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
Global Head Product Development
Sandoz
President & Co-Founder
Camargo Pharmaceutical Services
Partner | Vice President
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 120G43
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
Vice President, Operations, Early Phase Development, Oral Drug Delivery
Catelent
Head of Business Development
Dr. Reddy’s Custom Pharma Services

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 110D50
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]
With an increased focus on sustainability throughout the supply chain, Packaging companies face a key challenge in developing innovative solutions with a reduced environmental impact - without compromising the safety, security and efficacy of drug products. This panel will assess the latest trends and developments in the sustainable packaging space.

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

Sponsored by:

Participants of this session will get first class insights into the most recent developments of the best growing international OTC & Pharma markets. After attending this session you will know more about the most promising Emerging Markets and on how to plan your successful Market Entry. If you are interested in expanding your international business to Europe, Latin America, Asia or CIS/CEE and generating Extra Sales in those regions you are exactly right here.
We would like to invite you to an exciting 25 minute journey around the globe.

Reiner Christensen has 20+ years of experience in the international pharma markets and is happy to discuss with you and to answer your questions after the presentation.

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.

Continuous manufacturing: Current and Future Role of Excipient Suppliers
12:30 - 13:00 61D61
CPhI Theatre
Principal Scientist, Pharma Solutions
DuPont Nutrition & Biosciences

Sponsored by:

Continuous manufacturing of oral solid dosage forms is a trend whose early adopters are larger innovator pharma companies. It seems that, now a second wave of implementation at Contract Development and Manufacturing Organization (CDMO) is enabling medium and smaller sized companies to leverage capacity and knowledge. In this way the burden of high investment costs and time consumed in know-how development are mitigated. Excipients typically build the major part of a tablet formulation and as the technology of continuous manufacturing is advancing the key role of excipients to address quality and productivity challenges is becoming more and more important. DuPont Nutrition & Biosciences has a broad portfolio of excipients that are engineered to facilitate tableting processes in an integrated manner. There is a range of particle-engineered and co-processed ingredients developed to facilitate this new process setup. It is true that commonly used excipients like the industry standard AVICEL® PH102 and even some ‘less commonly used’ excipients are suited for a continuous manufacturing platform as well. The next stage of realizing the projected benefits of continuous manufacturing will be however based on intensified cooperation of pharmaceutical companies, equipment vendors and excipient suppliers.     

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.

The Future of Pharma Packaging – Developments, Trends and Solutions in Secondary Packaging
12:30 - 13:00 110D50
InnoPack & P-MEC Theatre
Head of Marketing and Innovation
August Faller

Sponsored by:

Some important challenges lay ahead the pharmaceutical industry. Time to Market, Total Cost of Ownership, Cost of Goods, Digitalization, Serialization … just to name a few.
August Faller wants to give you an exclusive insight into the latest developments, trends and solutions in pharma secondary packaging.
 
Focus on: 
 Compliance & Convenience > Smart Packaging provides new possibilities
 Increased regulatory demands > Tamper Evidence Solutions and Serialization
 Flexibility > Launch Services and Digital Printing Solutions boost your Time to Market (TTM)
 Supply Chain Integration > intelligent ways to decrease Total Cost of Ownership (TCO)
Target:
As a long-time and very experienced specialist in secondary pharma packaging - we´d like to give you an exclusive insight into the latest development in the market and future possibilities. With pleasure we want to share our know-how with you, give food for thoughts and good ideas that create real benefits for you.
 
Target group:
Decision makers in the pharmaceutical and health care industry, persons responsible for and/or interested in the field of secondary packaging. 
 This comprises areas like development, marketing, packaging, distribution and purchasing.

Leading the way in capsule-based DPIs through customization with the Capsugel Zephyr Portfolio
13:10 - 13:40 61D61
CPhI Theatre
Business Development, Manager Innovative Products
Capsugel - Lonza

Sponsored by:

SimpliFiH™ Solutions – Integrated approach to First-in-Human for bioavailability challenged molecules
13:10 - 13:40 120G43
ICSE Theatre
Director, Commercial Development, Dosage Forms & Delivery Systems
Lonza

Sponsored by:

Oral administration of small molecules has become increasingly difficult due to a majority of new candidates demonstrating poor aqueous solubility. The bioavailability hurdle is made more challenging with the accelerated timelines, limited drug substance availability and financial restrictions associated with many of today’s drug programs. This presentation discusses a proven model-based technology selection methodology for poorly soluble molecules and an integrated formulation approach to minimize first-in-human timelines. The role of API development and supply, solid state characterization, micro-dosing and encapsulation best practices for FIH studies will also be discussed along with representative case studies.

Implementing aseptic filling with Ready-to-Use molded glass vials
13:10 - 13:40 110D50
InnoPack & P-MEC Theatre
Marketing Analyst
SGD Pharma

Sponsored by:

The introduction of Sterinity by SGD Pharma (Paris, France), a global leader of molded glass packaging, makes the manufacture of RTU molded glass vials commercially accessible for the first time. Powered by the well-established EZ Fill® platform from Ompi (Padua, Italy) this new product extends the commercial and practical benefits of RTU to a widest range of applications.
The Sterinity offer provides an ‘off-the-shelf’ solution for aseptic filling, producing RTU molded glass vials suitably packaged for streamlined, final ‘fill and finish’ processing in a range of proprietary filling technology. Sterinity is leveraging the advantages of Ompi EZ-fill® secondary packaging, that has been already tested and adopted in a wide range of fill-finish equipment platforms.
Vials are produced and 100% inspected in a clean room environment at the SGD Pharma plant, then washed with WFI, depyrogenized, packed and sterilized by ethylene oxide. Packed and sealed, RTU glass vials can be stored, with 5 years shelf life, and/or transported, ready for use as required.
The Sterinity offer uses molded glass vials made from Type I glass of exemplary quality. A steadily expanding portfolio of products in a range of sizes will be commercialized over the next one to two years, focusing on two core designs: a premium quality ISO design and an optimized EasyLyo® product. Both types of vial are currently available for use in tray format; nest and tub configurations are currently in development.
Sterinity boasts a diverse glass vial portfolio that meets all industry standards and customer requirements. As the need for flexible filling increases, companies will be seeking a cost-effective quality solution to streamline production and increase the speed of changeover. As the first commercial solution for RTU molded glass, SGD Pharma’s Sterinity platform is a viable answer to this pressing issue.

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).

HPAPIs and ADCs – a journey through high potency
13:50 - 14:20 120G43
ICSE Theatre
Senior Director, Head of Commercial Development, API
Lonza

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

Innovative system Guarders® - integrated solution  for monitoring and assessing baby’s  health during the first 18 months
13:50 - 14:20 110D50
InnoPack & P-MEC Theatre
Project Medical Scientific Advisor
Palma Group

Sponsored by:

Tailored Catalyst Processing
14:30 - 15:00 61D61
CPhI Theatre
General Manager
ECO-Mastermelt Pte Ltd

Sponsored by:

Precious metal catalysts are increasingly used in the pharmaceutical and chemical industries. In the Mastermelt showcase, we will share our tips for optimising returns from your on-site manufacturing route, as well as how our tailored recovery process can maximise your precious metal returns.

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.

The Importance of Terminal Sterilization in the Pharmaceutical Industry
14:30 - 15:00 120G43
ICSE Theatre
Technical Director - EO Pharma
Sterigenics

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

Data governance driving data integrity in computerized system validation
15:10 - 15:40 61D61
CPhI Theatre
Practice Manager, Compliance and Validation 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

Sponsored by:

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

Sponsored by:

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

Measuring the value of improved workflow efficiency and safety of drug administration with prefilled syringes
15:50 - 16:00 110D50
InnoPack & P-MEC Theatre
Acute Care Portfolio Manager
Becton Dickinson & Co

Sponsored by:

Understanding hospital and care center’s unmet needs is vital for providing them with impactful solutions. In the healthcare setting, patient safety concerns exist across the entire drug delivery spectrum. Specifically, in an acute care setting where decisions are often made quickly or under stress, error rates can be at their highest. Here we will discuss how differences in primary container options for injectable drugs can add value by offering care centers configurations that address universal pain points.

Analysis from the Tufts Center for the Study of Drug Development (CSDD) to Assess the Financial Benefits from Translational Pharmaceutics®: A Platform for Accelerating Product Development
15:50 - 16:20 120G43
ICSE Theatre
Executive Director and Head, Drug Development Solutions (EMEA)
Quotient Sciences

Sponsored by:

The drug development process has been demonstrated to be highly costly and lengthy, with significant rates of molecule attrition and development risk. Despite long-standing efforts by drug developers to operate more efficiently, traditional drug development programs have become costlier on average. To inform drug developers of the potential financial impacts ofalternative drug development processes and outsourcing models, the Tufts CSDD conducted a study comparing the traditional drug development paradigm with Quotient Sciences’ signature drug development platform, referred to as Translational Pharmaceutics, which has been widely used by pharmaceutical and biotech companies to accelerate product development. Key applications of Translational Pharmaceutics include the transition of molecules from First in Human (FIH) to proof of concept (POC), and in the development and optimization of clinical formulations. This presentation will provide a summary of the key findings of the Tufts CSDD research, with respect to the impact on development cycle times and their derivative effects on development economics and financial gains.

From HPLC to industrial-scaleseparations: a complete rangeof ion exchange, adsorbentand affinity resins for smallto medium biomoleculepurification
16:30 - 17:00 61D61
CPhI Theatre
Business Development Manager
Purolite Life Sciences

Sponsored by:

We present an overview of industrial applications in downstream processing of small/medium biomolecules using adsorbents, preparative RP resins and IEX resins. Purolite Life Sciences has expanded its product portfolio to include highly hydrophobic and hydrophilic resins, particle sizes from 5 to 1200 micron and many functionalities to support a wide range of applications. Here, we focus on new Chromalite methacrylic range of products.

Mucoadhesive tablets.
16:30 - 17:00 110D50
InnoPack & P-MEC Theatre
Co-Founder & BD manager
Tree of Life

Sponsored by: