Partnerships for Drug Delivery

Presents

Discover Strategic Innovations Within Licensing,Patent Opportunities, Delivery Technologies andAlliance Management

Highlights of This Program Include:• Identifying successful factors and strategies for leveraging delivery

partnerships

• Addressing patent opportunities in drug delivery concept

• Leveraging alliance management into partnerships

• Using innovative drug delivery formulations to extend the productlifecycle

• Discussing the needs and relationships of specialty pharma companieswith drug delivery companies

• Improving bioavailability and superiority through advanced drugdelivery systems

• Understanding the FDA requirements to streamline the process andobtain fast track approvals for drug delivery products

Media Partners:

Register by March 12, 2010 andreceive up to $600 off! See page 8 for details.

April 26-28, 2010 • Philadelphia, PA

ParticipatingOrganizations Include:

• GlaxoSmithKline• Pfizer, Inc. • Merck & Co.• AstraZeneca• Sanofi Aventis US• Novo Nordisk• Novartis• Boehringer-Ingelheim• Baxter Healthcare• Coviden• Purdue Pharma• Arsenal Medical

www.partnershipsdrugdelivery.com

Who will you meet at theconference: Vice Presidents, Directors, AssociateDirectors, Managers, Principals,Consultants, Business Leaders within:

Drug Delivery

Licensing

Business Development

Product Design

Technology Assessment

New Product Development

Life Cycle / Portfolio Management

Research & Development

Strategic Alliances

Regulatory Affairs

Manufacturing

2 Register Online at www.partnershipsdrugdelivery.com or Call 1-800-882-8684

Sponsorship andExhibition 0pportunities

Sponsorships and exhibits are excellentopportunities for your company toshowcase its products and services to high-level, targeted decision-makers attendingthe Partnerships for Drug DeliveryConference. Pharma IQ and IQPC helpcompanies like yours achieve importantsales, marketing and branding objectives bysetting aside a limited number of eventsponsorships and exhibit spaces, all ofwhich are tailored to assist yourorganization in creating a platform tomaximize its exposure at the event.

For more information on sponsoring orexhibiting at the Partnerships for DrugDelivery Conference, please call MarioMatulich at (212) 885-2719 [email protected].

For Registration Information and to Download the Complete BrochureVisit www.partnershipsdrugdelivery.com or Call 1-800-882-8684

P.S Highly interactiveand informative pre-conference workshops!See page 3 for details.


Dear Colleagues,

Drug delivery is an increasingly important sector within the pharmaceutical industry, which hasundergone rapid growth within the last few years. Drug delivery technologies are drivinggrowth of pharmaceutical companies and boosting their revenue by extending the product‘sprofitable lifecycle through new formulations, combinations and repositioning.This conference is designed to help pharmaceutical, biotechnology and drug deliverycompanies maximize deal making potentials and mitigate risks to achieve long-termsustainability. It will provide real life considerations for deal-making and drug deliverytechnology application strategies in your organization.

At this year’s Partnerships for Drug Delivery Conference, you will hear 17+ in-depth sessionsand case study examples including:• Reviewing the outcome of pharma partnering across the industry over the last 10 years• Evaluating if licensing is a good option for drug delivery partnerships• Understanding the FDA requirements to streamline the process and obtain fast trackapprovals for drug delivery products

• Examining late stage successful and unsuccessful diabetes licensing opportunities• Novel drug delivery technologies and therapeutics• Discussing the needs and relationships of specialty pharma companies with drug deliverycompanies• Integrating patent considerations into a deal making process

Benefit from industry presentations and perspectives shared by AstraZeneca, Merck, Pfizer,GlaxoSmithKline, Purdue Pharma, Coviden, Novartis, Baxter, Sanofi Aventis, Novo Nordisk,Boehringer-Ingelheim and many more pharmaceutical, biotech and CRO industry experts.This conference promises to be a networking and discussion-filled event leaving you with newideas and solutions to help you prepare for your next partnership or alliance. Join us in Philadelphia and learn from the experts on these vital strategies and technologies!

Simon CurtisSenior Conference Director, Pharmaceutical IQPharma IQ, a division of [email protected]


7:30 Registration and Coffee

8:30 Welcome Address and Chairperson’s OpeningRemarks

8:45 Opening Keynote Session: Evaluating theSuccesses of Pharma Partnering: Reviewing theOutcome of Pharma Partnering Across theIndustry over the Past 10 Years• Determining if the current model will sustain or inhibit growth

in future• Identifying the successful partnerships and uncovering the cost

of failed alliances• The role of big pharma: Can pharma survive as a

marketing vehicle rather than as an innovator?• Understanding if mega-mergers drive profits or stifle innovation:

How can they be used as a tool for organic growth?• Discussing novel approaches for the pharmaceutical industry to

ensure success in the next decade within the delivery partneringspace

Mahesh Chaubal, PhDDirector, Global R&D, Medication DeliveryBaxter Healthcare

PRE-CONFERENCEWORKSHOPS

AThe American financial market has declined in past year. Fund raising andventure capitalism within drug delivery has never been more important andchallenging during these volatile market conditions. The most critical partof life-cycle management strategies is to identify and leverage advancedtechnologies. This workshop will guide you through the process ofsearching for and working with the scientific society more effectively.

How You Will Benefit:• Learning how to raise funds in the global financial market• Understanding how to convince venture capital to invest in your deals• Identifying key areas for life-cycle management and pipeline extension • Understanding how licensing is playing a key role in life-cycle

management strategies

What Will Be Covered:• Examining existing financing colorations and how to get ready for

wider global implications• Discussing what venture capital expects from investments• Investigating how seed funding can be obtained through creative deal

structures• Ascertaining effective partnering & licensing strategies to identify

innovative technologies for life-cycle extension

Workshop Leader: Michael Lewis, Principal, Excend Consulting Group

Partnering with Venture Capitalists in the Declining Financial Market and Effective Partnering &Licensing Strategies to Identify Innovative Technologies for Life-Cycle Extension

9:00am – 12:00pm (Registration at 8:30am)

BWorking with a legal team has been a headache for most businessdevelopment professionals in drug delivery deals. Speaking the samelanguage with the legal team and understanding their concerns arebecoming more important than ever to ensure that you control the risksof the deals.

How You Will Benefit:• Understanding the legal framework of drug delivery technology• Knowing how to work with the legal team to manage patent issues in

the deal making process• Building an innovative deal structure to achieve life cycle management

What Will Be Covered:• Providing an update on recent FDA legislation on drug delivery• Highlighting IP issues in drug delivery deals• Utilizing global licensing strategies to acquire drug delivery technology• Discussing deal valuations from legal perspective

Workshop Leader to be announced.Please checkwww.partnershipsdrugdelivery.com for further details.

Legal Considerations for “Non-Lawyers” to Maximize Deal Making Potential

1:00pm – 4:00pm (Registration at 12:30pm – Lunch Included)

Monday, April 26, 2010

CONFERENCE DAY ONETuesday, April 27, 2010


Effective Deal Management and Business Development

9:30 Panel Discussion: The Voice from Big Pharma: DiscussingSuccessful Factors and Strategies for Leveraging DrugDelivery Partnerships• Providing advice on the decision making processes within large

pharmaceutical and biotech corporations• Exploring drivers and inhibitors in the deal making process for big pharma

companies• Knowing what qualities to look for from your potential partnering

organization• Identifying when and how to approach the right people within your

proposed partnering organization• Understanding and overcoming the most common headaches of

partnerships

Augustine YeeSenior Director, Global Strategic Planning and Business DevelopmentAstraZeneca

David ArvanDirector, US Business DevelopmentAstraZeneca

Vijay TammaraSenior Director, Regulatory AffairsMerck & Co.

10:15 Morning Networking Break

11:00 Understanding if Licensing is a Good Choice For DrugDelivery Partnerships• Examining the impact to future collaborators, buyouts, or licensing

activities related to your project• Discussing implications for manufacturing and scale-up activities • Identifying which people should be responsible for the technology that is

licensed• Utilizing a contract manufacturing organization for your project impacting

the licensing of technology• Analyzing who will own newly invented

IP as the project scales-up• Discussing whether licensing is going to make you more or less competitive

James Eshelby, PhDDirector, Strategic AlliancesPfizer, Inc.

11:45 Panel Discussion: Leveraging Alliance Management intoPartnerships• Leveraged alliance strategies to capitalize on technology and build

promising drug pipelines• Assigning responsibilities for alliance management within your own

decision-making structure• Cooperating with your drug delivery partners to avoid unanticipated

challenges • Evaluating the mechanisms and business models to determine the deal

value in the current competitive market

David H. Donabedian, PhD, MBAVice President, Strategic Alliances, US CEEDDGlaxoSmithKline

PJ AnandExecutive Vice President, Corporate DevelopmentArsenal Medical, Inc

Haro Hartounian, PhDChief Executive OfficerVyteris

12:30 Networking Luncheon

Legal and Regulatory Perspectives on Drug Delivery Partnerships

1:30 Successfully Acquiring a Biosimiliar in DrugDelivery for Partnering• Effectively tackling the approval process for biosimilars and

addressing the challenges posed by the sophisticatedmanufacturing processes of biologic drugs

• Successfully partnering an agreement to develop andcommercialize a biosimiolar in development for the potentialtreatment of Gaucher’s disease

• Passing Phase III clinical studies, and is preparing to complete arolling New Drug Application (NDA) with the U.S. Food andDrug Administration (FDA)

• Facilitating the development and expediting the review of drugsto treat rare conditions or diseases, as well as an EmergencyUse Authorization

• Aiming to meet the needs of many patient populations, includingthose affected by rare diseases both domestically and internationally

Christopher SlavinskyAssistant General Council, Established Products BrandPfizer, Inc.

2:15 Panel Discussion: Addressing PatentOpportunities in Drug Delivery Concept• Specialty pharma, drug delivery, biotech and even generic companies

can all greatly benefit from careful and early strategic patentplanning concerning products they propose to bring to market

• Recognizing that new drug development is a high risk venturewhich takes a great deal of time, has an exceptionally low successrate, and in the case of a successful new drug development

• Examining important opportunities for patent protection thatshould not be (but often are) neglected by specialty pharma,drug delivery and generic companies

• Establishing a successful patent lifecycle management team• Identifying the patent landscape• Beyond Big Pharma – Specialty Pharma, Branded and Non-

Branded Generics

Balu GuptaAssociate Vice President, Head, CNS Patent OperationsSanofi-Aventis US

Wendy A. Petka, PhD, J.D.Director & Senior Counsel, Intellectual PropertyBoehringer Ingelheim Corporation

Christopher SlavinskyAssistant General Council, Established Products BrandPfizer, Inc.

3:00 Understanding the FDA Requirements toStreamline the Process and Obtain Fast TrackApprovals for Drug Delivery ProductsInnovative pharmaceutical companies are faced withunprecedented challenges to get approvals from the FDA as theregulations are significantly tightened. • Thinking through the FDA perspective to achieve more with less • Understanding the stages of regulatory approval • Streamlining the filing processes with proven drug superiority • Creating internal synergy to accelerate the process


DAY ONE Continued...


3:45 Afternoon Networking Break

Diabetes Therapeutic Licensing Opportunities and Technology Assessment

4:15 Examining Late Stage Successful and Potential DiabetesLicensing Opportunities• Understanding future licensing opportunities within the diabetes and

metabolic space • Discussing what is required from smaller companies to promote their

successful clinical phase work further • Identifying successful investment opportunities within the diabetes licensing

market • Discussing future potential collaborative opportunities

Thomas Landh,Director, Strategy and SourcingNovo Nordisk

4:45 Technical Session: Updates within Novel Diabetes DrugDelivery TechnologyThis session will give three biotech companies who specialize within thediabetes drug delivery technology space the opportunity to deliver a 10minute presentation showcasing their novel delivery technology to ouraudience of potential partners and investors. This is a must attend for Pharma,biotech and the investment community. Presentation areas will include:• Late stage rapid acting injectable insulin• Ultra rapid injectable insulin• Clinical phase transdermal basal insulinContact Simon Curtis at [email protected] presentation opportunities

5:15 Panel Discussion: What is Restricting Big Pharma’s Involvement with Licensing & Partnering within the Diabetes Arena? • Discussing the successes and failures of past pharma and

delivery technology collaborations within the diabetes space• Identifying and forecasting successes of the future product

pipelines within a growing therapeutic area• Aligning your proposed partner’s aims and goals with your own• Understanding the incentives for large companies to seek small

specialized external sources• Enhancing the likelihood of a successful scouting process• The visibility in the pharmaceutical arena

Thomas LandhDirector, Strategy and SourcingNovo Nordisk

6:00 Chairperson’s Closing Remarks and End of Day One

8:00 Registration and Coffee

8:30 Welcome Address and Chairperson’s OpeningRemarks

Maximizing Product Exposure within the Marketplace

8:45 Novel Delivery Technologies & Therapeutics • Using technology to deliver patient centric and personalized

therapeutic solutions• Evaluation of new modalities to enable data driven investments

in technology • Early integration of technology to maximize

the potential of and differentiation of products. • Building a portfolio of technologies that can be ‘plugged in‘ as

needed.

David RobertsDirector, External Business Operations Technical R&DNovartis Institutes for BioMedical Research, Inc.

9:30 The Use of Modified Formulation and Delivery Technologies to Repurpose Old Drugs• Gaining a current and focused overview of formulation

technologies in the drug industry• Assessing and forecasting the future of innovation in the drug

formulations arena• Understand the issues faced in aligning drug formulation with

drug-delivery• Improve the efficacy of chemical entities and deliver the desired

therapeutic effect of drugs, both novel and established• Addressing formulation issues which occur within the CNS arena• Discussing advancements in technology, formulations being

developed enabling and benefiting technology transfer

Balu GuptaAssociate Vice President, Head, CNS Patent OperationsSanofi-Aventis US

Saran Kumar, PhDPrincipal Fellow, Pharmaceutical & Analytical DevelopmentNovartis Pharmaceuticals Corporation


CONFERENCE DAY TWOWednesday, April 28, 2010

DAY ONE Continued...


DAY TWO Continued...

10:15 Morning Networking Break

11:00 Improving Bioavailability and Superioritythrough Advanced Drug Delivery Systems• Alterations in drug delivery produce substantial changes in the

bioavailability which may lead to significant improvement onefficacy and tolerability

• Leveraging advanced drug delivery systems to consistentlyenhance patient compliance and overall drug effect is crucial forproduct enhancement strategies

• Examining the recent advancement of drug delivery systems • Analyzing the impact of drug delivery systems on bioavailability • Sustaining product value and combating generics by launching

the improved or next-generation

Saran Kumar, PhDPrincipal Fellow, Pharmaceutical & Analytical DevelopmentNovartis

11:45 Developing a Novel Active Transdermal DeliverySystem for Small Molecules and Peptides• Developed a proprietary active patch technology based on the

principle of iontophoresis• Consisting of a miniaturized pre-programmed controller and a

ready-to-use pre-filled patch• Examining a novel technology in it’s ability to control the flux of

drug through the skin by application of small and preciselycontrolled electrical current

• Discussing numerous preclinical and clinical studies for peptidesand small molecules to demonstrate the safety and efficacy

• Displaying completed Phase II clinical evaluation of the safetyand efficacy of several dosage strengths

Haro Hartounian, PhDChief Executive OfficerVyteris

12:30 Networking Luncheon

1:30 Innovations in Modified Release Systems• Developing products and formulation expertise for delayed

release and extended/controlled release applications• Supporting the demand of today’s pharmaceutical industry with

oral modified release dosage forms• Improving patient compliance through dosage frequency alteration• Leveraging novel drug delivery technologies• Case Study: Timed release oral drug delivery system

Vishal K. Gupta, MBA, PhDDirector, Pharmaceutical R&DCovidien

Forming an Effective Alliance

2:15 Discussing the Needs and Relationships ofSpecialty Pharma Companies with Drug DeliveryCompanies• Examining the relationships between specialty pharma and drug

delivery technology companies • How specialty pharma creates and evaluates new product opportunities • Debating whether specialty pharma is the future for Drug

Delivery technology companies

Allen G. DownsSenior Executive, Director, Licensing & Business DevelopmentPurdue Pharma L.P.

3:00 Afternoon Networking Break

3:30 Discussing the Strategic Benefits of MergingTwo Commercial Pipelines and Putting in PlacePlans for Effective Integration• Avoiding the main problems and issues with merging

commercial pipelines• Discussing key points in technology transaction negotiation• Assisting technology transfer to your organization• Uncovering examples of successful integration of commercial pipelines• Identifying approaches for shortening extremely long product

development cycles• Evaluating shorter testing cycles and getting faster approvals for

new compound entities (NCEs)

Mahesh Chaubal, PhDDirector, Global R&D, Medication DeliveryBaxter Healthcare

4:15 Integrating Patent Considerations into a DealMaking Process• Confirming patentability of the potential drug delivery technology

and the patent protection scope of this new technology• Defining patent inventorship such as employee inventions,

university collaborative research agreements and joint inventions• Conducting Freedom-To-Operate (FTO) to minimize the risks of

patent infringement

Wendy A. Petka, PhD, J.D.Director & Senior Counsel, Intellectual PropertyBoehringer-Ingelheim Corporation

Allen G. DownsSenior Executive, Director, Licensing & Business DevelopmentPurdue Pharma L.P.

5:00 Chairperson’s Closing Remarks and Close ofConference


ABOUT OUR PARTNERS

Drug Delivery TechnologyWebsite: www.drugdeliverytech.com

Drug Delivery Technology publishes scientific articles, special features, and market news covering the scienceand business of drug delivery, formulation development, product life-cycle management, technologyassessment, product development, contracting and licensing.Specialty Pharma is a self-contained featured section inside Drug Delivery Technology addressing the businessstrategies behind portfolio optimization, pipeline management, and partnering with contract service providersthroughout the drug development process.Drug Delivery Technology is committed to advancing the science, technology, and business of pharmaceuticaland biological delivery systems

PharmaVOICEWebsite: www.pharmavoice.com

PharmaVOICE magazine, reaching more than 17,500 U.S.-based life-sciences executives, is the forum thatallows business leaders to engage in a candid dialogue on the challenges and trends impacting the industry.PharmaVOICE, and its supporting VIEW publications, provide readers with insightful and thought-provokingcommentary in a multiple-perspective format through forums, topics, and articles covering a range of issuesfrom molecule through market. PharmaVOICE subscribers are also kept abreast of the latest trends andinformation through additional media resources, including WebLinx Interactive WebSeminars, Podcasts,Videocasts, White Papers, E-Surveys and e-Alerts. Additionally, PharmaVOICEMarketplace.com provides acomprehensive directory of products, services, and solutions for the life-sciences industry. To Raise Your VOICE,contact [email protected]

PharmCastWebsite: www.PharmCast.com

www.PharmCast.com is the world leading website designed specifically for pharmaceutical, clinical andbiotechnology professionals. www.PharmCast.com brings up-to-date information on pharmaceutical patents,FDA, news, jobs and Buyer's Guide to our visitors. It was created and is maintained by pharmaceutical andbiotechnology professionals. Visit www.PharmCast.com and discover for yourself why it is so popular amongprofessionals.

Pharmaceutical ManufacturingWebsite: www.pharmamanufacturing.com

Pharmaceutical Manufacturing is devoted exclusively to drug manufacturing and scale-up and dedicated tosharing best practices that will help drug industry professionals improve product quality, ensure compliance,reduce cycle times, eliminate organizational and information silos and reduce time to market for new drugs,drugs that can actually be manufactured.

CanBiotech Website: www.canbiotech.com

CanBiotech - A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. TheMarketplace features the Outsourcing Services Showcase; the Portal features our biopharmaceutical and venturecapital directories and databases. Publications include the Bio Outsourcing Asia© Publication. Read aboutopportunities in India, China, Malaysia, Singapore, Taiwan and more. www.canbiotech.com

Discover Strategic Innovations Within Licensing,Patent Opportunities, Delivery Technologies andAlliance Management


8

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Register Online at www.partnershipsdrugdelivery.com or Call 1-800-882-8684

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Register and Pay Register and Pay Standardby March 12, 2010 by April 9, 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