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APA FORMAT,TEXT citations required.(Please use those references ) Question 1) What is the role of MarComm (Marketing Communications) with the PRC, and what is MarComm’s connection with Sales? Question 2) What is the Physician Payment Sunshine Act designed to do? What is its purpose? Question 3) Does Marketing or Sales recommend the price of a drug? Question 4) How do you think a biotech prepares its Sales Force for product launch? Resources For first 4 * Slideshare: Arnzen Group: “Biotech Journey Through the Phases of Commercializing a Product,” by B Arnzen & S Nemetz, January 24, 2013 (with attention to Slide 11, which will inform your Primer’s Slide 4): https://www.slideshare.net/CBGBenefits/biotech-journeycommercializinga-productLinks to an external site. * PMA Conference: A PRC Conference Agenda (an example of what PRC’s do, what they are concerned with, issues they must consider, and general scope): http://www.pmaconference.com/C1048_web.pdfLinks to an external site. * SpringerLink: Journal of Commercial Biotechnology: “Biotechnology Marketing: Insider and outsider views,” by Pâivi Eriksson and Heidi Rajamâki, May 26, 2009: https://link.springer.com/article/10.1057/jcb.2009.16Links to an external site. * JDSUPRA(R): “Promotional Review Best Practices: 8 Key Questions and Answers,” by Jeremy Lutsky at Manett, Phelps & Phelps LLC, October 23, 2019: https://www.jdsupra.com/legalnews/promotional-review-best-practices-8-key-61549/Links to an external site. * [REPEAT from Module 7, but different section: pay attention to Slides 7-12] Arnold & Porter: FDA Regulation of Advertising and Promotion (Alex Toy, July 14, 2013): https://www.arnoldporter.com/-/media/files/perspectives/publications/2013/07/fda-regulation-of-advertising-and-promotion/files/publication/fileattachment/raps–fda-regulation-of-advertising-and-promotion.pdf?Links to an external site. * STAT+, Opinion Plus: “Making pharma’s post-Covid-19 future faster and smarter,” by Saul Helman and David Weiss, March 8 2021: https://www.statnews.com/2021/03/08/pharma-industry-post-covid-19-future-faster-smarter/Links to an external site. Question 5) At what point do you need Quality? Question 6) What are the different roles for Supply Chain, Quality and Manufacturing? Question 7) What does cGMP mean and why is it important? Question 8) Based on the 5 in 10 and readings in this module, which group has ultimate approval authority for the Company’s release of a product: Supply Chain, Quality or Manufacturing? (NOTE: FDA has technical authority to release vaccines; this question is about what we learned in this module, so in this case we are not talking about the FDA) Resources for question 5-8 * PharmTech “Creating Effective Biopharmaceutical Organizations,” by Edward R. Arling, Ralph Dillon, Joseph Noferl, August 22, 2014: http://files.pharmtech.com/alfresco_images/pharma/2014/08/22/f87435dd-a494-4469-9727-8b9fc8025d7e/article-22984.pdfLinks to an external site. — Please skim this; the purpose of the reading is to enable a full appreciation of how big and critical the Quality organization is in any regulated organization, especially biotech. * Master Control: GxP LifeLine: “FDA vs EU Inspections: Similarities and Differences,” Marie E. Dorat, CQA, CAA IPRF; RA/QA Consulting & International Product Registration EU-FDA Joint Initiative; October 14, 2014: https://www.mastercontrol.com/gxp-lifeline/fda-vs-eu-inspections-similarities-differences/Links to an external site. * EMA Compliance Overview, Human Regulatory: https://www.ema.europa.eu/en/human-regulatory/overview/compliance-overviewLinks to an external site. * Pharmaceutical Guidelines: “Difference Between GMP and GLP,” Ankur Choudhary, N.D, https://www.pharmaguideline.com/2018/01/differences-between-gmp-and-glp.htmlLinks to an external site. Note: during clinical trials, Good Clinical Practices are followed; GLPs are related to the labs but similar in many ways to GCPs * cGMPs (FDA): https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm169105.htmLinks to an external site. * GMP (EMA): https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practiceLinks to an external site. * 21 CFR 211 Subpart B: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=211&showFR=1&subpartNode=21:4.0.1.1.11.2Links to an external site. (<— This is where you learn how important the Quality, and specifically Quality Control, unit is…) * FDA Inspection Observations: https://www.fda.gov/ICECI/Inspections/ucm250720.htmLinks to an external site. and Form 483 Frequently Asked Questions: https://www.fda.gov/ICECI/Inspections/ucm256377.htmLinks to an external site. Manufacturing * DATED (2004): fascinating to see where biotech was 15+ years ago vs now, but a lot still holds true: Science: "Careers in Biotech Manufacturing," Jim Kling, April 23, 2004: https://www.sciencemag.org/careers/2004/04/careers-biotech-manufacturingLinks to an external site. * Biotechnology, Amgen: "A rare inside look into biotech manufacturing" (STAT): https://www.statnews.com/sponsor/2017/04/21/rare-inside-look-biotech-manufacturing/Links to an external site.
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