MSCI 689: Career Development for the Biomedical PhD Scientist Introduction to Medical Writing and Drug Development

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1 MSCI 689: Career Development for the Biomedical PhD Scientist Introduction to Medical Writing and Drug Development Danielle K Lewis, PhD April 28, 2017

2 One-Stop Shop Regulatory Submissions Regulatory Operations Regulatory Affairs Medical Writing & Disclosure Services Clinical Programming Biostatistics Data Management Medical Information Drug Safety & PV Clinical Development Support Data Abstraction GMP & GLP Services 2

3 Objectives Definition/Description of Medical Writing Drug Approval Process Discuss How the Documents We Write Fit into This Process Transitioning from Academia to Med Writing Tips and Tricks to Get That First Look 3

4 Medical Writing The art of communicating clinical and scientific data and information different from manuscript writing Communicates the effects of treatments/medications (interventions) on human subjects during clinical studies. Describes non-interventional (epidemiology, methodology, longitudinal etc.) study events and results in clinical study reports (CSRs). It also communicates the risk of a drug as well as the company plan for monitoring and negating those risks. 4

5 It is Global 5

6 Medical writing We submit documents all over the globe (eg, US, EU, Japan, Russia, Jordan, Brazil, Colombia, Mexico, South Africa, Thailand, Taiwan, Vietnam, ) 6

7 Medical Writing An ideal medical document/presentation is prepared with the audience in mind. The audience might be: A clinical/scientific team A government agency (FDA, EMA, PMDA) An objective 3 rd party reviewer/expert in the field A product consumer/public A well-written document will accurately present the information and successfully communicate the outcome in the most concise manner possible. 7

8 Medical Writing Questions medical writers ask about the documents they are writing: What is its purpose? Who is the target audience? What type of publication is it? Does a template exist? Are there previous similar documents that can be used as a guide? What are the proposed start and finish dates? Is there a specific style guideline/format that should be followed? Who will sign off on the document and at what stages? 8

9 Types of Documents Written by MMS Regulatory /Clinical Investigational new drug (IND) Clinical study protocol Case report form (CRF) Clinical study report (CSR) Common technical document (CTD) New drug application (NDA) Marketing authorization application (MAA) Summary of clinical efficacy (SCE) Summary of clinical safety (SCS) Orphan drug application Investigator s brochure (IB) update Briefing book/package Regulatory response Global feasibility document Risk management plan (RMP) Lay Summaries Marketing Academy of Managed Care Pharmacy (AMCP) dossier Medical slide deck Educational Medical training document Competitive intelligence Abstract Manuscript Poster 9

10 Drug Approval Process: Timeline, Documents Pre- Clinical Phase 1 Phase 2 Phase 3 Phase 4 Pre-IND Mtg IND Filing End of Ph2 Mtg Pre-licensing Mtg Approval NDA Filing Briefing Document IND IB CSRs Study documents: protocol; SAP; CRFs; table requirements) Briefing Document Briefing Document CTD Query Response PSURs (updated every 6 months) Annual Updates to IND, IB 10

11 Drug Approval Process: Clinical Trials Types of Clinical Trials in Humans Phase I: Try to determine dosing, document how a drug is metabolized and excreted, and identify acute side effects. Subjects: usually between 20 and 80 healthy volunteers Phase 2: Gather further safety data and preliminary evidence of the drug's beneficial effects (efficacy), and develop and refine research methods for future trials with this drug. Subjects: approximately people who have the disease or condition that the product potentially could treat. Phase 3: Further test the product's effectiveness, monitor side effects, and, in some cases, compare the product's effects to a standard treatment, if one is already available. Subjects: approximately 1,000-3,000 people with the disease. These studies also help define the safety profile of the drug 11

12 Drug Approval Process: Timeline, Documents Pre- Clinical Phase 1 Phase 2 Phase 3 Phase 4 Pre-IND Mtg IND Filing End of Ph2 Mtg Pre-licensing Mtg Approval NDA Filing Briefing Document IND IB CSRs Study documents: protocol; SAP; CRFs; table requirements and RMPs (for EMA) Briefing Document Briefing Document CTD Query Response PSURs (updated every 6 months) Annual Updates to IND, IB 12

13 Application for marketing authorization 13

14 Drug Approval Process: Timeline, Documents Pre- Clinical Phase 1 Phase 2 Phase 3 Phase 4 Pre-IND Mtg IND Filing End of Ph2 Mtg Pre-licensing Mtg Approval NDA Filing Briefing Document IND IB CSRs Study documents: protocol; SAP; CRFs; table requirements and RMPs (for EMA) Briefing Document Briefing Document CTD Query Response PSURs (updated every 6 months) Annual Updates to IND, IB 14

15 OK so what do you DO as a medical writer????? Writing Client interaction Manage timelines Set meetings up with client, go over client/writer expectations Usually work within a document management system of the client Interact with teams of 4 to 15 people and incorporate comments from said team. s, phone calls, SOP driven there is a defined process for everything 15

16 How do you transition from academia? My personal experience PhD Neuroscience Over 15 years of research Laboratory Skill Set Animal care surgery Had multiple projects to manage Wrote SOP and animals use protocols for lab Worked by myself for HOURS Wrote papers Lectured Team driven science 16

17 Come up with a new brand for yourself Laboratory Skill Set Animal care surgery - Had multiple projects to manage Wrote SOP and animals use protocols for lab Worked by myself for HOURS Had published scientific manuscripts Lectured Team-driven science Medical Writing Skill Set Ability to manage multiple timelines Writing skills Work independently Writing skills Can communicate effectively with people Ability to work in a team environment 17

18 How do you transition into Medical Writing? Write, write, write Informational interviews..network Publications, SOPs, laboratory safety, animal use protocols, grant writing Online sources: Upwork, The HittList, American Medical Writers Association Internships Showcase your skills Management and organizational skill set Teaching experience translates to ability to communicate effectively Meeting deadlines medical writing is driven by timelines 18

19 Pros and Cons of Medical Writing Pros Can do your job anywhere with secure wifi The documents are fun and interesting Job outlook is great Sense of accomplishment Cons Can do your job anywhere with secure wifi Teams can be difficult Spend a lot of time sitting 19

20 MMS Holdings Inc. MMS is a clinical research organization (CRO) based in Canton, MI. Worldwide presence (India, Europe, Japan, China, Middle East, South Africa) MMS is a growing company More than 20 new clients in new medical writers were hired at US and EU sites in

21 MMS Work Environment Professional colleagues On-site training Benefits: PTO, 401K with Employer Match, Life/Health Insurance, Flex Accounts, On-site Yoga and Chair Massages, Company Events 21

22 Questions? 22

23 Contact information Danielle K Lewis lewisdani67@gmail.com 23

24 Thank You! For additional information or questions regarding our services, visit our website: or Contact MMS: Scan with your smartphone or tablet to go to our website for more details. 24

25 Revision History Date Reason(s) Author(s) 06/13/2013 Original Philip Jessmon 02/12/2015 Updated for outreach opportunities 02/22/2017 Updated for Professional Development Series at UT/ new slide deck 04/28/2017 Updated for Texas A & M Career Development for the Biomedical PhD Scientist Lecture Teresa Cesena Jean Overmeyer Danielle Lewis 25