save $600 - pdd · 10:15—11:00 morning networking break pharma industry keynote 11:00—11:45...

JANUARY 20—22, 2016PGA RESORT AND SPA | PALM BEACH GARDENS, FL

The business development event bringing you visionary ideas, disruptive technology, and to maximize your product lifecycle and generate new revenue streams.

www.DDPevent.com | @DrugDeliveryIIR | #DDP2016

Smart Patients and Formerly

Google

DIGITAL HEALTH

Singularity University; Founder,

IntelliMedicine; Inventor of

MarrowMiner

DISRUPTIVE INNOVATION

Minnesota’s Third Congressional District

HEALTHCARE AND POLICY

Boehringer Ingelheim

PHARMACEUTICAL INDUSTRY

See inside for more details

Register now and SAVE $600

Visionary Keynote Speakers

www.DDPevent.com | @DrugDeliveryIIR | #DDP2016 2

JOIN PHARMA SCOUTS AS THEY IDENTIFY, EVALUATE AND TARGET NEW PARTNERS TO SECURE BUSINESS, GROWTH OPPORTUNITIES,

AND ESTABLISH RELATIONSHIPSAbbvie | Allergan | Amgen | BMS | Boehringer Ingelheim |Eli Lilly |

GSK | Janssen R&D | Medimmune | Novo Nordisk | SanofiSun Pharmaceuticals | Teva | AND MORE!

5+ Deal-Focused Case Studies

Develop lucrative partnerships by connecting theory to practice. Model your next deal after successful and profitable cases.

NEW ENGAGING FORMATS! YOUR CONFERENCE EXPERIENCE SHOULD INCLUDE MORE THAN LECTURES. TRADE IN THE SLIDES FOR:

30+ Delivery Presentations

Scout, qualify and valuate in 3 days the widest array of drug deliveries:

• Device

• Non-injectables

• Injectables

15+ RoundtablesSpeak off-the-cuff with your peers to openly discuss pressing topics and have open conversations during themed roundtable discussions

DDP Town HallHave your voice heard and contributions are recognized. Surround yourself with the power players in drug delivery to converge on forward thinking topics and make a difference in this open forum.

Closed Door Executive Leadership BoardroomHigh-level strategic decision makers in pharma and drug delivery convene how to influence technology, development and new ways of working, such as consortiums, pre-competitive space, shared capabilities.

Valuation Workshop

Everything you need to know about developing a winning deal structure from measuring risk vs. return to the key assessment areas, such as management, technology and the market.

DDP Shark TankAll delivery presentations will be rated by attendees

throughout the conference. This closed-door Shark Tank will provide a platform for the Top 5 Drug Delivery Technologies given the highest rating to re-present a 2 minute elevator pitch to a panel of experts who will judge and critique their “pitch”.

NEW!

NEW!

NEW!NEW!

NEW!

WHAT’S NEW IN 2016

• Emerging Markets• M&A Trends• Human Factors• Patent Trends• Rise of Biosimilars/

Generics• Drug Delivery for

Orphan Drugs• Reimbursement

• Bioavailability• OTC • Big Data – Data Use

& Sharing• Connected Health• Geriatrics Drug

Delivery• Drug Delivery for

Children

Led by


Themed ROUNDTABLE DISCUSSIONS

KEYNOTES

KEYNOTES

KEYNOTES

Top Drug Delivery Technologies to Watch


Deal-Focused

CASE STUDIES

CocktailReception

DDP PARTY


DEVICES

Valuation WORKSHOP

Closed DoorExecutive Leadership Boardroom

NEW!

Led byDA

Y 1

DA

Y 2

DA

Y 3

INJECTABLES

NON-INJECTABLES

DDP

TOWNHALL

Private

DDP Shark Tank

Consult with a Drug Delivery Partnerships Team Member to create an impactful strategic marketing program.

Companies A-LSarah Scarry(646) [email protected]

Companies M-ZPatricia Rose(508) [email protected]

Immerse yourself in this 3-day business development focused agenda designed to catalyze strategic alliances, licensing and commercialization for your business

AGENDA-AT-A-GLANCE


Your registration includes access at no additional cost. All registrants will receive notification several weeks prior to the event regarding log-in and usability instructions on the partnering system.

11+ HOURS

More dedicated partnering hours than ever before to jumpstart your next deal

Search. Request. Meet.Search for partners, customers or clients. Request meetings. Accept or decline requests from others. Arrive on site and meet.

Benefits of :

• Conduct more meetings at one conference than in the rest of the year

• Contact existing and potential partners prior to the conference

• Manage all your conference activities in one place

• Your meetings will be prescheduled to maximize your time onsite

More than 500 meetings expected in 2016. Be sure to sign-up early for maximum partnering and exposure!

Schedule At-a-GlanceDAY 1 | Wednesday

January 20thDAY 2 | Thursday

January 21stDAY 3 | Friday January 22nd

11:45—1:30 2:00—5:30

11:45—4:45 12:30—1:30


HELP DRIVE CHANGE AND HELP SHAPE THE FUTURE OF DRUG DELIVERY with game changers across the entire drug delivery ecosystem

DISRUPTIVE INNOVATIONDaniel Kraft, MD, Founder and Executive Director, Exponential Medicine, Singularity University; Founder, IntelliMedicine; Inventor of MarrowMiner Daniel Kraft is a Stanford and Harvard trained physician-scientist, inventor, entrepreneur and innovator.

Dr. Kraft has over 20 years of experience in clinical practice, biomedical research and healthcare innovation. Daniel chairs the Medicine track for Singularity University and is Founding Executive Director for Exponential Medicine, a program which explores convergent, exponentially developing technologies and their potential in biomedicine and healthcare. His various TEDTalks have over 1 Million Views.

Dr. Kraft named as one of the 40 Smartest People in Healthcare by Beckers’ Hospital Review. InternetMedicine.com named Dr. Kraft one of The Top Ten Internet-Smart Doctors in the World 2013. Daniel Kraft was recognized as one of the most inspiring leaders in Life Sciences, as determined by the readers of Pharma Voice 100.

HEALTHCARE AND POLICYCongressman Erik Paulsen, Minnesota’s Third Congressional DistrictIn January 2015, Congressman Erik Paulsen was sworn in to serve his fourth term representing Minnesota’s Third Congressional District. Congressman Paulsen has been a leader on Medical Technology issues since his time in the Minnesota statehouse. As Co-Chair of the House Medical Technology Caucus, he has worked to educate fellow members of Congress about issues facing the industry.

Congressman Paulsen has been a strong advocate for the life sciences and has worked to remove barriers to innovation. He was a leader in Congressional negotiations with FDA to pass the Food and Drug Administration Safety and Innovation Act (FDASIA) to streamline the FDA review process and increase stakeholder involvement.

DIGITAL HEALTHDr. Roni Zeiger, Former Chief Health Strategist, Smart Patients and Formerly GoogleRoni Zeiger, former Chief Health Strategist at Google, works at the cutting edge of technology, information, and healthcare. At Google, he developed innovative digital medical services like online medical records, Google Flu Trends, and Symptom Search. Now Roni is leading a new company called Smart Patients, which leverages the expertise and networks developed by patients.

Roni’s experience in digital medicine makes him one of the foremost speakers on how the internet is transforming modern healthcare. He designed Google Health, a system of patient-managed online personal medical records. On this plan, patients have access to their own records, can update them on their own, and can share them with caregivers and institutions across companies. Although this project is no longer active, Roni’s experiments are still used as models for the future of health records.

PHARMACEUTICAL INDUSTRYMark Langston, Acting Head Biosimilars, Boehringer IngelheimMark Langston is executive director of biosimilar marketing at Boehringer Ingelheim Pharmaceuticals, Inc. One of his areas of specialization is commercial strategy development; in addition, he has worked in regional and country management roles around the world. Mark has successfully launched specialty medicines for BI, and is currently leading the company’s commercialization of its biosimilar portfolio. He began his career in healthcare as a cardiothoracic intensive care nurse in the National Health Service in the UK.

VISIONARY KEYNOTESK

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7:00 Registration Opens and Morning Coffee for Symposia Participants

8:00 — 8:15 Chairpersons WelcomeSesha Neervannan, Senior Vice President, Pharmaceutical Development, Allergan Lee Shorter, Director, Disruptive Technology Seeker, GlaxoSmithKline

8:15 — 9:15 Panel Discussion

2020: A New Drug Delivery Landscape • How the move to Patient-outcomes based healthcare will open up a range of new opportunities for managing drug delivery • Opportunities and challenges presented by the present economic landscape and its impact on the traditional pharma model• Smart partnerships & positioning to remain ahead of the competition by 2020.• Where are products selling and are the product categories showing different trends?• How has innovation translated into market penetration?

PANELISTSSuresh Borsadia, Vice President, Sun Pharmaceuticals Jessica Ballinger, Senior Director, Protein Formulation Development, Biogen Idec Mary Gardner, Director, Technology Assessment, Hospira, Inc.Danchen Gao, Director of IP Strategy, AbbVie, Inc.

9:15 — 10:15

Panel Discussion

Connected Health... Taking Personalized Medicine to the Next Level?The dynamics of connected health create a virtuous cycle of integration that will shape the future of both connected health and drug delivery. The beginnings of major change are already underway. There is great potential to transform the role of patients in their own wellbeing through shared decision-making, active engagement with care teams, condition monitoring and chronic disease management. This session will focus on ways connected health can assist with the move towards personalized care and personalized medicine in drug delivery:

• How to build an integrated system that blend electronic medical records with methods of communication, remote care and process management to build seamless systems and workflows.

• Is it possible to redirect healthcare interventions away from expensive hospital settings through the use of telemedicine, remote care and mobile health?

• How to engage citizens in their health and wellness through a variety of connected health tools including the creation and use of personal health records.

• The part genomics will play as it offers the possibility of personalizing treatment and wellness plans, present clinicians with a powerful range of analytical and diagnostic tools, and enable managers to coordinate care, target resources and improve public health outcomes.

PANELISTSAndrew Walker, Head of Device Technology, GlaxoSmithKline Atul Patel, Director, Technical Development (Devices), Biogen IdecGraham Reynolds, Vice President, Marketing and Communications, Pharmaceutical Delivery Systems, West Pharmaceuticals

10:15—11:00 Morning Networking Break

PHARMA INDUSTRY KEYNOTE

11:00—11:45

Industry Spotlight

Current Biosimilars LandscapeBoehringer Ingelheim is committed to becoming a global leader in biosimilars and increasing the availability of high quality biologics. Founded in 1885, Boehringer Ingelheim provides innovative medicines to patients in more than 140 countries. The development of usable biosimilars has been an important topic of conversation for many years, recently gaining momentum with the first approval of a biosimilar in the US. Mark Langston is the Acting Marketing Head of Biosimilars for Boehriinger Ingelheim in the US and will share the company’s approach to developing usable biosimilars and reflect upon the future of biosimilars.

• A brief overview of Boehringer Ingelheim’s approach to manufacturing and marketing both biologics and biosimilars

• A look at how biologics will impact the drug delivery industry

• A look at how the new biosimilar legislation will impact biosimilar development and authorizations in the US

Mark Langston, Acting Head Biosimilars, Boehringer Ingelheim

AGENDADAY ONE WEDNESDAY, JANUARY 20TH, 2016

The dynamics of connected health create a virtuous cycle of integration that will shape the future of both connected health and drug delivery.


DON’T MISS — Oral Inhalation Drug Delivery Simplified by Andrea Leone-Bay, Vice President Pharmaceutical Development, MannKind Corporation on Thursday 21st @ 3:15

11:45—1:00

Begins!Top Drug Delivery Technologies to Watch


INJECT-ABLES

11:45 EFFECTIVE PATIENT TRAINING AND ONBOARDING FOR WEARABLE INJECTION DEVICESChris Evans – VP

of Research & Innovation, West Pharmaceutical Services

DEVICES

11:45 WEARAPUTICS ™ THE FUTURE IS HEREWearable technology is projected to have a profound impact on how biologics and pharmaceuticals are transported in the body in the

future. The regulated medical wearables market is projected to grow to a $15B industry by 2020. Major technology innovations have occurred in non-medical sectors that can be leveraged and applied to the drug delivery device market to improve the safety, efficacy and compliance of the compound. Mr. Bill Partridge, VP of Flex Medical will describe their vision for the future of drug delivery wearables and how traditional medical device companies can make their products smarter and more cost effective by incorporating advanced wearables technology into new drug delivery platforms.

Bill Partridge, Vice President Business Development, Flextronics

DEVICES

12:15 BENEFITS OF IP PARTNERING FOR DRUG DELIVERY TELEMANAGEMENT TECHNOLOGIES

Napoleon Monroe, Managing Director, New Directions Technology Consulting

12:15

12:25

INJECT-ABLES

12:30 BIOPHARMA REQUIREMENTS AND OPPORTUNITIES FOR PLATFORM-BASED WEARABLE

INJECTION SYSTEMSIan Hanson, Senior Vice President and General Manager for Wearable Injectors and Patch Pump Technologies, Unilife

12:35

12:45

AGENDADAY ONE CONTINUES WEDNESDAY, JANUARY 20TH, 2016

To present your product, contact:

Sarah ScarrySenior Business Development Executive(646) [email protected]

Patricia RoseSenior Business Development Executive(508) [email protected]



1:00: Networking Lunch for Conference Participants & Roundtable Discussions Roundtable 1 Realizing the Potential of Emerging Markets Through Partnerships

• The opportunity for pharmaceutical and drug delivery companies in the emerging markets

• Complexity and diversity within the emerging markets (why are these markets so different to developed markets) and barriers to entry

• Partnership models and success stories

• Challenges of conducting business in the emerging markets (cultural and logistical)

Roundtable 2 Trends in M&A

How has the incredible uptake in M&A taken a toll on the life sciences market?

Improving the administration and compliance of drug delivery is a common lifecycle strategy to enhance product adoption in the biotechnology and pharmaceutical industries. Increased competition in the industry and regulatory requirements for end-user safety have driven product improvements in the injectable market, for both healthcare professionals and patients. Injection devices that facilitate preparation, ease administration and ensure safety are increasingly prevalent in the marketplace. While self-injection devices utilize proven technologies that enable commercialization within one to three years, differentiating these systems in a competitive marketplace requires considerable insight into disease state, market trends, and potential patient profile. Today many companies utilize Human Factors Engineering (HFE) to retain or gain competitive market share.

Roundtable 3 Human Factors

A new era of data-driven discoveries is under way, thanks in large part to health-monitoring devices like Apple Inc.’s watch and genetic information pulled from the likes of 23andMe Inc.’s spit kits. But, critics wonder, can Big Data actually fulfill the promise of developing and delivering better-targeted drugs faster? What’s more, some ask, at what cost are people signing away their prized health information? Still, there is little denying that data is coming from a widening net of sources that play off two of the Bay Area’s strengths: tech and biotech. In the end, some say, rich data sets potentially will help companies and academic researchers zero in on groundbreaking drugs and medical devices. The key word is “potentially.” This session will seek to discuss the opportunities and uses of big data and sharing case studies.

Roundtable 4 Improved Patient Outcomes through better Drug Design

This roundtable discussion will shed light on:

• The unmet need for improved outcomes, and the need for more intelligent drug design

• Aspects of design that are relevant to delivery technologies

• Products that can deliver better outcomes for patients, and how that in turn affects the marketing company’s likely market access/reimbursement probability

Roundtable Leader: Dr. Cornell Stamoran, Vice President, Strategy & Corporate Development, Catalent Pharma Solutions

Roundtable 5 OTCThe OTC pharmaceutical market on a global basis has been estimated by industry sources to be nearly $100 billion, and continues to grow. Projecting out over the next several years, OTC business will be strengthened by Rx-OTC switches, new categories (especially nutritionals), and emerging markets. This roundtable discussion will focus on:

• Review the business by category and geographical segment, providing insight on what opportunities exist for branded and private label businesses

• Examine the integration of novel and differentiating drug delivery for better products

Roundtable Leader: Bob Nissen, President, Nissen Consulting Group, LLC

Roundtable 7 Connected Health & “SMART” Medical DevicesThis roundtable will explore some of the benefits, opportunities and challenges in connected health for the pharmaceutical industry and provide insight into how the area might develop.In an increasingly connected world, with smart phones and tablets proliferating homes & healthcare environments alike and the implementation of electronic medical records reaching reasonable levels, the demand for “smart” medical devices is increasing.

• How wider adoption of this technology will provide a means to improve adherence, and hence clinical outcomes.

• How smart devices can reduce other healthcare costs and improve levels of service in some markets.

• Challenges presented by connected devices around regulation, reimbursement, patient confidentiality and the business case to support investment in this area.

Roundtable 6 Big Data – Data Use & SharingA new era of data-driven discoveries is under way, thanks in large part to health-monitoring devices like Apple Inc.’s watch and genetic information pulled from the likes of 23andMe Inc.’s spit kits. But, critics wonder, can Big Data actually fulfill the promise of developing and delivering better-targeted drugs faster? What’s more, some ask, at what cost are people signing away their prized health information? Still, there is little denying that data is coming from a widening net of sources that play off two of the Bay Area’s strengths: tech and biotech. In the end, some say, rich data sets potentially will help companies and academic researchers zero in on groundbreaking drugs and medical devices. The key word is “potentially.” This session will seek to discuss the opportunities and uses of big data and sharing case studies.

Roundtable 8 Special Groups in Oral Drug Delivery, Pediatric, Geriatrics and Orphan DrugsPediatric Drug Development is an increasingly critical yet high-risk process. The pediatric population has specific preferences and market needs in terms of what drug delivery methods work best. In addition, recent regulatory changes in the US and the EU have challenged pharmaceutical and biotech companies to revise the way they conduct their clinical trials. As an industry, how can we advance the development of new pediatric drugs to market as quickly, and efficiently, and safely as possible?

• Fulfilling the huge need for FDA approved pediatric drugs in light of current health epidemics like obesity

• Grasp a better understanding on if and how drug delivery vehicles have to change when being designed for the pediatric population

• Examine upfront considerations that are pivotal to pediatric drug development, from trial design through study implementation and regulatory compliance.

• Explore palatable trends in OTC pediatric oral delivery

• Grasp best use of patent extension opportunities through pediatric safety studies

Roundtable Leader: Daniel Bar-Shalom, Associate Professor, Department of Pharmacy, University of Copenhagen


2:00 Boardroom Workshops & Partnering Begin

INVITE ONLYCLOSED DOOR

EXECUTIVE LEADERSHIP BOARDROOM

Valuation WorkshopLed by

One-on-One Meetings

• Hot areas in drug delivery• What are the major areas/

opportunities• How does the landscape changing:• Internal vs external Drug delivery

developments• Partnerships/collaborations/deals

Welcome & Introduction to Valuation:

• The main drivers of valuation: measuring risk vs. return• How to Assess and Value a Company• Why is it important to assess a company before doing a valuation• The three key assessment areas: management - technology - market.• The 20 factors required to assess a company.• Basics of a company valuation

Workshop Leader Dr. Patrik Frei, Founder and CEO, Venture Valuation AG, Switzerland

3:00 — 3:30 Afternoon Refreshments Break

INVITE ONLY CLOSED DOOR

EXECUTIVE LEADERSHIP BOARDROOM CONTINUES

Valuation WorkshopLed by

One-on-One Meetings

• How Pharma can influence technology development

• New ways of working: consortiums, pre-competitive space, shared capabilities etc

• Product Valuation & Deal Structuring• Difference between company and product valuation.• What information do you need? - How to gather the information?• Product valuation: the Risk-adjusted Net Present Value (rNPV)• What factors can be influenced by the development team / key factors for scouting team• How to calculate the value of a company from several product valuations• How to use product valuation to determine a suitable deal structure?• Group work on a case study:• The audience will again be broken up in groups of 4-5. After reading the case (which will be sent

prior to the course), each group has the opportunity to calculate the value of a pharmaceutical product in development. The groups will then present and discuss their results in a plenary discussion

Workshop Leader Dr. Patrik Frei, Founder and CEO, Venture Valuation AG, Switzerland


5:30: OPENING COCKTAIL RECEPTION (INSIDE EXHIBITION HALL)


AGENDADAY TWO THURSDAY, JANUARY 21ST, 2016

8:00 — 8:15 Chairpersons Opening Remarks Sesha Neervannan, Senior Vice President, Pharmaceutical Development, Allergan Lee Shorter, Director, Disruptive Technology Seeker, GlaxoSmithKline

8:15 — 9:15 Keynote Panel

Creating Value for your Patient Centric Device Platforms Patient-centric is one of those terms we suddenly seem to hear mentioned often. Everyone in pharma wants patients to know that it’s their comfort and well-being that are always at the forefront of development efforts for medicine and delivery devices. But true patient centricity is not about saying the right things at the right time. Nor is it thinking about the patient only when it comes time to present a product to them. Rather, it involves thinking of the end user at the very beginning of the discovery process, and keeping them in focus throughout the product development cycle. With the sequencing of the human genome high expectations evolved that future diagnostics and drug therapy will become a personalized and stratified treatment significantly changing our healthcare provision. Despite disappointments that occurred along the way, silently pharmacogenomics have entered into daily practice. In a similar way, patients have been recognized as an important factor in achieving health outcomes as well as they got more involved in the healthcare decisions. These trends have already progressed into realty in certain areas and will continue to change the healthcare landscape in the near future. This panel will discuss the actual state of the art as well as the perspectives and opportunities that will arise in the near future in personalized medicine and patient centric drug products.

PANELISTSSesha Neervannan, Senior Vice President, Pharmaceutical Development, Allergan Anand Subramony, Vice President Drug Delivery & Device Development, Medimmune, Global Biological Arm, AstraZeneca Keith Horspool, Ph.D, VP Pharmaceuticsm, Boehringer IngelheimFernando Salles, VP, Head of Global Search, Teva Pharmaceuticals Paul Jansen, PE, aVP Medical Device Development, Sanofi

9:15 — 10:00

Innovation Keynote

The Next Generation of Social Media: Taking Digital Health & Connected Health to the Next LevelDr. Roni Zeiger, Former Chief Health Strategist, Smart Patients and formerly Google

10:00—10:45 Navigating the Regulatory Landscape for Combination Products Drug delivery devices are having a big year in different ways. A big challenge they are facing right now is in the expectations of the regulatory agencies. The bar is changing rapidly and companies developing delivery devices are finding it difficult to keep up. The whole area of human factors and usability is driving a lot of the behavior, along with the emergence of mobile technologies and applications – and area that could potentially revolutionize how people deliver their medications and measure their success. In addition, The FDA changed its rules on cGMP for combination products, effective in July 2013. There has already been a significant warning letter issued regarding a major biologic delivered via an auto-injector. The new regulations will be explained and the implications for all drug delivery systems considered both in the US and globally.

• Definition of Combination Products and the New Regulation

• Discussion of FDA’s actions and Effect of Rules Change

• Human factors requirements and other regulatory hurdles

• Complexities of commercialization

• The defined GMP rules for CP and the possibility of the change in the AE/MDR reporting, in the U.S. & Japan, and the rest of the world.

PANELISTSDoug Mead, Senior Director, GRA-CMC, Medical Devices and Combination Products, Janssen R&DRobert Walsh, MD, MBA, Medical Director, Pharmacovigilance and Patient Safety, AbbVie

10:45—11:15 Morning Refreshments Break


AGENDADAY TWO CONTINUES THURSDAY, JANUARY 21ST, 2016

11:15—12:45 TOP DRUG DELIVERY TECHNOLOGIES TO WATCH

TOP DRUG DELIVERY TECHNOLOGIES TO WATCH

INJECT-ABLES

11:15 Intelligent Subcutaneous Delivery: Moving Beyond the Bolus

Descriptive paragraph of proposed talk: With an increasing number of injectable drugs and biologics coming to market, the industry is looking for innovative

technology that can simplify delivery, offering improved patient adherence and increasing clinical efficiencies. Conventional methods of injection, such as syringes and pens, provide answers for simple bolus injectable delivery. Advances in intelligent subcutaneous delivery can help address the problems of complex dosing regimens, including interval and continuous infusion.

Key takeaways:• Route of administration is a key consideration

during pharmaceutical development• Conventional methods have limitations, restricting

the growth of subcutaneously delivered drugs• Complex, intelligent subcutaneous delivery opens

new doors in the drug development landscape

Michael Graffeo, VP Business Development, Delivery Systems, Insulet

Continues

AWARDS

12:45: NETWORKING LUNCH & DDP AWARDS

To present your product contact




AGENDADAY TWO CONTINUES THURSDAY, JANUARY 21ST, 2016

THE NEW PARTNERING LANDSCAPE:DEAL STRUCTURES, BEST PRACTICES & CASE STUDIES

TOP DRUG DELIVERY TECHNOLOGIES TO WATCH

Continues

2:00 — 2:30 Combination Product Development: A Harmonized Roadmap for Efficiency, Compliance and Speed to MarketWhat comes first, the chicken or the egg? As the pharmaceutical, biologics, and medical device industries have found new and novel ways for the delivery of targeted therapies to patients, the industry itself is currently grappling with recently published regulations and regulatory expectations for combination products. The traditional pathways for pharmaceutical and medical device development can be measurably offset by companies choosing to develop a combi-nation product therapy, as the two product worlds converge. There are many up front considerations companies must not only under-stand, but strategize to in early stage development. It is incumbent upon global organizations to have an integrated development ap-proach so that speed to market can be achieved. Both branded and generic product companies can benefit from an integrated product development roadmap. How companies choose to employ their own roadmap may vary widely, but the most important end goal is a complete regulatory product dossier that is stand alone, and is right the first time from a filing standpoint. The purpose of this presen-tation is to analyze traditional development pathways vs. a more integrated approach for combination products. The presentation will offer one such way in which to attain complete integration, and will demonstrate the value add that a contract design, development, and manufacturing organization can provide. The presentation will place an added emphasis on respiratory care products in various dosage and delivery platforms.

• The Regulatory Pathway Summarized• Lessons Learned from Current Industry Examples• An Integrated Product Development Approach• The Value of Choosing A Trusted Outsource Partner.

Winston Brown, Vice President of Global Quality, Phillips-Medisize Corporation

2:45 — 3:15 Afternoon Refreshments Break

3:15-4:00A Catch-Up & Behind the Scenes with Mannkind Corporation: Where are they now?

Oral Inhalation Drug Delivery Simplified – It’s Not Just for Pulmonary Disease AnymoreOral inhalation has long been the standard of care for delivering medicines directly to the lung for treating pulmonary diseases like asthma and COPD. Only within the last decade has it been applied to therapies requiring systemic exposure. An example of such an application is Afrezza®, an orally inhaled insulin approved by FDA in 2014 for diabetes. The technologies underlying Afrezza delivery comprise advanced, engineered dry powders and patient-friendly, breath-powered inhalers. These can be readily applied to a wide variety of drugs including proteins and peptides. Oral inhalation drug delivery using this technology is characterized by a rapid onset of action that is ideally suited for various clinical indications. • Oral inhalation delivery as an option for “new” and “old” drugs• Patient-friendly, easy-to-use inhalers• Developing orally inhaled products

Andrea Leone-Bay, Vice President Pharmaceutical Development, MannKind Corporation

2:15

4:00—4:50 TBC 2:30

2:45

3:00

3:15

3:30

3:45

4:00

4:50: DDP PARTY (held outside the exhibit hall)

To present your product contact




AGENDADAY THREE THURSDAY, JANUARY 22ND , 2016

8:45—9:00 Chairpersons Opening Remarks Sesha Neervannan, Senior Vice President, Pharmaceutical Development, Allergan Lee Shorter, Director, Disruptive Technology Seeker, GlaxoSmithKline

9:00 —10:00

Innovation Keynote

DISRUPTIVE INNOVATIONDaniel Kraft, MD, Founder and Executive Director, Exponential Medicine; Medicine Track Faculty Chair, Singularity University; Founder, IntelliMedicine; Inventor of MarrowMiner

10:00—10:45

Healthcare Policy Keynote

Creating Value for your Patient Centric Device Platforms View from the Hill: ACA, Medical Device Tax and more!Congressman Erik Paulsen, Minnesota’s Third Congressional District

10:45—11:15 Morning Refreshments Break

10:45—11:45

FIRESIDE CHAT

Understand the Payer Perspective and Adjust Your Strategies Accordingly to Ensure Reimbursement of Your Drug Delivery ProductIn past years, getting reimbursed on a product was a simple as developing an extended release formulation of a successful immediate release product. These days, it is far more difficult as payers are less willing to pay for mere convenience. Incremental value is no longer worth the money it takes to develop it and the industry currently struggles with how much change is enough to get payer buy-in. On top of that, the Affordable Care Act is here to stay, you don’t have a choice but to embrace it, how does that impact you? After this session you will come away with a clearer picture of the current reimbursement landscape and what you need to think about when developing your products to safeguard against payer rejection.

PANELISTRay Tancredi, RPh, MBA, CSP, VP, Specialty Pharmacy Development, Walgreens William Winkenwerder, Former CEO, Highmark

11:45-12:30

CRS Panel(Research, Academia Panel/ Scientists and Professors)

The Controlled Release Society’s mission is to promote delivery science. For nearly 40 years the CRS has supported and fostered drug delivery innovation and commercialization. In studying the success stories in our industry you will find that many if not most of those have a beginning in an academic setting. The pathway to market for each product is unique but innovation and subsequent development typically begins with a collaborative relationship between university and industry. CRS will lead a discussion regarding the power and synergies of the academic and industry relationship. The CRS panel will offer the audience multidisciplinary expertise that has been developed over years of managing and driving collaborative relationships. The panel will provide advice for those looking to mine the vast intellectual property and expertise that resides within leading Universities in the US and abroad. Industry and University leaders will sit together on this panel to offer their insights and strategies for addressing key industry challenges that cannot be met alone by either group.

INTRODUCTION OF PANELDebra Bingham, Partner, Valeo Partners (President, Controlled Release Society (CRS))MODERATORUniversity Head of Incubator

PANELISTSChristine J. Allen, Professor , GlaxoSmithKline Chair in Pharmaceutics and Drug Delivery, Leslie Dan Faculty of Pharmacy, University of Toronto (CRS Treasurer Elect)Justin Scot Hanes, Ph.D, Director, Center for Nanomedicine, Professor of Ophthalmology, John Hopkins University (CRS Member at Large)Matthew Burke, Head of Drug Delivery, Pharmaceutical Development, GlaxoSmithKline Speaker TBC, Pfizer

12:30—1:30 DDP Town Hall & Roundtable DiscussionThis session is designed for you…by you!

DDP’s inaugural Town Hall will break up the audience intro groups based on key themes and issues that have been brought up time and time again during the course of the last 2.5 days. This “Deep Dive” into the key challenges will ensure no question goes un-answered.

PRIVATE PRESENTATIONS DDP SHARK TANK

Top 5 Company Presentations 12:15

12:30

12:45

1:00

1:15

1:30: DDP CONCLUDES

Voting for Top 5

will take place onsite


DRUG DELIVERY PARTNERSHIPS IS WHERE KEY INDUSTRY DECISION-MAKERS MEET to learn about innovative products, exchange cutting-edge industry insights and best practices, develop important business alliances, and network with peers and partners.

WHO YOU WILL MEET

HIGHLIGHTED SPONSORSHIP OPPORTUNITIES-LIMITED AVAILABILITY

BY

IND

UST

RY

■ Consulting ■ Academic ■ Med Device ■ Other

37%

24%

23%

13%

3%

43%

30%

5%

3%

15%

4%

■ Drug Delivery Applied Technology | Business Development | C-Level | Commercialization | Engineering | Innovation | Marketing & Sales | Product / Device Development | R&D / Scientist Technology Development

■ Pharma�Business Development | Combination Products | Engineering | Formulation | Licensing | Life Cycle | Marketing & Sales | Packaging | Pharma Development | Product / Device Development | R&D | Regulatory | Sourcing | Technology Development

37%

24%

23%

13%

3%

43%

30%

5%

3%

15%

4%

BY

SE

NIO

RIT

Y

■ Director ■ Manager

■ C-Level ■ Other

■ VP/SVP/Head/Principal/Lead

Top Drug Deliveries to Watch Featured Presentations Throughout the conference, 30+ companies will have the opportunity to showcase their latest technology innovations and expertise in drug delivery and design to attending pharmaceutical companies. With 3 categories – devices, injectables, and non-injectables – presenting companies will compete for a private session in the DDP Shark Tank.

DDP Shark TankFollowing the Featured Presentations, attendees will vote for the most compelling, innovative presentations. Winning companies will present their solutions to a select group of pharmaceutical leaders in a closed room, Shark Tank session, providing them the invaluable opportunity to receive feedback from respected industry leaders and hone their product pitches.

Additional Sponsorship Opportunities:• Event Partnerships

• Conference Chair

• Executive Leadership Boardroom

• Exhibition Hall

• PartneringONE® Private Meeting Room

• DDP Town Hall

• Roundtable Discussions

• Workshops Presentations

• Innovation Technology Track

• Track Session Presentations

• Track Chairperson

• Content Contributor on Blog

• Pre-Conference Webinars and Podcasts

• Seat Drops

• And more!

To present your product contact Sarah ScarrySenior Business Development Executive(646) [email protected]


Be a part of the event influencing the industry and interact with the key executives shaping drug delivery systems.


ALL ATTENDEES SAVE $600! REGISTER BY 11/13/15

SAVE $200 REGISTER BY 12/11/15

SAVE $100 REGISTER BY 1/8/16

STANDARD RATES From 1/9/16 UNTIL THE EVENT

3 Day Pass $2,795 $3,195 $3,295 $3,395

2 Day Pass(Includes Wednesday & Thursday ONLY)

$2,195 $2,595 $2,695 $2,795

Teams of 3 —4 people SAVE 10% off Standard Rates

Teams of 5 —9 people SAVE 15% off Standard Rates

For teams of 10 or morePlease contact Brian Schiff at [email protected] or 646-616-7625 to customize a registration package

REGISTRATION & HOTEL

NOTE: Promotion and discount codes as well as group/team discounts must be applied at time of registration. Discounts cannot be applied retroactively to existing registrations. Tiered pricing is valid through expiration date. New pricing takes effect at specific dates indicated. All fees must be paid in full by expiration date or your price will increase to the next level tier. All registrations are subject to IIR approval

TEAM BUILDING & GROUP DISCOUNTSDDP 2016 DESIGNED TO BENEFIT YOUR ENTIRE TEAM. SEND YOUR FULL TEAM TO:• Maximize ROI. With 3 days of

PartneringONE®, inspiring keynotes, deal-focused case studies and 30+ delivery presentations, your team can divide and conquer and then regroup to share outcomes and actions

• Be inspired. Get out of the office and disrupt your day job as a team, and get a fresh perspective on the new partnering opportunities that can help drive your business forward

• Innovate. Split up in the exhibit hall to find all the collaboration partners you need by gaining access to the latest technologies, tools and methodologies all in one place

Need help customizing your team package and experience? Contact Brian Schiff at [email protected].

To be eligible for team savings, all team members must be from the same company and register at the same time. Payment must be made within 30 days of registration, per IIR Payment Policy, or the registration rate will be adjusted to the current rate.

PGA NATIONAL RESORT & SPA400 Avenue of the Champions, Palm Beach Gardens, FL 33418

• RESERVATION NUMBER: 888-758-0945

3 WAYS TO REGISTEREMAIL:[email protected]

CALL:888.670.8200

EASIEST:www.DDPevent.com

ROOM RATE

$279.00

Expires

12/30/15

save $600 - pdd · 10:15—11:00 morning networking break pharma industry keynote 11:00—11:45...

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