Bree Harlin
, who used to be director of clinical operations at
Loxo Oncology
, now
Loxo@Lilly
, is now in the C-suite for the first time.
Harlin started at
TC BioPharm
on Wednesday as chief clinical officer, the biotech announced Friday — but her journey starts more than 20 years before then. After graduating from college, she moved to Boston, working in academia at some of the Harvard teaching hospitals in endocrinology and CNS.
She later got convinced to interview with a company her neighbor founded, which was developing a gadolinium-based contrast agent used in diagnostic imaging. That’s where she got her start in the industry, moving from a clinical trial associate position to a clinical research associate role and got her first experience filing an NDA.
While that NDA was rejected, it made an impact on Harlin.
“It got me really hungry to learn more about how trials are run and more about the industry and in general,” Harlin added.
That impact drove Harlin to other biotech and pharmaceutical companies, including
Pfizer
,
Forest Pharmaceuticals
(pre-buyout from
Actavis
/
Allergan
) and
Shire
, with her latest stint being director of clinical operations at Loxo and helping to run Phase I to Phase IV trials.
For Harlin, all of those jobs working with clinical trials and being a part of NDA and IND filings have conglomerated into a cornucopia of experience that, in her words, can be applied to her new job at TC BioPharm in order to “hit the ground running.”
She’s already started meeting the team, hopping on meetings and instituting plans to get clinical trial sites on board in the US and outside the UK, where TC BioPharm is based.
Currently the biotech is looking at expanding its cell therapy candidate outside the UK. Harlin’s goal is to utilize her experience to start recruiting trial sites in the US and in the EU, and navigate the clinical trial process to bring on board the right people. As far as the US goes, TC BioPharm is looking to file an IND with the FDA later this year in a bid to start up a Phase I trial, most likely in acute myeloid leukemia.
CEO
Bryan Kobel
told
Endpoints News
that it was obvious Harlin was the right fit for the job, calling the entire process a matter of serendipity after the previous clinical director stepped aside to pursue a personal passion.
“That put us in a really weird position where we had to find a chief clinical officer, and do it quickly,” Kobel added.
After company leadership put together a sort of candidate attribute wishlist, Kobel said that he started cold-calling people — and Harlin was the first interview. After talking with eight to 10 more candidates, Harlin was still the top choice, and was brought on board.
The chief executive added that the company looks for people who have experience working as part of a team and know how to communicate with them in high pressure situations without adding more stress or tension.
While also noting the aspects of leading by example, “It’s hard to build a culture; it’s really easy to destroy it. So we need to be really, really prudent with who we add, how we add them, and the time we take to add them,” Kobel said.
—
Paul Schloesser
→ Although he “retired” after 14 years as CEO of
Exelixis
in 2010, and “retired” again from the top spot at
Biogen
in 2016,
George Scangos
assured Endpoints on Wednesday that
Vir Biotechnology
would be the last company he leads.
We don’t know what the rest of 2023 holds in the industry, but we’ll be hard-pressed to find a bigger CEO transition this year than the 74-year-old Scangos passing the baton to
Bayer
’s high-flying business leader
Marianne De Backer
on April 3. On De Backer’s watch, Bayer would swing deals like
the acquisitions
of
AskBio
and
Vividion
before either of them had the opportunity to go public. “I’m going to be called the IPO terminator,” De Backer said jokingly
after the Vividion buyout
.
After turning Biogen’s fortunes around with the approval of MS drug
Tecfidera
in 2013, Scangos set off for Vir, where he put the biotech on the map by teaming up with
GSK
on
sotrovimab
for mild-to-moderate Covid-19.
In an interview with John Carroll
where he expressed his admiration for De Backer and a desire to travel with family, Scangos also discussed his risk-taking approach — invoking
Kenny Rogers
in the process. “I’ve always felt in my career that I would rather go down in flames by having failed big time than live my life in mediocrity because I was afraid to try,” Scangos said. “You can’t be in this industry if you’re not an optimist, but you have to be realistic and you have to know when to hold them and when to fold them.”
→
Kimball Hall
has left the CDMO
Abzena
to become president and CEO
of Irish biotech
Innocoll
, encompassing both
Innocoll Biotherapeutics
and the CDMO subsidiary
Syntacoll
. Hall, who rose to VP of manufacturing during her 14 years at
Amgen
, then moved on to
Genentech
as SVP of manufacturing biologics drug substance. She joined Abzena in 2019 as operations chief and was elevated to president a year later.
→ Launched in November and scouring the “secretome” for new therapies,
Juvena Therapeutics
has filled
several leadership positions, with chief corporate development officer
Neil Berkley
leading off. A business development veteran with GSK and
Cadence Pharmaceuticals
(which was sold to
Mallinckrodt
in 2014), Berkley had a yearlong stay at
AbCellera
as CBO before leaving on June 29, according
to an SEC filing
. AbCellera CEO
Carl Hansen
has yet to name a replacement.
Juvena has also welcomed the following: Amgen and
Merck
vet
Gayathri Swaminath
(SVP of discovery);
Mo Tabrizi
(VP of preclinical and nonclinical development), another Merck alum and the former senior director of pharmacology for
Ascendis Pharma
; and
Eddie Moler
(VP of data science).
Mubadala Capital
and
Horizons Ventures
headlined
Juvena’s $41 million Series A financing
.
→
Jane Henderson
has landed
at immunology and inflammatory disease biotech
Apogee Therapeutics
, which emerged from stealth
with a $149 million Series B
and $169 million in total. The new CFO — no relation to Apogee’s CEO
Michael Henderson
— owned the same title at
Invivyd
, the
Tillman Gerngross
antibody developer that hit the scene with a lot of flash and a boatload of money as
Adagio Therapeutics
. But
a substantial flop with its Covid-19 candidate
led to a shakeup that included the
departures of Gerngross
, Henderson
and the dismissal
of an undisclosed number of staffers. She was previously the CFO of
Voyager
and
Turnstone Biologics
, and has board seats at
Akero Therapeutics
,
Ventus Therapeutics
and
Iveric Bio
.
→ The xenotransplantation experts at
eGenesis
have picked up
Knut Niss
as chief technology officer. Niss carried the same title at
Mustang Bio
, and he was part of the CMC leadership team at
Novartis
for
Kymriah
before it earned the distinction as the first approved gene therapy in the US. Last April,
Michael Curtis
replaced
Paul Sekhri
as CEO of eGenesis, the CRISPR upstart that’s trying to beat its xeno competitors to the clinic with its gene editing tech. Sekhri is
currently the chief executive
at
vTv Therapeutics
.
→ Thyroid eye disease biotech
Sling Therapeutics
, located south of the University of Michigan campus,
has tapped
Jeffrey Kent
as CMO. Kent logged more than 10 years at
Horizon
and was EVP, medical affairs and outcomes research when Amgen struck M&A gold
with a $28 billion deal
in December. Sling’s lead asset
linsitinib
was in-licensed from
Astellas
, where Kent worked as an executive medical director before joining Horizon. We caught up with
Gossamer Bio
chief
Faheem Hasnain
when he was named chairman
of Sling, which debuted with a $35 million Series A last June.
→ It’s been an eventful week for
Pliant Therapeutics
,
raising $250 million
after
touting positive Phase IIa data
with its idiopathic pulmonary fibrosis (IPF) drug
bexotegrast
. The Pliant news continues
with the selection
of
Lily Cheung
as chief human resources officer. Cheung brings HR experience from
Actelion
and
Rigel Pharmaceuticals
, and she had been VP of human resources for
Synthekine
since December 2021.
→ Right on Cue:
Matteo Levisetti
has been promoted
to CMO at
Cue Biopharma
, setting the stage for acting medical chief
Kenneth Pienta
to step into a clinical advisory role. We had Levisetti
in this space in February 2021
when he was named SVP of clinical development at the Boston biotech, whose pipeline is centered on IL-2. He’s been around the block in Big Pharma (Merck,
Roche
,
Pfizer
) and spent a year as global clinical lead for
sitravatinib
at
Mirati
.
→
Sri Ryali
has signed on
as CFO of
Codexis
, the enzyme engineering outfit
that sent 18% of its staff packing
in November under first-year CEO
Stephen Dilly
. An Amgen finance alum, Ryali just completed four years as CFO of
Eiger BioPharmaceuticals
and was VP of finance at
Aimmune
from 2015-18. Earlier, he played a few quick measures at
Jazz Pharmaceuticals
as senior director, financial planning & analysis.
→ Targeting cancer and inflammatory bowel diseases like Crohn’s and ulcerative colitis with site specific immunomodulators (SSIs),
Qu Biologics
out of British Columbia
has enlisted
Matt Cahill
as COO. Cahill was on the original crew at another Canadian company,
Deep Genomics
, as VP of finance & business operations, and he’s still on the board of directors with founder/CEO
Brendan Frey
,
Nessan Bermingham
and others.
→
Shawn Levy
has been promoted
to CSO and SVP of applications at DNA sequencing company
Element Biosciences
. Peer Review introduced you to Levy in February 2022
when he first came to Element
as SVP of applications and scientific affairs.
→ Molecular diagnostics shop
BillionToOne
, which kept the cash flowing
with a $125 million Series C
in March 2022,
has installed
Amgen alum
Gary Palmer
as CMO, oncology. The ex-VP of medical affairs at
Foundation Medicine
and
Genomic Health
also had a three-year run as CMO of
Tempus Labs
.
→ Aurora, CO-based neuro biotech
Cerebral Therapeutic
s
has appointed
Julie Foster
as COO. Foster put in 35 years at
Medtronic
, taking on such roles as VP of the cardiac and vascular businesses in the EMEA (Europe, Middle East and Africa) region and VP of customer experience, diabetes.
→
IO Biotech
was one of the last trains out of the IPO station in late November 2021 before things went pear-shaped in the market, and this week the IDO/PD-L1 player
has recruited
Devin Smith
as general counsel and chief compliance officer. Smith is an
EMD Serono
legal vet who was general counsel at
Yumanity
before
it reverse merged
with
Kineta
and shipped off Parkinson’s drug
YTX-7739
— along with an assortment of other candidates — to
J&J
back in June.
→ CEPI’s mRNA vaccine partner
SK bioscience
has a pair of new execs
:
Richard Kensinger
(VP of R&D project management) is an 18-year
Sanofi
veteran who comes from
Affinivax
, where he was executive director of process development and protein sciences. And
Kenneth Lee
(VP of the biologic business development department at SK’s R&D center in Pangyo, South Korea) led the commercial division in the Americas region for
GenScript ProBio
, the CDMO subsidiary of
GenScript
that racked up a $224 million Series C
last week.
→ Speaking of CDMOs, Columbus, OH’s
Forge Biologics
has $90 million more
in the bank and
a couple more VPs
on the team.
Chris McPherson
(VP of GMP manufacturing), a
WuXi AppTec
alum, just finished a four-and-a-half-year tenure at
Samsung Biologics
, and
Taleen Barsoumian
(VP of client development) is an ex-senior sales consultant at Novartis who was recently US director of sales and business development for cell and gene therapy at
Barkey
. Meanwhile,
Adam Davis
has been promoted to VP of analytical development. Davis ventured off to Forge Biologics in October 2020 after serving as director of manufacturing for
Abeona Therapeutics
.
→ Bayer-backed cryogenic electron microscopy (cryo-EM) specialist
Gandeeva Therapeutics
has elected
Brenda Cooperstone
to the board of directors. Cooperstone had held the roles of chief development officer, rare disease and Pennsylvania site head at Pfizer, but left the Big Pharma in December after 24 years overall.
→ Ex-
Adicet Bio
interim chief
Donald Santel
has been given
a seat on the board of directors at
Aerovate Therapeutics
, chaired by
Kala Pharmaceuticals
CEO
Mark Iwicki
. Santel also helmed
Hyperion Therapeutics
and is chairman of
Tentarix Biotherapeutics
and
Ocelot Bio
.
