Org Prep Daily

September 9, 2017

Breaking Bad in South Florida – The Aftermath

Filed under: Uncategorized — milkshake @ 7:15 pm

This is a work of fiction. Names, characters, businesses, places, events and incidents are either the products of the author’s imagination or used in a fictitious manner. If you find any resemblance to actual persons, living or dead, or actual events, deadly or lively, or actual molecules, carbons or heteroatoms, it is purely coincidental.

The Aftermath

(here is Part 1Part 2Part 3Part 4Part 5, Part 6, Part 7, Part 8, Part 9, Part 10)

It has been difficult for me to find a job since I went against the company. The pattern has been the same: a successful phone interview followed (after few weeks) by a brief communication that the position got already filled. The company also sent the campus police after me last October. I was suddenly called by the university police and asked to immediately report to the campus where they served me a trespass notice and a permanent campus ban – supposedly for previous loitering outside the incubator building. (I did walk by the building once, curious if the labs were still in use – they are on the ground floor, with floor-to-ceiling glass wall so one can easily look into them from the distance).

The purpose of this theatrics was to paint me as an unstable disgruntled loner who is about to bomb the campus. I think it was the idea of our research director – and the university obliged: three police cars and four armed overweight campus police officers puffed up making the campus safe for the drug kingpin in their biotech incubator…

At this time my father became critically ill, I had to go to Prague to look after him so I did not have the energy to fight this baloney trespass. By the time I returned to Florida, I pretty much gave up – I was rather depressed and tired of the affair.
__________________________________________________________________

It probably looks petty – what helped me to pick up the fight again were the recent company research publications: The company has been publishing our old research results to impress the potential investors and buyers. I saw enough of my work published without my name on it and I was getting resigned about it. In one case I still caught a publication in the galley proofs because the co-authors alerted me and after my protests the research director reluctantly added my name back to the author list.

But then in summer 2017, the company published a summary overview of its proprietary polymer chemistry – showcasing the remarkable ease of manufacture of new version of our elaborate polymers and the simple-yet-effective drug encapsulation with the self-assembled nanoparticles – and my name was left out again. The scheme was my proposal, and about 30% of the man-hours spent on it was also mine. The research director actually asked me to write the official history of the project for the company in 2015 because I am the main inventor on the patent claiming these polymers. But when I contacted the authors on the paper and asked them to submit an addition/correction to put my name back on the author list, they told me to get lost; some of them in a rude way.

Lucky for us, this is an ACS journal – they have the COPE guidelines for cases just like this one: The journal editors already opened an investigation. I can’t predict the outcome but there is an overwhelming evidence that it was my work and I was left out on purpose – I hope this will give me an opportunity to tell my story in C&EN.

Another issue is the clinical candidate currently in the Phase 1. The company was under the obligation to provide all available safety and efficacy animal data in the IND submission to obtain the approval for the Phase 1 clinical trials. I am not sure they submitted everything: The research director despised the animal data that were showing a poor stability of the drug-loaded nanoparticles in mouse blood – it is the research study for which my biologist friend was fired after presenting his results. I believe that the FDA probably found out about the problems with the IND data submission recently, together with the company background story. They never comment on the ongoing investigations so it is hard to confirm; the only people who will know with certainty are employed by the company, or at CDER.

And then there are the shareholders who saw the value of their investment plummet over the years – who got diluted by the acquisition of a virtual biotech company (because of a poorly-done due diligence) and recently they were diluted yet again by the investment fund. If the company is acquired or goes public, the early investors who are getting hurt will probably question why the management involved itself in cooking MDMA and other drugs in 2013-14. The continuing presence of our research director will predictably turn into a magnet for the shareholder lawsuits. When it happens I will be there to help.

354963_touche

September 8, 2017

Breaking Bad in South Florida (10)

Filed under: Uncategorized — milkshake @ 3:26 am

This is a work of fiction. Names, characters, businesses, places, events and incidents are either the products of the author’s imagination or used in a fictitious manner. If you find any resemblance to actual persons, living or dead, or actual events, deadly or lively, or actual molecules, carbons or heteroatoms, it is purely coincidental.

Part 10

(here is Part 1Part 2Part 3Part 4Part 5, Part 6, Part 7, Part 8, Part 9)

A week after I spoke with the university chief compliance officer, the DEA got back to me – a senior special agent called me up and asked me to come for an interview the following week.

I had couple more calls that day: In the morning, an unexpected conference call – some university officials and lawyers urgently needed to hear the complete story of manufacturing MDMA and DMT at the company. I did not get to meet them, they did not invite me to talk to them in person afterwards. I don’t even have their names. The second call came from DEA, to set up the meeting. Then I got several frantic calls from the company lawyer – she was trying to find out what the hell just happened. Our research director never told her about illegal drugs: she had been handling the company terminations for several months already, oblivious… I explained the lawyer she really needed to speak with the research director and I wasn’t going to take part in any company-run self-investigation. The following day, the lawyer sent me a Cease and Desist letter to keep me from talking to the university and the law enforcement. I wished her good luck trying to sue me for talking to the DEA, and I suggested that she should excuse herself due to a client conflict.

The trigger for all this sudden activity was an e-mail that I wrote to our research director. The subject line: “Today is your special day! Wednesday 23rd is a perfect day to resign.“ My e-mail mentioned the university EthicsPoint misconduct submission line and also the possible involvement of his wife in the previous university investigations of our company. I sent it at 7 in the morning. At 10 am, the university officials were calling me already, then the DEA called an hour later to set up the meeting, and finally the company lawyer.

I did not realize that the university was coordinating its actions with the company and the DEA: Our research director already informed the university about the drug-manufacturing operation, to push out the CEO and to whitewash his own role in the drug ring. Our research director became the new CEO, and the university conveniently overlooked that he set up, supplied and maintainined the lab that was making illicit drugs for almost 2 years…

Now that I talked to the chief compliance officer, I became a new source of problem. At first, it was wait-and-see. (If EH&S found safety violation serious enough to push the company off campus, maybe the affair would go away. At least that was the unofficial deal we worked out with the chief compliance officer). But I was impatient, writing e-mails about going full expose. Our research director panicked after reading my e-mail on 23rd, he run to the university for help and provoked this sudden response. DEA contact people were asked to go-ahead and interview me because it wasn’t possible to delay it much further and the university really did not want to reopen its own inquiry into this scandal – they knew there were things they did not want to find out.

At the time, I did not know enough about the three previous investigations of our company – every one of them a cover up – so I underestimated the role played by the university: it wasn’t just one high-ranking official who helped to protect the good name of the university (and perhaps shielded her husband from criminal investigation too). By now, it was the presidents office, the leadership of a major university calling in political favors and going through the State Attorney office and “comparing the notes” with the DEA, trying to avoid a scandal that would tarnish the university and its biotech incubator, and implicate one of their own in the previous cover up. The university and our company were in the same boat.
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I met two special agents from DEA District Office Tactical Diversion Squad on Thursday, last week of March 2016 at 11am. They were pleasant, charming, understanding. Right off the bat they offered me an unspecified but large amount of cash if I worked for them as a paid informant: they said I was perfect because of my background in setting up synthetic labs. I politely turned that offer down – I thanked them but it wasn’t the right career path for me.

We walked a short distance over to a nearby shopping mall. Sitting in front of an entrance to Macy’s, we talked for about 90 minutes (I was nervous about the DEA building and I also wanted a decent cappuccino while interviewed – it was the first time I went to the law enforcement to turn someone in.) Later we moved back to the federal building where the officers were going through their case files, writing few comments on the margins. I think we spent about two hours together – my long-winded story probably kept the agents hungry through the lunch.

Surprisingly they did not ask me in detail about the precursors, their names and quantities, even though diversion of precursors for drug manufacture was very much within their field of investigation. This alone should have made me suspicious of the whole interview. Also, I told the officers where we could find the evidence in the company records, if they wanted to build the case based on the precursor purchases. And my senior chemistry grouchy colleague actually saved an NMR sample with MDMA produced at the company – it should be still in the fridge. But the DEA officers were not interested in getting a search warrant – They said the company was cooperating (about which I had serious doubts).

What they really wanted to know was who were the sources that could confirm my story, and any photographic evidence I might have. They warned me that their investigation will proceed in a slow methodic way and I should not expect any criminal charges any time soon. Maybe never. But they assured me that the culprits will get a kick in their pants, should not be able to continue in their position at the company and the university. And certainly they should not be able to buy any listed precursors in the future or obtain DEA permits for controlled substances. That was good enough for me – after all, I wasn’t really trying to get anybody thrown in jail, and I did not like the idea of having to testify in court or be called in front of a grand jury. I would have been satisfied with our research director stepping down and the company moving off campus.

I must say the officers looked just as I imagined them, after watching Breaking Bad: no-nonsense, cautious, savvy. But the DEA facilities were pretty run down – lots of empty offices with battered police precinct-like metal desks and chairs. The oversized office space was cluttered but deserted and gave impression of neglect.

Not much happened in the following months. The unusually slow pace of interviewing witnesses – maybe one interview every few weeks – was worrying me: I though the DEA was giving too much time for the company to do a damage control. I did not expect the current employees to talk to the DEA but several already laid-off people also didn’t, or claimed a total ignorance. I originally suspected maybe the DEA was slow-boating the case because they were using our former CEO (or maybe the research director) as an informant-provocateur, the same thing they offered to me but signed them with help of a sealed indictment against them. I imagined there must be some big gangster case they don’t want to compromise by blowing the identity of their informants, etc. The reality was more mundane: The DEA agents were asked to run errands for the university.

From the phone conversations I had with the DEA over the last year, I learned few details about the previous company investigations and I figured out what made the DEA special agent rather grumpy about this case: We were just “a bunch of knuckleheads and clowns, only interested in keeping our nice jobs and paychecks” for not going to the DEA before the first cover up. The DEA agents were not learning any substantially new details from anyone, or building a case that had a chance to go to court – the only reason they were wasting time interviewing us was to patiently handle some neurotic unemployed scientists, making sure no one makes a tantrum in public… I sensed that they would have loved to have the case prosecuted to the hilt: unlike the garage meth labs, the Ecstasy busts in US are exceedingly rare – and a professionally equipped superlab operating from within a biotech company on university campus would be a stuff of legend. And they sure have no love for a privileged punk with a PhD making fools of them and getting away with it. I am sure they were thwarted, and directed to mind the university reputation above anything else.
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No one was charged. The company continues renting the office and lab space at the university research incubator, not really doing any research since shutting down the labs in 2016. EH&S performed a lab inspection, found few minor problems and wrote a mild citation. Unofficially, the company was warned by the university to never use the biotech incubator labs for a dangerous scale up manufacturing again. The polymerizations are technically challenging and several hazardous materials are tightly regulated – it is really difficult to contract out the entire manufacturing process to a CRO. My guess is that the company will need to build its own manufacturing facility, away from the densely populated areas.

The university did some house-cleaning – they asked the wife of our research director to resign from her post of vice president for research integrity and compliance in the summer of 2016. Our technician from the formulation lab whom she hired after the layoffs, to work in her department, was pushed out too – he only found out when he saw his own position advertised on the university job bulletin board. He was completely innocent and he never got a chance to defend himself, the university canned him just for his association.

The company lawyer resigned, nominally for a client conflict but really for being misled and manipulated. The company soon hired a new law firm – more cautious and more expensive. Also the business development guy left – he developed a serious drinking problem, it got worse at the end of March 2016. He had a heart attack recently, and died. I heard there was cocaine involved… He was a great person I admired: A self-made man. I think the sleaze did not originate with him, he found out about it only too late and the unraveling crushed his dream – it probably pushed him over the edge.

The company recently raised millions from an investment fund, for the clinical trials. A new business guy came aboard. They are going to the phase 1 trial with a polymer-based i.v. formulation of an old chemotherapy drug. It is the same problematic nanoparticle formulation over which my biologist friend was fired.

morce

 

September 3, 2017

Breaking Bad in South Florida (9)

Filed under: Uncategorized — milkshake @ 12:27 am

This is a work of fiction. Names, characters, businesses, places, events and incidents are either the products of the author’s imagination or used in a fictitious manner. If you find any resemblance to actual persons, living or dead, or actual events, deadly or lively, or actual molecules, carbons or heteroatoms, it is purely coincidental.

Part 9

(here is Part 1Part 2Part 3Part 4Part 5, Part 6, Part 7, Part 8)

When I received the settlement documents from the company, I saw they did a quick job: there were typos, only two months of medical, instead of a temporary job extension at a reduced pay it was a straight separation, with a severance paid out in installments over a period of four months. The pay amount was the only thing that remained from our agreement, the rest was something else. The lawyer who drafted it had no clue. It was actually the same company lawyer who negotiated with the biologist fired couple months before – and our research director again did not feel like telling her about all the drugs that the management used to cook at the company, or the promises he just made to me…

I called the research director and protested that this wasn’t what we agreed on. He pretended like he did not see the documents – he assured me “he wasn’t trying to sneak this one on me”. Then the second version of documents came: it was the same text just with the typos corrected. I was supposed to apply to COBRA to get my medical and the company would reimburse it maybe later. The research director explained that he was working hard to come up with the agreement that “encapsulates” what we discussed on the dinner meeting on Monday. He just thought it expedient not to keep his word even though we shook hand on it. Instead, he proposed to have another meeting to renegotiate.

Meanwhile I saw that the Mac I got from him was trying to upload massive volumes of data to the cloud – it was tying up the connection and filling up the computer memory. (I did not have the net connection at home set up yet, I just ordered it and the Verizon guys were taking their sweet time so I was temporarily using a free login guest account on wifi radiating from a retirement community nearby; their connection was frail and slow). Then I noticed someone was reading an unopened message from my laid-off colleague in my private gmail account – and he tried to mask it by deleting the message and emptying the trash bin. So I checked the security settings: the Mac was set on enabled remote access and the firewall was down… I had pretty good idea who was reading my private e-mails and trying to upload my files to find out if I had any interesting piece of evidence on my computer. The offer about consulting and working from home was probably a ruse from the beginning, to have me take the backdoored Mac.

I changed my passwords, disabled the auto-backup cloud uploads and the remote access. I wrote the research director that it was difficult to take seriously anything he promised, and I was not slighted as he implied – not even surprised – but getting progressively more tired of everything that happened with the company and the role he played in it, as he kept making the same mistakes and excuses over again. And if we meet and try to reach a new agreement it should be final this time and not re-interpreted, modified or encapsulated.

To which I got a reply from the research director that he was cancelling our meeting and the deal was off. It was time for the lawyers. Instead, I went to war.

_________________________________________________________________________________

At this point it wasn’t about money anymore: I wrote to the research director and the business development guy explaining that the research director needs to resign from his role of a CEO – and I promised to do my part to get the company raided by the police and pushed out of the campus if he does not step down soon.

I also informed my freshly laid-off colleagues about the negotiations with the company. Some of them reacted with a surprise – they only got two weeks of severance – but they were hurt and not in a fighting mood: if anything, they were more angry with me that I got a better offer (and did not take it – because they would).

Next I called the DEA – they asked me to come over immediately but I wanted to meet some officer who investigated our company before, for repeated attempts to purchase the Ecstasy precursors. They said they would find out who that was and call me back. It took few days for them to do that.

I also paid a visit to the Chief compliance officer at the university: We had a long evening meeting and he promised to help. I knew his boss was the wife of our research director so it was tricky for him; she was the university vice-president for research integrity and compliance. I hoped he would not go to her straight away if I explained how much the whole affair stank. And I think he didn’t – but it is likely that he talked to someone else, in the university president’s office.

The university chief compliance officer was quite taken aback by the stories of drug cooking at our company – and he wanted to have absolutely no part in investigating it. He was saying it was a job for the police. So I also described some of the mishaps and close calls in our manufacturing, the risks of running kilo-scale polymerizations of ethylene oxide in a sealed glass reactor without automated cooling backup, without a burst disc and even without a reaction temperature internal thermometer. I mentioned the hectoliter volumes of flammable solvents in the lab and the nature of work with potassium metal, KH and diphosgene. We had no specialized safety training or sensors for detecting ethylene oxide leaks as required by the regulations. I showed him a picture of myself in a gas mask standing next to a 15L reactor full of concentrated HCl and heavy metal complex – parked next to a fume hood because we lacked a walk-in hood for the reactor.

Now we were on the same page. The university chief compliance officer told me that the fire safety people at the university were still having nightmares about our manufacturing lab ever since that fridge explosion and fire in February 2014. He said he would talk to EH&S at the university and he was pretty sure these safety violations alone should be enough to get the company kicked out of the research incubator. He said he would write the report using anonymous online EthicsPoint submission to the university, and he would do it by himself because he knew what to put in there to have the right effect. So he wrote it and I never saw his report.

sergey-kolesov-little-black-dress

September 1, 2017

Breaking Bad in South Florida (8)

Filed under: Uncategorized — milkshake @ 2:56 am

This is a work of fiction. Names, characters, businesses, places, events and incidents are either the products of the author’s imagination or used in a fictitious manner. If you find any resemblance to actual persons, living or dead, or actual events, deadly or lively, or actual molecules, carbons or heteroatoms, it is purely coincidental.

Part 8

(here is Part 1, Part 2, Part 3, Part 4, Part 5, Part 6, Part 7)

The Board of Directors met on Thursday, the last week of February 2016. Our research director did not stop to chat in the chemistry lab as he would usually do after these long meetings.

The next Friday morning I almost missed my termination interview when I showed up two hours late for it. But I was lucky, the managers were waiting and still willing to see me. (An experiment the night before was taking a long time – eventually I had to turn off the distillation, leaving it unfinished, past midnight). When I arrived to work, my colleagues were already mostly gone and the labs deserted – all quiet. Our grandmotherly administrator said that the boss needed to see me right away. There was a firmness in her voice that did not make it sound like a birthday surprise bonus check or the stock options promised to me by the previous CEO two years before.

Still, I did not realize it was the grand finale until on my way there I saw a colleague walking back with an empty box in her hands, sobbing. I kept the firing squad waiting a little longer and helped my colleague to pack her books and papers, we carried it to her car. It gave me time to compose myself. (I even thought about just driving off without ever returning to the office but the result would have been the same and I did not like the idea of the company collecting and packing my belongings.)

So there was our research director with the business development guy waiting seated in a little stuffy office – and they looked heartbroken but they had no other choice and they were giving us two weeks of salary plus two months of medical as a severance if I please sign the papers right here at the dotted line. I told them they were way too generous and I couldn’t possibly accept their excellent offer: they should take their severance papers and use them in whichever way they find enjoyable.

I just figured that the list of people being laid off was probably put together three months ago, the HR consultant was already “helping with the transition” at the beginning of December last year, and the main factor that earned me the membership in the layoff club was that I made the CEO and the research director stop their illicit drug manufacture at the company. I explained that I was happy to fight the company with everything I got. The next thing they tried was the offended pose, to show me their indignation and they accused me of blackmailing them. The business guy taunted me about not having any evidence that there were drugs cooked at the company.

I walked out of that meeting and the research director run after me and brought me back to his office and he said that perhaps they should be able to work out some consulting arrangement since I was tremendously valuable to the company. Before I even finished packing my box, the research director wrote me two e-mail messages to my gmail address (my company e-mail account already stopped working) and he attached consulting agreement proposal and he wanted me to stop by at his office, to see me again on my way out. He also set up a dinner meeting with me the next Monday.

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Here is the Standard Model of corporate downsizing: The first principle is to keep all preparations secret till the last minute to better catch the subjects unaware what is about to happen so that they don’t sabotage the company or gather kompromat; ideally they should be off-guard even as they are sitting down with the “exit specialist”. Next, it is important to try to have them sign the prepared papers that they are accepting the severance and will not sue the company – this is best done by applying mild pressure while the subject is still shell-shocked. After that, you just get those bums out of the building, one by one, escorting them gently but firmly to control the unpleasant scene. The layoff theory stipulates that it is important to downsize on Friday (or better yet, on the last day before Christmas) because the ex-employees will have more time to exhaust themselves with anger and beer, and get depressed. After a weekend or holiday they will be less likely to return to the company with a shotgun. I don’t know how well the theory worked in my case but I did relax over the weekend and I was genuinely looking forward to the meeting on Monday.

On Monday night, our research director brought me the nice widescreen Mac that I was using at the company: he already prepared it by removing the company files but leaving everything else – it came installed with Chemdraw and MS Office so that I could work from home. He handed it to me in the restaurant parking lot.

I wasn’t keen on his vague consulting agreement where the number of work hours depended on the company whim. I wanted to see the exact income figure, the medical plan, my obligations laid down in a clear language. In the end, we shook hands on a fixed-term four-month extension contract: 3 extra months of salary spread over 4 months, with four months of continuing full medical coverage. I would be working from home. (There was actually plenty of research results to write up for publication and patents so this wasn’t a sinecure but a real contract, and the company actually did this once before, to accommodate our colleague who had to be in Vancouver with his family).

I thought this package wasn’t great given the circumstances but I did not want to fight or deal with the lawyers – I thought it was reasonable enough: I could interview for a new job and still remain employed for a little longer, and I wouldn’t have to worry about medical insurance in the meantime. This convenience alone had a value for me. We could even remain on friendly collegial terms… So we shook on it and I was relieved. One huge problem solved, or so I though.

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