Pharma Insight Briefings

All times displayed for Europe/Berlin timezone.

Global Outlook: The Future of Biosimilars
10:30 - 11:40 61D61
CPhI Theatre
Senior Consultant
IQVIA
Vice President & General Manager
Samsung Bioepis
Executive Editor at Generics bulletin
Informa Pharma Insights
Managing Director
Strategy&
Global Head of Commercial
Sandoz Biopharmaceuticals

Biosimilars are an indispensable tool for providing patient access to innovative, effective therapies whilst keeping healthcare costs sustainable. This panel will assess the global outlook: Europe’s reasonably mature market, new Asian players and the challenges to adoption in the US.
• Creating a sustainable market in Europe
• How can the US adopt biosimilars?
• Future commercial opportunities
• Strength of Asian players
• How do biosimilars affect non-reference therapies?
• Incentivizing innovation
• Humira – one year on the market

Understanding the Cell & Gene Technology Opportunity
10:30 - 11:40 120D40
ICSE Theatre
Associate Editor
PharmSource – a GlobalData Product
President & CEO, Bionavigen & Chief Scientific Officer
Seneca Therapeutics
Senior Manager
Strategy&
Vice President, Business Development – Manufacturing
Oxford BioMedica
Vice President – Market Access, ALira Health & EU Director of Market Access
The Alliance for Regenerative Medicine
VP and GM of Viral Vector Services
Thermo Fisher Scientific

Cell and Gene therapies provide treatment solutions to patients with previously unmet needs, and with regulators poised ready for an influx of product approvals in the coming years, the sector offers a significant commercial opportunity. This panel will discuss the investment opportunity for those looking to enter this ever-evolving sector.
• Sector outlook and long-term opportunities
• What is the right investment now for CDMOs?
• Creating the right infrastructure to support innovation
• Commercialisation & pricing challenges
• Logistics & supply dynamics

Improving Patient-compliance and adherence through Packaging/Device innovations
10:30 - 11:40 110D40
InnoPack & P-MEC Theatre
VP of Regulatory Affairs
ObvioHealth
Executive Vice President, Front-End Innovation
Phillips-Medisize
Vice President Marketing Pharma Division
Constantia Flexibles
Managing Director & Executive Director
NVC Packaging Centre & HCPC Europe

Sponsored by:

In collaboration with Pharmapack Europe

“Ceutical” Renaissance in Isolated Derivatives and Extracts of Cannabis
11:50 - 12:20 61D61
CPhI Theatre
President/CEO
KGK Science

Sponsored by:

With recent regulatory changes tostate and national laws, cannabis is undergoing a period of rediscoveryandattraction from industries. Hemp was a vital crop and form of currency in the American colonies, but tobacco and cotton pushed hemp to the side as a major cash crop by the late 1800s. The re-evaluation of U.S. and Canadian medical marijuana laws over the past decade has driven novel innovation in food products with hemp-derived cannabinoidssuch as cannabidiol (CBD). Chronic CBD users represent 7% of the American population,and North American use rates areexpected to rise as access to hemp-derived CBD food products increases.In preclinical studies, CBD shows potential therapeutic efficacy against a diverse assortment of medical conditions including seizure disorder, psychosis, anxiety, depression, inflammation, cancer, cardiovascular disease, neurodegeneration, multiple sclerosis and chronic pain. Other than rare seizures, there are clinical trial research gaps in CBD use for mostmedical conditions. Investment to substantiate structure-function claims (occasional pain, sleeplessness, anxiety, and inflammation) is also lacking. Time will tell whether this CBD renaissance is met with scientific rigor

Analytical Development and Technico-Regulatory expertise all along the pharmaceutical development and manufacturing
11:50 - 12:20 120G43
ICSE Theatre
Analytical Development Manager
Skyepharma

Sponsored by:

Skyepharma is a CDMO specialized in controlled release and other complex drug formulation.In support to development and manufacturing, analytical development and regulatory teams are involved at the beginning of the project since the quotation. Case studies from Skyepharma portfolio will be presented and discussed. They will illustrate our agility to be operational as
soon as the project begins using the expertise of support teams

Session Title TBC
11:50 - 12:20 110D50
InnoPack & P-MEC Theatre

Sponsored by:

Session Title TBC
12:30 - 13:00 61D61
CPhI Theatre
Shifting from Productivity to Innovation: How the Right Outsourcing Partner Can Catalyze Your Integrated Drug Development Initiative
12:30 - 13:00 120G43
ICSE Theatre
Chief Commercial Officer
Syngene International

Sponsored by:

Ashu holds a BA (Economics) degree from the University of Delhi, India as well as a Post Graduate Diploma in International Marketing from the Delhi School of Economics. He completed his MBA from IMT Ghaziabad, India and has over 20 years experience in the global biopharmaceuticals industry which includes Sales and Account Management leadership across consulting & outsourcing services in Research & Development. Ashu is based out of New Jersey and has global responsibility for Syngene’s commercial activities, including leading the businessdevelopment team as well as developing new capabilities in marketing, brand building, digital & account management. As a member of the Executive Committee, he plays an important role in driving strategy as it relates to Commercial activities. Prior to joining Syngene, Ashu was at IQVIA (formerly QuintilesIMS), Infosys and Accenture.

Biotech market trends enhancing new requirements for PFS sealing solutions: BD™ Premium Coat 1mL Plunger Stopper offering for biologics
12:30 - 13:00 110D50
InnoPack & P-MEC Theatre
Global Strategic Marketing PFS
Becton Dickinson & Co

Sponsored by:

Biotech market for chronic disease application is evolving at a high pace. Market dynamics are creating new challenges for pharma enhancing new requirements for drug delivery solutions. Developing and providing pharma companies with high quality integrated and continuously improving combination product solutions as well as supporting our customers through the effort of biologic drug development is BDM-PS mission. With the rise of evolving challenges around biologic drug viscosity, volume and advanced formulations, requirements to raise the bar in terms of injection system functionality and predictability become a 'must have'. The new PFS sealing solution - Premium Coat 1mL Plunger Stopper offering for biologics - is one example of how BDM-PS holds the challenge of providing pharmaceutical companies with the system performance and predictability expected for tomorrow's injectable biologics.

How Silica (gel) has enabled Pharma and Nutraceutical Manufacturing to Overcome Regulatory and Developmental Challenges
13:10 - 13:40 61D61
CPhI Theatre
Global Marketing Leader
Grace

Sponsored by:

The pharma IP and regulatory environment is in a constant state of flux. These changes have forced the pharma sectorto innovate and or reformulate their products not only to comply with regulations or to differentiate their products but also to manage cost. From continuous manufacturing to Mesoporous Therapeutic Delivery, amorphous silica gel has been successfully usedto overcome several formulation challenges. By means of some representative case studies this talk outlines where key challenges commonly faced in the pharma and nutraceutical sector were overcome through the incorporation of mesoporous silica gel into the formulation.

Session available for booking
13:10 - 13:40 110D50
InnoPack & P-MEC Theatre
The latest trends of the CDMO small molecules APIs
13:10 - 13:40 120G43
ICSE Theatre
Senior Vice President Business Development
ADVITECH

Sponsored by:

collection of Reports on the active pharmaceutical ingredients (APIs) world.
The Advitech Reports offer an original contribution to the APIs business community, comprising APIs producers, clients and investors/shareholders providing an information tool, based on the analysis of companies operating in this important sector.
The last efforts of APIs TRENDS collection are concentrated on the global contract development and manufacturing organization (CDMO) market which is experiencing a constant growth and increasing interest in the healthcare world.
The CDMO rise is a key aspect of the pharmaceutical industry’s evolution, where two-thirds of pharmaceutical manufacturing is outsourced and Advitech has identified the major trends impacting this sector, with a specific focus on small molecules.
Advitech has now combined the previous CDMO Benchmarking Report - Baseline Analysis with the latest data and we are able to outline a three-year trend update, CDMO Benchmarking Report 2017-2018, an unprecedented approach in this industrial sector.

Quality by Design and Continuous Improvement as a basis for high product quality
13:50 - 14:20 61D61
CPhI Theatre
Senior Director Quality
Capsugel - Lonza

Sponsored by:

Why inhalation is the drug delivery technique to watch
13:50 - 14:20 120G43
ICSE Theatre
Global Key Account Director for Inhalation
Recipharm

Sponsored by:

Inhalable drug products offer several advantages when it comes to ensuring targeted drug delivery. However, they also present several challenges during development and manufacturing, requiring experience and technical capability. While drug companies often have in-house expertise for drug discovery, early development and small-scale production, few can manufacture inhalation drugs for clinical trials and –assuming they win approval –commercial supply. In this briefing, Recipharmreviews the key advantages and challenges associated with inhalation drug development and explores techniques to reduce time to market. In summary, the session will cover:-Challenges and key considerations during inhalation drug development-Navigating scale-up and tech transfer-Reducing time to market -Regulatory considerations (including the 505(b)(2) pathway)-An overview of Recipharm Inhalation Solutions™

Driving Foreign Particulate Analysis: How to Choose Between Manual and Automated
13:50 - 14:20 110D50
InnoPack & P-MEC Theatre
President
Gateway Analytical

Sponsored by:

Foreign particulate analysis is a critical aspect of pharmaceutical manufacturing and non-conformance investigations. The approaches and methodologies for analyzing foreign particulates vary depending on single particle investigations or population studies. During this presentation, a brief overview of manual and automated techniques used for foreign particulate matter (FPM) investigations will be presented. A variety of different case studies utilizing manual or automated techniques to determine identification of FPM and forensic approaches to source determination will be discussed. This presentation will also highlight how rapid turn-around identification techniques can quickly provide answers during investigations.

Managing the natural variability of plant-based pharmaceutical ingredients (example of Vegetable oils)
14:30 - 15:00 61D61
CPhI Theatre

Sponsored by:

Why managing variability?Pharmaceutical ingredients play a key role in drug formulation.Variations in their composition and physicochemical properties can have significant impact on the final drug product performances like safety, physical and chemical stability and bioavailability. In the recent past, ingredient variability has been at the origin of FDA recalls.Natural-based products are by definition subject to a certain degree of variability but appropriate solutions can be developed to manage this variability and propose consistent plant-based pharmaceutical ingredients. As a manufacturer of highly purified vegetable oils, SIO has implemented a full management of this natural variability.Risk assessment can be used to understand variability of naturally-derived pharmaceutical ingredients and identify which material attributes have an impact on the performances of the final dosage form.

Applying innovative thinking to analytical services: Techniques to reduce time to market
14:30 - 15:00 120G43
ICSE Theatre
Director, Analytical Development
Recipharm

Sponsored by:

Analytical methods are crucial for the development of any pharmaceutical drug product, be it generic or new drugs. Applying new, innovative techniques and modern instruments can significantly reduce time to market, helping to bring new drug products to patients faster. Advanced instrumentation plays a significant role in not only estimating “what is expected” of the drug product, but also what is not expected. That said, producing quality products is only possible with a forward-thinking mindset and keen attention to these technological advances. In this briefing, Recipharm provides case study examples of where improvements to method development and validation have resulted in significant time savings. Dr. Ramesh Jagadeesanalso explores the need for effective problem solving during analytical chemistry and why expertise in drug development and commercial manufacturing can help to improve efficiencies. In summary, the session will cover:-The importance of innovation during analytical chemistry-How time to market can be reduced during the analytical testing stage-Case study examples of improved method development and validation-Why knowledge of the entire drug development and manufacturing process is of value during analytical testing.

Advantages of Nasal Powders for Drug Repurposing
14:30 - 15:00 110D50
InnoPack & P-MEC Theatre
Director, Scientific Affairs
Aptar Pharma

Sponsored by:

Although nasal spray drug products have been around for a number of years, recent developments have brought renewed interest to this market. The scientific and medical advantages of drug delivery using nasal sprays are well documented and include a non-invasive approach removing any associated pain or anxiety related to injection, rapid onset of action, good bioavailability compared to oral administration and high levels of acceptability resulting in improved comfort and compliance for patients. As compared to oral forms of treatments, intranasal delivery also benefits from the avoidance of first pass metabolism.

With healthcare costs rising globally there is a growing demand for therapeutically relevant medications that can be developed quickly and at reasonable costs for a variety of diseases and also for high unmet medical needs. Nasal drug delivery continues to offer significant opportunities for repurposing drugs. This talk will look at some of the advantages and challenges of developing some of these drug repurposing candidates as nasal powders.

Lonza Engine™ equipment portfolio for small molecule bioavailability enhancement, particle engineering and drug product development
15:10 - 15:40 61D61
CPhI Theatre
Technical Service Engineer
Capsugel - Lonza

Sponsored by:

Fill & Finish of live vaccines – a CDMO perspective
15:10 - 15:40 120G43
ICSE Theatre
Sr. Director - Head of Sales
Bavarian Nordic

Sponsored by:

The fill&finish operations for viral vaccines require some specific attributes to facility and equipment. In this presentation Bavarian Nordic will guide you through the design, construction and qualification of their new fill&finish facility at their headquartersin Denmark.This facility will allow for filling and lyophilization of live vaccines in a BSL2 environment and will have dedicated capacity for CDMO services

Beyond Pharmaceutical Packaging: New Solutions to Old Challenges
15:10 - 15:40 110D50
InnoPack & P-MEC Theatre
Director, Corporate Business Integration
Aptar CSP Technologies

Sponsored by:

Tablets and capsules are today’s most popular drug delivery forms. However, in their development, there are many challenges overcoming moisture, oxygen and reactive impurities. These challenges are likely to increase with the development of more potent API’s, larger molecules and modified release profiles
As traditional packaging options can be ineffective and/or inefficient, there is a need for new and specialized active packaging solutions. Additionally, repetitive design processes and reformulations, from stability failures, are costly and can delay product launches.
This presentation will look at the sources of moisture and oxygen in oral solid dose (OSD) blister packaging and common approaches to mitigate. Active desiccant and scavenger management technology (Activ-Blister™ Solutions), can meet these challenges and expedite time-to-market.

The 3 phase active polymer platform technology provides integrated solutions applicable for oral solid dose,Dry Powder Inhalers, pMDIs, and Transdermal drug products. The platform technology improves stability, shelf-life extension, and secures speed to market. They are also suitable for marketed products seeking to extend shelf life and/or optimize packaging.

Session Title TBC
15:50 - 16:20 120G43
ICSE Theatre
Executive Director, Technical Services
Cambrex

Sponsored by:

Session available for booking
15:50 - 16:20 110D50
InnoPack & P-MEC Theatre

Sponsored by:

Building Oligonucleotide Manufacturing Capabilities within an Established Peptide CMO
15:50 - 16:20 61D61
CPhI Theatre
PhD, Business Development Manager
Bachem

Sponsored by:

Bachem’s specialty as a successful Contract Manufacturing Organization is the controlled manufacture of high-value, pharmaceutical-grade peptides using chemical synthesis technologies. Bachem now is strategically diversifying its technology platform to include the manufacture of synthetically accessible RNA and DNA molecules (oligonucleotides). This presentationdescribes the building up of oligonucleotide capabilities while exploiting manufacturing technology, analytical know-how, and regulatory compliance synergies with peptides. The presentation will also point out processing differences between the two drug classes and learnings to be undertaken on the way to the first “Tides CMO” offering large-scale manufacturing services for both, peptides and oligonucleotides.

Assessing the compatibility of Drug/device combination products – finding a perfect match
16:30 - 17:00 120G43
ICSE Theatre
PhD, Department Head Micro and Pharma
Nelson Labs

Sponsored by:

The increasing use of and interest in innovative combination products –products combining a drug anddevice,–is raising significant challenges both for regulators and the industries they regulate.Using specific case studies, this talk will present the challenges that Nelson Labs Europe has overcome in drug-device compatiblitystudies of drug/device products from a practical, analytical and regulatory point of view.

How to export medicine to China? Updates on pharma regulations and “4+7” procurement policies
16:30 - 17:00 61D61
CPhI Theatre
Senior Consultant of Regulatory Affairs
Accestra Consulting Company

Sponsored by:

After China joined ICH, China begins to close the drug development gap and has significantly reformed its drug regulatory system and introduced a whole new pharmaceutical procurement policy called “4+7” in piloting cities. This industrial systematic reformopened large opportunities for overseas pharmaceutical companies. On one side, the “4+7” policy gives transparent and open competition environment towards both local and overseas pharma producers, moreover, along with the 4+7 procurement policy, Chinese government launched “accelerated approval” drug registration review system with the purpose of encouraging innovation and reducing regulatory burden to attract more medicines with high quality and urgent clinically needs to the Chinese market. Companies that follow Chinese government’s orientation can make use of the concessions under the reforms and enjoy the reduced R&D cost and faster enter to the second-largest market in the world. In this seminar, you will find the interpretation of China’s current pharmaceutical regulation and the newly published “4+7” rules. Besides, regulatory compliance suggestions will be provided to the overseas companies who are interested in the opportunities of this attractive market.

Ready-to-use packaging solutions to transform injectable drug manufacturing
16:30 - 17:00 110D50
InnoPack & P-MEC Theatre
Director Business Development Sterile Solutions
SCHOTT Pharmaceutical Systems
Sr. Global Product Manager Glass PFS syriQ
SCHOTT Pharmaceutical Systems

Sponsored by:

The global Pharma industry is changing with the advent of specialized biotech drugs, personalized medicine and cell and gene therapies. Injectable drug manufacturing must become more efficient, flexible and less complex. These objectives can be met by shifting from bulk to ready-to-use (RTU) containers/systems (vials, cartridges, PFS). Creating a universal standard for all RTU containers will offer highest flexibility and reduce the risk for Pharma companies and to patients. We will share insights on how RTU solutions like SCHOTT’s iQ™ platform will accelerate and ease drug development, manufacturing and delivery of complex biotech drugs. We will also highlight the use of “big data” analytics in injectable drug manufacturing.