Programme 2022

27th-29th June 2022, Berlin, All Timings in CET

7:40 AM - 8:40 AM

Registration & Refreshments

8:40 AM - 8:50 AM

Chair's Opening Remarks

8:50 AM - 9:35 AM - Panel Discussion

Technology & Innovation

How Will AI and Machine-Learning Technologies Change our Industry?

Sebastian Kube, Senior Data Scientist, Boehringer Ingelheim

Sune Andersen, Principal Scientist in Particle Engineering, Janssen

Lorenzo Gentiluomo, Associate Principal Scientist, Lonza

  • Digitalization starts in the labs where the data is produced – better invest in tablets for technicians than invest in the next big AI promise on the horizon?
  • The carrot: Try-out and implement advanced data analytics in very limited but easily overseeable use cases first
  • The stick: Proper data management is key to any digitalization effort!
  • Making the data FAIR creates already a first business value for data-driven drug product development
  • Big application use case for AI in drug product development?
  • Data wrangling: the 80-20 data science dilemma

9:40 AM - 10:10 AM - Case Studies

Small Molecules

Optimal Self-Assembly of Liquid Nanoparticles (LNP) in a Ring Micromixer

Mostafa Nakach, Head of formulation and Process Development, Sanofi

Biologics

Supercharging Proteins with Multivalent Excipients is a Much More Effective Strategy for Increasing Aggregation Resistance than Using Mutagenesis

Robin Curtis, Senior Lecturer, University of Manchester

  • A panel of scFv mutant proteins have been studied using multiple techniques for characterizing their aggregation properties
  • Supercharging proteins by mutagenesis greatly reduces aggregate growth rates, but enhances formation of small aggregates due to reducing conformational stability.
  • Aggregation behaviour for multiple proteins has been investigated in solutions with different types of multivalent ionic excipients
  • Poly-phosphate ions (adenosine tri-phosphate, tri-polyphosphate) are promising excipients due to their  superior effectiveness at suppressing aggregate growth, and in some instances, increasing conformational stability
  • A set of rules are provided for choosing ionic excipients to increase shelf stability of biopharmaceuticals.

Technology & Innovation

25 Years After the Ro5 – Trends in the Chemical Space and Drug Delivery

Sven Stegemann, Professor, Graz University of Technology

Lipinski’s Rule of 5 (Ro5) published in 1997 defined the chemical space for oral drug delivery by a molecular weight (MW) ≤ 500 Da, calculated LogP (cLogP) ≤ 5 and ≥ 0, hydrogen bond acceptors (HBAs) ≤ 10, and hydrogen bond donors (HBD) ≤ 5. The Ro5 considered that if more than one of the rules is exceeded it cannot be delivered orally based on the 90th percentile prediction. Twenty-five years after, we analyzed the physicochemical characteristics of the drug products launched over the recent years with regard to the trends in the chemical space from a holistic perspective. The analysis revealed that the Ro5 maintained their validity, but many incremental scientific and technological advances including drug delivery have contributed to broaden the chemical space for oral drug delivery. A review and outlook on the science and technological trends and the emerging opportunities will be discussed.

Device Development

Impact of the EU MDR on the Risk Management Process for Drug-Device Combination Products

Dr. Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices, Combination products and eHealth, Bayer

  • Regulatory landscape changes
  • EU MDR requirements on device risk management process
  • Impact of the EU MDR on drug-device risk management process
  • Usability engineering/Human Factors (HF)
  • Benefit -risk assessment of drug-device combination product

10:15 AM - 10:45 AM - Solution Spotlights

Small Molecules

Biologics

Trehalose and Sucrose: Essential components of Platform Biopharma Formulations and Covid 19 Applications

Christian Lotz, General Manager EMEA, Pfanstiehl GmbH

  • Commercial Biotherapeutics Stabilized with Trehalose and Sucrose
  • Key Issues in Biopharma Formulation Development
  • Essential components of a “Platform Biopharma Formulation”
  • Examples for utilizations and functionalities of Sucrose and Trehalose in Covid 19 related formulations/vaccines and techniques (m-RNA, Viral vectors, mAbs etc.)
  • Understanding important physicochemical properties of Trehalose and Sucrose
    • Instability of sucrose at low pH – free glucose, protein glycation
    • Phase transition and crystallization of trehalose
    • Importance of Control of Glucose levels in Sucrose as well as Trehalose
  • Purity, Quality, Consistency in Pfanstiehl’s Trehalose and Sucrose
    • β-glucans in sucrose – interference with endotoxins
    • Trace metal specifications for Sucrose and Trehalose
    • Upcoming compendial changes
  • Advantages of Trehalose over Sucrose
  • Pfanstiehl’s Biopharma Stabilization Portfolio incld. newly launched L-Arginine and L-Histidine base and HCl
  • Conclusions

Technology & Innovation

Session Title TBC (Nanoform)

Tamas Solymosi, Lead Scientist , Nanoform

Device Development

Session Title TBC (Gerresheimer)

10:45 AM - 11:35 AM

1-2-1 Pre-Scheduled Meetings & Networking Break

11:35 AM - 12:05 PM - Case Studies

Small Molecules

New Insights in the Endothelial Transport of Orally Administered PEGylated Mixed Micelles

Rene Van Nostrum, Associate Professor, Pharmaceutical Sciences, Utrecht University

  • Mixed micelles from bile acids and phospholipids are currently used as oral formulations for poorly soluble drugs including vitamin K. 
  • PEGylation improves the gastrointestinal colloidal stability and mucus penetration of mixed micelles. 
  • PEGylated mixed micelles interact with Scavenger Receptor B1, imposing a mechanism for intestinal transport that may be used for other poorly soluble drugs. 
  • Animal studies indicate that PEGylated mixed micelles may especially be useful to improve oral bioavailability in patients suffering from cholestasis. 

Biologics

Novel Nanosystems for Oral Delivery of Biologics

Driton Vllasaliu, Senior Lecturer in Pharmaceutics, King’s College London

Oral administration is the most convenient and preferred way of taking drugs. However, apart from a few exceptions, oral administration is currently not an option for biologics. The use of absorption enhancers has limitations, including safety issues and its applicability to a narrow range of biologics. Different delivery strategies are therefore urgently needed. Nanomedicine-based approaches have promising potential for oral biologics, though one has to apply a deep understanding of the gastrointestinal tract physiology and barriers in the design of nanosystems for oral delivery of biologics. In this talk, I will summarise the latest findings from my lab on nanomedicine-based approaches, including bovine milk exosomes, and their potential for oral delivery of biologics.

Technology & Innovation

Novel Nanotechnologies for Mucosal Delivery of Small Molecules and Biologics: Old Problems but New Solutions

Dr. Andreas Bernkop-Schnürch, Head of the Department Center for Chemistry and Biomedicine, Innsbruck University

Device Development

Parenteral Drug-Device Combination Products – Data Package, Integrated Control Strategy, and Platform Approach for Successful Submissions

Corinna Sonderegger, Executive Director Competence Center, Global Device & Packaging Development (GDPD), Novartis

Health Authority expectations in USA, Europe, China and around the world have risen strongly. Extensive data requirements and statistics on product robustness and user capability even under worst-case conditions require a change in mindset from the very start of product design, applying thorough scientific and engineering principles, true cross-functional collaboration, an integrated drug-device control strategy, and smart platforming, to enable successful market registrations, competitive products, and reasonable use of resources. Examples will be provided mainly for prefilled syringes with needle-safety systems and autoinjectors, the principles apply across all combination products.

12:10 PM - 12:55 PM - Solution Spotlights

Small Molecules

Dispersome® – Novel Bioavailability Enhancement Technology for Poorly Water-Soluble APIs Scalable from Grams to Tons

Pedro Valente, R&D Director - Oral Drug Product Development, Hovione

Korbinian Lobmann, CSO, Zerion Pharma

The Dispersome® technology is a novel solubility enhancing approach that is based on using the protein beta-lactoglobulin (BLG) as novel pharmaceutical excipient. By mixing a drug compound with this by-product from cheese production, one obtains a unique amorphous composition of small molecule drugs and proteins.

The technology has been shown to dramatically increase the solubility and bioavailability of poorly soluble drugs, which will be demonstrated by selected case studies in this presentation. These co-amorphous drug-BLG formulations can be manufactured by Spray Drying which is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. A roadmap of the Spray Drying development process will be presented, with all the main steps to bring these new formulations from the laboratory to production scale suitable for Metric Tons.

A focus will be given to the importance of lab-scale familiarization and supporting studies throughout the development process and how computational, statistical tools combined with prior knowledge can be capitalized to reduce risk while maximizing time and resources.

Why you should attend:
  • Learn more about innovation in bioavailability enhancement using BLG
  • Learn how these formulations can be scaled-up to meet commercial supply demand

Biologics

Lycagel® : Soft Capsule Performance/ Stability vs Gelatin

Steve Amoussou-Guenou, Global Technical Developer, Roquette

Technology & Innovation

Extended-Release Depot Technologies and Advanced Delivery Modalities Utilizing Lactide-Glycolide Chemistry

Patrick Duffy, R&D Team Leader, Manufacturing Manager for Bioresorbable Polymers, Ashland

  • Polymer chemistry, formulation formats and tuning release profiles
    • Effective processing of bioresorbable polymers
    • Customized ViatelTM polymers & complimentary excipients
  • Advanced delivery modalities utilizing bioresorbable polymers
    • New approaches to in-situ forming depot technologies
    • Nano-particle technologies

This presentation will provide scientists and technical stakeholders working in drug delivery with a detailed overview on an exciting extended-release technology platform for parenteral applications based on bioresorbable polymers (lactide, glycolide, caprolactone chemistries and some novel PEGylated variants for newer/complex delivery needs).

The session will explore control mechanisms, demonstrating how theoretical chemistry is coupled with formulation knowledge in different formulation formats including in-situ forming implants, microspheres/nanoparticles and pre-formed solid implants to successfully accomplish extended-release drug delivery over periods of days, weeks and up to several months. Ashland will also highlight how customized and novel chemistries can be used to overcome technical development challenges for respective molecule delivery strategies.

Technology & Innovation

Controlled and Long-Acting Release for Ophthalmic and Sub-cutaneous Administration with Biodegradable DelSiTech Silica Matrix Technology

Frederic Dargelas, Head of Business Development and Alliance Management , DelSiTech Ltd

DelSiTech Silica Matrix is highly versatile delivery platform. The technology is not only suitable for both, small molecule and biological drugs but applicable for multiple administration routes as well. Besides the more common subcutaneous administration DelSiTech Silica Matrix can remarkably be utilized for both, topical ophthalmic and intravitreal delivery.

12:55 PM - 1:55 PM

Networking Lunch

1:55 PM - 2:25 PM - Panel Discussion

Device Development

Improving Care Quality Through Connected Drug Delivery Devices

  • Reducing dosage complexity through improved delivery
  • Connected devices and apps as digital devices, the role played in care at home
  • Challenges and opportunities

Biologics

Latest Advances in the Oral Delivery of Biologics

Patrick Garidel, Head of Process, Purification and Pharma Development, Boehringer Ingelheim

Dr. Stefan Bracht, Vice President Head of Drug Delivery Innovation, Bayer

Driton Vllasaliu, Senior Lecturer in Pharmaceutics, King’s College London

  • Current research areas for the oral delivery of biologics, what is most promising
  • New materials and technologies that can enable oral delivery
  • Importance of oral delivery to patients

1:55 PM - 2:25 PM - Case Studies

Small Molecules

Novel Twin-Screw Granulation Technologies for Increased Drug Solubility and Bioavailability

Dennis Douroumis, Professor in Pharmaceutical Technology and Process Engineering, University of Greenwich

Twin Screw granulation (TSG) has gained significant interest in pharmaceutical industry as it offers several advantages over traditional batch granulation. TSG offer flexibility during manufacturing of commercial products including time and cost reduction that are currently critical aspects in pharmaceutical industry. Moreover TSG processes it is possible to optimize the processing parameters to achieve high quality attributes of the end product by applying QbD approaches and PAT coupling for quality control.

Technology & Innovation

Challenges In Development Of Highly Drug Loaded, Redispersible API Nanoparticle Containing Tablets

Christoph Nüboldt, Scientist  , Invite-GmbH

  • Stabilization of nanosuspensions
  • Spray-drying of nanosuspensions
  • Tabletting of nanoparticle containing powders

2:30 PM - 3:00 PM - Solution Spotlights

Small Molecules

Formulation and Processing Considerations with Long-Acting PLGA-Based Microparticles or Implants

Biologics

Solution Spotlight By TBC

Technology & Innovation

Innovative Gastro-Retentive and Chronotherapeutic Drug Delivery Technologies for Reinventing Challenging Compounds

Pavan Handa, Senior Vice President, Specialty Portfolio Management, Amneal Pharmaceuticals

Dipen Desai, Vice President Formulation & Analytical, Amneal Pharmaceuticals

  • Advanced drug delivery technologies for challenging oral compounds to address poor solubility, low bioavailability, high doses, high variability, and poor tolerability
  • Differentiating features of next generation gastro-retentive and chronotherapeutic technologies and their utility in untapping the therapeutic potential of a wide range of molecules
  • Case studies of challenging drugs using these technologies to improve the drug’s efficacy, adverse effects, and compliance.

Device Development

Miniature Active Implants – The Key Area for Innovation in Next-Generation Drug Delivery

Harshal Shah, Head of Global BioPharma Commercial, Cambridge Consultants

Cambridge Consultants' Harshal Shah, head of global BioPharma medical technology presents on how miniature active implants are a key area for innovation in next-generation drug delivery.

Innovation in drug delivery devices has evolved at a constant pace for 30 years, improving outcomes with better delivery of lifesaving drugs. Now, we’re entering a new era – as we look forward to a decade of innovation and commercial opportunity in active implants.

3:15 PM - 4:05 PM

1-2-1 Pre-Scheduled Meetings & Networking Break

4:05 PM - 4:35 PM - Case Studies

Small Molecules

Strategic Selection for Development Candidate Targeting Oropharyngeal Administration

Philippe Lienard, Pre-Clinical Leader, Pasteur Institute

  • Research candidate properties to master for maximizing probability of success
  • Design of the formulation for intended clinical studies
  • Device selection for fit-4-purpose oral application in clinical studies

Biologics

Biopharmaceutics of mAbs: Challenges in Subcutaneous Bioavailability Prediction

Mikolaj Milewski, Principal Scientist, MSD

Reliable prediction of clinical subcutaneous bioavailability of monoclonal antibodies (mAbs) remains challenging. Only limited success was reported in use of preclinical-to-clinical translation, ex vivo methods, or in silico methods. This gap has a direct impact on human subcutaneous dose selection and cost of goods in development of a new drug product.

This presentation will review the biopharmaceutics of mAbs with special emphasis on the subcutaneous absorption process and hypotheses behind incomplete systemic absorption. These are related to formulation-related events (e.g. precipitation at the site of injection or strong nonionic interaction of mAbs with SC tissue) and physiological events (e.g. nonspecific metabolic degradation at the site of injection or during transit in the lymphatic system). A deeper understanding of these processes may facilitate developing better predictive tools, streamlined development, and cost savings.

Technology & Innovation

Transforming Rectal Therapies for Ulcerative Colitis Using Novel Hydrogel Formulation

Ravi Pamnani, CEO, Intact Therapeutics

  • Rectal therapy is the most effective way to manage acute flares of ulcerative colitis, but current options either do not have adequate coverage of the colon (suppositories, foams) or are intolerable for patients (enemas)
  • Intact has developed a thermally responsive gel formulation which is self-administered as a liquid but transitions to a viscous gel inside the colon
  • Gel enables better retention of the formulation and potential for improved efficacy
  • Gel platform has been tested with mesalamine in clinical trials
  • Platform can be used to deliver range of therapies to the distal colon

Technology & Innovation

4:40 PM - 5:10 PM - Case Studies

Small Molecules

Advanced Medicated Dressings as Delivery Platforms for Chronic Wound Healing

Joshua Boateng, Professor in Pharmaceutics and Drug Delivery, School of Science, University of Greenwich

  • Biologically active dressings that take an active part in the wound healing process to achieve expeditious healing but at cost effective rate is an unmet clinical need  
  • A major focus is the treatment of chronic wounds and prevention of complications such as amputations,  
  • Medicated biomaterial-based dressings containing various therapeutic agents targeting different phases of wound healing will be discussed.  
  • The dressings have the potential to tackle severe infection and help to reduce swelling and pain associated with continuous inflammation in chronic wounds. 

Biologics

Developability Assessment of Biologics and Formulation of Novel Molecules

Shahid Uddin, Director of Formulation & Stability, Immunocore

  • Platform technology for novel biologics
  • Steps from discovery to development
  • Developability steps
  • Formulation dev
  • Compatibility

The presentation will explore the approaches taken for formulating novel biologics and the importance of applying developability screening methods to risk mitigate late stage development.

Technology & Innovation

Biopredictive Tools for the Development of Injectable Drug Products

Matthias Gerhard Wacker, Associate Professor, National University of Singapore

Today, biopredictive performance assays play a key role in the development of peroral drug products. They enable the early prediction of the bioavailability of drugs in animals or humans. Most injectables are developed for smaller patient populations and require a technologically more advanced formulation design. In this area, biopredictive tools are at the infant stage and only few methods are applicable these advanced therapeutics. With more biopharmaceuticals entering the global healthcare market, a growing number of niche busters are developed for the intravenous or subcutaneous route of administration. The talk will showcase recent advances in the development of biopredictive performance assays for intravenous nanomedicines and subcutaneous depot formulations. Current challenges and knowledge gaps will be highlighted.

Device Development

Designing Medications with Human Behavior in Mind

Tiffany  McIntire, Principal Human Factors Engineer, Pharma Technical Development Biologics Europe Device and Packaging Development, Roche

  • Background on behaviour design
  • Early considerations for formulation teams
  • Examples of how Human Factors, behaviour design, and formulation teams can work together

A molecule’s discovery and development begins long before most teams even come to know of its existence. In that process, sometimes one of the most important aspects can get missed: Can the patient or caregiver give the medication correctly? Various aspects like storage, in-use periods, preparation, and dosing complexity can make what seems to be a simple process difficulty for busy lay users to comply to. Here we attempt to provide considerations and strategies for teams based on human behavior on how to improve the drug products we develop and how they are intended to be used.

5:15 PM - 6:00 PM - Keynote

Small Molecules

Process Intensification of Solid Oral Dosage Forms Manufacturing via Semi-Continuous Fluidized Bed Granulation

Adrian Funke, Head of CMC Predictive Development Bayer Science Fellow, Bayer

  • Bayer’s rationale and approach to intensify manufacturing processes of solid oral dosage forms
  • Strategic partnership with Syntegon to advance semi-continuous fluidized bed granulation
  • Consistency of sub-lot quality in semi-continuous fluidized bed granulation processes
  • Practical aspects of semi-continuous fluidized bed granulation equipment, e.g. cleaning procedures

Continuous manufacturing processes have been gaining in importance in the pharmaceutical industry for various reasons such as greater flexibility in terms of batch size, smaller footprint of the equipment, lower investment costs, lower drug substance consumption for process development and avoidance of scale-up risks and efforts.  These advantages are also fully met by intensified semi-continuous process such as Syntegon’s XELUM fluidized bed granulation technology.

6:00 PM - 6:05 PM

Chair’s Closing Remarks

6:05 PM - 7:05 PM

Evening Networking Reception

8:00 AM - 8:30 AM

Registration & Refreshments

8:30 AM - 8:45 AM

Chair's Opening Remarks

8:45 AM - 9:15 AM - Keynote

Biologics

Polymers and Peptides for Stabilization and Targeted Delivery of Nucleic Acids in Vivo

Dr. Manfred Ogris, Professor Department of Pharmaceutical Sciences, University of Vienna

  • Molecular conjugates
  • Gene therapy
  • Virus coating

9:20 AM - 9:50 AM - Case Studies

Small Molecules

Value Added Reformulations Using Novel Technologies

Ajay J. Khopade, Vice President-R&D, Formulation Development (Non-Orals), Sun Pharma Advanced Research

Drug delivery technologies are one of the product life cycle extension strategies to combat generic competition and harness value of the product to the maximum. Generally, it is based on the principles of improved usage and compliance, safety and efficacy and indication extension. Some of the successful examples from Sun Pharma are Xelpros, Bevetex, Cequa, Bromsite etc. The presentation shall cover few successful case studies from SPARC that has endured all the developmental, clinical and regulatory challenges to eventually enter into the market.

Biologics

From Liposomes over Lipoplexes to LNPs and back: Nanoparticle Drug Delivery Technologies for RNA

Dr. Heinrich Haas, Vice President Formulation & Drug Delivery , BioNTech

The successful development of messenger RNA (mRNA)-based COVID-19 vaccines in extraordinarily short time has attracted great public attention to both, messenger RNA (mRNA) as a therapeutic molecule, and nanoparticles for drug delivery. For both, this was made possible due to previous, long-time, research in these fields, with liposomes and DNA-lipoplexes as earlier systems in development. There are some common features, which are shared by most of these products: (i) they are complex colloidal systems by nature, (ii) they are obtained by self-assembly processes (e.g. between RNA and positively charged lipids), (iii) the properties may sensitively depend on molecular composition, characteristics of the bulk phase and process parameters.

Insight obtained from basic research on biomembranes and concepts from colloid and interface sciences can be helpful for a better understanding of these drug delivery systems and thus provide a contribution for rational pharmaceutical development. Extended physicochemical characterization, including advanced techniques such as SAXS/SANS measurements, allow to reveal structural and functional coherencies inside these systems, which can be relevant to specify product characteristics and quality-related parameters. In this presentation, taking selected nanoparticle formats for RNA delivery as examples, key characteristics are described, and options to correlate physicochemical parameters to activity are outlined.

Technology & Innovation

Oral Biologics Delivery

Thomas von Erlach, Co-Founder and Chief Scientific Officer, Vivtex

  • Despite decades of research, most peptide therapeutics and other macromolecule drugs require needle administration due to insufficient oral bioavailability.
  • A new gastrointestinal (GI) model system, called the GI-ORIS, enables high-throughput screening of oral drug absorption for the systematic identification of formulations that enhance oral bioavailability. The system is highly predictive of oral bioavailability in vivo while allowing a sample throughput of several thousand samples per day.
  • GI-ORIS screening experiments identified new oral formulations for peptide and antisense oligonucleotide therapeutics that achieve substantial oral bioavailability enhancement suggesting widespread application of this new approach.

Device Development

Considerations in Formulation and Device Development for Plasma Derived Therapies

Andreas Liebminger, Head of Pharmaceutical Sciences and Devices for PDT R&D , Takeda

  • What are Plasma Derived Therapies?
  • Why are Plasma Derived Therapies different from other modalities?
  • What strategies do we have to tackle high drug volumes and comprehensive administration systems?
  • Challenges of higher protein concentration
  • Strategies to maintain protein stability
  • Conclusions

9:55 AM - 10:25 AM - Solution Spotlights

Small Molecules

Modified Release Development Strategies to Achieve Your Target Product Profile

Andrew Lewis, Vice President, Pharmaceutical Sciences, Quotient Sciences

Show more

Biologics

Surfactants in Bioformulation: Are We at the End or the Beginning of a Journey?

Philipp Hebestreit, Regional Technical Service Manager , BASF

  • Excipient impact on biologics formulations
  • Stability studies related to chemical and enzymatic degradation
  • Reduction of mAB- and protein aggregates
  • Excipient safety, e.g. Poloxamer 188 (Kolliphor® P 188 Bio), Polysorbates 20 and 80, Kolliphor® HS 15, Kolliphor® ELP

Technology & Innovation

Continuous Manufacturing: Rheological Powder Characterisation of Excipients to Understand Their Behaving During the Feeding Step

Vanessa Havenith, Technical Sales Manager, SE Tylose GmbH & Co. KG

  • Powder rheology analysis of excipients with FT4
  • Influence of moisture on excipients flow behaviour
  • Correlation with feeding trials
  • L-HPC a multi-functional excipient: case study (twin screw wet granulation)

Device Development

Dissolvable Microneedles – From Product Development to Commercial Manufacturing

Dr. Sebastian Braun, Head of Formulation Development 1 and Head of Manufacturing MAP, LTS Lohmann Therapie-Systeme AG

For the past decade, innovation in microneedles has been a focus within the pharmaceutical world. Today, microneedles are seen as a viable option for the delivery of drugs such as biologicals, vaccines and difficult-to-deliver small molecules through the skin, in both immediate-release and long-acting products. The widely recognized benefits of transdermal administration in terms of pain-free delivery, convenience and patient compliance, make microneedles an ideal platform for an increasing number of therapeutic areas.

In the first half of the presentation, you will get an insight into the options of transdermal applications. A brief comparison of a variety of transdermal application including injection systems will provide a better understanding of problems faced while using such system. In the second half of the presentation, we will take a deep look into the field of microneedle systems. In addition to current designs and compositions we will look into the development, manufacturing and analytical testing of microneedle system. The final topic will be the commercial manufacturing of microneedle systems. What are the challenges for CDMOs and how to develop suitable manufacturing equipment in a still shifting microneedle technology environment?

This will give you the complete picture from product development to commercial manufacturing.

10:25 AM - 11:15 AM

1-2-1 Pre-Scheduled Meetings & Networking Break

11:15 AM - 11:45 AM - Case Studies

Biologics

Technology & Innovation

Challenges of Downstream Manufacturing of Amorphous Solid Dispersions

Tatiana Marcozzi, Senior Scientist – Oral Solid Development, Janssen

Device Development

Connecting the Dots in the User Experience of Self-Injection

Soren Skov, Senior Expert Human Factors / User Experience , Novartis

  • The practical and personal problems of self-injection
  • Connected injectors and their role in expanding patient support
  • Improving the patient journey using digital technology and tools such as companion apps
  • Insight into developing a connected ecosystem

Technology & Innovation

mRNA/LNP Formulations from Therapeutics to Vaccines

Erik Oude Blenke, Associate Principle Scientist, AstraZeneca

  • mRNA as therapeutic modality
  • Improvements of LNP formulations
  • Impact of expression kinetics and protein half-life
  • Vaccine applications and future developments

11:50 AM - 12:20 PM - Solution Spotlights

Technology & Innovation

ChemoSeed®: An implantable drug delivery technology for the localised treatment of High Grade Gliomas

Dr. Chris McConville, Chief Scientific Officer, Extruded Pharmaceuticals Ltd

  • High grade gliomas (HGGs) are difficult to treat due to the presence of the blood brain barrier
  • Current standard of care involves surgical resection with most recurrence occurring within 5mm of the original tumour
  • This provides an opportunity for delivery of a high local dose of chemotherapy to the resection margin
  • We previously investigated the local delivery of Irinotecan (IRN) into the resection cavity in a Phase I clinical trial with toxicity issues and slight improvement in survival.  However, the drug was removed from the cavity within 5o hours
  • ChemoSeed was developed to be implanted directly into the resection cavity margin and deliver 0.11mg of IRN for at least 7 days.
  • Up to 60 seeds would be implanted 3mm deep into the resection cavity with a 3mm spacing between each seed.
  • 30% w/w  IRN-loaded ChemoSeeds showed only signs of mild toxicity, with no necrosis of brain tissue or the typical systemic toxicities associated with IRN.
  • 30% w/w IRN-loaded ChemoSeeds resulted in 148 day survival in mice, with no sign of tumour recurrence
  • ChemoSeed offers a novel treatment option to improve the survival of HGG patients with no increase in toxicity.

Biologics

Understanding Biopharmaceutical Detergents

James Humphrey, Research & Technology Specialist, Croda Pharma

  • The role of detergents in biopharmaceutical formulations
  • Discussing the stability of detergents in biopharmaceutical formulations
  • Exploring formulation effects on detergents

Small Molecules

Molecular Modelling to Support Drug Formulation for Small Molecule and Biologic Drugs

John C. Shelley, Fellow, Schrödinger

Show more

Device Development

Oral delivery of Non-Absorbed Biomolecules to the GI tract

Dr Fiona MacDougall, Director of Biopharmaceutics, BDD

A knowledge-based strategy for understanding and optimising the delivery of biomolecules for local activity in the human GI tract, including microbiome, bacterial therapeutics, enzymes, vaccines and monoclonal antibodies.

12:25 PM - 12:55 PM - Case Studies

Biologics

Thermokinetic Modelling of Biologics as a Tool for Accelerating Development

Martin Huelsmeyer, Head of Science Affairs & Strategic Initiatives, NBE Formulation Sciences, Senior Principal Research Scientist, AbbVie

Show more

Biologics

Solvent-Free Material Processing for the Development of Drug Delivery Systems Using Supercritical Carbon Dioxide (scCO2)

Vivek Trivedi, Lecturer in Drug Delivery, Medway School of Pharmacy, University of Kent

Show more

Small Molecules

Multicomponent cocrystals manufactured via HME

Dunja Šilić, Senior Product Development Scientist, Pliva

  • Application of HME for multicomponent cocrystals - case study 1: ionic cocrystal
  • Application of HME for multicomponent cocrystals - case study 2: drug-drug cocrystal
  • Scale up of HME for the synthesis of ionic cocrystals
  • Excipient compatibility and formulation of HME ionic cocrystals

Device Development

Design Verification of Combination Products

Ajay Bapurao Chintawar, Drug Delivery Systems Development Lead , Pharmathen

  • Characterization testing for generic combination products – what is expected?
  • Robust verification strategy & regulatory agency expectations
  • Importance of Engineering qualifications – Impact of failures during final DV
  • Utilizing verification data from CRO/CMO into OEM data
  • Attribute vs Variable (why variable testing is preferred) – Test case
  • Possible ways to balance between design changes, verification, and usability at the same time – Test case.

12:55 PM - 1:55 PM

Networking Lunch

1:55 PM - 2:25 PM - Case Studies

Small Molecules

Printing of Non-Printable: 3D Printing of Pharmaceutical Oral Solid Dosage Forms by a Fused Deposition Method

Valentyn Mohylyuk, Pharmaceutical Scientist (research fellow), Queen's University Belfast

Show more

Biologics

Modelling Rheology of Highly Concentrated Proteins

Jean-Rene Authelin, Global Head of Pharmaceutical Engineering, Sanofi

Technology & Innovation

3D Printed Drug Delivery Systems & Biodegradable Implants

Dimitrios Lamprou, Professor & MSc Director, Queen’s University Belfast

The 3D printing (3DP) process patented in 1986; however, only in the last decade has been used for medical applications, as well as being utilized in the fields of bio-fabrication and pharmaceutical printing. 3DP or Additive Manufacturing (AM) is a family of technologies that implement layer-by-layer processes to fabricate physical prototypes, based on a Computer Aided Design (CAD) model. 3DP permits the fabrication of high degrees of complexity with great reproducibility, in a fast and cost-effective fashion, offers a new paradigm for the direct manufacture of individual dosage forms, and has the potential to allow variations in their size and geometry varied to control dose and release behaviour. 3DP thus offers the perfect innovative manufacturing route to address critical capability gaps hindering the widespread exploitation of personalised drug delivery systems and medical implants. Ideally, the design and fabrication of such systems should be customised to each individual patient. This talk will focus in the manufacturing of drug delivery systems & medical implants (e.g. vascular grafts, meshes, microneedles) using innovative 3DP and bioprinting technologies. The studies include in-house prepared Bio-inks using natural or synthetic polymers, and preparation of drug-loaded or empty filaments by hot-melt extrusion (HME).

Device Development

Combination Products Under MDR (article 117)

Heinrich Martens, Vice President Regulatory Affairs - BU Devices Pharmaceuticals and Devices Division, Fresenius Kabi

  • What is a combination product
  • The meaning of Article 117
  • The role and task of the Notified Body
  • Manufacturer responsibilities
  • Evidence and fulfilment of the GSPRs
  • Notified Body opinion

2:30 PM - 3:00 PM - Solution Spotlights

Small Molecules

An End-to-End Pharmaceutical Development Pathway to Rapidly Bring Poorly Soluble New Chemical Entities to the Market

Alexandre Gil , Ph.D., Director, Business Development , WuXi STA

  • Pharmaceutical development pathway integrating patient needs, development considerations and physico-chemical/biopharmaceutical compound profile
  • Integrated CMC platform from developability assessment, formulation design and process optimization leading to a robust commercial dosage form
  • Case studies showcasing how an integrated CMC platform can accelerate timelines

Biologics

Polymeric Implants for the Long-Acting Delivery of Biologics

Christian Schneider, New Business Development Manager, Celanese Corp

Show more

Technology & Innovation

Creating the Future of Solubility and Bioavailability Enhancement with Apisolex™ and Apinovex™ Polymers

Nick DiFranco, MEM, Global Market Segment Manager for Oral Treatments, Lubrizol Life Science Health

Joey Glassco, Senior Global Market Manager for Parenteral Drug Delivery, Lubrizol Life Science Health

Robert W. Lee, President of the CDMO Division, Lubrizol Life Science Health

As many as 90% of new APIs suffer from poor aqueous solubility and/or bioavailability, creating significant challenges for drug formulators. While there are excipients and techniques available to address these issues, they often have low efficiency and lead to complex manufacturing processes or undesired side effects for patients.

Lubrizol Life Science Health’s injectable-grade Apisolex™ and oral-grade Apinovex™ polymers were designed to overcome poor solubility and unlock the future of drug delivery. Join us to learn how Apisolex and Apinovex polymers enable:

  • Efficient parenteral and oral delivery of low solubility compounds
  • Development of patent-protected formulations for new chemical entities (NCEs) and differentiated 505(b)(2) products
  • Simple, scalable manufacturing processes using readily available equipment
  • High drug loading and stability benefits versus other excipients, demonstrated by experimental data with model APIs

Device Development

Article 117 - Approaches for Integral Drug-Device Combination Product Platforms

Beat U. Steffen, Founder & CEO , confinis ag

The MDR Article 117 introduces a new requirement that a Notified Body Opinion (NBOp) must accompany regulatory documentation for an integral drug-device combination (iDDC) product being submitted to National Competent Authorities (NCAs) or EMA.

In practice, many Marketing Authorization Holders use the same device constituent parts for various medicinal products. However, since the intended use, the user(s) and the environment of the medicinal product are different, a new NBOp is required for an already approved iDDC.

This session will highlight possible approaches and concepts to address such cases. Platform examples will include prefilled syringes and autoinjectors but the take-aways should be equally applicable to other types of iDDC.

3:15 PM - 4:05 PM

1-2-1 Pre-Scheduled Meetings & Networking Break

4:05 PM - 4:35 PM - Case Studies

Small Molecules

Miniaturization of the dry Granulation Process to Accelerate the NCE Drug Development

Corentin Larcy, NCE Drug Product Expert, UCB

The terminology amorphous solid dispersion (ASD) was coined about 40 years ago to specifically describe solid pharmaceutical formulations in which the active pharmaceutical ingredient (API) is amorphously embedded in a polymer matrix. ASD as a formulation strategy, enables an increase in the apparent solubility and bioavailability of poorly-water soluble APIs, typically those in the Biopharmaceutics Classification System (BCS) II and IV. Over the last decades, significant scientific progress has been made to mechanistically understand ASDs and to address the challenges associated with their manufacturability, stability, and performance. In this presentation, an overview of recent progress made on the formulation and process modeling front to address these challenges will be discussed. Furthermore, emerging modeling techniques to address current deficiencies or gaps will be highlighted.

Technology & Innovation

Oral Application of the Hepatitis B Peptide Drug Myrcludex B

Gert Fricker, Director at the Institute of Pharmacy and Molecular Biotechnology in the Faculty of Biosciences, University of Heidelberg

Aim of this study was the development of a liposomal formulation containing specific tetraether lipids for the oral administration of the hepatitis B peptide drug Myrcludex B. Tetraether lipids were extracted from extremophilic Sulfolobus acidocaldarius and purified in order to obtain the desired glycerylcaldityltetraether lipids (GCTE). Myrcludex B was synthesized by solid-phase synthesis and incorporated into liposomes containing 5mol% of GCTE. These liposomes showed a size, polydispersity index and zeta potential comparable to the standard liposomes. Cryo-EM micrographs displayed low lamellarity, the prerequisite for high drug loading capacity. Long term storage of the GCTE-liposomes was achieved by freeze-drying using 100-500mM sucrose or trehalose as lyoprotectors. The lyophilized product showed high stability with a recovery rate of 82% of intact Myrcludex B observed after storage for 3months at -20°C as compared to a recovery rate of 83% directly after the freeze-drying process. In vivo, the GCTE-liposomal formulation led to substantial enhancement of the liver uptake of iodine131-labeled Myrcludex B in Wistar rats. 3h after oral application, approximately 7% of the initial dose could be detected in the liver. In summary, the GCTE-liposomes enabled efficient oral administration of Myrcludex B and provided long term storage by freeze-drying.

Device Development

The Design Development and Commercialization of a High Accuracy Low Volume Dosing Syringe

Frank Van Reeth, Director Ophta and IHD Device Portfolio, Global Device & Packaging Development (GDPD) in TRD, Novartis

  • The visisure® syringe and the application kit
  • Description of the unmet need
  • Design of the syringe
  • Set-up for commercial supply
  • Future opportunities

4:40 PM - 5:10 PM - Keynote

Technology & Innovation

Formulation & Device Lifecycle Management for Biotherapeutics - The Value of Platform Technologies

Beate Bittner, Senior Portfolio Strategy Director, Roche

Formulation and device lifecycle management covers all improvements related to the drug delivery and administration profile of a medication. Associated activities most frequently commence either during late-stage development or once the product has already entered the market. This step-wise approach aims at initially bringing novel medicinal products to patients as timely as possible. Optimizations of the drug presentation, the administration route and the overall dosing procedure are of lower priority in case these would push out availability of the treatment. 

In this context, especially biopharmaceuticals that need to be administered parenterally are expected to benefit from an improved drug delivery profile. Reducing the dosing complexity can enable broader access to medications by facilitating a flexible care setting. This setting includes the option for home- and patient self-administration and contributes to a patient-centric disease management, leaving the choice of the treatment location to patients and their caregivers. 

To enable timely availability of product optimizations, technology platforms that are applied to multiple molecules across different disease areas and updated over time are expected to enhance early market entry of the most appropriate product presentation; ideally already at initial launch of a biological molecule. 

This presentation will discuss advantages and disadvantages inherent to using formulation and device platform technologies to improve the drug delivery profile of medicinal products, highlight development and commercialization aspects that can be leveraged across different molecules and indications, as well as aspects that need to be assessed for each molecule individually.

5:10 PM - 5:15 PM

Chair’s Closing Remarks

5:15 PM - 6:15 PM

Evening Networking Reception

8:30 AM - 9:00 AM

Registration & Refreshments

9:00 AM - 9:05 AM

Chair’s Opening Remarks

9:20 AM - 9:50 AM - Keynote

Technology & Innovation

Oral Drug Delivery for Beyond Rule of Five Molecules – Chemical and Physical Approaches

Dr. Stefan Bracht, Vice President Head of Drug Delivery Innovation, Bayer

9:55 AM - 10:25 AM - Case Studies

Small Molecules

Hot Melt-Extrusion as an Advanced Continuous Technology for The Manufacture of Age-appropriate Anti-Malarial Combinations

Suha Dadou, Research Fellow, Queen’s University Belfast

Biologics

A Photostability Testing Strategy for High Throughput Formulation Screenings

Paulina Luisa Fischer, PhD Student, AbbVie

Technology & Innovation

Technology & Innovation

Scratching the Surface – Surface Characterization of Pharmaceutical Powders for Oral Solid Dosage Forms

Lena Mareczek, Scientist, Merck KGaA

  • Introduction to different surface characterization methods for pharmaceutical powders
  • Comprehensive drug-excipient characterization
  • How do surface properties of powders influence mechanical tablet properties?

10:30 AM - 11:00 AM - Solution Spotlights

Small Molecules

Observations of Tribo-Charging Two Separate Filler-Binders for Continuous Manufacturing Operations

Michael Black, Head of Sales Pharma, Beneo

Powder feeding is the first and most critical step of continuous manufacturing operations. A major root cause of feeder mass flow deviations is tribo-charging, which can induce material adhesion on the equipment surfaces. This study compares the tribo-charging observations of two separate filler-binders: a spray-dried mannitol and an agglomerated isomalt grade.

Biologics

Session Title TBC (Precision Nanosystems)

Technology & Innovation

A Transition from Batch to Continuous Mixing

Dr. Sara Fathollahi, Product Application Specialist, Oral Solid Dosage, DFE Pharma

Show more

Device Development

Solution Spotlight By TTP

11:00 AM - 11:50 AM

1-2-1 Pre-Scheduled Meetings & Networking Break

11:50 AM - 12:20 PM - Case Studies

Small Molecules

Machine Learning-Enhanced Sub-Visible Particles Analytics

Dr. Angela Lopez del Rio, Scientist    , Boehringer Ingelheim

  • Machine learning models leverage large quantities of data to enhance subvisible particle analytics. 
  • Which are the limitations and challenges of such models? 
  • New insights on our data: what can we expect of machine learning? 

Technology & Innovation

Pediatric Formulation Development –Patient Centricity for the Pediatric Population

Leonie Wagner, Senior Formulation Scientist, Roche

  • What does patient centricity mean for the pediatric population
  • How to incorporate those aspects into the development process of a pediatric formulation
  • QbD elements for a pediatric product
  • Key challenges faces in pediatric formulation development
  • Conclusion and outlook

12:25 PM - 12:55 PM - Solution Spotlights

Small Molecules

Polymer-Based Excipients in Drug Delivery: Solubility Enhancement Technology for Hydrophobic APIs

Thomas Delacroix, R&D Director , PMC Isochem

Encapsulation technology is one of several solutions that address the low water solubility and bioavailability of hydrophobic active pharmaceutical ingredients. Vitamin E TPGS and poly(amino acids) are polymer-based amphiphilic surfactants capable of loading small hydrophobic molecules for use as drug delivery systems. Vitamin E TPGS is a safe FDA-approved pharmaceutic adjuvant that has already found multiple applications over the past 70 years as a water-soluble source of vitamin E, solubilizer or antioxidant. Poly(amino acids) are tailor-made polymers composed of amino acid units with interesting biocompatibility and biodegradability properties. These polymers are attracting increasing interest, especially for their use in nanomedicine.

Biologics

Inhaled Delivery of Biologics: Why it’s a Good Solution

Mark Parry, Technical Director, Intertek Melbourn

Biologics present numerous challenges in their successful manufacture, formulation, and delivery to the patient. Respiratory delivery of biologics presents opportunities for both targeted delivery of these drug substances as well as alternative systemic delivery routes to the traditional needle-based administration options currently used. This presentation will discuss the available technologies and approaches being used to build effective products, as well as a discussion of the regulatory considerations when taking this complex combination of new drug modalities and delivery routes through to market.

Technology & Innovation

Particle Size Control Through Micronization: Challenges and Solutions

Salvatore Mercuri, Associate Director, NPI & MSAT, Monteggio, Lonza

Micronization is an important technique in drug formulation, but not all substances are simple to process.
This presentation will give an insight into how micronization processes can be developed for challenging inhalation materials.
What technical issues need to be addressed if an API is to be successfully micronized?
A robust process development strategy will be presented that ensures all attributes critical for quality are maintained, even for the most challenging.
A case study on the micronization of a highly potent inhalation API with a tendency to undergo surface amorphization will also be presented.
Key findings, including solid-state characterization and post-micronization conditioning, will be disclosed

Device Development

Session Title TBC

12:55 PM - 1:55 PM

Networking Lunch

1:55 PM - 2:40 PM - Case Studies

Technology & Innovation

Computer-Aided Formulation Development: From Early Excipient Screening to Final Formulation

Gabriele Sadowski, Professor Laboratory for Thermodynamics, TU Dortmund University

The poor water solubility and hence bioavailability of most newly developed active pharmaceutical ingredients (APIs) challenges formulators in industry in the development of a suitable formulation. Different enabling techniques for the bioavailability enhancement are available and need to be evaluated based on a limited available data, restricted amount of material and within short time lines. The here presented approach allows taking scientifically based decisions at stages from early drug development (e.g. finding the best stabilizing excipient class for a given API based on predicted intermolecular interactions) via formulation development (e.g. identifying optimal API loads, cosolvents or excipients, predicting the influence of different storage conditions) to the selection of a rational manufacturing process (e.g. designing a robust manufacturing process and defining critical quality attributed for that). By combination of thermodynamic and molecular mobility models, it is even possible to predict the shelf life (API crystallization) in metastable formulations.

This computer-aided approach is universally applicable to different formulation types during all stages of formulation development and thus a powerful tool for scientists in formulation development.

Device Development

Signal Management Devices Life Cycle Management

  • The need for better signal detection, new EU regulations
  • Post-market surveillance and feeding back to device engineers
  • Challenges

Small Molecules

A Case Study in Leveraging In Silico Tools to Rapidly Prototype

Melanie Marota, Principal Scientist, MSD

Abstract TBC

Biologics

Novel Formats of Protein Therapeutics: Challenges in Development and Administration

Kishore Ravuri, Pharmaceutical Development & Supplies, PTD Biologics Europe (PTDE-P), Roche

  • Abstract TBC

2:45 PM - 3:15 PM - Case Studies

Small Molecules

Amorphous Solid Dispersions: Current Perspectives, Challenges and Opportunities (1)

Samuel Kyeremateng, Principal Scientist , Abbvie

The terminology amorphous solid dispersion (ASD) was coined about 40 years ago to specifically describe solid pharmaceutical formulations in which the active pharmaceutical ingredient (API) is amorphously embedded in a polymer matrix. ASD as a formulation strategy, enables an increase in the apparent solubility and bioavailability of poorly-water soluble APIs, typically those in the Biopharmaceutics Classification System (BCS) II and IV. Over the last decades, significant scientific progress has been made to mechanistically understand ASDs and to address the challenges associated with their manufacturability, stability, and performance. In this presentation, an overview of recent progress made on the formulation and process modeling front to address these challenges will be discussed. Furthermore, emerging modeling techniques to address current deficiencies or gaps will be highlighted.

Biologics

Peptide Nanomaterials for Drug Delivery: A Preliminary Study of Diphenylalanine

Wenqian Chen, Assistant Professor , National University of Singapore

Peptides are interesting biomaterials whose physicochemical properties can be tuned precisely through the design of amino acid sequence. For example, diphenylalanine is a short peptide that readily forms nanotubes and microtubes upon solidification from the dissolved state. Our preliminary study shows that the diphenylalanine microtubes can effectively be loaded (loading capacity up to approx. 20%) with the model molecule, Rhodamine B, whose chemical structure is similar to doxorubicin. Future studies will focus on more nanomaterials derived from peptides of different amino acid sequence for drug delivery purposes.

Technology & Innovation

Biopharmaceutics Tools to Understand Performance of Parenteral Liposomal

Nikoletta Fotaki, Reader in (Bio)Pharmaceutics, University of Bath

• Abstract TBC

Device Development

Development of Inhalers That Guide Patient Technique

  • Current issues with improper use
  • Medication loss
  • Programming smart inhalers to inform patients of medication adherence

3:15 PM - 4:05 PM

1-2-1 Pre-Scheduled Meetings & Networking Break

4:05 PM - 4:35 PM - Case Studies

Small Molecules

Selection of the Spray-Drying Process Design Space for an ASD Formulation via Thermodynamic Modelling

Stefanie Dohrn, Principal Scientist, AbbVie

Amorphous solid dispersions (ASDs) are commonly manufactured using spray-drying processes. The choice of process parameters can decisively influence product quality. Following the quality-by-design approach, identifying the spray-drying process design space is thus an essential task in drug product development. Aiming for a solvent-free and homogeneous ASD, API crystallization and amorphous phase separation must be avoided during drying. This approach provides a predictive tool for determining spray-drying process conditions via considering thermodynamic driving forces for solvent drying and ASD-specific API/ polymer/solvent interactions and glass transitions. The ternary API/polymer/solvent phase behavior is calculated using the Perturbed-Chain Statistical Associating Theory (PC-SAFT) combined with mass and energy balance.

Technology & Innovation

Session Title TBC (Biopharmaceutical development and clinical relevance)

Christophe Tistaert, Principal Scientist , Janssen

Device Development

Challenges and Opportunities in Combination Product Design, Development and Use (1)

  • Importance of coupling device design with drug formulation
  • Main challenges of designing user friendly devices

4:40 PM - 5:10 PM - Keynote

Technology & Innovation

Future Opportunities for New Modalities

  • Innovation through new modalities
  • Antibody drug conjugates, Nucleic acid delivery, AAV, Cell therapy, Immune targeting Nanomedicine
  • mRNA therapeutics and delivery hurdles
  • Future outlooks

5:10 PM - 5:25 PM

Poster Presentation Award

5:25 PM - 5:30 PM

Chair’s Closing Remarks