Galien week of innovation
GALIEN WEEK OF INNOVATION 2024
Speakers in the category "Best Biotechnology Product"
Amanda Gunn
Sr Analyst, RWD Health Informatics, Norstella
Neeraj Chawla
Managing Director, Life Sciences Technology, Accenture
Neeraj is a Managing Director with Accenture and leads the Life Sciences Technology practice for the West. He has 25 years of experience in IT, managing global accounts, delivery of large-scale complex transformation programs - strategy, consulting, design & operations of Enterprise Applications & Infrastructure.
Prior to joining Accenture, Neeraj founded a Life Sciences IT & BPO start-up, set up global capabilities offshore and had a successful exit in six years.
Neeraj holds a BS in Computer Sc.& Engineering graduating at Punjab Engineering College, India and is a Fellow of the Advanced Study Program from MIT for Commercializing Brain Science & Engineering.
- Invited speaker at industry forums: Data Driven Pharmaceuticals - Conference - New York and SAP Life Sciences Innovation Day. Board Member: Cybersecurity Advisory Council, California State University, Chico
Kailash Swarna
Managing Director & Global Lead of Clinical Development for Life Sciences R&D, Accenture
Kailash Swarna
Managing Director & Global Lead of Clinical Development for Life Sciences R&D, Accenture
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.
Shelby Lipton
General Manager, VYVGART and Global Commercial Lead, argenx
Product: VYVGART®
Company: argenx
About the Product:
VYVGART Hytrulo is a subcutaneous injection designed for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive, and FDA approved in June 2024 for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo targets the neonatal Fc receptor (FcRn)—a key biological pathway with the potential to address over 100 autoimmune diseases mediated by pathogenic IgGs. By binding to FcRn, VYVGART Hytrulo effectively reduces the levels of circulating IgG antibodies in the body, providing targeted therapy for CIDP and gMG.
Product: Brukinsa®
Company: BeiGene
About the Product:
BRUKINSA (zanubrutinib) is a selective small molecule inhibitor of Bruton’s tyrosine kinase (BTK) currently under global evaluation in a broad clinical program. It is being studied both as a monotherapy and in combination with other therapies to treat various B-cell malignancies. BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. In March 2024, the FDA granted BRUKINSA accelerated approval for an additional indication, marking BRUKINSA’s fifth indication in B-cell malignancies in the U.S. and the broadest label in its class globally.
Mark Rutstein
Global Head of Oncology Clinical Development, Daiichi Sankyo, Inc.
Mark Rutstein
Global Head of Oncology Clinical Development, Daiichi Sankyo, Inc.
Product: ENHERTU®
Company: Daiichi Sankyo & AstraZeneca
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 has five FDA approved indications as a treatment for certain types of breast, lung and gastric cancers and is the first HER2 directed treatment and ADC to receive a tumor agnostic indication for the treatment of certain metastatic solid tumors. For full Prescribing Information, including Boxed WARNINGS, and Medication Guide, visit ENHERTU.com.
Tahamtan (Tahi) Ahmadi
Executive Vice President, Chief Medical Officer, Genmab and AbbVie
Tahamtan (Tahi) Ahmadi
Executive Vice President, Chief Medical Officer, Genmab and AbbVie
Product: EPKINLY
Company: Genmab and AbbVie
About the Product:
EPKINLY (epcoritamab) is a bispecific antibody targeting CD20 on B-cells and CD3 on T-cells, created utilizing Genmab’s proprietary DuoBody® technology. Epcoritamab stands out as the first and only subcutaneously administered CD3xCD20 available and was granted accelerated approval (FDA) and conditional marketing authorization (EMA) for the treatment of both relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma after at least two prior lines of therapy. EPKINLY offers the advantage of being off-the-shelf with a manageable safety profile. Additionally, EPKINLY has shown impressive results in combinations, earlier treatment lines and across various B-cell malignancies, showcasing its combinability and versatility.
Len Friedland
Vice President, Director Scientific Affairs and Public Health, GSK Vaccines
Len Friedland
Vice President, Director Scientific Affairs and Public Health, GSK Vaccines
Product: AREXVY
Company: GSK (GlaxoSmithKline)
About the Product:
RSV was one of the major infectious diseases without an adult vaccine until May 2023, when the world’s first adult RSV vaccine, Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted), was approved by the U.S. FDA. In the U.S. Arexvy is indicated to prevent lower respiratory disease from RSV in people 60 years and older, or those in their 50s at increased risk. Now licensed in 50 countries, Arexvy has the potential to substantially reduce RSV disease burden for older adults at risk of severe disease.
Product: Xacduro
Company: Innoviva Specialty Therapeutics, Inc.
About the Product:
XACDURO® is the first pathogen-targeted antibacterial developed and approved to treat hospital acquired and ventilator-associated pneumonia caused by Acinetobacter baumannii. Previously, there was no clear standard of care antibiotic regimen for Acinetobacter infections resulting in a mortality rate ranging from 30-70%. The approval of XACDURO addresses a global public health threat and delivers a safe and effective treatment option for patients suffering from these serious and life-threatening infections.
Deepu Madduri
Senior Director, Compound Development Team Leader, Johnson & Johnson Services, Inc.
Deepu Madduri
Senior Director, Compound Development Team Leader, Johnson & Johnson Services, Inc.
Product: CARVYKTI®
Company: Johnson & Johnson and Legend Biotech
About the Product:
CARVYKTI ® is a BCMA-directed, genetically modified autologous T-cell immunotherapy for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. The treatment involves reprogramming a patient’s own T-cells with a transgene encoding chimeric antigen receptor (CAR) that directs T-cells to eliminate cells that express BCMA. CARVYKTI is redefining the patient experience by delivering extraordinary efficacy and a manageable safety profile as a one-time infusion.
Christoph Heuck
Vice President, Global Medical Head for Talquetamab, Innovative Medicine, Johnson & Johnson
Christoph Heuck
Vice President, Global Medical Head for Talquetamab, Innovative Medicine, Johnson & Johnson
Product: TALVEY™
Company: Johnson & Johnson Services, Inc.
About the Product:
TALVEY® is a first-in-class bispecific T-cell engaging antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. TALVEY targets CD3 on T cells and GPRC5D on myeloma cells, directing T cells to attack these cells. It is being explored in combination with other therapies, including proteasome inhibitors, immunomodulatory drugs, and other novel agents, reinforcing its versatility in managing multiple myeloma for this patient population who face limited treatment options.
Product: TECVAYLITM
Company: The Janssen Pharmaceutical Companies of Johnson & Johnson
About the Product:
TECVAYLI® is a treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. It was the first approved off-the-shelf (or ready-to-use) B-cell maturation antigen (BCMA)×CD3 bispecific therapy with a precision-based dosing schedule. TECVAYLI® is a first-in-class, bispecific antibody that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the BCMA expressed on the surface of multiple myeloma cells and some healthy B-lineage cells.
Heather Platt
Section Head, Pneumococcal Vaccines, Merck Research Laboratories, Merck & Co Inc.
Heather Platt
Section Head, Pneumococcal Vaccines, Merck Research Laboratories, Merck & Co Inc.
Product: CAPVAXIVE™
Company: Merck & Co Inc.
About the Product:
CAPVAXIVE is Merck’s approved 21-valent pneumococcal conjugate vaccine indicated for active immunization for the prevention of invasive disease and pneumonia in adults 18 years of age and older. CAPVAXIVE is specifically designed to help address Streptococcus pneumoniae serotypes predominantly responsible for adult invasive pneumococcal disease (IPD), including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B compared to other pneumococcal vaccines. CAPVAXIVE is administered as a single dose.
Product: DNBSEQ-T20
Company: MGI Tech
About the Product:
DNBSEQ-T20 is the first and only one product in the world which drops genome sequencing price to sub $100, while the average in the field is still on $200 or more. In order to gather health data around the world, researchers needed a standardized collection process of clinic and hospital data and databases. However, large-scale whole genome sequencing technologies are difficult to carry out. Over the years, researchers have made great strides to drive the science forward. From higher throughput to greater data accuracy and efficiency, genomics companies nationwide have been working hard to push the boundaries of sequencing technologies.
Product: ABRYSVO®
Company: Pfizer
About the Product:
A vaccine to help prevent respiratory syncytial virus (RSV) had been an elusive public health goal for more than half a century. Pfizer’s ABRYSVO® is the only RSV vaccine that helps protect two of the most vulnerable populations: adults 60 years of age and older, as well as infants from birth through six months through maternal immunization. ABRYSVO is a bivalent vaccine that provides protection against lower respiratory tract disease caused by the respiratory syncytial virus, inclusive of both major subgroups RSV-A and RSV-B. ABRYSVO continues Pfizer’s commitment to helping prevent serious respiratory disease in infants and older adults.
Product: Prevnar 20®
Company: Pfizer
About the Product:
PREVNAR 20® 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 broad serotype coverage, helping protect against the 20 serotypes in the vaccine. PREVNAR 20 continues Pfizer’s commitment to help alleviate the burden of pneumococcal disease for babies and eligible children and adults, as well as for our healthcare systems globally.