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Large Pharma/Biotech Evaluation & Partnering PanelBoehringer Ingelheim ● Biogen Idec ● Johnson & Johnson Hospira ● Pfizer ● Ranbaxy Labs ● Roche ● Vertex

How Delivery is Changing the Therapeutic LandscapeAlcyone Lifesciences ● Alnylam ● MedtronicShire HGT ● US CEEDD, GSK

Developing & Commercializing Early Stage Technologies from AcademiaBioPontis ● Enlight BioSciences ● GSKPfizer ● UC Santa Barbara

Strategies for Developing and Commercializing Biobetters & BiosimilarsMomenta Pharmaceuticals ● Shire HGT STC Biologics

Drug Delivery Business Models: The View from Wall StreetSROne ● Thomas McNerney & Partners

Track One - Drug Delivery Formulation Technologies Company presentations on formulation technologies that can enhance, enable, or facilitate delivery of a drug.

Track Two - Drug Delivery Device Technologies Company presentations on needle-free delivery devices, auto injectors, pen injectors, powder injection devices, microneedle systems, inhalation devices, nasal delivery devices, non-biodegradable implants or similar, transdermal patches, patch pumps and other wearable drug administration systems, etc.

2012 CONFERENCE HIGHLIGHTS DRUG DELIVERY PRESENTATIONS

Keynote Speaker

Robert Langer, PhDDavid H. Koch

Institute ProfessorMIT

Chair

Barbara Lueckel, PhDGlobal Business

Development DirectorRoche

Device Keynote Speaker

Stephen N. Oesterle, MDSenior Vice President for Medicine and Technology

Medtronic

Organized byExecutive Sponsors

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Dear Life Science Executive,

The Conference Forum is delighted to present the 2nd Annual PODD, Partnership Opportunities in Drug Delivery. This event is designed with three purposes:

1. To present a strategic level program for pharma and biotech business development and external licensing professionals with a thorough overview of the latest drug delivery technologies available along with an update on deals and opportunities to enhance patients’ quality of life, improve therapies and extend the life cycle of a drug.

2. To provide drug delivery and specialty pharma companies with a platform to present their technologies and get the latest insights from established pharma and biotechs as well as emerging companies on what the delivery and formulation needs are.

3. To offer ample networking time, facilities and services for one-on-one meetings to establish new business contacts and enhance existing ones.

The ultimate goal for PODD is to foster a meeting place that inspires innovation and advancement of drug development and delivery as well as providing support for the leaders behind the movement.

Sincerely,

Michelle McDermott Valerie BowlingConference Producer Executive Director

Moji Adeyeye, PhDPresident & Chief ScientistElim Pediatric Pharmaceuticals

PJ AnandFounder, President & CEOAlcyone Lifesciences, Inc.

Jessica BallingerSenior Director, Protein Formulation DevelopmentBiogen Idec

Richard A. BasileCEO & PrincipalBioPontis Alliance LLC

Kevin Bitterman, PhDBoard MemberKala Pharmaceuticals

and

PrincipalPolaris Venture Partners

Weiguo Dai, PhDScientific Director, Janssen FellowJohnson and Johnson

David H. Donabedian, PhD, MBAVice President, Formerly, Global New Deal Strategy & DevelopmentUS CEEDD, GSK

Mary GardnerDirector, Technology AssessmentHospira

Philip Green, PhDSenior Director, Drug Delivery DevicesMerck Bioventures, Merck Research Laboratories

Baruch Harris, PhDVice President, Strategy & OperationsEnlight Biosciences

Benoit Hebert, Ph.D., MBAVice President, Business Development & LicensingPediapharm, Inc.

Keith Horspool, PhDVice President, Pharmaceutical DevelopmentBoehringer Ingelheim

Patrick Hughes, PhDSenior Director, Drug Delivery SciencesAllergan

PODD: PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY OVERVIEW

OVERVIEW SPEAKING FACULTY

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Anil Kane, PhD, MBAExecutive Director, Global Science & Technology, Pharmaceutical Development ServicesPatheon

Robert Langer, PhDDavid H. Koch Institute ProfessorMIT

Ashley LawtonSenior Director, Business DevelopmentShire HGT

Andrea Leone-BayVice President, Pharmaceutical DevelopmentMannkind

Magdalena Leszczyniecka, PhD, MBAFounder & CEOSTC Biologics

Barbara Lueckel, PhDGlobal Business Development DirectorRoche

Samir Mitragotri, PhDProfessor of Chemical EngineeringUC Santa Barbara

Sesha Neervannan, PhDVice President, Pharmaceutical DevelopmentAllergan

Ron NewboldHead - Strategic Research Partnerships, External R&D Innovation, Worldwide Research & DevelopmentPfizer

Stephen Oesterle, MDSenior Vice President, Medicine & TechnologyMedtronic, Inc.

David PhilipsManaging PartnerSROne

Julia Rashba-Step, PhDSenior Director, Novel Delivery TechnologiesPfizer

Laurence Reid, PhdSenior President & Chief Business OfficerAlnylam Pharmaceuticals

Jonathan Rigby, PhDPresident & CEOSteadyMed Therapeutics

Jim Roach, MDSenior Vice President, Development & CMOMomenta Pharmaceuticals, Inc.

Barbara RosengrenVice President, Strategic Product DevelopmentMomenta Pharmaceuticals, Inc.

Anne RoushBusiness Development Manager3M Drug Delivery Systems Division

Daniel E. Schaufelberger, PhDScientific Director, Pharmaceutical Development & Manufacturing Sciences, Pediatric Center of ExcellenceJanssen R&D, LLC

Lisa Shafer, PhDDirector, CNS Drug Therapy R&DMedtronic

A. Lee Shorter, PhDDirector, Disruptive Technology SeekerGSK

Phil Smith, PhDPNP Smith Advisors, LLC

Cornell StamoranVice President Strategy & Corporate DevelopmentCatalent Pharma Solutions

Sven Stegemann, PhDPresidentGeriatric Medicine Society

Anand Subramony, PhDHead of Novel Delivery Technologies & TherapeuticsNovartis

Hayden Thomas, PhDSenior Director, Formulation DevelopmentVertex Pharmaceuticals

Avinash Thombre, PhDResearch FellowPfizer Global R&D

Arthur Tzianabos, PhDVice President & Head of ResearchShire HGT

Darin Zehrung, MBAPortfolio Leader, Vaccine Delivery TechnologiesPATH

Alex ZissonPartnerThomas McNerney & Partners

SPEAKING FACULTY PODD: PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY

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TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

8:00 amBreakfast and Registration

8:30 amChair’s Opening RemarksBarbara Lueckel, PhDGlobal Business Development Director, Roche

8:45 amOpening Keynote Address: The Future of Drug DeliveryRobert Langer, PhDDavid H. Koch Institute Professor, MIT

At the inaugural 2011 event, Dr Langer gave a wonderful presentation on drug delivery technologies and opportunities. For the 2012 event, Dr Langer will share his insights into the future of drug delivery.

Dr. Langer is a widely recognized and cited researcher in biotechnology, especially in the fields of drug delivery systems and tissue engineering.  He operates the world’s largest biomedical engineering lab in the world and is a prolific inventor with approximately 790 issued and pending patents worldwide. 

Dr. Langer’s patents have been licensed or sublicensed to over 220 pharmaceutical, chemical, biotechnology and medical device companies; a number of these companies were launched on the basis of these patent licenses.

Among the products which have stemmed from his research: a long acting growth hormone formulation that prevents dwarfism in children; the PreludeTM SkinPrep system for needle-free drug delivery and analyte extraction; and the Gliadel Wafer, the first therapy to extend the lives of patients with glioblastoma multiforme brain cancer. Dr. Langer has co-founded multiple companies including MicroCHIPS, Momenta Pharmaceuticals, TransForm Pharmaceuticals, Pervasis Therapeutics, Arsenal Medical, and Selecta Biosciences, and sits on the Board of more than twenty companies including Alkermes, Cerulean Pharma, Kala Pharmaceuticals, and Humacyte.  

9:45 amHow Biotech and Pharma Currently View Drug Delivery Technologies: Evaluation & Partnering

• What are the key delivery technologies of interest?

• Review of key therapeutic categories requiring DDS technology

• How companies are sourcing DDS technologies?

• What are the major hurdles in partnering with a DDS company?

• What are the keys to a successful pharma-DDS partnership?

Moderated by:

Barbara Lueckel, PhD, Global Business Development Director, Roche

Panelists:

Jessica Ballinger, Senior Director, Protein Formulation Development, Biogen Idec

Weiguo Dai, PhD, Scientific Director, Janssen Fellow, Johnson and Johnson

Mary Gardner, Director, Technology Assessment, Hospira

Keith Horspool, PhD, VP Pharmaceutical Development, Boehringer Ingelheim

Julia Rashba-Step, PhD, Senior Director, Novel Delivery Technologies, Pfizer

Hayden Thomas, PhD, Senior Director, Formulation Development, Vertex Pharmaceuticals

10:30 amNetworking Break and Partnering Hour (Partnering Service Desk Opens)

11:30 amThe DDS Company Viewpoint on Partnering

In this collaborative voice of drug delivery companies, we get a solid understanding of the obstacles and challenges they face in executing and managing a successful partnership.

• What DDS companies are looking for in a partner

• Challenges of partnering with big pharma

• Types of collaborations and deal terms

• Keys to successful partnerships

Moderated by:

Barbara Lueckel, PhD, Global Business Development Director, Roche

Panelists:

Andrea Leone-Bay, Vice President Pharmaceutical Development, Mannkind

Jonathan Rigby, President & CEO, SteadyMed Therapeutics

Anne Roush, Business Development Manager, 3M Drug Delivery Systems Division

PODD: PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY AGENDA

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DAY ONE - MONDAY, OCTOBER 1, 2012

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12:15 pmStrategies for Developing and Commercializing Biobetters & Biosimilars

In this panel, we explore the development strategies and role of drug delivery to differentiate biosimilars. What you must know and understand about opportunities in this area is central to the discussion along with the following:

• Extend half-life, drug-device combos, reduce adverse effects

• US draft guidance released

• FDA guidance allows use of different drug delivery devices for Biosimilars

• US-EU harmonization

• Market outlook – key players, opportunities for partnering

• Payor perspective – costs, improved compliance

• Patient/Physician Feedback: perceived value and utilization of biobetters/biosimilars

Moderated by:

Phil Smith, PhD, Founder, PNPSmith Advisors, LLC

Panelists:

Ashley Lawton, Senior Director, Business Development, Shire HGT

Magdalena Leszczyniecka, PhD, MBA, Founder & CEO, STC Biologics

Jim Roach MD, Senior Vice President, Development & CMO, Momenta Pharmaceuticals, Inc.

Barbara Rosengren, Vice President, Strategic Product Development, Momenta Pharmaceuticals, Inc.

12:45 pmAn Unbiased Approach to Drug Development Technologies

In this presentation, our presenter discusses options for drug development technologies including parallel drug formulation screening and formulation technology use to increase bioavailability class II and IV products.

Anil Kane, PhD, MBA, Executive Director, Global Science & Technology, Pharmaceutical Development Services, Patheon

1:00 pmLuncheon and Partnering Meetings

AGENDA PODD: PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY

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2:00 pm - 6:00 pmDrug Delivery Technology Presentations (3:45 pm - 4:00 pm Break)

Track One - Drug Delivery Formulation TechnologiesChaired by: Avinash Thombre, PhD, Research Fellow, Pfizer Global R&DApproximately 12-14 companies present formulation technologies that can enhance, enable, or facilitate delivery of a drug. Examples: nanoparticles, polymers/biodegradable materials, liposomes, tablets/capsules/liquids, conjugates, microparticles, lipids/emulsions, excipients, orally-disintegrating tablets/films, etc.

Presenting Companies:AptalisGrace/Formac PharmaceuticalsGSKOctoplusDLVR TherapeuticsConvoy TherapeuticsEnduRXCIMAHovioneMedincellXeris PharmaceuticalsCeruleanEndo Health SolutionsUnigene Laboratories

Track Two - Drug Delivery Device TechnologiesChaired by: Philip Green, PhD, Senior Director, Drug Delivery Devices, Merck Bioventures, Merck Research LaboratoriesApproximately 12-14 companies present needle-free delivery devices, auto injectors, pen injectors, powder injection devices, microneedle systems, inhalation devices, nasal delivery devices, non-biodegradable implants or similar, transdermal patches, patch pumps and other wearable drug administration systems, etc.

Presenting Companies:3MMannkind CorporationHovioneMystic PharmaceuticalsSteadyMed TherapeuticsWeinberg/OtomagneticsWest PharmaBD MedicalPolyActivaBattellePolyActivaNovozymes BiopharmaSpringLeaf Therapeutics

If you are interested in presenting your technology, please contact Msands@theconferenceforum.org.

TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

6:00 pmNetworking Reception

8:00 amBreakfast and Partnering Meetings

8:30 amChair’s Welcome

Barbara Lueckel, PhDGlobal Business Development Director, Roche

8:40 amFrom Enabling Delivery to Delivering Payor, Regulatory & Patient Outcomes: The New Imperative for Advanced Technologies

Developers of medicines face increasing expectations for improved outcomes - from payors, from regulators, and from patients.  The role of advanced delivery technology providers must shift from ensuring achievement of the desired delivery profile to driving therapeutic benefits. This will require both developers and technologists to use different approaches, different partnerships, and different mindsets.

Cornell Stamoran, Vice President Strategy & Corporate Development, Catalent Pharma Solutions

9:00 amGame-Changer: Case Discussion of How Delivery Changed and is Changing the Therapeutic Landscape

Examples include:       

• Shire: Lysosomal Storage Disease

• Medtronic: Parkinson's Disease

• Alnylam Pharmaceuticals: Huntington's Disease

Post example discussion:

• Change in outlook regarding delivery options by biopharma-what is driving this?

Moderated by:PJ Anand, Founder, President & CEO, Alcyone Lifesciences, Inc.

Panelists:David H. Donabedian, PhD, MBA, Vice President, Formerly, Global New Deal Strategy & Development, US CEEDD, GSK

Laurence Reid, PhD, Senior Vice President & Chief Business Officer, Alnylam Pharmaceuticals

Lisa Shafer, PhD, Director CNS Drug Therapy R&D, Medtronic

Arthur Tzianabos, PhD, Vice President & Head of Research, Shire HGT

9:50 amDevice Keynote Presentation: Targeted, Controlled, Local Delivery Using Implantable Devices

Stephen Oesterle, MD, Senior Vice President, Medicine & Technology, Medtronic, Inc.

10:30 amNetworking Break and Partnering

11:15 amInjectable Drug Delivery Trends

Justin M. Wright, PhD, Director of Pharmaceutical Development, BD Medical

11:30 amPartnering Spotlight Talks

In this session, Allergan, Novartis and PATH, discuss their partnering philosophy, current needs and scouting interests as related to drug delivery.

Sesha Neervannan, PhD, Vice President, Pharmaceutical Development, Allergan

Anand Subramony, PhD, Head of Novel Delivery Technologies & Therapeutics, Novartis

Darin Zehrung, Portfolio Leader, Vaccine Delivery Technologies, PATH

12:30 pmEffective Deal-Making in Drug Delivery

• Examples of successful deals

• The terms and strategies to close the deal

• How deal-making has changed over the past 5-10 years

Moderated by:

Barbara Lueckel, PhD, Global Business Development Director, Roche

PODD: PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY AGENDA

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DAY TWO - TUESDAY, OCTOBER 2, 2012

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2:00 pmDeveloping & Commercializing Early Stage Technologies from Academia

Some of the most exciting developments in drug delivery are coming from academia. This session is dedicated to helping you understand how to access early stage technologies and become involved with the development and ultimate commericalization of such technologies.

• Types of partnering models, beyond straight licensing and sponsored research; examples of recent deals resulting in DDS start-ups

• Opportunities and challenges:  reproducibility; tech transfer/license challenges; balance between investor and PI/institution needs; examples of what is working

• Intellectual property issues:  assignments, conflict of interest, shared interests, research collaborations, working with 3rd parties, solutions to address (e.g. incubators)

Moderated by:

Baruch Harris, PhD, Vice President, Strategy & Operations, Enlight Biosciences

Panelists:

Richard A. Basile, CEO & Principal, BioPontis Alliance

Kevin Bitterman, PhD, Board Member, Kala Pharmaceuticals and Principal, Polaris Venture Partners

Samir Mitragotri, PhD, Professor of Chemical Engineering, UC Santa Barbara

Ron Newbold, Head - Strategic Research Partnerships, External R&D Innovation, Worldwide Research & Development, Pfizer

A. Lee Shorter, PhD, Director, Disruptive Technology Seeker, GSK

2:45 pmDrug Delivery Business Models: The View from Wall St.

• What does Wall St. think of drug delivery in general?

• How have business models evolved over the years?

• Which business models are in and out of favor at the moment?

• Tips on raising Wall Street funds for your company

• A few guesses at the future

David Philips, Managing Partner, SROne

Alex Zisson, Partner, Thomas McNerney & Partners

3:30 pm Opportunities in Pediatrics and Geriatrics

Utilizing the examples of geriatrics and pediatrics, we explore unmet needs of specific patient populations and how drug delivery technologies can play a significant role. More specifically:

• Formulation needs and challenges related to drug delivery for pediatrics and geriatrics

• Delivery technologies available to meet these special needs

• Key pediatric and geriatric therapeutic indications requiring novel DDS

• Examples of partnering opportunities – drug delivery platform technologies, specific drug formulations

• Regulatory hurdles for gaining approval of patient-centric formulations

Panelists:

Moji Adeyeye, PhD, President & Chief Scientist, Elim Pediatric Pharmaceuticals

Benoit Hebert, Ph.D., MBA, Vice President, Business Development & Licensing, Pediapharm, Inc.

Daniel E. Schaufelberger, PhD, Scientific Director, Pharmaceutical Development & Manufacturing Sciences, Pediatric Center of Excellence, Janssen R&D, LLC

Sven Stegemann, PhD, President, Geriatric Medicine Society

4:15 pmConference Concludes

AGENDA PODD: PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY

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1:00 pmLuncheon Sessions

Attendees have a choice to be part of our open networking luncheon or join a round table discussion luncheon dedicated to a specific topic. Each of the topic round tables has a dedicated moderator with expertise in the particular area.

The Potential Impact of Disruptive Innovation for Pharma R&DModerator:A. Lee Shorter, PhD, Director, Disruptive Technology Seeker, GSK

Drug Delivery Systems for Emerging MarketsModerator:Avinash Thombre, PhD, Research Fellow, Pfizer Global R&D

Ocular Delivery of Protein TherapeuticsModerator:Patrick Hughes, PhD, Senior Director, Drug Delivery Sciences, Allergan

TO REGISTER, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

The Boston Park Plaza Hotel50 Park Plaza at Arlington StreetBoston, MA 02116-3912Tel: 617-426-2000www.bostonparkplaza.com

The Boston Park Plaza Hotel & Towers is located only 3 miles from Logan International Airport and only 200 yards from Boston Common & the Public Garden. The hotel is easily accessible to shopping along world renowned Newbury Street, Faneuil Hall Marketplace, the Theatre & Financial Districts and most historic landmarks.

Book early and be sure to request the special “PODD” conference room rate.

Business Development

• External Licensing

• Technology Licensing

• Portfolio Management

• Research & Technology Development

• Pharmaceutical Formulation/Sciences

From Drug Delivery and Specialty Pharma:

• Business Development

• Licensing

• Marketing

• Formulation Sciences

• Technology Development

• Commercial Development

The Investment Community

The early bird conference fee of $1,895 covers all program sessions and includes breakfasts, lunches, reception, access to partnering services and conference documentation.

Discount ProgramsGroup Registration - Receive a 10% discount off each registration when two or more colleagues from the same company register.

Full time academicians and government employee rates available. Partial and full scholarships for start up biotechs available. Large group discount rates available.

Please contact us at Service@theconferenceforum.org for discount rates and scholarships.

Two Ways to RegisterOnline - www.theconferenceforum.org

Telephone - 646-350-2580

Payment PolicyPayment must be received in full by the event date. All discounts will be applied to the Conference fee only (excluding add-ons), and cannot be combined with any other offer.

Substitution and Cancellation PolicyIf you are unable to attend and would like to register a substitute, please email us at Service@theconferenceforum.org. If you need to cancel your registration, please note the following policies based on the start date of the event:

Ten or more business days prior: A full refund less the administration fee of $295, or a pass to another event valid for two years from the date of issue.

Less than ten business days prior: A pass to a future event for either yourself or a colleague from the same company valid for two years from the date of issue.

Do You Want To Reach the Audience at This Event? Share your expertise and showcase your product or services to key industry decision-makers. For information on sponsorship or exhibit opportunities, please contact our Sales Department at Sales@theconferenceforum.org or 646-350-2586. To get involved as a Press or Media partner, please contact Customer Service at Service@theconferenceforum.org or call 646-350-2580 Ext 310.

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PODD: PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY REGISTRATION

REGISTRATION

SPONSORSHIP OPPORTUNITIES

VENUE

WHO SHOULD ATTEND

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SPONSORS PODD: PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY

MEDIA PARTNERS

TECHNOLOGY SPONSORS

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EXECUTIVE SPONSORS

EXHIBITORS CONFERENCE SUPPORTER

CO-SPONSOR LUNCHEON SPONSOR