Preliminary Agenda

Day One - Monday, May 21, 2018

Summit Registration and Morning Coffee

Chairperson’s Welcome and Opening Remarks

UNDERSTAND CURRENT AND FUTURE TRENDS AND CHALLENGES IN THE BIOLOGICS DRUG DELIVERY FORMULATION AND TECHNOLOGY INNOVATION LANDSCAPE TO PREPARE FOR 2020

The drug delivery landscape continues to rapidly evolve with advancements in personalized medicine and pharmaceutical development. As the industry continues to see a growing role of bio therapeutics in commercial and clinical phases, new opportunities and challenges arise for novel drug delivery methods of biologics. Explore future trends of Biologics and drug delivery to develop strategic plans for a biologics portfolio.

• Explore opportunities and challenges in for novel drug delivery methods of biologics Explore strategic partnerships for a biologics portfolio
• Assesses the continuing M&A activity in the pharmaceutical industry and how that is affecting drug delivery

PATIENT-FOCUSED DRUG DELVIERY: LEVERAGE PATIENT AND PAYER INSIGHTS TO IMPROVE THE PATIENT EXPERIENCE THROUGH ESTABLISHING MORE CONVENIENT METHODS OF FORMULATION AND DRUG DELIVERY

Biologics that are formed with short plasma half-lives require more frequent administration, therefore making it more difficult for patients to comply with their regimens. Although these drugs have advantages over conventional drugs in that they are more selective, effective, and have limited side effects, manufacturers face a lack of adherence and compliance to these drugs due to the design of the drug and mode of delivery.  Manufacturers will have to address these challenges in the drug development process, and inform patient focused drug development initiatives with insights from patients and payers. As payers are heavily focused on outcomes, what payers perceive to be valuable and reimbursement decisions has become ever increasingly important. In this session we will discuss how improve formulation strategies to enhance patient convenience and adherence to improve patient outcomes, establish more convenient methods of delivery, and improve payer partnerships.

• Focus drug delivery technology efforts based on patient, care giver, and payer insights
• Drive patient focused biologic formulation development to improve patient outcomes, payer reimbursement and novel technology efforts
• Understand the reimbursement landscape to inform drug formulation and development strategies
• Understand how to employ pre-formulation development strategies to improve patient convenience
• Leverage devices and analytical tools to develop patient centered biologic drugs and integrate devices in early development

Networking and Refreshment Break

UNDERSTAND THE IMPACT OF BIOSIMILARS ON THE DRUG DELIVERY LANDSCAPE

The promise of Biosimilar became a reality after the first biosimilar entered the market in 2015. With more biosimilar under the FDA regulatory approval process, it is imperative to understand how they will impact the drug delivery landscape. Gain an inside perspective into how the industry is developing and using biosimilar in the future.

• Understand the similarities between biosimilar and biologics
• Discover tools to characterize biologics
• Understand the future of biosimilar and how they will affect the field of biologics

UNDERSTAND THE EVOLUTION OF DIGITAL HEALTH AND CONNECTED DEVICES IN HEALTHCARE AND THEIR IMPACT ON THE DRUG DELIVERY LANDSCAPE AND MEDICATION MANAGEMENT

The use of biologics is on the rise and novel delivery approaches for chronic health conditions is shifting the role of the patient. As biologics are highly concentrated and require specific dosages, challenges to deliver consistent dosages impacts patient adherence. As the role of the patient is transforming to have more independence and control of their treatment, wearable drug delivery technology is projected to improve the user experience, drive adherence, and ensure patient engagement. In this session, discover how to provide patients with novel approaches to drug delivery through the use of connected health devices.

• Ensure consistent dosage administration for patients with chronic diseases
• Leverage connected drug delivery devices to ensure patient adherence and convenience

Luncheon

DISCOVER THE NEXT GENERATION FORMULATION, DEVELOPMENT AND DELIVERY OF USE OF CELL AND GENE THERAPY TECHNOLOGIES

The evolution of DNA sequencing and personal genomics has paved a way for researchers to identify drug delivery systems that can deliver messenger RNA to target cells in the body. Such technologies can aid doctors in treating genetic disorders in a targeted way. Discover new tools developed for genome editing and the future reach of these technologies.

• Discover drug delivery systems for next-generation gene therapies
• Leverage cell and gene technologies to enhance drug delivery systems 

LEVERAGE BIG DATA AND ARTIFICIAL INTELLIGENCE TO IMPROVE ANALYTICAL CAPABILITIES FOR DRUG DELIVERY SYSTEMS

Big data and analytics are transforming research and development. Advancements in technology has created opportunity to leverage big data from patients, caregivers, retailers and the research and development process. The use of big data as well as molecular and clinical data paves the way for predictive modeling to identify molecules that can be developed into biologics. Discover the evolution of big data and how it is transforming drug delivery.

• Identify opportunities to use big data for predictive modeling
• Establish safe and effective biological targets through the use of molecular and clinical data
• Data aggregation Data and patient centricity

Networking and Refreshment Break

ESTABLISH PARTNERSHIPS TO CREATE NOVEL BIOLOGIC DRUG DELIVERY SYSTEMS  AND IMPROVE BUSINESS DEVELOPMENT GOALS

The key to improving the therapeutic effects of a biologic and extending the lifecycle of a drug is to develop partnerships between pharmaceutical and biotech companies and novel drug delivery companies to improve safety, efficacy, and effectiveness. Learn how to develop partnerships to establish innovative drug delivery systems and employ new technologies.

• Assess and evaluate novel and new drug delivery technologies to aid with your business development goals
• Discover take-away learnings from successful deals to develop beneficial partnerships and collaborations

Solution Presentations:

4:30 - 4:45 Injectables Pitch 1 Wearable injection devices/ injectables
4:45 - 5:00 Non- injectables Pitch 2 Needle free drug delivery device / Devices
5:00 - 5:15 Devices: Pitch 3 parental device development
5:15 - 5:30 Pitch 4 Non injectable devices

Cocktail and Networking Reception

Day Two - Tuesday, May 22, 2018

Summit Registration and Morning Coffee

Chairperson’s Opening Remarks

Formulation strategies for improved delivery of biologics

New Technologies for biologics delivery and targeting

NOVEL BIOLOGICS FORMULATION DEVELOPMENT SHORT COURSE

This seminar will explore key ways to overcome challenges in protein formulation.

• Opportunities for Patient Centric Formulations

NEW TECHNOLOGIES FOR BIOLOGIC DELIVERY AND TARGETING SHORT COURSE

This seminar will focus on the evolution of targeted delivery technologies: Past, Present, and Future.

• Human Factors

Design and formulation of solid oral drug products to prevent or treat diseases of the gut microbiome

• Biological delivery to targeted GI tract location
• Modified release formulation to multiple GI target sites
• Non-absorbed, localized activity
• Excipient selection

NEW TECHNOLOGIES FOR COMBINATION PRODUCTS

Networking Break

EMPLOY EFFECTIVE FORMULATION STRATEGIES TO ESTABLISH QUALITY AND STABILITY IN ANTIBODY CONJUGATES AND SITE SPECIFIC ANTIBODY MODIFICATION

Antibodies require complex conjugation methods and components and require a strategic design in order to achieve their fullest therapeutic potential. As Antibody drug conjugates are highly potent, they require advanced drug delivery formulations in order to improve drug efficacy. Explore the current trends in optimization strategies and how to leverage antibody drug conjugates. 

• Understand specific antibody modifications to the nucleotide
• Discover conjugation methods and approaches to antibody drug conjugates
• Leverage technology that targets antibody drug conjugates properties

TRANSFORMING THE PATIENT EXPERIENCE WITH A NOVEL NEEDLE FREE DRUG DELIVERY DEVICE

Needle free delivery devices is making a positive impact on the market. Key driving factors for the increased use of needle free drug delivery devices include the ability to prevent transference of chronic diseases such as Hepatitis C and Aids due to the use of injections, and the need for self-administration methods. As the needle free drug delivery device market continues to expand, drug delivery experts must understand how to leverage these devices to provide a pain free way for patients to receive drugs. 

• Discover how needle free drug delivery devices are being used in the industry
• Understand the evolving market and new needle-free technologies

DISCOVER PARENTERAL PEPTIDE FORMULATION STRATEGIES FOR LARGE MOLECULE FORMULATIONS

Parenteral delivery is the most common mode of administration for protein and peptide therapeutics. A key challenge is to improve the biological half-life, stability and therapeutic efficacy to improve protein and peptide delivery. Formulators must develop stable, sterile and particulate free, yet the unique physicochemical properties of peptides present formulation challenges that differ from small molecules. Formulators must overcome parenteral formulation challenges to establish solubility, chemical, and physical stability in the formulation. It is important for scientists to consider the impact of peptide half-life at the formulation stage to reduce frequent administration and ensure the safety and efficacy of the biologic for enhanced patient adherence. 

• Parenteral formulations for peptides
• Strategies for developing parenteral protein device combination products

EXPLORE THE APPLICATION OF NANO TECHNOLOGY FOR EFFICIENT DRUG DELIVERY METHODS FOR TARGETED NANOPARTICLES

Researchers continue to look for more effective methods to target nanoparticles that carry therapeutic drugs directly to diseased cells. The use of nanoparticles to deliver drugs to cancer cells requires the use of nanotechnology in drug delivery. As the benefits in the use of Nano technology continue to expand, drug delivery experts must understand how to utilize nanotechnology to reach Nano particles.

• Understand the benefit in the use of Nano technology to target Nano particles
• Discover the use of nanomedicine applications in drug delivery 

FORMULATION STRATEGIES IN EARLY AND PRE-COMMERCIAL DEVELOPMENT

In order to ensure long-term stability and rapid formulations, formulators must identify appropriate tools and efficient approaches to biologic formulation. Establishing phase-appropriate formulation and process designs is essential for improving product stability. Identifying phase appropriate formulations can accelerate clinical and commercial development and scale up the formulation process.

• Understand how to identify phase appropriate formulation and process designs
• Optimize formulation strategies to minimize the amount of API use and predict the solubility of a biologic 
• Early stage biologic development and formulation strategies- bio specific molecule
• Formulation and capabitbility of clinical use.

APPROACHES FOR DELIVERY OF BIOLOGICS ACROSS THE BLOOD BRAIN BARRIER

The blood brain barrier denies many therapeutic agents access to brain tumors and other diseases of the central nervous system, and requires novel drug delivery methods to reach the brain. Explore innovative technologies that can pass through the blood brain barrier and allow the passage of drug molecules through a safe and effective manner.

• Efficient and safe biologics for diseases of CNS
• Biologics that benefit the brain
• Deliverable Biologics at the blood brain barrier

End of Summit - See you Next Year!