4th Improving Solubility

Uncovering Novel Advances inEnhancing Solubility, AmorphousForms, Bioavailability & Lipid-Based Formulation of Drugs

March 29-31, 2010Philadelphia, PA

Learn Best Practice Strategies on How to:

• Make development of an insoluble drug candidate possible by using solid dispersions• Approach parenteral delivery of poorly soluble drugs• Utilize pharmaceutical co-crystals to enhance solubility and dissolution of insoluble APIs• Effectively understand the difference between thermodynamic vs. kinetic stability• Maximize exposure of water-insoluble drugs in toxicology evaluation and early

formulation development• Enhance the bioavailability of poorly soluble compounds using lipid-based formulations

1-800-882-8684 • www.improvingsolubility.com

Improving Solubility

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Conference Co-Chairs:

Speakers Include:

Ron Liu, PhD MBAPresident & Chief Executive OfficerAustarPharma

Michael Pikal, PhDProfessor and Pfizer DistinguishedChair, Pharmaceutical Technology,University of Connecticut

• Naír Rodríguez-Hornedo, PhD, AssociateProfessor of Pharmaceutical Sciences, The Collegeof Pharmacy, The University of Michigan

• Harry G. Brittain, PhD, FRSC, Institute Director,Center for Pharmaceutical Physics

• René Holm, PhD, Head, Preformulation,H. Lundbeck Denmark

• M. Sherry Ku, PhD, Senior Director,Pharmaceutical Development, Pfizer, Inc.

• Robin H. Bogner PhD, Associate Professor ofPharmaceutics, School of Pharmacy,University of Connecticut

• Satej Bhandarkar, PhD, Senior Manager, Analytical SciencesDepartment, Sanofi-Aventis U.S.

• Jaymin Shah, PhD, Research Fellow, Parenteral DevelopmentCentre of Emphasis, Pfizer, Inc.

• Yun Alelyunas, PhD, Principal, Scientist I, Head of PhysicalProperties Team, AstraZeneca

• Feng Qian, PhD, Senior Research Investigator, Bristol-Myers Squibb• Xiaoming (Sean) Chen, PhD, Drug Product Development & Manufacturing, OSI

Pharmaceuticals, Inc.• Vivian Bi, PhD, Associate Principle Scientist, Early Development, PAR&D,

AstraZeneca• Yaling Wang, PhD, Research Fellow, Merck & Co.• Jeffrey Skell, PhD, Director, DMPK & Pharmaceutics, Drug and Biomaterial R & D, Genzyme Corporation

4th

Sponsors: Media Partners:

Register by Jan. 29thand save up to$1,796. See page 6

for details.

www.FuturePharmaUS.comDriving the Industry Forward

Chief Scientific Officers, VicePresidents, Directors, Heads,Scientists, Chemists, ResearchLeaders/Fellows/Advisors, &Managers specializing in:

• Formulation• Pre-Formulation• Discovery R&D• Preclinical Development• Analytical Development• Drug Delivery• Drug Discovery• Medicinal Chemistry• Analytical Chemistry• Chemical Development• Product Development• Toxicology• Pharmaceutics• Physiochemistry• Chemical Engineering• Solid States• Process R&D

“Excellent networking anddiverse sessions, good tohave theoretical discourse.”- Dr. Jeff Skell, Director, DMPL andPharmaceutics, Genzyme

“Very good! Great mix ofdetails (technical) plusexamples.”- Dr. Debra Walker, Research Fellow,Merck & Co.

“Great networking anddiscussion sessions.”- Dr. Ly Phan, Senior Director,Medicinal Chemistry, EnantaPharmaceuticals

Who will you meet atthe conference?

Sponsorship andExhibition OpportunitiesSponsorships and exhibits are excellentopportunities for your company to showcaseits products and services to high-level,targeted decision-makers attending the 4thImproving Solubility conference. IQPC andPharma IQ help companies like yours achieveimportant sales, marketing and brandingobjectives by setting aside a limited number ofevent sponsorships and exhibit spaces – all ofwhich are tailored to assist your organizationin creating a platform to maximize itsexposure at the event and reach key decisionmakers in your field.

For more information on sponsoring orexhibiting at the 4th Improving Solubilityconference, please contact Mario Matulichat 212-885-2719 or [email protected].

2 1-800-882-8684 • www.improvingsolubility.com

Improving Solubility

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Dear Colleague,Improving drug solubility is one of the biggest challenges for pharmaceutical companies asthey are always looking for new strategies to increase bioavailability of new drugs.Building on the success of last year’s event, IQPC’s 4th Improving Solubility conference isback by popular demand. With an ever increasing number of poorly soluble drugs comingto market, pharmaceutical and biotech companies are looking for ways to adopt novelsolutions to maximize the time-to-market on their drug development pipelines. Discoverthe latest solubility strategies and techniques to guarantee success in your drugdevelopment pipelines.

You will hear over 18 in-depth sessions and case study examples including:• Nanocrystalline drug-polymer solid dispersions for poorly water-soluble drugs• The role and function of solubility measurement from a central laboratory in drugdiscovery• Implication of BCS: Solubility and permeability class on drug formulation• Lipid-based drug delivery to effectively overcome physical and biological barriers• Oral lipid-based formulations for the enhancement of poorly soluble compounddelivery

• API crystal forms and their bioavailabilities• Novel strategies for salt selection concerning solubility enhancement, salt stability andstabilization

Attend our pre-conference workshops which include “Biopharmaceutical Considerations intheDesign of Oral Modified Release Drug Delivery Systems”, “Toxicology FormulationDevelopment: Challenges and Solutions”, and “Enhancing Solubility by LiposomeTechnologyFor Water-Insoluble Drugs in Parenteral Application”, amongst other areas.Additionally, benefit from industry presentations from AstraZeneca, Merck, Novartis, Pfizer,Sanofi-Aventis, Bristol-Myers Squibb, Lundbeck, AustarPharma, and many morepharmaceutical, biotech and academic experts. This conference promises to be anetworking and discussion-filled event leaving you with new ideas and solutions to helpyou maximize and enhance your drug-solubility boundaries.

We look forward to seeing you in Philadelphia in March!

Best Regards,

Simon CurtisSenior Conference Director, Pharma [email protected]

March 29-31, 2010 Philadelphia, PA

P.S Don’t miss the highly

interactive and informative

pre-conference workshops!

See page 3 for details.

4th


A Challenges and Opportunities in Controlling Drug Substance Properties

8:30 – 11:30 (Registration at 8:00)

In order to control drug substance (DS) properties one has to select an optimal form(specific polymorph or hydrate of free form, salt, or co-crystal) and be able toconsistently manufacture it with the same particle size (PS), particle size distribution(PSD), and crystal surface attributes.

The use of automated and robotic systems in salt/co-crystal and polymorphscreening, and in early crystallization development experimentation, facilitates DSform selection. Ultimate properties of DS are largely determined by the way thebatch precipitation or crystallization processes are conducted and to obtaincrystalline material of desired properties consistently, these processes must becarefully controlled. This can be accomplished via in-situ seeding that simplifies thedesign and control of batch precipitation/crystallization and gives the resultscomparable with the conventional seeding approach. Continuousprecipitation/crystallization removes the risk of batch-to-batch variability and ensuresan optimal control of PS, PSD, and particle surface attributes.

C Toxicology Formulation Development: Challenges and Solutions

2:30 – 5:00 (Registration at 2:00)

Toxicology formulation is an essential component of drug development to enablesuccessful toxicology study of new drug candidate. The requirement for adequateexposure at high doses to establish a safety window often imposes formulationchallenges to poorly soluble compounds. Novel formulation technologies andexcipients may be required to achieve the exposure target. However, a balancebetween implementing novel formulation technologies and controlling the safetyrisk of excipients needs to be considered.

What will be covered:• Toxicology formulation development: basic procedures and general considerations• Excipient acceptance criteria in toxicology formulation• Toxicology formulation development from a toxicologist perspective

• Review on toxicology formulations in NDA filing of marketed drugs• Novel formulation technologies to enhance exposure in toxicology species

Benefits of attending:• Basic procedures and general considerations of toxicology formulation development• Learn safety of common and novel excipients• Broaden the knowledge of acceptable toxicology formulations• Understand what a toxicologist needs from a toxicology formulation• Learn novel formulation technologies that solve exposure limit of poorly soluble

compounds

Your Workshop Leader: Chong-Hui Gu, PhD, Associate Director, PharmaceuticalDevelopment, Vertex Pharmaceuticals

B Biopharmaceutical Considerations in the Design of Oral Modified Release Drug Delivery Systems

11:30 – 2:00 (Registration at 11:00) Lunch Included

This workshop will highlight biopharmaceutical factors that must be considered inthe design, evaluation and development of modified release dosage forms. It willinclude hydrophilic matrices, osmotic pump and multi-unit delivery systems. Theinfluence of electrolyte concentration and polymer character, drug properties on thetextural and micro-environmental conditions within delivery systems relative to theconditions of gastro-intestinal tract, drug release and absorption will be discussed.Examples for each class of drug based on their BCS (Biopharmaceutical ClassificationSystem) scheme will be presented and relative influence of formulation design,transit time and GI physiology on absorption and bioavailability in the context ofIVIVC will be discussed.

What will be covered:• Displaying the influence of electrolyte concentration and polymer character • Uncovering delivery system textural properties

• Discussing issues related to insoluble drugs and or highly soluble drugs based onBCS system

• Identifying drug release mechanisms and methodologies in connection with IVIVC

Benefits of attending:• Uncovering a series of fundamental considerations in oral modified release drug

delivery systems • Discovering many novel drug release mechanisms and methodologies applied in

their evaluation • Specific case studies will be used to illustrate textural properties of delivery systems

relative to the GI environment

Your Workshop Leader: Reza Fassihi, Ph.D, AAPS Fellow, Professor ofBiopharmaceutics and Industrial Pharmacy, Temple University

D Enhancing Solubility by Liposome Technology for Water-Insoluble Drugs in Parenteral Application

5:30 – 8:00 (Registration at 5:00) Dinner Included

Liposomes are unique as drug carriers in that they can encapsulate drugs withwidely varying polarities. Hydrophilic drugs can be entrapped in the aqueous spaceswhile lipophilic drugs can be incorporated into the lipid membranes. Using aliposomal formulation can dramatically increase the apparent aqueous solubility of alipophilic drug, making possible delivery of a dose much higher than its watersolubility. A stable liposomal formulation entrapped water-insoluble drug is oftenachievable without precipitation upon dilution. Scalable manufacturing of liposomesis challenged, but process development and optimization can usually overcomesome scale-up issues. A case study of the latest FDA-approved marketed productwill be discussed during the session.

What will be covered:• Basic procedures and general considerations of liposomal formulation

development• Excipient acceptance criteria in liposomal formulation

• Process consideration and manufacturing scalable batches• Injectable liposomal formulation development for water-insoluble drugs – case

study of an latest FDA-approved product

Benefits of attending:• Understand the basic concepts of phospholipids, bilayer structures and liposomes• Learn how to develop liposomal formulations based on bilayer structure and

physicochemical properties of compounds• Learn the process development of liposomes• Learn the aseptic process of liposomal formulations• Understand what a formulator needs to know the key parameters in scalable

liposomal manufacturing• Learn how to take advantage of drug-delivery technologies to develop quality

based improved products to the marketplace

Your Workshop Leader: Ron Liu, PhD MBA, President & Chief Executive Officer,AustarPharma

Pre-Conference WorkshopsMonday, March 29, 2010

What will be covered:• Why investigate the solid-state of your drug? • Polymorphism • Addressing polymorphism: Screening and characterization • Crystallization of difficult-to-crystallize materials • Selection of optimum solid form of drug substance • Chiral material analysis • Drug substance specifications

Benefits of attending:• Understand best strategies for selecting an optimal form to control drug substance• Weigh the pros and cons of different automated screening systems • Discover the benefits of in-situ seeding for batch design and control• Display methods and techniques for reducing risk of batch-to-batch variability

Your Workshop Leader:Peter Karpinski, PhD, US Leader of Salt & Polymorphism and Particle EngineeringNetworks, Novartis Pharmaceuticals Corp

7:30 Registration and Coffee

8:25 Welcome Address and Chairperson’s Opening RemarksRon Liu, PhD MBAPresident & Chief Executive OfficerAustarPharma

8:30 Opening Keynote Presentation: Thermodynamic vs.Kinetic Stability: Knowing Which is Which• Understanding the distinction between thermodynamic and kinetic

stability• Exceeding the equilibrium solubility to give a supersaturated solution• Measuring equilibrium solubility and metastable solubility within a

substance• Knowing accurately if and when the substance is metastable or

undergoing a change• Recognizing when equilibrium solubility is actually a consequence of

kinetic solubilityHarry G. Brittain, PhD, FRSC, Institute Director, Center forPharmaceutical Physics

Solid Dispersion in the Development Stage

9:15 Demonstration of Bioavailability EnhancementThrough the Use of Biorise and Diffucaps TechnologiesBiorise® • Displaying the production, stabilization and characterization of

amorphous and nanocrystalline composites• Preclinical demonstration of efficacy• Clinical demonstration of efficacyDiffucaps® • Discussing the production of bioavailability-enhanced extended release

formulations using control of pH microenvironments• Clinical demonstration of efficacy• Mathematical modeling of pharmacodynamic response Troy Harmon, Vice President, Business Development, Eurand

10:00 Morning Networking Break

10:45 Nanocrystalline Drug-Polymer Solid Dispersions forPoorly Water-Soluble Drugs• Nanocrystalline drug-polymer solid dispersion was formed by co-spray

drying drug and Pluronic or PEGs• Nanocrystalline solid dispersion showed improved in vitro dissolution rate

and in vivo exposure• Physical structure of the nanocrystalline solid dispersions was

characterized by PXRD, DSC, AFM and TEM• Mechanism led to the formation of nanocrystalline solid dispersion

formation was investigated Feng Qian, PhD, Senior Research Investigator, Bristol-Myers Squibb

11:30 Making Development of an Insoluble Drug CandidatePossible by Using Solid Dispersions: A Case Study• Displaying first in man studies of a highly insoluble compound with

micronized drug substance in capsules• Exposure was very low and there was no dose-proportionality at low

doses. • Evaluating multiple formulation strategies in a clinical study to obtain

adequate bioavailability to proceed with further clinical trials• Selecting for developing a solid dispersion with 20% drug load in HPMC • Describes the polymer selection, physicochemical characterization,

formulation development, stability results, and testing strategy for thesolid dispersion product

• Understanding the challenges associated with commercial development Satej Bhandarkar, PhD, Senior Manager, Analytical Sciences Department,Sanofi-Aventis U.S.

12:15 Networking Lunch

1:15 Pharmaceutical Co-Crystals: A Solubility Perspective• Understanding the pharmaceutical co-crystal concept • Utilizing pharmaceutical co-crystals to enhance solubility and dissolution

of insoluble APIs • Discussing mechanisms by which co-crystal solubility is enhanced• Examining co-crystal structure-solubility relationships• Identifying the PK impact • Analyzing literature case studiesNaír Rodríguez-Hornedo, PhD, Associate Professor of PharmaceuticalSciences, The College of Pharmacy, The University of Michigan

2:00 Amorphous Dispersion Approaches for AchievingRapid Onset for Orally Administered Low-SolubilityCompounds• Outlining the need for increased solubility and rapid absorption• Assessing the impact of enteric dispersions on absorption rate• Developing rapidly dissolving amorphous formulations• Pursuing formulation and process development for amorphous drug-

polymer nanoparticlesDavid Lyon, PhD, Vice President, Physical and Biological Sciences, BendResearch, Inc.

2:45 Afternoon Networking Break

3:30 Panel Discussion: How to Effectively Formulate PoorlySoluble Drugs• Nanoparticles• Amorphous forms• Salt selection: Suitable salt properties for later stage development: stability,

solubility, purity, etc.• Polymorphs: Screening and characterization• Cyclodextrins: Toxicology and pharmacokinetic properties and uses in

development• Assessing permeability and solubilityJeffrey Skell, PhD, Director, DMPK, Genzyme Corp.

Solubility and Discovery Techniques

4:15 The Role and Function of Solubility Measurement froma Central Laboratory in Drug Discovery• Summarizing of solubility methods and practices• Evaluating kinetic vs thermodynamic solubility• Comparing precipitation vs. aggregation aspects• Understanding the relationship of solubility and in vitro biology and DMPK

assays• Discussing conclusions and recommendationsYun Alelyunas, PhD, Principal, Scientist I, Head of Physical PropertiesTeam, AstraZeneca

5:00 Implication of BCS: Solubility and Permeability Class onDrug Formulation• Examining the importance of tailoring your formulation platform based

on BCS class• Discussing the extension of BCS classification for formulation selection • Evaluating pH-solubility profile and modified solubility criteria• Comparing a Caco-2 in-vitro Permeability vs in-situ rat perfusion study • Using BCS-based Formulation Decision Trees M. Sherry Ku, PhD, Senior Director, Pharmaceutical Development, Pfizer, Inc.

5:45 Chairperson’s Closing Remarks and End of Day One

6:30 Networking DinnerContinue the networking experience by joining your colleagues fora dinner following the end of day one. Separate booking necessary.We hope you will join us!

Main Conference Day OneTuesday, March 30, 2010


7:45 Registration and Coffee

8:25 Welcome Address and Chairperson’s Opening RemarksMichael Pikal, PhDProfessor and Pfizer Distinguished Chair, Pharmaceutical Technology,University of Connecticut

8:30 Opening Keynote: Strategies of Maximizing Exposure ofWater-Insoluble Drugs in Toxicology Evaluation and EarlyFormulation DevelopmentCompounds optimized solely on the basis of receptor-based potency are usuallyhydrophobic and as a result, more than 40% of newly discovered drugs or NCEsare poorly water soluble or water-insoluble. In toxicological evaluation for water-insoluble drug candidates, maximizing the systemic exposure of these drugcandidates is very critical, though the approach of solubilizing the drug intoxicological evaluation may not be relevant to the approach used for the finalfinished product. This session will discuss some commonly and less commonlyused solubilization techniques in the toxicological formations. • Approaches of maximizing exposure

• Solution• Liquid dispersions • Solid dispersion/nanocrystal/amorphous • Suspension

• Categorize “conventional” and “non-conventional” approaches • Accessibility/ convenience.- pH adjustment, micelles, lipid based and self-

emulsifying systems, complexation, and co-solvents • Dissolution limited vs solubility limited – liposomes, polymeric micelles,

emulsion/ microemulsion/ self-emulsifying systems, some micellar systems,and complexation

• Low dose vs high dose: all the methods needed to try to increasesolubility

• Vehicles to be considered; Interaction with membrane, toxicity/acceptability inhumans, physical phenomena e.g., precipitation in GI fluid

Ron Liu, PhD MBA, President & Chief Executive Officer, AustarPharma

Lipid-Based Formulations

9:15 How to Enhance the Bioavailability of Poorly SolubleCompounds Using Lipid-Based Formulations• Design strategies for the successful development of lipid-based formulations

must give due consideration to the formulation’s digestibility and dispersibility• Discussing the mechanism by which these two important formulation

considerations enhance absorption• Presenting cases studies that illustrate the importance of digestion and

dispersion • Selecting a suitable oral liquid dosage form for delivery of lipid-based

formulations- the use of softgels either with conventional gelatin-based shellsor plant-based shells

Jeff Browne, PhD, Director, Technical Support, Business Development, CatalentPharma Solutions

10:00 Morning Networking Break

10:45 Lipid-Based Drug Delivery to Effectively Overcome Physicaland Biological Barriers• Utilizing lipid-based formulations, solubilization approaches and self-emulsifying

solutions• Overcoming poor aqueous solubility and stability membrane permeability, drug

efflux and bioavailability issues• Discussing biopharmaceutical considerations of lipid-based formulations seen

from an industrial perspective René Holm, PhD, Head, Preformulation, H. Lundbeck Denmark

11:30 Oral Lipid-Based Formulations for the Enhancement ofPoorly-Soluble Compound Delivery• Understanding the nature of lipid excipients and the lipid formulation

classification system (LFCS)• Discussing why lipid-based formulation is useful for bioavailability enhancement

• Understanding when to use lipid-based formulations - Compound suitabilityfor lipid-based formulations

• Recognizing how to suitably screen lipid-based formulations (formulationscreening flow & in vitro screening tests)

• Displaying other unique challenges related to lipid-based formulationsVivian Bi, PhD, Associate Principle Scientist, Early Development, PAR&D,AstraZeneca

12:15 Networking Luncheon

Solubility Enhancement Techniques and Strategies

1:15 Approaches for Parenteral Delivery of Poorly SolubleDrugs• Outlining the need for solubilization and limitations imposed by parenteral

route of administration• Highlighting pre-formulation studies to determine the need and degree of

solubilization required• Precedented approaches for solubilization and their limitations• Displaying novel solubilization approaches such as cyclodextrins, emulsions

and nanoparticlesJaymin Shah, PhD, Research Fellow, Parenteral Development Centre ofEmphasis, Pfizer, Inc.

2:00 Experiences with Captisol: Demonstrating SolubilityImprovements, Formulability and Clinical Use• Why not use Captisol?• Displaying case study examples of successful applications, challenges and

limitations• Understanding Captisol improvements• Discussing regulatory interactionsJames D. Pipkin, PhD, Senior Director, New Product Development, CyDexPharmaceuticals

2:45 Afternoon Networking Break

3:15 Predicting Oral Absorption of Amorphous CompoundsThat Precipitate in the GI Tract• Ascertaining the factors that lead to precipitation of drugs in the

gastrointestinal tract• Identifying assumptions necessary for relating in vitro dissolution to

bioavailability estimates• Provide simple expressions to predict bioavailability from in vitro

concentration vs. time curves• Estimating the bioavailability enhancement from the extent and duration of

supersaturation• Discussing impact of precipitation on variations in bioavailabilityRobin H. Bogner, PhD, Associate Professor of Pharmaceutics, School ofPharmacy, University of Connecticut

4:00 API Crystal Forms and Their Bioavailabilities• Screening API crystal forms• Understanding crystal forms and bioavailability• Selecting a suitable API crystal form• Controlling the desired API form in formulation and process development Xiaoming (Sean) Chen, PhD, Senior Development Investigator, Drug ProductDevelopment & Manufacturing, OSI Pharmaceuticals, Inc

4:45 Novel Strategies for Salt Selection Concerning SolubilityEnhancement, Salt Stability and Stabilization• Discussing salt selection strategy and processes• Areas of discussion will include:

• Feasibility analysis• Determination of salt stability • Approaches to stabilize a salt

Yaling Wang, Research Fellow, Merck & Co.

5:30 Chairperson’s Closing Remarks & End of Conference

Main Conference Day TwoWednesday, March 31, 2010


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Special Discounts Available: A limited number of discounts are availablefor the non-profit sector, government organizations and academia. For moreinformation, please contact customer service at 1-800-882-8684.Details for making payment via EFT or wire transfer:JPMorgan Chase - Penton Learning Systems LLC dbaIQPC: 957-097239ABA/Routing #: 021000021Reference: Please include the name of the attendee(s) and the eventnumber: 10521.004Payment Policy: Payment is due in full at the time of registration andincludes lunches and refreshment. Your registration will not be confirmeduntil payment is received and may be subject to cancellation.For IQPC’s Cancellation, Postponement and Substitution Policy, pleasevisit www.iqpc.com/cancellation Venue Information: Venue is to be announced. Please check the website atwww.improvingsolubility.com for updates and announcements.Special Dietary Needs: If you have a dietary restriction, please contactCustomer Service at 1-800-882-8684 to discuss your specific needs.©2009 IQPC. All Rights Reserved. The format, design, content andarrangement of this brochure constitute a trademark of IQPC. Unauthorizedreproduction will be actionable under the Lanham Act and common lawprinciples.

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Register & Pay By Register & Pay By Standard1/29/2010 2/26/2010 Price

Conference Only $1,199 $1,599 $1,799(save $600) (save $200)

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Workshops $549 each $549 each $549 each

Networking Dinner $99 $99 $99

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About our Sponsors:Eurand is a specialty pharmaceuticalcompany that develops,manufactures and commercializes

enhanced pharmaceutical and biopharmaceutical products based on itsproprietary pharmaceutical technologies. Eurand has had six productsapproved by the FDA since 2001 and has a pipeline of productcandidates in development for itself and its collaboration partners. TheCompany's technology platforms include bioavailability enhancement ofpoorly soluble drugs, custom release profiles, taste-masking, orallydisintegrating tablet (ODT) formulations, and drug conjugation.Website: www.Eurand.com

CyDex Pharmaceuticals, Inc. is a specialtypharmaceutical company focused on thedevelopment and commercialization of drugs

specifically designed to address limitations of current therapies inselected established markets. We have developed a portfolio of productcandidates utilizing our drug formulation technology using Captisol®cyclodextrins. Captisol® cyclodextrins are a patent protected, specificallymodified family of cyclodextrins designed to improve solubility, stability,bioavailability, safety and/or dosing of a number of activepharmaceutical ingredients, or APIs. Website: www.cydexpharma.com

Catalent Pharma Solutions is a leading provider of advanceddose form and packaging technologies as well as development,manufacturing and packaging services for pharmaceutical,

biotechnology and consumer health companies. Catalent applies its local marketexpertise and technical creativity to advance treatments, change markets andenhance patient outcomes. Catalent’s proprietary drug delivery and packagingtechnologies enable customers to achieve their desired clinical and market outcomes,and are used in many well-known products. With experience in more than 100countries and a global facility network that spans five continents, Catalent is wellpositioned to serve you, wherever you do business Website: www.catalent.com

Bend Research Inc. specializes in the invention,advancement, development, and commercialization ofpharmaceutical and health science technologies. We

develop drug-delivery solutions from a base of fundamental understanding,provide formulation and dosage-form assistance, and advance drug candidates allthe way to commercialization. We have a number of proprietary platformtechnologies available for licensing, including our spray-dried dispersion (SDD)technology that increases the bioavailability of low-solubility compounds. At BendResearch, we seek to develop strong alliances with companies that havechallenging drug-delivery problems to solve. Please call Bruce Johnson at 541-382-4100 to learn more about our research, development, and GMP manufacturingcapabilities. Website: www.bendresearch.com

March 29-31, 2010Philadelphia, PA


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