Introduction to the
Physical Pharmacy and Biopharmaceutics (PPB) section
of AAPS and
Careers in the Pharmaceutical and Biotech Industries
PPB Section
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
Outline
Part I
•AAPS Overview and Student Benefits
•AAPS PPB section
• PPB ambassador program
What is AAPS ?
• 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.
Who we are?
Engineers
Physicians
Biologists
Chemists
Many more
related fields
AAPS
members
Multidiscipline involved in the discovery, development, and manufacture of
pharmaceutical products and therapies  the Goal of this outreach initiative!
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
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.
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3.
4.
5.
6.
7.
8.
9.
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
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.
PPB: a Multidisciplinary Science
Material science
Drug
Substance/Formulation
Solubility, pKa, etc.
amorphous/crystalline
Nanotech
(polymorphs, forms,
salts), physical stability
and chemical stability
Solubility
↑ Bile Salt
↑ In vivo solubility
↓ Precipitation Rate
↑
↑
↓
↑
GI physiology:
Stomach pH
Stomach emptying Time
Intestinal pH
GI blood flow
Permeability:
Inhibition of Efflux or
Uptake Transporters
Dissolution
Profile
Biorelevant
Solubility
PBPK models
Fabs , F
Precipitation
Time
Disposition PK
(CL, Vd)
Effective
Permeability
In vitro-In vivo
Scaling
Caco-2 or
MDCK Papp
GI transporter
Jmax, Km
PPB section
Mission:
•
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 Development
e.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:
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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
•
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-viewon-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!
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
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•
•
•
•
•
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Dermatopharmaceutics
Discovery Modeling and Simulation
Drug Candidate Selection
Excipients
Inhalation and Nasal Technology
Lipid-Based Drug Delivery Systems
Modified Release
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)
AAPS/PPB
(~6000 followers)
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
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 contact:
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)
Tycho Heimbach, PPB Chair (tycho.heimbach@Novartis.com)
Agenda
Part I
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 ?
Pre-formulation, Formulation, & DMPK
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 Embryo Fetal Tox Range finding studies - Rat
2 species
5 Day Tox
Embryo Fetal tox studies - Rat/Rabbit
studies
Fertility studies
14C/3H
radiosynthesis
Stable isotope synthesis
Preclinical PK profile
FIM PACKAGE
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 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
concentration
In vitro metabolic profiling, rate, active metabolites and formulation support throughout the development process
structure & ID (Human, dog, monkey, rabbit, rat, mouse)
23
Time
Where do scientists and engineers
fit into the drug product development process?
Early Development
Late Development
DRUG
DISCOVERY
PRODUCT
LAUNCH
Drug Discovery
Biopharmaceutics
Pre-Formulation
Formulation
Biopharmaceutics R&D: Functions in Early Phase
Physicochemical
properties
Toxicology
Formulation
Drug Form
Selection
Biopharmaceutic
characterization
Exploratory Pharm
Applied Drug Delivery
Technology
Phase I
Clinical Formulation
IND Stability
Biopharmaceutics R&D: Functions in Advanced Phase
Commercial Formulation
Development
Dosage Form
Properties
Pharmaceutical
excipients
Oral absorption /
Bioavailability
Pharmaceutics/
Biopharmaceutics
Drug delivery
strategies
Preformulation
Drug transport
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!!!