BCMAS LATEST UPDATED ACTUAL QUESTIONS AND
ANSWERS SURE A+
✔✔What are the advantages of point-of-care diagnostics?
Faster decision making
Better compliance
Patient convenience
Lower operational costs
All choices are the advantages of point-of-care diagnostic - ✔✔All choices are the
advantages of point-of-care diagnostic
✔✔Which of the following types of data in a publication refer to a drug that is already
approved by the FDA?
Phase II
Phase IV
Phase I
Phase IIa - ✔✔Phase IV
✔✔True or False: An MSL may provide a fully paid conference travel to an HCP as part
of their ongoing collaboration.
True
False - ✔✔False
✔✔Company X is planning the life cycle of a drug for the treatment of glaucoma. The
company is in the process of formulating the various advisory boards that can help them
answer critical questions. Which of the following would not be a recommended
participant for any of the advisory boards?
A marketing analyst from a globally recognized firm regarding medications for the eye
An expert cardio-surgeon
A representative who previously worked for a government-sponsored insurance plan
covering patients aged 65 and older
An ophthalmologist who is a Key Opinion Leader in the field of glaucoma - ✔✔An expert
cardio-surgeon
✔✔The main role of an advisory board is to:
Provide strategies for creating the gold standard
Provide expert opinion on needs of stakeholders
Help the pharmaceutical company gain market access
Provide financial assistance to the company - ✔✔Provide expert opinion on needs of
stakeholders
,✔✔True or False: Effective communication is an essential qualification for MSLs.
True
False - ✔✔True
✔✔True or False: Pharmacokinetics/pharmacodynamics profile of a drug is assessed
during phase 1 of clinical trial.
True
False - ✔✔True
✔✔The sequence best describing the supply chain process is:
Raw material --> distributors --> manufacturing units
Raw material --> distributors --> central warehouses
Raw material --> manufacturing units --> distributors
Raw material --> regional warehouses --> central warehouse - ✔✔Raw material -->
manufacturing units --> distributors
✔✔True or False: Medical Affairs usually serve as the publication team.
True
False - ✔✔False
✔✔Which of the following statements correctly describe similarities between the IDE
and IND process?
There is the requirement of oversite by an IRB
There is a document containing information required under 21 CFR 807 Subpart E
There is the requirements of legal review by the company
There is a need for a formally approved protocol for clinical trials - ✔✔There is the
requirement of oversite by an IRB
There is a document containing information required under 21 CFR 807 Subpart E
There is a need for a formally approved protocol for clinical trials
✔✔You are preparing to present on a recent Phase III clinical trial, which reports the
results of a new oral protease inhibitor for patients with Type 1 Hepatitis C. The
audience consists of expert hepatologists. Which of the following is most important to
put at the beginning of the presentation?
Current treatment modalities for patients with hepatitis C
An overview of the disease state
The differences between novel and current protease inhibitors
No choices are correct - ✔✔No choices are correct
,✔✔True or False. Sarah is an HEOR director at a mid-size biotech company and is
trying to determine what the most common discount rates are in the literature. She
conducted a literature review and uncovered that the most common discounted rates
currently seen in the literature are 3% to 5%.
True
False - ✔✔True
✔✔True or False: Pharmacogenetics is defined as the study of variations in DNA
sequence as related to drug response
True
False - ✔✔True
✔✔Which of the following may be used to study rare outcomes or multiple exposures?
Cohort Study
RCT
Case-Control
Case Series - ✔✔Case-Control
✔✔Why are ISS valuable to a pharmaceutical company?
They provide a good reputation to the company
They may lead to exemption from submitting an NDA
They may identify usage in an area of unmet needs
They may support data presented in clinical studies - ✔✔They may identify usage in an
area of unmet needs
✔✔An advantage of Investigator Initiated Studies is:
Study can never be biased
Eliminates any results that conflict with available evidence
Investigators are required to complete the study
Results showing new drug indications - ✔✔Results showing new drug indications
✔✔You are preparing to present to a group of endocrinologists on the latest class of
type 2 diabetes drug, the SGLT-2 Inhibitors. Which of the following information is of
lowest priority to share:
Efficacy & Safety Data for the new drug
The difference between Type 1 & 2 diabetes
Mechanism of action of SGLT-2 inhibitors
No choices are correct - ✔✔The difference between Type 1 & 2 diabetes
, ✔✔An ISS may (Select all that apply):
Leave the Sponsor with expensive equipment
Include a budget for training
Be conducted using drug samples
Assess a drug's efficacy in a new indication
Circumvent the ethical requirements to which a pharmaceutical company must adhere
Include an investigator meeting - ✔✔Include a budget for training
Assess a drug's efficacy in a new indication
Include an investigator meeting
✔✔Which of the following is a self-assessment that measures multiple aspects of a
patient's perceived well-being?
Health Status Assessment
Cost-benefit Assessment
Quantity of Life Assessment
Patient Preference Assessment - ✔✔Health Status Assessment
✔✔A medical director has recently completed the final draft for a poster she is
presenting at the upcoming American Heart Association (AHA) meeting. In order for the
poster to be presented, she will need to work with which of the following internal
functions for approval of the poster and its contents? (Select all that apply):
Commercial
Clinical
Regulatory
Legal - ✔✔Clinical
Regulatory
Legal
✔✔True or False: The FDA has a program called MedWatch to monitor serious adverse
events in postmarketing studies.
True
False - ✔✔True
✔✔Patent of a drug usually expires after:
10 years
15 years
20 years
30 years - ✔✔20 years
ANSWERS SURE A+
✔✔What are the advantages of point-of-care diagnostics?
Faster decision making
Better compliance
Patient convenience
Lower operational costs
All choices are the advantages of point-of-care diagnostic - ✔✔All choices are the
advantages of point-of-care diagnostic
✔✔Which of the following types of data in a publication refer to a drug that is already
approved by the FDA?
Phase II
Phase IV
Phase I
Phase IIa - ✔✔Phase IV
✔✔True or False: An MSL may provide a fully paid conference travel to an HCP as part
of their ongoing collaboration.
True
False - ✔✔False
✔✔Company X is planning the life cycle of a drug for the treatment of glaucoma. The
company is in the process of formulating the various advisory boards that can help them
answer critical questions. Which of the following would not be a recommended
participant for any of the advisory boards?
A marketing analyst from a globally recognized firm regarding medications for the eye
An expert cardio-surgeon
A representative who previously worked for a government-sponsored insurance plan
covering patients aged 65 and older
An ophthalmologist who is a Key Opinion Leader in the field of glaucoma - ✔✔An expert
cardio-surgeon
✔✔The main role of an advisory board is to:
Provide strategies for creating the gold standard
Provide expert opinion on needs of stakeholders
Help the pharmaceutical company gain market access
Provide financial assistance to the company - ✔✔Provide expert opinion on needs of
stakeholders
,✔✔True or False: Effective communication is an essential qualification for MSLs.
True
False - ✔✔True
✔✔True or False: Pharmacokinetics/pharmacodynamics profile of a drug is assessed
during phase 1 of clinical trial.
True
False - ✔✔True
✔✔The sequence best describing the supply chain process is:
Raw material --> distributors --> manufacturing units
Raw material --> distributors --> central warehouses
Raw material --> manufacturing units --> distributors
Raw material --> regional warehouses --> central warehouse - ✔✔Raw material -->
manufacturing units --> distributors
✔✔True or False: Medical Affairs usually serve as the publication team.
True
False - ✔✔False
✔✔Which of the following statements correctly describe similarities between the IDE
and IND process?
There is the requirement of oversite by an IRB
There is a document containing information required under 21 CFR 807 Subpart E
There is the requirements of legal review by the company
There is a need for a formally approved protocol for clinical trials - ✔✔There is the
requirement of oversite by an IRB
There is a document containing information required under 21 CFR 807 Subpart E
There is a need for a formally approved protocol for clinical trials
✔✔You are preparing to present on a recent Phase III clinical trial, which reports the
results of a new oral protease inhibitor for patients with Type 1 Hepatitis C. The
audience consists of expert hepatologists. Which of the following is most important to
put at the beginning of the presentation?
Current treatment modalities for patients with hepatitis C
An overview of the disease state
The differences between novel and current protease inhibitors
No choices are correct - ✔✔No choices are correct
,✔✔True or False. Sarah is an HEOR director at a mid-size biotech company and is
trying to determine what the most common discount rates are in the literature. She
conducted a literature review and uncovered that the most common discounted rates
currently seen in the literature are 3% to 5%.
True
False - ✔✔True
✔✔True or False: Pharmacogenetics is defined as the study of variations in DNA
sequence as related to drug response
True
False - ✔✔True
✔✔Which of the following may be used to study rare outcomes or multiple exposures?
Cohort Study
RCT
Case-Control
Case Series - ✔✔Case-Control
✔✔Why are ISS valuable to a pharmaceutical company?
They provide a good reputation to the company
They may lead to exemption from submitting an NDA
They may identify usage in an area of unmet needs
They may support data presented in clinical studies - ✔✔They may identify usage in an
area of unmet needs
✔✔An advantage of Investigator Initiated Studies is:
Study can never be biased
Eliminates any results that conflict with available evidence
Investigators are required to complete the study
Results showing new drug indications - ✔✔Results showing new drug indications
✔✔You are preparing to present to a group of endocrinologists on the latest class of
type 2 diabetes drug, the SGLT-2 Inhibitors. Which of the following information is of
lowest priority to share:
Efficacy & Safety Data for the new drug
The difference between Type 1 & 2 diabetes
Mechanism of action of SGLT-2 inhibitors
No choices are correct - ✔✔The difference between Type 1 & 2 diabetes
, ✔✔An ISS may (Select all that apply):
Leave the Sponsor with expensive equipment
Include a budget for training
Be conducted using drug samples
Assess a drug's efficacy in a new indication
Circumvent the ethical requirements to which a pharmaceutical company must adhere
Include an investigator meeting - ✔✔Include a budget for training
Assess a drug's efficacy in a new indication
Include an investigator meeting
✔✔Which of the following is a self-assessment that measures multiple aspects of a
patient's perceived well-being?
Health Status Assessment
Cost-benefit Assessment
Quantity of Life Assessment
Patient Preference Assessment - ✔✔Health Status Assessment
✔✔A medical director has recently completed the final draft for a poster she is
presenting at the upcoming American Heart Association (AHA) meeting. In order for the
poster to be presented, she will need to work with which of the following internal
functions for approval of the poster and its contents? (Select all that apply):
Commercial
Clinical
Regulatory
Legal - ✔✔Clinical
Regulatory
Legal
✔✔True or False: The FDA has a program called MedWatch to monitor serious adverse
events in postmarketing studies.
True
False - ✔✔True
✔✔Patent of a drug usually expires after:
10 years
15 years
20 years
30 years - ✔✔20 years
