1. Introduction to the Physical Pharmacy and Biopharmaceutics (PPB) section of AAPS and Careers in the Pharmaceutical and Biotech Industries Introduction to the Physical Pharmacy and Biopharmaceutics (PPB) section of AAPS and Careers in the Pharmaceutical and Biotech Industries PPB Section

2. Outline Part I AAPS Overview and Student Benefits AAPS PPB section PPB ambassador program Part II Career Tips and Opportunities Personal career perspective – Speaker name Discussion Q&A

3. Outline

4. AAPS is the American Association of Pharmaceutical Scientists Founded in 1986 A professional, scientific association of approximately 11,000 pharmaceutical scientists employed in industry, academia, government, and other research institutes worldwide. AAPS provides a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to health. AAPS offers timely scientific programs, ongoing education, opportunities for networking, and professional development. What is AAPS ?

5. Who we are? Multidiscipline involved in the discovery, development, and manufacture of pharmaceutical products and therapies  the Goal of this outreach initiative!

6. What are Student Benefits? Networking opportunity AAPS Visiting Scientist Program Mentoring Events AAPS Sections, Focus Groups and Discussion Groups Up-to-date pharmaceutical news AAPS Newsmagazine AAPS Student Center Monthly Student/Postdoc Focus Emails eLearning, Webinars Professional development AAPS Career Network AAPS Awards/Travelships Programming and volunteers AAPS Student Center Student Representative to Sections and Committees

7. Choose the AAPS Section that’s Right for You 1.APQ - Analysis and Pharmaceutical Quality section 2.BIOTEC - Biotechnology section 3.CPTR - Clinical Pharmacology and Translational Research section 4.DDDI - Drug Discovery and Development Interface section 5.FDD - Formulation Design and Development section 6.MSE - Manufacturing Science and Engineering section 7.PPB - Physical Pharmacy and Biopharmaceutics section 8.PPDM - Pharmacokinetics, Pharmacodynamics, and Drug Metabolism section 9.RS - Regulatory Sciences section 1.APQ - Analysis and Pharmaceutical Quality section 2.BIOTEC - Biotechnology section 3.CPTR - Clinical Pharmacology and Translational Research section 4.DDDI - Drug Discovery and Development Interface section 5.FDD - Formulation Design and Development section 6.MSE - Manufacturing Science and Engineering section 7.PPB - Physical Pharmacy and Biopharmaceutics section 8.PPDM - Pharmacokinetics, Pharmacodynamics, and Drug Metabolism section 9.RS - Regulatory Sciences section AAPS sections are groups of AAPS members with interests in a particular area of the pharmaceutical sciences. The sections brochure will assist in selecting the best section for you.sections brochure

8. PPB section PPB is the Physical Pharmacy and Biopharmaceutics section A multidisciplinary section that focuses on preformulation, biopharmaceutics, drug absorption, nanotechnology, and drug delivery systems design and performance including targeted drug delivery. V ision: The PPB section will be recognized as the premiere global organization for scientists involved in physicochemical and biopharmaceutic characterization and delivery of small molecules and biologics.

9. 9 PPB: a Multidisciplinary Science Dissolution Profile Biorelevant Solubility Drug Substance/Formulation Solubility, pKa, etc. amorphous/crystalline Nanotech Precipitation Time Caco-2 or MDCK P app GI transporter J max, K m Effective Permeability In vitro-In vivo Scaling PBPK models Fabs, F GI physiology: ↑ Stomach pH ↑ S tomach 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, V d ) Material science (polymorphs, forms, salts), physical stability and chemical stability

10. PPB section M ission: Forum for the open interchange, discussion, and dissemination of emerging scientific developments, technologies, and regulatory knowledge regarding the principles and practices of physical pharmacy and biopharmaceutics Promote the continued growth of the sciences underpinning physicochemical and biopharmaceutic characterization of small molecules and biologics, pharmaceutical excipients and adjuvants, drug candidate selection, drug transport and absorption, preformulation, and biopharmaceutics data guiding the formulation and drug delivery strategies Foster pharmaceutical education, career growth, and professional development of the section membership Encourage the publication of physical pharmacy and biopharmaceutics related research and data in AAPS publications Recognize excellence in achievements and professional contributions of PPB members and collaborating with and supporting other AAPS sections, focus groups, and international professional/scientific organizations

11. PPB membership benefits Awards/Fellows/Travelships Communication e.g. PPB newsletters Professional Development e.g. PPB mentorship program Education Focus Groups Volunteer Opportunities PPB Section Reception at AAPS Annual Meeting

12. Highlights of Monthly edition of PPB section Newsletter includes:  Important Updates and Notices  PPB Goals  Upcoming Webinars (http://www.aaps.org/webinars/)http://www.aaps.org/webinars/  Upcoming Courses  Focus Group Updates  AAPS Blog Updates (http://aapsblog.aaps.org/)http://aapsblog.aaps.org/  Important announcements  AM updates and other programing details For details please click the link below to access a copy of July 2014 edition: PPB Newsletter- July 2014 EditionPPB Newsletter- July 2014 Edition

13. Matches student and postdoctoral mentees with mentors positioned in industry, government organizations, and academia Provides mentees with valuable knowledge, insight, encouragement, and career guidance Level of time commitment is flexible and determined by each mentor/mentee pair For a more personal view on the PPB mentoring program and its benefits, please read a mentee’s blog post: http://aapsblog.aaps.org/2014/06/10/personal-view- on-the-aaps-mentoring-program/#more-4161 http://aapsblog.aaps.org/2014/06/10/personal-view- on-the-aaps-mentoring-program/#more-4161 Visit http://www.aaps.org/Sections_and_Groups/Sections/Physical_Pharmacy_and_Bi opharmaceutics_Section/PPB_Students/ for more information and to sign up! http://www.aaps.org/Sections_and_Groups/Sections/Physical_Pharmacy_and_Bi opharmaceutics_Section/PPB_Students/

14. Focus groups encourage members in specialized fields to participate in open, dynamic communications with colleagues tackling similar challenges and to forge new relationships. PPB's Primary Focus Groups Nanotechnology Oral Absorption Preformulation Targeted Drug Delivery and Prodrugs PPB's Secondary Focus Groups Dermatopharmaceutics Discovery Modeling and Simulation Drug Candidate Selection Excipients Inhalation and Nasal Technology Lipid-Based Drug Delivery Systems Modified Release

15. Other benefits Broaden and Share Your Scientific Knowledge Career Development (2014 AAPS Career Fair)2014 AAPS Career Fair PPB Section takes special cares to international student members who intended to or are already working in US – Upcoming events to: 1.Understand their challenges and needs 2.Provide tips and trainings on their soft skills 3.Offer a channel to communicate between the PPB leaderships and them

16. How to connect with PPB section?  Find useful information on everything from searching for a job to moderating an AAPS meeting and take advantage of these learning and networking opportunities and actively expand your connections by joining the PPB section today!joining the PPB section  To stay up to date with the latest information, connect through (with links by clicking the icons): (~ 700+ members) (~6000 followers) AAPS/PPB

17. 2014 PPB Leadership Team Chair: Tycho Heimbach (Novartis) Chair-Elect: Weiguo Dai (J&J) Vice Chair: Roy Haskell (BMS) Secretary/Treasurer: Allen Templeton (Merck) Past-Chair: Ping Gao (Abbvie) 17

18. This program is intended to Raise awareness amongst students about PPB-related mentorship and career development opportunities, especially in industry Create open communication channels between academia and PPB Better-prepare new hires for industry – Role of PPB scientist/engineer in Pharma and Bio – Job expectations Identify ways to enrich academic programs with industrial topics related drug development and discovery. If interested click the link below: http://www.aaps.org/Sections_and_Groups/Sections/Physical_Pharmacy_and_Biopharmaceutics_Section/PPB_Students http://www.aaps.org/Sections_and_Groups/Sections/Physical_Pharmacy_and_Biopharmaceutics_Section/PPB_Students

19. PPB Ambassador program contact: Rakesh Gollen, PPB Newsletter (rakeshgollen@gmail.com)rakeshgollen@gmail.com Sophia Fong PPB International Student Representative (sophiaykfong@gmail.com)sophiaykfong@gmail.com Maria Lipert PPB Student Representative (mlipert@umich.edu)mlipert@umich.edu Maria Nadeau, AAPS Staff Liason (nadeaum@aaps.org)nadeaum@aaps.org Tycho Heimbach, PPB Chair (tycho.heimbach@Novartis.com)tycho.heimbach@Novartis.com

20. Agenda

21. What skills are most valued in the Pharma/Biotech Industry? Scientific/Technical Excellence Leadership and Responsibility Teamwork and Communication Acceptance of Challenges and Risks

22. PPB scientist Question: What is the ideal skill set ? Answer: What kind of a job ? What are my day-to-day responsibilities ?

23. 23 Order drug substance 123456789101112131415161718 CANDIDATE 14 C/ 3 H radiosynthesis Stable isotope synthesis Preclinical PK profileFormulation support studies (formulation optimization) FIM PACKAGE QWBA in pigmented rats (melanin binding) QWBA in albino rats (Toxicity) - distribution & binding Plasma protein binding/Erythroctyte-Plasma ratio-(human) Interspecies (Human, dog, monkey, rabbit, rat, mouse) Mass Balance - ADE studies (Tox’ species - rat & dog) 5 Day Tox studies 4 week Tox studies 2 species Acute Tox studies 2 species Embryo Fetal Tox Range finding studies - Rat Embryo Fetal tox studies - Rat/Rabbit Fertility studies In vitro metabolic profiling, rate, active metabolites and formulation support throughout the development process structure & ID (Human, dog, monkey, rabbit, rat, mouse) In vivo metabolic profiling, plasma, urine, feces, bile structure & ID (dog & rat) Typology - ID of major metabolizing enzymes Enzyme inhibition and induction studies PK/PD support Months Pre-formulation, Formulation, & DMPK concentration Time

24. Drug Discovery Pre-Formulation Formulation Biopharmaceutics Where do scientists and engineers fit into the drug product development process? PRODUCT LAUNCH DRUG DISCOVERY Early Development Late Development

25. Biopharmaceutics R&D: Functions in Early Phase Physicochemical properties Toxicology Formulation Phase I Clinical Formulation Drug Form Selection Biopharmaceutic characterization Exploratory Pharm IND Stability Applied Drug Delivery Technology

26. Pharmaceutics/ Biopharmaceutics Commercial Formulation Development Pharmaceutical excipients Oral absorption / Bioavailability Dosage Form Properties Drug delivery strategies Preformulation Drug transport Biopharmaceutics R&D: Functions in Advanced Phase

27. PPB scientist skill set Pharmaceutical aspects – Pharmacy courses – Pharmacokinetics – Physical pharmacy Material properties – Material Science – API powder properties – size, morphology, form – Final product properties – flow, compaction Formulation – Chemistry – Excipients – Chemical interactions, stability – Pharmaceutics

28. PPB scientist skill set Technical writing – Development reports – NDA sections Basic regulatory knowledge – Familiarity with ICH guidelines And further……… Project management Soft skills e.g. communication capability

29. PPB skill set Education: – B.S./M.S. in Pharmaceutical Sciences, Chemistry, Biology, Biomedical Engineering, Chemical Engineering, Statistics, or related fields – Pharm.D. – Ph.D. in Pharmaceutical Sciences, Biochemistry, Biotechnology, Chemical Engineering, or related fields – Education doesn’t stop once you’ve ‘landed the job’ Courses – Pharmaceutical sciences – Chemistry and biochemistry – Engineering principles Research experience

30. If not you then WHO ?

31. Questions ?? Feel free to contact us and Welcome to join PPB!!!