Chapter 6 - Medical Affairs
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Because without medical affairs, life in Pharma would be pretty boring.
- 1.Medical Affairs often serves as the internal ___________ between the research and commercial sides of a pharma company.
- A.
Obstacle
- B.
Bridge
- C.
Road
- D.
Hurdle
- 2.Which consideration (question) is NOT a driver for medical affairs activities?
- A.
What services will generate the maximum amount of profits in the long run based on the company's current level of penetration of a specific therapeutic area.
- B.
What services are of high value, given the degree of innovation represented by company products, the cost and complexity of care regimens, and the nature of the target disease states?
- C.
What services can products in the portfolio "afford", given the revenue potential?
- D.
What services does the company have the internal capabilities to execute effectively?
- 3.What is the primary purpose of the medical information center?
- A.
Responding to customer concerns, specifically dosing information
- B.
Responding to calls from healthcare professionals, specifically product related inquiries.
- C.
Responding to internal concerns regarding specific products
- D.
Providing medical information to the external community
- 4.What is not required by Medical Affairs to ensure that information disseminated by the Medical Information Center is clear and accurate?
- A.
Standardized operating procedures
- B.
Experience with the development of the product
- C.
Robust systems and tools
- D.
Intensive training
- 5.What role does Pharmacovigilance play in Medical Affairs?
- A.
The Robin Hoods of the Pharma world.
- B.
Dealing with negligent behavior during clinical drug trials.
- C.
Dealing with the enforcement of restrictions by the FDA during clinical trials.
- D.
Dealing with reports of adverse events in patients during clinical trials.
- 6.What is the role of Medical Affairs in Preclinical Research?
- A.
Medical Affairs controls all Preclinical Research
- B.
Medical Affairs provides value perspective/vision based on its understanding of alternative products and unmet medical needs
- C.
Medical Affairs acts as the liaison between the Regulatory Department and the Discovery team to ensure that the two divisions are working together to meet the strategic needs of the company.
- D.
Medical Affairs plays no role in Preclinical Research.
- 7.What role does Medial Affairs play in registrational clinical trials?
- A.
Medical Affairs is consulted when the trial is moving between the phases to provide strategic planning advice.
- B.
Medical Affairs is in charge of everything related to registrational clinical trials.
- C.
Medical Affairs plays no role in registrational clinical trials.
- D.
Limited primarily to the recruitment of trial investigators.
- 8.What role does Medical Affairs typically have in non-registrational clinical trials?
- A.
Medical Affairs plays no role in non-registrational clinical trials.
- B.
Medical Affairs assumes responsibility for all post approval studies.
- C.
Medical Affairs plays a limited governance role in post approval trials.
- D.
Medical Affairs is on-call and provides assistance when necessary in post approval trials.
- 9.What are Phase IIIb trials?
- A.
Studies that are a necessary component of the application for regulatory approval.
- B.
Additional studies that piggy back onto the normal phase 3 trials that cropped up due to significant reports of adverse events.
- C.
Studies conducted after a submission to regulators for marketing approval but before that approval is actually granted.
- D.
Phase 3 studies that are being repeated due to the discovery on an off-label usage of the product.
- 10.Which is NOT a reason to conduct non-registrational trials?
- A.
To increase local market presence and experience
- B.
To evaluate product use in a variety of "real-world" settings
- C.
To evaluate off-label usage of the product
- D.
To enhance product differentiation
- E.
To gather additional safety information
- 11.True or False: The term "off-label' can encompass any change to regulator-approved language regarding use of a product up to the examination of an entirely new indication.
- A.
True
- B.
False
- 12.True or false: In the event an "off-label" study seems promising, Medical Affairs usually assumes responsibility of the necessary Phase 2 and 3 clinical studies required for approval of that off label usage.
- A.
True
- B.
False
- 13.True or False: Companies are required to market/promote the information gathered during off label non-registrational trials when it becomes available.
- A.
True
- B.
False
- 14.Why can't the company who created the initial product be involved in any way in the actual conduct of an investigator-initiated trial?
- A.
The conclusions drawn from the trial must be the independent judgment of the investigating physicians.
- B.
Affiliation with the company who created the product would bias the reputation of the study.
- C.
The company is only allowed to be involved with the actual conduct of the trial if they are supplying the test material.
- D.
A and C
- E.
B and C
- 15.What is an investigator-initiated trial?
- A.
A type of phase 4 clinical trial.
- B.
A company-sponsored study.
- C.
A study to investigate a new application of an approved drug without submission of an IND.
- D.
A study regarding a different use of the product conducted by a competitor under the approval of the original product owner.
- 16.What is the name for the studies Medical Affairs performs involving financial and quality of life impacts of a disease; the limitations of other therapies, including the existing standard of care; and the different characteristics of a company product in terms of cost and patient outcomes?
- A.
Pharmacoeconomics
- B.
Pharmacovigilance
- C.
Health economics and outcomes studies
- D.
Cost-benefit ratio in financial terms
- 17.How does Medical Affairs impact product messaging?
- A.
Medical Affairs has nothing to do with product messaging.
- B.
Medical Affairs is in charge of product messaging.
- C.
Medical Affairs can impact the brand messaging by offering medical and scientific insights.
- D.
Medical Affairs defines the promotional product messages.
- 18.Which is NOT a consideration that would normally be addressed in outcomes studies?
- A.
Incidence and intensity of adverse effects
- B.
Adherence to the recommended drug regimen.
- C.
What the cost-benefit equation is in financial terms.
- D.
Overall quality of life.
- 19.Within Medical Affairs, what is the role of Medical Communications?
- A.
Medical Communications is responsible for disseminating information that supports the positive outcomes of the company's products.
- B.
Medical Communications acts as a relay center between Medical Affairs and the outside world, performing triage and routing calls from healthcare professionals and patients.
- C.
Medical Communications is responsible for the brand messaging and marketing materials for a new product.
- D.
Medical Communications is responsible for communicating unbiased non-promotional information the company's products.
- 20.What is the primary matter addressed by Publication Planning?
- A.
How to brand and market a new product.
- B.
Determining when and where to publish information about a product.
- C.
When articles are published about a product, how to use the peer-reviewed literature to the advantage of a drug.
- D.
The overall plan of the NDA application submitted to the FDA.
- 21.What piece of material do the Medical Writers NOT play a role in creating?
- A.
The package insert.
- B.
Journal articles.
- C.
Summaries of published articles, or abstracts.
- D.
Oversized summaries of preliminary trial results, or posters.
- 22.Why is it important for a pharma company to enlist the expertise of KOLs in the development of a new drug?
- A.
The KOL's are plugged into the industry and understand where gaps are for the pharma company to exploit.
- B.
The opinion of a KOL carries much weight with the community and can influence healthcare officials with prescribing power around them.
- C.
KOL's will be more apt to prescribe a drug that they helped develop.
- D.
Pharma companies can use the expertise of KOL's to help refine their lead series to formulate a more promising compound.
- 23.Who, within Medical Affairs, is responsible for cultivating long term relationships with external KOL's?
- A.
The head of Medical Affairs
- B.
The most famous/prominent scientists on staff at the particular pharma company.
- C.
The Medical Liaison
- D.
Internal KOL's
- 24.Which is NOT a primary reason that KOL's important to pharma companies?
- A.
KOL's may educate fellow physicians about therapeutic options they consider the best.
- B.
KOL's can offer insights into treatment issues and unmet needs inside the therapeutic area.
- C.
KOL's may provide disease-state education to their fellow physicians/build awareness
- D.
KOL's run the external continuing education programs as a representative of the sponsoring pharma company.
- E.
KOL's may agree to serve as investigators on clinical trials thereby increasing the impact of such trials on the perception of other healthcare professionals.
- 25.What makes a Medical Liaison successful in securing access to KOL's and AMC's (Academic Medical Centers)
- A.
A large supply of alcohol, hot girls, money, and other niceties that are good to have on hand when trying to influence KOLs.
- B.
A smooth, sales-guy persona who can sell ice to an eskimo.
- C.
Their access to the board of governors at the target AMC to influence the prescribing physicians from the top down.
- D.
Their demonstrated mastery of the latest research related to a therapeutic area, disease state, and drug.
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