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Jan 29
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7:30am - 7:55am

Registration and Breakfast

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7:55am - 8:00am
Chairpersons' Opening Remarks

Chairpersons' Opening Remarks

  • Jeannie Joughin, PhD - Chief Commercial Advisor, Enable Injections, Inc.
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Showing of Streams
Showing of Streams
Showing of Streams
5:30pm - 6:30pm

Cocktail Reception

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7:30am - 7:55am 25 mins
Registration and Breakfast
7:55am - 8:00am 5 mins
Chairpersons' Opening Remarks
  • Jeannie Joughin, PhD - Chief Commercial Advisor, Enable Injections, Inc.
8:00am - 8:30am 30 mins
Info
Driving Innovation
Drug Delivery Efficacy - an IT SaMD Job?
  • Michael Meissner, Ph.D. - CTO and VP, MED Tech, Device Development, Sanofi

A common challenge for pharma is the high variability in measured outcome of drugs between clinical trials and real world use, especially in some of the costly chronic disease areas. With drug delivery data increasingly being digitized, opportunities arise to leverage IT to combine that data with other data sources (GPS, BGM/CGM, activity, nutrition, etc.), ultimately reducing the performance gaps between clinical trials and real world use. Leveraging IT goes well beyond “there is an app for this” as data needs to be collected, stored, analyzed and turned into meaningful insights for physicians, care teams and patients alike to improve the adherence. My Dose Coach is an IT solution for diabetes insulin dosing, collecting physicians’ data on titration schemes as well as the daily blood glucose and insulin data from patients to advise them according to their physican’s prescription. The solution includes a data backend, a patient app, and web access for physician and administrators to manage their clinic and patients. With an effective discussion occurring between physicians and patients, there is demand for additional data sources to be added in order to further enrich the dialogue as well as learning, allowing patients to make decisions based on these gained insights. Drug delivery efficacy is becoming an IT job requiring pharma companies to adopt new skills and capabilities in order to play in such a digital drug delivery world.


8:00am - 10:30am 150 mins
Info
partneringONE®
20+ Hours of partneringONE® Meeting Potential in 2018

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

  • 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 on site.
8:30am - 9:00am 30 mins
Info
Driving Innovation
A Case Study: The Value of a Robust System Integration for Advanced Drug Delivery Solutions
  • Lionel Maritan - Associate Director, R&D, Becton Dickinson

A robust system integration of a prefillable syringe in an Autoinjector is critical to ensure a safe and effective drug delivery to patients. Through BD Physioject Autoinjector case study we will review the benefits of system integration and lessons learned after 8 years commercialization.

9:00am - 9:30am 30 mins
Driving Innovation
The Role of Digital Biomarkers in the Future of Drug Delivery
  • Christopher Kovalchick, Ph.D. - Chief Engineer, Eli Lilly and Company
9:30am - 10:00am 30 mins
Info
Driving Innovation
AstraZeneca’s Science & Innovation Strategies and Future Pipeline
  • Stanko Skrtic, MD, PhD, MBA - Senior Science & Innovation Medical Director, AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company and one of only a handful of companies to span the entire life-cycle of a medicine from research and development to manufacturing and supply, and the global commercialisation of primary care and speciality care medicines. Pharmaceutical Technologies & Development (PT&D) develops technologies to support products from initiation of clinical studies through to post product launch. The PT&D Innovation Strategy & External Liaison (IS&EL) team introduce new technology platforms and capabilities, improve PT&D’s readiness to support the future portfolio and works towards establishing an industry leading global capability.

Our partnering approach is to seek out collaborations that drive real progress, are founded on trust and transparency, are innovative and value-adding, and enhance our expertise.


10:00am - 10:45am 45 mins
Driving Innovation
Morning Networking & Exhibition Break
10:15am - 10:30am 15 mins
Info
New Drug Delivery Technology
3D Printing For Advanced Pharmaceutical Development and Commercialization
  • Don Wetherhold - Senior Executive Advisor & SVP, Aprecia Pharmaceuticals

Pharmaceutical companies strive to bring differentiated products to market faster and enhance their value propositions throughout the longest possible lifecycle. 3DP manufacturing enables rapid clinical development and dosage form options that go beyond the capabilities of conventional manufacturing technologies. Topics for discussion include rapid prototyping for clinical supply, commercialization of novel NCEs, and lifecycle management for existing products.

10:45am - 11:15am 30 mins
Info
Driving Innovation
Device Connectivity Solutions for Drug Delivery
  • Kevin Deane - Executive Vice President, Front-End Innovation, Phillips-Medisize, a Molex Company

Connected Health remains a hot topic of discussion in the drug delivery industry. However very few systems have actually made it to the market so far. Part of the reason for this is the challenge and high cost of implementing connectivity on the devices that increasingly are being used by patients for home delivery of costly and life-saving medicines. Phillips-Medisize has been delivering a range of solutions to address this problem, including the first such connected drug-device solution approved by FDA. This session will explore the technical and economic challenges, and present a range of ‘ready to use’ solutions, from low cost connectivity to reusable devices, including our collaboration with Credence MedSystems which has resulted in our latest electronic reusable autoinjector using their Companion® range of safety syringes.

11:15am - 12:00pm 45 mins
Patient Centricity
Panel: Creating Value in Your Patient Centric Platform
  • Moderator Srini Sridharan, Ph.D. - Group Director, Materials Science & Engineering, Bristol-Myers Squibb
  • Paul Jansen, PE - Board Member & Snr Advisor Haselmeier, Haselmeier, Subcuject
  • Laurie Reed - Senior Director, Human Factors Engineering, Farm Design, a Flex Company
  • Joshua Horvath, Ph.D. - Associate Director, Device Development, Genentech
11:15am - 12:15pm 60 mins
partneringONE®
20+ Hours of partneringONE® Meeting Potential in 2018
12:00pm - 12:30pm 30 mins
Patient Centricity
Matching Devices with Users: A Case Study
  • Molly Story, PhD - Head, Global Usability Engineering and Risk Management, Sanofi, USA
12:30pm - 1:40pm 70 mins
Patient Centricity
Networking Lunch
12:30pm - 1:40pm 70 mins
partneringONE®
Networking Lunch
1:40pm - 1:45pm 5 mins
Track 3: Case Studies: Drug Delivery Partnerships
Chairperson’s Opening Remarks
  • Bastiaan deLeeuw - Head of Business Development, Drug Delivery, Cambridge Design Partnership
1:40pm - 1:45pm 5 mins
Track 4: Formulations
Chairperson’s Opening Remarks
  • Bob Nissen - President, Nissen Consulting
1:40pm - 4:45pm 185 mins
Info
partneringONE®
Profile. Search. Meet

More than 500 meetings expected in 2018.

Be sure to sign-up early for maximum partnering and exposure in 2018!

1:45pm - 2:15pm 30 mins
Info
Track 3: Case Studies: Drug Delivery Partnerships
Case Study: Patient-Focused Partnerships and Development of Drug Delivery Devices
  • Matt Huddleston - EVP and Chief Technical Officer, Enable Injections
  • Mark DeStefano - Associate Director, Advanced Technology R&D, Teva

To develop truly patient-centric products, pharmaceutical and combination products companies need to consider several factors. By keeping the technology, user needs, and patient perspective at the forefront of development, combination product developers can create a drug delivery system with an improved user experience. In this session, two seasoned combination product developers share their experiences with combining technology with patient-centered design.

1:45pm - 2:15pm 30 mins
Track 4: Formulations
Combination Delivery with Multiple Formulations
  • Diane Doughty, Ph.D. - Senior Scientist, Drug Delivery & Device Development, MedImmune
2:15pm - 2:45pm 30 mins
Info
Track 3: Case Studies: Drug Delivery Partnerships
A Partnership Study: Haselmeier & Common Sensing
  • Terry O'Hagan - General Manager, Haselmeier Inc.
  • Kevin Schmid - Chief Executive Officer, Common Sensing, Inc.

The implementation and market launch of new technologies can be challenging.  Partnering with another company can often provide a faster market entry with new technology versus internally developed products.  This presentation will discuss the rationale for the Haselmeier and Common Sensing partnership, discussing how the synergy of each company’s technology and capabilities provides long term benefits to both.  We will discuss the structure of the partnership, outlining the key roles and responsibilities of each company along with the expected benefits.

2:15pm - 2:45pm 30 mins
Track 4: Formulations
Drug Delivery For Over The Counter (OTC) Brands- Monograph Formulations Leading to Quick Business Wins
  • Bob Nissen - President, Nissen Consulting
2:45pm - 3:15pm 30 mins
Track 3: Case Studies: Drug Delivery Partnerships
Case Study: No Man (or company) is an Island - A Strategic Partnering Success Study
  • Doug Nesta, PhD - Senior Director, Biopharm Product Sciences, GlaxoSmithKline
2:45pm - 3:15pm 30 mins
Info
Track 4: Formulations
Innovative Precipitation Nanotechnology – Bringing Added Value to Product Development and Patients
  • Wolfgang Beier, Ph.D. - Co-Founder & CSO, leon-nanodrugs GmbH

Poor water solubility of majority of marketed therapeutics is a major challenge for sufficient bioavailability
Nanotechnology provides a solution to overcome the issue of poor solubility
Nano-formulated products can lead to added values for patients: GREATER FLEXIBILITY , SAFER, MORE CONVENIENT
MJR® Technology platform: a tool for the development and production of pharmaceutical drug products based on nanoparticle & nanoemulsion solutions

3:15pm - 4:00pm 45 mins
Track 3: Case Studies: Drug Delivery Partnerships
Networking Refreshment Break
3:15pm - 4:00pm 45 mins
Track 4: Formulations
Networking Refreshment Break
3:15pm - 3:30pm 15 mins
Info
New Drug Delivery Technology
Transmucosal Delivery – Using the Mucofilm® Technology to bypass the first pass effect
  • Sebastian Braun, PhD - Head of Science & Technology, tesa Labtec GmbH

The oral mucosa seems to be the ideal location for delivering large APIs systemically and still avoiding the first pass effect. Certain challenges arise when developing such a dosage form. The product has to adhere on a wet and high mobile surface, needs to resist enzymatic degradation and increased saliva flow and has to simple disappear after a few minutes or a few hours. Challenges that can be overcome to develop the next generation of large molecule application systems.

3:30pm - 3:45pm 15 mins
Info
New Drug Delivery Technology
Enabling High Dose Biologic Delivery for Targeted User Populations
  • Armando Rios Jr. - Sr. Global Marketing Manager, BD

As high dose biologic formulations push the limits of injection into 1-2 ml formats and beyond, delivery systems that are intuitive and easy to use, and targeted to specific user populations, are becoming necessary. This presentation highlights ways to establish a delivery system strategy early in formulation development that enables commercial teams to target a variety of end users.

4:00pm - 4:30pm 30 mins
Info
Track 3: Case Studies: Drug Delivery Partnerships
Precision Guided Drug Delivery Surgery
  • Ben Wicks, Ph.D. - Head of MedTech, Team-Consulting

New surgical tools are equipping surgeons with the ability to see and treat with ever greater fidelity. We will explore how new precision-guided drug delivery tools are enabling specific tissues, even individual tumors, to be targeted with therapeutics during surgery. We’ll review the challenges and consider how such tools could enhance the use of therapeutics during surgery.

4:00pm - 4:30pm 30 mins
Track 4: Formulations
Oral Delivery of Biologics
  • Samir Mitragotri - Hiller Professor of Bioengineering, Harvard University
4:30pm - 5:00pm 30 mins
Track 3: Case Studies: Drug Delivery Partnerships
Drug Device Development: Adapting to a New Normal
  • Karthik Balasubramanian, PhD - Associate Director, Global Device R&D, Teva
  • Daniel Becker - Associate Director, Global Device R&D Operations, Teva
4:30pm - 5:00pm 30 mins
Info
Track 4: Formulations
Case Studies: Enhanced Bioavailability of Poorly Soluble Drugs
  • Albert Mihranyan, PhD - Professor of Nanotechnology, Wallenberg Academy Fellow, Nanotechnology and Functional Materials, Department of Engineering Sciences, Uppsala University

Formulation of poorly soluble BCS Type 2 drugs is a topic of great industrial interest. A robust dry powder formulation platform for direct compression tableting is developed that allows increasing the solubility and dissolution rate for a wide range of drugs from diverse pharmacological classes. This platform can potentially eliminate the need for formulating poorly soluble drugs in the form of soft gel capsules or salt conjugates, offering both clinical benefits and cost-efficiency. The platform is based on the use of large surface area analogue of microcrystalline cellulose. For formulation, the technology platform utilizes the most basic industrial equipment in 2-3 straight steps and completely avoids the use of solvents, whether organic or aqueous, for drug loading. It further does not rely on expensive mesoporous inorganic carriers, which may show enhanced solubility but particle size dependent dissolution profile. Pre-clinical case studies will be presented covering two distinct pharmacological classes, viz. pain management and anti-hypertensives.

5:00pm - 5:30pm 30 mins
Info
Track 3: Case Studies: Drug Delivery Partnerships
Improving Care and Outcomes Through Collaboration and Innovation
  • Moderator Joe Reynolds - Research Manager, Noble
  • Panelist Paul Jansen, PE - Board Member & Snr Advisor Haselmeier, Haselmeier, Subcuject
  • Panelist Mark Tunkel - Partner, Insight Product Development
  • Panelist Chris Evans - Vice President, West Pharmaceutical Services

This panel discussion will bring together thought leaders from across the drug delivery industry to discuss how value can be created through meaningful collaborations and innovative products and patient services. Panelists will share their experiences and provide attendees with takeaways that can be applied to improve patient care and commercial outcomes.

5:30pm - 6:30pm 60 mins
Cocktail Reception