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Days
Day 2 Tuesday, 29 January 2019 |
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Streams
Registration and Breakfast
Chairpersons' Opening Remarks
Drug Delivery Efficacy - an IT SaMD Job?
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.
A Case Study: The Value of a Robust System Integration for Advanced Drug Delivery Solutions
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.
The Role of Digital Biomarkers in the Future of Drug Delivery
AstraZeneca’s Science & Innovation Strategies and Future Pipeline
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.
Morning Networking & Exhibition Break
Device Connectivity Solutions for Drug Delivery
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.
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.
3D Printing For Advanced Pharmaceutical Development and Commercialization
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.
Panel: Creating Value in Your Patient Centric Platform
Matching Devices with Users: A Case Study
Networking Lunch
20+ Hours of partneringONE® Meeting Potential in 2018
Networking Lunch
Concurrent Tracks
Chairperson’s Opening Remarks
Case Study: Patient-Focused Partnerships and Development of Drug Delivery Devices
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.
A Partnership Study: Haselmeier & Common Sensing
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.
Case Study: No Man (or company) is an Island - A Strategic Partnering Success Study
Networking Refreshment Break
Precision Guided Drug Delivery Surgery
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.
Drug Device Development: Adapting to a New Normal
Improving Care and Outcomes Through Collaboration and Innovation
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.
Chairperson’s Opening Remarks
Combination Delivery with Multiple Formulations
Drug Delivery For Over The Counter (OTC) Brands- Monograph Formulations Leading to Quick Business Wins
Innovative Precipitation Nanotechnology – Bringing Added Value to Product Development and Patients
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
Networking Refreshment Break
Oral Delivery of Biologics
Case Studies: Enhanced Bioavailability of Poorly Soluble Drugs
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.
Profile. Search. Meet
More than 500 meetings expected in 2018.
Be sure to sign-up early for maximum partnering and exposure in 2018!
Transmucosal Delivery – Using the Mucofilm® Technology to bypass the first pass effect
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.
Enabling High Dose Biologic Delivery for Targeted User Populations
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.
Cocktail Reception
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.
Leverage partneringONE® to identify and qualify technology leads and close the deal that expands your product lifecycle.
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.
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.
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.
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.
Concurrent Tracks
More than 500 meetings expected in 2018.
Be sure to sign-up early for maximum partnering and exposure in 2018!
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.
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.
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
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.
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.
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.
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.
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.
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