Introduction to the Physical Pharmacy and Biopharmaceutics (PPB) section

1. 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 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

4. What is AAPS ? • AAPS is the American Association of Pharmaceutical Scientists • Founded in 1986 • A professional, scientific association of approximately 11,000 pharmaceutical scientistsemployed 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.

5. Who we are? Engineers Physicians Many more related fields Biologists Chemists AAPS members Biopharmaceutics scientists Pharmacists Pharmaceutics scientists 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 Student Center • Student Representative to Sections and Committees • AAPS Career Network • AAPS Awards/Travelships • Programming and volunteers

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

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. Vision:The PPB section will be recognized as the premiere global organization for scientists involved in physicochemical and biopharmaceuticcharacterization and deliveryof small molecules and biologics.

9. PPB: 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 Biorelevant Solubility Precipitation Time Dissolution Profile GI physiology: ↑ Stomach pH ↑ Stomach emptying Time ↓ Intestinal pH ↑ GI blood flow PBPK models Fabs , F Disposition PK (CL, Vd) In vitro-In vivo Scaling Effective Permeability Permeability: Inhibition of Efflux or Uptake Transporters GI transporter Jmax, Km Caco-2 or MDCK Papp

10. PPB section Mission: • Forumfor 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. PPB Newsletter Highlights of Monthly edition of PPB section Newsletter includes: • Important Updates and Notices • PPB Goals • Upcoming Webinars (http://www.aaps.org/webinars/) • Upcoming Courses • Focus Group Updates • AAPS Blog Updates (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 Edition

13. PPB Mentoring Program • 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 • Visit http://www.aaps.org/Sections_and_Groups/Sections/Physical_Pharmacy_and_Biopharmaceutics_Section/PPB_Students/ for more information and to sign up!

14. PPB Focus Groups 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) • PPB Section takes special cares to international student members whointended to or are already working in US • Upcoming events to: • Understand their challenges and needs • Provide tips and trainings on their soft skills • 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! • 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)

18. PPB Ambassador Program 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

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

20. Agenda 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

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. Pre-formulation, Formulation,& DMPK concentration Time Months 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Order drug substance 4 week Tox studies 2 species CANDIDATE Acute Tox studies 2 species FIM PACKAGE Embryo Fetal Tox Range finding studies - Rat 5 Day Tox studies Embryo Fetal tox studies - Rat/Rabbit Fertility studies 14C/3H radiosynthesis Stable isotopesynthesis Preclinical PK profile Formulation support studies (formulation optimization) 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) 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

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

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

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

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!!!