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Jan 28
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7:30am - 8:15am

Registration and Coffee

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Showing of Streams
Showing of Streams
6:00pm - 7:00pm

Cocktail Reception

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7:30am - 8:15am 45 mins
Registration and Coffee
8:15am - 8:30am 15 mins
Chairpersons’ Opening Remarks
  • Keith Horspool, PhD - Vice President Pharmaceutics, Boehringer Ingelheim
8:30am - 9:00am 30 mins
Info
Life Cycle Management Through the Lens of 25 Years of Experience
  • Avinash Thombre, PhD - Research Fellow, Pfizer

Maximizing the value of an asset via life cycle management strategies is becoming more and more important in the light of the high cost and long development timelines for developing a new chemical entity. Among the life cycle management options, new formulations, particularly those that utilize advanced controlled release technologies, represent a unique opportunity. Controlled release formulations can provide significant medical and commercial differentiation as they have the potential to improve patient compliance, improve safety and reduce side effects, and improve efficacy. They could also provide additional protection from competition via a new formulation patent. These factors coupled with factors such as appropriate promotion, pricing, and launch timing, especially if the product can be switched to the new formulation prior to loss of exclusivity, could assure commercial success and provide important medicines to patients.


8:30am - 9:45am 75 mins
Info
20+ Hours of partneringONE® Meeting Potential in 2018

You need more time for meetings with partners, customers and clients. Last year, 400+ meetings wasn't enough, so DDP 2018 will offer more than 20+ hours of partnering time through EBD Group's partneringONE®. Leverage partneringONE® to identify and qualify technology leads and close the deal that expands your product lifecycle.

It's easy as…

  1. Request meetings. 
  2. Accept or decline requests from others.
  3. Arrive on site and meet.
9:00am - 9:45am 45 mins
Marry to Market Panel: Making the Most of Partnerships
  • Moderator Jeannie Joughin, PhD - Executive Vice President and Chief Commercial Officer, Enable Injections, Inc.
  • Panelist Alex Zuyev - Sr. Director, Device Development, Sanofi
  • Panelist Mitesh Patel - Director, Lilly Research Labs at Eli Lilly and Company
9:45am - 10:30am 45 mins
Morning Refreshment Break
9:45am - 10:30am 45 mins
Morning Refreshment Break
10:00am - 10:15am 15 mins
Morning Presentation 1
10:15am - 10:30am 15 mins
Info
New Developments in Connected, Needle-Free Drug Delivery
  • Patrick Anquetil, PhD - CEO, Portal Instruments, Inc.

Portal Instruments will provide an update on their needle-free injector, including recent patient and payer research, highlighting the market readiness for a next-generation connected drug delivery device.

10:30am - 11:00am 30 mins
Innovation in Drug Delivery
  • Uri Baruch - Head of Drug Delivery, Cambridge Design Partnerships
10:30am - 12:00pm 90 mins
20+ Hours of partneringONE® Meeting Potential in 2018
11:00am - 11:30am 30 mins
State of the Pharmaceutical Industry
  • Daniel Cohen - Managing Director, RBC Capital Markets LLC
11:30am - 12:00pm 30 mins
What to Expect in 2019 from the President and the Congress Relating to Health Care
  • Speaker Brent Del Monte - Senior Vice President, BGR Government Affairs
12:00pm - 1:15pm 75 mins
Networking Luncheon in the Exhibit & Poster Hall
12:00pm - 1:15pm 75 mins
Networking Luncheon in the Exhibit & Poster Hall
12:15pm - 12:30pm 15 mins
Lunch Presentation 1
12:30pm - 12:45pm 15 mins
Lunch Presentation 2
12:45pm - 1:00pm 15 mins
Lunch Presentation 3
1:15pm - 1:45pm 30 mins
Track 1: Drug Delivery Technologies
Innovation in Packaging, Devices and Sensors – AstraZeneca Perspectives
  • Lubomir Gradinarsky, PhD - Science & Innovation Director, AstraZeneca
1:15pm - 1:45pm 30 mins
Info
Track 2: Strategies and Insights: Patient-Centric Design and Development Principles
Bridging User Needs & Design Requirements
  • Nick Lesniewski-Laas - Director of Electrical Engineering, Sunrise Labs

Translating user needs into formal design requirements that pass regulatory muster is a key step in medical product development.  In this session, we'll talk about how to read between the lines of user feedback, best practices for drafting design requirements, a systems approach to requirements management, and de-risking Validation through better Verification.  

1:15pm - 5:00pm 225 mins
Info
partneringONE®
partneringONE® Meetings

Leverage partneringONE® to identify and qualify technology leads and close the deal that expands your product lifecycle.

1:45pm - 2:15pm 30 mins
Info
Track 1: Drug Delivery Technologies
Choosing the Right Connectivity for Your Drug Delivery Product
  • Joan Vrtis, PhD - SVP, Design and Engineering, Flex

In an age where more than 25 billion devices are expected to be connected by 2020, drug delivery devices such as inhalers, injection pens and pumps are no exception; incorporating wireless technology into them can increase dose compliance and ultimately patient outcomes. Joan Vrtis discusses how to choose a protocol (e.g., Bluetooth, Wi-Fi, cellular, NFC) that balances the tradeoffs in cost, connection distance, and performance.

1:45pm - 2:15pm 30 mins
Info
Track 2: Strategies and Insights: Patient-Centric Design and Development Principles
Pfizer’s Evolving Drug Delivery Strategy: Focus on Patients
  • Advait Badkar, PhD - Sr. Director- Pharmaceutical R&D, Pfizer

This talk will focus on the R&D focus areas within Pfizer and the patient focused drug delivery strategy that we have implemented. The talk will also highlight specific areas of interest for Pfizer within the scope of delivery technologies to enable new modalities and new products.

2:15pm - 2:45pm 30 mins
Info
Track 1: Drug Delivery Technologies
Mechatronics for Life – The Drug Delivery Platform for Reconstitution, Large-Volume and Combination Therapies
  • Thomas Mayer - Sales and Application Manager, Medtech, Sonceboz SA

Drug products undergo different stages during their lifecycle and drug products come in a variety of formulations and containers. By leveraging on a flexible fluid-path architecture Sonceboz is offering a wearable injection device platform aimed to ease drug administration from clinical trials to Lifecycle-Management activities by offering unprecedented options such as dual-cartridge, automatic reconstitution and large-volume injection - all while adapting to existing container technology.


2:15pm - 2:45pm 30 mins
Track 2: Strategies and Insights: Patient-Centric Design and Development Principles
Panel: Design and Perspective on Biologics Treatments
  • Moderator Cornell Stamoran, PhD - Vice President of Corporate Strategy, Catalent Pharma Solutions
2:45pm - 3:30pm 45 mins
Track 1: Drug Delivery Technologies
Networking Refreshment Break
2:45pm - 3:30pm 45 mins
Track 2: Strategies and Insights: Patient-Centric Design and Development Principles
Networking Refreshment Break
3:00pm - 3:15pm 15 mins
New Drug Delivery Technology
Afternoon Presentation 1
3:15pm - 3:30pm 15 mins
Info
New Drug Delivery Technology
The Credence MedSystems Platform of Innovative Drug Delivery Devices: The Journey to a New Standard in Drug Delivery
  • John Merhige - Chief Commercial Officer, Credence MedSystems, Inc

BioPharmaceutical companies have used delivery systems to differentiate their products for years, but in the world of syringes, safety, and reconstitution, innovation has been lacking. Credence MedSystems is on the path towards creating a new standard in drug delivery for the benefit of patients, healthcare professionals and Pharma companies striving to improve patient care and differentiate products.

3:30pm - 4:00pm 30 mins
Info
Track 1: Drug Delivery Technologies
An Integrated Solution for Combination Products: The Stevanato Group’s 4D Approach
  • Steven Kaufman - Vice President Drug Delivery Systems, Stevanato Group

With increased demand in the market for combination products, biopharmaceutical companies are now actively utilizing drug delivery devices such as auto injector, pen injector and wearable injection systems.  Now, we see the urgent need to enhance communication and collaboration between service providers involved in these programs.  Steven will talk about the importance of the primary container in terms of characterization and optimization for device programs, will highlight the challenges of device design, development and scale-up of manufacture, touch on related device testing needs, and will introduce an innovative equipment solution for sub assembly, final assembly and packaging. This presentation will illustrate how to address key challenges through an integrated solution utilizing combined capabilities, technologies and services which is referred to as the SG4D approach.

3:30pm - 4:00pm 30 mins
Track 2: Strategies and Insights: Patient-Centric Design and Development Principles
Ultimate How To: Incorporating the Patient Perspective in Drug Delivery
  • Lilly Stairs - Head of Patient Advocacy, Clara Health
4:00pm - 4:30pm 30 mins
Info
Track 1: Drug Delivery Technologies
The Creation and Use of Valuable Patents
  • John Goetz - Principal, Fish & Richardson
  • Karl Renner - Principal, Fish & Richardson P.C

Abstract:  How do you create valuable patents and use them to generate real-world marketplace value?  We will explore best practices for implementing internal company procedures—and attitudes—that lead to high-quality, commercially valuable patents and patent portfolios.  We will also discuss how to use patents either to preserve marketplace exclusivity (litigation) or to generate revenue (licensing) down the road, focusing in particular about what companies should be doing now to maximize the value of these activities later.


Key Takeaways:  

 

  • Having better technology can lead to initial success but competition eventually will come, and there will be a fight.  Companies that arm themselves by working to create valuable patents early, usually win that fight. 

  • Remember that a patent is a business tool to protect your innovations and market space, but not all patents are treated the same.  There are good patents (valuable) and bad patents (worse than worthless).   

 

  • The most successful innovative businesses believe that patents are vital to the company’s long-term health, with upper management instilling this belief into a pervasive, company-wide attitude.  A scalable in-house patent program requires educating employees, rewarding them, regular brainstorming sessions, and a patent-filing review board. 

  • While a robust patent program can be expensive, focused initial patenting efforts can add early real-world value.    

  • Thinking early about valuable patents means thinking early about litigation and licensing.  For litigation, nurture the “invention story” and improve it where you can.  Early education here is critical as well, so that communication and privilege protocols are properly understood and followed from the start.  

  • While out-licensing core technology may be neither beneficial nor desired, a strong patent program will inevitably develop tangential assets that could mature into future revenue streams.  Early thinking about valuable technology space (market gaps or competitor products) and pricing strategies will maximize revenue down the road.  


4:00pm - 4:30pm 30 mins
Track 2: Strategies and Insights: Patient-Centric Design and Development Principles
Special Population Considerations – Pediatrics & Geriatrics
4:30pm - 5:00pm 30 mins
Track 1: Drug Delivery Technologies
Case Study: Novel Technology - Patch Option for Schizophrenics
  • Ralph Lipp, Ph.D. - Vice President and Chief Scientific Officer, Noven Pharmaceuticals, Inc.
4:30pm - 5:00pm 30 mins
Track 2: Strategies and Insights: Patient-Centric Design and Development Principles
Designing for Pediatric and Geriatric Users
  • Molly Story, PhD - Head, Global Usability Engineering and Risk Management, Sanofi, USA
5:00pm - 5:30pm 30 mins
Info
Track 1: Drug Delivery Technologies
A Quality by Design (QbD) Approach Towards Manufacturing of Elastomeric Components for Parenteral Packaging Applications
  • Rahul Thakar - Technical Key Account Manager, Datwyler Pharma Packaging

Visible particles are a concern for the pharmaceutical industry. In the last few years, a quarter of all sterile injectable drug recalls were linked to particulate found in finished drug products. This poses a significant challenge to address Quality requirements, and to comply with regulatory authorities in various geo-regions. This presentation will focus on innovations in the manufacturing of parenteral packaging components to address the demanding needs for packaging sensitive drug molecules. Process related advancements such as automation and their impact on product quality will be explained. Additionally, product optimization of elastomeric components to realise functionality requirements will be presented through a case study.

5:00pm - 5:30pm 30 mins
Info
Track 2: Strategies and Insights: Patient-Centric Design and Development Principles
Design for Adherence: a New Model to Predict and Improve Medication Adherence
  • Daniel Lock - Consultant, TTP plc

Medication adherence is often studied after a drug or delivery device is developed, but what if we were able to predict levels of adherence during development? In this presentation, we introduce a deterministic model of adherence and design toolkit developed at TTP. The model can help to evaluate and select concepts, understand commercial impact, and develop device/service solutions for adherence.

5:15pm - 5:30pm 15 mins
New Drug Delivery Technology
Reception Presentation 1
5:30pm - 5:45pm 15 mins
New Drug Delivery Technology
Reception Presentation 2
5:45pm - 6:00pm 15 mins
New Drug Delivery Technology
Reception Presentation 3
6:00pm - 7:00pm 60 mins
Cocktail Reception