Career Opportunities for PharmDs in the Pharmaceutical Industry: Research & Development

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Career Opportunities for PharmDs in the
Pharmaceutical Industry Research Development
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Outline

• Describe the functions and responsibilities
  performed by various departments within
  pharmaceutical industry RD.
• Highlight career opportunities within these
  departments for which individuals with a PharmD
  degree are well-suited.

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Goal of Pharmaceutical RD

• The underlying goal of pharmaceutical RD is to
  create new knowledge, upon which a commercial
  product (and company) can be financially
  successful.
• Specific RD goals vary for different
  pharmaceutical companies based on focus, size,
  history, risk tolerance, available resources, and
  expertise.

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Major RD Departments(bringing molecules to
market)
Discovery Pharmacology
Toxicology
Pharmaceutics
Chemistry
Project Management
Licensing
Pharmacy
PK
Clinical Development
Regulatory
Market Planning
Literature Services
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Steps From Concept to Marketed Product

• Identify the medical need.

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Steps From Concept to Marketed Product

• Identify the medical need.
• Define the molecular target.

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Steps From Concept to Marketed Product

• Identify the medical need.
• Define the molecular target.
• Design a series of new compounds that hit the
  target.

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Steps From Concept to Marketed Product

• Identify the medical need.
• Define the molecular target.
• Design a series of new compounds that hit the
  target.
• Screen these compounds preclinically for optimum
  effects and potential safety and pharmacokinetic
  considerations. Select the best candidate based
  on desirable properties and conduct more
  definitive tests.

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Steps From Concept to Marketed Product

• Identify the medical need.
• Define the molecular target.
• Design a series of new compounds that hit the
  target.
• Screen these compounds preclinically for optimum
  effects and potential safety and pharmacokinetic
  considerations. Select the best candidate based
  on desirable properties and conduct definitive
  tests.
• Formulate the compound.

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Steps From Concept to Marketed Product

• Study the compound clinically through a series of
  clinical trials that establish the safety and
  efficacy for the intended population.

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Pr. 994-13/-14 Study Design
Study Design
S
R
T
A
R
Regimen A
N
A
Gemcitabine
HDAC-I
D
T
Baseline
O
I
Follow-Up for 12 months after last patient
enrolled

Evaluation
M
F
I
I
Z
C
A
A
Regimen B
T
T
Gemcitabine
Placebo
I
I
O
O
N
N
Administered as a 28-day course as long as
medically appropriate
Regimen A Gemcitabine 1000 mg/m2 IV on days 1,
8 and 15 of a 28-day cycle HDAC-I 6 mg/m2
PO days 1-21 of a 28-day cycle
Regimen B Gemcitabine 1000 mg/m2 IV on days 1,
8 and 15 of a 28-day cycle Placebo 6 mg/m2
PO days 1-21 of a 28-day cycle
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Steps From Concept to Marketed Product

• Study the compound clinically through a series of
  clinical trials that establish the safety and
  efficacy for the intended population.
• Satisfy Regulatory agencies that the compound is
  safe and effective for the intended purpose.

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Steps From Concept to Marketed Product

• Study the compound clinically through a series of
  clinical trials that establish the safety and
  efficacy for the intended population.
• Satisfy Regulatory agencies that the compound is
  safe and effective for the intended purpose.
• Launch, promote, and sell the product.

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Steps From Concept to Marketed Product

• Study the compound clinically through a series of
  clinical trials that establish the safety and
  efficacy for the intended population.
• Satisfy Regulatory agencies that the compound is
  safe and effective for the intended purpose.
• Launch, promote, and sell the product.
• Support the commercial success of the product
  with post-marketing studies.

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Major RD Departments(bringing molecules to
market)
Discovery Pharmacology
Toxicology
Pharmaceutics
Chemistry
Project Management
Licensing
Pharmacy
PK
Clinical Development
Regulatory
Market Planning
Literature Services
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Pharmacy Services in RD

• Support RD through participation on all project
  teams.
• Manage supplies and flow of NCE between Chemical
  Development, Pharmaceutics/ Formulation, and
  users (preclinical and clinical studies).
• Package, label, distribute, and maintain
  accountability for clinical trial materials.
• Common entry point for PharmDs with no industry
  experience.

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Clinical Development Department

• Responsible for creating the optimal strategy to
  assess the clinical utility of the new compound.
• Responsible for planning and conducting a series
  of clinical protocols designed to assess the
  efficacy and safety of the new compound, with the
  goal of getting the compound registered.

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Major Components of the Clinical Development
Department
Clinician
Data Services
Statistician
Clinical Research Associate
Outcomes Research
Medical Writer
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Conducting a Protocol (101)

• Clinician writes the protocol to accomplish
  specific scientific objectives.
• Clinician recruits Investigators (MDs) to conduct
  the study by treating their eligible patients
  according to the protocol and recording the study
  data.
• CRAs monitor the completeness and accuracy of the
  investigators data and bring the data in-house.

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Conducting a Protocol (101)

• Data handling specialists enter the data and
  program the output.
• Statisticians analyze the data.
• Clinician interprets the data.
• Medical Writer summarizes the data.
• Clinician utilizes the new knowledge in the
  design of the next protocol.

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Phases of Clinical Development

• Phase 1 protocols
• Objectives are to establish dose ranges,
  pharmacokinetics and safety/tolerance.
• Conducted in normal volunteers or in patients
  with targeted indication

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Phases of Clinical Development

• Phase 2 protocols
• Objectives are to assess the activity of the
  compound in patients with the target disease and
  to assess safety/tolerance.

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Phases of Clinical Development

• Phase 3 protocols
• Objectives are to assess the efficacy and safety
  of the compound in patients with the target
  disease, relative to standard therapy.

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Phases of Clinical Development

• Phase 4 (post-marketing) protocols
• Objectives are to further characterize the
  effects in subpopulations or with an emphasis on
  additional endpoints.

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Job Description for Clinical Scientist

• Responsible for developing new protocols,
  implementing, conducting, interpreting, and
  summarizing clinical studies. Presentation of
  plans and data internally and externally as
  appropriate.

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Job Description for Clinical Scientist

• Requirements cited from several current job
  postings
• PharmD minimum of 1 year (to 5 yrs) of related
  experience
• Fellowship in Clinical Pharmacology is desired
• Experience in academic and industry early phase
  clinical trial design conduct
• Knowledge of bone metabolism desirable

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Ideal Candidate for Clinical Scientist Position
(in Oncology)

• Formal training in a clinical discipline
  knowledge of clinical labs, disease states,
  pharmacology, pharmacokinetics,
• Specific knowledge of oncology disease states,
  treatments, complications,
• Knowledge of clinical trial methodologies,
  statistics, endpoints,
• Experience in industry-sponsored RD.

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Clinical Research Associate

• Responsible for ensuring the validity, accuracy,
  and completeness of clinical research records by
  monitoring clinical trial data.
• Responsible for ensuring that study conduct
  complies with required Regulatory procedures.
• Common entry point for PharmDs
• with limited industry experience.

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Medical Writer

• Responsible for creating internal documents that
  summarize the results of clinical trials. Works
  with research projects from early studies through
  final FDA document preparation.
• A possible, but not common, entry point for
  PharmDs with limited industry experience.

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Outcomes Research Scientist

• Responsible for developing protocols,
  implementing, conducting, interpreting, and
  summarizing clinical studies that focus on
  quality of life endpoints, clinical utility
  measures, pharmacoeconomic assessments, etc.
• Generally would require some specialized training
  (as per a Fellowship?)

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Regulatory Affairs Department

• Responsible for managing the interface between
  the Sponsor and Regulatory Agencies (eg, FDA) so
  that the information gained through the RD
  process meets the criteria for product
  registration.
• A possible, but not common, entry point for
  PharmDs with limited industry experience.

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Additional Departments with Possible Career
Opportunities for PharmDs

• No further degree or formal training program is
  required
• Clinical Quality Assurance Department
• Safety Surveillance Department
• Possible, but not common, entry points for
  PharmDs with limited industry experience.

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Additional Departments with Possible Career
Opportunities for PharmDs

• Formal degree, training, or experience is usually
  required/preferred
• Pharmacokinetics Drug Metabolism Department
• Licensing Acquisitions Department
• Literature Services Department
• Project Management
• Market Planning Department

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So, how can I get a cushy RD Job without having
RD Experience?
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So, how can I get a cushy RD Job without having
RD Experience?

• Be prepared to start with a job other than your
  ideal job. Gain industry-based RD experience,
  establish your reputation, look for internal or
  external opportunities.

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So, how can I get a cushy RD Job without having
RD Experience?

• Initially seek employment with
• a Contract Research Organization (CRO) that
  supports pharmaceutical-based RD, or
• an academic center that has a strong clinical
  research component.

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So, how can I get a cushy RD Job without having
RD Experience?

• Build your knowledge and experience level to
  match the desired attributes.
• Seminars or courses in clinical trial design,
  statistics, business, etc.
• Specialized disease knowledge
• Publish (something -- anything!)
• Research fellowship

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Career Opportunities for PharmDs in the
Pharmaceutical Industry Research Development