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January 26-28, 2015 | Hilton Boston Logan Airport | Boston, MA
ALL-NEW CASE STUDIES:
TO REGISTER/ Call 866-207-6528 or visit www.exlpharma.com/bioavailability
FOUR IN-DEPTH PROGRAM TRACKS FOCUSING ON THE NEWEST BIOAVAILABILITY ENHANCEMENT TECHNIQUES:
• Modeling & Simulation for Enabled Formulations
• Managing Formulation Evolution Throughout Drug Life Cycles
• Team Leadership Styles for Advanced Formulation Development
• Rethinking Early-Stage Formulation Methods
Michael Ausborn Site Head, Pharma Research & Early Development F. HOFFMAN – LA ROCHE
• Agnostic modalities in future drug development
• Action plans to proceed without real human data
• Solid-state chemistry as the next focal point for drug design
• Latest challenges in simulating supersaturation
• Adjust to the shorter developmental timelines of fixed-dose
combinations
• Optimal screening approaches for cocrystals
• Identify and address pH-dependent absorption
• Risk protocols for photoreactivity and phototoxicity
• Transition your teams from small to large molecule work
• Device-based oral biologic delivery
DRUG FORMULATION
& BIOAVAILABILITY
4th
Mehran Yazdanian Director, Global R&D, Branded Products TEVA
Keith Horspool VP, Pharmaceutical Development BOEHRINGER-INGELHEIM
Evan Thackaberry Therapeutic Area Leader, Safety Assessment GENENTECH
Sponsors/
Distinguished Speaker Faculty Includes:
Breakthrough Techniques in Optimizing the Screening, Delivery, Solubility, and Stability of Drugs and Biologics to Enhance Product Life Cycles
TWO EXTENSIVE INTERACTIVE WORKSHOPS SETTING
BEST PRACTICE FOR YOUR GREATEST CHALLENGES:
• The Industry’s Technical and Regulatory Path Forward for Pediatric Formulations
• Selecting Methodologies, Priorities, and Risks in Salt and Polymorph Screening
Riccardo Panicucci Global Head, Chemical & Pharma Profiling NOVARTIS
Liping Zhou Senior Scientist, CMC & Engineering IPSEN
“An excellent event with very focused views of new technologies.” — Senior CMC Team Leader, ALCON
HOTEL INFORMATIONHilton Boston Logan Airport One Hotel DriveBoston, MA 02128
To make reservations, please call 1-800-445-8667 and request the negotiated rate for ExL’s 4th Drug Formulation & Bioavailability Conference. You may also make reservations using the following weblink: http://www.hilton.com/en/hi/groups/personalized/B/BOSLHHH-EXL-20150125/index.jhtml. The group rates are available until January 5, 2015.
DEAR COLLEAGUE, The biopharma industry, facing unprecedented regulatory and patent-life pressure, is
leaning harder than ever on its formulation teams in order to accelerate time-to-market,
expand product life cycles, and maximize revenue. Longstanding challenges to drug
solubility are still causing development slowdowns, with 90% of APIs and 40% of drugs
at market believed to be poorly-soluble. Only by employing the most innovative new
formulation and delivery technologies, and accurately matching each type of molecule
to its optimal design and delivery method, can you make significant progress against this
challenge.
And amidst these ever-present problems, you are now facing new regulatory hurdles,
particularly regarding FDA’s position on the development of pediatric formulations for all
new drug candidates.
That is why you cannot afford to miss ExL Pharma’s 4th Drug Formulation &
Bioavailability conference. Built specifically around feedback from YOU – our audience
– the 2015 conference features an all-new program that targets your greatest and most
immediate formulation, solubility, permeability, and bioavailability challenges.
Across 3 full days, and featuring more than 6 hours of unparalleled networking, 4 unique
program tracks, 2 in-depth interactive workshops, and over 200 of the industry’s most
distinguished drug formulation, preformulation, and delivery experts, your attendance
will prepare you to:
9 Develop action plans when real human data is lacking
9 Explore the potential for solid-state chemistry as the next breakthrough in drug
design
9 Select the optimal technologies for advancing drug candidates and maintaining a
robust pipeline
9 Transition your formulators from small-molecule work to peptides and biologics
9 Improve your modeling & simulation tactics for enabled formulations
9 Successfully redesign previously-unworkable drugs on a molecular level
9 Set priorities and risks in salt and polymorph screening
9 Adapt to new scientific and regulatory challenges in the development of pediatric
formulations
I look forward to welcoming you to Boston alongside the leaders of the biopharma
industry so we can set next practice together!
Sincerely,
Matt GreenbaumMatt Greenbaum
Senior Conference Producer
ExL Pharma
WHO SHOULD ATTEND: Pharmaceutical and biotech executives responsible for:
9 Pharmaceutical development
9 Preclinical development
9 Formulation
9 Preformulation
9Medicinal / Analytical / Solid-State Chemistry
9 Physicochemistry
9 Pharmaceutics
9 Pharmacokinetics / DMPK
9Drug Delivery
9Drug Discovery
9Material Science
9 Life-Cycle / Portfolio Management
9 Toxicology
9Chemical Engineering
9 Process R&D
THIS PROGRAM WOULD ALSO BE OF INTEREST TO:
9 Solubility / Formulation Characterization service providers
9Drug Delivery specialists
9API manufacturers / providers
9CROs
9CMOs
SPONSORSHIP & EXHIBITING OPPORTUNITIESDo you want to spread the word about your organization’s solutions and services to potential clients who will be attending this event? Take advantage of the opportunity to exhibit, underwrite an educational session, host a networking event, or distribute promotional items to attendees. ExL Pharma will work closely with you to customize a package that will suit all of your needs.
To learn more about these opportunities, please contact: Jeffrey Friedman Business Development Manager, 917-258-5163, [email protected]
WELCOME TO BIO EAST!
“Very good examples provided. Great explanations to questions raised!”
– Associate Director, Pharmaceutical Sciences, TAKEDA
PRE-CONFERENCE WORKSHOP DAY – MONDAY, JANUARY 26TH, 2015
8:30 Registration and Continental Breakfast for Morning Workshop Participants
9:00 MORNING WORKSHOP:
The Industry’s Technical and Regulatory Path Forward for Pediatric Formulations g Overview of FDA preferences for the developmental timeline of pediatric versions of all new drugs and the need for greater regulatory clarity g Brainstorm the development of more discriminating methods than the hundred-person profile g Isolate the formulations, ingredients, excipients, and sugars linked to pediatric products that represent the greatest analytical challenge g Understand acceptable levels of degradation of pediatric products g Extrapolation from adult products to pediatrics – when does it work and when doesn’t it? g Determine the best data submission packages for your PIP and pediatric strategy to different regulatory agencies g Reorient your development cycle around these additional formulation needs
Manuel Sanchez-Felix, Senior Fellow, Formulation, NOVARTIS
Elizabeth Galella, Research Scientist, BRISTOL-MYERS SQUIBB
Madhavi Srikoti, Research Scientist, BRISTOL-MYERS SQUIBB
12:00 Luncheon for AM Workshop Participants; Registration for Afternoon Workshop
1:00 AFTERNOON WORKSHOP:
Selecting Methodologies, Priorities, and Risks in Salt and Polymorph Screening g Target the screening techniques that give you the highest confidence in form stability and solubility g Employ different crystallization methods to give the clearest understanding of the compound’s purity profile g Understand the full scope of relationships between crystallization and screening methods – pros and cons of each g Maximize form stability during scale-up through exploring different solvents, ratios, and procedures g Ensure you maintain the same API ratio in cocrystals during production scale-up – compare and contrast different methods g Instill new habits of mind for cocrystal screening based on understanding our system, the importance of proper crystallization,
and avoiding impractical techniques i.e. Grinding, melting g Set best practice on screening and bioavailability testing based on your company’s acceptability criteria g Measure amorphous content and particle size during and after scale-up of salts to test characterization and solubility g Differentiate between essential elements of molecular and formulation screening g Determine the ideal material for further stability and solubility steps based on the amount of crystal in your sample g Focus patenting strategy on platform technology in cases where you are partnering with other companies on co-developed molecules g Predetermine cases where the formulation is so instrumental to function that you must patent both molecule and formulation
Marianne Langston, Senior Scientist, Chemical Development, TAKEDA
Brian Chekal, Senior Principal Scientist, Crystallization Process Development, PFIZER
4:00 End of Workshop Day
TO REGISTER/ Call 866-207-6528 or visit www.exlpharma.com/bioavailability
“Informative and thought-provoking. Great panel discussions!”
– President, AMYLYX PHARMACEUTICALS
“A very well-organized event!”
– Scientist, DMPK, LEXICON PHARMACEUTICALS
WORKSHOP DAY CHAIRPERSON: Keith Horspool, VP, Pharmaceutical Development, BOEHRINGER-INGELHEIM
7:45 Registration Opens & Continental Breakfast
8:45 Chairperson’s Day One Welcome and Opening Remarks
9:00 KEYNOTE: Future Trends in Drug Formulation: Agnostic Modality
g Consider a broader focus beyond pill formulations g Expand delivery tools in early discovery to design molecules for various
administration routes g Brainstorm minimally-invasive delivery of poorly permeable drugs g Design delivery systems to support better patient adherence
Robert Saklatvala, Director, Basic Pharmaceutical Sciences, MERCK
9:45 KEYNOTE: An Action Plan for the Lack of Real Human Data
g Gain insight into formulation methods through awareness of failures as much as successes
g Grasp the significance of the knowledge gap between preclinical and clinical AUC and CMAX data
g Reorient knowledge-sharing towards the correlation of specific methodologies with human outcomes
g Examine the threats to formulation timelines and budgets when different suppliers of the same API yield slightly different purity profiles, processing, performance, and bioequivalence result
DONGMEI QIANG, Senior Principal Scientist; Manager, External Collaborations, BOEHRINGER-INGELHEIM
10:30 KEYNOTE: Selecting Technologies that Overcome Solubility Challenges and Advance Drug Delivery and Pipeline Robustness
Michael Ausborn, Site Head, Pharma Research & Early Development, Basel, F. HOFFMAN-LA ROCHE
11:15 Networking & Refreshment Break
11:45 PANEL: “Think Outside the Tablet”: Examine and Explain the Slowdown in New Formulation Approaches
g Understand the limiting scientific explanations behind why no novel widespread formulation approaches have been adopted since solid dispersion technology
g Identify what the industry is missing through an excessive focus on oral administration
g Examine the prospects for achievable new drug targeting and device techniques for parenteral delivery that would not require new formulations
Moderator: Mehran Yazdanian, Director, Global R&D, Branded Products, TEVA SPEAKER TO BE DETERMINED, ABBVIE
12:45 Luncheon
MAIN CONFERENCE, DAY ONE – TUESDAY, JANUARY 27TH, 2015
TRACK A Modeling & Simulation for Enabled Formulations
TRACK B Managing Formulation Evolution Throughout Drug Life Cycles
1:45 Nanoformulations to Enhance Bioavailability of APIs
Suresh Bandari, Principal, ST. PETER’S INSTITUTE FOR PHARMACEUTICAL SCIENCES
Utilization of Formulation Design Space to Accelerate Early Clinical Development of Drug Products
g How the inclusion of formulation design space within clinical programs gives real-time flexibility in dose and composition of drug products
g Benefits and applications across the development life cycle including first-in-human studies and optimization of drug product formulations
g Case studies: overcoming solubility challenges for BCS II compounds, optimizing MR formulations, performing early assessments of IVIVCs and developing non-oral dosage forms
Peter Scholes, CSO, QUOTIENT CLINICAL
2:30 Nanonization of API to Enhance Solubility g Exploring opportunities, challenges, and applications of poorly-soluble drugs and
NCEs g Using top-down methods for particle size reduction to enhance solubility g Examining the process parameters and fundamental limits of using bead mills for
particle reduction g Selecting the correct machine design and materials for specific applications g Overview of the clinical benefits and commercialized drugs utilizing nanotechnology
David Watkins, Application Manager, Pharmaceuticals, NETZSCH
Formulation Bridging and Relative Bioavailability Risk Assessment Throughout Development
g Regulatory requirements and expectations for bioavailability assessment at multiple development stages
g ”Biowaivers” for changes to drug product g Risk-based approach to relative bioavailability decisions g Examples of risk assessment outcomes
David Sperry, Research Advisor, Small Molecule Design & Development, ELI LILLY
TO REGISTER/ Call 866-207-6528 or visit www.exlpharma.com/bioavailability
MAIN CONFERENCE, DAY ONE – TUESDAY, JANUARY 27TH, 2015
3:15 Latest Challenges in Simulating Supersaturation g Overview of the enhancements made to enable supersaturated formulations g Select the best methods for predicting how long supersaturated conditions will be
sustained g Estimate how much supersaturation impacts overall formulation performance g Design in-vitro models best capable of predicting and assessing supersaturations
Chris Towler, Principal Scientist, NOVARTIS
Novel Automated Analysis Methods for Biorelevant Dissolution
g In vitro methods show how APIs and formulations behave in presence of simulated gastric and intestinal pH and biorelevant media (FaSSIF and FeSSIF); the quest for IVIVC
g In vivo predictive dissolution methodology; biphasic dissolution to model GI dissolution and absorption
g Monitoring precipitation from supersaturated solutions and studying the effect of precipitation inhibitors
John Comer, CSO, SIRIUS ANALYTICAL
4:00 Networking & Refreshment Break
4:30 Dosing and Dispersability Studies to Model Supersaturation g Look into excipient options that would allow you to predict or maintain
supersaturation and prevent rapid precipitation g Identify the trends in compound crystalline structure most associated with rapid
nucleus formation, alignment, and precipitation g Properly dose your amorphous solid dispersions for animal studies g Gauge the likelihood of maintaining an amorphous state while in oversaturated
solution
Mengwei Hu, Development Fellow, Basic Pharmaceutical Sciences, MERCK
CASE STUDY: Addressing pH-Dependent Absorption
Michael Perlman, Senior Scientist II, Pharmaceutical Profiling, MILLENNIUM PHARMACEUTICALS
5:15 Avoid Underpredicting Exposures through Better Modeling of Enabled Formulations
Manuel Sanchez-Felix, Senior Fellow, Formulation, NOVARTIS
Stepwise Approach to Preformulation and Formulation Development to Maximize Success
Paul Sabo, Senior Technician, PDS Formulation Development, PATHEON
6:00 End of Day One
TO REGISTER/ Call 866-207-6528 or visit www.exlpharma.com/bioavailabilityTO REGISTER/ Call 866-207-6528 or visit www.exlpharma.com/bioavailability
“Very well-organized with great
content. This event will be a great
reference for the future!”
– Scientist, Pharmaceutics, PHARMATEK LABORATORIES
“Fascinating mix of industry researchers and technologies.”
– Director of Pharmacy Nanotechnology, CONCORDIA UNIVERSITY OF WISCONSIN SCHOOL OF PHARMACY
”Great presentations - clear and knowledgeable.”
– VP, Product Development R&D, CORERX
11:00 KEYNOTE: Oral Delivery for Biologics: Formulations and Device-Based Strategies
g Though IV delivery of standard biologics gives 100% bioavailability, oral formulations can sometimes deliver better results or an improved clearance rate
g Survey the different approaches industry is taking towards oral biologic formulations, through new technical tools and cross-company partnerships
g Identify why some oral formulations fail and carry those lessons forward into the next generation of biologics
g Transcend standard formulation challenges through device-based consumable oral delivery methods
Riccardo Panicucci, Global Head of Chemical & Pharmaceutical Profiling, NOVARTIS
11:45 In Situ Concentration Monitoring as a Measurement Tool within In Vivo Predictive Dissolution Systems
g Recognize the greater need for analyzing realtime free drug concentration g Identify the challenges to in-situ monitoring presented by bio-relevant
simulated fluids and complex foods containing dissolution media g Deploy in-situ measurement tools to reduce mechanical complexity of
pumping-based sampling systems and provide a very high density of realtime concentration data
g Gain insight into drug and formulation behavior via combining the dual-chamber dissolution-permeability setup with the ability to monitor concentration in both compartments
Konstantin Tsinman, Director, Science & Research, PION
12:30 Luncheon
1:30 Crystallization Screening Options: A New Approach to Cocrystals
g Develop new methods for studying polar interactions that do not focus on stacking efforts
g Explore the likelihood of prior cocrystal failures due to compounds “hiding” the part of the molecule that would tend to associate with water and impact solubility
g Assess the benefit of matching polar moieties with less hydrophilic portions of cocrystals
John Morrison, Senior Research Investigator, Discovery Pharmaceutics, BRISTOL-MYERS SQUIBB
2:15 WRAP-UP PLENARY DISCUSSION: Enable Breakthroughs in Manufacturing and Drug Design through Rational Formulations
g Improve understanding of why certain technologies make formulations more effective
g Recognize the limits of empirical approaches and substitute rational formulation methods when determining the feasibility of new technologies
g Build an understanding of molecular features and molar design into formulations in a manner that empirical techniques cannot equal
3:00 Conference Concludes
8:30 Continental Breakfast
TRACK A Team Leadership Styles for Advanced
Formulation Development
TRACK B Rethinking Early-Stage Formulation Methods
9:00 Instill Team-Based Support for Development of Novel Fixed-Dose Combinations
g Establish stability of merging multiple APIs into a triple-combination tablet g Engineer entirely new developmental methods appropriate for the challenges of
multiple degradants and impurities g Streamline formulation methods along the shorter developmental timeline typical for
fixed-dose combinations
Elizabeth Galella, Research Scientist, BRISTOL-MYERS SQUIBB
Solid-State Chemistry: The Next Focal Point for Drug Design g Grasp the scope of change in the industry’s molecular portfolio that has allowed
some companies to bypass solubility issues altogether g Target your preformulation approaches and particle engineering to yield physical
forms that will never need to change dosage form designs g Focus on solid-state chemistry as the key step in formulation development for a
new generation of drugs
Weili Yu, Senior Principal Scientist, PFIZER
9:45 Transition your Formulators from Small-Molecules to Peptides and Biologics
g Make industry progress towards larger-molecule formulations when companies are not hiring new specialized staff for this purpose
g Clarify how peptide and biologic specifications are set and formulations are implemented with teams more accustomed to working with small molecules
g Build off foundational analytical / bioanalytical skills to enable quicker transitions into peptide and biologics work
Liping Zhou, Senior Scientist, CMC & Engineering, IPSEN
A Strategic Approach to the Regulatory Challenges of Phototoxicity Assessment
g Track the history of photoreactive compounds and their impact on both solubility and patient phototoxicity
g Understand the recent ICH regulatory guidelines and interpret the most likely next steps from FDA and EMEA
g Design protocols and evaluate methods for photoreactivity and phototoxicity risk assessment
Evan Thackaberry, Therapeutic Area Leader, Safety Assessment, GENENTECH
10:30 Networking & Refreshment Break
PLENARY SESSION
TO REGISTER/ Call 866-207-6528 or visit www.exlpharma.com/bioavailability
MAIN CONFERENCE, DAY TWO – WEDNESDAY, JANUARY 28TH, 2015
