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September 9 - 10, 2019 | Boston THE FUTURE OF PHARMACEUTICAL DEVELOPMENT POST EVENT REPORT 9th American

THE FUTURE OF PHARMACEUTICAL DEVELOPMENT€¦ · Recombinant human albumin. An effective approach for hard-to-stabilise biologics ORAL THIN FILMS - WHY THE MUCOFILM® AND THE RAPIDFILM®

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Page 1: THE FUTURE OF PHARMACEUTICAL DEVELOPMENT€¦ · Recombinant human albumin. An effective approach for hard-to-stabilise biologics ORAL THIN FILMS - WHY THE MUCOFILM® AND THE RAPIDFILM®

September 9 - 10, 2019 | Boston

THE FUTURE OF PHARMACEUTICAL DEVELOPMENT

POST EVENT REPORT

9th American

Page 2: THE FUTURE OF PHARMACEUTICAL DEVELOPMENT€¦ · Recombinant human albumin. An effective approach for hard-to-stabilise biologics ORAL THIN FILMS - WHY THE MUCOFILM® AND THE RAPIDFILM®

learned something new

and useful

97.8%

would recommend to

a colleague

97%

said the Summit had greatly exceeded,

exceeded, or met their expectations

90%

would attend again

89.4%

Statistics

registered attendees

Over

250

companiesand organisationsrepresented

150+

Highlights video2016 2017 2018 2019

Summit growth:

166

atte

ndee

s

181

atte

ndee

s

205

atte

ndee

s

253

atte

ndee

s

2

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“Good experience and exposure to current ongoing developmental and

technical improvements”Faisal Khan, Senior Research Associate, Takeda

Pharmaceuticals Company

“It is a good opportunity to learn all the updated technologies for Drug

Delivery and Formulation.”Wenjiao Song, Senior Scientist, Pfizer Inc.

“Excellent program”Peixuan Guo, Endowed Chair

Professor, The Ohio State University

“It was very informative, the talks were interesting.”

Eric Ehrnsperger, Principal Scientist, Ferring Pharmaceuticals

“High quality presentations”Dan Groszmann, Senior Manager, Amgen

Testimonials

“Great summit”Yan He, Principal Scientist, Sanofi

“Great event, great presentations, met new people”

Miranda Perry, Senior Scientist, AbbVie

“Well organized conference with great talks.”

Istvan Enyedy, Principal Scientist, Biogen

3

Page 4: THE FUTURE OF PHARMACEUTICAL DEVELOPMENT€¦ · Recombinant human albumin. An effective approach for hard-to-stabilise biologics ORAL THIN FILMS - WHY THE MUCOFILM® AND THE RAPIDFILM®

PresentationsClick on the buttons below to view the presentation slides.

Unlocking Full Formulation Performance through Advanced ExcipientsDrug Delivery & Formulation SummitBoston, Massachusetts

Kathryn Hewlett, PhDSeptember 9th, 2019

Current Trends in Technology and Regulatory Landscapes for Developing and Bringing Generics and Innovative Medicines to MarketRosario LoBrutto, Head of Scientific Affairs, Sandoz

Ultrasmall Targeted Nanoparticles with Engineered Antibody Fragments for Imaging of HER2-overexpressing Breast CancerMarcello Marelli, Senior Scientist Antibody Discovery and Protein Engineering, AstraZeneca

Unlocking Full Formulation Performance through Advanced ExcipientsDr. Kathryn Hewlett, Application Development & Innovation Scientist, DuPont Nutrition & Biosciences

Ultrasmall Targeted Nanoparticles with Engineered Antibody Fragments for Imaging of HER2-overexpressing Breast Cancer

Marcello MarelliAntibody Discovery and Protein Engineering (ADPE)

Company Restricted17 May 2019

Current Trends in Technology and Regulatory Landscapes for Developing and Bringing

Complex Generics and Innovative Medicines to Market

Sandoz, Inc (A Novartis Division)

Rosario LoBrutto, Ph.D.Head of Scientific AffairsSandoz Pharmaceuticals

Presentation: DDF, Sept.9, 2019 (Boston, USA)

Intracutaneous Microneedle Patch Delivery System for the Treatment of Acute Migraine

September 9, 2019

Yi Ao

©2019 Zosano Pharma Corp.

Hard-to-Stabilize Proteins and Peptides: Can Recombinant Human Albumin be an Effective Approach?Eleonora Cerasoli, Ph.D., Science Manager, Technology Group, Albumedix

Incorporating Behaviour Design into Digital Health ToolsPaul Upham, Head, Smart Devices, Genentech

Intracutaneous Microneedle Patch Delivery System for the Treatment of Acute MigraineYi Ao, Associate Director, Zosano Pharma

Incorporating Behavior Design into Digital Health ToolsPaul UphamHead, Smart DevicesRoche / Genentech

9 September 2019Eleonora Cerasoli American DDF Summit - 2019 Boston

Recombinant human albumin. An effective approach for hard-to-stabilise biologics

ORAL THIN FILMS -WHY THE MUCOFILM® AND THE RAPIDFILM® ARE EXACTLY WHAT YOU NEED

Dr. Ahmad Ghoniem – tesa Labtec – your global CDMO for patches and films – by your side from iea to market

Formulation Development Gap Assessment for An In-licensed Program: A Case StudyNazila Miller, Director, Drug Product Development, Takeda

Modelling Autoinjector Injection Time DistributionJean-René Authelin, Global Head of Pharmaceutical Engineering, Sanofi

Transmucosal Delivery – Using the Mucofilm® Technology to Bypass the First Pass EffectDr. Ahmad Ghoniem, Pharmacist - Business Development Manager, tesa Labtec North America

Modeling of Autoinjectors

JR Authelin SANOFI R&D, Pharmaceutical Sciences Operations In name of the team : Thomas Van der Burg, Maximilian Michel, Michel Becker, Iwo Iwnicki, Lionel Bardet, Nima Ajaghari DDF Boston September 10th 2019

DDF Boston Mathematical Modelling of Autoinjectors 1

Formulation Development Gap Assessment for An In-licensed Program: A Case Study 10 Sept 2019, DDF Summit, Boston, MA

Drug Product Development, Shire HGT Inc., Lexington, MA, A Takeda Company Nazila Miller, Ph.D., Director

Confidential - for internal use only

4

Page 5: THE FUTURE OF PHARMACEUTICAL DEVELOPMENT€¦ · Recombinant human albumin. An effective approach for hard-to-stabilise biologics ORAL THIN FILMS - WHY THE MUCOFILM® AND THE RAPIDFILM®

PresentationsClick on the buttons below to view the presentation slides.

Understanding Developability Assessment of Small MoleculesSudhakar Garad, Global Head of Chemical and Pharmaceutical Profiling, Novartis Institutes for BioMedical Research

Solubility Strategies at the Interface of Drug Discovery and DevelopmentPhilippe Lienard, CMC Pre-Development Science Leader, SanofiSolubility Strategies at the Interface

of Drug Discovery and Development Dr. Philippe LIENARD

Pho

to c

redi

ts: ©

Drug Delivery and Formulation Conference, Boston

Understanding Developability Assessment of Small Molecules

Sudhakar Garad, Ph.D.Novartis Cambridge, [email protected] 9th 2019

Applying ICH Q12 to Combination ProductsDiane Harper, Director Regulatory Affairs-CMC, Merck

Machine Learning Models for Predicting P-gp and BCRP Mediated EffluxIstvan Enyedy, Principal Scientist, Biogen

1Biogen | Confidential and Proprietary

September 9, 2019

Istvan J. Enyedy

Machine Learning Models for Predicting P-gp and BCRP Mediated Efflux

APPLYING ICH Q12 TO COMBINATION PRODUCTS

Diane Harper, PhD, JD, RACDirector, Regulatory-CMC Combination ProductsMerck & Co., Inc.

2019 American Drug Delivery & Formulations SummitBoston, MA; September 2019

Harnessing the Power of the Digital Exhaust to Improve Patient OutcomesGraham Jones, Director of Innovation, Novartis

RNA Nanotechnology for Drug Delivery and FormulationPeixuan Guo, Sylvan G. Frank Endowed Chair in Pharmaceutics and Drug Delivery Systems, The Ohio State University

RNA Nanotechnology for Drug Delivery and Formulation

Peixuan Guo

Endowed Chair, College of Pharmacy and College of Medicine, Director, Center for RNA Nanobiotech and Nanomedicine,

The Ohio State University, Columbus, OH USA

President, International Society of RNA Nanotechnology and Nanomedicine (ISRNN)

Harnessing the Power of the Digital Exhaust to Improve Patient Outcomes

DDF – September 9, 2019Graham B. Jones

Director of Innovation, Novartis AGProfessor of Medicine, Tufts Medical Center

Thinklabs

5

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Who was there? The summit attracts senior pharmaceutical development and formulation scientists from across industry and academia. Organisations in attendance in 2019 included:

6

10th Global

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Who was there?

10th Global

7

Page 8: THE FUTURE OF PHARMACEUTICAL DEVELOPMENT€¦ · Recombinant human albumin. An effective approach for hard-to-stabilise biologics ORAL THIN FILMS - WHY THE MUCOFILM® AND THE RAPIDFILM®

Who was there?

10th Global

77.4% 18.2% 4.4%Pharmaceuticals Delivery / Formulation

ServicesUniversities

Oral

Stability

Injection

Solubility

Pre-formulation

Polymers

Bioavailability

Excipients for solid dosage forms formulations

Extended release

Nanotechnology

Excipients for injectables

formulations

Sustained release

Spray drying

Nano

Lipids

53.4%

53.4%

48.3%

48.3%

48.3%

46.6%

44.8%

43.1%

41.4%

37.9%

37.9%

36.2%

34.5%

32.8%

32.8%

8

By seniority: Scientist/specialist 54.1% Director 27.3% VP 6.6% C-level 4.9% Manager 3.8% Head 3.3%

By company type:

Common job functions:

• R&D • Analytical Development • Pharmaceutical Development • Formulation Development • Technical Development • Device Development • Process Development • Drug Development • CMC • Human Factors • Innovation • Business Development

Priority investment areas

Page 9: THE FUTURE OF PHARMACEUTICAL DEVELOPMENT€¦ · Recombinant human albumin. An effective approach for hard-to-stabilise biologics ORAL THIN FILMS - WHY THE MUCOFILM® AND THE RAPIDFILM®

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

Foster Delivery Sciencewww.deliveryscience.com

Enable Injectionswww.enableinjections.com

DuPont Nutrition & Healthwww.dupont.com

Captisolwww.captisol.com

Biopharma Groupwww.biopharma.co.uk

Albumedixwww.albumedix.com

Emergent BioSolutionswww.ebsi.com/CMO

Datwylerwww.datwyler.com

Cambridge Design Partnershipwww.cambridge-design.com

Arcinovaarcinova.com

Agilentwww.agilent.com

DPT Laboratorieswww.dptlabs.com

Intertekwww.intertek.com

LTS Lohmannwww.ltslohmann.de

Microporemicroporetech.com

Leon-Nanodrugswww.leon-nanodrugs.com

Lonza Pharma and Biotechwww.lonza.com

MedPharmwww.medpharm.com

Halo Labswww.halolabs.com

Gore & Associateswww.gore.com/pharmbio

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Page 10: THE FUTURE OF PHARMACEUTICAL DEVELOPMENT€¦ · Recombinant human albumin. An effective approach for hard-to-stabilise biologics ORAL THIN FILMS - WHY THE MUCOFILM® AND THE RAPIDFILM®

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

Pace Life Scienceswww.pacelifesciences.com

Precision Nanosystemswww.precisionnano systems.com

Munitwww.munit.com

PMC Isochemwww.pmcisochem.fr

Quotient Scienceswww.quotientsciences.com

Upperton Pharma Solutionsupperton.com

Sorrel Medicalwww.sorrelmedical.com

Sensile Medicalwww.sensile-medical.com

Tesa Labtecwww.tesa-labtec.com

Soncebozwww.medical.sonceboz.com

Redshift Bioanalyticsredshiftbio.com

Commecial Partner Testimonials

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BOOK YOUR PLACE EARLY

As a delegate

We return to San Diego in 2020 with more exclusive case studies from leading pharma experts. You can expect an agenda featuring the world’s leading brands. The speakers will once again be senior executives with a wealth of experience to share with you. Subjects covered will include:

• Formulation design for poorly soluble compounds• The potential of nanotechnology for better deliverability• The latest controlled released technologies• Improving patient compliance by harnessing data and the latest smart device technology• Optimising formulations for continuous manufacturing• Overcoming the blood brain barrier and challenges in oral delivery of biologics• Reformulation and biosimilar As a commercial partner

If you sell solutions or services in the drug development or delivery space, then get in touch asap. Prime spaces on the agenda and in the exhibition hall always sell out early.

Follow us:#DDFSummit

Looking ahead to 2020

To find out more about commercial partner opportunities contact

Alexandra Krcho on [email protected]

or call her on +44 (0) 203 874 9205

10th American

September 14 – 15, 2020 | San Diego

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