1. AAPS 2015 Annual Meeting Program Planning Jamboree July 27-29, 2014 Jasmine Musakhanian (Chair-Elect Lipid-Based Drug Delivery Focus Group) & Joe Reo (Vice-Chair, FDD Section)

2. Objectives of the meeting  Program planning for 2015 AAPS Annual Meeting  Mine ideas from all Sections and Focus Groups  Bundle into main programming themes  Collaborate to maximize programming “freshness”  Network with key counterparts for future discussions and combined programming

3. Jamboree Meeting  ~ 70 attendees : 9 Sections / 44 Focus Groups  30 of whom work on NBC programming  Competition for Open and Allocated Programming slots very high ! FDD section alone has 10 focus groups  Start with ~ 335 programming ideas reduce to 45 (5 themes/programming ideas from each of 9 Sections)

4. Meeting Flow Advocate/Refine Ideas  Day 1 : FDD Leads met with Affiliated FG Leads; Sections and FGs intermingle for idea refinement  Round I: Each FG presents 5 min. - top “three” ideas to the FDD Leads  Round II: Each FG selects “one” idea to advocate to 2 or 3 other sections to obtain their support as an Open Slot idea, refine ideas/themes to broaden support, enrich the idea  Day 2 : Repeat of Day 1,  Round III: Continuation of Round II, complete the advocacy process for remainder of the Sections  Re-group of FDD Section with Affiliated FGs: Pare down to 5 ideas or themes for FDD (same process for all Sections)

5. FDD Programming Themes

6. ThemeMajor ElementsProgram TypeSupporting Sections and FGs Biopharmaceutical Parenteral /inhalation Excipients Stability Enablement QbD Risk Function Characterization Regulatory acceptability Toxicity for pediatrics Short CourseBIOTEC PPB, APQ, ExFG, LBDDFG PABCFG SPFG SFG Can’t Have a Product without a Package – Unique Challenges Global needs Regulatory aspects Animal special needs Consumer Protection Utility Unique formulation need Glass lamination Extractable/Leachable Symposium or Short Course/Worksh op PPB APQ RS PCPMFG PFG, Nutraceutical FG

7. ThemeMajor ElementsProgram TypeSupporting Sections and FGs Clinically Relevant Specifications – Where are we today? Across DFs Across small molecule, proteins, peptides, macromolecules Roundtable and Workshop RS, APQ, CPTR Modified Release of biologics Ocular/parenteral/oral/skin Stimuli responsive technologies Modeling/Simulation Multiple Sessions APQ, MSE, RS, BIOTEC, Chemistry, Biology, Engineering as applied to formulation design and development Imaging (nanoparticles) Pro-drugs/”soft drugs” Particle engineering for solid oral DFs Risk assessment of drug delivery systems malfunction Ex Vivo/3D cell cultures Lipophilicy, too much or not enough? Drug Candidate Selection. Multiple Sessions PPB, BIOTEC, PPDM, APQ

8. Other Sections: MSE, BIOTEC, PPB, DDDI, APQ, PPDM

9. MSE Section key topics  Manufacturing Challenges and Strategies for Microbial Based Platforms- "Medium Molecules".  Small scale drug product methods to shorten timelines and reduce risk.  Manufacturing of Vaccines- a global and regulatory perspective  Return on Science on emerging technologies: 3-D printing/ Personalized Medicine  Supply chain management  Impact of Raw Material Variability and Process Capability Index on Bio-Process Control

10. Biotech Section key topics  Biotransformation of Biologics  Enabling technologies - toolbox;  Impact of drug delivery on bioavailability  Predictability of ex-vivo models, cross-species relevance  Biosimilars  Mechanistic Pharmacology

11. PPB Section Key Topics  Predicting the risk of Nanotech based drug delivery  Integrating tools / technologies  in-silico, invitro, and preclinical tools to predict performance of enabling technologies  Macromolecules…

12. DDDI Section Key Topics  Can BCS be budged? Small vs. large molecule; solid state; formulation effect  Roundtable by Drug Candidate Selection FG  Health Wave Meets Disease Tx,  Mini-Symposium  Retro-metabolic / “Soft Drug” Design  How to Discover your own Discovery Company?  Mini-Symposium or Roundtable or Plenary

13. APQ Section Key Topics  Stability of Global Medicines  USP / JP Harmonization  Cross linking of capsules  Surfactants?! in dissolution media  Personalized Medicine  Application of LC/MS/MS for protein therapeutics devel.  Clinically Relevant Specification

14. PPDM Section Key Topics  Reactive intermediates; drug metabolizing enzymes  3D models, novel tools in drug metabolism  Microdialysis as a tool for PK/PD  Intracellular Drug Exposure  Drug Trafficking / metabolism; mitochondrial / nuclear therapeutics  Non-traditional barriers  Lungs, eyes, heart, testes  Alternative medicines

15. Top 5 Ideas for Each Section: Details

16. Summary  Engage now  Vet your program: Gain feedback on your programming idea(s) Submit programming ideas to FDD-affiliated Focus Groups - FGs (see next page for list of the FGs – email the Chair or Chair-Elect, via AAPS website: https://www.aaps.org/FocusGroups/) https://www.aaps.org/FocusGroups/  OR: Submit programming ideas directly to the MIRA site, see attached link www.aaps.org/AMSubmit15 for details.www.aaps.org/AMSubmit15 DEADLINE: DEC. 12, 2014

17. FDD-Affiliated Focus Groups 1.Animal Pharmaceutics & Technology 2.Dermatopharmaceutics 3.Excipients 4.Inhalation & Nasal Technology 5.Lipid-Based Drug Delivery Systems 6.Modified Release 7.Ocular Drug Delivery & Disposition 8.Patient-Centric Drug Development, Product Design & Manufacturing 9.QbD & Product Performance 10.Sterile Products