engineering process to bring the different systems cooperating together in one performing system. BD has developed deep domain knowledge to support the development of more robust, well-designed systems such as its new BD Intevia™ Platform.

Revolution Beyond Innovation: Topical Application of Botulinum Toxin Type C Peptide in Pharmaceutical and Aesthetic Applications
15:50 - 16:00 61D61
CPhI Theatre

Sponsored by:

There are eight types of Botulinum toxins(BTX) known(A-H) and A and B are used in commercially and medically. Type C-G are less common in human and cause disease in animals. Peptide toxin(PTx) is a small peptide that has shown enzymatic cleavage activity in Syntaxin and SNAP-25 which decreases acetylcholine release in nerve cell, in result. Clinical test of topical PTx has shown strong wrinkle improvement, down regulation of sebum and pore size, and soothing effect in skin redness. Into the bargain, all other evidences imply that PTx can be used in topical in pharmaceutical applications, like hyperhidrosis, acne, atopic dermatitis, chronic pain relief, etc

Session Title TBC
15:50 - 16:00 120G43
ICSE Theatre

Sponsored by:

Needs in intravenous drug delivery through prefillable syringe systems
15:50 - 16:00 110D50
InnoPack & P-MEC Theatre
Acute Care Portfolio Manager
Becton Dickinson & Co

Selecting the right prefillable syringe system when delivering drugs for applications such as anesthetics in an Acute care setting is of utmost importance. If the optimal prefillable syringe system is not used, issues may arise in connection performance when delivering high risk medications potentially impacting work-flow efficiency and patient safety. To reduce risks in the clinical work-flow, the syringe connection performance and the necessity of a prefillable syringe needs to be evaluated.

From HPLC to industrial-scale separations: a complete range of ion exchange, adsorbent and affinity resins for small to medium biomolecule purification
16:30 - 16:30 61D61
CPhI Theatre
Business Development Manager
Purolite Life Sciences

Sponsored by:

Session available for booking
16:30 - 16:30 120G43
ICSE Theatre
Session available for booking
16:30 - 16:30 110D50
InnoPack & P-MEC Theatre