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2nd Annual Global Drug Bioavailability Enhancement Summit

January 24th — 25th, 2017 - Westin Times Square Hotel - New York, NY RegisterBrochure

Day One – Tuesday, January 24, 2017

7:45am – 8:15am

Registration Opens & Continental Breakfast for Attendees

8:55am – 9:00am

Chairperson’s Day One Welcome and Opening Remarks

9:00am – 9:40am

Trends in Drug Bioavailability Enhancements and Its Impact on Portfolio Strategy
  • Accelerating the drug development pipeline; leveraging early signs of efficacy and other tools to inform portfolio strategy
  • Advancing the delivery of medicines for patients – designing the best possible medicines, developing novel formulations
  • Diversity in drug development paradigms that consider patients early in development and offer flexibility in dose and delivery profile
Linda Lohr

Linda Lohr

Senior Director, Portfolio Strategy, Pfizer

9:40am – 10:20am

Examining Technologies for the Development & Evaluation of Modified Release Oral Pharmaceutical Dosage Forms

In this session, we will discuss how to assess commercially approved technologies successfully utilized in the pharmaceutical modified release solid oral dosage forms, including hydrophilic tablets, osmotic drug delivery systems, gastroretentive drug delivery systems, etc.

Sree Nadkarni

Sree Nadkarni

Sr. Director, Pharmaceutical Development (CMC), Biotie Therapies

10:20am – 11:00am

Key Scientific Principles Governing Use of Enabling Formulations in Preclinical and Early Clinical Studies

Preformulation studies are the starting point of all new drug development programs and can define the strategies used for drug product development.  It is critically important to utilize various preformulation characterization techniques to fully profile preclinical candidates from various aspects to avoid any surprise in late stage product development.  This session will discuss:

  • Major preformulation aspects including molecular properties, solid-state properties, API form development and formulation development
  • Best practices for tailoring the studies based on the target product pforile and properties
  • Manners to mitigate potential risk
  • Typical pitfalls and risk scenarios in new drug development
  • How to effectively utilize preformulation studies to guide drug development
James Ormes

James Ormes

Associate Principal Scientist, Merck

11:00am – 11:30am

Morning Refreshment Break

11:30am – 12:10pm

Improving Oral Bioavailability by Solid Dispersions: An OSPHENA® (Ospemifene) Case Study
This case study session will share:
  • 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 in pH 6.8
  • The spray dried solid dispersions are physically and chemically stable during stability study
  • Discuss the four formulations that were selected for animal PK studies
Zhengming (Jimmy) Chen

Zhengming (Jimmy) Chen

Senior Director, Pharmaceutical Science, Shionogi Inc

12:10pm – 12:50pm

Bioavailability Enhancement with Fine Particle Technology
  • Media milling can produce drug particles that are much smaller than can be achievedwith air jet milling or other particle size reduction approaches.
  • Wet media milling technology has been used to enhance oral bioavailability in several
    prescription drug products.
  • More recently dry (waterless) media milling has been used for bioavailability
    enhancement.
  • Examples of bioavailability enhancement using both approaches will be provided.
Jason Coleman, PhD

Jason Coleman, PhD

Associate Director of Pharmaceutical R&D, iCeutica

12:50pm – 2:00pm

Networking Lunch

2:00pm – 2:40pm

Assessing the Molecular Properties of mAb Clones at Early Lead Selection Stage in cellulo by Using the ER as a Physiological Test Tube.

Have you selected promising lead mAb clones only to find out later during pre-formulation stage that they have poor solubility issues? How can we avoid costly mistakes of selecting physicochemically unfavorable mAb clones and unknowingly advancing such mAbs in drug
discovery/development pipeline? Are there any rational approaches? In this talk, I will illustrate the predictive values of overexpression-induced cellular phenotypes in assessing high concentration solution behaviors of individual mAb clones. By examining the biosynthetic steps of various human IgG mAbs for which prominent solution behavior problems were known (e.g., aggregation, crystallization, gelation, LLPS, cryoprecipitation, viscosity, agitation sensitivity, etc.), we found that condensation-prone IgG mAbs induces three types of prominent cellular phenotypes during mAb overexpression. Apparent correlations between solution behaviors in vitro and biosynthetic events in the endoplasmic reticulum (ER) can be leveraged to identify unfavorable mAb clones that are not suitable for high-level expression and high concentration liquid formulation. Our approach paves the way for a preemptive elimination of unfavorable mAb clones from the lead panel from the very beginning, at an early transient expression testing stage even without protein purification.

Haruki Hasegawa

Haruki Hasegawa

Principal Scientist, Amgen Inc.

2:40pm – 3:20pm

Interactive Roundtable Discussions

Identifying Novel Technologies for Pulmonary and Nasal Delivery

Microneedle Particles for Drug Delivery to Large Surface Area Tissues

Addressing the Challenges of Therapeutic Proteins in Polymer-Based Pre-Fillable Syringes

Digital Chemistry:  Creating Innovative and Personalized Medicine & Enhancements with Big Data & Data Analytics

3:20pm – 3:50pm

Afternoon Refreshment Break

3:50pm – 4:30pm

Examining Nanoparticles as Drug Delivery Systems

Continuing improvement in the pharmacological and therapeutic properties of drugs is driving the revolution in novel drug delivery systems. In fact, a wide spectrum of therapeutic nanocarriers has been extensively investigated to address this emerging need. This session will:

  • Review recent developments in the use of nanoparticles as drug delivery systems to treat a wide variety of diseases
  • Discuss challenges of nanoparticles
  • Introduce future nanotechnology strategies to overcome limitations in this field
Esmaiel Jabbari

Esmaiel Jabbari

Professor, Chemical Engineering, Biomedical Engineering, University of South Carolina

4:30pm – 5:10pm

Oral Delivery for Biologics: Formulations and Other Potential Strategies
  • Though IV delivery of standard biologics gives 100% bioavailability, oral formulations can sometimes deliver better results or an improved clearance rate
  • Survey the different approaches industry is taking towards oral biologic formulations, through new technical tools and cross-company partnerships
  • Identify why some oral formulations fail and carry those lessons forward into the next generation of biologics
  • Transcend standard formulation challenges through device-based consumable oral delivery methods
  • Opportunities and Challenges in Peptide and Protein Drug Bioavailability Enhancements
Eric Munson

Eric Munson

Professor in Pharmaceutical Sciences, University of Kentucky

5:10pm – 5:15pm

Chairperson’s Day One Closing Remarks

5:15pm – 6:15pm

Cocktail Reception

Day Two – Wednesday, January 25th, 2017

7:45am – 8:55am

Continental Breakfast for Conference Participants

8:55am – 9:00am

Opening Remarks

9:00am – 9:40am

Rational Design of Oral Nanoparticle Delivery Systems

This session will provide an in-depth overview of the usage of nanoparticle delivery systems to address bioavailability challenges in oral drug delivery. This session will

  • Review preformulation aspect for choosing nanoparticle delivery systems
  • Review benefits of amorphous and crystalline nanomaterials
  • Discuss manufacturing strategies to produce
  • Discuss current challenges and issues with oral nanoparticle drug delivery
Joseph Della Rocca

Joseph Della Rocca

Senior Scientist, Merck

9:40am – 10:20am

An Integrated Biopharmaceutics Approach for Effective Drug Development for Clinical Trials
  • Understanding the compound (physicochemical and biological attributes)
  • Rapid screening techniques for solubility enhancement
  • Clinical requirements – Formulation considerations
  • Sharing case study examples
Rob Harris, PhD

Rob Harris, PhD

Chief Technical Officer, Juniper Pharma Services

10:20am – 11:00am

Co-Crystals: Myth and Fact
Dabing Chen, PhD

Dabing Chen, PhD

Senior Principal Scientist, Boehringer Ingelheim Pharmaceuticals

11:00am – 11:30am

Morning Refreshment Break

11:30am – 12:10pm

Enabling Pharmaceutical Development by Co-processing with Silicates
    Co-processing of drugs with silicates is increasingly finding applications in pharmaceutical development as a commercially viable strategy to overcome development challenges such
    as poor drug solubility and/or dissolution rate. However, identifying relative merits of the silicate based co-processed systems with other strategies such as use of polymers in hot melt extrusion and spray drying for overcoming development challenges requires a thorough understanding of the technology. This talk focusses on co-processing with silicates as a potential strategy to produce physically stable amorphous drugs and will provide fundamental understanding pertaining to the impact of co-processing techniques, formulation variables, and processing conditions on degree of amorphization. Additionally, a mechanistic understanding pertaining to the physical stabilization of co-processed amorphous solids and dissolution enhancement will be discussed. Finally, the strengths and challenges in adopting novel drug delivery applications of silicates will be highlighted.
Deepak Bahl

Deepak Bahl

Associate Principal Scientist, Pharmaceutical Sciences & Clinical Supply, Merck

12:10pm – 12:50pm

Challenges of Developing Viable Innovative Technologies in Oral Care
    The statistics about innovation failure rates in healthcare are significant. It’s commonly acknowledged that more than 95% of new drugs fail human studies. Of the remaining 5% that do get to market, over a third fails to meet their commercial objectives. Likewise, in medical device and consumer healthcare industry lack of major innovation and high rate of failures are evident. A large number of technologies emerge from academic and research laboratories, but fail to make their way to global market as a result of the complex and highly regulated development process. These products are dependent on regulation, intellectual property protection and complicated barriers to enter different markets. This lecture will focus on challenges in developing new oral care products, the transitional gaps and utilizing innovation enablers to manage the translational research journey from initial laboratory concepts to marketed products. Discussing the need for collaboration between academia, healthcare companies, regulatory agencies, and service providers to discover the innovation demand space and identify or develop relevant viable technologies.
Nima Roohpour

Nima Roohpour

Principal Innovation Scientist, GlaxoSmithKline

12:50pm – 2:00pm

Networking Lunch

2:00pm – 2:40pm

First in Patient Trials: Choosing a Form of API to Support This
  • Need to assess physicochemical properties for formulation design and biopharmaceutics performance
  • How to make a decision in early stage?
Fady Ibrahim

Fady Ibrahim

Principal Scientist, Pfizer

2:40pm – 3:20pm

Regulatory Expectations and Challenges for Delivery System Combination Product Development and Registration
  • Overview of global regulatory expectations
  • Strategies for overcoming common challenges
  • Building a sustainable regulatory dossier
Suzette Roan

Suzette Roan

Associate Director, Regulatory Affairs CMC Combination Products, Biogen

3:20pm – 3:40pm

Afternoon Refreshment Break

3:40pm – 4:20pm

Subcutaneous Bioavailability of Biotherapeutics: Issues encountered in accurate calculation of bioavailability for proteins exhibiting nonlinear pharmacokinetics

The era of personalized medicine is shifting the focus of pharmaceutical development and manufacturing activities from small molecules to biologic drug products.  This session will discuss the challenges and opportunities presented by these complex macromolecules.  We will examine such things as:

  • High patient doses required for biologic therapeutics
  • Intravenous infusion
  • Enabling large-volume doses of high-viscosity formulations with acceptable patient discomfort
  • Liquid formulations in prefilled syringes and autoinjectors
  • Patch pumps or on-body injectors
  • Wearable devices
  • Drug packaging
Anjaneya Chimalakonda

Anjaneya Chimalakonda

Principal Scientist, Bristol-Myers Squibb

4:20pm – 5:00pm

Drug Deliveries of Biologics at High Concentrations and Low Concentrations
Salman Muzammil, PhD

Salman Muzammil, PhD

Drug Product Development, Janssen, Pharmaceutical Companies of Johnson and Johnson

5:00pm – 5:10pm

Closing Remarks & Conclusion of Summit

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