• FULL PROGRAM
  • DAY 1
  • DAY 2
  • PROGRAM AT A GLANCE
  • Show All
  • Biologics
  • Innovation
  • Small Molecules
Day 1 – June, 13 2016 – Monday
7:45-8:30 AM
Registration

8:35-9:05 AM
Small Molecules
Utilizing Novel Technology to Accelerate Drug Development, Save Money and Improve the Efficiency of Drug Delivery and Formulation

 

  • Apply new technology to accelerate drug development pipeline and develop a novel formulation
  • Delivering benefit to the patient while creating novel formulations
  • Translating the technology from use in R&D to clinical output

Jeffery Liu
Director, Clinical Development
GSK

9:05-9:35 AM
Innovation
Highlights on Prodrug Design, Evaluation and an Ambitious Case Study on Improving Permeability via a Prodrug Strategy

 

The ideal oral drug is one that is well absorbed from the GI tract, has an acceptable PK profile, and is easily formulated into a conventional dosage form.  If some of these attributes are not met, conversion to a prodrug often can alleviate the deficits.   It follows that the ideal prodrug is one that achieves its desired therapeutic goal, is non-toxic, and breaks down efficiently and quantitatively to the parent drug and to known and safe byproducts.

Functional prodrugs must be thoughtfully designed, while rapid and efficient characterization of their physiochemical and biopharmaceutical properties allows us to effectively assess the likelihood of success and challenges for clinical development.  This lecture describes some strategies towards these ends, along with an interesting and ambitious case study on a prodrug approach to improve the permeability of raltegrivir.

John Higgins
Senior Principal Scientist, Discovery Pharmaceutical Sciences
Merck Research Labs

9:35-9:40 AM
Please move to your next session

9:40-10:10 AM
Technology Spotlight
Small Molecules
Beyond Aseptic Processing

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.

Mason Schwartz
Technology Director
REVOX

Technology Spotlight
Biologics
Formulate and Characterize More Biologic Formulations Than Ever Before

 

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.   

Russell Burge
Senior Application Scientist
Unchained Labs

10:10-10:55 AM
iSolve Meetings, Meet the Speakers & Refreshment Break

 

10:55-11:25 AM
Case Study
Biologics
Stability challenges in designing mAbs formulation

 

The greatest challenge in the development of protein therapeutics is to prevent both physical and chemical changes to protein. This presentation will summarize various physical and chemical instabilities in proteins and discusses environmental factors that could affect the physical and chemical instabilities of proteins. The approach and challenges in formulation development, stress conditions and analytics to measure stability will also be discussed.

Arvind Srivastava
Director of Formulation Development
Eli Lily and Company

Case Study
Innovation
Utilizing Continuous Granulation to Reduce Time to Market and Increase Your Development Flexibility

 

Understand how the traditional granulation process is being converted to continuous granulation in this exciting case study on modified controlled-release formulation by Dr Lin Zhu. Together with illuminating both the benefits and problems encountered during the feasibility study, Dr Zhu will also:

  • Clarify what benefits this new process brings to the manufacturing of solid dosage forms
  • Explore how robust the process truly is
  • Compare product quality from continuous granulation process and traditional granulation process

Lin Zhu
Technical Section Manager
AbbVie

11:25-11:30 AM
Please move to your next session

11:30-12:00 PM
Technology Spotlight
Small Molecules
Captisol® Technology – Evomela® (melphalan) for Injection Development: A Case Study

 

  • Introduction to Captisol Technology
  • Evomela® Product Development – Highlights
  • Captisol-enabledTM Evomela® (melphalan) for injection vs. Alkeran®
  • Reconstitution and admixture solutions stability study
  • Stability study of CE-Melphalan reconstitution solution at refrigerated conditions

Ramsharan Singh
Executive Director, Pharmaceutical Developments
Spectrum Pharmaceuticals Inc.

Technology Spotlight
Innovation
BEPO, the Game-changing Long-acting Injectable Technology Platform

 

Based on a combination of co-polymers, solvent and API, the BEPO technology can provide a controlled release of drug for days, weeks or months from a fully biodegradable depot that forms after subcutaneous injection or local delivery of the formulated API.

The presentation will focus on long-acting injectables benefits and opportunities and on BEPO advantages including improved patient compliance, efficacy and tolerability, as well as, versatility, speed of development and low manufacturing costs.

Alexandre Melin
Strategic Alliances – Business Development & Licensing Executive – Corporate Legal Operations
Medincell

12:00-12:05 PM
Please move to your next session

12:05-12:35 PM
Case Study
Small Molecules
Nab Formulation Technology Platform for Small Molecule Drugs

 

  • The Nab (nanoparticle albumin-bound) platform is a unique technology for the delivery of hydrophobic molecules
  • Abraxane (nab-paclitaxel) is the first protein based nanoparticle approved and marketed
  • Abraxane has improved efficacy and safety profile compared to solvent-based cremophor-paclitaxel formulation in multiple tumor types
  • Nab technology exploits unique properties of albumin to enhance distribution and penetration of drug to the tumor

Willard Foss
Director, Early Biologics Development
Celgene

Case Study
Innovation
Computational Approaches for Predictive Biopharmaceutics Risk Management

 

Identification of biopharmaceutics risk and prospective management of those risks through predictive computational modeling during earliest stages of clinical drug development can provide significant enhancement in speed and confidence in establishing safety, PK and PK-PD for new chemical entities. The real challenge for the industrial formulation scientist and clinical pharmacologist is to have computational framework that provides high fidelity, insightful information on factors influencing oral absorption in the absence of any clinical data.

Availability of a simulation tool that is flexible, customizable and adaptive to address the specific needs of drug molecule would enable applicability to the broad structural diversity of drug molecules. In this presentation, the speaker will present case studies on how simulation helped understanding the biopharmaceutics risks associated with transition of compounds from preclinical to FIH studies

Fady Ibrahim
Prinicipal Scientist
Pfizer

12:35-12:40 PM
Please move to your next session

12:40-1:10 PM
Technology Spotlight
Small Molecules
Advances in application of hot-melt extrusion technology as a platform for specialty pharmaceutical applications – Examples of different solid oral dosage forms of abused drugs

 

Hot-melt extrusion (HME) technology has been advanced to create a platform for different solid oral dosage forms with abuse-deterrent characteristics. The session will provide insights into:

  • Concepts of the use of HME in abuse-deterrent technology
  • Formulation and process design to achieve abuse deterrent properties for a wide range of products
  • Aspects of scale up and commercial manufacturing of HME based abuse-deterrent products
  • Further applications and advancements of HME in the pharmaceutical industry

Dr Eric Galia
International Project Leader
Grunenthal GmbH

Technology Spotlight
Biologics
Particles: When Size Matters Ensure Confidence with Complementary Techniques

 

Significant advances have been made in analytical technology for the characterization and identification of particles present pharmaceutical products. With these advances comes a tremendous amount of new data with which to characterize biologics, devices, and small molecules. Careful interpretation of data and in-depth understanding of the method limitations is of utmost importance for using complementary methods to characterize particle profiles. This presentation demonstrates how multiple particle techniques can be used to characterize therapeutic products and their particle populations. We provide case studies to highlight the advantages of particle methods for characterizing

  • A commercially available brand of filgrastim and its biosimilar
  • A commercially available Recombinate and its infusion system
  • A commercially available topical ointment consisting of two API’s of distinct PSDs

Amber Fradkin
Associate Director, Particle Characterization Core Facility
KBI Biopharma, Inc.

1:10-2:10 PM
Networking Lunch

2:10-2:40 PM
Technology Spotlight
Biologics
Nanoporous Silica – An Unexploited Technology Platform for Delivery of Biologics?

 

  • Nanologica’s nanoporous silica technology is a versatile drug delivery platform that can be tailored to different clinical needs.
  • Beyond poorly solubles: Benefits of nanoporous silica will be showcased by presenting recent developments in our research effort on sustained release of peptides.
  • Targeted and sustained delivery of peptide mimetics – the therapeutic platform of the future?

Prof Adam Feiler
Chief Technical Officer
Nanologica

Case Study
Innovation
Enzyme Replacement Therapies that Cross the Blood-Brain Barrier

 

The blood-brain barrier (BBB) represents a formidable challenge for leveraging enzyme replacement therapy to treat the CNS sequelae associated with lysosomal storage diseases. We have targeted the endogenous BBB receptor-mediated transport system of the human insulin receptor (HIR) or transferrin receptor (Trf) with a monoclonal antibodies (MAb) re-engineered with enzyme fusions to treat  mucopolysaccharidoses.

The emerging data from these ongoing clinical trials and pipeline plans will also be presented. This work further advances the theory that re‑engineering of biotherapeutics enables safe and rapid BBB penetration for treatment of the neurological sequelae in a range of disorders.

James Callaway
President & CEO
ArmaGen

2:40-2:45 PM
Please move to your next session

2:45-3:15 PM
Case Study
Small Molecules
Drug Delivery Applications in Ophthalmic Product Development

 

The presentation will evaluate the value proposition using drug delivery for ophthalmic combination product development. Current ophthalmic market, drug delivery technologies, current marketed product, and pipeline candidates are reviewed.

The final part of the presentation will focus on performance characteristics for drug delivery systems, and general considerations in drug product development.

Hui Liu
Senior Technical Lead, Formulation
Alcon, a Novartis Company

Case Study
Innovation
Leveraging Predictive Modeling in Guiding Formulation Decisions

 

  • Formulation technologies available to modify drug release profile and improve absorption for oral dosage forms
  • Multiple considerations in making these formulation decisions, such as in vivo performance, stability, manufacturability, and business drivers
  • Models and simulations used as a powerful tool to integrate in silico, in vitro, and in vivo data to bridge the gap between CM&C and in vivo performance
  • Case studies will be presented

Hannah Yu
Principal Research Scientist, Drug Product TS/MS Commercialization
Elanco, Eli Lilly and Company

3:15-3:20 PM
Please move to your next session

3:20-3:50 PM
Technology Spotlight
Small Molecules
Leveraging Single-Step Manufacturing of Monodisperse Controlled Powders for Oral and Parenteral Administration for Increased Patient Compliance

 

  • Controlled release powders offer the most format flexible solution for oral and parenteral drugs
  • Finely controlling particle size affords many advantages for controlled-release
  • Single-step manufacturing enables increased throughput and reduced operating costs
  • Orbis’ can enable many new drug formats for existing formulation technologies with uniform microspheres and microcapsules

Nathan Dormer
Director of Formulation Sciences
Orbis Biosciences

Technology Spotlight
Innovation
ElectroNanospray: Realizing the Benefits of Being Nano-Sized and Amorphous

 

This session will highlight the benefits of ElectroNanospray (ENS), which yields amorphous API as sub-micron-sized particles to solve the formulation challenges of poorly soluble drugs.

  • Operating under ambient conditions using pharmaceutically acceptable excipients and solvents
  • Enhancing performance beyond results obtained with commonly used drug delivery technologies
  • Commercially relevant, cGMP-compliant manufacturing process
  • Aternative formulations for a wide range product targets, including 505(b)(2), ANDA, and NCE opportunities

Chris Wertz
Senior Director of R&D
Nanocopoeia

3:50-4:35 PM
iSolve Meetings, Meet the Speakers & Refreshment Break

 

4:35-5:05 PM
Innovation
Continuous Manufacturing – Lessons Learned From a Successful Approval Process

 

Having interacted with both the FDA and MHRA to secure approval for continuous manufacturing of a drug, gain insight on the lessons learned and implemented in this insightful case study.

  • Rationale for implementation
  • Cost savings anticipated
  • Verifying materials tracking and justifying a materials segregation strategy
  • Utilizing predictive models to predict process and product performance alongside offline testing
  • Validation

Steven Dale
Scientist I – Continuous Manufacturing
Vertex Pharmaceuticals

5:05-5:10 PM
Please move to your next session

5:10-5:40 PM
Case Study
Biologics
De-risking Vaccine Formulation Design

 

  • To de-risk vaccine formulation development we have looked to complement animal immunogenicity studies with the response in fresh human whole blood (hWB)
  • As a Proof-of-concept for the approach we demonstrate a profound adjuvant-modulated antigen-specific response with a candidate TB vaccine combined with two different adjuvant formulations
  • We present a potential application by screening different vaccine formulations and show a critical need for an excess of adjuvant
  • Potential next steps will be discussed

Roger Brookes
Senior Scientist
Sanofi Pasteur

Case Study
Small Molecules
Solubilization Strategies for Poorly Water Soluble Drug Candidates

 

  • Avoiding costly trial and error: how to select the right approach based on evaluation of the physicochemical properties of the drug
  • Proven solubilisation strategies to enhance bioavailability
  • Common absorption issues in modern compounds and how to overcome them
  • Strategies to address low drug solubility: cyclodextrin complexation, particle size reduction-nano formulation, amorphous solid dispersion

Ron Chen
Principal Scientist
Takeda

5:40-6:25 PM
Innovation
Your Say Panel Discussion

 

In this engaging and animated finish to the day, the unique “Your Say” panel discussion poses a series of questions to the audience, who vote on 1 of 2 options. These questions will explore some of the key points raised throughout the day. Throwing the floor open, a nominee from each half of the audience is then invited to outline why they voted how they did. After both sides present their case, the panel will discuss the results and the arguments raised.

Always enlightening, never dull, these interactive discussions provide a great insight into industry’s current thinking and let you have your say.

James Callaway
President & CEO
ArmaGen

Hovik Gukasyan
Senior Principal Scientist
Pfizer

Rosario LoBrutto
Senior Director, Head of Development Sterile Products
TEVA Pharmaceuticals

6:25-6:30 PM
Chairman’s Closing Remarks

6:30-8:30 PM
Reception

Day 2 – June, 14 2016 – Tuesday
8:00-8:30 AM
Registration

8:35-9:05 AM
Biologics
A Second Chance: Overcoming the Unique Challenges in the Revival of a Discarded Drug

 

 

 

 

The presentation provides an insight to the revival of a drug that has been previously terminated due to liver toxicology despite completion of two successful Phase II trials.

It provides an outline of using companion diagnostic, preclinical and formulation strategies to justify further development and solutions to overcome the previous clinical challenges.

Stefan Proniuk
Chief Development Officer
Arno Therapeutics

9:05-9:35 AM
Innovation
Improving Oral Solid Dose Manufacturing Process Efficiencies Through Excipient Design

 

Processing technologies used in pharmaceutical dosage form manufacturing have grown rapidly in recent years, adapting to evolving industry challenges for cost control, flexible manufacturing and innovative dosage forms. However, as these processes become more specialized it has become clear that existing excipients limit their production capabilities and efficiency. Through the modification of excipient physical and chemical properties it is possible to fully enable their use in existing and emerging technologies.

Tailored functional excipients optimized for specific manufacturing processes and their impact on process efficiencies will be discussed. This includes materials designed for direct compression tableting, dry powder coating, spray drying, hot melt extrusion, and continuous granulation.

Kevin O’Donnell
Associate Research Scientist, R&D
The Dow Chemical Company

9:35-9:40 AM
Please move to your next session

9:40-10:10 AM
Case Study
Small Molecules
Topical Formulation Development: Challenges and Opportunities

 

  • Regulatory challenges: Lack of recognised method for demonstrating bioequivalence between clinical phases and hence, need for early formulation lockdown.
  • Topical formulation challenges: Complex colloidal systems
  • How do you choose the right API for topical? How do you select the lead formulation?

Sujatha Sonti
Head, Formulation and Process Development
Stiefel, a GSK company

Case Study
Biologics
High Throughput Screening Methods in Formulation Development of Biologics

 

High throughput (HT) screening methods are routinely employed in the formulation development of biologics to expedite drug product development. Although HT methods offer significant advantages in screening of formulations, there are several pitfalls that should be avoided when using these methods in formulation development.

This presentation will:

  • Review current HT screening methods in formulation development of biologics
  • Identify benefits and limitations of HT methods
  • A case study will be presented

Salman Muzammil
Drug Product Development
Janssen

10:10-10:15 AM
Please Move to Your Next Session

10:15-10:45 AM
Case Study
Small Molecules
How Lipids & Spray Dried Dispersion Affect Bioavailability from in Vitro, in Vivo and in Silico Assessment & Case Studies

 

  • Bioavailability challenges with BCS II compounds
  • Strategies for using lipids and spray dried dispersion in formulation development
  • In vitro, in vivo and in silico tests on biopharmaceutics risk of lipids and spray dried dispersion
  • Case studies with improved bioavailability of lipid formulations, learnings and outcomes

Yan Xu
Research Investigator
Bristol-Myers Squibb

Case Study
Biologics
Analyzing the Evolution of Antibody Drug Conjugates as Cancer Targeting Technology

 

For the last couple of decades antibody-drug conjugates (ADCs) have continued to gain popularity as a drug targeting technology for the treatment of cancer.  This presentation will highlight the origin of ADCs, the failure of the first approved ADC (Mylotarg), and the current commercially available ADCs (Adcetris® and Kadcyla®).  The development and commercialization of ADCs is fraught with many challenges at the conjugation level, formulation and manufacturing,  stability, and analytical levels.  This presentation will focus on the interplay of these challenges to a successful CMC package needed for the regulatory submission of an ADC in context to a case study.

Nila Das
Senior Research Investigator
Bristol-Myers Squibb

10:45-11:30 AM
iSolve Meetings, Meet the Speakers & Refreshment Break

 

11:30-12:00 PM
Case Study
Innovation
Case Study – Development of an Award Winning Delivery System

 

Almost all Drug Delivery systems contain; a formulation, primary container, a drive mechanism, tissue interface, and secondary packaging/labelling. The key to a truly exceptional system is to understand the constraints and implicit User Needs early, and build around them, such that the user experience is not compromised.

Anthony Schaff
Director Advanced Development, Delivery and Device R&D
Eli Lilly and Company

12:00-12:05 PM
Please move to your next session

12:05-12:35 PM
Case Study
Small Molecules
Multimeric Drug Conjugates with Cancer-targeted Enhancements

 

The total cost to develop and gain marketing approval for a new drug is high, about $2.6 billion, and the clinical development success rates for investigational drugs are dismal with 1 in 10 drugs that enter clinical phases going through to FDA approval and to reach the market. In this case study, Sang Van will explore strategies that Annam Biosciences are utilising to overcome these challenges in the development of new multimeric drug conjugates with cancer-targeted enhancements.

  • Expediting the time for development and approval, and improving the cost and success rates of drug development
  • Attaching enhancements to FDA-approved drugs to generate new therapeutic entities
  • Extending patent through new intellectual property protection

Sang Van
CEO
Annam Biosciences

Case Study
Biologics
Injectable Self-assembling Peptide Nanofiber Hydrogels and Liposome-like peptide Nanovesicles for Sustained Release Applications of Small Molecules and Proteins

 

  • Injectable peptide hydrogel and liposome-like peptide nanovesicles vs. traditional drug delivery systems
  • Controlled release of drugs using designer self assembling peptide hydrogels and nanovesicles
  • Targeted delivery of small, model drug compounds and proteins through the injectable peptide hydrogel and peptide nanovesicle systems
  • Self assembling peptide nanovesicle formulations as permeation enhancers

Sotirios Koutsopoulos
Research Scientist, Center for Biomedical Engineering
Massachusetts Institute of Technology

12:35-12:40 PM
Please move to your next session

12:40-1:15 PM
Technology Spotlight
Small Molecules
RapidFACT: Using Clinical Data to Drive Effective Formulation Optimisation

 

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

Kieran Crowley
Senior Director of Translational Pharmaceutics
Quotient Clinical Ltd.

Technology Spotlight
Small Molecules
Innovative Calcium Phosphate Excipients

 

  • Current products
  • Market demands for excipients- Ideal excipient characteristics
  • Role of Innophos to keep up with market demands for excipients
  • Discussion on various new products of Innophos with some study data

Chintan Shah
Global Commercial Development Specialist, Pharma and Nutrition
Innophos

1:15-2:15 PM
Networking Lunch

 

Sponsored by Grunenthal

 

2:15-2:45 PM
Case Study
Small Molecules
Design, Development & Manufacture of Modified Release, Liquid Oral Dosage Forms

 

  • Age-appropriate drug formulations are a challenge in drug development.  Due to difficulties in swallowing solid dosage forms, liquid dosage forms for oral administration are are superior to classic tablets or capsules among the children and the elderly.
  • Development of modified release liquid oral dosage forms is particularly challenging, since the formulation should maintain its modified release characteristics over the shelf life in a liquid environment and yet provide the desired release profile upon administration.
  • Another problem with liquid dosage forms is palatability, especially considering that taste sensation differs age-dependently and inter-individually.
  • This presentation will review the technologies that have been used successfully in the development of modified release, multi-particulate, liquid oral dosage forms.

Sree Nadkarni, Ph.D
Senior Director, Pharmaceutical Development (CMC)
Biotie Therapies

Case Study
Innovation
Analytical Quality by Design: Strengthening the link between Analytical and Formulation

 

  • Science and risk based approach: Design of methods which consistently deliver the control of the quality attributes of the product
  • Methods Quality: How the combined changes on the critical method variables affect the quality of the method
  • Formulation Coverage: How the formulation variability is controlled by the method capabilities

Rosario LoBrutto
Senior Director, Head of Development Sterile Products
TEVA Pharmaceuticals

2:45-2:50 PM
Please move to your next session

2:50-3:20 PM
Case Study
Biologics
Harnessing the Benefits of Nanoemulsions as Novel Dermal & Mucosal Delivery Systems

 

 

  • Serves as a unique topical and mucosal delivery system for small and large molecules (e.g. peptide, proteins, etc.)
  • Nanoemulsion adjuvants multiple antigen types and elicits IL17 & mucosal protection following IN administration
  • The unique composition allows sterilization via autoclaving
  • Broad antimicrobial activity vs. bacteria, fungi & viruses

Susan Ciotti
Director of Formulations
NanoBio Corp

Case Study
Innovation
High Concentration Formulation Challenges and Novel Formulation Control Approaches

 

  • Current challenges and future trends in high concentration liquid formulation development
  • Multidimensional engineering and formulation based approaches to routinely achieve ultra-high concentration formulation
  • Impact on drug delivery and patient convenience

Sathish Hasige
Associate Director of Strategic Planning: Formulation and DP Process Development
MedImmune

3:20-3:25 PM
Please move to your next session

3:25-4:10 PM
Innovation
Keynote – Closing Panel Discussion

 

What’s coming next

– Market predictions for the future

– Preparing for new manufacturing strategies

– The evolution of formulation challenges

Ralph Heasley
VP Research
Mallinckrodt Pharmaceuticals

Nila Das
Senior Research Investigator
Bristol-Myers Squibb

Jeffery Liu
Director, Clinical Development
GSK

Brian Meyer
Principal Scientist
Merck

4:10-4:15 PM
Chairman’s Closing Remarks