CRO Writing Opportunities: More Than Just Regulatory. Cindy van Dijk Principal Scien3fic Communica3ons & Medical Marke3ng

Transcription

1 CRO Writing Opportunities: More Than Just Regulatory Cindy van Dijk Principal Scien3fic Communica3ons & Medical Marke3ng

2 Contract Research Organiza4on Over 1,100 CROs found around the world from full- service to niche special4es All sizes and shapes Large (>$ 1 bil) Mid ($50 mil- $1 bil) Niche/Small ($<50 mil) What is a CRO?

3 Anatomy of a CRO Early Development Goals: Make as efficient as possible or fail fast Strategic development Clinical Development Central Lab, clinical monitoring, data management, sta4s4cs, feasibility, manufacturing, packaging, regulatory, clinical supplies, imaging studies Commercializa4on and beyond Contract sales, REMS, reimbursement, health outcomes, safety surveillance, pricing assessments, quality

4 What do CRO s do? Offer a broad and fragmented set of services across the spectrum of life science product development. Niche to full service capabili4es and func4ons Func4ons include: Nonclinical (since the 1940 s) Central Laboratory for clinical studies Compounding Biomarkers Genomics Imaging/cardiac niche Clinical development Regulatory consul4ng Manufacturing Logis4cs, supply chain Contract sales Market access Registries Reimbursement support Supply Chain/ Logis4cs (IVR/ IWR, Packaging) Clinical Nonclinical Contract Research Organiza4on Commercializa4on Manufacturing

5 Why CRO s are Used Life science companies (Pharma, biotech, device) are realizing it is beber to lease or use assets rather than own assets The trend is toward: Insourcing core ac4vi4es, outsourcing non- core Can occur at any phase of development Reduce redundancies, costs, delays Mi4gates the high s and low s of fluctua4ng pipelines Use CROs for strategic sourcing CRO focus is on process efficiencies as opposed to IP

6 Pharma Alliances Moving from Tac4cal to Strategic Recent Strategic Alliance Announcements Quin4les & Astra Zeneca (clinical pharmacology) Quin4les & Lilly (Revenue stake with Cymbalta) Quin4les & Eisai (oncology early development to phase II) Quin4les & Samsung (biosimilars) Quin4les/Covance & Takeda (global development programs) Covance & Lilly (strategic partnering, toxicology, developmental biologics tes4ng) Covance & sanofi- aven4s (discovery, toxicology, chemistry) Covance & Merck (discovery support) Covance & Kellogg (analy4cal support- nonclinical) Paraxel & PPD with GSK (Clinical development) Paraxel & Lilly (Asia Pacific development programs) ICON & Daiichi- Sankyo (oncology)

7 The Top 10 Major Players

8 CROs: Major/Mid Players Revenues (2010) Employees # of countries US Headquarters Year Founded Public/Private QuinFles $3 billion 23, Durham, NC 1982 Privately held Covance $2.038 billion 10, Princeton, NJ 1946, 1976 Public- launched 1997 PPD $1.47 Bil 11, Wilmington, NC 1985 Public Charles Rivers $ Wilmington MA 1947 Public (2000) Labs billion Parexel $1.13 Bil 10, Waltham, MA 1982 Public ICON $900 mil North Wales, PA 1990 Irish Kendle $338 mil Cincinna4, OH 1981 Public (1997) PharmaNet $451 mil Princeton, NJ 2000 private PRA InternaFonal INC n/a ($410 mil in 2009) $250 mil (2009) Raleigh, NC 1981 Private 2, Raleigh, NC 1998 private INC picked up the Clinical Development assets of MDS pharma in 2009/2010

9 Where are the Wri4ng Opportuni4es?

10 Types of Non- Regulatory Wri4ng Opportuni4es at CROs Internal Newslebers Annual Reports/Financial & Investor informa4on Training & Educa4on Business Development/ Proposals Presenta4ons Video scripts Awards/presenta4ons Communica4ons planning External Abstracts Case Studies Trade ar4cles Journal ar4cles White papers Press releases Webinar summaries Presenta4ons Marke4ng communica4ons Web site content

11 Trades & Journals Targeted at the CRO/Development Services Market DIA Journal The Monitor (ACRP) Pharmaceu4cal Outsourcing ODT Magazine (Device) European Pharmaceu4cal Contractor SCRIP (clinical research) Gene4c Engineering & Biotechnology News Pharmaceu4cal Technology ICT (Interna4onal Clinical Trials) * This is not a comprehensive lis4ng Applied Clinical Trials PharmaVoice CenterWatch publica4ons Contract Pharma Bioprocess Interna4onal Drug Discovery & Development Medical Device & Diagnos4c Industry Pharmaceu4cal Manufacturing Good Clinical Prac4ce (GCP) Journal

12 Training & Exper4se Needed to Work with CROs Core Medical Writer skills Knowledge of the drug development process Sensi4vity to global cultures/working across 4me zones Therapeu4c specialty experience nice, but not necessary Willingness to learn & ask ques4ons

13 Biggest challenge: Be flexible Access to content owner s exper4se can be challenging Consistently overscheduled Compe44on with the billable hour Dynamic structure: Don t get comfortable, the organiza4onal structure is always changing (silos, matrix management, etc.) Fees: project vs. hourly

14 Wri4ng for CROs is Beber than Pharma Because Benefits Rarely have to endure lengthy legal/regulatory reviews found in pharma The people you work with are genuinely nice and appreciate the value you add They pay faster, contracts are straighuorward Turnover doesn t mean the end of a rela4onship, it means an opportunity to expand and grow with your contacts

15 Breaking in: Who Do You Call? Business Development Marke4ng Internal Communica4ons Head, Business Development & Marke4ng Manager, Proposals & Marke4ng Marke4ng & Corporate Communica4ons Investor Rela4ons E- Marke4ng Managers Client service Coordinator Event Manager Public Rela4ons Specialist

16 Websites of interest Quin4les: Covance: Paraxel: PPD: Kendle: ICON: PRA: PharmaNet: Charles Rivers Labs: INC: ResearchPoint:

17 QuesFons, Comments or Smart Remarks? or call me: Cindy van Dijk

18 Brought to you from: Wonderful Washington state..