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546 posts categorized "Biobiz news"

March 26, 2015

Cardio3 reports losing $18 million in 2014

Cardio3 released a financial report today with a lot of interesting tidbits like it's building in the Minnesota BioBusiness Center due to an agreement with Mayo Clinic.

Also it's developing a U.S. headquarters… in Boston.

Here's most of my article on this:

The Belgium-based biotech firm building a manufacturing facility in downtown Rochester reported today that it lost $18.1 million in 2014, up from the $15.9 milCardiobioscience_jpeglion it lost in 2013.

Cardio3 BioSciences, which works closely with Mayo Clinic and is taking over the fifth floor of the Minnesota BioBusiness Center, reported its financials for 2014, plus some highlights of its activities in 2015.

Cardio3 is publicly listed on the European stock markets of NYSE Euronext Brussels and NYSE Euronext Paris, although it is not traded publicly in the United States.

Mayo Clinic owned 2.69 percent of Cardio3, as of March 3. Mayo Clinic first acquired equity in Cardio3 in 2007, when it licensed stem cell research by Mayo Clinic's Dr. Andre Terzic and Dr. Atta Behfar. Its cardiopoiesis technology repairs patients' hearts by re-programming their own stem cell to regenerate cardiac tissue.

6a00d83451cc8269e201a511d8e824970c-250wiThe Hong Kong-based Medisun, which is opening an office in Rochester, owned 7.2 percent of Cardio3 on March 3.

In the years since 2007, Mayo Clinic has developed a close working relationship with the Belgian company. Mayo Clinic is participating the U.S. clinical trial of Cardio3.

"We made significant strategic, operational and financial advancements in 2014 as we seek to build C3BS into a global specialty therapeutics company," stated Cardio3 CEO Dr. Christian Homsy in the announcement.

The annual report highlighted "a non-exclusive preferred access agreement" signed with Mayo Clinic in October that cleared the way for Cardio3 to build a facility in the City of Rochester's BioBusiness Center building.

"With this agreement, Cardio3 BioSciences agreed to give preferred consideration for Rochester, Minnesota to the U.S. to build a manufacturing facility for the production of C-Cure, at a facility located adjacent to the campus of the Mayo Clinic, and the Mayo Clinic agreed to periodically review with Cardio3 BioSciences its portfolio of regenerative medicine technologies, including in the areas of cardiology and oncology, with a view towards future potential licensing," according to the Cardio3 report.

Cardio3's prototype manufacturing facility will occupy the 14,963-square-feet of space on the fifth floor of the downtown building. Mayo, which leases the fourth through eighth floors, moved its employees out of the fifth floor earlier this year. Cardio3's five-year lease calls for it to pay a rent of $18 per square foot, or $22,444.50, per month. The city agreed to pay for $600,000 in equipment and improvements to the space.

The Minnesota Department of Employment and Economic Development also agreed to give Cardio3 a Minnesota Job Creation Fund award of $357,000, if the company invests $1.5 million in Rochester within a year and hires 33 employees within two years.

The ultimate goal of this project is for the city and RAEDI to eventually convince Cardio3 to build a 100,000-square-foot manufacturing facility with 350 employees in Rochester, according to officials at RAEDI.

However, Rochester is not the only city wooing the Belgium company. While the Rochester facility is Cardio3's first official U.S. location, the company's report show that it also has plans to build a U.S. headquarters in Boston, Mass.
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The company also reported that it's re-stating its 2013 financial reports "to reflect errors" found by PriceWaterhouseCoopers.

"After due consideration with its auditors, we decided that the shareholders convertible loans should have been accounted for as a financial debt instead of equity (previously called 'quasi equity') as originally posted in our 2013 financial statements, because the loans were convertible into a variable number of shares," according to today's statement from the company.

March 06, 2015

10 years of blogging Rochester

On March 4, 2005, I wrote my first blog post. Kiger's Notebook blogo 2x

It was my sixth year at the Post-Bulletin. I created the "Heard on the Street" column about three years before the blog began. 

More  than 6,200 posts, stacks of columns, mountains of tweets and many gray hairs later, I'm still here writing about business and things vaguely related to businesPhoto on 2015-03-03 at 18.11s in southeastern Minnesota.

It'syou, the readers, who make this career such a fulfilling and entertaining one. Thank you everyone for your feedback, criticism and support over these past 10 years. 

10 years of blogging Rochester

On March 4, 2005, I wrote my first blog post.Kiger's Notebook blogo 2x

It was my siPhoto on 2015-03-03 at 18.11xth year at the Post-Bulletin. I created the "Heard on the Street" column about three years before the blog began. 

More than 6,200 posts, stacks of columns, mountains of tweets and many gray hairs later, I'm still here writing about business and things vaguely related to business in southeastern Minnesota.

It's you, the readers, who make this career such a fulfilling and entertaining one. Thank you everyone for your feedback, criticism and support over these past 10 years.  

March 02, 2015

Mayo Clinic-linked NeoChord looking to drum up $1.5 million

NeoChord, a medical device firm I first wrote about in 2007, filed with the SEC in February to raise $1.5 million in funding. So far it has pulled in $457,000 or so of that.

I need to give a nod to the intrepid Katharine Grayson of the Minneapolis/St. Paul Business Journal for first pointing this out. I'm always impressed by how closely she tracks Form D filings for financing.Portfolio-neochord-260x138

The Eden Prairie-based NeoChord surfaced locally in 2007, when it licensed technology designed by Mayo Clinic cardiac surgeons Dr. Richard Daly and Dr. Giovanni Speziali. Speziali was named as the company's chief medical officer in 2013. 

Beside licensing its technology, Mayo Clinic has also previously invested in NeoChord. I'm checking to to see if that is still the case.

Neochord deviceThe NeoChord DS1000 device is used to treat a heart condition called mitral regurgitation. Mitral regurgitation means the valve or leaflet that controls the flow of blood from the left atrium to the left ventricle is not working properly.

Treatment typically consists of “cracking the chest,” stopping the heart and doing surgery. NeoChord's approach is much less invasive and can be done on a beating heart.

A tool is inserted between the ribs and into the heart. Then it is used to attach a chord to the faulty valve leaflet, which is tethered to the heart.

The market for less invasive techniques for mitral valve repair has been estimated at more than $2 billion. There are 50,000 surgeries done in the U.S. each year. An estimated 2 million patients are treated due to the risks of surgery.

Since it formed in 2007, NeoChord's lifeblood has been venture capital funding. By 2008, it had raised $3 million. It raised another $5.1 million in 2011 to finance the European clinical trial. In March 2013, it raised $3 million through the sale of its series B-2 preferred stock.

 

February 25, 2015

City to lease former Mayo Clinic space to Cardio3

This has been in the works for quite a while. It looks like it's now a done deal, at least on the city, RAEDI and DEED side.

We'll see what happens next. After following this for more than a decade, it will be interesting to see how it plays out. I'm particularly fascinated with how the China piece of this, including Medisun and Danny Wong, turns out.

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After amending its original lease, Belgium-based Cardio3 BioSciences is now finally cleared to take over the entire fifth floor C3BS_may_spotlightof Rochester's Minnesota BioBusiness Center.

In December, the Rochester City Council originally approved a five-year agreement with Cardio3 for the 14,963-square-feet of space to use as a prototype manufacturing facility. However, the company then asked for "an early termination provision" in the lease.

The deal is being driven by the city, Rochester Area Economic Development Inc., Mayo Clinic and the Minnesota Department of Employment and Economic Development to make Rochester more attractive to Cardio3, so that the company will build a major manufacturing plant here.

This is the second phase of deal funded by $1.2 million from the city of Rochester's economic development sales tax fund. The first phase was developing little more than 5,000 square feet of unused space on the third floor of the BioBusiness Center to build a special manufacturing lab for Cardio3.

Mayo Clinic and Cardio3 have collaborated for years on the cardiopoiesis technology the company uses to repair patients' hearts by re-programming their own stem cells to regenerate cardiac tissue. Mayo Clinic owned 2.96 percent of the company as of Jan. 21. It's also managing a clinical trial for Cardio3.
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On Wednesday, city council members voted to add an early termination provision to the deal that allows Cardio3 to end the five-year lease after just two years in the space. That provision kicks in only if Cardio3 decides to "construct or lease a larger production facility in Rochester" or the clinical trial on its regenerative heart treatment is not successful.

To leave early, Cardio3 will need to notify the city six months ahead of time. Under the modified lease, the earliest that the regenerative medicine firm could pull out is April 30, 2017. Cardio3 would need to pay the city $269,334 if it did leave earlier than five years. That amount equals about one year of base rent.

If Cardio3 does leave before its lease is up, all of the city-funded fixed equipment and improvements will become the city of Rochester's property. The city agreed in the lease to pay for $600,000 in equipment and improvements to the space.

The final version of the lease calls for Cardio3 to pay a rent of $18 per square foot or $22,444.50 a month.

Mayo Clinic, which leases the fourth through eighth floors of the BioBusiness Center, moved its employees out of the fifth floor earlier this year. At one point, Mayo Clinic Global Products' corporate accounts had offices on the fifth floor.

In earlier discussions about this project, RAEDI estimated that Cardio3 will need 30 to 50 employees to staff the proposed prototype manufacturing facility on the fifth floor.

The ultimate goal of this project is to convince Cardio3 to build a 100,000-square-foot manufacturing facility with 350 employees in Rochester. That's what Cardio3 anticipates it will need if the Federal Drug Administration gives it a green light to take its stem cell treatment to market.

RAEDI President Gary Smith calls it "the big enchilada."

January 27, 2015

Mayo looks to attract more patients from China

To take advantage of the rapidly growing medical tourism market, Mayo Clinic has deepened its relationship with a Hong Kong firm to bring more Chinese patients to Rochester.

Medisun Holdings Ltd. announced Monday it has signed a collaLogoborative deal to "Ensure efficient referral of patients" to Mayo Clinic. The agreement also calls for Mayo Clinic "to provide health care consulting services to aid Medisun’s work" in Hong Kong and mainland China.

This will allow Mayo Clinic to enlarge its patient pipeline from China. It has added a Web page in Mandarin Chinese and has hired interpreters, the article notes. The Wall Street Journal recently reported increasing numbers of Chinese residents are going overseas "in search of treatment that is either unavailable or ineffective in China."
800px-Gonda_building,_closer_up
Mikel Prieto, medical director of Mayo Clinic's international office, told the Wall Street Journal that "China, probably of all countries, is the one where we see the greatest growth right now."

Melissa Goodwin, Mayo Clinic's manager of global referrals, told China's Caixin Media this summer the number of Chinese people going to Mayo has climbed to 200 in 2013. That's up from just 30 in 2008 and 100 in 2012. She estimated that number would reach 400 by the end of 2014. 

H3-treesDetails of the new Medisun/Mayo Clinic arrangement still are being hammered out, according to Dr. Jason Zhang, of Medisun.

Zhang did confirm that a $1 million office being built in Titan Development and Investments's new H3 Plaza complex on South Broadway will house Medisun's Rochester operations. It's being built under the name Alphaomega Healthcare, though Zhang said he expects it to eventually change to Medisun.

He explained the office will be used to support Chinese patients traveling to Rochester for treatment.

"The medical service will be provided by Mayo, and everything else will be provided by Medisun," Zhang said.

The Medisun office is expected to open in March or April in the west corner of H3 Plaza at 300 S. Broadway, he said. The office will occupy parts of the second and third floors of the seven-story complex, which is being developed by Titan's Andy and Gus Chafoulias.

“Consulting with Mayo Clinic, and leveraging Medisun’s top-quality medical institutions in Hong Kong … Medisun’s experienced medical team will facilitate access to Mayo Clinic’s world-class model of care in order to provide patients in China and Asia with superior medical services,” Medisun's Chairman Danny Wong said in Monday's announcement.
20150126_03A
Wong visited Rochester this summer in connection to his company's investment in Cardio3 Biosciences. Cardio3, a Belgium company with deep business and scientific ties with Mayo Clinic, is negotiating a lease deal with the City of Rochester for the fifth floor of the Minnesota Biobusiness Center.

While in Rochester, Wong had his photo taken at the clinic with local leaders, including Gus Chafoulias and Mayo's Lisa Clarke, who leads the Destination Medical Center initiative.

Wong recently showed his interest in Rochester by buying two large estates here. On Oct. 31, he bought an estate at 2515 Crest Lane SW for $1.4 million. Wong followed that up by buying a Pill Hill house at 615 10 Ave. SW for $1.31 million.

January 15, 2015

Roch. start-up licenses virus to pharmaceutical giant

An international pharmaceutical giant has signed a deal to license a cancer-killing virus from Rochester drug company.

MedImmune, which is owned by London-based AstraZeneca, is licensing a genetically engineered strain of the vesicular stomatitis virus from Omnis Pharmaceuticals. Omnis is a Rochester start-up founded by Dr. Stephen J. Russell, Dr. Kah-Whye Peng, Shruthi Naik and Mark Federspiel, who all work at Mayo Clinic in Rochester. A fifth founder, Glen Barber, is based at the University of Miami.

The companies now will collaborate to combine the Omnis virus with a check point inhibitor created by MedImmune. The goal is to eventually create a treatment for types of cancer affecting the liver, but potentially could be developed to treat a broad array of cancers.

"For us, it's a very big and very important step forward," Omnis CEO Russell said. "Essentially, we have AstraZeneca/MedIummune saying, 'We love this lead product of yours. We want to pick it up, cover the development costs and run with you to bring it to market.' That's a huge accelerator for this development program."

He explained that oncolytic viruses, similar to the one MedImmune is licensing from Omnis, have been found to be effective in destroying cancer cells. Many companies, in the U.S. and internationally, are working on their own treatment based on viruses.

"That's why they're excited about this virus. They can inject it directly into a tumor and kill tumor cells. That wakes up immune system, which adds to the attack," Russell said. "Then if you get the check point inhibitor antibody, the hope is that will lead to major tumor destruction."

This collaboration could mean a lot to Rochester. The US cancer vaccine market was estimated in 2012 to be worth about $14 billion. With about 1.5 million Americans being diagnosed with cancer every year, that market could possibly grow to reach $20 billion by 2020.

While the companies declined to release any financial details of the deal, it's clear the upfront payment portion of the agreement has given Omnis a boost to pursue its own goals, parallel to MedImmune project.

"Our obsession, if you like, is to develop viruses that could be given as systemic intravenous anti-cancer therapy," Russell said.

This virtual start-up, which was founded in late 2013, is "based" on the first floor the Minnesota BioBusiness Center in downtown Rochester in the facilities of Imanis Life Sciences.

Imanis is a related company that was founded by Russell, Peng and Dennis E. Young. It launched in the Mayo Clinic Business Accelerator on the second floor of the building and soon leased 1,736-square-feet of space for its offices and a "wet lab." Imanis makes genetic tracking agents for use in medical research. It also does medical imaging and conduct experiments for clients.

Russell said while Omnis has a lot of potential to break new ground scientifically, Imanis is the more likely candidate to grow into a economic driver and job creator in Rochester.

"That company (Imanis) will probably grow to occupy a fairly large footprint. This company (Omnis) is less likely to arrive at that point," he said.

In 2015, Peng said, "We hope to build it faster to up to 30 to 50 people as we do more manufacturing. We hope to be able to keep it in downtown Rochester. This is our home."

The group also has a third virtual start-up company called Magnis Therapeutics, which is working on a cancer treatment based on the measles virus.

Having three companies with names that end in "-nis" seemed like a good idea at first, said Russell with chuckle. But now, he admits it might be a bit confusing.

January 07, 2015

Cardio3 buys cancer-fighting firm for $10 million

Cardio3 BioSciences, which works closely with both Mayo Clinic and the City of Rochester, has paid $10 million for the oncology division of a New Hampshire firm.

The Belgium-based Cardio3 agreed to pay Celdara Medical $6 million in cash and $4 million in new shares for the division called OnCyte. Celdara could receive up to $50 million, if its lead product in-development CM-CS1 hLogo_cardio_3its specific development and regulatory milestones.

The same type of payments for milestones could also reach $21 million per product for others in the pipeline. If CM-CS1 reaches market and net sales top $1 billion, Celdara will receive up to $80 million in payments from Cardio3.
OncyteCM_png
This is Cardio3's second acquisition in recent months. In November, it purchased a virtual company called CorQuest Medical Inc. Corquest is developing a sheath to provide a minimally invasive way to insert therapeutic devices. The CorQuest technology platform is complementary with Cardio3’s C-Cathez and C-Cure systems. Financial terms were not released.

The OnCyte expands Cardio3's reach beyond regenerating cardiac tissue by entering into the rapidly growing immuno-oncology cancer treatment area using chimeric antigen receptor (CAR) T cells. OnCyte's CM-CS1 uses (CAR) technology to destroy cancer tumors. The Federal Drug Administration has cleared CM-CS1 to begin a clinical trial using patients with acute myeloid leukemia /advanced myelodysplastic syndrome and multiple myeloma. Juno Therapeutics, Amgen and Kite Pharma and others are developing products based on this concept.

In an interview with Bloomberg News, Cardio3 CEO Dr. Christian Homsy described acquiring OnCyte as “Our first foray into an area that is of very high interest… It opens a new reach, a new broad area of growth for the company that is of very high value to us and our shareholders.”

Those shareholders include Mayo Clinic, which held 3 percent ownership of Cardio3, as of Aug. 4. Mayo Clinic first acquired equity in Cardio3 in 2007, when it licensed stem cell research by Mayo Clinic's Dr. Andre Terzic and Dr. Atta Behfar. The cardiopoiesis technology uses to repair patients' hearts by re-programming their own stem cell to regenerate cardiac tissue.

When announcing the acquisition, Homsy said that four of Cardio3's top shareholders supported the move. A Belgium family-owned holding company called Tolefi SA is the lead shareholder with 32.23 percent of the shares. The Hong Kong-based Medisun, which is building an office in Rochester, owns 8.08 percent.

In the years since 2007, Mayo Clinic has developed a close working relationship with the Belgian company. Mayo Clinic is leading the U.S. clinical trial of Cardio3 and is using a lab in the Minnesota Biobusiness Center in downtown Rochester.

A possible deal is in the works for Cardio3 to occupy the entire fifth floor of the city-owned Minnesota Biobusiness Center. Gary Smith of the Rochester Economic Development Inc. said the company has not signed a lease yet and some financial details still need to be worked out.

If Cardio3 does decide to occupy the fifth floor, Mayo Clinic will need to move its staff that currently fills the space.

November 08, 2014

Mayo Clinic docs make millions by consulting with drug/device companies

Here's some from the lead article in my package of stories about Mayo Clinic doctors and their financial relationships with drug/medical device companies in this weekend's Post-Bulletin.

FYI, the front page article is continued on page A2 and more articles and data are printed on page B4.

An unprecedented disclosure of payments from drug companies shows that $3.07 million for consulting was paid in 2,388 payments to Rochester-based Mayo Clinic researchers, doctors and hospitals during five months last year.

11082014drugmoneygraphicHowever, Mayo Clinic officials point out that they have a strict policy about such payments, which all must be approved by its Conflict of Interest Committee. Such policies, which many medical centers have, are a way of preventing medical professionals from being unduly influenced by money from drug companies in their decisions, such as what drugs they prescribe.

For the same period, Cleveland Clinic staff collected $4.3 million in private money for consulting, while Johns Hopkins Hospital employees took in a mere $4,627.

Dr. Richard Ehman, vice-chair of the Conflict of Interest Committee, said that Mayo Clinic's restrictive policies are unusual within the medical industry.

"We know all of the financial relationships of our staff. That's unheard of," said Ehman.

Cleveland Clinic and Johns Hopkins urge their employees to disclose their private contracts, though they stop short of requiring it in every case, according to their policies posted on their websites. Mayo, Cleveland and Johns Hopkins all agree that a physician or scientist serving as primary leader of a research project are banned from having private contracts with the companies involved.

800px-Gonda_building,_closer_upHundreds of Mayo Clinic doctors are receiving millions from drug companies and medical device makers for private consulting every year, while many others are paid one-third of the royalties generated by their work.

Disclosing all of the financial contracts between private companies and doctors is the goal of the Open Payments website run by Centers for Medicare and Medicaid Services. It features a database of doctors and the money they receive from outside sources. It's now required by the Physician Payment Sunshine Act, which was part of the Affordable Care Act health reform.

In late September, data from August to December 2013 was released on the site. This batch of records includes about 4.4 million payments made to about 550,000 doctors and 1,360 teaching hospitals. However, some of the information reported by private companies is incomplete, confusing and, in some cases, incorrect.

For Mayo Clinic doctors, 100 percent of the payments for private consulting go directly to them. Mayo began allowing such consulting contracts in 1999, when it changed the rule that required all consulting payments to go to the clinic.

The payments for those five months show all different types, including royalties, research money and royalties.

In addition to the consulting payments during those five months, a total of 68 payments totaling $3.01 million were made to Mayo Clinic for research, according to the database.

All research money, like grants, goes directly to Mayo Clinic.

However, physicians or researchers receive one-third of the amount of royalty payments received by the clinic from drug companies, according to clinic policy. During the five months of reports, Mayo Clinic received a total of $1.9 million in royalties.

Just one company -- DePuy Synthes Sales Inc., a subsidiary of heath care giant Johnson & Johnson, reported paying a total of more than $1.15 million to Mayo Clinic or its doctors in 278 payments from August to December.

In the wake of the recent federally-mandated deluge of information about the financial ties between doctors and private drug/medical device companies, Ehman explained that Mayo Clinic does allow its employees to personally profit from such agreements. However, every financial relationship must be approved by the Conflict of Interest Committee.

Mayo Clinic approved 1,003 consulting contracts for 308 doctors and researchers in 2013 to personally work with private companies on their own time. The Mayo Clinic committee, which meets every other week, approved 953 such agreements with 301 individuals in 2012 and 1,071 for 292 employees in 2011.

October 15, 2014

Ex-Mayo exec accused of stealing trade secrets

A former top Mayo Clinic executive is being sued for allegedly hiding his hiring by a competitor of Mayo Medical Laboratories for months while he continued to work for Mayo and for stealing trade secrets.

Franklin-cockerillMayo Clinic filed a lawsuit alleging misappropriation of trade secrets and breach of contract against Dr. Franklin R. Cockerill III, who was president and chief executive officer of the for-profit Mayo Medical Labs for eight years. The case was filed Tuesday in Olmsted County District Court. Mayo Clinic released the lawsuit to the media this morning.
 
A Mayo Clinic statement released by Bryan Anderson this morning said, “We do not take this action lightly. Dr. Cockerill was a valued Mayo Clinic clinician, leader and colleague.  We will vigorously defend and protect our intellectual property to ensure we can continue to meet our charitable mission,"

A call to Dr. Cockerill's southwest Rochester residence went unanswered this morning. Asked to comment, Quest Director of Media Relations Wendy Bost said the company received the complaint this morning and is reviewing it. "We do not comment on pending litigation," Bost said.

According to the complaint:

On July 17, an emotional Cockerill told his department that he was "retiring" to help his 85-year-old mother run her fertilizer business in Nebraska. Co-workers lauded his almost 30-year career with Mayo Clinic and gave him an appreciative send-off that built up to his final day of work on Sept. 30.

All of that changed on Oct. 1. Instead of retiring to Nebraska, Cockerill went to New Jersey to work for a major MML competitor, Quest Diagnostics Inc. He stepped into the position of vice president and chief laboratory officer for the multibillion public company.

Using emails as evidence, Mayo Clinic contends Cockerill had been talking to Quest about a job since February. He had a phone interview with Quest in March followed by a face-to-face interview in May, when Cockerill said he needed the time off to help his mother with a business problem. The lawsuit alleges he accepted the Quest position in June. Instead of informing Mayo Clinic, he continued to work at Mayo and attend confidential meetings, where issues were discussed that could cause irreparable damage to MML and Mayo Clinic in the hands of Quest.

Cockerill exchanged emails discussing business strategies with Quest CEO Stephen Rusckowski in August, according to Mayo's suit.

Mayo Clinic alleges Cockerill left with at least seven clinic-owned USB memory drives and that he used four of them to "download information from Dr. Cockerill's computer in the days before … (he) started working for Quest."

Mayo Medical Labs and Quest vie for millions in medical test contracts. Mayo Medical Labs performs about 20 million tests for more than 4,000 hospitals annually. Quest says it does 1.5 billion tests a year. Many of the clinical tests conducted by both MML and Quest are proprietary and generate millions in revenue.

The lawsuit also claims Cockerill attempted to recruit "at least one long-term key Mayo employee to consider retiring early to 'consult' with the lab industry," though he did not specifically mention Quest to the female executive.