Surviving (and Perhaps Thriving) as a Scientist
in the Constantly Evolving Global
Pharmaceutical Industry
(This talk will focus on Regulatory Pharmaceutical Science)
Steve Colgan, Ph.D
Senior Director; Global CMC
Pfizer Global R&D; Groton CT
University of Connecticut; December 2013
Who am I and Why am I here?
• Analytical Chemist - 27 Years at Pfizer
• Currently in a Regulatory role representing
chemists, analysts, formulators,
manufacturing
• AAPS APQ Section Past-Chair
• Father of a UConn Pharm D – with another
one (hopefully) in the queue
• New Englander
; gardener; trail runner;
music lover
Who am I and Why am I here?
• Describe what it’s like in the Pharmaceutical
Industry
– Highlight a bit about drug development & Pharmaceutical Science
– Introduce what a pharmaceutical regulatory scientist does
• Highlight a few thoughts on career
development and soft skills that are important
in industry (and what you may not learn in school)
• Introduce you to the AAPS
• Provide you with a few interviewing tips
• Offer my assistance to you 
The Long Road to a New Medicine
10 to 15 years
Phase II:
Candidate
Tested in 100 to
300 Patients
Phase III: Candidate
Tested in 3,000 to
10,000 Patients
Commercial
Application
Candidate
Manufactured
Phase I: Candidate
Tested in Healthy
Volunteers
Extensive
Safety
Studies
Formulation
Developed
Screening
Candidate
Drug Discovery and Development Process
Hypothesis
Generation
Candidate Development
Commercialization
Target
Identification
and
Validation
Assay
Development
Lead
Optimization
First
Human
Dose
Phase
IA
Phase
IB/II
Phase
III
Submit
Global
Launch
Global
Optimization
Company
Goals
Average cost
to develop one drug:
$1.7 billion (USD)
Lead
Generation
For every drug that ultimately makes it to
the patients, up to 10,000 other compounds
are tested that do not.
Project Phase
Program Phase
Product Phase
Industrial Pharmaceutical Science
• Pharmaceuticals are composed of
– Active Pharmaceutical Ingredient (API)/Drug Substance (DS)
– Drug Product (DP)
• Tablets, capsules, oral solution, lyophile/solutions for
injection, topical, patches …
• Cross functional teams
– Develop API route and process
– Develop DP presentation and process
– Develop analytical methods
– Manufacture clinical supplies
– Transfer to commercial manufacturing sites
– Manufacturing commercial supplies
– Prepare clinical and commercial regulatory applications
Global Chemistry and Manufacturing Controls
• Chemistry and Manufacturing Controls (CMC) = Regulatory
arm of Pharmaceutical Science
• Lead the CMC Regulatory Strategy
– Assemble clinical and commercial applications
– Respond to Regulatory queries
– Communications with regulatory agencies
• All phases of development & commercial
– Phase I through IV
– Commercial products
Current GCMC Staff Demographics
• 321 GCMC colleagues/~340 contractors
– 37 locations
– 18 countries
• Experience
– Technical/Scientific Expertise:
Chemists/Biologists/Engineers/Pharmacists/Formulators/
Pharmacologists/Information, Operations & Systems Managers
– Language Proficiencies: Arabic, Chinese, Dutch, English, Flemish, French,
German, Greek, Gujarati, Hindi, Indonesian, Italian, Japanese, Malay,
Marathi, Nigerian, Portuguese, Punjabi, Russian, Spanish, Swedish, Tamil,
Teluga, Urdu, etc.
– Average ~15 years pharmaceutical industry experience; Average ~7 years
regulatory experience
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What do Regulatory Filings look like?
Registration Documents
– Investigational Stage
• IND / IMPD
– Commercial Marketing Stage
• NDA / MAA
• Annual Reports / Renewals
• Post Approval Changes (PAC)
– Common format for major markets
• CTD (Common Technical Document)
– www.ich.org/products/ctd/html
CTD Modules
Module 1 – Regional (US)
• Cover Letter, Regional Forms, Label, Risk Mgt Plan, EU product labelling: Summary of Product
Characteristics , Patient Information Leaflet (PIL), carton/blister text, Environmental Analysis,
DMF LOAs
Module 2 – Nonclinical and Clinical Summaries
– Nonclinical Written and Tabulated Summaries, Nonclinical Overview (NCO), Quality Overall
Summary (QOS), Clinical Overview, Clinical Summaries of Efficacy and Safety
Module 3 – Quality (CMC)
• Drug Substance, Drug Product, Appendices, Regional (Process Validation – EU, Master
Batch Record and Executed Batch Records – US, Method Validation – US, Comparability
Protocols)
Module 4 – Nonclinical Study Reports
– Nonclinical Study Reports, Publications
Module 5 – Clinical Study Reports
– Clinical Study Reports, Publications, Protocol and related documentation
CTD: The Drug Substance Story
•
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•
•
•
3.2.S.1
3.2.S.2
3.2.S.3
3.2.S.4
3.2.S.5
3.2.S.6
3.2.S.7
General Information
Manufacture
Characterisation and Impurities
Control of Drug Substance
Reference Standards / Materials
Container Closure System
Stability
CTD: The Drug Product Story
• 3.2.P.1 Description and Composition of the
Drug Product
• 3.2.P.2 Pharmaceutical Development
• 3.2.P.3 Manufacture
• 3.2.P.4 Control of Excipients
• 3.2.P.5 Control of Drug Product
• 3.2.P.6 Reference Standard and Materials
• 3.2.P.7 Container Closure System
• 3.2.P.8 Stability
Evolution of the Pharmaceutical Industry
• The importance of the Emerging Markets
• Today’s Employment Trends
Industrial Focus beyond 2013
• Movement away from the traditional focus
regions (US, EU, J) towards the Emerging
Markets –
– Especially the BRICK-MT
• Brazil, Russia, India, China, Korea, Mexico, Turkey
• Emerging markets consist of 70% of the
world's population, generate 31% of GDP and
will account for 30% of global pharmaceutical
spending by 2016.
•
Jun. 19, 2013 Hussain Mooraj, global managing director, Accenture Life Sciences' Supply Chain
Source: http://www.booz.com/media/file/BoozCo_Pharma-Emerging-Markets-2.0.pdf
Emerging Markets
Over the past five years, sales generated in emerging markets have
doubled, totaling USD US$191 billion in 2011, and representing
approximately 20 percent of the global market volume.
Source: http://www.booz.com/media/file/BoozCo_Pharma-Emerging-Markets2.0.pdf
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Differences in Regulatory Expectations
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Level of Detail for Regulatory Commitments
Process Validation vs. Quality Verification
Bioequivalence Criteria
Site Specific Stability Data
Viral Clearance
Master vs. Executed Batch Records
Segregated vs. Multi-Use Mfg. Suites
Application Forms & CPIDs
Quality Summary vs. CTD
Local In-Use Compatibility Studies
Plant Master Files
Mfg. Site Master Plans
Pre-Approval Inspections
Change Management Protocols
Impurity Qualification & Controls
Page-by-Page Wet Signatures
Ancillary Documents
For Example:
Attestations
Each pin reflects a dossier with separate regulatory commitments for
LoAs
one product application…..24 separate registrations for one product
Certifications
Notarizations
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Lean Stability Team 
Steve Colgan Raquel Oblessuc Debora Germano Mariele Ungaro Rob Timpano
Mike Lynch Anthony Ventura
Ana Paula Ferreira Steve Baertschi
OK – so how can I get a job?
The Perception of Millennials
The bad bits:
• High degree of entitlement: T-ball; promotion every 2 years
regardless of performance “atmospheric expectations”
• Lowest civic engagement/political participation
– Informed but inactive: Hate Joseph Kony but wont do
anything about it
• Lack empathy & low concern for other’s point of view
• Very dominated by peers (social media)
– To develop intellectually, you’ve got to relate to older people
The Perception of Millennials
The good bits:
• Millennials are nice – most like you
– Positive: internet is now 90% positive (from 50%)
• More accepting of differences/subcultures
• Challenge Convention: Continuous improvement
• Financially Responsible – less credit card debt than parents 
• Pragmatic idealists
• World is flat/no leaders
– Occupy Wall Street/Tahrir Square have less change than
previous rebellions
– Don’t respect authority – but also don’t resent it
Once I have a have a job…
How do I keep it………..?
How do I thrive………..?
Today’s Employment Trends
• Large pharmaceutical companies are turning
over more drug development to smaller
companies and this had led to growth in
Contract Research Organizations (CROs)
– Quick/Lean/Efficient
• Broadening your skill set is core to finding
employment
– One person now needs to do the work of three!
– Companies tend to value those who know a “little
bit about a lot”
Today’s Employment Trends
• Companies are looking for candidates with
great technical breadth with strong
nontechnical skills
• Disciplines that blend well with Pharmaceutical
Science include:
– Business development
– Project management
– Operations
– Law
1st things 1st 
• You get no credit for being smart or working
hard (there is no shortage of people with
these qualities) 
• Industry wants to hire people that are
– Trustworthy
– Self aware
– Well rounded
– Flexible with the (ability to learn)
– Happy working in teams
Building Trust
Resistance a Impact/Trust
How does one develop/demonstrate Trust????
• Veracity of your scientific data, resume
• Association with trusted institutions, advisors
• Network, References
• Delivering when you don’t have to: volunteer
organizations, summer jobs, etc
Are you Self-Aware?
• People who are self-aware:
– Are easier to manage
– Are more likely to improve their weaknesses
– Perform better in teams
– Find themselves in the “right job” more quickly
What are your priorities?
Self
(mental and physical health)
Your Garden
Friends
Girlfriend
School
Community
Religion
Your
Addiction
Team
Family
Do you know your Personality Type?
http://www.truity.com/view/types
Read more:
http://www.t ruit y.com/view/t ypes#ixzz2jtVZhEoP
Extraversion/Introversion describes your
approach to managing your energy level
Sensing/Intuition describes your style of thinking
about facts and ideas
Thinking/Feeling describes your orientation to
personal values
Judging/Perceiving describes your approach to
goals and time management
Shuck et al; American Journal of Pharmaceutical Education Vol. 63, Spring 1999
Academia
• More independent work environment
• More flexible schedule
• Opportunity to mentor scientists of the future
Industry
• Work on the process of bringing a drug to market
• Team-oriented atmosphere
• Work on several projects at once
• See the bigger drug development picture
Government
•
•
•
•
Unique environment; similarities to both academia & industry
Protect public health by ensuring drug safety/effectiveness
Provide public with accurate information on drugs
Opportunity to be part of a world-class, science-based public
health agency
Important things you may not learn in school
• You are never done learning
– In reality, you have just started learning
– In 5 yrs, you will probably be doing something completely
different
 Seek out opportunities to learn
• Perception is reality
– Dress appropriately, act appropriately
– All interactions should be professional – emails, IM, dinners,
professional societies…
•A friend at a different company was brought to HR for
inappropriate emails in his group
•At a recent conference, a candidate had a few too many drinks
at a company’s reception – and was eliminated from
consideration
Important things you may not learn in school
• Communication is key
– Communicate appropriately
– Not everyone has the same beliefs, backgrounds, education,
beliefs, culture, religion
– Know who your audience is – difference points of reference
•Talking to your research team is different than talking to your
friends
•Talking to senior management is different than talking to your
research team
Important things you may not learn in school
• Accomplishments will open doors for you
– Achievements slowly fade
– Mistakes/problems also slowly fade
• Suggestion: Make a different mistake every time! Tell your
boss ASAP – before she finds out from someone else
– It is a small world and achievements/problems will follow you
• Relationships are extremely important
– Your work accomplishments are team based and you will be
dependent on others
– Getting along with people is more important than what you do
Important things you may not learn in school
• You will work for more than one company  You need to network
– Get involved with professional societies
– Network  within your classmates and within your company
– It is a small world
• Work life balance is critical
– Your career should be something you are passionate about
– You don’t get extra points for not taking vacations
Your Sphere of Influence should
Expand as your Career Develops
Your Division
Your
Department
Your Team
Yourself
Can you get to the middle?
What your
company
needs
What
you’re
passionate
about
What you
do well
Mission Statement
AAPS provides a dynamic international
forum for the exchange of knowledge
among scientists to enhance their
contributions to health.
We offer timely scientific programs,
ongoing education, opportunities for
networking, and professional development.
Vision Statement
AAPS will be the premier organization of all
scientists dedicated to the discovery,
development and products and therapies
through advances in science and technology.
The American Association of
Pharmaceutical Scientists (AAPS)
• A professional, scientific association of
approximately 11,000 members employed in
industry, academia, government, and other
research institutes worldwide.
• Founded in 1986
The American Association of
Pharmaceutical Scientists (AAPS)
• The purpose of AAPS is to serve its
membership,
– by providing open forums for the exchange and
dissemination of scientific knowledge
– by fostering the education and career growth of
members and recognizing individual achievement;
– by influencing the formation of public policy
relevant to health and related issues of public
concern.
Opportunities/Benefits – e.g. American Association
of Pharmaceutical Scientists
• Annual meetings
• Student Initiated Programs
• Mentorship programs
• Student Chapters
• Awards and Travelships
• Leadership and Networking
“Students are the
future of AAPS”
Student Programs
Communications to students:
•Targeted monthly email newsletter
•Graduate Focus Articles in AAPS Newsmagazine
•Quarterly telecons with all Student Chapter Chairs by region
•Online Student Center
•Student information in AAPS Booth at Annual Meeting
•Social Media (Twitter, Facebook, Youtube, Linkedin)
AAPS Student Chapters
• Enable Students to…
o Enhance their knowledge of the latest advances and
discoveries in the pharmaceutical sciences
o Participate in outreach activities of AAPS at the local,
regional and national levels
AAPS – Student Information
• https://www.aaps.org/Sections_and_Groups/
For_Students/Student_Resources/
Questions
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A few thoughts on interviewing
Interviewing 101
• There are more skilled applicants than
available jobs
• There is no more important decision than the
selection of a candidate
– Most would rather not make an offer to 10 skilled
candidates instead of hiring a “bad” candidate
• 1 month to hire / 5 years to fire
– 1 strike and you’re out 
Interviewing 101
• Resume must be perfect
• Phone screens usually are 1st followed by inperson interviews
• Don’t expect anyone to have read your
resume or even remember that you have an
interview that day
– Bring extra copies of your resume and everything
else you have already provided
Interviewing 101
• Most interviewers make their “decision” in the
1st 30 seconds – 1st impressions are huge
• Confident but humble
• You MUST ask questions that indicate that you
have done your homework
• Dress conservatively
• Listen more than you speak
• Take notes
Interviewing 101
• Bring notes
– What you do well
– What you need to work on
– Your references
– Your questions
– High level summary of your thesis/focus areas
• Usually at the end of the interview, you will be
asked if there is anything you want to highlight
or if something important was not covered.
Interviewing 101
• Your credit score is important
– Relates to how responsible you are
• Your on-line personality is fair game
• Turn you phone off!
• Be ready for specific questions about what
you have done in the past
– STAR: Situation/Task/Action/Result
• Past behavior is the best indicator of future
performance
Interviewing 101
• Leave with the next step defined
– When can I expect to hear from you?
– Would it be OK if I contacted you in 2 weeks?
– Send a thank you note (email is fine – ask for a
business card before you leave)
Interviewing Questions
• Tell me about yourself
• Give me an example of a conflict you needed
to work through
• Give me an example of where you have shown
initiative
• If you could be a superhero, what type of
power would you choose?
• Specific scientific questions based on your
resume
Interview Preparation
• Employer’s goal in the interview is to confirm
you are capable of performing the position
and to determine the following about you:
– Energy level/Enthusiasm
– People skills
– Reasoning skills
– Ambition/Initiative/Drive
– Personality
– Knowledge of company
Passion for position
Listening skills
Goals
Strengths/Weaknesses
Attitude
Appearance
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Interview Preparation
• Your goal in the interview is to determine if
you could accomplish the following:
– Work for this manager
– Work at this company – within the corporate
culture
– Accept the position if offered or move on to the
next step in the interview process
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Questions
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