For­mer MiMedx CEO and COO are con­vict­ed on fraud, con­spir­a­cy charges

The MiMedx saga — which has in­clud­ed a months-long in­ves­ti­ga­tion, FBI in­volve­ment and al­le­ga­tions that the com­pa­ny fraud­u­lent­ly boost­ed its sales — has re­sult­ed in the con­vic­tion of two for­mer ex­ec­u­tives. But it isn’t quite over yet.

Park­er “Pe­te” Pe­tit

For­mer CEO Park­er “Pe­te” Pe­tit and for­mer COO William Tay­lor have been con­vict­ed on a se­cu­ri­ties fraud count and a con­spir­a­cy count, re­spec­tive­ly, in the South­ern Dis­trict Court of New York. The Man­hat­tan US at­tor­ney’s of­fice ac­cused the men of false­ly re­port­ing $9.5 mil­lion of rev­enue in 2015 to boost the com­pa­ny’s stock and fill their own pig­gy banks, per a Law360 re­port.

But the de­fen­dants have de­nied the ac­cu­sa­tions, and say they plan on ap­peal­ing the ver­dict. Pe­tit was ac­quit­ted on a se­cu­ri­ties fraud count, while Tay­lor was ac­quit­ted on a fraud count.

William “Bill” Tay­lor

“We are pleased that the ju­ry ac­quit­ted Mr. Tay­lor of se­cu­ri­ties fraud. We are of course dis­ap­point­ed in the ver­dict on the con­spir­a­cy count, but Mr. Tay­lor ful­ly in­tends to seek to have the ver­dict over­turned,” Tay­lor’s lawyer William Bur­ck told Law360.

MiMedx $MDXG, which pro­duces sur­gi­cal and tis­sue-graft prod­ucts for vet­er­ans and mil­i­tary hos­pi­tals, ran in­to trou­ble back in Feb­ru­ary of 2018, when the FBI showed up at the door of Marc Co­hodes. The vo­cal short sell­er had in­sult­ed the com­pa­ny and Pe­tit in hun­dreds of tweets. Af­ter FBI agents or­dered Co­hodes to stop, his lawyer went to the US De­part­ment of Jus­tice with a com­plaint.

The DOJ seemed to be al­ready in­ves­ti­gat­ing MiMedx’s sales and dis­tri­b­u­tion prac­tices. The com­pa­ny faced law­suits brought by ex-em­ploy­ees who ac­cused it of fraud­u­lent­ly boost­ing sales. And it spent sev­er­al years chal­leng­ing the FDA on whether its prod­ucts met reg­u­la­to­ry stan­dards.

MiMedx said it was con­duct­ing an in­ter­nal in­ves­ti­ga­tion in Feb­ru­ary of 2018, and that it would re­state its fi­nan­cial state­ments go­ing back six years. It part­ed ways with Pe­tit and Tay­lor and slashed 24% of its work­force to start a “new chap­ter.” By No­vem­ber, it delist­ed from Nas­daq.

The in­ter­nal in­ves­ti­ga­tion, con­duct­ed by King & Spald­ing with KP­MG as an au­di­tor, turned up a slew of ac­cu­sa­tions, in­clud­ing that MiMedx made ma­te­r­i­al mis­state­ments and omis­sions about its deals, that Pe­tit lied un­der oath when dis­cussing its largest dis­trib­u­tor, and that the com­pa­ny’s ac­tions were “de­signed to ma­nip­u­late the tim­ing and recog­ni­tion of rev­enue.”

The com­pa­ny’s shares, which once trad­ed at a high of $16.75, closed at $6.79 apiece on Thurs­day.

What comes next for the for­mer ex­ecs? Pe­tit is sched­uled for sen­tenc­ing on Feb 23, and Tay­lor is due back the fol­low­ing day. Pe­tit could be look­ing at up to 20 years for the se­cu­ri­ties fraud count, while Tay­lor’s con­spir­a­cy count could land him up to 5 years.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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Nick Leschly at Endpoints' JPM20 Breakfast Panel (Jeff Rumans for Endpoints News)

2sev­en­ty: Nick Leschly brings a trio of top ex­ecs with him on top-speed flight from the blue­bird nest

After serving more than a decade as bluebird bio’s chief bluebird, Nick Leschly is switching it up.

At some point this year, Leschly will officially become the CEO of 2seventy — the new company that will house bluebird’s oncology business while Andrew Obenshain, the current president for severe genetic diseases, will take over as CEO to oversee the rare disease pipeline remaining at bluebird.

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Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Aindrea Campbell, Zymergen

Q&A: Ain­drea Camp­bell goes small, step­ping away from Ap­ple to head man­u­fac­tur­ing at Zymer­gen — where am­bi­tions are big

Over the past 22 years, Aindrea Campbell has worked with just two corporate giants, Ford Motor Company and Apple, with generations of experience between them. But in her new role as Zymergen’s chief manufacturing officer, Campbell comes to a company with years — eight — of history, not decades.

This month, Campbell joined synthetic biology player Zymergen to lead manufacturing for the company’s “biofacturing” process, which ferments genetically engineered molecules to create products that can be used in a range of potential applications, including electronics, consumer health and agriculture, just to name a few. The process, Zymergen says, obviates the need for toxic chemicals and huge infrastructure demands in traditional manufacturing, potentially cutting costs by 90% in half the time.

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