2012 Conference Program
Program - Day One30th April 2012
Applying predictive and simulation modelling in formulation and delivery
- Utilizing particle engineering and predictive pharmaceutical modelling to predict form and performance
- Exploring how best to capture early phase data, analyze and forward screen to assess risk
- Readily accessing necessary tools for data comparison in development - The Cambridge Crystal Database
- Balancing the challenge of becoming smarter & faster whilst maintaining compliance
- Setting up later stage predictive parameters
- The Need for Captisol Continues
- A Year of Changes & Deals – What’s New?
- Exploring the Captisol-enabled® Product Pipeline
- The Product-Enabling Experience - A Partner’s Perspective
Successfully Responding to the Development Demands of Pediatrics
- Exploring current & forecasted trends and requirements - Where do we stand?
- Pediatric Investigation Plan (PIP) - Incorporating a potential conversion plan for pediatric therapies for all drug filings
- An Industry Outlook on Patient-centric Drug Product Development – How are we meeting the demand?
Daniel Schaufelberger
CMC Leader & Director, Portfolio Management, Pharmaceutical Development & Manufacturing Sciences
Johnson & Johnson USA
Updates & Forecasts in Geriatric Development
Perspectives from a Geriatrician
- Analysing the increasing continental life expectancy and understanding the contributing factors
- Identifying clusters of morbidities that contribute to a common biology in target selection
- Realising the importance of including the elderly population in clinical trials
- Deploying a more integrated method of therapy to treat chronic, multi-morbid illness
Rationale Formulation Design for Poorly Soluble Compounds
A holistic view from excipient, material science and process perspectives
- How to choose suitable formulation technologies for poorly soluble APIs - Conventional vs. non-conventional formulation approaches
- What needs to be considered when selecting an excipient to maximize formulation performance - physicochemical properties, processibility, regulatory considerations etc.
- When should formulation process be considered and how does this impact formulation selection - Understanding advantages and limitations of different process technologies
High Throughput Nanoactive™ Technology Platform in Improving Drugability
- Reducing transformation parameters including amount of required API and formulation time with the automated High Throughput NanoActive™ Technology
- Integrating the platform into discovery and early drug development R&D
- Scalability in GMP production
- Utilizing the technology in life-cycle management
Experimental Methods for Investigating and Modifying Supersaturation to Enhance Drug Bioavailability
- The use of supersaturation to increase bioavailability of drugs for GI absorption
- Fast experimental techniques for assessing the extent and duration of supersaturation
- How supersaturation can be enhanced using additives and excipients
- GI Dissolution assays for exposing small pellets of API to changing pH conditions and lipids to simulate passage of drugs through the GI tract
Deploying highly sophisticated engineering strategies in designing a World Class & cost effective facility
- Forcing extreme design vision and innovation in attaining World Class status
- Benchmarking against existing development and manufacturing facilities in selecting and enhancing preferable technologies and processes
- Producing maximally contained unit operations in the development of highly potent compounds
- Highlighting enhanced process engineering technologies
- Smoothening tech transfer knowledge and technologies
- PAT applications & drivers in optimising containment
Jerry Parker
Former Associate Director, Global Pharmaceutical and Analytical Sciences (Retired)
Abbott Laboratories USA
Bridging the Gap between API, Formulation & Device
- Exploring the tools needed in taking complex formulations through development
- Promoting early but long-term thinking to avoid escalated and unseen challenges
- Understanding that a key tool is sharing industry knowledge - Learning from others' mistakes and thus avoiding interruptions
- Accelerating mechanical, solubility & analytical models
- Exploring multiple sources in establishing what methodologies should be used for what delivery systems
Biological Characterization
Exploring Key Aspects and Potential Pitfalls in Future Vaccine Development
- Establishing more in-depth characterization tools for multi-component protein-based vaccines
- Understanding to what extent a vaccine can be characterized
- What is the demand for characterization, in each product case?
- Selecting which product features should be evaluated and characterized
- Characterization in deepening our understanding of antigen starters
- Evaluating expected results using varying techniques
Implementing Stage Gate as a Transitional Instrument for Effective NDA Product Development
“Climbing a Higher Mountain”
- USL history and transition to Rx pharmaceutical development
- Organizational culture and barriers to change
- Stage Gate assessment, optimization and findings
- Implementation process – structure and governance
- Team responses and Organizational struggles
- Outcomes: present and future state
Empowering your Laboratories for Sustained Growth
- How can new technologies be utilized to meet increased demand by customers?
- Developing a growth strategy for your laboratories based upon increased efficiencies
- Maintaining consistent and compliant workflows whilst expanding capacity
Emulsion Technology for Micro Encapsulation (ET4ME)
- Innovative technology platform for controlled particle engineering
- Product differentiation by applying uniform and reproducible PLGA microsphere formulations for sustained release of APIs
- Non-invasive therapeutic and preventive vaccination by chitosan mucosal delivery systems
Innovative Tamper Resistant Formulation (TRF) Technology
Protecting intended drug action
- An update on the pandemic problem of prescription drug abuse in the US
- How are opioid prescription drugs abused?
- Best practices in overcoming hurdles of abuse
- INTACTM - Innovative Tamper Resistant Formulation (TRF) technology – Protecting intended drug action
Delivery Platforms for siRNA Therapeutics
Challenges and Opportunities
- What are the available siRNA delivery platforms and how can they be best applied?
- Evolutions in lipid nanoparticles and their implications on targeted delivery
- Incorporating polymer technologies into existing delivery platforms - Forecasts & challenges
James Cunningham
Associate Director, Product Value Enhancement, Pharmaceutical Sciences
Merck & Co USA
Evaluating Winning Technologies for Biological Drug Delivery
Analysing & sourcing technologies to suit the target & therapy indication of the molecule portfolio
- Gathering & analysing molecule data in early and/or late phase development
- Distinguishing strategies for molecules in early phase development vs. late
- Determining whether the technology can be standard or whether more advanced systems need to be utilized
- Sourcing compatible technologies and conducting feasibility studies on the system & company
- Working with your partners to evaluate proof of concept & whether their technology is suitable
Utilizing Modelling & Simulations to Predict Formulation Dependent PK/PD
PK/PD Models to Predict Clinical Outcomes in Development
- Relevant in vitro, in vivo & in silico data to predict formulation performance for all BCS, BDDCS Classes
- Translation of preclinical data to accurately predict clinical outcome
- Predicting the impact of formulation changes on clinical food effects and PK/PD for FIH and beyond
- Case study I: Applying models to small molecule development
- Case study II: Extrapolating these models to suit large molecule development
Providing a structured framework for the development of high quality formulations
- Winning strategies in QbD implementation
- Defining an appropriate Quality Target Product Profile (QTPP)
- Assessing the risks related to product development
- Establishing a design space
- Finalizing a control strategy
Steven Laurenz
Director, Formulation Development & Quality Strategic Planning
Abbott Laboratories USA
Quality by Design: A Wasted Investment?
- What are the best strategies for implementing a QbD approach for drug substance and product development?
- If a formal process exists for QbD implementation, what part of the organization should manage and enforce it?
- What value can be gained by taking a QbD approach?
- Does QbD mean safer & cheaper drugs coming to market more rapidly?
- What has been the impact of QbD strategies on global filings?
- Will QbD enable a fully computational product design (similar to defence and aerospace industries)?
Steven Laurenz
Director, Formulation Development & Quality Strategic Planning
Abbott Laboratories USA
Sponsored by Ligand Pharmaceuticals
Program - Day Two1st May 2012
Taking appropriate countermeasures to sustain the R&D model
- Deploying effective strategies to overcome the patent cliff & maintain competitive edge over generics
- Realising the current reimbursement & attrition landscape and the potential model forecasts
- Exploring relevant countermeasures – Best practices and challenges in deployment & maintenance
- Examples of chosen strategies in the industry – open innovation, new business models, translational & personalised medicines & collaborations
Adopting a more transparent attitude to the development arena
- Looking to the future - What direction is the development industry expected to move in?
- Sourcing distinctive technologies to suit the evolving development & drug targeting space
- Enhancing the level of transparency utilized when sourcing delivery partners - Sharing total product knowledge to promote successful, shared development
- Sourcing external innovation from non-pharma industries
- Boosting creativity in the development space
- Breaking down silos to create brainstorming teams & encourage outside thinking
A. Lee Shorter, PhD
Director, Disruptive Technology Seekers, Platform Technologies and Science
GSK USA
Delivering Drugs in the Upper GI tract for Enhanced and Sustained Systemic Availability
The rationale and concept of delivering drugs in the upper GIT
- GR formulation - Choice of a drug candidate
- Approaches to increase the retention of peroral dosage forms in the stomach
- Strategies to delay gastric emptying – including attempts to change the motility pattern of stomach
- PK characterization of a GR formulation – what to expect; Any surprises?
- In vitro and in vivo evaluation of a GR formulation
- Patient compliance and challenges in clinical practice
Vaccine Formulation Development
Discussing challenges to successful vaccine development and the approaches taken in overcoming them
- Exploring the challenges & benefits to different vaccine types - Subunit, live-attenuated & VLPs
- Approaches in overcoming formulation instability issues of these vaccine types
- What are the requirements of sensitive assays vs. MAb protein formulations?
- What are the true capabilities of solid dosage forms? - Freeze & spray-drying
- Emphasising the benefits of solid dosage forms vs more-traditional aqueous forms
- Adopting developments in ajuvanted vaccine formulations
Balancing Device Technology Enhancement with Patient Usability & Drug Product Limitations
- Collating data of patient needs and generating a subsequent development strategy
- Optimising product usability utilizing efficient and effective engineering and testing
- Designing ergonomic & usable products using patient-centered design strategies
Transforming the Early Development Process
Integrating Pharmaceutical Sciences and Clinical Testing
- Limitations of the conventional formulation development paradigm – what needs to change and why?
- Translational Pharmaceutics™ - what does it mean and what are the benefits?
- Novel CMC and regulatory strategies to enhance flexibility and precision in developing clinical formulation prototypes
- Rapid make-test cycle times to accelerate formulation and clinical development
- Using formulation design space concepts within Phase I / PK protocols
- Case studies demonstrating selection and real-time optimization of formulation compositions based on human clinical data
Managing Disruptive Technologies in the Pharmaceutical Industry
The example of Mesoporous Silica
- Increasing the pipeline of lead candidates
- Expanding revenue life cycle throughout product development
- Bioequivalence and the case for protection against generic manufacturers through new technology platforms
Simplifying Inhaled Drug Delivery, Formulation and Device in the Treatment of Acute Pain
- Providing ultra-rapid drug delivery using technosphere dry powder formulations
- Powder inhalation with small, breath-powered inhalers using pre-metered, single use cartridges
- Exemplifying inhalation technology using several drugs with a focus on peptides for the treatment of pain
Overcoming Aggregation Aggravation and other Obstacles to Effective Therapeutics
- Exploring how peptides of only 5 – 8 amino acids can have sub picomolar high receptor affinity
- Obtaining complete resistance to proteases for oral activity and good pharmacodynamics without losing potency
- Solving aggregation issues for long term storage of intranasal formulations
Applying Drug Delivery Principles to Existing Medical Devices
Overcoming common challenges in the development of drug-eluting devices
- Overcoming common challenges in the development of drug-eluting devices
- Analyzing primary mode of action of combination products using drug delivery principles
- Identifying common bottlenecks and discussing real life challenges in the development of drug-eluting devices
- Recommending mitigation approaches to address interdisciplinary challenges
Led by Ligand Pharmaceuticals
Captisol Quality & Supply Chain Management Enhancements
Led by Waters Corporation
Greening by Design
Laboratory testing is by definition the most anti-Green portion of business. Green is a secondary color and is opposite of Red, a primary color.
So where does it really fit in the business model?
Led by Freeslate Inc.
Supporting QbD Initiatives
Technologies to streamline range-finding & robustness studies for drug substance & product development
Led by ReSearch Pharmaceutical Services (RPS)
Leveraging ICH and Quality by Design for Genotoxic Impurity Control
Approaching a Real Time Release Product
Dean Ellison, PhD
VP, Analytical & Product Development Services
ReSearch Pharmaceutical Services USA
Led by Pharmatek
Is there such a thing as QbD P1 CTM?
Ensuring Quality at each phase of GMP Manufacturing
Led by Catalent Pharma Solutions
Enhancing Oral Bioavailability: Recent Advances for Overcoming the Challenge
Successfully Developing and Commercializing Combination Products
- Patient-centric device design – Evaluating patient requirements, ease-of-use and aesthetics
- To what extent does clinical testing of combination products need to be carried out?
- What device –related factors affect the outcome of clinical tests?
- Sourcing devices for combination product development
- Looking to the future – What are the market & technology trends & forecasts for the next 5 years?
Mapping U.S.-Based Regional CRO Clusters
- Exploring trends affecting pharmaceutical outsourcing practices - what do they mean for the industry?
- Understanding the size and growth of contract clinical development
- Assessing the adoption of more integrated sponsor-CRO relationship
- Outlining sponsor outsourcing practices and requirements
- Why do we need to map the contract services market?
Novel Concepts in Pharmaceutical Analysis in Supporting Formulation
- Moving away from the model of design space development for specific formulations
- Presenting analytical method validation data covering formulation extremes, & thus any formulation structure, to the regulator
- Applying Qb8 principles to method validation to reduce cost & time wastage
- Ensuring all applications are well-defined to reduce late-stage hurdles
- Where is innovation coming from these days and how has the 'R & D Paradigm' shifted in recent years?
- What sort of culture has your company created (if any) to support innovation? Has it been successful?
- Maximizing the ability to develop innovative new products using user-focused vision setting and design in facilities and processes
- Ensuring all groups of experts get the opportunity for input, including those who are frequently overlooked or downplayed
- What innovative methods, systems or processes have you tried/participated in to ensure on-time completion?
- Are CROs and companies from emerging markets offering better 'costs' to discover a new molecule and bring it up to a Proof of Concept' (POC) stages? Is Licensing Post POC compounds the best option for 'Big Pharmas'?
Jerry Parker
Former Associate Director, Global Pharmaceutical and Analytical Sciences (Retired)
Abbott Laboratories USA
- How is the development landscape changing in the 2010’s? - R&D attrition & patent expirations, Pharma investment pre-POC vs venture capital, business development and alliances, precision medicines, emerging markets etc.
- A retrospective look on what we have seen over the past 5 years
- Moving forward, how is the landscape evolving and what should we as an industry expect?
- What implications will these changes have in the drug delivery and development arena?
For more information concerning the facility tour please ask one of the WTG staff members onsite or speak directly to a Pharmatek representative
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