#FDDC17 - formulation-congress.com and informal meeting opportunities offer delegates the chance to discuss ... Faculty of Pharmacy Paris ... stabilize proteins in solution preventing

2017 Speakers Include:

Ahmed Youssef Heike Schoepper Michael Keller Sanofi Merck KGaA Novartis

Meet Senior Decision Makers

Over 300 VPs, Directors and Senior Managers from leading pharmaceutical organisations, biotech companies and academic institutions will attend the event. Delegate job titles include:

Discover New Solutions

Formal and informal meeting opportunities offer delegates the chance to discuss key solutions with leading service providers. Services to be discussed include:

Benefits to Attending

✓ Hear from and meet with the key innovators in formulation & drug delivery. Attendees include: Senior Director, Takeda

Vaccines, Inc.; Senior Director, Pfizer, Inc.; Senior Director, AstraZeneca

✓ Discover collaborative solutions to large and small

molecule formulation challenges. The congress brings

together key opinion leaders to discuss novel protein & peptide

formulation strategies, formulation development for vaccines

and biosimilars

✓ Discuss the latest innovations in large and small molecule

drug delivery including vaccines delivery, advanced

microneedle delivery systems and updates in ocular drug

delivery

✓ Unparalleled networking opportunities. This two-day

congress offers dedicated networking breaks creating an

interactive platform for scientific discussions and 1-1 meetings.

The exhibition hall and poster presentation spaces offer a

relaxed and professional environment for discussion

✓ A high-quality programme devised with the help of our

esteemed advisory board. Presentations will cover the areas

of understanding and control of amorphous solid dispersions,

innovative delivery approaches of NBE and NCEs as well as

novel Quality-by-Design approaches

✓ Co-located with the highly anticipated 2nd Annual Inhalation &

Respiratory Drug Delivery Congress

Formulation Development Formulation Sciences Pre-formulation

Drug Delivery Technologies Drug Delivery Innovation Device Development

Solid State Characterisation Solid State Chemistry Stability Testing

Sustained Delivery Small Molecule Development Nanotechnology

Pre-formulation Screening Pre-formulation Testing Solubility Enhancement

Solubility Management Sterile Formulations Hot Melt Extrusion

Parenteral Formulations Drug Delivery Platforms Formulation Design

Spray Dried Dispersions Excipient Compatibility Self-emulsifying Delivery Systems

Day 1 Stream 1 – Large Molecule Drug Formulation

• New strategies for protein & peptide formulation

• Formulation of new, upcoming & more complex molecules

• Formulation development for vaccines

• Updates in biosimilar formulation development

• Characterising protein & peptide formulations

• Ensuring the quality and stability of biologic formulations

• Formulating highly potent molecules

• Solids, liquids or advanced protein formulations

• Novel regulatory considerations

Day 1 Stream 2 – Small Molecule Drug Delivery

• Recent advancements in small molecule drug delivery

• Nanoparticles: preparation, progress and future opportunities

• Oral-delivery vs lipid-based systems

• Enhancing bioavailability with drug delivery systems

• Versatile technology for small molecule drug delivery

• Updates in nanofiber-based drug delivery systems

Day 2 Stream 1 – Small Molecule Drug Formulation

• Overcoming key formulation challenges for small molecules

• Nano-formulations: predicting physical stability

• Oral suspensions: solubility & stability

• Improving chemical and physical stability in liquid formulations

• Novel Quality-by-Design approaches

• Understanding and control of amorphous solid dispersions

For booking details & registration fees please refer to the last page or visit:

http://www.formulation-congress.com/marketing/

Day 2 Stream 2 – Large Molecule Drug Delivery

• Making the best use of delivery systems in the areas of: o Protein delivery o RNA/DNA delivery o Vaccines delivery

• Updates in device development

• Microneedle technology for large molecule delivery

• New biologics drug delivery systems

• Advanced ocular drug delivery

• Gene delivery systems: viral and non-viral

• Approaches for delivery of biologics across the blood-brain barrier

• Advanced ocular drug delivery

Featuring exclusive insights into regulatory updates and drug safety perspective!

Download Our Free Webinar Recording

API Physical Form Selection: Chances vs Challenges For Formulation Development – Download from here.

http://www.formulation-congress.com/marketing/

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For more information please contact [email protected]

If you’re on Twitter, make sure to follow us on @FDDCongress and join the congress conversation #FDDC17

2017 Formulation & Drug Delivery Congress Confirmed Speakers Include:

• Advait Badkar, Senior Director, Pfizer, Inc.

• Anders Holmén, Head of Pharmaceutical Sciences, AstraZeneca, Innovative Medicines and Early Development

• Vadim Y Dudkin, Scientific Director, Janssen R&D

• Marcus-Hillert Schultze-Mosgau, Director, Pharmacokinetic Expert, Bayer Pharma

• Brian Lobo, Associate Director, Group Leader, MedImmune

• Martinus Capelle, Associate Scientific Director, Janssen Vaccines

• Sathish Hasige, Associate Director, MedImmune/AstraZeneca

• Muthusamy Jayaraman, Associate Director, Alnylam Pharmaceuticals

• Marc Du Jardin, Regional Head Pharmaceutical Developability (Beerse), Janssen Pharmaceutica

• Michael Siedler, Head of NBE Formulation Development, AbbVie Deutschland GmbH & Co KG

• Derek O'Hagan, Global Head of Discovery Support and New Technology, GSK Vaccines

• Ahmed Youssef, Head of Parenteral Unit, Sanofi

• Jörg Schiewe, Head of Global CMC Experts, Boehringer Ingelheim Pharm GmbH & Co. KG

• Heike Schoepper, Head GDS PV Management, Merck KGaA

• Kerstin Walke, Head of Pharmaceutical Development Biologicals, Boehringer Ingelheim GmbH & Co.KG

• Mostafa Nakach, Head of Pharmaceutical Engineering Section, Sanofi

• Praveen Hiremath, Head of Lab, Formulations Technology, Bayer Animal Health GmbH

• Martin Will, Section Head Analytical Chemistry, Sanofi

• Bernd Liepold, Group Leader, Senior Principle Research Scientist, AbbVie

• Michael Keller, Senior Fellow, Novartis Pharma AG, Biotechnology Development & Manufacturing

• Dan (Dina) Zhang, Senior Principal Scientist, MSD

• Sune Klint Andersen, Principal Scientist, Novo Nordisk A/S

• Aimee Reynolds, Principal Scientist, Novartis

• Markus Hemminger, Senior Engineer, Hoffmann-La Roche

• Anuji Abraham, Senior Research Investigator, Bristol-Myers Squibb

• Axel Becker, Senior Scientist / Manager, Merck KGaA

• Husain Attarwala, Scientist, DMPK Modeling and Simulation, Alnylam Pharmaceuticals

• Michael W Harrison, Associate Engineering Advisor, Eli Lilly and Company

• Mauro Sergi, Head Formulation Development - TDB/BTDM, Novartis NTO c/o Sandoz GmbH

• Ipsita Roy, Professor, University of Westminster

• Constantin Coussios, Director, Oxford Institute of Biomedical Engineering, University of Oxford

• Jean-Michel Scherrmann, Professor in Pharmacokinetics, Faculty of Pharmacy Paris Descartes

• Jayne Lawrence, Professor, King’s College London

• Ryan F. Donnelly, Chair in Pharmaceutical Technology, Queen's University Belfast

• Maya Thanou, Senior Lecturer, King’s College London 2017 Inhalation & Respiratory Drug Delivery Congress Confirmed Speakers Include:

• Holger Memmesheimer, VP and Head, Respiratory Drug Delivery, Boehringer Ingelheim

• James Kraunsoe, Senior Technical Director, AstraZeneca

• Stavroula Rozou, Director, Analytical and Documentation Operations R&D, Elpen Pharmaceuticals

• Simon Hiskett, Senior Manager, Respiratory Regulatory CMC, Mylan Pharmaceuticals

• Katerina Athanassiou, Clinical Research Director, Elpen Pharmaceuticals

• Valerie Fenster, Senior Manager, Human Factors Engineering, Amgen

• Frank Thielmann, Operational Leads, Inhalation New Solids, Novartis

• Jonathan Philips, Principal Scientist, Amgen

• Christoph Kreher, Global Pharmaceutical Expert, Boehringer Ingelheim Pharma GmbH & Co. KG

• Frans Franek, Senior Scientist Biopharmaceutics Inhalation, AstraZeneca

• Jonathan Reid, Professor, University of Bristol

• Sven Stegemann, Professor, University of Graz

• Jakob Löndahl, Associate Professor, Lund University

• Nathalie Heuze Vourc'h, Associate Professor and Research Scientist, University of Tours

• Imran Saleem, Reader in Nanomedicine, Liverpool John Moores University

• Francesca Buttini, Assistant Professor, University of Parma and Visiting Professor, King’s College London

• Rémi Rosière, Spin-Off Developer (InhaTarget), University of Brussels

mailto:[email protected]

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2017 Formulation & Drug Delivery and Inhalation & Respiratory Drug Delivery Sponsors Include:



3rd Annual Formulation & Drug Delivery Congress Day One – 8th May 2017

07.30 – 08.20 Registration: Foyer

Conference Room 1: Ballroom 1&2

08.20 – 08.25 Oxford Global’s Welcome Address

08.25 – 08.30 Chairperson’s Opening Address: To Be Confirmed

08.30 – 09.00 Keynote Address: Drug Delivery For Biologics – Challenges And Opportunities This talk will focus on emerging trends for drug delivery for biotherapeutic compounds, and the overall shift of perspective in technologies from “product enhancing” to “product enabling.

Advait Badkar, Senior Director, Pfizer, Inc.

Conference Room 1: Ballroom 1&2 Conference Room 2: Montague

Large Molecule Drug Formulation Small Molecule Drug Delivery

Stream Chair: To Be Confirmed Stream Chair: Luigi Boltri, R&D Director, Innovation and Technology Liaison, Adare Pharmaceuticals

09.00 – 09.30 Stream Keynote Address:

Formulation Development For Antibody Drug Conjugates

Brian Lobo, Associate Director, Group Leader, MedImmune

Stream Keynote Address: Pharmacokinetics And Pharmacodynamics Of An Intravaginal Ring Releasing Anastrozole And Levonorgestrel In Healthy Premenopausal Women: A Phase 1 Study An attractive approach to the treatment of endometriosis-associated pelvic pain may be an intravaginal ring (IVR) that provides systemic delivery of a combination of the aromatase inhibitor anastrozole (ATZ) and a low dose of the progestin levonorgestrel (LNG). This Phase 1, first-in-human study assessed the pharmacokinetics, pharmacodynamics and safety/tolerability of different dosing combinations of ATZ/LNG administered by an IVR in healthy premenopausal women. The primary aim was to identify well-tolerated doses of ATZ that are sufficient to block aromatase activity, and therefore inhibit production of estrogens. A further aim was to find a dose of LNG that results in exposure similar to that reported for approved low-dose LNG formulations, which have well established contraceptive effects. These results are intended to guide the selection of doses for investigation of this combination IVR in further studies.

Marcus-Hillert Schultze-Mosgau, Director, Pharmacokinetic Expert, Bayer Pharma

09.30 – 10.00 Recombinant Human Albumin: An Effective Approach For Stabilization Of Hard-To-Formulate Biopharmaceuticals • Aggregation and depletion of proteins and peptides in

drug formulations is a major source of dosage form and storage instability. The presence of aggregates and sub-visible particles also compromises the safety and efficacy of the drug formulations and may lead to a series of problems during manufacturing, handling and post administration

• Recombinant human serum albumin has the ability to stabilize proteins in solution preventing adsorption, aggregation and oxidation

• We demonstrate the use of Albumedix™ Recombumin®, a recombinant albumin product, as a stabilizing agent for model biopharmaceuticals, both peptides and monoclonal antibodies (mAbs) at high concentration, and elucidate on potential mechanisms

Neil Dodsworth, Science Manager, Albumedix

Solution Provider Presentation

10.00 – 11.20 Exhibition Room: Ballroom Section 3&4 Morning Coffee & Refreshments, One to One Meetings x3, Poster Presentation Sessions






11.20 – 11.50 Complexities Of Vaccine Product Development • Liquid, lyophilized and adjuvant formulations

• Use of spectroscopic screening tools

• Ebola case study

Martinus Capelle, Associate Scientific Director, Janssen Vaccines

Innovative Delivery Approaches For Parenteral & Topical Drug Delivery Of NBE And NCEs • Learnings from transdermal drug delivery studies

• Liposomal Drug Delivery to the skin: selection of o optimal formulation based on physicochemical stability, in vitro and in vivo models o Proof of concept in humans – learnings

• Application of innovative analytical methods: ITC as a case study

Michael Keller, Senior Fellow, Novartis Pharma AG, Biotechnology Development & Manufacturing

11.50 – 12.20 Designing And Building The Next Generation Of Vaccine Adjuvants

• The discovery of Small Molecule Immune Potentiators (SMIPs)

• Formulation options for vaccine adjuvants

• The unique challenges of vaccine characterization and performance

Derek O'Hagan, Global Head of Discovery Support and New Technology, GSK Vaccines

Controlled Drug Delivery Using Natural Polymers Of Bacterial Origin • Production of Polyhydroxyalkanoates (PHAs)

• Formulation of PHAs in to microspheres/nanospheres for Controlled Drug Delivery

• Applications in Cancer Therapy, Medical devices - Drug eluting Stents, Implants, Tissue Engineering and Regenerative Medicine

Ipsita Roy, Professor, University of Westminster

12.20 – 12.50


For sponsorship opportunities please contact

[email protected]

Veltis Engineered Albumin Conjugates For Small Molecule Drug Delivery • Veltis engineered albumins as a drug delivery system

• Thioalbumins with extra cysteines for increased drug loading

• Linker chemistries for albumin conjugation

Nicholas Martin, Research Scientist, Albumedix

12.50 – 13.50 Exhibition Room: Ballroom Section 3&4 Lunch

13.50 – 14.20 Novel Strategies/Tools To Facilitate Ultra-High Concentration Drug Product Development This talk will focus on (1) Trends shaping the Industry (2) Challenges associated with high concentration liquid formulation development (3) Evolution from a “gate keeper” strategy to “DESIGNER mAb” approach and (4) Future opportunities to increase patient convenience.

Sathish Hasige, Associate Director, MedImmune/AstraZeneca

Stabilization And Comparison Of Manufacturing Technologies For The Production Of Nano-Crystalline Suspension Recently research works on parenteral nanotechnologies have shown that many nano objets of therapeutic interest including (nanocrystalline suspension, Emulsion, liposomes, polymeric nanoparticles) can be manufactured using High pressure homogenization. However, most of these studies are focused on exploratory research activities. One of the major hurdles to reach the market is pharmaceutical development; it is design of stable commercial formulation, process scaling up and cGMP manufacturing in aseptic environment. Sanofi has developed specific capabilities and technology platform to support projects development from preclinical to industrialization and launch. In the present communication, we will focus on the presentation of 3 pillars: (i) Physico-chemistry based methodology of formulation and engineering (ii) Process development and scale-up (iii) Modelling of bead milling process

Mostafa Nakach, Head of Pharmaceutical Engineering Section, Sanofi







14.20 – 14.50 Tech Transfer, The Way From The Lab To The Filling Line. What To Consider for Protein Therapeutics? • A robust formulation reduces the risk of tech. transfer

failure

• Special features of a protein therapeutic in comparison to small molecules with respect to tech. transfer

• Process gap analysis and risk assessment case study

• Tech. transfer management (e.g. Tech transfer team, scope, documentation, etc…)

Ahmed Youssef, Head of Parenteral Unit, Sanofi

Local Delivery Platforms To Enable Early Preclinical Programs At Novartis • Local delivery platforms are being developed to support

preclinical programs at Novartis, enabling teams to pursue indications unsuited for systemic treatment

• To encourage adoption in development, novel platforms should be compatible with multiple molecules, disease areas and delivery routes, and have clearly defined scientific rationale for use

Aimee Reynolds, Principal Scientist, Novartis

14.50 – 15.20

Unleash Automated Buffer Exchange • Early-stage formulation screening to formulation

development

• Buffer preparation, exchange and analysis in one portfolio

• Impeccable mass recovery

• Analytical data supports protein handling equal to or better than dialysis and Amicon centrifugal devices

Quincy Mehta, Product Manager, Unchained Labs

New Opportunities For Patient Centric Formulations • The challenge of therapeutic principles for certain

patient populations, such as pediatric, geriatric and dysphagic patients, adolescents and patients with neurological disorders will be addressed

• Illustrate the versatility of drug delivery solutions in the field of oral dosage forms to meet the needs of patients, thereby encouraging adherence while supporting optimal disease management and ultimately providing opportunities for improved outcomes

• Case studies will be featured —demonstrating novel/improved proprietary formulation technologies for oral delivery —core competencies of Adare Pharmaceuticals

Holger Neecke, Director, Business Development, Adare Pharmaceuticals and Luigi Boltri, R&D Director, Innovation & Technology Liaison, Adare Pharmaceuticals

15.20 – 16.20 Exhibition Room: Ballroom Section 3&4 Afternoon Refreshments, One to One Meetings x2, Poster Presentation Sessions

16.20 – 16.50 Pharmacovigiliance From Early Development To Life Cycle Management Of Mature Products • Drug Safety Perspective - Manufacturing & Patient

Risk

• Risk minimization measures – Case Studies

• Medication errors – Real World examples

Heike Schoepper, Head GDS PV Management, Merck KGaA

Development And Characterization Of Liquid Crystal Drug Delivery Systems The talk will cover practical aspects of developing liquid crystal drug delivery systems to meet desired target product profile, and the state of the art analytical tools and techniques such as NMR, SAXS and Optical Microscopy to fundamentally understand the phase behaviour of liquid crystal formulations.

Anuji Abraham, Senior Research Investigator, Bristol-Myers Squibb

16.50 – 17.20 Optimization Of Physicochemical And Biophysical Properties Of Peptide Properties To Enable Physical And Chemically Stable Drug Products The development of a preclinical peptide candidate to a commercial drug is a challenging and time consuming process. Due to very poor oral bioavailability, peptides are generally administered as aqueous formulation. The physicochemical and biophysical properties of a peptide are key to enable good drug products. Therefore, we include those parameters in our optimization process. Our general optimization process and selection of suitable peptides will be discussed.

Martin Will, Section Head Analytical Chemistry, Sanofi

Chemo- Or Biotherapy Delivery To The Brain: Beyond Crossing The Blood-Brain Barrier • Complexity and heterogeneity of the brain

• The brain barriers Where are the active fraction and molecular target of drugs?

• Treat a diseased brain Jean-Michel Scherrmann, Professor in Pharmacokinetics, Faculty of Pharmacy Paris Descartes






17.20 – 17.50 High-Throughput Lab Automation For Physicochemical Characterization Of Protein Formulations • Business driver for implementing high-throughput

formulation screening

• Lessons learned during implementing HT formulation on: o Analytical method development o Lab automation o Data management o Data evaluation o Required skill sets

Michael Siedler, Head of NBE Formulation Development, AbbVie Deutschland GmbH & Co KG

Novel Biodegradable, Rapidly Eliminating Lipids (“reLipids”) For The Systemic Delivery Of siRNAs • The most advanced lipid nanoparticle (LNP)-based

delivery systems for RNAi therapeutics comprise of ionizable lipids, which enable packaging, transport and release of the siRNA payload after delivery to cells in vitro and in vivo

• To improve metabolic clearance and elimination from target tissues of the ionizable lipids, biocleavable linkages such as esters and acetals were introduced in the acyl chains

• Comprehensive structure-activity studies allowed us to refine the lipids to achieve the desired physicochemical properties as well as in vivo performance of the LNPs, both in terms of efficacy as well as tissue elimination and safety

Muthusamy Jayaraman, Associate Director, Alnylam Pharmaceuticals

17.50 – 18.20 Formulation Development For Biosimilars • Overview of strategy and main activities

• Biosimilar specific challenges

• Case studies and lesson learnt

Mauro Sergi, Head Formulation Development - TDB/BTDM, Novartis NTO c/o Sandoz GmbH

Nanoparticles: Preparation And Progress Our group has an interest in the potential of lipid nanoparticles as delivery vehicles for poorly water-soluble drugs. Our studies have shown that the capacity of lipid-in-water nanoparticles (or nanodispersions) to solubilize a poorly-water soluble drug depends not only on the solubility of the drug in the lipid but also on the nature of the lipid. Indeed, it has been proposed that the manner in which the lipid is incorporated into the nanodispersions plays an important part in determining its ability to solubilise drug. This presentation will describe the formulation and characterisation (using a range of techniques including small angle neutron scattering) of lipid nanoparticles suitable for drug delivery, with particular emphasis on determining the detailed molecular architecture of the particles to understand how the lipid influences the ability of the nanoparticles to solubilise drug.

Jayne Lawrence, Professor, King’s College London

18.20 Exhibition Room: Ballroom Section 3&4 Networking Drinks & End of Day One



3rd Annual Formulation & Drug Delivery Congress Day Two – 9th May 2017


Stream Chair: Kaspar van den Dries, Senior Director & Principal Scientist, Solid Dose Development Europe, Patheon

08.30 – 09.00 Keynote Address: AZ’s approach To Nanomedicines • Case studies from our efforts in Oncology and Cardiovascular disease

• What’s next for us?

Anders Holmén, Head of Pharmaceutical Sciences, AstraZeneca, Innovative Medicines and Early Development


Small Molecule Drug Formulation Large Molecule Drug Delivery

Stream Chair: Kaspar van den Dries, Senior Director & Principal Scientist, Solid Dose Development Europe, Patheon

Stream Chair: To Be Confirmed

09.00 – 09.30 Stream Keynote Address: Small Molecules Formulation Strategies And Issues From Very Early Discovery Into Early Toxicology Screening • Team organization, right expertise at the right moment

in time

• Vehicle tolerability issues in early discovery

• Very promising and potent, but lacking “high speed development characteristics”. Case study

Marc Du Jardin, Regional Head Pharmaceutical Developability (Beerse), Janssen Pharmaceutica

Stream Keynote Address: Centyrins: A Next Generation Targeting Platform For Delivering Biotherapeutics The biophysical properties of Centyrins make them ideal as targeting agents for a variety of novel delivery technologies. Centyrex is exploiting this platform via novel therapeutic applications aimed at addressing outstanding challenges in the creation of next-generation modular therapeutics. The latest in-vitro and in-vivo results with Centyrin-mediated targeted delivery of drugs, polymeric platforms, and nanoparticles will be discussed.

Vadim Y Dudkin, Scientific Director, Janssen R&D

09.30 – 10.00 Solution Provider Presentation



[email protected]

10.00 – 10.40 Exhibition Room: Ballroom Section 3&4 Morning Coffee & Refreshments, One to One Meetings x2, Poster Presentation Sessions


Cristina Freire, Director, Formulation, Aptuit (Potters Bar) Limited

Title To Be Confirmed

Rob Steendam, Chief Technology Officer, InnoCore Pharmaceuticals

11.10 – 11.40 Understanding And Control Of Stability Of Inhalation Powder Formulations • Understanding inter-particle forces in powder

formulations

• Product related and environmental factors influencing physical stability

• Protecting packaging design

Jörg Schiewe, Head of Global CMC Experts, Boehringer Ingelheim Pharm GmbH & Co. KG

Device & Combination Product Development For Biologicals • Drug and device development process

• Human factors considerations

• Discussion of current regulatory requirements and resulting strategies

• Review of a published combination product development for a biosimilar combination product

• New trends for combination products in the biologics space

Kerstin Walke, Head of Pharmaceutical Development Biologicals, Boehringer Ingelheim GmbH & Co.KG






Small Molecule Drug Formulation Large Molecule Drug Delivery


Workshop



[email protected]

12.10 – 12.40

12.40 – 13.30 Exhibition Room: Ballroom Section 3&4 Lunch

13.30 – 14.00

Redispersibility Of Nanosolids: Challenges And Opportunities ▪ Formulation and processing impact on

nanosuspensions ▪ Solidification of nano-formulations. ▪ Re-dispersibility of nanosolids: physical stability and

characterization

Dan (Dina) Zhang, Senior Principal Scientist, MSD

Ocular Injection – PFS Development • Ocular drug delivery-inherent physiology and natural

barriers

• Drug product administration

• Specific requirements and challenges (e.g. sterility of PFS, outer surface, particle specification, dosing accuracy)

Markus Hemminger, Senior Engineer, Hoffmann-La Roche

14.00 – 14.30 Progress In Understanding And Control Of Amorphous Solid Dispersions • Relevance and applicability of amorphous solid

dispersions

• Efficient ASD formulation development

• Insights into drug release mechanism and physical stability modelling

• Understanding and control of hot melt extrusion process

• Uncovering the black box: looking into the running extruder, watching the formation of an amorphous solid dispersion (video)

Bernd Liepold, Group Leader, Senior Principle Research Scientist, AbbVie

Opportunities Within And Beyond The Drug Delivery System To Revolutionize Subcutaneous Delivery Of Large Molecules • Parenteral packaging and injection devices have long

been designed to keep the contained drug product safe throughout storage and deliver the correct dose to the right tissue in the body with good success

• Our industry is poised to introduce technology that not only satisfies these essential requirements, but can also reduce the burden of disease, minimize cost, and influence decision making across the healthcare ecosystem

• This talk will focus on new design directions that can be explored for parenteral packaging and injection devices, a new wave of delivery systems (e.g., artificial pancreas) entering the market today, and Eli Lilly and Company’s approach to developing new delivery systems to meet these new goals

Michael W Harrison, Associate Engineering Advisor, Eli Lilly and Company

14.30 – 15.00 Formulation Development Using Spray Drying Processes – An Enhanced Quality-By-Design Approach • QbD in formulation development using spray drying

• Sources of variability for spray drying processes

• Accounting for spray drying scale-up impact on formulation development

Sune Klint Andersen, Principal Scientist, Novo Nordisk A/S

Advanced Microneedle Delivery Systems • Microneedle delivery systems for delivery of

therapeutically-relevant drug doses

• Administration of biomolecules

• In-skin deposition of long-acting delivery systems

• Translation of microneedles to clinic for patient benefit

Ryan F. Donnelly, Chair in Pharmaceutical Technology, Queen's University Belfast

15.00 – 15.30 Exhibition Room: Ballroom Section 3&4 Afternoon Refreshments, Poster Presentation Sessions






15.30 – 16.00 Solid-state Selection Of APIs: Opportunities, Challenges, And Lessons Learned From An Industry Perspective • Solid-state form classification: Navigating through the

solid-state landscape

• Solubility vs stability: a never-ending fight

• Drug Substance case study: Solid-state form selection approaches for fine-tuning of API physical properties

• Drug Product case study: Formulation aspects of API physical form selection

Axel Becker, Senior Scientist / Manager, Merck KGaA

Nanoparticles For Image Guided Drug Delivery • Theranostic nanoparticles for cancer targeted drug

delivery

• Labelled drug nanoparticles for MRI and for NIRF imaging

• Loading with anticancer agents, stability and release characteristics

• Triggered and targeted drug release in tumours

• Drug Development for MRgFUS drug treatments

Maya Thanou, Senior Lecturer, King’s College London


16.00 – 16.30 Nanomedicines Translation Into Commercial Products – Challenges And Approaches The limited clinical success of nanomedicines is mainly due to challenges in formulation optimization, batch-to-batch consistency, robust and reproducible manufacturing and scale-up, characterization and screening methods, regulatory barriers, and instability under biological environments. In this presentation challenges associated with the successful translation of nanomedicines from preclinical to commercial stage and some suggested approaches to achieve this translation are discussed.

Praveen Hiremath, Head of Lab, Formulations Technology, Bayer Animal Health GmbH

16.30 – 17.00 Ultrasound-Enhanced Oncological Delivery Of Antibodies, Viruses, Oligonucleotides And Other Nanomedicines • Macromolecular agents suffer from poor extravasation and penetration in solid tumours

• This is particularly challenging for modern biologics, such as therapeutic antibodies and oncolytic viruses, but generally applies to all oncological drug classes

• Most current therapeutics rely on passive diffusion through the leaky tumour vasculature, and delivery is limited to the perivascular space

• Externally applied physical stimuli, such as ultrasound, can facilitate the active transport of macromolecules from the bloodstream into the tumour without the need to modify the drug in any way

• Such active transport results both in increased extravasation and improved distribution of the therapeutic throughout the tumour, yielding greater therapeutic efficacy

• A similar approach, using shock waves, can also be used to facilitate delivery of oligonucleotides in either free or liposomal form across the cell membrane

• Both in vitro and in vivo results across a broad range of therapeutics, including antibodies, viruses and oligonucleotides, will be presented to illustrate the utility of these ‘device+drug’ approaches

Constantin Coussios, Director, Oxford Institute of Biomedical Engineering, University of Oxford

17.00 – 17.30 RNAi Mediated Lowering Of Intestinal Interleukin-15 And Transglutaminase 2 Expressions In Mice For The Treatment Of Celiac Disease • Rationale and formulation of multi-compartmental systems for oral siRNA delivery

• Efficacy of lowering IL-15 and TG2 expressions in an in vitro model of celiac disease

• Pharmacokinetics and biodistribution of orally administered siRNA targeting TG2

• Efficacy of lowering intestinal IL-15 and TG2 expressions in a mouse model of celiac disease

Husain Attarwala, Scientist, DMPK Modeling and Simulation, Alnylam Pharmaceuticals

17.30 End of Conference


3rd Annual Formulation & Drug Delivery Congress Conference: 8 - 9 May 2017, London, UK

www.formulation-congress.com

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Agreed Terms between the Organiser (Oxford Global Marketing Ltd) and the Delegate: Delegate Booking Fee The Delegate Booking Fee includes: lunches and refreshments throughout the Congress event, conference presentations, workshop and panel sessions, scheduled one-to-one meetings and networking/social events, conference and speaker notes. Delegates may attend, free of charge, all sessions arranged by the Organiser. An admin surcharge of £50 + VAT will be applied to payments settled following the receipt of an invoice. This charge will not be applied to pay-ments settled online. Vendor Delegates will not be eligible for one to one meetings unless they purchase a sponsorship meetings package. These can only be purchased directly from Oxford Global Marketing Ltd and not via the online booking facility. Poster Presentations Those who have booked a poster presentation at the event must provide the poster title, abstract (200 words or less), principal author, organisation, mailing address, email, telephone, fax and additional authors, within a month of registration. All poster spaces will be for A0 (841mm x 1189mm) portrait size. Cancellation and Curtailment Delegates and vendor delegates are subject to the following charges and refunds upon withdrawal or cancellation. More than 6 months prior 35% cancellation fee / 65% refund Between 6 and 3 months prior 75% cancellation fee/ 25% refund Less than 3 months prior to the event Full cancellation fee / No refund Data Protection The data controller is the Organiser. The Organiser may disclose such personal information to Registered Event Sellers (Solution Providers) and other Delegates but solely for the purposes of the Event. The Delegate consents to the use of his/her personal and company information on the terms set out herein. Miscellaneous This Agreement may not be transferred or assigned by either the Delegate or the Delegate’s Company. The Organiser will determine the scope and content of Congress conference events, seminars, workshops and activities throughout the Event. The Organiser reserves the right to cancel the Event without liability to Delegate’s Company or individual Delegate. If for any reason the Organiser has to cancel or postpone this Event, the Organiser reserves the right to transfer this Booking to another Congress within the same sector to be held within twelve months. Should another Congress in the same sector not be available within this period, the Booking Fee will be refunded.

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How to Pay (choose one of the following payment options)

I would like to attend: (Please tick as appropriate) Industry Delegates (Biopharma, Pharma or Biotech Companies)

Congress £799 plus VAT 1 day pass £499 plus VAT

Day 1 Day 2

Academic Delegates

Congress £499 plus VAT 1 day pass £299 plus VAT

Day 1 Day 2

Vendor Delegates (CROs, Consultants, Technology and Service Providers)

Congress Only £1350 plus VAT 1 day pass £799 plus VAT

Day 1 Day 2 Poster Presentation £250 plus VAT

PROMOTIONAL LITERATURE DISTRIBUTION

Distribution of your company’s promotional literature to all conference attendees £999 plus VAT

Documentation

I cannot attend but would like to purchase access to the following:

Access to the online conference presentations £499 plus VAT Conference presentations - paper copy £499 plus VAT

VAT is charged at 20% on the attendance fees for all delegates. VAT is also charged on online and paper copy documentation and promotional literature distribution for all UK customers and for those EU customers not supplying a registration number for their own country here.

If you have any further queries please call the marketing team on +44(0)1865 248455 or email [email protected]

Terms & Conditions of Booking

Delegate Details

http://www.formulation-congress.com

Documents

#FDDC17 - formulation-congress.com and informal meeting opportunities offer delegates the chance to discuss ... Faculty of Pharmacy Paris ... stabilize proteins in solution preventing