Bio­science in­dus­try stake­hold­er col­lab­o­ra­tion key to ad­dress­ing in­equal­i­ty

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When a glob­al pan­dem­ic hit, the bio­science in­dus­try an­swered the call for vac­cines and ther­a­pies in record time, which will save mil­lions of lives. This re­sponse was pos­si­ble be­cause of a sus­tained in­vest­ment of risk-cap­i­tal by the ven­ture cap­i­tal in­dus­try in life sci­ences com­pa­nies, peak­ing in 2020. Great sci­en­tists, vi­sion­ary lead­er­ship and high-qual­i­ty in­vestors that backed new sci­ence and bold en­tre­pre­neurs led to the in­no­v­a­tive tech­nolo­gies of BioN­Tech and Mod­er­na that con­tributed to the ini­tial Covid-19 vac­cines.

As the sec­tor right­ly basks in the glow of this year’s ac­com­plish­ments, there is a con­cur­rent re­al­i­ty to con­front. Covid-19 has fur­ther ex­posed the in­equities in so­ci­ety, dis­pro­por­tion­ate­ly im­pact­ing women and mi­nori­ties. This im­bal­ance is al­so ev­i­dent in the bio­science com­mu­ni­ty, pro­vok­ing many lead­ers to act on in­equal­i­ty.

Ven­ture cap­i­tal­ists find­ing rea­sons to change

The ven­ture cap­i­tal in­dus­try, not on­ly with­in life sci­ences, has well-doc­u­ment­ed chal­lenges with di­ver­si­ty, eq­ui­ty and in­clu­sion. On­ly 2.6% of to­tal VC fund­ing in 2020 has gone to Black and Lat­inx founders, and fund­ing for fe­male founders has sunk to lev­els not seen since 2017. De­spite that, I per­ceive a grow­ing ap­petite for change. The ques­tion is – How?

In VC firms, the low at­tri­tion of in­vest­ment part­ners and the lim­it­ed ex­pan­sion of firms lim­its ca­reer op­por­tu­ni­ties for the many tal­ent­ed As­so­ci­ates and Prin­ci­pals that rep­re­sent the fu­ture. With no vis­i­ble route to part­ner, these em­ploy­ees seek op­por­tu­ni­ty else­where, out­side ven­ture cap­i­tal. The loss of such tal­ent re­duces the chance to in­tro­duce more di­ver­si­ty among a ven­ture firm’s part­ner ranks.

A lack of di­ver­si­ty among VCs great­ly in­flu­ences in­vest­ment de­ci­sions and cap­i­tal al­lo­ca­tion. For ex­am­ple, re­search shows how in­ter­ac­tions with in­vestors dif­fer be­tween men and women en­tre­pre­neurs (We Ask Men to Win and Women Not to Lose: Clos­ing the Gen­der Gap in Start­up Fund­ing. Kanze, Huang, Con­ley and Hig­gins). The ques­tions di­rect­ed at men ex­plore the size and mag­ni­tude of the op­por­tu­ni­ty. In con­trast, women are more like­ly to be ques­tioned about pre­ven­tion fac­tors and down-side risk.

Cre­at­ing a new com­pa­ny in life sci­ences, and grow­ing it, in­vari­ably re­lies on ven­ture fi­nance. VC firms have a strong in­flu­ence over the com­pa­ny build­ing process, in­clud­ing the com­po­si­tion of boards and se­nior man­age­ment, as well as the tal­ent and cul­ture. In­suf­fi­cient di­ver­si­ty among ven­ture in­vestors can lim­it a port­fo­lio com­pa­ny’s com­pet­i­tive­ness in the tal­ent mar­ket be­cause di­verse can­di­dates se­lect em­ploy­ers where they see them­selves rep­re­sent­ed and suc­cess­ful. Just 3% of VC in­vest­ing part­ners are racial or eth­nic mi­nori­ties and around 11% are women. This leads to an ex­ist­ing bias among VCs to­wards his­tor­i­cal suc­cess pat­terns, which has been to the detri­ment of mi­nori­ties and women.

Pri­vate com­pa­nies re­act to pub­lic mar­ket re­quire­ments

The re­cent Nas­daq pro­pos­als to the SEC on board di­ver­si­ty and dis­clo­sure, along­side new state laws and reg­u­la­tions, are forc­ing many pub­lic com­pa­nies to be­come more di­verse. Mean­while, pri­vate com­pa­nies in the bio­science sec­tor re­main strong­ly in­flu­enced by ven­ture in­vestors who many per­ceive as pas­sive re­gard­ing di­ver­si­ty and in­clu­sion.

The in­ter­play be­tween ven­ture in­vestors and port­fo­lio com­pa­nies is a source of great op­por­tu­ni­ty to ad­vance DE&I in the sec­tor. In­creas­ing di­ver­si­ty will cre­ate val­ue for all stake­hold­ers, and re­duce the fric­tion points as com­pa­nies tran­si­tion from pri­vate ven­ture own­er­ship to the pub­lic mar­kets. Chang­ing the com­po­si­tion of the board and the man­age­ment team takes time and en­er­gy and can cause a com­pa­ny to lose vi­tal mo­men­tum. Cul­ture is of­ten seed­ed ear­ly in a com­pa­ny’s life and pos­i­tive­ly ad­dress­ing cul­ture from the get-go re­duces the need for cul­tur­al cor­rec­tions as a com­pa­ny ma­tures.

The pow­er of the col­lec­tive

For small com­pa­nies, with­out the ex­per­tise and hu­man cap­i­tal, the in­tent to im­ple­ment DE&I prac­tices, tools and poli­cies of­ten fails. Prac­tices bor­rowed from large in­ter­na­tion­al com­pa­nies are not rou­tine­ly ef­fec­tive ei­ther.

The range and com­plex­i­ty of DE&I is­sues com­pa­nies need to tack­le, make the task daunt­ing and com­pli­cat­ed. In­stead of or­ga­ni­za­tions in­di­vid­u­al­ly piec­ing to­geth­er a DE&I strat­e­gy, con­stituents have an op­por­tu­ni­ty to work col­lab­o­ra­tive­ly and pre-com­pet­i­tive­ly to de­vel­op DE&I so­lu­tions that are de­signed for the op­er­a­tional re­quire­ments of ven­ture cap­i­tal firms and ven­ture-backed pri­vate com­pa­nies. The Bio­science & In­vestor In­clu­sion Group (BI­IG) is one such op­por­tu­ni­ty (www.bioin­clu­sion.org).

Bio­science & In­vestor In­clu­sion Group chan­nels col­lec­tive com­mu­ni­ty ac­tion; some­thing the bio­science sec­tor does well. BI­IG en­ables com­pa­nies and in­di­vid­u­als to con­tribute their per­spec­tive or ex­pe­ri­ence to struc­tured work­ing groups ini­tial­ly pri­or­i­tiz­ing In­vestor In­ter­ac­tions; Hir­ing and On­board­ing, and Peo­ple Growth and Re­ten­tion. The DE&I so­lu­tions BI­IG de­vel­ops will be freely ac­ces­si­ble to help ad­vance and ac­cel­er­ate DE&I in the in­dus­try.

When in­vestors and en­tre­pre­neurs link arms in the face of chal­leng­ing prob­lems, they are ca­pa­ble of re­mark­able achieve­ments. This uni­ty and the open and col­lab­o­ra­tive spir­it of the bio­science com­mu­ni­ty can tack­le an­oth­er big prob­lem the sec­tor must con­front — in­equal­i­ty.

Karl Simp­son is the CEO of Lift­stream and a founder of The Bio­science & In­vestor In­clu­sion Group.

Biotech Voic­es is a con­tributed col­umn from se­lect End­points News read­ers. Read more here.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

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Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

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The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

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Horizon Therapeutics announced last week that it was in talks with three pharmaceutical giants that could take over the company. You can now remove one of them from the equation.

J&J’s Janssen, after Horizon reported its initial involvement in early discussions to acquire the rare disease biotech, issued a statement Saturday that said Janssen “does not intend to make an offer for Horizon,” and that Janssen is bound by restrictions set in Rule 2.8 of the Irish Takeover Rules. These rules are in place for any company interested in taking over Irish companies, with Horizon Therapeutics currently based in Dublin.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

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Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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