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.

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• 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.

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

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.

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.

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?

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.

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.

Interactive discussion  of recent events and trends related to connected combination products. Relevant to other connected pharma products as well.

More than 500 meetings expected in 2018.

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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.

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®.

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.

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.

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.

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.

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.

• Three main currents underlying change in US healthcare
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  • 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

Silicone is the gold standard lubricant for prefilled syringes. However, concerns exist that silicone may contribute to elevated particle levels, potential drug/silicone interactions or incomplete drug delivery due to stalling Autoinjectors. With the innovative XSi coating BD introduces a technology that addresses silicone related concerns. XSi leverages the vast body of evidence on glass syringes and is perfectly compatible with existing fill/finish infrastructure.

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.

• 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

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