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.DSenior Director; Global CMCPfizer 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

10 to 15 years

The Long Road to a New Medicine

Commercial Application

Extensive Safety Studies

Phase III: Candidate Tested in 3,000 to

10,000 PatientsPhase II: Candidate

Tested in 100 to 300 Patients

Formulation Developed

Candidate Manufactured

Candidate

Phase I: Candidate Tested in Healthy

Volunteers

Screening

Drug Discovery and Development Process

Project Phase Program Phase

Average cost to develop one drug:

$1.7 billion (USD)

Product Phase

TargetIdentification

andValidation

Assay Development

LeadGeneration

CompanyGoals

Hypothesis Generation

Candidate DevelopmentCommercialization

Phase III

Submit Global Launch

Global Optimization

Lead Optimization

First Human

Dose

Phase IA

Phase IB/II

For every drug that ultimately makes it to the patients, up to 10,000 other compounds are tested that do not.

• 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

Industrial Pharmaceutical Science

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

8

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• 3.2.S.1 General Information• 3.2.S.2 Manufacture• 3.2.S.3 Characterisation and Impurities• 3.2.S.4 Control of Drug Substance• 3.2.S.5 Reference Standards / Materials• 3.2.S.6 Container Closure System• 3.2.S.7 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

16

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-Markets-2.0.pdf

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 Attestations LoAs Certifications Notarizations

For Example:

Each pin reflects a dossier with separate regulatory

commitments for one product application…..24 separate registrations for one product

17

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 MillennialsThe 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 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)

Family

Friends

Community

School

Team

ReligionYour

Addiction

Girlfriend

Your Garden

Do you know your Personality Type? http://www.truity.com/view/types

If you do not know your type, no problem! Simply take the TypeFinder assessment to help you figure it out.

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           

                                                                                                                                                                                                                                                                                                   

 

Read more: http://www.truity.com/view/types#ixzz2jtVZhEoP

If you do not know your type, no problem! Simply take the TypeFinder assessment to help you figure it out.

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           

                                                                                                                                                                                                                                                                                                   

 

Read more: http://www.truity.com/view/types#ixzz2jtVZhEoP

Extraversion/Introversion describes your approach to managing your energy levelSensing/Intuition describes your style of thinking about facts and ideasThinking/Feeling describes your orientation to personal valuesJudging/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

Can you get to the middle?

Mission StatementMission 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.

Mission StatementMission 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 StatementVision 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.

Vision StatementVision 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

• Mentorship programs

• Awards and Travelships

• Student Initiated Programs

• Student Chapters

• Leadership and Networking

““Students are the Students are the future of AAPS”future of AAPS”

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)

Student Programs

• 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 Chapters

AAPS – Student Information

• https://www.aaps.org/Sections_and_Groups/For_Students/Student_Resources/

51

Questions

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 in-

person 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

60

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 Passion for position– People skills Listening skills– Reasoning skills Goals– Ambition/Initiative/Drive Strengths/Weaknesses– Personality Attitude– Knowledge of company Appearance

61

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

62

Questions