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Informa
Jan 23
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7:30am - 8:15am

Registration and Breakfast

8:15am - 8:30am

Chairpersons' Opening Remarks

  • Chairperson Ann L. Daugherty, PhD - Senior Manager, Drug Delivery, Pharmaceutical Development, Genentech Inc.
  • Chairperson Richard Korsmeyer, PhD - Drug Delivery and Innovation Expert, Korsmeyer Consulting, LLC; Pfizer (ret)
Showing of Streams
12:30pm - 1:45pm

Networking Lunch

Showing of Streams
Showing of Streams
7:30am - 8:15am 45 mins
Registration and Breakfast
8:15am - 8:30am 15 mins
Chairpersons' Opening Remarks
  • Chairperson Ann L. Daugherty, PhD - Senior Manager, Drug Delivery, Pharmaceutical Development, Genentech Inc.
  • Chairperson Richard Korsmeyer, PhD - Drug Delivery and Innovation Expert, Korsmeyer Consulting, LLC; Pfizer (ret)
8:30am - 9:00am 30 mins
Driving Innovation
Pharmaceutical Applications of Three Dimensional Printing (3DP) and Additive Manufacturing
  • Jaedeok Yoo, PhD - Advanced Automation Researcher, R&D Platform Technology & Sciences, GlaxoSmithKline
more

Three Dimensional Printing (3DP) and Additive Manufacturing (AM) have been receiving much attention for its applications in a wide range of industries, including aerospace, automotive, consumer products, fashion, and even food.  Almost constant stream of new applications and advances in the underlying technologies make it an exciting yet challenging field to stay abreast with the progress.  While early adopters in other industries (e.g. aerospace) are now starting to reap benefit, pharmaceutical industry has been somewhat lagging in its acceptance of this useful tool.  This presentation will highlight key 3DP opportunities in the pharmaceutical industry.  Specific application examples include rapid prototyping of formulations, controlled release tablets, orally dispersing dosage forms, and dosage forms with built-in anti-counterfeit measures.  Different versions of the 3DP processes will be discussed to compare relative strengths and current gaps of each technique.  How the changing landscape of the 3DP and pharmaceutical industries may impact the future of drug discovery, development, manufacturing, and distribution will be discussed.

8:30am - 12:30pm 240 mins
partneringONE®
20+ Hours of partneringONE® Meeting Potential in 2018
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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.
9:00am - 9:30am 30 mins
Driving Innovation
Targets, Trials, & Translation: Digital Disruption in Pharmaceutical R&D
  • Jonathan Usuka, PhD - Senior Analytics Expert, McKinsey & Company
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9:30am - 10:00am 30 mins
Driving Innovation
The Value of Tangibles in Capturing Usability Insights
  • Kate Stephenson - Academic Partnerships and Business Development, iO life science
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If a picture is worth a 1000 words, how much more can be gained from holding something solid in your hand? In every medical device venture, the clearest, most actionable design input is received when a user holds the nearly completed product in their hand. Ironically, this is also the point at which the design is least open to modification. In an ideal process, a human factors study would be able to gather the concrete information supplied by engaging with the end product, before the resources are actually invested to design it.

This is a core tenant to iO Life Science’s patient focused design process. Instead of seeing usability as a purely passive process of data gathering via surveys and interviews, iO Life Science creates engaging design conversations by presenting users with tangible objects to manipulate and test. In this presentation, iO will present the value in creating “tangible” experiences in usability studies, as well as specific, practical strategies for doing so efficiently and effectively at the earliest stages of the design process

10:00am - 10:30am 30 mins
Driving Innovation
Morning Networking & Exhibition Break
10:30am - 11:00am 30 mins
Driving Innovation
At the Crossroads of a New Quality Paradigm: Innovation, Acceleration & Regulatory Harmonization
  • Roger Nosal - Vice President & Head of Global Chemistry, Manufacturing, and Controls, Pfizer, Inc.
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The pharmaceutical industry is at a crossroads. Breakthrough therapies, accelerated development & transformative technical innovations are poised to shift the conventional regulatory paradigm & improve product quality assurance. However increasingly divergent global regulatory expectations & lengthy approval times for manufacturing optimizations & continuous improvement initiatives pose a significant and complicated, punitive burden for product supply chains & ultimately creates barriers to innovation. Reducing regulatory complexity demands global regulatory convergence, joint collaboration among regulatory authorities & incentives to establish a NEW quality paradigm.

11:00am - 11:30am 30 mins
Driving Innovation
Using Digital Health to Enhance Medication Management
  • Douglas McClure - Senior Director, Head of Product, BD
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Going beyond reminders - the use of cognitive and learning systems to meet people where they are and support them in the way they need.  Care plan and medication management through highly personalized engaging experiences that put the person in control.

11:30am - 12:00pm 30 mins
Driving Innovation
State of the Pharmaceutical Outsourcing Industry – Wall Street Perspective
  • Daniel Cohen - Managing Director, RBC Capital Markets LLC
more
12:00pm - 12:30pm 30 mins
Driving Innovation
What to Expect in 2018 from the President and the Congress Relating to Health Care
  • Brent Del Monte - Senior Vice President, BGR Government Affairs
more

Now that the Trump Administration and the Congress have been working for more than six months, what have they been able to accomplish (legislatively or Administratively) pertaining to health care, and what remains to be done in 2018?

12:30pm - 1:45pm 75 mins
Networking Lunch
1:45pm - 2:15pm 30 mins
Track 1: Developing and Launching Technology Products
Drug Delivery Meets Automotive - The Creation of a Wearable Drug Delivery Device Platform
  • Tom Mayer - Sales Manager, Sonceboz
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Sonceboz is combining knowledge in medical devices with a proven track record in automotive actuation - creating cost effective reliable drug delivery systems. We are developing and manufacturing a novel wearable device platform enabling our customers to work with single or dual primary containers - covering the injection of high-volume/high-viscosity, dual-drug combinations and finally the automatic reconstitution of lyophilized formulations.

1:45pm - 2:15pm 30 mins
Track 2: Drug Delivery Methods and Strategies
Device Technology and Partner Selection Process for Combination Products – A Customer’s Perspective
  • John Skoug, PhD - Director, AbbVie
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Device Technology and Partner Selection Process for Combination Products – A Customer’s Perspective

Authors:  John W. Skoug, Lin Laurusonis, Robert Nesbitt

Combination products are inherently complex as they require integration of the pharmaceutical /drug development with medical device development processes and quality systems.  Many Pharma companies rely upon partnering with device companies to access technology that is then used with varying degrees of customization to fit the particular product need as defined in the quality target product profile.  This presentation will focus on the considerations that apply in the selection of a device partner for development or customization of a combination product.  While the delivery system technology, its stage of development, and extent of customization needed are key factors in the partner selection decision, the assessments of the capabilities of the partner by key cross-functional stakeholders must be integrated to form a balanced and long-term view of the potential relationship.  The presentation will outline the process by which the evaluation, feasibility assessment and selection of technology partners has been conducted at AbbVie that integrates the assessments of partner capabilities and processes related to device development, quality systems, manufacturing/supplier controls, sustaining engineering, and complaint management.  Based on these criteria, a scoring system is established that allows an objective assessment to choose the most appropriate partner for the particular product need.

Disclosures: All authors are employees of AbbVie. The design, study conduct, and financial support for this research was provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the publication.

1:45pm - 2:15pm 30 mins
Track 3: Digital Health and Connected Health
Connected Combination Products Breaking News
  • Napoleon Monroe - Managing Director, New Directions Technology Consulting, LLC
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Interactive discussion  of recent events and trends related to connected combination products. Relevant to other connected pharma products as well.

2:00pm - 4:45pm 165 mins
partneringONE®
Profile. Search. Meet
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More than 500 meetings expected in 2018.

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

2:15pm - 2:45pm 30 mins
Track 1: Developing and Launching Technology Products
The Role of User Experience in Shaping Product Development
  • Rick Bente - Vice President of Strategic Alliances, Insulet
more

Improving patient adherence is a key driver behind the innovation of on-body, wearable devices for subcutaneous delivery. Success in new product development goes beyond the surface of dose volume and treatment regimen and instead stems from understanding the patient experience, struggles and capabilities. Developing a unique, patient-focused approach provides industry innovators with valuable insights that should be integrated into the engineering design and development process of new drug delivery solutions.

2:15pm - 2:45pm 30 mins
Track 2: Drug Delivery Methods and Strategies
Oral Thin Films from Development to Commercialization
  • Moderator Zhengming (Jimmy) Chen, PhD - Senior Director, Pharmaceutical Sciences, Shionogi, Inc.
  • Panelist Thierry Bilbault, PhD - Head of Technical Operations, Sunovion Pharmaceuticals Inc.
  • Panelist Niraj Vasisht, PhD - Chief Technology Officer, BioDelivery Sciences International, Inc.
  • Panelist Mark Schobel - Chief Innovation & Technology Officer, Monosol Rx
  • Panelist Scott Barrnhart - Technical Director, ARx LLC.
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Oral films are postage-stamp-sized versions of existing or novel drugs that dissolve on the surface of or under the tongue, or against the cheek. They can carry very low doses of prescription drugs and larger doses up to 80 mg.  They are emerging as a trend in drug delivery in treatments from Parkinson’s disease to diabetes to erectile dysfunction.  Oral films are easy to administer, and in most cases, do not require water, especially for pediatric, geriatric and neurodegenerative disease patients where proper dosing can be difficult. In chronic care, films give caregivers the ability to medicate regularly without injections.  They are also a means of differentiated marketing for off-patent drugs.  In this panel, we will discuss the current status and emerging trends of the oral film market and technologies.  We will share our stories about the development of a sublingual bi-layer Apomorphine Film, and the technology basis for four commercial Rx products – Suboxone®, Onsolis®, Bunavail® and Belbuca®.

2:15pm - 2:45pm 30 mins
Track 3: Digital Health and Connected Health
Developing Your Device into a Connected System
  • Jim Turner - Director of Software Engineering, Sunrise Labs
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A Smart, interconnected system, has positive implications for a stakeholder’s entire value proposition and revenue model. Benefits include quicker access to patient data, increased adherence and product usage, improved end user experiences, and allows manufacturers to stay engaged through the full product life cycle. This presentation will help you evaluate development strategies when designing a connected device ecosystem.

2:45pm - 3:15pm 30 mins
Track 1: Developing and Launching Technology Products
Collaboration for Better Innovation in a World of Rapidly Evolving and Converging Technology
  • Bill Rich - Vice President, Device and Final Drug Product Technologies, Amgen
  • John Carlson - President, Flex Health Solutions, Flex Ltd.
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he integration of new technology lags in the medical space; partly due to regulation and long product development cycles.  Pharma and device companies were historically independent and self-reliant in innovation and development. It is increasingly difficult to stay current and maintain technology expertise independently.  Patient expectations for ease of use,  compliance tools, and remote disease management are critical components of therapy efficacy, not to mention lack of user error.  Risk factors are minimized through marriage of design excellence, and advanced technologies in combination with pharmaceutical expertise.  This convergence is best accomplished in strategic partnership vs. a traditional supplier relationship. Bill Rich, Vice President, Device and Final Drug Product Technologies at Amgen, and John Carlson, President, Flex Health Solutions will speak about partnership in bringing together cross industry technology expertise and pharmaceutical expertise to create true innovation, new possibilities for patients, and a best practice for managing the collaboration in innovation.

2:45pm - 3:15pm 30 mins
Track 2: Drug Delivery Methods and Strategies
Enhancement of Solubility and Bioavailability of BCS Type 2 and 4 Substances in Mixtures with Cellulose
  • Albert Mihranyan, PhD - Professor of Nanotechnology, Wallenberg Academy Fellow, Uppsala University
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A proprietary platform is developed for enhancing the solubility and bioavailability of poorly soluble BCS Type 2 and 4 substances in mixtures with microcrystalline cellulose analogues based on nanotechnology principles. The technology platform is particularly attractive for oral formulations produced by direct compression tableting. The vast data generated during the past 3-4 years includes density functional theory simulations, solid-state characterizations, in vitro drug release, and in vivo pharmacokinetic animal studies. The platform is robust and suitable both for reformulation of well-known generic drugs and development of novel proprietary products.

2:45pm - 3:15pm 30 mins
Track 3: Digital Health and Connected Health
Essential Ingredients for Drug Delivery Development
  • Uri Baruch - Head of Drug Delivery, Cambridge Design Partnership
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We have integrated a unique new service that complements traditional user-insight capabilities, and offers quantified data to supplement patient feedback. This approach enables detailed analysis of actual patient behavior, without the need for 1-on-1 analysis. By placing the patient experience at the core of this technology offering, we're able to help our clients uncover opportunities for innovation, as well as providing them with the first step along the roadmap to future device connectivity – where such a device is focused on improving the user experience, and ultimately improving outcomes. This way we can bridge the gap between traditional user studies and real patient experience and get a holistic understanding of the interplay between the user and their environment.

3:15pm - 3:45pm 30 mins
Track 1: Developing and Launching Technology Products
Refreshment and Exhibition Break
3:15pm - 3:45pm 30 mins
Track 2: Drug Delivery Methods and Strategies
Refreshment and Exhibition Break
3:15pm - 3:45pm 30 mins
Track 3: Digital Health and Connected Health
Refreshment and Exhibition Break
3:45pm - 4:15pm 30 mins
Track 1: Developing and Launching Technology Products
The Case for Early Partnering: A Flexible Platform to Enable your Portfolio!
  • Michael Hooven - President and CEO, Enable Injections
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3:45pm - 4:15pm 30 mins
Track 2: Drug Delivery Methods and Strategies
Innovative, Cost Effective Solution for Self-Administration of Bio-similar Drugs
  • Tsachi Shaked, MBA - Marketing and BD Director, Elcam E3D
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The purpose of this presentation is to identify and present a cost effective method and devices to self-administration of biosimilar drugs and molecules while keeping the entire process safe and easy to use.Disposable auto-injectors have their advantages of safe and simplicity, but pose an additional cost of materials to a bio-similar drug / molecule.Reusable auto injectors are more cost effective, but the ones in the market are complicated, are not easy to use and not completely safe.In this presentation we will present a new, innovative, method for easy and safe yet cost effective way for self-administration of biosimilar drugs/ molecules. These innovative devices might be a perfect partner with the biosimilar drug as they are not only cost effective, safe and easy to use, but also have a lower environmental impact of plastic parts and trash.We will discuss mechanical auto-injectors and electronic auto-injectors while in both the only disposable part is the cassette that holds the PFS with the drug inside.

3:45pm - 4:15pm 30 mins
Track 3: Digital Health and Connected Health
Currents in the US Healthcare Marketplace
  • Edmund Pezalla, MD, MPH - Founder and CEO, Enlightenment Bioconsult, LLC
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  • Three main currents underlying change in US healthcare

    • On-going reforms focused on improving quality and outcomes while managing costs
    • Legislative and policy movements aimed at reducing government payment/intervention in insurance and access to healthcare
    • Mergers and acquisitions which are responses to other changes in the market including economic challenges and uncertainty
  • These currents are working in somewhat opposite direction so the ultimate outcome is still uncertain
  • Implications for the pharmaceutical industry include the need to be more responsive to cost issues and to focus on big improvements in outcomes rather than incremental improvements
4:15pm - 4:45pm 30 mins
Track 2: Drug Delivery Methods and Strategies
OTC Drugs, Drug Delivery and the "New" Monograph- How to Accelerate Partnerships and Business Growth
  • Robert Nissen - President, Nissen Consulting Group, LLC
  • Helmut Albrecht, MD, MS, FFPM - President, H2A Associates, LLC
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On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held its first hearing to examine draft legislation to create a new user fee program and completely revamp the review process for OTC drug applications. The bill reforms the existing monograph process – established by FDA in the early 1970s – that relies on notice and comment rulemaking, and replace it with a system that would use administrative orders to authorize drug marketing. Similar to prescription drug and medical device review programs, it pays for the new review process by establishing a user fee program for product applicants and manufacturers” (per Lexology.com, 9-13-2017)

In order to reform the system under which OTC drugs can be marketed in compliance with an OTC Monograph, an OTC user fee solution was recently submitted as part of the OTC Monograph Safety, Innovation, and Reform Act of 2017. Such new regulations would result in changes and opportunities for companies that develop and market OTC drugs in the US.

In a thought provoking presentation, two OTC experts will provide an overview of the OTC market, the opportunity for drug delivery within the Monograph system for OTC drugs, and the path leading forward in capitalizing on the expected changes in the regulatory system. The OTC market worldwide is in excess of $130 billion, and drug delivery has always played a key role in brand extensions and organic growth. The US Monograph system for OTC drugs has been designed to help quickly introduce new technologies for safe and effective product alternatives. Understanding the changing landscape is important in gaining a competitive edge in the future.

4:15pm - 4:45pm 30 mins
Track 3: Digital Health and Connected Health
Your Bot Will Run Your Health: How Mixed Reality and AI are Changing Healthcare
  • Derek Mathers - Director, Advanced Development, Worrell
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  • How voice-assisted technology is creating opportunities to improve medication and therapy adherence as well as improved long-term patient engagement
  • How augmented reality can help train and engage clinical field reps, healthcare professional and patients with drug delivery and instructions for use
  • How to leverage Alexa and Google Home for clinical trial data and guiding patients via voice-enabled technology to improve study success
4:45pm - 5:15pm 30 mins
Differentiated Disease Therapy via Integrated Device and Connected Health Strategy
  • Kevin Deane - Executive Vice President, Front-End Innovation, Medicom Innovation Partner, a Phillips-Medisize Company
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4:45pm - 5:30pm 45 mins
partneringONE® Meetings
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Leverage partneringONE® to identify and qualify technology leads and close the deal that expands your product lifecycle.

5:15pm - 5:45pm 30 mins
Patient-centric Ideation, Design and Development of Novel Drug Delivery Systems
  • Ralph Lipp, PhD - Vice President and Chief Scientific Officer, Noven Pharmaceuticals, Inc.
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5:45pm - 6:45pm 60 mins
Cocktail Reception