Intro to AAPS for students, student chapters, prospect members Tuesday, October 6. 2015

Introduction Presenters: Rachel Saylor, DDDI Shraddha Thakkar, BIOTEC Manjeet Pimparade, FDD Yamini Gorantla, MSE Sophia Fong, PPB Nicole Zane, PPDM Anqi Wan, RS Shraddha Thakkar, BIOTEC Katie Maass, SPOD Vibhuti Agrakari, SPOD Paddy Eangoor, APQ Tanzir Mortuza, BIOTEC Amelia Deitchman, CPTR Johannes Kast, CPTR

AAPS Mission and Vision AAPS advances the capacity of pharmaceutical scientists to develop products and therapies that improve global health. Vision AAPS will advance the pharmaceutical sciences to drive prevention and cures. Core Values Learning Innovation Service Inclusiveness Integrity

AAPS Students and Postdoc Membership 1,825 Student Members 401 Postdoc Members

Over 100 AAPS Student Chapters across the world

Webinar Overview AAPS provides robust networking community and countless opportunities: AAPS Sections Focus Groups Education and Resources Student/Postdoc Outreach Committee Career Center AAPS members can choose from nine sections comprised of members who share interests in broad areas of the pharmaceutical sciences. Sections unite scientific disciplines into forums to share experiment results, explore, and disseminate research findings; exchange ideas; present scientific data; and examine regulatory and ethical concerns. This is your opportunity to interact with colleagues in the field who share your specific interests.

Introduction to AAPS Sections & Focus Groups

AAPS Sections Groups with interests in broad areas of pharmaceutical sciences. Responsibility for governance Broad in scientific scope, Share research Serve on AAPS committees Participate in meetings and workshops

Section Offerings for students AAPS Mentoring Travelships Awards Moderating Opportunities

AAPS Sections APQ —Analysis and Pharmaceutical Quality section BIOTEC — Biotechnology section   CPTR — Clinical Pharmacology and Translational Research section 

AAPS Sections DDDI — Drug Discovery and Development Interface section FDD — Formulation Design and Development section MSE — Manufacturing Science and Engineering section 

AAPS Sections PPB — Physical Pharmacy and Biopharmaceutics section PPDM — Pharmacokinetics, Pharmacodynamics, and Drug Metabolism section  RS — Regulatory Sciences section

AAPS Student Membership

AAPS Focus Group Within each section are multiple focus groups (FG) There are over 40 focus groups FG can be shared by multiple sections Collaboration opportunities Networking opportunities DDDI  Primary FG: Discovery Model & Simulation Other affiliated sections: PPDM, PPB

PRESENTER: Padmanabhan (paddy) Eangoor, Mercer University APQ PRESENTER: Padmanabhan (paddy) Eangoor, Mercer University

APQ—Analysis and Pharmaceutical Quality section Goals: Provide a forum for the exchange of information pertaining to analytical techniques, bioanalytical techniques, regulatory and compendial issues, and assurance of quality Leadership: Chair: Peter D. Bryan, Ph.D. Chair-elect: Dilip R. Choudhury, Ph.D. Vice-chair: Eliza Fung, Ph.D. Secretary/Treasurer: Mark E. Arnold, Ph.D. Past chair: Kenneth Jay Norris, M.S. Student representative: Paddy Eangoor (Mercer University) Paddy’s recent blog post: Turning Point of a Graduate Student Members: 2159 Student members: 208

APQ—Analysis and Pharmaceutical Quality section Primary focus groups Secondary focus groups Bioanalytical  Contract Research Organization (CRO)   In Vitro Release and Dissolution Testing  Non-clinical Dose Formulation and Analysis  Pharmaceutical Impurities  Stability  Chemical and Biological Active Pharmaceutical Ingredient Manufacturing Technology   Biosimilars  Chemistry, Manufacturing, and Controls (CMC)   CMC Statistics   Generic Pharmaceuticals   Ligand Binding Assay Bioanalytical   Microdialysis   Nutraceuticals and Natural Products   Process Analytical Technology 

APQ—Analysis and Pharmaceutical Quality section Opportunities: Mentoring program Student travelships to attend annual meeting Awards at the Annual meeting AAPS APQ Best Poster Award AAPS Graduate Student Research Awards in Analysis and Pharmaceutical Quality AAPS Outstanding Manuscript Award in Analysis and Pharmaceutical Quality APQ Research Achievement Award

APQ—Analysis and Pharmaceutical Quality section More opportunities Webinars and interviews with thought leaders of APQ section APQ newsletter: Volunteers can contribute AAPS APQ Education initiation award Planning for a robust APQ Student Section Committee Seeking volunteers to serve on the committee Volunteer opportunities in affiliated focus groups For more information about APQ section, please visit: https://www.aaps.org/APQ/

PRESENTER: Tanzir Mortuza, University of Georgia BIOTEC PRESENTER: Tanzir Mortuza, University of Georgia

BIOTEC—Biotechnology Section Vision: Unite multiple scientific disciplines in a forum where experimental results and experiences are shared and evolving concerns on the research, development, and manufacture of biotechnology based pharmaceuticals are discussed

BIOTEC—Biotechnology Section BIOTEC Leadership – Chair - Gopi Shankar, Ph.D., MBA Chair-elect - Meena Subramanyam, Ph.D. Vice Chair - Scott Fountain, Ph.D. Secretary/Treasurer - Boris Gorovits, Ph.D. Past Chair - Tapan K. Das, Ph.D.

BIOTEC—Biotechnology Section Current Student Committee (BSSC) Chair – Tanzir Mortuza (University of Georgia) Secretary – Katherine Hickey (West Virginia University) NBC Liaison – Fizal Nabbie (University of Science Philadelphia) Student Rep – Hardik Mody (Ohio State University)

BIOTEC—Biotechnology section Opportunities for students Mentor and Mentee opportunity 25 matches Matches were based on interests and geographical locations Student Rep opportunity For primary and secondary focus group Placed student rep for Ligand Binding Assay Bioanalytical FG (LBABFG) Student Professional Development Webinar – April 15th, 2015 The Do’s and Don’ts that Define Success for Academic Job Applications Speakers – Dr. Christopher McCurdy (University of Mississippi) & Dr. Brian Cummings (University of Georgia)

BIOTEC—Biotechnology section More Opportunities Awards and Travelships – Travelships up to $750 (graduate/undergraduate students, postdocs eligible) AAPS Graduate Student Research - Award in Biotechnology sponsored by Janssen Newsletter/ Blog contribution BIOTEC Section Townhall Meeting and Reception at 2015 Annual Meeting Monday, October 26 5:00 PM–7:30 PM Hyatt Regency Orlando - Florida B

BIOTEC—Biotechnology section Future Goals: 1 more Webinar before end of the year 2 Student Development Webinars for year 2015- 2016 Increase student participation in BIOTEC 25 Co-moderator placement at Annual Meeting Initiate mentor-mentee interactions

BIOTEC—Biotechnology section Primary Focus Groups Biosimilars Ligand Binding Assay Bioanalytical Protein Aggregation and Biological Consequences Therapeutic Product Immunogenicity For more information about APQ section, please visit: http://www.aaps.org/BIOTEC/

Presenter: Amelia dEItchman & Johannes kast, University of Florida CPTR Presenter: Amelia dEItchman & Johannes kast, University of Florida

CPTR—Clinical Pharmacology and Translational Research section Vision “The AAPS CPTR section is dedicated to clinical and translational research and development of human pharmaceutical products, particularly related to issues of clinical pharmacology or applied pharmacotherapy (including adverse drug reactions and special populations), clinical pharmacokinetics and pharmacodynamics, clinical trial design and simulation, pharmacogenomics, and contract research of human pharmaceuticals. The scope of the CPTR section extends beyond the development of human pharmaceuticals into the postmarketing phase and ultimately the clinical performance of medicines administered to patients.”

CPTR—Clinical Pharmacology and Translational Research section Leadership Chair: Alexander Vinks, PharmD, PhD, FCP (Cincinnati's Children’s Hosipital) Chair-elect: Arnab Mukherjee, PhD (Pfizer) Vice Chair: Adel H. Karara, PhD, FCP (U Maryland Eastern Shore) Secretary/Treasurer: John D. Davis, PhD (Regeneron) Past Chair: Joan M. Korth-Bradley, PharmD, PhD (Pfizer) Student Representatives: Amelia Deitchman, PharmD (University of Florida) Johannes Kast, RPh (University of Florida)

CPTR—Clinical Pharmacology and Translational Research section Opportunities for Students Mentoring Program (mentors from across the pharmaceutical industry, regulatory, and academic settings) Student Travelships & Awards AAPS Graduate Student Research Awards in PPDM & CPTR (Sponsored by Eli Lilly)

CPTR—Clinical Pharmacology and Translational Research section Focus Groups Primary Biomarkers in Translational Medicine Pharmaceuticals in Global Health Pharmaco-imaging Pharmacogenomics (PGx) Pharmacometrics Systems Pharmacology Secondary Animal Pharmaceutics & Technology Drug Transport Microdialysis Protein Aggregation and Biological Consequences Therapeutic Product Immunogenicity For more information visit: http://www.aaps.org/CPTR/

Presenter: Brittany Duerk Spitznagel, Lipscomb University DDDI Presenter: Brittany Duerk Spitznagel, Lipscomb University

DDDI—Drug Discovery and Development Interface section Goal: DDDI focuses on issues at the critical interface between drug discovery and drug development and provides a collaborative forum for interactions among scientists from academia, industry and government institutions. Leadership: Chair: Susan L. Mercer, Ph.D. Chair-elect: Robin M. Zavod, Ph.D. Vice Chair: Caroline McGregor, PhD Secretary/Treasurer: David A. Colby, Pharm.D., Ph.D. Student Rep: Rachel Saylor (University of Kansas)

DDDI—Drug Discovery and Development Interface section Focus Groups Primary Secondary Discovery Modeling and Simulation  Drug Candidate Selection   Nutraceuticals & Natural Products  Drug Metabolism   Drug Transport   Nanotechnology   Oral Absorption   Pharmaco-imaging   Pharmacogenomics (PGx)   Targeted Drug Delivery and Prodrug 

DDDI—Drug Discovery and Development Interface section Opportunities for students DDDI Mentoring Program Awards/Travelships DDDI newsletter and eBlast Planning for a DDDI Student Section Committee Volunteer opportunities in affiliated focus groups For more information visit: http://www.aaps.org/DDDI/

Presenter: Manjeet Pimparade, University of Mississippi FDD Presenter: Manjeet Pimparade, University of Mississippi

FDD—Formulation Design and Development section Vision: The Formulation Design and Development section will be the premier worldwide forum for scientists dedicated to the design and development of all dosage forms for drugs, biologics, and combinations thereof as well as drug/biologic device combinations. Leadership Chair: Panayiotis P. Constantinides Chair-elect: Joseph P. Reo Vice-chair: Jeffrey Hemenway Secretary/Treasurer: Linda A. Felton Past-Chair: Michael A.Repka Student Representative: Manjeet B.Pimparade (Ole Miss)

FDD—Formulation Design and Development section Opportunities for students The FDD section benefits its members both personally and professionally through various activities. Awards/Fellows/Travelship Communication  Education Focus Groups Volunteer Opportunities

FDD—Formulation Design and Development section Focus Groups Primary Animal Pharmaceutics and Technology   Dermatopharmaceutics   Excipients     Inhalation and Nasal Technology   Lipid-Based Drug Delivery Systems   Modified Release   Ocular Drug Delivery & Disposition  Patient-Centric Drug Development, Product Design, and Manufacturing  QbD and Product Performance   Sterile Products  Secondary In Vitro Release and Dissolution Testing  Nanotechnology   Nutraceuticals and Natural Products   Preformulation   Process Development   Process Modeling and Simulation  Contract Research Organization (CRO) For more information visit: http://www.aaps.org/FDD/

Presenter: Yamini Gorantla, Mercer University MSE Presenter: Yamini Gorantla, Mercer University

MSE—Manufacturing Science and Engineering section Vision: The Manufacturing Science and Engineering section will be recognized globally as the premier organization of individuals dedicated to the advancement of science and engineering as applied to the design and manufacture of investigational and commercial pharmaceutical and pharmaceutically related products. Leadership: Chair : Vidya Swaminathan Chair-elect : Ruta Y. Waghmare Vice Chair : Sharmista Chatterjee Secretary/Treasurer: Claire Scanlan Past Chair: Tom Sam Student Representative: Yamini Gorantla (Mercer University)

MSE—Manufacturing Science and Engineering section Goals Provide a forum for open interchange and dissemination of scientific knowledge and technical advances related to manufacture of pharmaceutical and pharmaceutically related products. Provide timely programming, strong networking and membership interactions, recognition of scientific achievement, and vigorous inter- organizational collaboration. Foster graduate education, career growth, and professional development of the membership while promoting continued growth and implementation of science and technology as applied to manufacturing. Collaborate with other AAPS sections, focus groups, and other scientific organizations associated with the development, registration, control, production, and troubleshooting of pharmaceutical products. Recognize excellence and achievement of its members, encourage programming and publication of manufacturing-related scientific works by its members in AAPS-sponsored journals, and fosters graduate education and career growth and development of MSE members.

MSE—Manufacturing Science and Engineering section Focus Groups Primary Secondary Chemical and biological active pharmaceutical ingredient manufacturing technology Process Analytical Technology Process Development Process modeling and simulation Chemistry, Manufacturing and Controls(CMC) CMC Statistics Modified Release Patient-Centric Drug Development , Product Design, and Manufacturing Pharmaceutical Impurities QbD and Product Performance Sterile Products

MSE—Manufacturing Science and Engineering section Opportunities for students: 5 Travel ships 2 Graduate student research achievement awards Volunteer opportunities on various committees with in the section Mentoring program Ambassador Program MSE newsletter Networking Discussions in AAPS Blog and Linkedin (https://www.linkedin.com/groups/AAPS-Manufacturing-Science- Engineering-MSE-3910244/about) For more information visit: http://www.aaps.org/MSE/

Presenter: Sophia Fong, University of southern Denmark PPB Presenter: Sophia Fong, University of southern Denmark

PPB Section— Physical Pharmacy and Biopharmaceutics Vision: recognized as the premiere global organization for scientists involved in physicochemical and biopharmaceutic characterization and delivery of small molecules and biologics. Leadership: Chair: Weiguo Dai (J&J) Chair-Elect: Roy Haskell (BMS) Vice Chair: Allen Templeton (Merck) Secretary/Treasurer: Eric Munson (University of Kentucky) Past-Chair: Tycho Heimbach (Novartis) Student representative: Sophia Y.K. Fong (University of Southern Denmark)

Drug Substance/Formulation PPB Section— Physical Pharmacy and Biopharmaceutics a Multidisciplinary Science Material science (polymorphs, forms, salts), physical stability and chemical stability Drug Substance/Formulation Solubility, pKa, etc. amorphous/crystalline Nanotech Solubility ↑ Bile Salt ↑ In vivo solubility ↓ Precipitation Rate Dissolution Profile Biorelevant Solubility Precipitation Time GI physiology: ↑ Stomach pH ↑ Stomach emptying Time ↓ Intestinal pH ↑ GI blood flow PBPK models Fabs , F Disposition PK (CL, Vd) Caco-2 or MDCK Papp GI transporter Jmax, Km Effective Permeability In vitro-In vivo Scaling Permeability: Inhibition of Efflux or Uptake Transporters

PPB Section— Physical Pharmacy and Biopharmaceutics Focus Groups Nanotechnology   Oral Absorption   Preformulation  Targeted Drug Delivery and Prodrugs 

PPB Section— Physical Pharmacy and Biopharmaceutics As of July 2014

PPB Section— Physical Pharmacy and Biopharmaceutics Opportunities for students: Awards/Travelships PPB mentorship program Mentors from pharmaceutical industry, academia and regulatory bodies PPB newsletter and eBlast Student executive committee Welcome student volunteers to join! PPB Education Initiative Funding for student chapters to invite renowned PPB scientists for 1-2 days event International ($1,500), US ($1,000) PPB Ambassador Program encourage volunteers to visit local universities and utilize the presentation slide deck to introduce AAPS and PPB Section For more information visit: http://www.aaps.org/PPB/

Presenter: Nicole Zane, university of North Carolina PPDM Presenter: Nicole Zane, university of North Carolina

PPDM- Pharmacokinetics Pharmacodynamics Drug Metabolism Vision: Dedicated to discovery, development, and manufacturing of pharmaceutical products & therapies with focuses on the biopharmaceutics, pharmacokinetics, pharmacodynamics, metabolism, and transport of new and existing drugs. Leadership: Chair: Reina Bendayan Chair-Elect: Pankaj Desai Vice Chair: Maciej Zamek-Gliszcynski Secretary/Treasurer: Shannon Dallas Past- Chair: Douglas Sweet Student Representatives: Camille Alam (University of Toronto) Hari Ananthula (University of Cincinnati)

PPDM- Pharmacokinetics Pharmacodynamics Drug Metabolism Specific research interests: Transporters Enzyme-mediated metabolism Preclinical pharmacokinetics Microdialysis Translating preclinical to clinical In vitro-in vivo extrapolation Systems pharmacology

PPDM- Pharmacokinetics Pharmacodynamics Drug Metabolism Focus Groups Primary Drug Metabolism Drug Transport Microdialysis Cellular and Molecular Toxicology Secondary Animal Pharmaceutics and Techonology Bioanalytical Bioequivalence Biomarkers in Translation medicine Contract Research Organization (CRO) Dermatopharmaceutics   Discovery Modeling and Simulation  Drug Candidate Selection  Non-clinical Dose Formulation and Analysis   Ocular Drug Delivery & Disposition   Oral Absorption   Pharmaco-imaging  Pharmacometrics   Systems Pharmacology   Targeted Drug Delivery and Prodrug 

PPDM- Pharmacokinetics Pharmacodynamics Drug Metabolism Opportunities Moderator Program Students moderate workshops at the annul meeting and national biotechnology conference PPDM Education Initiative Funds student chapters to invite prominent PPDM scientists to travel to the chapter and teach about their research Newsletter Students encouraged to submit news and stories that are distributed bi-annually to all members For more information visit: http://www.aaps.org/PPDM/

Presenter: Anqi Wan, University of Arkansas for Medical Sciences

RS—Regulatory Sciences section Vision: To provide an international forum for advancing regulatory sciences by proactively fostering the development and realization of innovative, science-based regulatory solutions, which ensure the safety and efficacy of drugs, biologics, devices, and combination products. Leadership: Chair: Nagesh Bandi, Ph.D (Pfizer) Chair-Elect: Monica Le Whitmire, MS Vice Chair: Lynn C.Gold, Ph.D. Secretary/Treasurer: Edward A. Narke Past-Chair: Thirunellai G Venkateshwaran, Ph.D. Student representative: Anqi Wan (University of Arkansas for Medical Sciences)

RS—Regulatory Sciences section Defining features: Unique environment exhibiting characteristics similar to both academia and industry. Protect public health by ensuring the safety and efficacy of drugs. Provide public with accurate, science-based information on medications. Empowers individuals with outstanding opportunities to serve the public as members of a world-class, science- based Public Health Agency. Some defining features regarding regulatory sciences include:

RS—Regulatory Sciences section Focus Groups Bioequivalence Chemistry, Manufacturing and Controls (CMC) CMC statistics Generic Pharmaceuticals

RS—Regulatory Sciences section Opportunities for students: Awards/Travelships Networking opportunities Mentoring program Mentors from pharmaceutical industry, academia and regulatory bodies RS newsletter For more information visit: http://www.aaps.org/RS/

AAPS Student/Postdoc Outreach Development Committee (SPOD) Advocates and addresses issues of concern for students and postdoctoral fellows in the pharmaceutical and related sciences; Provides program funding Visiting Scientist Program Professional Development opportunities K – 12 STEAM outreach SPOD Student Representatives: Vibhuti Agrahari (UMKC) Katie Maass (MIT) For more information visit here. Addresses issues of concern of students and postdoctoral fellows in the pharmaceutical and related sciences; Sponsors broad-based industrial/academic programs of interest to students and post-doctoral fellows; Facilitates interaction between established pharmaceutical scientists and students and post-doctoral fellows in the pharmaceutical and related sciences through the Visiting Scientist Program and the Section Mentoring Programs; Creates professional development opportunities for students and post-doctoral fellows; and Educates and engages future generations of scientists in the pharmaceutical sciences through K–12 Outreach, such as annually supporting Intel ISEF.

AAPS Career Center and Services

Questions? For more information about AAPS, visit: www.aaps.org Or email Mary Jo Bean at BeanM@aaps.org