Ex-Takeda exec hits the ground running at the helm of rare disease biotech — with 3 priorities off the bat; Seasoned CEO jumps to ALS upstart
→ After spending years in the biopharma and rare disease space, Tauhid Ali finally got the opportunity to fulfill a personal ambition: to co-found and create a biotech company in the rare disease space. And he’s officially joining the transatlantic biotech, which has personnel in both the UK and the US, as CEO.
After the company was founded in the second half of 2021, Oak Hill Bio officially emerged from stealth in February with Takeda throwing its weight behind the biotech — by out-licensing Takeda assets and taking an equity stake in the company. Takeda sent over some talent to kick things off with a bang: CMO Victoria Niklas, most recently global program leader a Takeda asset, now one of Oak Hill’s lead programs, as well as Norman Barton, the exec behind the other lead program at Oak Hill. Daniel Curran, Takeda’s head of rare genetics and hematology therapeutic area unit, also joined the board of directors.
While the biotech is getting its feet off the ground, Ali has already went ahead on some of the groundwork, starting with networking at the global healthcare conference currently being hosted by RBC Capital in NYC.
And in the meantime, Ali sat down with Endpoints News.
Ali, originally from Scotland, grew up with a science background — his father was a physician, and also grew up alongside people who suffered from different chronic illnesses.
“And I was just motivated to do something in my life that I could look back on and say I was a part of a team — with a stress on team — that contributed to getting a therapeutic to market and more importantly to patients,” Ali said.
With that background, Ali then went to university, getting his master’s degree from the Welsh School of Pharmacy and then going on to get his PhD at Cardiff University, specializing in Parkinson’s disease. From there, it was pretty much nothing but rare disease, working with big companies such as UCB, Ipsen, and Shire Pharmaceuticals before Shire got bought out by Takeda, where Ali eventually ended up spending a few years.
While at Takeda, Ali founded a virtual rare disease unit called TAKcelerator, an in-house semi-autonomous accelerator. The goal, according to Ali, was looking at single assets, and then take them through preclinical and early clinical stages. After that’s done, pivot to working with VCs and spin out single-asset biotechs with an emphasis in rare disease.
“It was a way to learn — one, about rare disease drug development, patient advocacy, and also, interestingly, on operational execution. That was, how can we be more agile and laser focused in the way that we do R&D,” Ali added.
The biotech’s focus so far (albeit not very long yet) is rare disease and neonatal indications — which could open the door for a substantial share of the market in the US if the biotech is successful.
The biotech’s lead drug candidate, OHB-607, is a former Shire drug that was designed to treat complications for extremely preterm infants. The candidate is a recombinant version of insulin-like growth factor 1, which has been noted as a key driver of fetal growth that the fetus produces very little of until reaching 30 weeks.
Oak Hill noted that the drug showed a “statistically significant improvement” in preventing a severe form of a chronic lung disease called bronchopulmonary dysplasia.
The most famous neonatal drug in the US, Makena, was approved to reduce the rate of premature births back in 2011 via accelerated approval. While the drug is still available, an FDA advisory committee voted 9-7 to pull the approval in 2019 in a still-ongoing, highly controversial saga. The FDA will hold a meeting later this year to review the approval.
As for the company’s first steps, there’s actually three things Ali is focusing on for now in both short term and the long term. First thing — expand the team. The headcount at Oak Hill is currently about 13 employees, but Ali said it will go up to 15 in about a month. Secondly is to execute on the clinical programs, which include restarting a Phase IIb trial and starting up a brand new Phase II trial for its two lead, ex-Takeda drugs. And in the meantime, raise more capital for “key inflection points,” which include clinical trials. According to Ali, those trials should have readouts sometime in 2024.
— Paul Schloesser
→ Eli Lilly vet Kimberly Blackwell will take over as CEO at Zentalis, where she has served as independent director since 2020. Blackwell was VP of early phase oncology and immuno-oncology at Lilly, and she also served as CMO at Tempus. At Pfizer-partnered Zentalis, which concurrently raised $200 million, Blackwell will look to advance two of the biotech’s lead candidates, Wee1 inhibitor ZN-c3 and BCL-2 inhibitor ZN-d5.
→ Following his arrest over allegations of domestic violence, longtime Seagen CEO Clay Siegall resigned from his post at the Washington-based biotech earlier this week, as well as his board seats at Umoja Biopharma and Nurix Therapeutics. Siegall was arrested on April 23, and police reports along with a subsequent temporary restraining order described a pattern of abusive behavior. Siegall has denied the claims. Seagen launched its own investigation, although the biotech noted that Siegall’s departure was not driven by findings from that exploration. CMO Roger Dansey has stepped up as interim CEO while the company searches for a permanent successor, and Felix Baker is replacing Siegall as board chair.
→ ALS is one of the most difficult diseases in drug development. Earlier this year, Medical Excellence Capital joined forces with the nonprofit Project ALS and leading researchers at Columbia University to launch ProJenX, a biotech focused on treatments for ALS and other debilitating brain diseases. Now they’re tapping an expert to build it up. Stan Abel is taking the reins, after leaving his post as CEO of SiteOne Therapeutics. The longtime chief executive is known for guiding biotechs through Big Pharma acquisitions: He was CEO at Corthera through its sale to Novartis, CFO of Cerexa through its sale to Forest Laboratories, and CFO of Peninsula through its sale to Johnson & Johnson. Now he’ll focus on bringing ProJenX’s candidate prosetin through a three-part Phase I trial in ALS.
→ Effective May 23rd, Phuong Khanh Morrow will take over as CMO at CRISPR Therapeutics. Morrow most recently served as VP and global therapeutic area head of hematology, GI oncology, GU oncology, and bone at Amgen. She has also served as assistant professor, department of breast medical oncology at the University of Texas MD Anderson Cancer Center.
→ Stacey Davis has joined tumor-selective immuno-oncology biotech Xilio Therapeutics as CBO. Davis most recently served as VP, lung and immuno-oncology franchise, US oncology at Novartis Oncology. She has also served as SVP and general manager at Prominex as well as US immunology, head, commercial strategy, insights and operations at Janssen Biotech.
→ Effective June 30th, Ofer Gonen will transition from board member and CEO of Clal Biotechnology Industries to CEO of MediWound. He will replace current CEO Sharon Malka, who will take a seat on the board of directors. Before joining Clal, Gonen was general manager of Biomedical Investments, and the founder and managing Partner at Arte Venture Group.
→ Visiox Pharma has been relatively quiet since bursting onto the eye therapy scene with two lead candidates licensed from Sun Pharma Advanced Research Company back in December. Now, the company says it’s ready to approach the FDA this year — and it’s tapping a chief executive to lead the way. Ryan Bleeks is coming aboard to “to build a business for the future,” he said in an announcement on Tuesday. Before this, Bleeks was the VP of all things sales at RVL Pharmaceuticals, where he helped launch the acquired blepharoptosis product Upneeq. The new CEO is already lining up two NDA submissions later this year in the glaucoma and cataract surgery markets.
→ UK vaccine outfit iosBio has another C-suite exec in its ranks — just a month after recruiting Ben Warriner, the former finance VP from fellow UK-based Freeline Therapeutics, to be its new chief financial officer. This time, it went across the pond to Canada and brought Craig Laferrière onboard as its new chief development officer. Laferrière, whose last stop was as a vaccine design consultant, had done stints at GSK and Pfizer Canada as a researcher, later as a medical advisor to Pfizer Canada’s vaccine leadership team.
→ Cachexia physician Daniel Marks has taken over as CMO at Endevica Bio. He has worked out of Oregon Health & Science University in Portland, OR for the last 2+ decades, working his way up from a scientist and pediatric endocrinologist to being a man of many hats, such as senior associate dean of research, the director of the Papé Family Pediatric Research Institute and director of the patient resiliency program for the Brenden-Colson Center for Pancreatic Care. While at the university, Marks was a senior consulting advisor for the Bill & Melinda Gates Foundation on its birth, growth & development team for 4.5 years and worked as a pediatric endocrinologist at St. Luke’s Children’s Hospital from 2009-2013.
→ Promontory Therapeutics, a small molecule oncology immunotherapy company, has appointed Johan Baeck as EVP and CMO. Baeck most recently served as SVP, clinical development and medical affairs at Jounce Therapeutics. By moving into this position, Baeck will replace former CMO Joseph O’Donnell, who will now serve as senior medical director focusing on patient eligibility, enrollment and clinical case management.
→ Helsinn Group has a new group COO — Melanie Rolli, who officially starts on June 1. A doctor by training, she worked as a research fellow at the Scripps Research Institute before jumping on board with Novartis, where she spent more than a decade before leaving as its global head of medical safety. After that, Rossi went on multiple stints as biotech CEO for PIQUR Therapeutics AG and AELIX Therapeutics.
→ After falling on hard times amid the current bear market, Aquestive Therapeutics announced that longtime CEO Keith Kendall is hitting the exit. While the company didn’t provide a reason for the change, it noted that the move was “unrelated to the Company’s strategy, operations, financial condition, reported financial results, internal controls or disclosure controls and procedures.” COO Daniel Barber is moving up the ranks to replace Kendall — and it looks like he’ll have his work cut out for him. The company’s stock $AQST is down more than 70% since the start of 2020, as the FDA continues to weigh its once-rejected drug application for oral film to treat seizures. Barber has been at Aquestive since 2007, serving in high-ranking positions such as SVP and chief strategy and development officer over the past eight years.
→ As Endpoints’ own Kyle LaHucik reported earlier this week, Bruce Car will no longer serve as Agios‘ CSO. The long-time Bristol Myers Squibb vet departs amid a round of layoffs at Agios, as the company shifts to focus on research and beef up its pipeline.
→ Just a month after showing off its first clinical data to investor applause, the CMO at NK cell therapy specialist Nkarta has decided to resign. Kanya Rajangam — just shy of crossing the 3.5 year mark at the biotech — had done stints at Exelixis, Onyx and Atara Biotherapeutics before landing at the outfit in 2018. The company said that Rajangam, whose resignation becomes final on June 5, had decided to resign to go oversee R&D at a yet-undisclosed biotech. In the meantime, taking her place is David Shook, a two-year veteran at Nkarta with the new title of VP, clinical development.
→ As SMA outfit Scholar Rock announced earlier this week that it laid off 25% of its staff, the company also revealed that CMO Yung Chyung has decided to step down to explore “new career opportunities,” according to an SEC filing. His last day is set for June 30 — while the biotech searches for a replacement in the meantime. The Harvard-trained doctor had spent time working up the ladder at Massachusetts General Hospital as a fellow until he made the jump over to biotech in 2010 with Genzyme and Dyax before joining Scholar Rock as CMO in 2016.
→ The man in charge at penny stock player Adamis Pharmaceuticals is now retired. After being on the receiving end of two CRLs in a 12-month period before getting an FDA approval for its high-dose naloxone injection ZIMHI late last year, ex-CEO and president Dennis Carlo handed over the keys of the biotech to David Marguglio, an Adamis co-founder who was the biotech’s chief business officer since 2017. Marguglio had spent time in the financial sector at Citigroup and Merrill Lynch before joining Adamis in 2006 as VP, business development and board director.
→ Charlottesville, VA-based Diffusion Pharmaceuticals, which is trying to find therapeutics to enhance the body’s ability to deliver oxygen, has added to its C-suite. Raven Jaeger joined the company Thursday as its CRO. Jaeger will be responsible for the development and implementation of regulatory and related strategies to support the development and commercialization of Diffusion’s drug candidates. Jaeger joins Diffusion from BridgeBio Pharma, where she was most recently SVP for regulatory affairs.
→ Malvern, PA-based biotech Reaction Biology has made some moves at the top level — bringing in two industry veterans into the C-suite. Alan Findlater has been appointed to the position of CCO and Emily Doyle to the position of chief people officer. Findlater, a 25+ year veteran of the life sciences industry, will oversee Reaction’s BD operations, client services and sales functions. Prior to joining Reaction, Findlater was most recently CCO of BioIVT, and he had prior executive or directorial roles at Vium, Charles River Laboratories and WIL Research Laboratories.
Doyle is bringing more than 20 years experience into her position, with a background in human resources, organizational development and talent acquisition. She will be responsible for Reaction’s people strategy, including talent acquisition, leadership development, compensation, and diversity and inclusion. Before Reaction brought Doyle aboard, she was most recently SVP, human resources at Inzen Therapeutics, and previously served as Strongbridge BioPharma‘s chief HR officer.
→ Valo‘s CMO Dave Morris has been promoted to president of therapeutics and technology. Prior to serving at Valo, Morris was the CMO of Enterprise Therapeutics and an operating partner of the Novartis Venture Fund. He also served as global head of clinical operations, analytics, and regions during his time at Novartis.
→ The man who once headed up Bristol Myers’ global pharmaceuticals division back in the day — and snatched up board appointments like John Maraganore — stepped back for a bit in 2019. But it now looks like he is coming back. Don Hayden, who committed to being CEO at WindMIL a few years back, accepted a board position on Wednesday at OrbiMed’s TKI play in Theseus Pharmaceuticals, seven months after it went public and scored $160 million. It’s his latest board appointment after serving on the board of multiple companies such as Otsuka’s US subsidiary, REGENXBIO and Amicus Therapeutics.
→ The GSK-backed developer of synthetic rescue therapies, Adrestia Therapeutics, has named John Perry as its VP of human genetics. Perry, an expert in human population genetics, is a professor at the University of Cambridge. His expertise will aim to complement Adrestia’s technology platform, progressing a series of therapies to treat diseases with a genetic component.
→ A small molecule player out of CRISPR pioneer David Liu’s lab is getting a new executive VP of drug discovery as it continues to push forward in what it believes could be blockbuster indications. Stephanos Ioannidis is joining the team at Exo Therapeutics. Ioannidis brings more than 20 years of experience in neuroscience, oncology and inflammation — the latter two of which are big focuses for Exo — and a resume stacked with companies such as H3 Biomedicine, FORMA Therapeutics, and AstraZeneca. Before joining Exo, Ioannidis was executive VP and head of discovery at IFM Therapeutics, where he led a group focused on immune system therapeutics.
Exo is also bringing on Catherine Scholz as senior VP of program management. Scholz hails from H3 Biomedicines, but she’s also made stops at Kura Oncology, EMD Serono, Millennium Pharmaceuticals and Bayer Schering Pharma.
→ CureDuchenne has promoted Lianna Orlando to VP of research and has added Bradley Hodges as partner of CureDuchenne Ventures. Orlando started at CureDuchenne in 2019 as senior director of research, while Hodges is the founder of Prothelia and has served as a discovery consultant for Third Rock Ventures.
→ Geneva-based women’s health biotech ObsEva brings back Annette Clancy as chair of the board. Clancy, an investor with Sanofi-backed French VC Jeito, held the chair position in 2013-2016 after joining the board earlier that year. A GSK veteran, Clancy spent 30 years in the UK pharma’s BD division before moving more into the VC realm, which was initially as a senior advisor to Frazier Healthcare Ventures. She is also the chair of the board at ENYO Pharma. Clancy replaces Frank Verwiel, the former president and CEO at Aptalis Pharma who has stepped down from ObsEva’s board and who currently has a board position at Intellia Therapeutics.
→ David Fajgenbaum will join Creyon Bio as company advisor and board observer. Fajgenbaum is an assistant professor of translational medicine and human genetics at the Perelman School of Medicine at the University of Pennsylvania and associate director of patient impact at the Penn Orphan Disease Center.
→ David John Jeans has been appointed as a board of directors of Singapore-based HistoIndex, an artificial intelligence digital pathology platform for fibrotic diseases. Jeans has held senior leadership positions in major corporations such as Smith & Nephew, Bristol Myers Squibb, J&J and Amersham plc, which is now GE Healthcare. He was previously the chairman of Cardiff University, deputy chief executive of the Medical Research Council, chaired the Trustee Board of MRC Technology and served as a trustee of the Francis Crick Institute.
→ Mereo BioPharma has appointed Abdul Mullick to its board of directors. Mullick currently serves as president & CEO of Kyowa Kirin International, a subsidiary of Japan-based Kyowa Kirin Co. He has also served at Novartis as global head of the diabetes franchise.
→ Talaris Therapeutics has added Karen Smith to its board of directors. Smith currently serves as CMO at Novosteo, and also sits on the board of Sangamo Therapeutics, Capstan Therapeutics and Antares Pharma.
→ Lefei Sun has been appointed as non-executive director at HutchMed. Since 2018, Sun has served as managing director and head of China healthcare for General Atlantic.
→ Physics-based discovery unit Schrödinger appointed Arun Oberoi to its board of directors earlier this week. Oberoi, a former software executive, held previous positions at Red Hat, the software group at IBM and once worked in IT giant Hewlett Packard’s sales division.
→ Ezra Cohen, the division chief of UC San Diego Health Hematology-Oncology and co-director of the San Diego Center for Precision Immunotherapy, has been appointed as the chairman of the scientific advisory board at Pangea Biomed.
→ A day after announcing that it’s expanding its R&D operations in Boston, Vertex appointed Big Pharma veteran Suketu Upadhyay to its board of directors. Upadhyay is currently executive VP and CFO at the Indiana-based orthopedic medical device company Zimmer Biomet — but he’s previously held several high-ranking finance and strategy roles at Bristol Myers Squibb, Endo International, AstraZeneca and Johnson & Johnson.
Correction: A correction has been made to reflect that Makena is still available in the US, despite the FDA voting 9-7 back in 2019 to pull it from the market.