WHAT DO YOU WANT TO BE WHEN YOU GROW UP? Tinker, Tailor, Soldier, Spy (PART I)
Submitted by Maida Taylor on Thu, 2012-05-10 06:00
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Mergers and acquisitions are rampant in the pharmaceutical industry.  As companies consolidate and reorganize,   downsizing is the norm and many talented people lose their jobs.  Some will take early retirements.  Some may  take a break if they get  severance.  But most are thrown onto the job market.

In my area, the female health sector, things are dismal.  This area of work was pushed off a cliff in 2002 after the first reports from a study called   The Women’s  Health Initiative.  The study was conceived and constructed in part as a pivotal trial to prove that estrogen alone or in combination with a progestogen,  would lessen the incidence of cardiovascular events in healthy women, not unlike  the statin drugs.  In initial reports not only were  no CV benefits, evident,   but preliminary data suggested that estrogen actually might increased cardiovascular events,  particularly in women over the age of 60. 

While the WHI assessed many other health effects of hormones (and other interventions) having yield over 400 publications to date, the failure to prove the primary endpoint,  cardiovascular risk reduction,  had a devastating effect on research on women’s health.  Commercial entities hoped that the WHI would prove that estrogen was indeed a panacea, mitigating all the ailments and complaints associated with aging in women…osteoporosis, genital atrophy, mood and cognitive changes, sexual function,  and the most important killer of women, cardiovascular disease.  The entire  field of menopausal medicine was poised for the WHI to show positive results.  The large manufacturers hoped to greatly expand the indication for estrogens, possibly doubling or tripling the patient pool by adding cardiovascular prevention to the label.  New “boutique”  estrogens,  while really not new, no innovative, just new methods of delivering drug,  had been developed – gels, creams, lotions, sprays.  All of these small companies were hoping that when the WHI hit and the market expanded,  that the rising tide from increased prescribing would help not only the market leaders, but would float all boats.  

And so menopause medicine fell into a death spiral.  Major manufacturers not only failed to get a  bump in market share,  but in fact experienced a fall in sales of more than 60%. Small boutique manufacturers were crushed,  and would never recoup the  investments they made in developing new delivery systems. 

And major players were so sure that estrogen would prove to be a panacea for aging and they wagered heavily and only on that bet. Everyone made the same bet and everyone lost.   There was very little  R and D investment in non hormonal approaches to menopause.  When the estrogen market collapsed,  there was no fall back position.   The  non hormonal pipeline for menopause was virtually empty, and even now,  10 years after the first publication from the WHI,  alternatives to estrogen are lacking, and the pipeline is still just a giant gaping void.

The women’s health research and development stream  has dried to a trickle.  First menopause research dwindled away.  At the same time,  contraceptive research stalled owing to suggestions that newer formulations carried higher risks, and to pressure from managed care directing prescribers to write for generic versions of oral contraceptives. Selective estrogen receptor modulators, once seen as a promising alternative to estrogens, failed to meet clinical and  commercial expectations.  

After 10 years toiling in the reproductive endocrinology trenches, I found work opportunities withering on the vine. So I started to explore the possibility of a lateral transition. Regulatory affairs struck a responsive chord for me.  Regulatory affairs seemed like good fit for my personality because  in my heart of hearts,  I think I am a regulator.  In a job  interview, I was asked how strongly I felt about drug safety on a scale of 1 to 10, and I answered   “12”.   Drug safety supersedes all other parameters in my  mind and working in the regulatory field seemed to be a compatible direction.  But regulatory affairs encompasses much more than just drug safety.

Regulatory affairs personnel, depending on their level of background and experience,  help to keep drug and device companies in compliance with all laws and regulations in the USA and aboard.

Typical functional areas include:

1. Overseeing and coordinating regulatory and quality compliance with federal and international regulations.

2. Participating in the regulatory approval process

3. Formulating and communicating the overall regulatory  process to other groups and teams like internal marketing, legal and medical affairs,  to board of directors,   and outside agencies.

4. Overseeing registration-filing

5. Assisting in the preparation of drug informational and research dossiers.

6. Developing, tracking and monitoring risks and outcomes 

7. Establishing and maintaining systems to insure compliance with regulations.

8. Assuring the quality of documents that are assembled to support all regulatory submissions.

9. Working with quality and regulatory personnel at all clinical research organizations,  research sites, and other outside agencies to define their roles and the standards that must be met to be compliant with regulations.

I guess that regulatory affairs sounds like being part traffic cop, part district attorney,  part mother superior,  and part scientific writing factor checker.   

So how do you get there?  Is there a path?  Is there a defined career development plan that leads to a job in this area? 

I tried to find the avenues that led to regulatory expertise and jobs.   My search brought me to websites and schools that offer regulatory degrees or regulatory certificate. Around that time, coincidently,  BIOCAREERS received a query from a student asking if a  “ticket” like a degree or certificate would indeed  facilitate  entry into the regulatory affairs field.  Just around that time,  I actually had started “attending” information sessions on line from institutions offering training programs in this field.  In my next posting, I will pass on what I have learned in my recent search.   Stay posted. 



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