Programme 2019

September 9-10, 2019; Boston, MA

7:40 AM - 8:40 AM

Registration & Refreshments

8:40 AM - 8:50 AM

Chair’s Opening Remarks

8:50 AM - 9:25 AM - Keynote

Biologics

Emerging Opportunities in Biologics Delivery

Sudhakar Garad, Global Head of Chemical and Pharmaceutical Profiling, Novartis Institutes for BioMedical Research

  • Changing regulatory landscape including paediatric regulations  
  • Demand in the market
  • Challenges in the industry to be addressed
  • The changing landscape of collaboration

9:30 AM - 10:05 AM - Case Studies

Small Molecules

Current Trends in Technology and Regulatory Landscapes for Developing and Bringing Generics and Innovative Medicines to Market

Rosario Lobrutto, Head of Scientific Affairs, Sandoz

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Biologics

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

Marcello Marelli, Senior Scientist Antibody Discovery and Protein Engineering, Medimmune

  • Construction and efficient assembly of silica-based ultrasmall nanoparticle with anti-Her2 targeting antibodies
  • Targeted nanoparticles effectively localize to Her2 expressing tumors in vivo
  • Nanoparticles show low liver accumulation and high tumor to background ratios in vivo
  • Targeted nanoparticles have the potential for use in staging, risk stratification, treatment planning and development of next generation therapeutics.

Device Development

Biopharm Combination Product Development: Injection Force Modeling and Container Closure Selections/Criteria

Aarti Gidh, Technology Development Team Lead, GSK

  • Viscosity, injection force and delivery time modeling study for different needle gauge and autoinjector spring combinations.
  • Cross-functional selection criteria and assessment tools applied to propose new selections and justify changes of container closure platforms.

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

Small Molecules

Session TBC (DuPont)

Biologics

Session TBC (Albumedix)

Device Development

Chlorine Dioxide Sterilization Effects on Elastomeric Closure (FM457/0 with and without Omni Flex) Physicochemical and Functional Characteristics

Eugene Polini, Technical Key Account Manager, Datwyler Pharma Packaging, Inc.

In order to understand the functional and physicochemical effects on elastomeric closures after normal and prolonged exposure to chlorine dioxide gas (CD) sterilization procedures closures will be exposed to different levels of CD and then tested for functional and physicochemical properties.

Take home benefits:

Audience will come away with new knowledge on a novel sterilization made with respect to their parenteral packaging.

10:45 AM - 11:35 AM

iSolve & Networking Break

11:35 AM - 12:10 PM - Case Studies

Small Molecules

Solubility Strategies at the Interface of Drug Discovery and Development

Dr. Philippe Lienard, CMC Pre-Development Science Leader, Sanofi

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Biologics

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

Istvan Enyedy, Principal Scientist, Biogen

The Design of therapeutic agents that penetrate the blood-brain barrier is challenging mainly due to the promiscuity of efflux transporters. The structures of P-gp and BCRP have been published allowing us to build machine learning models that combine the transporter structural information with traditional ligand-based descriptors. The performance of these models will be presented.

Device Development

Incorporating Behaviour Design into Digital Health Tools

Paul Upham, Director, Smart Devices, Genentech

When the intended uses of a digital health solution include things like: remote monitoring of the subject; helping to improve medical adherence or persistence; increasing engagement; and clinical decision support, it is likely that the design of that solution would benefit from incorporating principles rooted in behavior neuroscience – especially related to how to encourage behavior change and the adoption of new or modified behaviors. Historically, the med-tech and pharmaceuticals industry has developed and launch digital tools with many of these intended uses, but were unsuccessful in achieving meaningful, sustained results. The consumer technology world, however, has demonstrated that the careful application of behavior design to the user experiences in digital products can significantly change human behavior in ways that achieve meaningful, sustained value. This presentation will provide examples of failures and success and introduce key aspects of behavior design that can be incorporated into the device design and development process.

12:15 PM - 12:50 PM - Solution Spotlights

Small Molecules

Session TBC (Foster Delivery Science)

Technology & Innovation

Session TBC (Lonza Pharma & Biotech)

Device Development

Session TBC (Enable Injections)

12:50 PM - 1:50 PM

Networking Lunch

1:35 PM - 2:10 PM - Case Studies

Small Molecules

Building a Chemical Space Map for in- silico Prediction of Supersaturation by Mesoporous Silica

Suman Luthra, Senior Principal Scientist, Pfizer

Abstract

Biologics

Quest for Quality Drug – Use of First Principle Based Biophysical Assays to select Manufacturable Molecule

Sathya Venkataramani, Associate Director, Janssen Biotherapeutics

According to Trends in Clinical Success, only ~10% of drugs that enter Phase I are destined to get FDA approval. One of the potential factors that has commonly impacted the success rate is poorly behaved molecules. To save cost and to expedite development that will enable higher success rate, it is undoubtedly critical to characterize the intrinsic properties of molecules early on. This talk is designed to highlight few high throughput assays and first principle based biophysical tools to select molecules that are risk free from manufacturing challenges.

Device Development

Harnessing the Power of the Digital Exhaust to Improve Patient Outcomes

Graham Jones, Director of Innovation, Novartis

2:15 PM - 2:50 PM - Solution Spotlights

Small Molecules

How do I quickly develop first-in-human (FIH) dosage forms and avoid CMC delays while achieving proof-of-concept (POC)?

Kieran Crowley, Executive Director and Head of Drug Development Solutions North America, Quotient Sciences

  • Choosing the appropriate dosage form for first-in-human/Phase I trials – fit for purpose, fit for phase?
  • Compounding or GMP manufacturing – how to balance cost, time and dose flexibility?
  • Challenges with poorly soluble molecules in early development – what technologies can we deploy?
  • Bridging to robust and scalable Phase II drug products – how to avoid losing time in development?
  • Integrating pharmaceutical sciences and clinical testing to de-risk and accelerate drug product development

Biologics

Session TBC (Biopharma group)

Device Development

Solution Spotlight (Sonceboz)

2:50 PM - 3:40 PM

iSolve & Networking Break

3:40 PM - 4:15 PM - Case Studies

Biologics

Nanoemulsion-Based Therapies: Antimicrobial, Anti-inflammatory and Drug Delivery Properties

Susan M. Ciotti, Director of Formulation Development, Ann Arbor MI, Adjunct Professor, Pharmaceutical Sciences, University of Michigan, Ann Arbor MI, BlueWillow Biologics

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Device Development

Intracutaneous Microneedle Patch Delivery System for the Treatment of Acute Migraine

Yi Ao, Associate Director, Zosano Pharma

  • Overview of Zosano’s intracutaneous microneedle patch delivery technology
  • Evaluating the stability and delivery of zolmitriptan intracutaneous microneedle patch system
  • Clinical assessment on efficacy and safety of zolmitriptan intracutaneous microneedle patch system for the treatment of acute migraine

4:20 PM - 4:55 PM - Case Studies

Small Molecules

Orthogonal Method to Determine the Glass Transition Temperatures of Commercial Biopharmaceutical Product

Younghoon Kim, Scientist- Biologics Drug Product Development and Manufacturing Group, Sanofi

Biologics

Novel CART Cell Therapy Based Tumour Treatments

  • Challenges and solutions to finding correct antigens
  • Overcoming hostile environment associated with tumours

Device Development

Development of Inhalers That Guide Patient Technique

  • Setting out the problem with improper inhaler use
  • Can we reduce the amount of medication lost from inhalers?
  • Programming smart inhalers to inform patients of medication adherence
  • Integrated sensors to warn patients of environmental asthma triggers

5:00 PM - 5:30 PM - Keynote

Panel Discussion: Preparing for Patient-Centric Drug Development Regulations

Zhengming Chen, Senior Director, Pharmaceutical Science , Shionogi

Diane Harper, Director Regulatory Affairs-CMC, Merck

  • What do the recent FDA Guidelines on Patient-Focused Drug Development (PFDD) mean to us?
  • Why do we need more patient focussed thinking and design of drug products, medical devices and combination products?
  • How will become more patient focussed shake up the industry and make us more competitive

5:30 PM - 5:35 PM

Poster Presentation Award

DDF Poster 2019 Winner Announcement and Award Presentation

5:35 PM - 5:40 PM

Chair’s Closing Remarks

5:40 PM - 6:40 PM

Evening Drinks Reception

8:00 AM - 8:45 AM

Registration & Refreshments

8:45 AM - 8:50 AM

Chair’s Opening Remarks

8:50 AM - 9:25 AM - Keynote

Biologics

9:30 AM - 10:05 AM - Case Studies

Small Molecules

Formulation Challenge and Strategy for Supporting Toxicology and First in Human Studies.

Chris Ho, Senior Director, Head of Early Formulation Development, PDS, U.S., Sanofi Genzyme

  • Abstract TBC

Biologics

Understanding the Polysorbate 20 Hydrolysis During the Life-time of Protein Formulations: A De-risking Case Study

Keethkumar Jain, Senior Drug Product Development Scientist Process Development, Formulation Development, Takeda

  • Abstract TBC

Device Development

Applying ICH Q12 to Combination Products

Diane Harper, Director Regulatory Affairs-CMC, Merck

With the anticipation of ICH Q12 guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management proceeding to Step 4 in late 2019, combination product sponsors have an opportunity to level set expectations on CMC life cycle management as well as to improve the CMC submission strategy and dossier. Perspectives on how ICH Q12 can be implemented for drug-device combination products will be discussed with a focus on the device constituent. Additionally, current thinking on the use of Established Conditions to create a performance-based device constituent control strategy will be shared.

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

Small Molecules

Session TBC (Cydex Pharmaceuticals)

Technology & Innovation

Solution Spotlight (LTS Lohmann)

Device Development

Solution Spotlight (Session TBC)

10:45 AM - 11:35 AM

iSolve & Networking Break

11:35 AM - 12:10 PM - Case Studies

Small Molecules

Oral Controlled-Release Liquid for a Low Potency Drug

Alfred Liang, Senior Director, Pharmaceutical Sciences, Ferring

  • Overview of current oral controlled-release liquid technologies
  • Challenges of developing a palatable controlled-release liquid for high dose, low potency drugs
  • Examples of viable delivery options

Biologics

mRNA delivery: Lipid Nanoparticles and Beyond

Puneet Tyagi, Senior Scientist Dosage Form Design & Development, AstraZeneca

mRNA is an exciting new class of drug that has the potential to play a role in gene therapy. With several advantages over DNA, including the lack of any requirement for nuclear localization or transcription and the nearly negligible possibility of genomic integration of the delivered sequence, mRNA holds tremendous potential to cure diseases. However, the labile nature of mRNA is an important limitation to its in vivo application. Thus, its paramount to develop mRNA delivery strategies for its success as a therapeutic. In this presentation, drug delivery platforms will be discussed, with focus on commercial application and viability.

Device Development

Challenges and Opportunities in Combination Product Design, Development and Use

12:15 PM - 12:50 PM - Solution Spotlights

Small Molecules

Unleashing the Potential of Poorly Water Soluble Drugs with the Next Generation Nano Technology

Andrea Cusack, Managing Director & Chief Business Officer, Leon-nanodrugs GmbH

  • SMART nanoparticle™ technology
  • Oral & parenteral case studies
  • Easy scale up & low complexity
  • Bringing improved products to market

Technology & Innovation

Solution Spotlight (tesa Labtech)

Device Development

Solution Spotlight (Session TBC) (1)

12:50 PM - 1:50 PM

Networking Lunch

1:35 PM - 2:10 PM - Case Studies

Small Molecules

Inner Ear Drug Delivery: Distribution and Retention of Neurotrophin-3 in Cochlea (tentative)

Qi-Ying Hu, Director of Formulation and Drug Delivery, Decibel Therapeutics

Abstract TBC

Biologics

DMPK studies during discovery and development with focus on BBB

Doug Burdette, Director, DMPK, Biogen

  • Abstract TBC

Device Development

Medical Apps and a New Generation of Combination Products

  • The next logical step: How, why and when to include an app with your drug or device
  • What benefits can an app provide the patient
  • Regulations on apps and data

2:15 PM - 2:50 PM - Solution Spotlights

Small Molecules

Solution Spotlight (Session TBC) (3)

Biologics

What's in your formulation?

John Proctor, Vice President Marketing , Halo Labs

  • Impact of refractive index on sub-visible particle measurement techniques
  • Measuring 96 samples in 96 minutes
  • Analyzing insoluble protein aggregates in most formulations with only 25uL
  • Fluidics-free sub-visible particle counting with the HORIZON® system

Device Development

Solution Spotlight (Session TBC) (5)

2:50 PM - 3:40 PM

Networking Break

3:40 PM - 4:15 PM - Case Studies

Small Molecules

Biologics

Challenges in Developing Co-formulated Monoclonal Antibody Drug Product

Yuan Cao, Staff Scientist, Regeneron

To date, there is limited number of commercialized drug product composed from multiple protein entities…To be updated later

Device Development

Ophthalmic Drug Delivery

  • Avoiding drug loss through thermoresponsive polymer formulation
  • in-vitro evaluation of ophthalmic drug release
  • Performance characteristics of ophthalmic drug delivery

4:20 PM - 4:55 PM - Panel Discussion

Device Development

Session TBC (Constellation)

Jatin Patel, Senior Director, CMC, Constellation Pharmaceuticals

·         What are the current and anticipated hurdles to novel drug delivery?

·         What are the current biggest challenges to developing new combination products and how will this affect LCM?

·         How will new technology change current products (special focus on apps and connectivity)

4:55 PM - 5:10 PM

Chair’s Closing Remarks