partnerships opportunities in drug delivery · 10/14/2014 · a strategic level partnering event...

A strategic level partnering event with

a wide range of drug delivery technologies

4th Annual

Partnerships Opportunitiesin DruG DeliveryOCTOBER 14 - 15, 2014 RENAISSANCE BOSTON WATERFRONT HOTEL, BOSTON, MAPO

DD

REGISTER AT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580

Follow us on Twitter @ConferenceForum #PODD

KEYNOTERobert Langer, PhD

David H. Koch Institute Professor

MIT

PHARMA KEYNOTEJames Spavins

SVP, Head of Pharmaceutical Sciences

Pfizer

CHAIRBarbara Lueckel, PhD

Global Business Development Director

Roche

Executive Sponsor Organized by

DEVICE CHAIRShawna Gvazdauskas

Global Head of Device Strategy, External Opportunities & IT Liaison

Sanofi

FORMULATION CHAIRBruce Kerwin, PhDScientific Director

Amgen

http://WWW.THECONFERENCEFORUM.ORG



OVERVIEW

The Conference Forum is delighted to present the 4th Annual PODD, Partnership Opportunities in Drug Delivery event. This annual Boston-based conference is designed with three purposes:

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

2. To provide drug delivery and specialty pharmas with a platform to present their technologies and get the latest insights 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 4th annual event is chaired by Barbara Lueckel, PhD, Global Business Development Director, Roche and keynoted by Robert Langer, PhD, David H.Koch Institute Professor, MIT. We have the first draft of the program available for your viewing. Take advantage of the early bird pricing and let us know if you have any questions.

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.

Valerie BowlingExecutive Director

Michelle McDermottConference Producer

Jessica RothenbergMarketing Director

SPEAKING FACULTY

Bala Ambati, MDFounderiVeena

PJ AnandFounder, President & CEOAlcyone Lifesciences, Inc.

Jessica BallingerSenior Director, Protein Pharmaceutical DevelopmentBiogen Idec

Rush Bartlett, PhD, MBAFounder & Chief Technology OfficerLyoGo

Lew BenderPresident & CEOIntensity Therapeutics

David Berry, MD, PhDPartnerFlagship Ventures

James Callaway, PhDPresident & CEOArmaGen Technologies, Inc.

Sarath Chandar, MBAVP, Strategic Development and Technology LicensingSPI Pharma

Eric ChanieDirector, Head of Innovation Medical DevicesMerck Serono

Tomasz Ciach, PhDFounderNanovelos

Abla Creasey, PhDSenior Scientific Director, Primary Container & Drug Delivery Systems/PDMSJanssen

Steven DamonPresident & CEO4P Therapeutics

Kevin DeanePartner, Technology GroupPA Consulting Group

4TH ANNUAL PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY OVERVIEW

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Frank Diana, PhDVP, Pharmaceutical DevelopmentEndo Pharmaceuticals

Tony Eglezos, PhD, MBAVP, Business DevelopmentStarpharma

Jason Ehrick, PhDAssociate Director, Respiratory Product DevelopmentMerck Research Laboratories

Nazar Elkarim, PhDDirector, Project ManagementBanner Life Sciences

Adam FeilerChief Technical OfficerNanologica

Barbara Fox, PhDCEOAvaxia Biologics, Inc.

Brian Gallagher, Jr, PhDPartnerSR One Ltd.

Mary Gardner, MBA, BEngScDirector, Technology AssessmentHospira, Inc.

Shawna GvazdauskasGlobal Head of Device Strategy, External Opportunities & IP LiaisonSanofi

Matthew Hilborn, MBA&EStrategic Technology & Business Development SpecialistGSK

David Hirsch, MD, PhDManaging DirectorLongtitude Capital

Michael HoovenPresident and CEOEnable Injections

Keith Horspool, PhDVP, Pharmaceutical DevelopmentBoehringer Ingelheim

Jeff Hrkach, PhDChief Technology OfficerBIND Therapeutics

Paul JansenVP, Medical Device DevelopmentSanofi

Bruce Kerwin, PhDScientific DirectorAmgen

Dan Koerwer, MBASVP, Business Development & CommercialBIND Therapeutics

Richard Korsmeyer, PhDSenior Research Fellow and Head of External Technology & Collaborations, PTx PS Technology and InnovationPfizer, Inc.

Jay Kranzler, MD, PhDGlobal Head, Neuroscience, Pain & Sensory Disorders, External R&D Innovation (ERDI), Worldwide R&DPfizer, Inc.

Peter Krulevitch, PhDEngineering Director, Fellow, Primary Container & Drug Delivery SystemsJanssen R&D, LLC

Tomas Landh, PhDDirector, Strategy & Sourcing, Diabetes Research UnitNovo Nordisk

Robert Langer, PhD (Keynote)David H. Koch Institute ProfessorMIT

Andrew Lewis, PhDDirector, Novel Formulation Technologies, CMC & Engineering PeptidesIpsen

Barbara Lueckel, PhD (Chair)Global Business Development DirectorRoche

Kenneth Mandell, MD, PhDPresident & CEOLayerBio, Inc.

Corey McCann, MD, PhDFounder and CEOPear Therapeutics

Nozer Mehta, MDChief Scientific OfficerEnteris BioPharma

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SPEAKING FACULTY 4TH ANNUAL PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY




Pieter Muntendam, MDPresident and CEOscPharmaceuticals

Ajit Narang, PhDSenior Research Investigator, Drug Product Science & TechnologyBristol-Myers Squibb

Sesha Neervannan, PhDVP, Pharmaceutical DevelopmentAllergan

Riccardo Panicucci, PhDGlobal Head of Chemical & Pharmaceutical Profiling (CPP)Novartis Institutes for BioMedical Research, Inc.

Atul PatelDirector, Technical Development (Devices)Biogen Idec

William Podd, JDPresident & Executive DirectorLandmark Angels, Inc.

Alexey Popov, PhDDirector, Formulation Development and Alliance ManagementKala Pharmaceuticals, Inc.

Raghu Raghavan, PhDPartner and PresidentTherataxis, LLC

Julia Rashba-Step, PhDSenior Director, Novel Delivery TechnologiesPfizer BioTherapeutics

Mike RatiganSVP, Chief Commercial OfficerUnilife

Patrick RyanDirector of Business Development and Product DevelopmentMedPatch, Inc.

Rob Saklatvala, PhDDirector, Discovery Pharmaceuticals SciencesMerck Research Laboratories

Michael Sarmento, MBADirector, Business Development; Modified Release TechnologiesCatalent Pharma Solutions

Kevin SchmidVP, Business Development and Advanced TechnologyInsulet

A. Lee Shorter, PhDDirector, PTS Advanced Automation, PD MGMT US, RD Platform Technology & ScienceGSK

Catherine SoldanoVP, R&D, New Therapeutic EntitiesTeva Pharmaceuticals

James SpavinsSVP, Head of Pharmaceutical SciencesPfizer

Anand Subramony, PhDVP, Drug Delivery & Device DevelopmentMedImmune

Stephen TindalDirector, Softgel FormulationsCatalent Pharma Solutions

Arthur Tipton, PhDPresident & CEO, Southern Research Institute and President, Controlled Release Society

Mark Tomai, PhDHead of TLR and MRS Business Development3M Drug Delivery Systems

Ajay Verma, MD, PhDVP, Experimental MedicineBiogen Idec

John Vrettos, PhDSenior Principal Scientist, Formulation DevelopmentEnteris BioPharma, Inc.

Ping Yeh, PhDExecutive Director, Drug Product Development Process & Product DevelopmentAmgen

De-Min Zhu, PhDPresident, CEOCureport, Inc.

Alex ZissonPartnerThomas McNerney & Partners

4TH ANNUAL PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY SPEAKING FACULTY

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DAY ONE - TUESDAY, OCTOBER 14, 2014

8:00 amBreakfast & Registration

8:45 amChair’s Opening RemarksBarbara Lueckel, PhDGlobal Business Development Director, Roche

9:00 amKeynote Fireside Chat with: Robert Langer, PhDDavid H. Koch Institute Professor, MIT

with

Barbara Lueckel, PhDGlobal Business Development Director, Roche

Arthur Tipton, PhDPresident & CEO, Southern Research Institute and President, Controlled Release Society

9:50 amCurrent Thinking on Scouting External Drug Delivery Technologies

• Understanding the process and specific technology interests

• Methods of sourcing external delivery technologies and DDS-enabled products

• Key factors and criteria used during a scouting/evaluation process

• Types of collaborations and deal terms

• Examples of “high priority” DDS technologies of interest

• Licensing platform technologies vs. drug-specific delivery system

Moderator:Richard Korsmeyer, PhDSenior Research Fellow, Head of External Technology & Collaborations, Pfizer

Panelists:Jason Ehrick, PhDAssociate Director, Respiratory Product Development, Merck Research Laboratories

Mary Gardner, MBA, BEngScDirector of Technology Assessment, Hospira

Matthew Hilborn, MBA&EStrategic Technology & Business Development Specialist, GSK

Keith Horspool, PhDVP, Pharmaceutical Development, Boehringer Ingelheim

Riccardo Panicucci, PhDGlobal Head of Chemical & Pharmaceutical Profiling (CPP), Novartis Institutes for BioMedical Research, Inc.

10:30 amNetworking Break & Partnering Meetings

11:15 amNon-invasive Delivery of Biotherapeutics Panel: Progress, Hurdles and Commercialization Prospects

Biologic drugs, such as insulin and antibodies, are currently delivered via injection, one of the least desirable routes of administration. Despite improvements in delivery devices, there remains great interest in non-invasive delivery of these drugs. Pulmonary, nasal, transdermal and oral delivery represent promising alternatives. With biologics representing a $120 billion market, non-invasive biologic formulations address a significant unmet need for patients around the world.

• Is oral delivery of macromolecules still considered the Holy Grail of drug delivery?

• Technical challenges associated with non-injectable administration

• Which non-invasive delivery approaches show the most promise and why?

• What criteria are used to evaluate non-invasive delivery technologies?

• What is the future of inhaled insulin (or biologics in general)?

Moderator:Julia Rashba-Step, PhDSenior Director, Novel Delivery Technologies, Pfizer BioTherapeutics

Panelists:Barbara Fox, PhDCEO, Avaxia Biologics, Inc.

Tomas Landh, PhDDirector, Strategy & Sourcing, Diabetes Research Unit, Novo Nordisk

AGENDA 4TH ANNUAL PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY

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Andy Lewis, PhDDirector Novel Formulation Technologies, CMC & Engineering Peptides, Ipsen

Rob Saklatvala, PhDDirector, Discovery Pharmaceutical Sciences, Merck

Ping Yeh, PhDExecutive Director, Drug Product Development, Process and Product Development, Amgen

11:55 amDrug Delivery Partnering Case Study featuring BIND Therapeutics, Inc. and AstraZeneca

Successful Partnerships in Nanomedicine: The BIND-AstraZeneca AZD1152 Collaboration

Jeff Hrkach, PhDChief Technology Officer, BIND Therapeutics

Dan Koerwer, MBASVP, Business Development and Commercial, BIND Therapeutics

12:25 pmTechnology Spotlight: Progress on Developing 3M’s Hollow and Solid Microneedle Systems

Mark Tomai, PhDHead of TLR and MTS Business Development, 3M Drug Delivery Systems

12:45 pmLuncheon & Partnering Meetings

4TH ANNUAL PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY AGENDA

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2:00 pm - 5:30 pmDrug Delivery Presentations in Three Tracks

Attendees can choose between sessions in the following three simultaneous technology tracks (see below):

TRACK ONE - Non-Injectable Formulation Technologies

Chaired by:Abla Creasey, PhDSenior Scientific Director, Primary Container & Drug Delivery Systems/PDMS, Janssen

Approximately 12-14 companies present non-invasive formulation technologies that can enhance, enable, or facilitate delivery of a drug. Examples include: orally disintegrating tablets/films, modified release oral dosage forms, bioavailability enhancement technologies, ophthalmic delivery platforms, mucosal penetration systems, buccal dosage forms, and topical/transdermal delivery systems.

Non-Injectable Formulation Presenting Companies:

• SkyePharma

• Patheon

• Enteris

• SWRI

• SPI Pharma

• Catalent

• Aptalis Pharmatech

• Kala

• Nanologica

• Medincell





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TRACK TWO - Injectable Formulation Technologies

Chaired by:Bruce Kerwin, PhDScientific Director, Amgen

Approximately 12-14 companies present novel injectable formulation technologies. Examples include: sustained release depots and implants, targeted nanoparticles, controlled release microspheres, microparticles, modified release hydrogels, biodegradable polymeric systems, and drug conjugate technology.

Injectable Formulation Presenting Companies:

• OctoPlus

• Novozymes

• Nitto Denko

• Aequus BioPharma

• StarPharma

• Nanomi

• Cristal Therapeutics

• Nanovelos

• Viscogel

TRACK THREE - Device Technologies

Chaired by:Shawna GvazdauskasGlobal Head of Device Strategy, External Opportunities & IP Liaison, Sanofi

Approximately 12-14 companies present innovative delivery devices. Examples include: 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.

Device Presenting Companies:

• 3M

• Lyogo

• Renishaw

• West

• Enable

• scPharmaceuticals

• Battelle

• Oval Medical

• Credence MedSystems

• Insulet

• Vetter

• Unilife

• Biocorp

3:30 pm - 3:45 pmBreak & Meetings

5:30 pmNetworking Reception & Partnering Meetings




DAY TWO - WEDNESDAY, OCTOBER 15, 2014

8:00 amBreakfast & Partnering Meetings

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

8:45 amPharma Keynote Presentation: Innovation Matters - The Future of Pharmaceutical R&D

James SpavinsSVP, Head of Pharmaceutical Sciences, Pfizer

9:30 amDelivery Device Platforms: A Strategy for Improving Development Cycle Times and Reducing Costs

A platform drug delivery device can be attractive for pharma and biotech companies, potentially offering shorter development timelines and lower manufacturing costs. Companies are moving away from the bespoke device and exploring platform devices for pipeline and portfolio drugs, but this requires implementing a new device strategy which presents a new set of challenges. Therefore, this panel will discuss:

• What steps should be taken to determine if a platform device strategy makes sense internally?

• How do you implement and manage a platform device strategy

• Pros and cons of licensing a platform device technology vs. developing internally

• How have other industries done this successfully

Moderator:Paul JansenVP, Medical Device Development, Sanofi

Panelists:Eric ChanieDirector, Head of Innovation Medical Devices, Merck Serono

Kevin DeanePartner, Technology Group, PA Consulting Group

Peter Krulevitch, PhDEngineering Director, Fellow, Primary Container and Drug Delivery Systems, Janssen R&D, Johnson & Johnson

Atul PatelDirector, Technical Development, Devices, Biogen Idec

Anand Subramony, PhDVP, Drug Delivery & Device Development, MedImmune

10:10 amNetworking Break & Partnering Meetings

11:10 amFourth Annual Company Spotlights

In this session, we highlight companies that discuss their partnering philosophy, current needs and scouting interests as related to drug delivery.

Biogen Idec’s Unmet Patient Needs – How can your Drug Delivery & Device options help us?Biogen IdecJessica BallingerSenior Director, Protein Pharmaceutical Development

Drug Delivery Partnering and Endo’s Approach to Addressing Unmet Patient NeedsEndo PharmaceuticalsFrank Diana, PhDVP, Pharmaceutical Development

GSKA. Lee Shorter, PhDDirector, PTS Advanced Automation, PD MGMT US, RD Platform Technology & Science

Role of Platform Technology in New Therapeutic EntitiesTeva Pharmaceutical IndustriesCatherine SoldanoVP, R&D, New Therapeutic Entities

12:30 pmLuncheon Roundtable Sessions & Partnering Meetings

Delivery Challenges of Low Potency/High Dose Drugs with Low BioavailabilityModerator:Sandra O’ConnorDirector, Sterile Product Development, Cubist Pharmaceuticals

Alternative Vial SystemsModerator:Mary Gardner, MBA, BEngScDirector of Technology Assessment, Hospira

4TH ANNUAL PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY AGENDA

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Spinning-out Technologies from AcademiaModerator:Innovation Partners Healthcare

Impact of Excipients on Drug Product Stability and BioavailabilityModerator:Ajit Narang, PhDSenior Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb

In today’s challenging healthcare environment what must drug delivery companies offer as a value proposition to be successful?Moderators:Lew BenderPresident & CEO, Intensity Therapeutics

Alex ZissonPartner, Thomas McNerney & Partners

1:45 pmTechnology Spotlight: Lipid-based System for Oral Peptide Delivery

Stephen TindalDirector, Softgel Formulations, Catalent Pharma Solutions

2:05 pmThe Drug Delivery Investor Climate

In this session, a panel of investors will discuss the current investment climate for drug delivery companies. Key discussion points:

• Overall market outlook for drug delivery investing

• Trends in small company investing

• Trends in drug delivery partnering

• Sources of funding: traditional and non-traditional

• Technology areas generating “buzz” and attracting investors

Moderator:Alex ZissonPartner, Thomas McNerney & Partners

Panelists:Lew BenderPresident & CEO, Intensity Therapeutics

David Berry, MD, PhDPartner, Flagship Ventures

Brian Gallagher, Jr., PhDPartner, SR One, Ltd.

David Hirsch, MD, PhDManaging Director, Longitude Capital

William Podd, JDPresident & Executive Director, Landmark Angels, Inc.

3:45 pmGame-Changing Technologies for Targeted Delivery & Therapy for Chronic Brain Disorders

Many diseases, such as Parkinson’s disease and epilepsy, are caused by the misfiring of neurons in the brain. The most promising treatments involve targeted delivery to the brain, but this remains a challenge, primarily due to the blood-brain barrier (BBB). This panel will explore cutting-edge targeting technologies that have the potential to change the way brain disorders are treated.

Moderator:PJ AnandFounder, President and CEO, Alcyone Sciences, Inc.

Panelists:James Callaway, PhDPresident & CEO, ArmaGen Technologies, Inc.


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2:30 pmDDS Technology Soapbox@PODD sponsored by Pfizer

This session features five-minute talks on cutting-edge technologies, inventions and ideas. The PODD Soapbox section is open to start-up entrepreneurs, inventors, licensing officers and university researchers.

Moderator:Julia Rashba-Step, PhDSenior Director, Novel Delivery Technologies, Pfizer BioTherapeutics

Soapbox Presenting Companies:

• 4P Therapeutics

• Cureport, Inc.

• Intensity Therapeutics

• iVeena

• LayerBio, Inc.

• MedPatch, Inc.

• Therakine

If you are interested in presenting on the Soapbox, please let us know at [email protected].



mailto:[email protected]



Jay Kranzler, MD, PhDGlobal Head, Neuroscience, Pain & Sensory Disorders, External R&D Innovation (ERDI), Worldwide R&DPfizer, Inc.

Corey McCann, MD, PhDFounder and CEO, Pear Therapeutics

Raghu Raghavan, PhDPartner and President, Therataxis, LLC

Ajay Verma, MD, PhDVP, Experimental Medicine, Biogen Idec

4:30 pmConference Concludes

HOTEL INFORMATION

Renaissance Boston Waterfront Hotel606 Congress StreetBoston, MA 02210617-338-4111

For reservations, call 877-901-6332 or 617-338-4111 and ask for the Partnership Opportunities in Drug Delivery group rate.

The Renaissance Boston Waterfront hotel is the newest addition to the Boston Harbor. See link below for details on highlights in the local area and for a local map:

http://www.marriott.com/hotels/local-things-to-do/boswf-renaissance-boston-waterfront-hotel/

REGISTRATION & PRICING

1st Early Bird - before May 30, 2014 $1,595

2nd Early Bird - before July 25, 2014 $1,695

3rd Early Bird - before September 12, 2014 $1,895

Standard - after September 12, 2014 $1,995

The conference fee includes the program, morning coffee/tea, reception, luncheons, and conference documentation.

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

Large group discounts available.Please contact [email protected] or call 646-350-2580 for any questions on discount rates.

Payment PolicyPayment must be received in full by the event date. All discounts will be applied to the Conference-Only fee (excluding add-ons)‚ cannot be combined with any other offer‚ and must be paid in full at the time of conference.

Substitution and Cancellation PolicyIf you are unable to attend and would like to register a substitute, please email [email protected]. Please ask your substitute to provide identification on-site.

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.

To cancel and receive a refund or pass, please email [email protected] or call 646-350-2580.

4TH ANNUAL PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY HOTEL INFORMATION / REGISTRATION

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Interested in Becoming a Sponsor or Exhibitor at this event?

For information on how to become a sponsor or exhibitor, please contact Meredith Sands at [email protected] or 646-350-2586.
















SPONSORS / PARTNERS 4TH ANNUAL PARTNERSHIP OPPORTUNITIES IN DRUG DELIVERY

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EXECUTIVE SPONSOR

MEDIA PARTNERS

EXHIBITORS

ASSOCIATE SPONSOR / SUPPORTING SPONSOR

TECHNOLOGY SPONSORS SOAPBOX SPONSORS



http://www.octoplus.nl/index.cfm/octoplus







http://www.patheon.com/






http://www.technologynetworks.com/PharmaOutsourcing





http://www.lifescienceleader.com





http://www.drugdeliverytech.com






partnerships opportunities in drug delivery · 10/14/2014 · a strategic level partnering event...

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