The right mix mat­ters in bio­phar­ma lead­er­ship

Break­ing the bio­phar­ma glass ceil­ing isn’t just a moral is­sue; it’s a share­hold­er is­sue. McK­in­sey re­port­ed in a re­cent study that com­pa­nies in the top quar­tile for gen­der di­ver­si­ty are 15 per­cent more like­ly to gen­er­ate fi­nan­cial re­turns above the in­dus­try av­er­age; those in the top quar­tile for racial and eth­nic di­ver­si­ty are 35 per­cent more like­ly to do so.

The right mix of ex­pe­ri­ence, per­spec­tives and back­grounds is al­so a pa­tient is­sue. Whether it’s choos­ing the right end­point for a prospec­tive ther­a­py or mar­ket­ing a prod­uct in a way that will en­able physi­cians and pa­tients to ac­cess the right med­i­cine at the right time, more com­pa­nies are be­gin­ning to un­der­stand the need to di­ver­si­fy their ranks and groom lead­er­ship teams as di­verse as the clin­i­cians and fam­i­lies they’re try­ing to reach. It’s good busi­ness and it’s good for pa­tients.

There are bio­phar­ma com­pa­nies mak­ing in­cred­i­ble progress in the di­ver­si­ty and in­clu­sion space. Oth­ers want to di­ver­si­fy and are ask­ing for help to broad­en ex­ec­u­tive and board search­es out­side of what are of­ten ho­moge­nous per­son­al net­works. That’s why the Biotech­nol­o­gy In­no­va­tion Or­ga­ni­za­tion — the world’s largest biotech trade and ad­vo­ca­cy group — is launch­ing a new in­dus­try­wide ini­tia­tive called The Right Mix Mat­ters.

Based on my con­ver­sa­tions, a crit­i­cal mass in biotech al­ready knows that we have a pipeline prob­lem. We should be fas­tid­i­ous in our ef­forts to pro­mote more women, mi­nori­ties and LGBT ex­ec­u­tives up the ranks. Many of us in C-suites and board rooms do feel a sense of ur­gency: More in­sti­tu­tion­al in­vestors and ven­ture cap­i­tal­ist are look­ing at lead­er­ship di­ver­si­ty as a fac­tor in where to put cap­i­tal. Frankly, this needs to be a wake-up call for our sec­tor.

Na­tion­al­ly, on­ly sev­en to nine per­cent of CEO po­si­tions at biotech com­pa­nies are filled by women, ac­cord­ing to na­tion­al sur­veys by Lift­stream. It still hap­pens that when I go to net­work­ing events with my fel­low CEOs, I’m of­ten the on­ly woman in the room.

Like al­most every fe­male physi­cian of my era in Scot­land, I re­ceived my med­ical train­ing dur­ing a time when it was as­sumed we would quit our jobs or work part-time when start­ing a fam­i­ly. As a doc­tor in train­ing, I lost count of the num­ber of times I was asked to make a cup of tea for every­one while my male col­leagues talked about their ca­reer paths with the con­sul­tants.

I be­came a doc­tor be­cause I care deeply about the wel­fare of pa­tients, and be­came a rheuma­tol­o­gist be­cause I’ve al­ways been at­tract­ed to the most con­found­ing ar­eas of med­i­cine. I dis­cov­ered help­ing pa­tients suf­fer­ing from vex­ing con­di­tions al­most al­ways re­quired more than even the most de­ter­mined doc­tor’s best ef­forts. The in­ter­ven­tions of the rheuma­tol­o­gist, nephrol­o­gists and oth­er spe­cial­ists might be life-sav­ing, but it was the phys­io­ther­a­pist, wound nurse and oc­cu­pa­tion­al ther­a­pist who made pa­tients’ lives liv­able. This recog­ni­tion that di­verse back­grounds pro­duce the best so­lu­tions has lived with me ever since.

My ca­reer took me to the Unit­ed States for a role in the bio­phar­ma­ceu­ti­cal in­dus­try in clin­i­cal de­vel­op­ment. I put in for a trans­fer on the com­mer­cial side, where­upon the head of mar­ket­ing and sales in­formed me, “You are fe­male, Scot­tish and an M.D. You’re just not the right fit.” For­tu­nate­ly, that com­pa­ny even­tu­al­ly got new lead­er­ship, and I found a cham­pi­on in the C-suite who saw some­thing in me. He spon­sored for a com­mer­cial lead­er­ship role even though I didn’t yet have all the ex­pe­ri­ence of the “per­fect” can­di­date. With­out a cham­pi­on will­ing to open the door to that first crack at broad­er lead­er­ship roles, many women and mi­nori­ties in cor­po­rate Amer­i­ca lan­guish in mid­dle man­age­ment in per­pe­tu­ity —un­able to move up and in­to the C-suite.

But I did move up. When I be­came a can­di­date for my first CEO role, I hired a coach to help me in­crease my ef­fec­tive­ness as a com­mu­ni­ca­tor. I pos­sessed that fa­mil­iar fem­i­nine trait of fail­ing to take enough per­son­al cred­it for my role in the suc­cess­es of teams I led. My coach helped me un­der­stand that in­ter­view­ing with boards is not the time to be mod­est. He was right. I learned how to bet­ter sell my cre­den­tials, ex­pe­ri­ence and abil­i­ties, be­com­ing one of the for­tu­nate few to crack the glass ceil­ing in the bio­phar­ma­ceu­ti­cal in­dus­try.

As the cen­ter­piece of BIO’s ef­fort, BIO Board­list went live this month. It’s a search­able on­line data­base of di­verse tal­ent where ex­ec­u­tives can nom­i­nate promis­ing tal­ent and where search com­mit­tees can find lead­er­ship can­di­dates that meet their busi­ness needs. The tool was de­ployed by the high-tech in­dus­try in 2017 in the wake of a firestorm ig­nit­ed by the con­tro­ver­sial writ­ings of a Google en­gi­neer that sparked an in­dus­try­wide dis­cus­sion about sex­ism. Now, BIO is bring­ing this tool to the bio­phar­ma sec­tor.

We al­ready have near­ly 50 out­stand­ing, pre-vet­ted can­di­dates who are search­able in BIO Board­list. Our job now is to add more high­ly qual­i­fied, di­verse lead­ers to the data­base. Once we do, BIO Board­list will be es­pe­cial­ly help­ful for small­er and emerg­ing bio­phar­ma com­pa­nies that do not yet have a ro­bust hu­man re­sources func­tion or the means to hire ex­ec­u­tive re­cruiters. BIO Board­list can help com­pa­nies iden­ti­fy, lift up and in­clude di­verse ex­ec­u­tives with lead­er­ship qual­i­fi­ca­tions and as­pi­ra­tions.

BIO al­so launched a sec­ond re­source — a di­ver­si­ty and in­clu­sion toolk­it. We have pooled to­geth­er the best re­sources from suc­cess­ful pro­grams across BIO mem­ber com­pa­nies. Com­pa­nies will find spe­cif­ic HR tem­plates that can be down­loaded and schol­ar­ly pieces and train­ing cours­es on such top­ics as un­con­scious bias, men­tor­ing and spon­sor­ship.

As a prac­tic­ing rheuma­tol­o­gist, I learned that it can take a vil­lage to give pa­tients a life worth liv­ing. Work­ing my way up the ranks to the CEO’s of­fice in bio­phar­ma, I have dis­cov­ered the same of­ten holds true to de­vel­op a med­i­cine worth tak­ing or a clin­i­cal pro­gram worth fund­ing. If you’re lead­ing a biotech com­pa­ny and want to do right by your con­sumers, in­vestors and share­hold­ers, the right mix re­al­ly does mat­ter.


Dr. He­len Tor­ley is CEO of Halozyme Ther­a­peu­tics in San Diego and chairs BIO’s Com­mit­tee on Work­force De­vel­op­ment, Di­ver­si­ty and In­clu­sion. Biotech Voic­es is a con­tributed col­umn writ­ten by se­lect End­points News sub­scribers.

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

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Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

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Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

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Michel Vounatsos, Biogen CEO (via YouTube)

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Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

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The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.