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www.exlevents.com/bioavailability EXECUTIVE SUMMARY DRUG FORMULATION, SOLUBILITY & BIOAVAILABILITY SUMMIT The Modeling and Enabled Formulation Expertise You Need to Maximize Drug Developability, Avoid Particle Formation, and Maintain Stability and Bioavailability 4th EXECUTIVE SUMMARY Join the Conversation Group: Enhancing Drug Bioavailability and Solubility

DRUG FORMULATION, SOLUBILITY & BIOAVAILABILITYinfo.exlevents.com/rs/195-NER-971/images/C768-ExecutiveSummary.pdf · A keynote presentation on “Future Trends in Drug Formulation:

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www.exlevents.com/bioavailability

EXECUTIVE SUMMARY

DRUG FORMULATION, SOLUBILITY & BIOAVAILABILITY S U M M I T

The Modeling and Enabled Formulation Expertise You Need to Maximize Drug Developability, Avoid Particle Formation, and Maintain Stability and Bioavailability

4th

EXECUTIVE SUMMARY

Join the ConversationGroup: Enhancing Drug Bioavailability and Solubility

2www.exlevents.com/bioavailability

CONTENTS

INTRODUCTION 3

PRESENTATIONS 4

RESOURCES FOR INFORMATION AND DISCUSSION 11

RECOMMENDED SERVICE PROVIDERS 12

3www.exlevents.com/bioavailability

INTRODUCTION: HERE’S WHAT YOU MISSED AT EXL PHARMA’S 4th DRUG

FORMULATION & BIOAVAILABILITY CONFERENCE

If you weren’t able to join us earlier this year, here is what you missed at ExL Pharma’s

4th Drug Formulation & Bioavailability Conference…

Dedicated to bringing together the industry’s leading formulation experts to share

and discuss emerging drug bioavailability and solubility enhancement strategies, the

4th annual summit was held January 26-28 in Boston. The conferencefocused on

breakthrough techniques in optimizing the screening, delivery, solubility and stability of

drugs and biologics to enhance product life cycles.

Built around specific industry feedback, 2015’s all-new program targeted the most

immediate formulation, solubility, permeability and bioavailability challenges. With

four unique program tracks, two in-depth interactive workshops, numerous networking

opportunities and more than 100 of the industry’s most distinguished drug formulation,

preformulation and delivery experts, the conference helped attendees develop

action plans for when real human data is lacking, explore the potential for solid-state

chemistry as the next breakthrough in drug design, select the optimal technologies for

advancing drug candidates and maintaining a robust pipeline and more.

All-new case studies centered on agnostic modalities in future drug development, the

latest challenges in simulating supersaturation, adjusting to shorter developmental

timelines of fixed-dose combinations, optimal screening approaches for cocrystrals,

risk protocols for photoreactivity and phototoxicity, and device-based oral biologic

delivery, among others.

Following are session summaries and highlights to give you an idea of what you may

have missed at our 4th Drug Formulation & Bioavailability Conference.

4www.exlevents.com/bioavailability

A keynote presentation on “Future Trends in Drug

Formulation: Agnostic Modality and Design for

Delivery,” presented by Rob Saklatvala of Merck

& Co., discussed a broader focus beyond pill

formulations, the design of delivery systems to

support better patient adherence, minimally invasive

delivery systems for poorly permeable drugs, and

more.

Pressures on the pharma industry include flat

productivity, high development costs and pricing

pressures. The future is fill of opportunity, with only

10 percent of the 3,000 genes believed to be linked

to disease currently targeted with FDA-approved

therapies; this will lead to a diverse portfolio to

formulate. The industry is seeing a shift to more

peptide drugs, because they are involved in various

physiological/pathological processes and play

important roles in regulating cell processes – they

may provide the best of small molecules and biologic

approaches, not to mention a potential for fewer side

effects, low tissue accumulation and high potency.

Modality agnostic approaches will see greater

interactions and synergy between small and large

molecule delivery groups. Currently, the overall cost

of poor adherence is about $310 billion annually, and

the success rates of various interventions further

opportunities in drug delivery. The challenge is in

identifying drug delivery opportunities sufficiently

early and compelling enough to warrant investments.

In summary, drug discovery pipelines are becoming

diverse in modality – complexity will increase, but so

will scientific opportunity. Formulation strategies and

technologies will need to evolve to consider multiple

modalities. Early consideration of drug delivery

strategy is important – it can identify gaps between

potential delivery options and competitive product

profiles. Understanding the needs and limitations

of delivery systems across modalities can enable a

design for delivery approach.

John Comer of Sirius offered a session focused on

“Novel Automated Analysis Methods for Biorelevant

Dissolution.” He noted that in vitro methods show

how APIs and formulations behave in the presence of

simulated gastric and intestinal pH and biorelevant

media and offered more details on in vivo predictive

dissolution methodology and monitoring precipitation

from supersaturated solutions. There are three ways

to measure concentration: 1) pH metric, which is good

for solutions whose pH is less than three units from

pKa; 2) in-situ UV, good for drugs that absorb UV;

and 3) offline, the best method if samples are very

turgid as well as different evaluation options. Sirius

inForm can set up a wide range of experimental

conditions. Keys to success include designing

experiments that discriminate well, deal with turgidity

and use innovative tests for investigating IVIVC.

Poor Adherence Leads to Poor Outcomes and Increased Healthcare Costs

7

Overall cost of poor adherence is close to $310B annually

Figure 1: Adherence rates of select conditions in US

Source: Andree Bates, “Ensuring Profitable Patient Adherence Programs”, Eularis, March 2010.

63%

62%

61%

60%

58%

57%

56%

54%

54%

54%

53%

52%

50%

0% 20% 40% 60% 80%

Enlarged prostate

Cancer

Cardiac problems

Parkinson's

Arthritis (Osteo)

Arthritis (Rheumatoid)

Incontinence

HIV/AIDS

GERD

Chronic bronchitis

Low back pain

Pain

Depression

SESSION SUMMARIES

©2015/3811

Dip probe for lipid

Lipid (25 mL)

pH electrode

UV dip probe

Stirrer (5-900 rpm)

Temperature probe

Reagent capillaries (6)

Inert gas

Aqueous solution

(30-70 mL)

Tablet holder

Cell and probes for pH-metric assays and biorelevant dissolution

Cell and probes for biphasic dissolution

5www.exlevents.com/bioavailability

“Nanoformulations to Enhance Bioavailability of

APIs” from Suresh Bandari of St. Peter’s Institute of

Pharmaceutical Sciences highlighted the increased

need to identify potential lead molecules which

had resulted in the discovery and development of

many drug candidates. About 95 percent of all new

potential therapeutics have poor pharmacokinetic

and biopharmaceutical properties. Drug delivery has

been an extremely demanding science because of

the emergence of the more challenging molecules,

increased use of biological materials and drug

targeting. Barriers in absorption of oral delivery are

solubility and permeability. Continued improvement

and accelerating research and development in

polymeric materials has played a vital role in the

progress of drug delivery technologies. After sharing

several case studies, he added that a host of current

industry issues include scalability, stability, regulatory

requirements for approval, cost of product, stability,

safety issues, efficacy and market potential.

“Solid State Chemistry: The Next Focal Point for

Drug Design and Development” was covered by

Weili Yu of Pfizer, who discussed optimizing solid

form selection strategies to improve bioavailability

and stability. Conversion to a more stable form will

generally occur more rapidly as the energy difference

between the two forms increases; therefore, the

common practice of selecting a more soluble form

may not provide the highest level of the drug in

solution in the GI track.

Small-scale experiments can be performed to

evaluate the potential for form conversion on the

time scale of absorption. Accurate prediction of

dosage form content uniformity allows the creation of

meaningful particle size acceptance criteria at early

stages of development. Prediction of the model can

be optimized as data from large-scale manufacturing

becomes available to guide late-state development

decisions. Overall, API solid form and the associated

physical attributes play a key role in drug design

from discovery to commercialization. Identification

and selection of the appropriate API solid form at

the earliest stage possible could be advantageous.

Organizations should leverage computational tools

and small-scale experiments with clinical and large-

scale manufacturing experience.

Stephen Tindal of Catalent focused on “Lipid-based

Systems for Oral Peptides.” Lipid-based delivery in

liquid-filled capsules involves the following: dissolve

required dose of API in maximum tolerated volume

of liquid; confirm stability/in vitro release/ in vivo

performance; and develop as a capsule dosage form.

Peptide therapy has challenges and several factors

can influence oral absorption. Improved permeability

of more lipophilic peptides is potentially related to

the displacement of the paracellular to transcelluar

route.

In presenting a case study on the oral delivery of

macromolecules, physiochemical and biochemical

properties were examined and the formulating

screening noted that lipid digestion products provide

enhancement. Capsule batches retained in the

stomach showed limited oral exposure while those

3

Pfizer Confidential │ 3

API Solid Form

Bioavailability

Manufacturabilty Stability

•  Solubility •  Dissolution rate •  Precipitation

•  Phase purity •  Excipient compatibility •  Hygroscopicity

•  Particle morphology •  Sticking tendency •  Compressibility

Why worry about API solid form?

6www.exlevents.com/bioavailability

reaching the duodenum delivered proper absorption.

In summary, LBS are a commercially viable but

underutilized technology; LBS can incorporate

excipients that are not feasible in powder-based solid

dosage forms. Incorporating water-soluble molecules

into LBS for peptide delivery requires advanced

expertise and advanced screening techniques.

Targeting the release of a permeation enhancer

upon digestion as part of the formulation requires a

reduced amount of PE and allows a healthy body to

recover quickly with less impact to other drugs.

“In Vitro Experiments and Simulation Approaches

to Identify and Address pH-dependent Absorption”

from Michael Perlman of Takeda Pharmaceuticals

discussed the use of in vitro dissolution and

simulation to design acidified formulations of weak

bases that minimize the impact of variable gastric

pH. About 50 to 70 percent of recently approved

targeted oral cancer therapies display pH-dependent

solubility. The therapeutic index for anticancer

drugs is often very narrow, and altered gastric pH

is known to impair absorption of many weakly

basic drugs. Dissolution assays of weak acids are

highly dependent on SIF buffer pH and capacity

– absorption is very dependent upon intestinal

pH. He noted that acid-reducing agents (such as

proton pump inhibitors) can impact absorption of

weak bases, and that acidifying agents can reduce

the impact of elevated gastric pH on absorption.

Supersaturation can play an important role in weak

base absorption, and non-sink in vitro dissolution

methods create predictive models for pH-dependent

absorption. Further, PBPK models can predict the risk

of pH-elevation and guide formulation development.

Paul Sabo of Patheon delivered a presentation with

details on “Stepwise Preformulation and Formulation

Development to Maximize Clinical Success.”

Understanding the target product profile involves

determining what you want from your clinical study,

what dose range you need to cover, the route of

administration and the most appropriate dosage

form – this entails some forward planning to ensure

that the formulation choice meets your clinical need.

Planning ahead will save time later and can help

avoid costly mistakes and delays to the study – he

suggested keeping it simple when possible. The

importance of physio-chemical properties includes

preclinical challenges.

Formulation approaches for Phase I studies should

include a simple risk assessment – bringing together

target product profile and prior knowledge/API

characterization. The main objective at this point

is to keep it simple; there is no need to waste time

and money on complex dosage forms unless you

have a specific need. The Quick to Clinic program

delivered by Patheon delivers in as little as 12 weeks

from receiving your API – you can have bulk clinical

trial materials for First in Human trials. Quick to

Clinic dosage forms include blend in capsule, API

in capsule, blend in bottle, API in bottle, oral liquid

and soft gel capsules. Bioavailability enhancement

involves multi-factorial challenges – no one solution

works for all molecules so there is a need to consider

integrated solutions. This is both time- and cost-

sensitive. Overall, defining your target product

profile, understanding the physical and chemical

properties of your molecule, keeping the formulation

development program simple and using good

planning are keys to success.

Mengwei Hu of Merck & Co. shared information on

“Early Investment in Controlled Release: Discovery

Controlled Release Formulation Assessment and

Case Studies.” The “why” of early investment is to

enable discovery to perform pharmacodynamics

studies with CR in preclinical species and to reduce

CR development risk by selecting candidates with

7www.exlevents.com/bioavailability

ideal properties. The “how” is early CrR investment

by multiple functional areas to leverage technology/

expertise from development combined with the

knowledge of discovery to achieve goals such as

evaluating CR feasibility and establishing PK/PD

relationship. And the “what” is API characterization,

modeling and simulation, and CR formulation for in

vivo evaluation to support PD studies. Challenges

include the physiology of preclinical species.

Three different case studies showed different

levels of CR assessment/support for discovery

programs: Case 1: enable PD study in rate to address

short half-life issue in a rat model using a chow

formulation strategy; Case 2: moderate level of

CR assessment with an extended PK profile to de-

risk AE and maintain efficacy for 24 hours with a

strategy of CR formulation development to meet

PK criteria; and Case 3: high level of CR assessment

to provide CR formulation for PD study in dog with

a focus on overcoming PK variation in dogs and

achieving minimal peak/trough ration and smooth

PD. Conclusions were that early investment in CR in

discovery provides resolution for short half-life issues

in preclinical disease models; further, early investment

CR assessment in discovery can effectively reduce

development risk. Finally, flexible assessment can be

achieved in a fast-paced discovery space based on

the specific PK/PD requirements and resources.

“Preclinical Utilization of IntelliCap Capsule

in Combination with Absorption Modeling to

Determine Key Oral Absorption Parameters”

from Manuel Sanchez-Felix of Novartis noted that

assumptions are made in GastroPlus while the

company wanted to determine if incorporating

stomach pH and GI transit times would improve

GastroPlus modeling for a compound. With poor

understanding of patients, dogs in a fasting state

were used to evaluated formulations. The study

showed that stomach pH of fasted dogs is highly

variable, and that pentagastrin and famotidine do

not always control stomach pH. There is a correlation

between stomach pH and gastric transit time of the

IntelliCap capsule. The compound is not retained in

the stomach for the same period as IntelliCap. Finally,

G+ simulations using IntelliCap pH and optimized

stomach transit time provided the best fits.

Larry Rosen of Merck provided insight on

“Overcoming Fixed Dose Combination Development

Challenges.” Fixed dose combination products

are two or more actives intended to be prescribed

concurrently to treat one or more conditions;

patient benefits include efficacy, safety, tolerability,

reduced bill burden, adherence and cost. Fixed dose

combinations are being developed earlier in the

product lifecycle and those containing three-plus

drugs are becoming more common.

Next generation challenges include beginning

development with less information and API supply,

which may be a constraint. A case study revealed that

increasing the concentration of the dispersion in the

tablet from 60 to 75 percent looks promising, and

increasing the NCE concentration in the amorphous

solid dispersion significantly decreases AUC. NCE

tablets all have disintegration times greater than

one hour. Efforts to reduce tablet size must focus

on increasing approved drug concentration in the

tablet. Recommendations, then, included proactive

Discovery Formulation Physicochemical characterization, CR risk assessment, and formulation development

Development Formulation

Provide specific technical expertise

Biopharmaceutics Bioperformance assessment Simulation and modeling

Pharmacology Perform CR PD studies

Pharmacokinetics Perform CR PK studies Provide PK parameters

Safety Provide safety margin information for Cmax and AUC

Discovery Chemistry Synthesize and identify lead candidates

Material Characterization

Phase selection

Process Chemistry Scale up to grams of AP

Saxena V, et al. J Pharm Sci. 2009;98:1962-1979.

How: Cross-functional Collaboration

8www.exlevents.com/bioavailability

alignment with regulatory agencies on fixed dose

combinations doses required for registration as

well as selecting external API suppliers as early as

possible, conducting a comprehensive preformulation

program, and exploring multiple formulation

approaches and initiating probe stability studies as

early as possible.

“Aligning Multiple Prediction and Evaluation

Methods for Preclinical Formulations” from

John Morrison of Bristol-Myers Squibb explained

that a “developable” drug candidate is designed

to balance physiochemistry, pharmacokinetics,

pharmacodynamic activity and safety characteristics.

Formulation performance criteria includes discovery

and development (effectiveness, capacity and

tolerability) and unique to discovery (throughput and

universality). Poor solubility limits oral absorption,

and solubilization can overcome slow dissolution,

but not low inherent solubility. Supersaturation

drives drug flux across the intestinal membrane

and overcomes both dissolution rate and solubility

limitations. In characterizing supersaturation, the

goal is to distinguish solution from solid. When it

comes to formula options in discovery, the key criteria

are effectiveness, capacity, tolerability, throughput

and universality. Furthermore, solubilization and

supersaturation are complimentary enabling

formulation strategies.

Konstantin Tsinman of Pion, Inc. presented “In Situ

Concentration Monitoring as a Measurement Tool

within in vivo Predictive Dissolution Systems,”

which recognized the greater need for analyzing

real-time free drug concentration. The low solubility

of novel drug candidates poses challenges not only

to formulators (how to make the drug more soluble

while keeping the formulation stable and scalable),

but also to analytic methods and techniques. There

are limitations to the in situ UV technique – real

complex dissolution media can obscure or totally

absorb the UV signal. Offline analytical methods like

HPLC or LCMS are labor-consuming, low-throughput

and lack real-time concentration monitoring benefits.

In terms of uFlux add on to in situ concentration

monitoring platform, permeability measurements

are allowed with real-time appearance/

disappearance monitoring, permeability assays

allow for investigation of complex formulations

and building realistic PK predictions, and complex

formulations can be studied by the flux response in

the receiver compartment. The permeability step

can be combined with dynamic media change and

other advanced dissolution studies. Finally, the

potentiometric technique can be time- and labor-

saving in comparison with HPLC when dealing with

UV-obstructive media.

“A Strategic Approach to the Regulatory

Challenges of Phototoxicity Assessment” from Evan

Thackaberry of Genentech examined phototoxicity,

including regulatory guidance, testing, models and

case studies. Phototoxicity is an acute light-induced

tissue response to a photoreactive chemical. It can

lead to cutaneous lesions or rashes in sun-exposed

areas. Many commonly used drugs and drug

classes have phototoxic liabilities, and therapeutic

indication drives risk/benefits assessment – for

example, phototoxicity may be tolerated in antibiotic/

oncology drugs, but it’s less desirable for chronically

Drug Discovery, Optimization and Selection

3 JS Morrison, Drug Formulation & Bioavailability (Boston, January 2015) Adapted from: Morrison AAPS

webinar, Oct 2014 (ref 1)

A “developable” drug candidate is designed to balance: 1)  physicochemistry

(Delivery) 2)  pharmacokinetics

(ADME) 3)  pharmacodynamic

activity (PD) 4)  safety characteristics

(Toxicology)

Delivery

ADMEpreclinical

PD

Tox

icol

ogy

Drug Candidate

AD

ME c

linic

al

Design

9www.exlevents.com/bioavailability

administered therapies. The most widely accepted

regulatory guidance on photosafety testing

recommends a stepwise approach – therapeutic and

route of exposure are critical. Predictivity of current

preclinical phototoxicity assays is poor (there is a

high false positive for in vitro 3T3 and predictivity of

in vivo rat assay is unknown). Further, understanding

the pharmacokinetics and distribution of drug in

preclinical species is critical; there are no known

models of ocular phototoxicity for ITV drugs.

Dongmei Qiang of Boehringer Ingelheim

Pharmaceuticals shared case studies on “An Action

Plan for the Lack of Real Human Data.” Following are

notable issues related to PK and PD data from human

clinical trials: bioavailability and exposure (API solid

form and formulation approach), dose proportionality

(impact of dose change on in vivo exposure), food

effect (API solid form and formulation approach),

half-life and clearance (dose regime), absorption

window in GI tract (feasibility of extended release

formulations), and pharmacodynamics response and

efficacy data (clinical proof of concept, dose and

exposure requirement). Physiological, physiochemical,

and formulation and process aspects all impact

bioavailability. Human PK studies may not be feasible

at early development stages, and predictive in vitro

tools are needed to select formulations for human

PK studies. Based on three different case studies, it

was determined that an in vitro dissolution method

assessing the extent of supersaturation in SIF may

be a viable tool to predict in vivo performance for a

basic drug. The viability of in vitro tools and animal

models to predict human bioavailability is compound-

and formulation-dependent. And early availability

of human pharmacokinetic data provides a more

confident basis for dosage form development.

David Sperry of Eli Lilly and Co. delved into

“Formula Bridging and Bioavailability Risk

Assessment through Development,” sharing the

drug development and formulation path. Any time

a drug product changes, it is important to consider

chemical and physical stability, manufacturing

capability, product design attributes, analytical

methods, packaging and in vivo performance. The

goal is to achieve the desired therapeutic outcome

for the changed drug product. Pharmacokinetic

studies (RBA and BE) can be used to determine if

formulations are equivalent. In vivo studies are the

gold standard for product performance assessment,

but that doesn’t mean the result is always right.

New standard methodology has been introduced to

determine if an RBA study is necessary. Risk-based

methods utilize well-established scientific principles,

and risk is quantified for CMC and PK considerations.

Output is then used to determine if an RBA study is

Practical Approach to Photosafety Testing Page 8

Photochemical Assessment Preclinical Assessment Clinical Assessment

Does the drug absorb within 290-700nm?

Is the MEC >1000 L/mol/cm?

Does the drug distribute to the

eyes/skin?

In vitro 3T3 Assay

In vivo Rodent Assay Clinical

Phototoxicity Evaluation

Recommend light protective measures

in the clinic

Yes

Yes Yes

Positive

Positive

Positive

Drug Development and Bioavailability

26 Jan 2015 © 2014 Eli Lilly and Company 3

Pre-­‐clinical   Phase  I   Phase  II   Phase  III   Commercial  

First  human  dose  formulaIon  

Commercial  formulaIon  

FormulaIon  

Development  path  

Clinical  formulaIon  has  the  potenIal  to  change  many  Imes  before  the  product  is  launched  

10www.exlevents.com/bioavailability

necessary. The impact is a consistent method that

diverse disciplines can all agree on, making the RBA

decision process much more efficient.

“The Latest Challenges in Simulating

Supersaturation,” presented by Stephanie Dodd of

Novartis, discussed in vivo solubility and examples

of GastroPlus predictions with in vivo solubility.

While formulators generate a tremendous amount of

solubility data, rarely is this data useful in explaining

the in vivo profiles observed for BCS Class II/IV

molecules. In terms of magnitude and duration of

supersaturation, behavior is key to predicting what

dose of a drug will fully absorb. For most species,

1,000 seconds is a good approximation encompassing

the main site of absorption for most molecules, the

duodenum. However, all poorly soluble molecules

are not created equal, and there is no correlation

between equilibrium solubility and supersaturation

solubility (in vivo solubility).

She shared an experiment that determined the in vitro

method for determining in vivo solubility values can

provide an accurate solubility value for understanding

drug absorption and solubility limitations, when used

in conjunction with GastroPlus simulation software in

both fasted and fed states. The in vivo solubility can

be utilized across species and may potentially give an

accurate forecast of dose plateau in a species from

an enabled formulation. In vivo solubility can forecast

how an enabled formulation will perform in vivo.

“Nanonization of API to Enhance Solubility,”

delivered by David Watkins of Netzsch, explored

opportunities, challenges and applications of

poorly soluble drugs to new chemical entities and

provided an overview of the clinical benefits and

commercialized drugs utilizing nanotechnology.

Challenges for pharma are that 40 percent of newly

discovered drugs have little or no water solubility,

which presents a serious challenge to the successful

development and commercialization of new drugs.

Likewise, most new chemical entities (NCE) are not

progressed to pre-clinical evaluation because of the

formulation challenges presently by poorly water-

soluble drugs. An opportunity lies in the fact that

more than 90 percent of drugs approved since 1995

have poor solubility, poor permeability or both.

Nanoparticles can be produced by spray freezing

into liquid, emulsification, rapid expansion from a

liquefied gas solution, high pressure homogenization

and bead milling, among others. When insoluble

APIs are reduced to the nanoscale, it leads to

increased bioavailability, reduced fed/fast variability

in bioavailability, better performance of the API and

lower dosages. Further, benefits of nanoparticles

for oral absorption include increased bioavailability,

increased rate of absorption, improved dose

proportionality and avoidance of uncontrolled

precipitation after dosing. A host of commercialized

products take advantage of the numerous benefits of

nanotechnology and nanosuspension.

www.netzsch.com 17

Benefits of Nanoparticles (Oral Delivery)

ExL’s 4th Drug Formulation & Bioavailability Conference, 2015

Large API Particles dissolution time >> GI transit time

Window of Absorption

API Nanoparticles dissolution time < GI transit time

11www.exlevents.com/bioavailability

RESOURCES FOR INFORMATION AND DISCUSSION

The 5th Drug Formulation, Solubility & Bioavailability Summit will take place January 25-27th, 2016 at The Rittenhouse Hotel in Philadelphia, PA.

Our 2016 event features an entirely revamped program that focuses on strategies for the constant day-to-day solubility challenges faced by the industry. Special features include:

n More than 30 speakers and 8 hours of networking in a 3-day program, featuring experts from Abbvie, Amgen, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Ferring, Genentech, GlaxoSmithKline, Johnson & Johnson, Lundbeck, Merck, Novartis and many other organizations

n By popular demand, a full-day Solubility Seminar intensively devoted to the challenges of working with amorphous solid dispersions

n Optimal techniques for managing dose loading while avoiding particle formation

n In-depth insights on the latest advances in subcutaneous, inhalation, oral and ocular delivery methods

n A road map for improving drug characterization techniques without getting swamped by an overabundance of data

…and much more!

For more information about our 2016 event and to register, please visit:

http://www.exlevents.com/bioavailability

Interested in sponsorship or exhibition opportunities? Please contact Dave Borrok at 212-400-6234 or [email protected]

DRUG FORMULATION, SOLUBILITY & BIOAVAILABILITY S U M M I T

The Modeling and Enabled Formulation Expertise You Need to Maximize Drug Developability, Avoid Particle Formation, and Maintain Stability and Bioavailability

5th

January 25-27, 2016 The Rittenhouse Hotel, Philadelphia, PA

12www.exlevents.com/bioavailability

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