Intro to AAPSfor students,student chapters,prospect membersTuesday, October 6. 2015

Introduction

Presenters:

Shraddha Thakkar, BIOTEC

Katie Maass, SPOD

Vibhuti Agrakari, SPOD

Paddy Eangoor, APQ

Tanzir Mortuza, BIOTEC

Amelia Deitchman, CPTR

Johannes Kast, CPTR

Rachel Saylor, DDDI

Manjeet Pimparade, FDD

Yamini Gorantla, MSE

Sophia Fong, PPB

Nicole Zane, PPDM

Anqi Wan, RS

AAPS Mission and VisionMission

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 Members6303

2225

Student/PostDoc Membership comprise 25% of all AAPS Membership

Regular Members Student/Postdoc Members

Over 100 AAPS Student Chapters across the world

Webinar OverviewAAPS provides robust networking community and countless opportunities: AAPS Sections Focus Groups Education and Resources Student/Postdoc Outreach Committee Career Center

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

APQ6%

BIOTEC10%

CPTR10%

DDDI11%

FDD32%

MSE5%

PPB11%

PPDM13%

RS3%

Students on AAPS Sections

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

APQPRESENTER: 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: 2159Student members: 208

APQ—Analysis and Pharmaceutical Quality section

Primary focus groups Bioanalytical 

Contract Research Organization (CRO)  

In Vitro Release and Dissolution Testing 

Non-clinical Dose Formulation and Analysis 

Pharmaceutical Impurities 

Stability 

Secondary focus groups

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

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/

APQ—Analysis and Pharmaceutical Quality section

BIOTECPRESENTER: 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

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/

CPTRPRESENTER: 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 sectionOpportunities 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

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

Focus Groups

For more information visit: http://www.aaps.org/CPTR/

DDDIPRESENTER: BRITTANY DUERK SPITZNAGEL, LIPSCOMB UNIVERSITY

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 andDevelopment Interface section

DDDI—Drug Discovery andDevelopment Interface section

Secondary Drug Metabolism  

Drug Transport  

Nanotechnology  

Oral Absorption  

Pharmaco-imaging  

Pharmacogenomics (PGx)  

Targeted Drug Delivery and Prodrug 

Focus GroupsPrimary Discovery Modeling

and Simulation 

Drug Candidate Selection  

Nutraceuticals & Natural Products 

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

DDDI—Drug Discovery andDevelopment Interface section

For more information visit: http://www.aaps.org/DDDI/

FDDPRESENTER: 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

The FDD section benefits its members both personally and professionally through various activities.

Awards/Fellows/Travelship

Communication 

Education

Focus Groups

Volunteer Opportunities

Opportunities for students

FDD—Formulation Design and Development section

Primary Animal

Pharmaceutics and Technology  

Dermatopharmaceutics   Excipients     Inhalation and Nasal Technolog

y  

Lipid-Based Drug Delivery Systems  

Modified Release   Ocular Drug Delivery & Disposit

ion 

Patient-Centric Drug Development, Product Design, and Manufacturing 

QbD and Product Performance   Sterile Products 

Focus Groups

Secondary In Vitro Release and Dissolution T

esting 

Nanotechnology   Nutraceuticals and Natural Produ

cts  

Preformulation   Process Development   Process Modeling and Simulation  Contract Research Organization (

CRO)

For more information visit: http://www.aaps.org/FDD/

MSEPRESENTER: YAMINI GORANTLA, MERCER UNIVERSITY

MSE—Manufacturing Science and Engineering sectionVision: 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

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.

Goals

MSE—Manufacturing Science and Engineering sectionFocus Groups

Primary Chemical and biological

active pharmaceutical ingredient manufacturing technology

Process Analytical Technology

Process Development

Process modeling and simulation

Secondary 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/

PPBPRESENTER: 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)

Dissolution Profile

Biorelevant Solubility

Drug Substance/Formulation

Solubility, pKa, etc.amorphous/crystalline

Nanotech

Precipitation

Time

Caco-2 or MDCK Papp

GI transporter

Jmax, Km

Effective Permeability

In vitro-In vivo

Scaling

PBPK modelsFabs , F

GI physiology:↑ Stomach pH↑ Stomach emptying Time↓ Intestinal pH↑ GI blood flow

Solubility↑ Bile Salt↑ In vivo solubility↓ Precipitation Rate

Permeability:Inhibition of Efflux or Uptake Transporters

Disposition PK (CL, Vd)

Material science

(polymorphs, forms, salts), physical

stability and chemical stability

PPB Section—Physical Pharmacy and Biopharmaceuticsa Multidisciplinary Science

Nanotechnology  

Oral Absorption  

Preformulation 

Targeted Drug Delivery and Prodrugs 

PPB Section—Physical Pharmacy and Biopharmaceutics

Focus Groups

PPB Section—Physical Pharmacy and Biopharmaceutics

Distribution of membership of PPB Section

4.37%

95.63%

95.6%4.4%

Regular members

Student members

As of July 2014

0

20

40

60

80

Origins of PPB international student membership

6.1%

Nu

mb

er o

f P

PB

stu

den

t m

emb

ers

6.1%

43.3%

11.7%

32.8%

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/

PPB Section—Physical Pharmacy and Biopharmaceutics

PPDMPRESENTER: NICOLE ZANE, UNIVERSITY OF NORTH CAROLINA

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- PharmacokineticsPharmacodynamics Drug Metabolism

PPDM- PharmacokineticsPharmacodynamics Drug Metabolism

Specific research interests: Transporters

Enzyme-mediated metabolism

Preclinical pharmacokinetics

Microdialysis

Translating preclinical to clinical

In vitro-in vivo extrapolation

Systems pharmacology

Focus GroupsPrimary 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- PharmacokineticsPharmacodynamics 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/

PPDM- PharmacokineticsPharmacodynamics Drug Metabolism

RSPRESENTER: ANQI WAN, UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES

RS—Regulatory Sciences sectionVision: 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.

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.

AAPS Career Center and Services

Questions?

For more information about AAPS, visit: www.aaps.org

Or email Mary Jo Bean at BeanM@aaps.org