12 – 14 March 2018 | Berlin

POST EVENT REPORT

ddfevent.com

registered attendees420

learned something new and useful that they can apply to their work

98.1%

would attend again

94.2%

would recommend

the summit to a colleague

98.1%

met somebody who can help with

their current challenges

76.9%

Summit growth

426 attendees

346 attendees

209 attendees

244 attendees

2015 2016 2017 2018

Highlights video

Statistics

2 9th Global DDF Summit

What did the attendees think?

Confirmation that DDF Summit is a great place for networking and learning what’s running in the Drug Delivery spaceLuigi Boltri, R&D Director, Adare Pharmaceuticals

Very good mix – academia, pharma industry and technology providers. High quality presentations with relevant case studies. Good networking opportunity Olaf Queckenberg, Head of Chemical and Pharmaceutical Development, Bayer

I was very well impressed with the event, especially with the very high technical level of the attendees and speakersMatheus Marques Costa, R&D Manager, Eurofarma Laboratórios

Very interesting summit combining scientific presentations either from academic or industry. I highly appreciate the opportunities to switch from small molecules, biologics and device topicsPatrick Garrouste, Drug Research & Development Director, Debiopharm

The DDF Summit is an important event worthy of being attended in the years to come!Danilo Aleo, Head of Drug Development, Medivis

Great! Very interesting and highly diverse talksBenjamin Franzmann, Senior Technician, Boehringer Ingelheim

First time at the summit. Great experience. Very professionally organised and executed. Many interesting presentations and meetings. Our company will definitely come back next yearAlbert Haeggström, CFO, Nanoform

9th Global DDF Summit 3

Device Development Stream

2018 saw the introduction of the Device Development Stream at DDF for the first time. Combination products are on the rise and drug developers are increasingly taking a delivery mindset right from inception. Therefore, the time was right to dedicate an entire room to device development challenges.

Leading device engineers and scientists shared their stories to a packed-out room. They covered topics such as risk management, human factors, regulations, clinical development and a host of delivery device types.

Device Development video

Very good summit. I liked the diversity of attendees and presenters and really appreciated the addition of the Device trackBjorg Hunter, Device Engineering Manager, GSK

Very good. Device stream talks were very well suited to my interests and good qualityDavid Grant, Head of Device Development & IP, Enesi Pharma

4 9th Global DDF Summit

Device Development Stream Explore the content

Small Molecules

For some presentations you

can also watch the full recording with

audio included.Click on the buttons

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Transforming Small Molecules into Medicinal ProductsDr Brian HenryVP, Drug Product Design, Pfizer

SLIDES FULL RECORDING

Microenvironmental pH Modulation: Effect on Dissolution & Absorption of Oral Solid Dosage FormsHelen HouScientist, Genentech

SLIDES FULL RECORDING

Using Oral Drug Delivery Technology InnovativelyJin-Wang Lai, PhDSenior Director, Pharmaceutical Development, Adare Pharmaceuticals

SLIDES FULL RECORDING

Mesoporous Silica Drug DeliveryFred MonsuurTCS and Business Development Manager Excipients, W.R Grace

SLIDES FULL RECORDING

The Unmet Need of Biodegradable Parenteral Controlled Release DDS: Concept, Performance & PerspectivesKarsten MäderProfessor of Pharmaceutics, Martin Luther University Halle-Wittenberg

SLIDES FULL RECORDING

Manufacturing Innovation – Bringing New Technologies from the Lab to the Shop FloorRobert MeyerPrincipal Scientist, Innovation and New Technology Development, MSD

SLIDES

Prediction Tools Enabling Speed to PatientsJatin PatelHead – Oral Product Design & Development, Bristol-Myers Squibb

SLIDES FULL RECORDING

Amorphous Solid Dispersions – What’s Next?Márcio TemtemAssociate Director for Drug Product Development, Hovione

SLIDES

Oral Delivery of Vitamin-K Using Mixed MicellesRene van NostrumAssociate Professor, Utrecht University Netherlands

SLIDES FULL RECORDING

Early Developability Assessment, Key to Success for Development PhasesPhilippe LienardCMC Discovery Coordinator, Sanofi

SLIDES

User Friendly MedicinesClive G WilsonProfessor, University of Strathclyde

SLIDES FULL RECORDING

How do I Develop Spray Dried Dispersions for Early Phase Clinical Trials and Beyond?Nikki WhitfieldVP, CDMO Services, Quotient Sciences

SLIDES FULL RECORDING

Ensuring Age-Appropriate Medicines for ChildrenDr Hannah BatchelorSenior Lecturer in Pharmaceutics, Formulation & Drug Delivery, Director of Research, School of Pharmacy, University of Birmingham

SLIDES

Suspendilicious! Unveiling the Marvels of Lipid SuspensionsKristof KimpePrincipal Scientist, Janssen

SLIDES FULL RECORDING

The Multiple Functions of Vitamin E TPGS: a Solution for your Drug Delivery InnovationYves RobinR&D Director, PMC Isochem

SLIDES

Predictive Stability in Pharmaceutical DevelopmentHelen WilliamsAssociate Principal Scientist in Predictive Science, Astra Zeneca

SLIDES

9th Global DDF Summit 5

Explore the content

Biologics

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can also watch the full recording with

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Biopharmaceutics Risk Assessment During Formulation & Clinical DevelopmentFilippos KesisoglouSenior Principal Scientist, Biopharmaceutics, Pharmaceutical Sciences & Clinical Supply, MSD

SLIDES FULL RECORDING

Quantitative Biopharmaceutics: Use of Modelling & Simulation to Inform API & Formulation DecisionsFilippos KesisoglouSenior Principal Scientist, Biopharmaceutics, Pharmaceutical Sciences & Clinical Supply, MSD

SLIDES FULL RECORDING

Biopharmaceutics in Global Public Health – Deworming Children More SafelyChristophe TistaertSenior Scientist, Janssen

SLIDES FULL RECORDING

Fixed Dose mAb Combinations: A Recent Case Study Highlighting CMC Development Challenges and StrategiesTarik KhanGroup Leader, Scientist, Roche

SLIDES

Biopharmaceutics as Catalyst for QbDJerome MantanusHead of Formulation and Process Characterization, UCB Pharma

SLIDES

A Thermodynamic Approach to Explore Excipient Mixtures and Novel Excipients in HCPFsDr Christoph BrandenbuschGroup Leader, TU Dortmund University

SLIDES

Understanding Sucrose: Matching Sucrose Quality to Functional NeedDr Christian LotzDirector, Business Development, Pfanstiehl

SLIDES

Rip Through Formulation Prep with a Junior, a Lunatic and an UncleJoe BarcoSenior Director of Marketing, Unchained Labs

SLIDES

Protein-Based Nanoparticles for Drug Delivery PurposesJuan M. IracheProfessor, University of Navarra

SLIDES FULL RECORDING

The Power of Predictive Stability Modelling in Drug Product DevelopmentDr Ellen VerheyenStability Expert, Janssen

SLIDES FULL RECORDING

Formulation of Hard-to-Stabilize BiopharmaceuticalsEleonora CerasoliSenior Research Scientist, Albumedix

SLIDES FULL RECORDING

Oral Peptide Technologies Progressing in the Clinic: Addressing Challenges to Bring New Products to the MarketJoel RichardSVP, Peptides, Ipsen

SLIDES

Sterilization Solutions for Today’s Drug/Device Combinations by REVOX Sterilization SolutionHerve Barre & James McCoyBD

SLIDES FULL RECORDING

Exploration of Anti Aggregation & Protein Stabilization Properties of Novel CarbohydratesSofiya YashchukTechnical Applications Specialist, Roquette

SLIDES FULL RECORDING

Continuous Twin-Screw Melt Granulation of Thermally Labile Drug – Case StudyFeng ZhangUniversity of Texas at Austin. Sponsored by Foster Delivery Science

SLIDES

6 9th Global DDF Summit

Explore the content Explore the content

Technology & Innovation

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can also watch the full recording with

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Smart Drug Delivery Systems: Going Inside Cells and to Individual OrganellesVladimir TorchilinUniversity Distinguished Professor, Director, Center for Pharmaceutical Biotechnology and Nanomedicine, Northeastern University

SLIDES FULL RECORDING

Implementation of QbD Based Control Strategy During Drug Product Continuous ManufacturingFrantz ElbazFormulator Project Leader & Pharm Development QbD Network Leader, Novartis

SLIDES FULL RECORDING

Manufacturing the Future – a Strategic Approach to Product & Process Development by Continuous ManufacturingGiustino Di PretoroAssociate Director, PDMS, Johnson & Johnson

SLIDES

Efficient & Predictive Screening Tools – Facilitation of the Development of Nanoparticulate Formulations for Oral, Parenteral & Topical ApplicationsDr Matthias RischlerDirector, Drug Delivery & Innovation Projects, Losan Pharma

SLIDES

Combining the Best of Two Worlds in Formulation Development for Biotherapeutics: Using High Throughput Physico-Chemical Testing & Biorelevant AssaysSabine EichlingSenior Scientist II, NBE High Throughput and Advanced Formulation Sciences, AbbVie

SLIDES

Novel Developments in the Formulation of Amorphous Solid DispersionsThomas RadesChair Pharmaceutical Sciences, University of Copenhagen

SLIDES FULL RECORDING

The Minipig as a Model for Subcutaneous Injection Current Status & OutlookTonio HocheDevice Engineer, Roche

SLIDES FULL RECORDING

Fill & Finish Operations of Biotech: Risk of AggregationJean-Rene AuthelinGlobal Head Pharmaceutical Engineering, Sanofi

SLIDES FULL RECORDING

Moving Multiparticulates from Pediatric Formulation to Patient Centric Drug Product DesignSven StegemannDirector, Pharmaceutical Business Development, Lonza

SLIDES FULL RECORDING

Tackling the Challenges of Natural Variability Related to Plant-Based Pharmaceutical IngredientsStéphanie BureauR&D Director, ADM-SIO

SLIDES

Recent Advances in the Development of Ocular Drug Delivery SystemsGrégoire SchwachHead of Drug Delivery Pharmaceutical Development and Supplies - Biologics Europe, Roche

SLIDES

A Closer Look into ASD Formulations – A Tale of Two Solid DispersionsDr Finn BauerMBA, Global Head of Solid Formulation R&D, Merck KGaA

SLIDES FULL RECORDING

Nucleic Acid Based Therapeutics for Cancer: Targeted Delivery Systems and In Vivo BioimagingManfred OgrisProfessor, Division of Clinical Pharmacy and Diagnostics, Vienna University

SLIDES FULL RECORDING

9th Global DDF Summit 7

Explore the content

Device Development

For some presentations you

can also watch the full recording with

audio included.Click on the buttons

below to choose.

Application of Decision Analytics to Device Selection and DevelopmentMartin McLoughlin, PhDHead of Device Development, Bristol-Myers Squibb

SLIDES FULL RECORDING

Left to Our Own Devices: Design Control & Risk Management Strategies for Combination ProductsRichard WedgeDirector, Design Control Implementation, Pfizer

SLIDES FULL RECORDING

Disposable Auto-Injectors: Can we Improve the Design?Dr Muriel DidierHead Human Factors Team, Novartis

SLIDES FULL RECORDING

Who Moved my Device? Adapting to Change within the Regulatory Combination Device LandscapeBjorg HunterDevice Engineering Manager, GSK

SLIDES FULL RECORDING

The Case for Early Partnering: A Flexible Technology to Enable your PortfolioMike HoovenPresident & CEO, Enable Injections

SLIDES FULL RECORDING

The Patient Experience by CDPTom Lawrie-FusseyDigital Services Specialist, Cambridge Design Partnership

SLIDES FULL RECORDING

Transforming the Patient Experience with a Novel Needle Free Drug Delivery DevicePatrick AnquetilCEO, Portal Instruments

SLIDES FULL RECORDING

An Insight into Patient Usability Preferences for Injection DevicesRichard FeatherstoneManaging Director, Medical Device Usability

SLIDES

Trends and Challenges in Inhaled Drug Delivery Transforming Respiratory Drug PortfoliosGunilla PeterssonScience & Innovation Director, AstraZeneca

SLIDES

Great summit with lots of outstanding presentations and nice talks in the breaksSebastian Wilczynski, Bench Scientist, Nordmark Arzneimittel

8 9th Global DDF Summit

Explore the content

It was an excellent opportunity to network with researchers from both academic and industrial backgroundRaghu Raj Singh Thakur, Senior Lecturer, Queens University Belfast

Who was there?

The summit attracts senior pharmaceutical development and formulation scientists from across industry and academia. Organisations in attendance in 2018 included:

Abbott

Adocia

Allergopharma

Astrazeneca

Beiersdorf

AbbVie

Alexion Pharmaceuticals

Amgen

AudioCure Pharma

Boehringer Ingelheim

Abiogen Pharma

Bristol-Myers Squibb

Aché Laboratórios

ALK

AristoPharma

BayerB. Braun

Chiesi

I enjoyed the breadth of talks and the opportunities for networkingHannah Batchelor, Senior Lecturer, University of Birmingham

10 9th Global DDF Summit

Who was there?

CSL Behring

Deva

EirGen Pharma

Esteve

Ferrer

Fertin Pharma

Daiichi Sankyo

Disphar

Eli Lilly

Forward Pharma

DBV Technologies

DSM Nutritional Products

Enesi Pharma

Freie Universität Berlin

Debiopharm

E-Pharma

Erytech Pharma

Eurofarma

Ferring Pharmaceuticals

Fresenius Kabi

Attending the summit was real pleasure for me. Useful presentations, networking with a number of experts, delicious lunches and elegant environment.Tímea Tari, Formulation Scientist, Richter Gedeon

9th Global DDF Summit 11

Who was there?

LEO Pharma

Janssen

Grupa Adamed

Gilead

GC Pharma

León Farma

Johnson & Johnson

GW Pharmaceuticals

GlaxoSmithKline

Gedeon Richter

MedImmuneMedichem

Kinderarznei

Helm

Glenmark Pharmaceuticals

Genentech

Medivir

Lundbeck

Martin Luther University Halle-Wittenberg

Ludwig-Maximilians- University Munich

Lek

Ipsen

Grünenthal

Ghent University

12 9th Global DDF Summit

Who was there?

Medivis

MSD

Niconovum

Novaliq

Orexo

PharOS

Merck Serono

Novartis

Orion Corporation

ProBioGen

Midatech Pharma

Nanomi

Nordmark Arzneimittel

Novo Nordisk

Pensatech Pharma

Queens University Belfast

Moberg Pharma

NeuroDerm

Northeastern University

Olainfarm

Pfizer

Recipharm

Inspiring summit providing Information on all aspects of drug deliveryLudger Kolbe, Chief Scientist, Beiersdorf

9th Global DDF Summit 13

Who was there?

Reckitt Benckiser

Roche

Sanovel

Statens Serum Institut

Swedish Medical Products Agency

Synthon Biopharmaceuticals

Recordati

Sandoz

Santen

Strathclyde University

Symphogen

Taro Pharmaceutical Industries

Regeneron

Sanofi

Servier

Sanofi Pasteur

Shire

Research Center Pharmaceutical Engineering (RCPE)

I was really pleased with the 2018 version. Excellent presentations from both Industry & Universities. I liked the fact that a lot of presentations contained case studies.Ben Van Hove, Associate Director Drug Product Development, Janssen Pharmaceutica

I found the summit to be very well organised and my interactions with the team organising were always clear, helpful and friendly. I thought that the exhibit and talks had good breadth across the industry.Katherine Bamsey, Senior Scientist, Midatech Pharma

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Will you be there in 2019?

Teikoku Seiyaku

TU Graz Austria

University of Navarra

Virbac Wurzburg University Zentiva

Teva Pharmaceuticals

UCB

The University of Birmingham

UCL School of Pharmacy

TU Dortmund

Universität Greifswald

Universität Innsbruck University of Copenhagen University of Greenwich University of Helsinki

Vifor Pharma

Well organized; I liked the parallel sessions, and the length of the presentation (30-35 minutes, short enough to keep focussed). The lengthy breaks were also highly appreciated.Ellen Verheyen, Senior Scientist – Stability Expert, Janssen

Who was there?

Vienna UniversityUtrecht University Netherlands

9th Global DDF Summit 15

Who was there?

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By company type:

Pharmaceuticals Delivery / Formulation

Services

Universities

59.7% 31.3% 8.5%

R&D 27.1%

Drug Development 21.1%

Business Development 15.1%

Formulation 12.3%

Professor 5.2%

Technical 4.4%

CMC 4.4%Device Development 4.1%

Quality 3.6%Marketing 2.7%

By job function:

By seniority:

Scientist 24.06% Director 21.05% Manager 20.80% Head 12.28% Specialist 5.76% Leader 5.51% Principal Scientist / Engineer 4.76% VP 3.26% C-Level 2.51%

1

7

2

5

6

4

10

9

8

3

Who was there?

9th Global DDF Summit 17

By country: By investment priorities:

Top 10 countries:1 Germany 24.8%2 United Kingdom 11.8%3 United States 9.3%4 Switzerland 7.8%5 France 6.8%6 Belgium 5.8%7 Denmark 5.3%8 Italy 4.3%9 Sweden 3.3%10 Spain 3.0%

Other countries represented:Netherlands Finland AustriaPortugal Israel SloveniaIreland Canada WalesJordan Greece TurkeyHungary PolandCzech Republic BrazilScotland Malta ChinaJapan Nigeria NorwaySouth Korea Latvia

Stability 62.6%Polymers

BioavailabilityInjection

Oral deliveryExcipients for injectables formulations

Extended releasePre-formulation

SolubilityExcipients for solid dosage formsLocal Drug Delivery: Implants, Film,

Fiber, Shapes, etc. Nanotechnology

Innovative platformsHot melt extrusion

DissolutionContinuous manufacturing

Laboratory equipmentExcipients for semi-solids

Intellectual propertySpray drying

formulations 37.4%36.4%36.4%36.4%

34.3%32.3%32.3%

31.2%

28.3%30.3%and liquids formulations 30.3%

41.4%44.4%45.5%46.5%46.5%

50.5%

54.5%51.5%

Technological Lac tose Excipients

Commercial partners

Adare Pharmaceuticalswww.adarepharma.com

Albumedixwww.albumedix.com

Dow Pharma & Medicalwww.dowpharmasolutions.com

Armor Pharmawww.armor-pharma.com

Foster Delivery Sciencewww.deliveryscience.com

Gracewww.grace.com/en-us

Aplicaps by Cloverwww.aplicaps.com/en

Cambridge Design Partnershipwww.cambridge-design.co.uk

Glattwww.glatt.com

Agilentwww.agilent.com

DFE Pharmawww.dfepharma.com

HARKE Pharmawww.harke.com

ADM-SIOwww.admsio.com

Datwyler Pharma Packaging Internationalwww.datwyler.com

Enable Injectionswww.enableinjections.com

Biopharma Groupwww.biopharma.co.uk

FreeThink Technologieswww.freethinktech.com

Thank you to our Commercial Partners, without their support the summit couldn’t exist.

Hovionewww.hovione.com

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Commercial partners

Medical Device Usability Ltdwww.medical-device-usability.com

PMC Isochemwww.pmc-group.com

ShinEtsu PFMDwww.se-pfmd.com

Merck KGaAwww.merck.com

Patheon, a part of Thermo Fisher Scientificwww.thermofisher.com/patheon

REVOX Sterilization Solutionswww.revoxsterilization.com

Lonza Pharma & Biotechwww.lonza.com

LTS Lohmannwww.ltslohmann.de/en

Nanoform Finland Ltdwww.nanoform.fi

Renishaw www.renishaw.com/Raman

Pfanstiehlwww.pfanstiehl.com

Precision NanoSystemswww.precisionnanosystems.com

W. L. Gore & Associateswww.gore.com/pharmbio

Meggle Excipients & Technologywww.meggle-pharma.com

leon-nanodrugs GmbHwww.leon-nanodrugs.com

Portal Instrumentswww.portalinstruments.com

Unchained Labswww.unchainedlabs.com

Munitwww.munit.com

Quotient Scienceswww.quotientsciences.com

Losan Pharmawww.losan-pharma.de

Roquettewww.roquette.com/pharma

9th Global DDF Summit 19

Looking forward to 2019

11 - 13 March 2019 | Berlin

10th Global

Each year we add more content, more innovation and more value. Which in turn attracts more delivery and formulation experts to this ever-growing community.

Next year we’ll be adding a third day to the new Device Development Stream. Giving you the full 4 streams of content on all 3 days.

The popular poster competition format will be expanded too. Bringing more science and innovation out of the conference rooms and into the networking hall.

New topics being researched for 2019 include:

Developing medical devices for wider eHealth integration Bringing device development closer to drug formulation Changing fundamental drug chemistry to promote personalised medicines Promoting new classes of mRNA based biologics and vaccines Key driving and restraining forces in the small molecule cancer drug market

To register your place or for more information please visit

ddfevent.com

The flagship DDF Summit will return to Berlin on 11 – 13 March 2019

If you offer services or solutions to drug developing companies and you have commercial responsibilities, then you can only attend as a Commercial Partner.

Contact Alexandra Krcho (alexandra.krcho@markallengroup.com, +44 (0) 20 3874 9205) to explore the possibilities.

It was a very good experience. I met with a lot of people and I found some ideas for my positionCarlos Diez, R&D Lab Head, Leon Farma

Very impressed especially at level of info on industrial priorities

Duncan Craig, Director, UCL School of Pharmacy

ddfevent.com

Mark Allen Group, St. Jude’s Church, Dulwich Road, London, SE24 0PB, UKmabconferences@markallengroup.com+44(0)20 7738 5454

Well organised, good mix of academics and industry and ample time for interaction with peers. Very good summit overall. Hans Platteeuw, CEO, Avivia

Excellent pharmaceutical science discussion in a perfect arrangement, congratulations!Francesco Amadei, Senior Scientist, Early Pharmaceutics Unit, Head, Chiesi Farmaceutici