Inaugural Formulation and Drug Delivery
Improving Solubility and Bioavailability with Enabling Technologies
The drug delivery field is emerging as a key sector in driving innovation towards bringing new therapies to market and increasing profitability. The Formulation and Drug Delivery conference will discuss the role of novel delivery strategies and advanced tools in developing difficult-to-deliver drugs, designing targeted delivery approaches, improving efficacy and safety, and leading to overall patient compliant therapies.
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Monday, June 3
9:00 - 12:00 pm Design and Interpretation of Stability Studies for Product Development
2:00 - 5:00 pm Development of Nanotechnology Application into Innovative Therapies
* Separate registration required
Tuesday, June 4
7:45 am Registration and Morning Coffee
8:30 Chairperson’s Opening Remarks
Bobby Singh, Ph.D., Chief Technology Officer, Corium International, Inc.
8:40 Nanomaterial for Drug Delivery: Opportunities, Challenges and Lessons Learned
Anil K. Patri, Ph.D., Deputy Director, Nanotechnology Characterization Laboratory, Advanced Technology Program, SAIC-Frederick, Inc., Frederick National Laboratory for Cancer Research
Advances in nanotechnology research are bringing about radical changes in early disease diagnosis and therapy. Nanotechnology based delivery systems can improve the delivery of approved therapeutics for better efficacy, and resurrect failed drugs by solving solubility, toxicity, and bioavailability issues. This talk will highlight the resources available for preclinical assessment, advances in nanomaterial technologies for cancer therapy, and the challenges in translation of nanomedicinie.
» 9:10 FEATURED PRESENTATION: Nanopreparations for Delivery of Non-Deliverable Pharmaceuticals
Vladimir Torchilin, Ph.D., D.Sc., University Distinguished Professor, Department of Pharmaceutical Sciences, School of Pharmacy, Northeastern University
Poorly soluble or highly unstable substances often represent promising drug candidates, however problems with their delivery and bioavailable dosage forms frequently prevents them from becoming real drugs. Various formulation strategies based on the use of nanocarrier systems to overcome poor solubility and instability of many drugs, including anticancer agents and siRNA, have been suggested, such as non-targeted and targeted polymeric micelles and layer-by-layer nanoparticles.
9:40 Accelerating the Translation of Nanotechnology Platform in Cancer through Public-Private Partnerships
Uma Prabhakar, Ph.D., Consultant, Office of Cancer Nanotechnology Research NCI-NIH
The Alliance for Nanotechnology in Cancer of the NCI initiated a public private industry partnership called TONIC to evaluate promising nanotechnology platforms for drug delivery, imaging and monitoring and, facilitate their successful translation from bench to bedside, to help, timely, effective and novel diagnosis and treatment options for cancer patients. The interactions with government, academia, patient advocacy groups and industry in advancing the translation of the will be discussed.
10:10 Coffee Break
10:40 Proven Predictive Models in Drug Development to Anticipate Clinical Outcomes
Tycho Heimbach, Ph.D., Associate Director & Senior Investigator II, Biomedical Research, Novartis Pharmaceuticals Corporation
Several case examples will be presented on predictive physiologically-based pharmacokinetics (PBPK) and PK/PD models to anticipate FIH and other clinical trials across all BCS/BDDCS class drugs. Successful integration preclinical and clinical data and application of custom (PBPK) software which significantly improved the accuracy of drug absorption and exposure prediction in humans will be discussed. In addition, examples where PBPK as a tool has impacted drug development will be shared.
11:10 Role of Pharmaceutics and Enabling Technologies in Discovery of Novel Acute Care Therapies
Akash Jain, Ph.D., Senior Scientist I, Discovery Pharmaceutics, Cubist Pharmaceuticals, Inc.
Presentation will focus on the applications of modeling and simulation, automation and novel delivery technologies during early drug discovery to enable selection of candidates with optimal developable profile for acute care therapies. Case studies will be discussed to highlight the role of early intervention of pharmaceutics in discovery to enable candidate selection and identifying novel delivery approaches to maximize a NCE’s therapeutic potential and its fit with intended clinical use.
11:40 Improving the Bioavailability of Poorly Soluble Compounds with Hybrid Nanoparticle Formulations
Per Andersson, Ph.D., CEO, XSpray
12:10 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:30 Plenary Keynote Panel Discussion: Advancing Pharma R&D through Communication & Collaborations: Bio-Connectivity at Work
Karim Dabbagh, Ph.D., Executive Director and Head, External R&D and Innovation Research Units, Pfizer Worldwide R&D
Glen N. Gaulton, Ph.D., Professor, Pathology and Laboratory Medicine; Executive Vice Dean and Chief Scientific Officer, Perelman School of Medicine, University of Pennsylvania
Peter Pitts, President and Co-Founder, Center for Medicine in the Public Interest
3:00 Grand Opening of the Exhibit Hall with Poster Viewing
4:00 Native-State Solubility and Thermal Stability Studies for Selecting De-Risked Drug Lead Candidates in Discovery
Michael Doyle, Ph.D., Senior Principal Scientist & Group Leader, Protein Science & Structure, Bristol-Myers Squibb Co.
Solubility is a key attribute of protein therapeutics that influences the ease with which they are discovered and developed. This presentation will describe a novel method for rank-ordering native-state solubilities of drug candidates, and how this information is applied in combination with thermal stability analyses to select drug candidates that have improved biophysical behavior.
4:30 Difficult DVD-Immunoglobulins: Lessons Learned from Early Screening towards Faster Formulation Development
Vineet Kumar, Ph.D., Senior Research Scientist II, Department of Pharmaceutics, AbbVie
The importance of preformulation work during the early screening of molecules will be discussed. Lessons learned from various DVDs were used in the adaptation of a suitable screening funnel. The screening necessitates an early interdepartmental collaboration between the different groups including PK, formulations, analytics and others. Case studies and the screening approach used will be discussed.
5:00 How to Connect Enabling Drug Delivery Strategies for Tox Assessment with Commercial Development to Reduce the Risk of Drug Failure: A Case Study
Ajit S. Narang, Ph.D., Sr. Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb, Co.
As more and more hydrophobic and poorly soluble drugs enter new drug development portfolio, solubilization strategies, such as cosolvent solution and amorphous drug dispersion in a hydrophilic polymer matrix, are frequently utilized to enable dose–exposure escalation in toxicological evaluation studies. This presentation will demonstrate the value of mechanistic understanding of drug-formulation-physiology interaction to translate delivery strategies of formulation-enabled drug candidates from tox studies to first-in-human dosing and commercial drug product development.
5:30 Welcome Reception in the Exhibit Hall with Poster Viewing
6:30 Close of Day
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