FDA's HSP/BIMO Progress Report

The FDA has released a progress report on its Human Subjects Protection/Bioresearch Monitoring Initiative (HSP/BIMO).  In the 18 months since launch several new regulations and guidelines have been produced, including:

• IRB registration;
• Expanded access to investigational drugs;
• A new informed consent essential element notifying subjects of study registry on the clinicaltrials.gov system;
• The final guidance on 1572s;
• New guidance on investigator responsibilities;

And a whole bunch more.  Included in the report is an update from the FDA/Duke University Clinical Trials Transformation Initiative (CTTI), which includes among many other things a joint initiative between FDA and EMA for good clinical practice.  The EMA/FDA GCP terms of engagement and procedures document is here.  The HSP/BIMO report is here.

FDA Limits Action Against HIV Investigator

A story linked via FierceBioTech today from an article published last week in the Chicago Tribune describes the apparently light touch the FDA is using to discipline an investigator whose clinic allegedly submitted fictitious data in a clinical drug trial.  Standard procedure in such cases is usually either disqualification from running clinical trials altogether or restriction of the number of trials an investigator may conduct or the number of patients they may enroll.  This investigator, whose writings about HIV are easily searchable on the Web, apparently escaped all such restrictions and instead is allowed to continue clincal trial operations under the supervision of an outside medical monitor for the next three years and is required to submit annual reports to the FDA in that same three year period.  This seemingly light slap runs counter to the message being sent to drug manufacturers themselves for whom the agency is stepping up its oversight with warning letters, product recalls and threats of prosecution, according to the Fierce story. 

Switching gears entirely, here is a link to the OHRP's 2010 International Compilation of Human Research Protections.  This is an absolutely invaluable resource covering the key organizations, legislation, regulation and guidelines pertaining to human subjects protection of 96 countries, updated every year with clickable links.  Every clinical research professional planning studies anywhere in the world including the emerging regions should make this document their first stop. 

Roche Jobs Shift to China

As a former Roche employee (and holder of a pension) my eye is always drawn to stories about changes at that company.  Last week they announced a major cost cutting effort in the US and Europe, letting slip an internal memo naming the employees responsible for each sector.  This week they are announcing a hiring boon in China, increasing headcount there by as many as 750 jobs.  This appears to be the sharp end of the stick in China that we have been watching for, as the Chinese government invests in its drug development capacity and more large sponsors move in to establish operations.  The Fierce article notes that Eli Lilly announced thousands of layoffs last year while staffing up in China.  I think this puts India under some pressure, as clinical trial application approval times there have slipped into 120 days and more, a not very welcoming gesture to sponsors interested in running clinical trials there and have the means to ensure patient safety and ethical conduct.

FDA's Marketing Crackdown

There has been a lot of news about the FDA cracking down on drug makers advertising direct to consumers, which is either a) poor ethical behavior or b) an indispensable way to educate the marketplace, depending on your biases.  I tend to lean toward the former.  Anyway FiercePharma has been following this issue closely, and has an item here worth checking out.

I read this blog from Steven Grossman called FDA Matters, which I found via GxP Perspectives.  The whole FDA is covered not just drugs, so I pick and choose the articles within my wheelhouse. Take a look.

I have a few more speaking engagements coming this year:  Managing CRO Partnerships in London October 4-5, and MAGI West in San Francisco October 24-27.  See the sidebar for links and details.

Also I will be moderating a panel at Astia's Silicon Valley Doing It Right session in San Francisco November 5.  Astia is a program that provides resources and training for women entrepreneurs in life sciences, technology and clean tech.

The fall term starts at UC Santa Cruz extension today; 10 weeks of GCP class.  It's not too late to sign up.

We've Hit the Big Time!

Two Decades just got listed on this posting at GxP Perspectives as a blog "well worth checking out".  Thanks Carl!

New Powers for the FDA?

Fierce Pharma had a piece yesterday revealing a new measure introduced in the House recently in the wake of the J&J recall hearings by Rep. Edolphus Towns (D-NY), calling for the FDA to have power to initiate its own recall rather than having to wait for the drug maker to do it.  Senator Michael Bennet (D-CO) has produced a bill of his own in the Senate that echoes the House bill's call for more power, including more agency oversight of foreign drug manufacturing.  In either case the legislation has a long way to go and can expect significant heel-digging by PhRMA.  It's all here.

More Student Advice

A lucky former student recently asked some advice on how to give notice at a job she loves, for a job she hopes will propel her career to new levels.  Here is my response.

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Congratulations! This is a very exciting time in your career, and I am gratified to be along for the ride.

I completely understand and empathize with the misgivings around giving notice to an organization that you have enjoyed working for, and where you got your early development opportunities. I have been there myself and it can weigh heavily on your heart. Here are a couple of thoughts that have helped me over the years.

1. Any good manager will understand your reasoning in leaving for a good opportunity, especially if that manager cannot create the same opportunity for you herself. No good manager would think of holding an employee back or resenting her for taking the next move in her career. A good manager needs to think about the team's best interests too, and realizes that letting you go in anything other than a head-up way would send a poor message to the remaining team members, and that would eventually undermine team cohesion.

2. Of course the above would not necessarily be true if an employee has been dishonest with her manager, or leaves before 'giving back' after having been trained. Managers don't appreciate promising employees who leave too soon. But this isn't the case with you; two-plus years in an organization is about the norm these days.

3. Leaving your current organization will create an opening for someone else to step up and show what they can do. In my early days as a manager I really worried if one of my stars left, but I came to see that there were always others waiting in the wings, ready to step in. Your departure may even create a job that someone from the outside can fill, giving someone a badly needed first chance as you got two years ago.

With all that said, my advice for you when the time comes is to tell your manager what you told me: that you value the opportunity your current job gave you and that you have enjoyed the organization and feel that you made a significant contribution, and now it is time to take the next step in your career. Be forthright and honest, describing why the next opportunity develops your career in the way you wish it to go. Offer to help train your replacement and be diligent in handing off your duties. For the reasons I stated above, your manager should accept your resignation graciously and send you on your way with her very best wishes and with the relationship very much intact.

On the remote chance that this does not go well, that there is resentment or ill feelings left behind, you need to know that you did everything right. That ultimately you cannot control what other people think or do, you can only control your own behavior. If you handle this professionally and honestly, you need not fear reprisals or burned bridges. As you say this is a small community and our colleagues have good instincts about these things; they will be able to judge for themselves that you handled yourself correctly in this episode. Remember that only you are in control of your own reputation and brand; no one can successfully pass untruths about you for very long. If you handle yourself professionally the ship will right itself - it always does.