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  • DAY 1
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  • Biologics
  • Innovation
  • Small Molecules
Day 1 – August, 28 2017 – Monday
07:30 – 08:25 AM
Registration & Refreshments

08:25 – 08:35 AM
Chair’s Opening Remarks

08:35 – 09:10 AM
Plenary
Improving Patient Convenience: Challenges from the Formulation Front
sano2
  • Patient centered integrated device implementation in early development
  • Role of developability and pre-formulation development
  • Analytical tools and workflows to assess device ability potential of therapeutic proteins.

Bernardo Perez-Ramírez, MSc, Ph.D.
Senior Scientific Director, Global Pharmaceutical Development-Biologics
Sanofi

09:15 – 09:45 AM
Case Study
Biologicals
High Throughput Screening of a monoclonal antibody. Practical Considerations.
gsk
  • Study Design and Constraints
  • Material Quality
  • mAb Stability as a lyophile: A case study

Myrna Monck
Director Biopharm Technologies
GSK

Case Study
Small Molecules
Molecular Dynamics Simulations of Amorphous Systems

UK

  • MD simulations reveal molecular interactions that may facilitate interpretation of experimental data
  • Energy calculations enable estimates of amorphous miscibility
  • Water uptake and the influence of water on drug-excipient interactions can be explored
  • Water clustering leads to domains having enhanced mobility

Bradley D. Anderson
Professor, Department of Pharmaceutical Sciences
University of Kentucky

09:50 – 10:20 AM
Solution Spotlight
Innovation
Beyond Aseptic Processing

revox

Increased sophistication of drug delivery methods and greater scrutiny of microbiological assurance standards are on a collision course. Learn the standards and methods of yesterday and today and the trends that will impact the way you assure your products microbiological safety in the future.

Solution Spotlight
Small Molecules
Nanoporous Silica Particles for Enhanced Drug Performance: Applications Beyond Increasing Solubility

nanologica 200

  • Nanologica’s nanoporous silica technology is a versatile drug delivery platform that addresses formulation challenges for improved clinical benefit
  • Key applications of NLAB SilicaTM are enhancing bioavailability, overcoming pH-dependent solubility issues and improving PK variability
  • Two case studies of reformulating anti-infectives with NLAB SilicaTM will illustrate how a Drug Delivery technology can be used for repurposing of marketed drugs
  • How value can be maximised by the right collaboration models between technology partner and pharma company
10:20 – 11:15 AM
Plenary
iSolve and coffee break

iSolve-logo

11:15 – 11:45 AM
Case Study
Biologicals
New Approaches to Advance Therapeutic Drug Delivery across the Blood-Brain Barrier to Brain and Brain Tumours
TTUHSC

• The blood-brain barrier restrict the brain delivery of most currently active anticancer agents used in the treatment of brain tumours.

• The magnitude of this restriction is extremely large (50-200 fold) for some of the most commonly used agents cytotoxic agents (paclitaxel, doxorubicin, vinorelbine,) and newer molecularly-target agents.
• In only a very small subset (<5%) of brain metastases is the barrier sufficiently compromised to allow marked drug accumulation.
• This restriction was found in matching human brain metastases.
• This drug delivery compromise can be overcome in brain metastases using several approaches, including drug agents which show poor affinity for barrier active efflux transport, enhanced barrier passive permeability, elevated active efflux, or molecularly targeting mechanism, such as those in using LRP, transferrin, insulin receptor, or other mechanisms.

Quentin Roberts Smith
Dean and University Distinguished Professor
Texas Tech University Health Sciences Center

Case Study
Small Molecules
Advanced Stability Predictions for Amorphous Pharmaceuticals

merck

  • Basic fundamentals of amorphous pharmaceutical stability predictions
  • Overcoming the limitations of RTD temperature sensors
  • Molecular mobility – considering the different molecular motions that exist in amorphous pharmaceuticals
  • Predicting the long-term physical stability of materials based on these molecular motions

Sunny Bhardwaj
Sr. Scientist
Merck

11:50 – 12:20 AM
Solution Spotlight
Innovation
New Possibilities using AFFINISOL™ Excipients – Exploring a Platform of Tailored Polymers for Solubility Enhancement

dow

  • AFFINISOL™ polymers are uniquely tailored to address solubilization performance requirements. Several case studies will be presented: TBC
  • AFFINISOL™ for Spray Dried Dispersions
  • HPMCAS products with a broad range of release properties-Creating an amorphous dispersion via top spray-granulation
  • AFFINISOL™ HPMC for Hot Melt Extrusion-New cellulosic materials maintaining the crystallization inhibiting properties of traditional HPMC, but can be extruded over a wide temperature range without the use of plasticizers-Next generation of AFFINISOL™-Innovative cellulosics and non-cellulosics based excipients addressing solubility challenges
Solution Spotlight
Small Molecules
RapidFACT: Using Clinical Data to Drive Effective Formulation Optimisation

quotient

This presentation will review the RapidFACT platform of integrated formulation and clinical services, specifically addressing the following topics:

  • Constraints of current development processes
  • Benefits of real-time adaptive product manufacturing
  • Rapid formulation development and optimisation strategies
  • Case studies in solubility enhancement, modified release formulation development and repurposing known compounds
12:25 – 12:55 AM

Case Study
Biologics
Protein vectors to cross the BBB for the delivery of therapeutic concentration of biologics
Bioasis
• Essential nutrients cross the Blood-Brain Barrier by Receptor Mediated Transcytosis?
• Incorporation of New Vectors into Therapeutics to cross the Blood-Brain Barrier?
• Delivery of therapeutic concentration of biologics to the CNS
• Delivery of Therapeutics to the Adequate Intracellular Compartment of Brain Cells
Case Study
Small Molecules
Advancements in Parenteral Nanosuspensions
phzer
  • Stability
  • Manufacturing challenges
  • Performance – the effect on Nanoparticles on PK after parenteral administration

Jaymin Shah
PhD, Research Fellow
Pfizer

12:55 – 13:55 PM
Networking Lunch

13:55 – 14:25 PM
Case Study
Biologicals
Advanced Photostability Risk Assessments

bristol

  • Going beyond ICH Q1B – understanding the risk of light exposure at the points of manufacturing and patient administration and putting controls around that
  • From empirical to modeling approaches – how to approach photostability risk assessment

Thiago Carvalho
Senior Research Investigator I
Bristol-Myers Squibb

Case Study
Small Molecules
Advances in Spray Granulation Techniques

nova

  • The importance of process parameters on in vitro and in vivo behaviour of dried nanosuspensions in spray granulation
  • Evaluating the effects of spray mode, spray rate and atomizing pressure for spray granulation of drug nanosuspensions
  • Use of fluid bed granulation for drying of pharmaceutical particulates on micron-sized granule substrates explores

Sonali Bose
Fellow / Project Leader
Novartis

14:30 – 15:00 PM
Solution Spotlight
Biologicals
Formulate and Characterize More Biologic Formulations Than Ever Before

unchained-labs

Forget about dialysis cassettes, desalting columns and running back and forth to the centrifuge. The GRUNT does all the manual dirty work for you. It completely automates buffer prep, buffer exchange and protein concentration and whips out more formulations than you could ever do before. Once you’ve made those formulations you still need to screen those formulations for stability. In this talk, we’ll present a rapid, total solution for formulating proteins, characterizing them for stability, predicting whether they will aggregate and determining the pathway of aggregation.

Solution Spotlight
Small Molecules
Overcoming Regulatory Hurdles When Developing New Formulations

quay

  • Session abstract TBC
15:05 – 15:35 PM
Case Study
Innovation
Knowledge-Based Selection Strategies Using the QbD Approach to Ensure Syringe Selection Decisions Meet Technical and Business Requirements

gsk

Presentation will contain comprehensive study results that evaluated available syringe products to identify the best fit for most biopharm requirements. The benefit is that a platform approach and second source not only ensures continuity of supply but also meets standardization for compliance advantage, minimizes process development and capital investment for new products and enables greater speed of decision making and implementation.

Aarti Gidh
‎Manager, BioPharmaceutical Product Sciences (BPS)
GSK

Case Study
Small Molecules

Challenges and Opportunities of Developing Pediatric Drug Formulations

tevaDevelopment of pediatric oral formulations is no child’s play! In fact, it can be quite scientifically challenging as children differ from adults in many aspects of pharmacotherapy, including capabilities for drug administration, medicine-related toxicity, and taste preferences. It is prudent that pediatric medicines are formulated to best suit a child’s age, size, physiologic condition, and treatment requirements. New regulations and research initiatives have resulted in some progress in the development of pediatric formulations.

Several challenges, however, still remain. Development of suitable dosage form to administer and taste-masking are two of the challenges unique for pediatric oral formulations and this session aims to address them in detail.

Suniket Fulzele
Group Leader, Formulation Development
Teva Pharmaceuticals

15:35 – 16:25 PM
iSolve and coffee break

16:25 – 16:55 PM
Case Study
Biologicals
Practical Considerations in Developing High Concentration Protein Formulations

Regeneron

  • Challenges and considerations: high viscosity, manufacturing challenge, device limitation, IP protection, etc.
  • Case studies in developing high concentration protein formulations
    1. Viscosity reducing strategies
    2. Balancing the viscosity reducing effect with stability
    3. DoE-based model understanding formulation viscosity vs. manufacturing variation to ensure consistent product performance

Qingyan Hu
Scientist
Regeneron Pharmaceuticals

Case Study
Innovation
Challenges and opportunities of development of salts of weak bases

pher

      • Effect of physicochemical properties of API and excipients
      • Implications of disproportionation on oral bioavailability
    • Alternative formulation approaches

Suman Luthra
Senior Principal Scientist
Pfizer

17:00 – 17:30 PM
Case Study
Biologicals
High Throughput Chemical Denaturation And Relative Viscosity Measurements Via Fluorescence During Formulation Development

Janssen

      • High Throughput Early and Late stage Pharmaceutical Development
      • Predictive analytics for therapeutic protein
      • Viscosity
    • Thermodynamic Stability

Salman Muzammil
Sr. Scientist
Janssen

Case Study
Small Molecules
Impact of Particle Size Distributions of Major Ingredients on the Compressibility of Tablets: Practical Approaches and Theoretical Hypothesis

nutrilite

  • The particle size distributions of major ingredients (more than 65 wt% in the formulae) including both actives and binders are focused in the presentation.
  • The impact of raw ingredient physical properties on the compressibility of tablets will be evaluated both experimentally and theoretically.
  • Recommendations on how to minimize the product failures and specify the raw ingredients properly will be given in the end, with the plausible theoretical hypothesis.

Tian Hao
Principal Scientist
Nutrilite

17:30 – 18:10 PM
Plenary
An Inter-Company Perspective on Biopharmaceutical Drug Product Robustness Studies

shire

      DP robustness studies are essential in developing a commercial product that:
      • is not on the edge of stability failure
      • meets quality standards when formulation and process parameters are within allowed ranges.
      Through the use of DOE, relationships between formulation attributes and manufacturing process parameters are established, ensuring DP production consistently meets CQAs.
      BPOG survey and manuscript reviews and discusses the current industry status with regard to the scope, design and execution of biopharmaceutical DP robustness studies.
      Common themes and alignment opportunities were identified with regard to the use of DP robustness studies.
    Recommendations for best practices and harmonization are integrated in the case studies.

James Kranz
Principal Scientist
Shire

18:10 – 18:15 PM
Chair’s Closing Remarks

Day 2 – August, 29 2017 – Tuesday
8:00 – 8:25 AM
Registration

08:25 – 08:30 AM
Chair’s Opening Remarks

08:30 – 09:05 AM
Plenary
In What Direction is the Drug Delivery Technology Space Moving?

MedImmune

  • Evaluating how fast the delivery technology field has evolved until now – are there limiting factors to its continued development?
  • What is the potential of less-traditional delivery routes such as nasal and ocular delivery?
  • Discussing the future of evolving areas including polymer technologies, auto injectors, microneedles etc.
  • Looking retrospectively, has the industry done all it can until now to maintain the R&D paradigm?

Anand Subramony
Vice President, Drug Delivery & Device Development
Medimmune

09:10 – 9:40 AM
Case Study
Biologicals
Recent Trends in the Similarity Assessment of Biosimilars

Biogen

      • Structural and functional data are the foundation of the similarity assessment of Biosimilars
      • Regulatory agencies require different similarity assessment approaches
      • FDA currently requires equivalence testing for those parameter with the highest clinical relevance and direct link to mode of action
    • The impact of this FDA requirement on biosimilar development and approval will be discussed
Case Study
Small Molecules
A Two-Phase Dissolution-Partition Test for Characterization of BCS II/IV Drugs and Formulations
images

 

      • Characterize the aqueous super-saturation resulting from dissolution of amorphous solid dispersions
      • Use the aqueous media with pH alteration for ionic drugs
      • Assess the interplay among three kinetic processes: dissolution, precipitation and partition
      • Facilitate evaluation of key formulation variables and functional excipients
    • Demonstrate IVIVC for several BCS II and IV products

Ping Gao
Research Fellow
Abbvie

09:45 – 10:15 AM
Solution Spotlight
Biologicals
Session TBC

captisol

  • Session TBC
Solution Spotlight
Small Molecules
Discussing the Latest in Subcutaneous Needle-Free Injection Drug Delivery

patheon

  • Session abstract TBC
10:15-11:15 AM
iSolve and coffee break

11:15-11:45 AM
Case Study
Biologicals
Non-Invasive Delivery Routes for Peptides: Focus on Successful Oral Technologies Progressing in the Clinic and Future Challenges

ipsen

Due to their physicochemical characteristics, peptides are usually administered through the parenteral route, often several times daily. Injectable sustained-release peptide formulations based on biodegradable microparticles or implants have been very successful to enhance patient adherence and convenience, and increase safety and efficacy. They are likely to remain a significant and important part of the new peptide products coming to the market. However, the tremendous developments in alternative non-invasive routes of delivery are likely to result in more and more peptides being delivered by the transdermal, nasal, inhalation and oral routes. The main purpose of this talk will be to analyze and compare the various alternative non-invasive peptide delivery technologies progressing in the clinic, discussing the pros and cons of these technologies in regards to stability, bioavailability, safety/efficacy balance, impact on costs of goods and manufacturability. A special emphasis will be put on oral peptide technologies progressing successfully in the clinic, the key learnings from ongoing clinical studies and the future challenges anticipated for filing and launching oral peptide products in the next years.

Joel Richard
Senior Vice President, Peptides Development
Ipsen

Case Study
Small Molecules
Maximizing Integration of Form with Formulation in Early Phase Development

phzer

  • Technical & Business Success Factors for Drug Delivery Programmes
  • Fighting the growing trend to outsource in an effort to maintain core skill sets
  • Minimizing initial investment to reduce risk and reduce costs later on
  • Integrating form with formulation in early development to maximise their values mutually
  • Developing a true understanding of both form and formulation for efficient development

Tao Zhang
Senior Scientist
Pfizer

11:50-12:20 PM
Solution Spotlight
Biologicals
Session title TBC

wyatt

  • Session abstract TBC
Solution Spotlight
Small Molecules
Accelerating innovation in formulation science

cas_color - 150

      • Learn new methodologies for finding intersections in literature from which to innovate
      • Leverage work done by others to speed your time to market and reduce costs
      • Uncover insights on how to solve vexing problems, such as hardness, stability, and more
      • Use trend analysis to gain a vivid understanding of the marketplace and it’s changing landscape
    • Review examples of deep analysis on excipient and properties trends to uncover insights
12:25 – 12:55 AM
Case Study
Biologicals
Thermal Stabilization of Freezing Sensitive Adjuvanted Vaccine Formulations Through Spray Drying

sanofi

Vaccination saves millions of lives each year, hence it is extremely important to maintain thermal stability and immunogenicity during manufacturing and cold chain storage of vaccines.

  • Spray-dry is an emerging technology recent increasingly investigated for biologics.
  • The POC study demonstrated that stable dried adjuvant-containing vaccine formulations can be successfully produced through spray dry for those freezing sensitive formulations, which often known easily decreased their immunogenicity during the conventional freeze drying process.
  • The physio-chemical properties were characterized and the potency was tested for the formulations.

Lillian Li
Formulation Scientist, Bioprocess Research & Development
Sanofi Pasteur

Case Study
Small Molecules
Advances in Supersaturating Drug Delivery Systems

bristol

  • What are Supersaturating Drug Delivery Systems (SDDS)?
  • Advances in developing and characterizing SDDS?
  • Complexity in in-vitro and in-silico characterization of SDDS?
  • Benefits and limitations of SDDS characterization tools and methods

Dhaval Patel
Senior Research Investigator II
Bristol-Myers Squibb

12:55 – 13:55 PM
Networking Lunch

13:55 – 14:25 PM
Case Study
Biologics
Optimizing Parenteral Delivery of Novel Class of Anticancer Drug Conjugates

tarveda

    • Pentarins are miniaturized drug conjugates that rapidly penetrate deep into solid tumors to drive efficacy
    • Pentarins can contain components with diverse physiochemical properties, such as amphiphilic conjugates, requiring careful formulation optimization for physical (solubility, aggregation/ Self-assembly)
    • Pentarins must be formulated with compatibile surfactants, complexing agents, and co-solvents
    • When there is a cleavable linker the Pentarin must have sufficient chemical stability (pH effect, temperature) in the formulation to enable in vivo testing
    • The high throughput optimization of Pentarins requires the in vivo evaluation of lead conjugates necessitating seamless interactions between medicinal chemistry, biology and formulation

Beata Sweryda-Krawiec
‎Research Leader
Tarveda Therapeutics

Case Study
Small Molecules
Improving Oral Bioavailability by Solid Dispersions: A Case Study

Shionogi

      • An overview of OSPHENA®
      • Solid dispersions of Ospemifene with hydrophilic polymers, enteric coating polymers and surfactants prepared by solvent casting, spray drying, and melt extrusion show solubility enhancement ranged from 2 to 1000 fold
      • The spray dried solid dispersions are physically and chemically stable during stability study
    • Discuss the four formulations that were selected for animal PK studies

Jimmy Chen
Senior Director, Pharmaceutical Sciences
Shionogi

14:30 – 15:00 PM
Case Study
Biologicals
Formulation and Process development of ADC Drug Products -A Case Study

ImmunoGen

      • Physicochemical properties of ADCs and its implication on DP development
      • Stability challenges and lessons learned from ADC formulation development
      • Product stability testing under clinical in-use conditions and setup of a clinical procedure for first in human studies
    • Development and optimization of a generic freeze-drying cycle for ADCs

Amy Leung
Scientist I
Immunogen

Case Study
Small Molecules
Comparison of Polymer Nanoparticle Fabrication Methods and Composition and their Effects on Nanoparticle Properties

phzer

  • Nanoparticle solubililization of drugs with poor aqueous solubility
  • Comparison of polymer nanoparticle fabrication methods and composition
  • Effect of nanoparticle fabrication method and composition on nanoparticle physical properties and parameters

Ghazal Hariri
Senior Scientist
Pfizer

15:05 – 15:45 PM
Plenary
Enhancing Open Innovation to Promote Sustainable Development
  • Encourage outside thinking by breaking down silos to create brainstorming teams
  • Implementing a transparent attitude to the development arena
  • What path is the development industry expected to move in?
  • Adapting to the evolving development and drug targeting space by sourcing distinctive technologies
  • Enhancing creativity in the development space
  • Allocating total product knowledge to promote successful, shared development
  • Allotting external innovation from non-pharma industries

15:45 – 15:55 PM
Chair’s Closing Remarks