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2013 Archived Content

Inaugural Formulation and Drug Delivery

Improving Solubility and Bioavailability with Enabling Technologies


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Wednesday, June 5

8:00 am Registration and Morning Coffee


8:30 Chairperson’s Remarks

Vladimir Torchilin, Ph.D., D.Sc., University Distinguished Professor, Department of Pharmaceutical Sciences, School of Pharmacy, Northeastern University

» 8:40 FEATURED PRESENTATION: Principles of Ligand-Targeted Drug Design 

Philip LowPhilip S. Low, Ph.D., Ralph C. Corley Distinguished Professor, Department of Chemistry, Purdue University

Because targeted therapeutics treat pathologic cells without damaging normal cells, they will likely dominate the drug market of the future. In this presentation, I will discuss the basic principles underlying the successful design of ligand-targeted therapeutics, using multiple examples of ligand-targeted drugs currently in the clinic or late preclinical development to illustrate each major principle.

9:10 Centyrins: A Novel Scaffold for New Therapeutics

Karyn O’Neil, Ph.D., Chief Scientific Officer, Centyrex Venture, Johnson & Johnson

Alternative scaffolds share properties with antibodies in terms of their specificity and potency and with small molecules in terms of simplicity and size. The Centyrin platform, a consensus fibronectin domain, has been optimized to enable selection of Centyrins that inhibit multiple classes of proteins. We will describe how the biophysical properties of Centyrins make them ideal for novel therapeutic applications including drug conjugates and targeted nanoparticles.

9:40 Development of Novel Targeted Cancer Therapies with BIND Accurins™

Jeff Hrkach, Ph.D., Senior Vice President, Technology Research & Development, BIND Therapeutics

Accurins™ are a new class of highly selective targeted therapeutics, precisely engineered to have long circulation half-lives, high drug loading levels, finely tuned pharmacokinetics and surface-bound targeting ligands that bind selectively to cell-surface receptors on diseased cells. Accurins achieve high and prolonged concentrations creating optimal therapeutic indices. BIND is developing Accurin targeted therapeutics, primarily focused on oncology.

10:10 Coffee Break in the Exhibit Hall with Poster Viewing

10:40 NanomAbs: New Leap in Antibody-Drug Conjugates

Stephane E. Allard, Ph.D., CMO, EpiCept Corp.

NanomAbs platform is a conjugate of a targeting moiety to chemotherapeutic drug loaded polymeric nanoparticles. Development of Immune’s linker technology enabled the optimized drug to mAb ratio using the mAb as a targeting moiety. Extensive preclinical research recently showed improved anti-cancer effect in several cancer models and beneficial safety profile. Leveraging the technology for targeted combo cancer drug delivery is underway showing synergistic effects in advanced tumors.

11:10 Addressing the Delivery Challenge for siRNA Therapeutics

Marian Gindy, Ph.D., Director, Pharmaceutical Sciences, Merck Research Laboratories

siRNA represents a promising therapeutic strategy, with potential to access molecular targets considered undruggable by small molecule and protein therapeutics. Challenge toward realizing this technology is the safe and effective delivery of siRNA to target tissues. siRNAs properties prevent diffusion across most cell membranes, requiring the use of delivery systems to confer intracellular access. Presentation will illustrate the development of such oligonucleotide delivery technologies.

11:40 Nanopharmaceutical Delivery of Toxic and Biodegradable Drugs: Case Studies of Camptothecin and siRNA

Sonke Svenson, Ph.D., Director, Research, Cerulean Pharma, Inc.

Cerulean’s nanopharmaceutical technology consists of polymeric nanoparticles carrying drug molecules conjugated to the constituent polymers. Encapsulation protects the body from toxic drugs, and protects biodegradable drugs from enzymatic or hydrolytic metabolism inside the body. Chemical conjugation of drug molecules to the carrier prevents burst release in favor of controlled drug release from the nanopharmaceuticals.

12:10 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own


2:00 Chairperson’s Remarks

Aihua Fu, Ph.D., CEO, NVIGEN Inc.

2:10 Visualizing Targeted Delivery of Polymer-Drug Conjugates

Ban-An Khaw, Ph.D., George D. Behrakis Professor of Pharmaceutical Sciences, Department of Pharmaceutical Sciences, School of Pharmacy, Northeastern University

Most chemotherapeutic agents are not target specific. They can be made target specific by antibody-drug conjugate technology. To improve targeting ability and highly efficient delivery of drugs, bispecific antibody complex pretargeting and targeting with polymer-drug conjugates (PDC) was developed. Targeting with radioisotope labeled or chemotherapeutic PDCs enabled visualization of very small cancer lesions, and therapy was as efficient as free drug but has no non-target toxicity respectively.

2:40 PET Imaging of Antibodies for Evaluation of Distribution, Clearance and PK in vivo

Vania Kenanova, Ph.D., Head, Preclinical PET/SPECT/CT Imaging Laboratory, Global Imaging Group, Novartis Institute for Biomedical Research

Quantitative PET imaging is routinely used for evaluation of antibodies in vivo. This involves radiolabeling of the antibody either by attaching radionuclide directly (I-124 to Tyr) or via a chelate (NODAGA [Cu-64], desferal [Zr-89]). The PET image is a result of the catabolism and clearance of the protein, chelate and radiolabel. This talk will go over the distribution and clearance of radiolabel alone, radiolabel-chelate and radiolabel-(chelate)-protein for PK analysis.

3:10 Facile Synthesis of Multifunctional Imaging Nanoparticles

Robert K. Prud’homme, Ph.D., Professor, Department of Chemical & Biological Engineering, Princeton University

Composite nanoparticles can be made is a single step process by block-copolymer-directed rapid precipitation to incorporate both therapeutic and imaging agents into the same nanoparticle. A wide range of imaging nanoparticles can be prepared using the same platform, and the process is scalable from the laboratory (mg) to manufacturing scale (kg). Examples will be presented of fluorescent dyes, MRI contrast agents, up-converting phosophors, and SPEC imaging nanoparticles.

3:40 Refreshment Break in the Exhibit Hall with Poster Viewing

4:10 Nanoscale Evaluation of Novel Dendritic Nanocarriers for Cancer Targeting

Seungpyo Hong, Ph.D., Assistant Professor of Pharmaceutics and Bioengineering, Department of Biopharmaceutical Sciences, University of Illinois College of Pharmacy

Although a myriad of promising nanocarriers have been recently developed, targeted drug delivery to cancerous regions still remains a tremendous challenge. This presentation will focus on new drug delivery platforms based on dendritic structures to take advantage of multivalent binding and enhanced self-assembly. Fundamental understanding as well as biological testing of those novel nanocarriers will be discussed.

4:40 Breakout Discussion Groups

When and Where to Introduce Delivery into the Product Development Pipeline

Moderator: Bobby Singh, Ph.D., Chief Technology Officer, Corium International, Inc.

  • Bringing down the silos
  • Technology and strategy selection and implementation
  • Collaboration to innovate and improve preclinical to clinical translation

The Science of Particle Size Analysis and its Impact on Translational Performance

Moderator: Pankaj Karande, Ph.D., Assistant Professor, Department of Chemical & Biological Engineering, Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute

  • Effect of surface chemistry, shape, size and density on a nanoparticle's tendency to escape
  • Why do several successful preclinical technologies fail in clinic
  • Tools and technologies for particle characterization and data interpretation

Working with a Small Amount of API: Pros and Cons of Miniaturization

Moderator: Weiguo Dai, Ph.D., Scientific Director, Fellow, Drug Product Development, Johnson & Johnson

  • Advantages and disadvantages of miniaturization and automation in drug development
  • Data correlation between early development and late development studies and how it can hasten or delay product development timelines
  • Evolving role of preformulation in faster development

5:40 Close of Day

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