Women in Pharma and Biotech

The clinical-stage biopharma CinCor is developing baxdrostat, a highly selective, oral small molecule inhibitor of aldosterone synthase, for hypertension. Catherine Pearce, chief operating officer and co-founder of CinCor, acknowledges that the company has received criticism for its plan to bring a new drug into the highly genericized blood pressure control market. “The reality is that…

The biosimilars firm Alvotech (Nasdaq:ALVO) has announced that its CEO, Mark Levick, will retire. As of January 1, the company will install Robert Wessman, executive chairman and founder, as its top exec. Reykjavik, Iceland–based Alvotech also announced that it had retained Hafrun Fridriksdottir as its chief operating officer. Fridriksdottir was formerly the executive vice president…

The U.S. Supreme Court’s decision in Amgen v. Sanofi could have far-reaching consequences for the biotech industry. The court will consider how much a patent must disclose to comply with enablement requirements. In February 2021, the Federal Circuit ruled that two Amgen patents (8,829,165 and 8,859,741) for the cholesterol drug Repatha (evolocumab) do not meet…

Tanya Sharma, the co-founder of the consulting firm Assurea LLC (Raleigh, North Carolina), helps startups in cell and gene therapy, biotech and food tech implement quality compliance frameworks. Within life sciences, the company helps clients “move from clinical to commercial, or preclinical to clinical,” Sharma said. “We help clients navigate regulatory requirements.” Sharma is also…

Founded in 2017, VeriSIM Life (San Francisco) has a quest to use biosimulation technology to streamline drug discovery and development. The company’s BIOiSIM virtual drug development engine helps pharma and biotech companies optimize R&D spending. The company’s founder and CEO, Dr. Jo Varshney, also wants to help reduce the need for animal testing in drug…

In 2021, Cherese Paloni founded MDliaison to connect healthcare sales reps with health care companies. After working as a sales rep, Paloni determined to address the high turnover rate in the life sciences industry. After determining that the high turnover in the non-health-care-provider community is a symptom of an antiquated onboarding process, Paloni decided to…

In September, the U.S. Senate unanimously passed the FDA Modernization Act 2.0, which would lift an 84-year-old federal mandate for animal testing for toxicity studies. While the bill doesn’t ban animal testing outright, it would allow drug developers to use alternatives when feasible. The Senate has sent the bill, also known as S. 5002, to…

The biomedical modeling and simulation company Metrum Research Group (MetrumRG) has promoted Michelle Johnson to be its CEO, succeeding founder Marc Gastonguay. Johnson had served as the chief operating officer of the Tariffville, Connecticut–based company, where she helped assemble the company’s business team. In her new role as CEO, Johnson looks forward to assisting clients…

Ensysce Biosciences CEO Lynn Kirkpatrick oversees the development of novel medicines to reduce or eliminate prescription drug abuse. The La Jolla, California-based company’s oxycodone prodrug candidate PF614 is now in a Phase 2 clinical trial. It is designed to offer similar pain relief as prescription opioids with a limited risk of drug abuse and addiction.…

Dr. Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, says her entry into the pharmaceutical industry was serendipitous. “I always wanted to be a doctor, and during medical school, I was fascinated by the science behind how cancer happens and what we can do to better treat it,” she said. After following this…

Ferring Pharmaceuticals Chief Scientific Officer Dr. Elizabeth Garner guides clinical development, medical affairs, pharmacovigilance, project planning and regulatory affairs. Garner has almost 30 years of experience in medicine and industry. Before joining Ferring in 2022, Garner held chief medical officer roles for biotech firm ObsEva and women’s healthcare company Agile Therapeutics. Earlier, she held leadership…

In January 2020, rare disease biopharma Insmed (Nasdaq: INSM) hired Sara Bonstein as its chief financial officer. At that point, Bonstein had more than 15 years of operational and financial experience in the life sciences industry. In the following interview highlighting her role as a female pharma leader, Bonstein shares what initially attracted her to…

Yvonne Duckworth, CRB’s director of digital technology, says she was fortunate to enter the pharmaceutical industry straight out of college. “My first job, 31 years ago, was a wonderful opportunity as an automation engineer with an engineering company servicing the pharmaceutical industry,” she said. Duckworth has maintained her pharma focus at CRB, where she has…

The electronic clinical outcome assessments (eCOA) firm THREAD has appointed Kim Boericke to be its first chief delivery officer. In her role, Boericke (pronounced “Berica”) will focus on supporting customers in implementing the THREAD platform to support decentralized clinical trial data collection. In addition, she will assist THREAD with decentralized clinical trials, working to include patients…

Kansas City, Missouri–based engineering, construction and consulting company CRB has named Valerie Silva as director of procurement. With experience in cost optimization, project management and supply chain issues in the automotive and pharmaceutical industries, Silva will work within CRB’s innovative Global Technical Operations team. Silva will help the company’s clients address challenges related to speed…

Two decades ago, the Canadian CDMO BioVectra installed Heather Delage as its director of business development. She was named vice president of business development in 2014. In 2021, she assumed the role of chief commercial officer. At the outset of her tenure with BioVectra, the company was beginning its journey to invest in large-scale cGMP…

The late 1980s and the 1990s were something of a gold rush for pharmaceutical companies focused on CNS drug development — especially those developing psychiatric drugs. In 1988, Eli Lilly introduced the blockbuster SSRI Prozac (fluoxetine), then a new type of antidepressant. Big Pharma companies launched several SSRIs in the years that followed.  By the…

The synthetics biology company CB Therapeutics recently named Tiffany Hurd as its new business development lead. At Carlsbad, California-based CB Therapeutics, Hurd will focus on creating business partnerships with companies in the psychedelic, cannabinoid and food tech industries.  In May, CB Therapeutics won a patent covering the use of microorganisms to produce psychedelic tryptamines and…

Amyotrophic lateral sclerosis (ALS) remains a bewildering disease. Although it is rare, it is not uncommon. The lifetime risk of developing the condition is roughly 1 in 300 by age 85.  The heterogeneity of the disease is also unique, said Tammy Pighin Moore, CEO of the ALS Society of Canada. “About 5% to 10% of the people diagnosed…

Biopharma services company Allucent has announced that it has named Katy Moore to lead a team of pharmacometricians to create custom modeling and simulation approaches for clinical trial designs. Moore’s official title will be president of clinical pharmacology, modeling and simulation (CPMS). “What inspired me to join Allucent was the opportunity to work for a…

Mission Bio (San Francisco) is a growth-stage company spun out of the microfluidics lab at the University of California San Francisco (UCSF) in 2014. “We have been commercial since late 2017,” said the company’s CEO, Yan Zhang, in a recent interview. Initially focusing on oncology, Mission Bio has cast its gaze across precision medicine to…

Focused on developing peripheral nerve regeneration and repair products, Axogen (Nasdaq:AXGN) announced that the Phase 3 RECON study met its primary endpoint in comparing its Avance nerve graft to conduits in digital nerve injuries. The primary endpoint was the return of sensory function based on static two-point discrimination. This test measures the ability to detect…

At the heart of Johnson & Johnson’s (NYSE:JNJ) $6.5 billion acquisition of Momenta Pharmaceuticals in 2020 is a portfolio of drug candidates for immune-mediated diseases. One of the promising compounds in the acquisition is nipocalimab, which Janssen sees as a potential “pipeline in a pathway.” Nipocalimab holds promise for an array of diseases, ranging from…

The contract research organization (CRO) Syneos Health has promoted Michelle Keefe to be its CEO and a member of its board. Keefe was previously the president, medical affairs and commercial solutions at Morrisville, North Carolina-based Syneos. The company’s departing CEO, Alistair Macdonald, is retiring after working at the company for two decades. Macdonald will serve…

The psychoactive compound 5-methoxy-2-aminoindane (MEAI) is unique among psychedelics with therapeutic potential.  First, the drug could be self-administered. Second, it is patented, unlike psychedelics such as LSD, psilocybin, MDMA and ketamine. And while psychedelic drug developers tend to focus on indications such as depression, anxiety and post-traumatic stress disorder, MEAI could potentially treat alcoholism.  MEAI…