Galien week of innovation

Kailash Swarna is a Managing Director and the Global Lead of the Clinical Development Domain in the Life Sciences R&D practice at Accenture. He and his team are focused on developing and executing a scalable and inclusive digitalization strategy to transform the discovery and development of therapeutic solutions to treat human disease and improve health.

Kailash has over 25 years of experience in Drug Discovery and Development and has held leadership positions at leading Life Sciences and Technology companies globally. At Accenture, he works with clients across the Life Sciences and Healthcare industry, Academic and Research Institutions, and Local and National governments to design, develop, and deliver innovative solutions to improve R&D productivity and bring better medicines, devices, and digital solutions and services to the patients and consumers who need them - faster and cheaper

Product: Brukinsa®

Company: BeiGene

Therapeutic Area: Oncology - Hematology

About the Product:

BRUKINSA (zanubrutinib) is a selective small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. In January 2023, the FDA approved BRUKINSA for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, its fourth indication.

Researcher:
Lusong Luo

Product: ENHERTU^®

Company: Daiichi Sankyo & AstraZeneca

Therapeutic Area: Pneumology

About the Product:

ENHERTU® is a HER2 directed antibody drug conjugate (ADC) designed using Daiichi Sankyo’s proprietary DXd ADC technology and is jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. ENHERTU is FDA approved for the treatment of certain types of breast, lung and gastric cancers. For full Prescribing Information, including Boxed WARNINGS, and Medication Guide, visit ENHERTU.com. Daiichi Sankyo and AstraZeneca have a comprehensive global development program underway evaluating the efficacy and safety of ENHERTU monotherapy across multiple HER2 targetable cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Research team:

• Toshinori Agatsuma
• Yuke Abe

Product: ELAHERE^®

Company: ImmunoGen, Inc.

Therapeutic Area: Gynecology

About the Product:

ELAHERE^TM is the first and only folate receptor alpha (FRa)- targeted antibody-drug conjugate (ADC) for platinum-resistant ovarian cancer (PROC) and the first therapeutic approved specifically for PROC since 2014. Prior to ELAHERE’s approval, there were no biomarker-driven therapies approved for platinum-resistant disease and treatment options were limited.

ELAHERE is currently approved under accelerated approval. Earlier this year, ImmunoGen reported positive data from the randomized confirmatory Phase III MIRASOL trial showing an overall survival benefit for the first time in this population. With these practice-changing results, ELAHERE is positioned to become the new standard of care for patients with FRa-positive PROC.

Research team:

• Ravi Chari
• John M Lambert
• Thomas Chittenden
• Victor S Goldmacher
• Olga Ab
• Laura M Bartle
• Daniel Tavares
• Christina N Carrigan
• Ben Wolf
• Rodrigo Ruiz-Soto
• Jose F Ponte
• Kelli L Running
• James O’Leary
• Karim S Malek
• Robert Lutz
• Kerry Culm
• Xiuxia Sun
• Hans Ericson
• Kate Lai
• Daniel Milano
• Robert Herbst
• Wenjie Cheng
• Godfrey Amphlett
• Adrienne Wildt

Product: Rylaze^®

Company: Jazz Pharmaceuticals

Therapeutic Area: Oncology - Hematology

About the Product:

Rylaze® is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients who have developed hypersensitivity to E. coli-derived asparaginase. With a worldwide shortage of an alternative non-E. coli-derived treatment causing disruptions in product availability, Jazz partnered with the Children’s Oncology Group to accelerate the development of Rylaze to ensure patients could complete their full treatment course. Rylaze represents a significant advancement through recombinant, modern manufacturing, which results in a ready-to-use, high concentration formulation with reliable supply, ensuring uninterrupted therapy for patients.

Product: TECVAYLI^TM (teclistamab-cqyv)

Company: The Janssen Pharmaceutical Companies of Johnson & Johnson

Therapeutic Area & Indication: Immunologic drug for patients with generalized myasthenia gravis causing muscle weakness and loss of motor control.

About the Product:

TECVAYLI® is a first-in-class, bispecific antibody that activates the immune system by binding to the CD3 receptor expressed on the surface of T cells and to the B cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. TECVAYLI® is the only approved off-the-shelf (or ready to use) BCMA×CD3 bispecific therapy with a precision-based dosing schedule for the treatment of triple-class exposed RRMM.

Research team:

• Arnob Banejee
• Rachit Desai
• Suzette Girgis
• Tynisha Glover
• Jenna Goldberg
• Yue Guo
• Brett Hanna
• Mindy Jaffe
• Megan Kendellen
• Rachel Kobos
• Baolian Liu
• Francis Meacle
• Nancy Nair
• Duncan Nickless
• Yunsi Olyslager
• Lixia Pei
• Kodandaram Pillarisetti
• Joke Schwencke
• Jennifer Smit
• Tara Stephenson
• Ivana Stracenski
• Ian Thomson
• Julia Tillkes
• Danielle Trancucci
• Clarissa Uhlar
• Rian Van Rampelbergh
• Raluca Verona
• Shun Xin
• Wang Lin

Product: CARVYKTI^® (ciltacabtagene autoleucel)

Company: The Janssen Pharmaceutical Companies of Johnson & Johnson

Therapeutic Area: Oncology - Hematology

About the Product:

CARVYKTI® is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding chimeric antigen receptor (CAR) that directs the CAR positive T-cells to eliminate cells that express BCMA. CARVYKTI is redefining the patient experience by delivering extraordinary efficacy and a manageable safety profile in a one-time infusion. It has the potential to become a preferred option in earlier lines of therapy.

Research team:

• Yusri Elsayed
• Adam Del Corral
• Peter Lebowitz
• Craig Tendler
• Jordan Schecter
• William Deraedt
• Ricardo Attar
• Jennifer Yohrling
• Nancy Nair
• Win Tao
• Ilya Safonov
• Alan Kick
• Dan Zhao
• Dong Geng
• Frank Zhang
• Jiaying Hao
• Liz Gosen
• Lei Yang
• Lin Wang
• Pingyan Wang
• Qiong Wang
• Qiuchuan Zhuang
• Tracy Luo
• Xiaohu Fan
• Ying Huang
• Yinghong Zhang
• Yuan Yuan
• Yuhong Qiu
• Yuncheng Zhao

Product: ADCETRIS^® (brentuximab vedotin)

Company: Seagen Inc.

Therapeutic Area: Oncology - Hematology

About the Product:

Historically, there were no significant new treatment options for stage 3/4 classical Hodgkin lymphoma (cHL), and up to 30% of patients with advanced-stage disease experienced progression after initial treatment. Seagen scientists tenaciously pursued an antibody-drug conjugate treatment aiming to combine specificity, stability and potency while reducing toxic side effects, resulting in ADCETRIS (brentuximab vedotin), the first FDA-approved regimen in frontline stage 3/4 cHL in more than 40 years. Six-year follow-up data showed a remarkable 41% reduction in risk of death compared to a prior standard of care – a clinically meaningful benefit which profoundly impacts patients in a curative-intent setting.

Research team:

Greg Geddes; Rema Assaf; Tae Kim; Gerald Engley; Lauren Cutler; Xun Wang; Phil Tsai; Shan Jiang; Aileen Murphy; Jon Ross; Nicole Okeley; Kerry Klussman; Steve Alley; Robert Lyon; Haley Neff-LaFord; Brendan Leeson; Corinna Palanca-Wessels , Akshara Richhariya, Brian Hall; Amit Garg; Michelle Fanale; Andrei Shustov; Andres Forero-Torres; Alan Ping; Alex Kovalevich; Alka Saxena; Bala Pitchuka; Brunhilde Weber; Bryan Husbeck; Che Hutson; Claudia Lee; Cristin Gordon-Maclean; Hailing Lu; Isabell Kang; Jecheima Andrade; Jennie Lorenz; John Kim; JT Brogan; Kalamo Farley; Kate Nyormoi; Keenan Fenton; Kelly Callahan; Kevin Roach; Kim Sakaue; Kristina Becker; Kristina Yu; Linda Ho; Linda Huskamp; Lisa Clark; Michael Harrison; Mike Lin; Nansi Kabonge; Oguz Bakkal; Patrice Lynds; Phil Yen; Preeti Madiman; Rajinder Parti; Robert Sims; Ruth Keoviphone; Sandra Heller; Sarthak Jain; Scott Knowles; Stephanie Sauvageau; Stuart Wilks; Fei Jie; Andrea Cecchetto; Anne Knoof; Consuelo Glenn; Dawn Hayes; Jie Ting; Julie Lisano; Kerry Need; Kwadwo Bediako; Markus Puhlmann; Michelle Fanale; Nick Liu; Roee Shahar; Ryan Heiser; Xin Wei; Matt Skelton , Kate Skrable, Marjorie Green

Nafeez Zawahir, MD is the Chief Medical Officer of Razorfish Health, where he is responsible for leading the medical strategy discipline for the agency. He applies clinical and real-world experience to help shape strategies for pharmaceutical and biotech clients. Dr. Zawahir focuses on the intersection of data translation, digital channels and HCP education, believing that better communication can lead to better outcomes for patients, HCPs, and the industry.

Dr. Zawahir has held previous positions leading peer-review at Medscape, as an expert medical consultant to the life sciences law firm Hogan Lovells, and as a medical lead at various biotech companies.

Product: VAXNEUVANCE

Company: Merck & Co., Inc.

Therapeutic Area: Pneumology

About the Product:

Streptococcus pneumoniae remains associated with significant residual disease burden. VAXNEUVANCE is a novel pneumococcal conjugate vaccine (PCV) approved for individuals 6 weeks of age and older for the prevention of invasive disease (e.g. meningitis, bloodstream infection) due to 15 pneumococcal serotypes. Administered as a single dose in adults and a four-dose series in young children, it maintains robust immunogenicity for all serotypes shared with the 13-valent PCV (PCV13) while inducing significantly greater immune responses for shared serotype 3 and unique serotypes 22F and 33F, key contributors to remaining disease. VAXNEUVANCE represents a bold innovation in the manufacturing of glycoconjugates.

Product: PREVNAR 20^®

Company: Pfizer Inc. 

Therapeutic Area: Pneumology

About the Product:

PREVNAR 20 ‘100 word’ Description Infections caused by Streptococcus pneumoniae (pneumococcus) are major causes of communicable disease morbidity and mortality worldwide. PREVNAR 20® builds on the legacy of PREVNAR 13® and PREVNAR® and provides the broadest serotype coverage of any available conjugate vaccine helping protect against the 20 serotypes in the vaccine. PREVNAR 20 continues Pfizer’s commitment to help alleviate the burden of pneumococcal disease for at-risk populations, as well as for our healthcare systems globally.

Product: PreHevbrio™

Company: VBI Vaccines, Inc.

Therapeutic Area: Gastroenterology - Hepatology

About the Product:

PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] is the only 3-antigen adult prophylactic hepatitis B vaccine that contains the full antigenic composition of the hepatitis B surface antigen, including the S, Pre-S2, and Pre-S1 hepatitis B surface antigens. PreHevbrio was approved in the U.S. in late 2021, in the EU/EEA/UK in 2022 under the brand name PreHevbri®, and in Israel in 2000 under the brand name Sci-B-Vac®.

Dr. Kalali, globally renowned physician-scientist and professor, was formerly Global Head of the Neuroscience Center of Excellence at Quintiles (now IQVIA).

He is currently board director of several companies, Co-Chair of the Decentralized Trials and Research Alliance (DTRA), Chairman and Chief Curator of the CNS Summit, Founding Chairman and current member of the Executive Committee of the International Society for CNS Drug Development (ISCDD), and sits on the Executive Committee of the International Society for CNS Clinical Trials and Methodology (ISCTM).

Dr. Kalali is also Editor of Innovations in Clinical Neuroscience, and Lead Editor of Essential CNS Drug Development.

Product: Bylvay®

Company: Albireo Pharma, Inc.

Therapeutic Area: Gastroenterology - Hepatology

About the Product:

Bylvay® (odevixibat) is approved in the U.S. for the treatment of pruritus in patients 3 months of age and older with all types of progressive familial intrahepatic cholestasis (PFIC), and in Europe and the UK for the treatment of PFIC in patients aged 6 months or older. This once-daily, non-systemic ileal bile acid transport inhibitor has minimal systemic exposure and acts locally in the small intestine. It can be taken as a capsule or opened and sprinkled onto food. Most common adverse reactions: diarrhea, liver test abnormalities, vomiting, abdominal pain, and fat-soluble vitamin deficiency. 

Product: VYVGART^®

Company: argenx

Therapeutic Area: Neurology

About the Product:

VYVGART (efgartigimod alfa-fcab) is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating immunoglobulin G (IgG) autoantibodies. It is the first and only approved FcRn blocker. VYVGART is approved in the United States and Europe for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive, and in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs).

Product: CAMZYOS^®

Company: Bristol Myers Squibb

Therapeutic Area: Cardiovascular

About the Product:

CAMZYOS® (mavacamten) is the first and only cardiac myosin inhibitor approved in the U.S., indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. CAMZYOS modulates the number of myosin heads that can enter “on actin” (power-generating) states, thus reducing the probability of force-producing (systolic) and residual (diastolic) cross-bridge formation. Excess myosin actin cross-bridge formation and dysregulation of the super-relaxed state are mechanistic hallmarks of HCM. CAMZYOS shifts the overall myosin population towards an energy-sparing, recruitable, super-relaxed state. In HCM patients, myosin inhibition with CAMZYOS reduces dynamic left ventricular outflow tract (LVOT) obstruction and improves cardiac filling pressures.

Research team:

• Founders: Christine and Jon Seidman; Leslie Leinwand; Jim Spudich Myokoardia
• R&D: Bob McDowell; Johan Oslob; Robert Anderson
• Bristol Myers Squibb core team: Marie-Laure Papi; Amy Sehnert; Jeff Lockman; Samira Merali; Ganesh Balaratnam; Victoria Florea; Kim Lindstrom; Mondira Bhattacharya; Albert DelMonte; Hilary Nelson; Roland Chen; Jay Edelberg

Product: EVKEEZA^®

Company: Regeneron Pharmaceuticals, Inc.

Therapeutic Area: Cardiovascular

About the Product:

Residents from an idyllic village in Italy – who were found to have very low cholesterol levels and live long lives – carried a genetic mutation that paved the way for Evkeeza® (evinacumab-dgnb), a first-in-class treatment for homozygous familial hypercholesterolemia (HoFH). Those findings were advanced by Regeneron’s scientists whose pioneering research uncovered the underlying biology of HoFH, discovering the mutation responsible for dangerously high cholesterol levels, leading to the development of this transformational medicine. This breakthrough not only benefits people with HoFH but also continues to deliver on the promise of genetics-based research to revolutionize treatment of these tough-to-treat diseases.

Research team:

• Shazia Ali
• Angela Alvarez-George
• Poulabi Banerjee
• Stephanie Biedermann
• Kuo-Chen Chan
• Dermot Curtain
• Richard DelGizzi
• Leah Fenley
• Evelyn Gasparino
• Dan Gipe
• Viktoria Gusarova
• Joanna Kang
• Yunji Kim
• Emily Leonard
• Garen Manvelian
• Jennifer Marinello
• Katherine Miller
• Manish Ponda
• Robert Pordy
• Robert Sanchez
• Paul Skiba
• Mark Sleeman
• Haley Tran
• Jesus Trejos
• Ryan Yu

Product: Dupixent^®

Company: Regeneron and Sanofi

Therapeutic Area: Dermatology

About the Product:

Type 2 inflammation is an overactive immune response that plays an important role in many atopic or allergic diseases. For decades, scientists have evaluated ways to inhibit the biologic pathways underlying these types of diseases. Dupixent® (dupilumab) is the first and only fully human monoclonal antibody that inhibits the signaling of interleukin-4 and interleukin-13, two of the key and central drivers of type 2 inflammation. It is approved for five indications in dermatological, respiratory and gastrointestinal diseases. Regeneron and Sanofi are studying dupilumab in a range of clinical development programs for diseases driven in part by type 2 inflammation.

Product: XVIVO Perfusion System (XPS™) with STEEN Solution™

Company: XVIVO Perfusion, Inc.

Therapeutic Area: Pneumology

About the Product:

The XPS™ with STEEN Solution™ is a fully integrated cardiac bypass system that uses innovative technology to perform normothermic ex-vivo lung perfusion (EVLP). EVLP is an advanced preservation technique where donor lungs are kept alive outside the body via perfusion and ventilation in an optimized environment so that a surgeon can properly assess, and potentially restore, lungs that may have been damaged at the time of the donor’s death. STEEN Solution™ is a buffered extracellular solution optimally designed to facilitate prolonged evaluation and promote stability of isolated lungs ex vivo without edema formation.