introduction to the physical pharmacy and biopharmaceutics (ppb) section of aaps and careers in the...
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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
OutlinePart 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
OutlinePart 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
• 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 ?
Who we are?
Pharmacists
Pharmaceutics scientists
Biopharmaceutics scientists
Chemists
Biologists
EngineersPhysicians
Multidiscipline involved in the discovery, development, and manufacture of pharmaceutical products and therapies the Goal of this outreach initiative!
AAPS members
Many more related fields
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
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
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.
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 biopharmaceutic characterization and delivery of small molecules and biologics.
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PPB: a Multidisciplinary Science
Dissolution Profile
Biorelevant Solubility
Drug Substance/Formulation
Solubility, pKa, etc.amorphous/crystalline
Nanotech
PrecipitationTime
Caco-2 or MDCK Papp
GI transporter Jmax, Km
Effective Permeability
In vitro-In vivoScaling
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 sectionMission:• 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
PPB membership benefits
• Awards/Fellows/Travelships• Communication
e.g. PPB newsletters
• Professional Developmente.g. PPB mentorship program
• Education• Focus Groups• Volunteer Opportunities PPB Section Reception at AAPS Annual Meeting
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
PPB Newsletter
• 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!
PPB Mentoring Program
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
PPB Focus Groups
Other benefits• Broaden and Share Your Scientific Knowledge• Career Development (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
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
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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)
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
PPB Ambassador Program
PPB Ambassador program contact:
Rakesh Gollen, PPB Newsletter ([email protected])
Sophia Fong PPB International Student Representative ([email protected])
Maria Lipert PPB Student Representative ([email protected])
Maria Nadeau, AAPS Staff Liason ([email protected])
Tycho Heimbach, PPB Chair ([email protected])
AgendaPart 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
What skills are most valued in the Pharma/Biotech Industry?
• Scientific/Technical Excellence• Leadership and Responsibility• Teamwork and Communication• Acceptance of Challenges and Risks
PPB scientist
Question:
What is the ideal skill set ?
Answer:
What kind of a job ?
What are my day-to-day responsibilities ?
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Order drug substance
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
CANDIDATE
14C/3H radiosynthesis
Stable isotope synthesis
Preclinical PK profile Formulation 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 studies2 species
Acute Tox studies2 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 processstructure & ID (Human, dog, monkey, rabbit, rat, mouse)
In vivo metabolic profiling, plasma, urine, feces, bilestructure & ID (dog & rat)
Typology - ID of major metabolizing enzymes
Enzyme inhibition and induction studies
PK/PD support
Months
Pre-formulation, Formulation, & DMPK
conc
entr
atio
n
Time
Drug Discovery
Pre-Formulation
Formulation
Biopharmaceutics
Where do scientists and engineers fit into the drug product development process?
PRODUCTLAUNCH
DRUGDISCOVERY
Early Development Late Development
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
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
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
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
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
If not you then WHO ?
Questions ??
Feel free to contact us and Welcome to join PPB!!!