Galien week of innovation

Jessica Federer is an investor and board member adept at deploying technology to make meaningful advancements for both business and society.

She was one of the first Chief Digital Officers in the pharma industry, leading the digital transformation for Bayer A.G. across the Pharmaceutical, Consumer Care, Crop Science and Animal Health businesses. She is recognized as one of the top 100 CDOs and a leading health tech influencer, and served on the United Nations ITU advisory board. Federer began her public health career as an analyst at the Agency for Healthcare Research and Quality in the US Department of Health and Human Services.

She earned a Bachelor of Science from the George Washington University, and a Master of Public Health from Yale.

Product: Guardant360 CDx

Company: Guardant Health, Inc.

Therapeutic Area & Indication: Liquid biopsy to detect and prevent solid tumors in cancer and yield treatment insights from comprehensive genetic profiling.

About the Product:
The Guardant360® CDx liquid biopsy is FDA approved for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor). The test is also approved as a companion diagnostic to identify patients with non-small cell lung cancer who may benefit from treatment with TAGRISSO® (osimertinib), RYBREVANT™ (amivantamab-vmjw), LUMAKRAS™ (sotorasib), and ENHERTU® (fam-trastuzumab deruxtecan-nxki).

Product: PYLARIFY® injection and PYLARIFY AI™

Company: Lantheus

Therapeutic Area & Indication: Injectable radioactive diagnostic agent for PET scan for recurrent and metastatic prostate cancer, and using AI to quantify individual disease burden.

About the Product:
PYLARIFY® (piflufolastat F 18) injection is an FDA approved fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue sites of disease to detect and localize sites of recurrent and/or metastatic prostate cancer. PYLARIFY AI™ is artificial intelligence medical device software developed to assist with the reading and quantification of PYLARIFY scans. The technology automatically analyzes a PSMA PET/CT image to segment anatomical regions – 51 bones and 12 soft tissue organs. This image segmentation enables automated localization, detection and quantification of potential PSMA-avid lesions in a PSMA PET/CT image, which data is then incorporated into the reporting system used by physicians.

Product: PYLARIFY® injection and PYLARIFY AI™

Company: Lantheus

Therapeutic Area & Indication: Injectable radioactive diagnostic agent for PET scan for recurrent and metastatic prostate cancer, and using AI to quantify individual disease burden.

About the Product:
PYLARIFY® (piflufolastat F 18) injection is an FDA approved fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue sites of disease to detect and localize sites of recurrent and/or metastatic prostate cancer. PYLARIFY AI™ is artificial intelligence medical device software developed to assist with the reading and quantification of PYLARIFY scans. The technology automatically analyzes a PSMA PET/CT image to segment anatomical regions – 51 bones and 12 soft tissue organs. This image segmentation enables automated localization, detection and quantification of potential PSMA-avid lesions in a PSMA PET/CT image, which data is then incorporated into the reporting system used by physicians.

Product: Signatera

Company: Natera, Inc.

Therapeutic Area & Indication: Personalized molecular residual disease assay using circular tumor DNA to identify cancer relapse earlier than standard-of-care diagnostics.

About the Product:
Signatera is a personalized blood test that detects minuscule traces of cancer left in the body after surgery, down to a single molecule of tumor DNA in a tube of blood. The test is custom built for each patient’s genetic signature, and tracks this unique fingerprint over time, enabling highly sensitive detection of molecular residual disease (MRD), often months to years before imaging, through a simple blood draw.

Product: Prospera

Company: Natera, Inc.

Therapeutic Area & Indication: Transplant assessment blood draw to evaluate and respond to risk of patient rejection of a donor kidney.

About the Product:
Prospera is a noninvasive test for detecting organ transplant rejection. By measuring the amount of free-floating DNA in the bloodstream that is shed from the donor organ – called donor-derived cell-free DNA (dd-cfDNA) – Prospera can detect early signs of all types of “active rejection” through a simple blood draw. Prospera can be performed following a heart, lung, or kidney transplant.

Product: Visby Medical Sexual Health Click Test

Company: Visby Medical, Inc.

Therapeutic Area & Indication: Instrument-free in-office PCR test for women in detection of three major STI’s.

About the Product:
The Visby Medical Sexual Health Click Test is a single-use (disposable), fully integrated, automated Polymerase Chain Reaction (PCR) in vitro diagnostic test intended for use in point-of-care or clinical laboratory settings for the rapid detection and differentiation of DNA from Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in self-collected female vaginal swab specimens using the Visby Medical Sexual Health Vaginal Specimen Collection Kit in a health care setting.

Product: Venovo™ Venous Stent System

Company: Becton-Dickinson (BD)

Therapeutic Area & Indication: Device re-opens blocked veins associated with iliofemoral occlusive disease.

About the Product:
The Venovo™ Venous Stent System is an open-cell, nitinol stent indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. It was designed with a balance of radial force, compression resistance and flexibility needed for the treatment of symptomatic post-thrombotic and non-thrombotic iliofemoral lesions. The Venovo™ features a tri-axial delivery system engineered to provide accurate deployment for optimal stent placement and lesion coverage, and is offered in a broad range of sizes. The unique 3mm flared ends of the Venovo™ are designed to reduce the risk of stent migration and maximize wall apposition.

Product: Venovo™ Venous Stent System

Company: Becton-Dickinson (BD)

Therapeutic Area & Indication: Device re-opens blocked veins associated with iliofemoral occlusive disease.

About the Product:
The Venovo™ Venous Stent System is an open-cell, nitinol stent indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. It was designed with a balance of radial force, compression resistance and flexibility needed for the treatment of symptomatic post-thrombotic and non-thrombotic iliofemoral lesions. The Venovo™ features a tri-axial delivery system engineered to provide accurate deployment for optimal stent placement and lesion coverage, and is offered in a broad range of sizes. The unique 3mm flared ends of the Venovo™ are designed to reduce the risk of stent migration and maximize wall apposition.

Research team:
Peter Dautzenberg
Anne Cadillo
Katie Retherford
Kulveen Dhatt
Martin Schroer
Rene Zusann
Santos Ramirez

Product: VersaCross Transseptal Platform

Company: Boston Scientific | Baylis Medial

Therapeutic Area & Indication: All in one platform for conducting a range of minimally invasive heart repairs.

About the Product:
The VersaCross® RF Transseptal Solution is the world’s first radiofrequency (RF) wire-based solution to percutaneous left heart access, reimagining transseptal practice for efficient and precise delivery of life-changing therapy sheaths to advance patient care. This platform improves atrial septal crossing efficacy, puncture safety and, most notably, eliminates multiple risky and non-value added catheter exchanges from the bloodstream that were routinely accepted when using conventional sharp needles for over 50 years. By unlocking procedural predictability and transforming how Electrophysiology and Structural Heart procedures are delivered, VersaCross advances the standard of patient care globally.

Product: Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent

Company: Edwards Lifesciences

Therapeutic Area & Indication: For use in the management of pediatric and adult patients with severe pulmonary regurgitation.

About the Product:
The Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) system combines the proven SAPIEN 3 transcatheter heart valve and the Alterra adaptive prestent to expand transcatheter therapy options for congenital heart valve disease patients who previously faced multiple open-heart surgeries over the course of their lives. The Alterra prestent compensates for variations in size and morphology of the right ventricular outflow tract to provide a stable landing zone for the SAPIEN 3 valve, expanding the range of patients who can now be treated with minimally invasive pulmonary valve replacement, and potentially reducing the number of invasive procedures these patients must endure.

Research team:
John Desrosiers
Christine Heyninck-Jantz
Charlie Bowen
Walter Lee
Ali Rodriguez
Tyler O’Dell
Julie Cuervo
Rob Gerard
Aaron Swartz
Chris Casalaspi
Yara Baker
Andy Schaffer
Caleb Godwin
Ed Cho
Lynne Shwed
Hannah Gibson
Carla Cerqueira
Erin Fletcher
Ryan Kelley
Paula Torrianni
Anthony Lam
Mahvish Iqbal
Erika Tequia Soto
Jason Lam
Rafie Baboldshtian
Rasha Alghusain
Mario Rivas

Product: GammaTile®

Company: GT Medical Technologies, Inc.

Therapeutic Area & Indication: Surgically targeted precision radiation therapy for patients with operable brain tumors designed to maximize the potency of treatment on site while protecting healthy tissue and minimize radiation side-effects, for a speedier recovery and tumor remediation.

About the Product:
Determined to improve the lives of patients with brain tumors and raise the standard of care, a team of brain tumor specialists formed GT Medical Technologies and innovated GammaTile® Therapy. FDA-cleared GammaTile Surgically Targeted Radiation Therapy (STaRT) is for all types of newly diagnosed malignant tumors and recurrent brain tumors. Embedded with radiation sources, the resorbable collagen GammaTiles are implanted at the completion of brain tumor removal surgery for immediate treatment—eliminating the standard delay for external beam radiation therapy. This treatment allows patients to receive radiation therapy as they go about their daily lives, without additional trips for treatment. 

Product: BF-UC190F Endobronchial Ultrasound (EBUS) Bronchoscope

Company: Olympus America, Inc.

Therapeutic Area & Indication: Endobronchial ultrasound bronchoscope for biopsy of minimally invasive lung cancer.

About the Product:
The Olympus BF-UC190F is the next generation EBUS Bronchoscope which has greater flexibility and a compact distal tip to meet physicians evolving needs. This bronchoscope is equipped with ultrasound capability to visualize and sample lymph nodes beyond the bronchial wall during a procedure called endobronchial ultrasound needle aspiration (EBUS-TBNA). Recognized by the American College of Chest Physicians as the “first best test” for the pathological staging of lung cancer, EBUS-TBNA allows physicians to obtain ample quantities of specimen needed for a comprehensive histological analysis, a benefit for patients who may be undergoing genetic testing as part of their cancer journey.

Kathy Moyer is Vice President, Content and Community for Skipta, a Citeline company. Kathy oversees HCP medical content development for Skipta’s online medical communities. She works directly with KOLs, Specialists, PCPs, NPs, PAs, and Pharmacists for medical Advisory Boards, KOL interviews, virtual panel discussions/lectures, surveys, and custom content.

Prior to joining Skipta, Kathy worked in the pharmaceutical industry in various HCP and Pharma client facing roles including Rx advanced analytics, new product development, business development, account management, management consulting, and pharma brand management.
Kathy attended Rutgers University in New Brunswick, NJ and graduated with a BA from Rutgers College of Arts & Sciences in Communications and Biological Sciences.

Product: AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (IOL)

Company: Alcon, Inc.

Therapeutic Area & Indication: Artificial lens implant for the visual correction of aphakia in adults.

About the Product:
The AcrySof® IQ Vivity® lens is the first of its kind, nondiffractive extended depth of focus intraocular lens (IOL) with Alcon’s proprietary X-WAVETM technology. Vivity allows for better intermediate (working on a computer, applying makeup or shaving) and some near (reading, knitting) vision compared to what a monofocal IOL would provide. With Vivity, patients have the opportunity for more spectacle independence and lower levels of visual disturbances, such as halos and glares. By introducing Vivity, more cataract patients have been able to receive advanced IOL (ATIOLs) allowing more patients the option of correcting their vision at the time of cataract surgery. 

Product: XIPERE®

Company: Bausch + Lomb

Therapeutic Area & Indication: Back of eye injectable for macular edema associated with uveitis, an inflammation leading to vision loss.

About the Product:
XIPERE® (triamcinolone acetonide suprachoroidal injectable suspension) is the first and only FDA-approved therapy to treat macular edema associated with uveitis. It is also the first and only therapy FDA-approved utilizing the eye’s suprachoroidal space for drug delivery, which offers unprecedented access to the back of the eye and provides targeted delivery of therapeutic agents to the retina and choroid. This innovative administration technique may potentially improve efficacy and compartmentalization of medication, limiting exposure to healthy parts of the eye. With the approval of XIPERE®, the door is now open for further exploration of the suprachoroidal space as an alternative administration route for retinal disease management.

Inventors:
Henry Edelhauser
Mark Prausnitz
Samir Patel
Vladimir Zarnitsyn

Core Research Team:
Daniel White
Glenn Noronha
Rafael Andino  
Keleigh Mahn
Brian Burke
Tom Godfrey
Shelley Hancock 

Core Commercialization Team - Clearside:
George Lazaii
Charlie Deignan
Tom Ciulla
Barbara Bauschka

Core Commercialization Team – B&L:
Yolande Barnard
Dave Fisher
Joseph Ponzo
Tom Furgal
Sagar Shah
Tom Peterson
Mary Harrell
Rob Kissling
Krista Barbour 
Helen DeCory
Kristy Marks
Joel Fein
Teresa Brevetti
Douglas Jordan
Dawnya Bieller
Krishna Kewalramani
Kirstie Cole
Dean Gass

Product: Trudhesa®

Company: Impel Pharmaceuticals Inc.

Therapeutic Area & Indication: Nasal spray device to treat active migraine with or without aura in adults.

About the Product:
Trudhesa® (dihydroergotamine mesylate [DHE]) nasal spray (0.725 mg per spray) is indicated for the acute treatment of migraine with or without aura in adults in the U.S. Using Impel’s proprietary Precision Olfactory Delivery (POD®) technology, Trudhesa gently delivers DHE—a proven, well-established therapeutic—quickly to the bloodstream through the vascular-rich upper nasal space. By bypassing the gut and potential absorption issues, Trudhesa offers the potential for rapid, sustained, and consistent relief, even when administered hours after the start of a migraine attack. The result for patients is IV-like outcomes, without the need for injection or infusion. Impel is also evaluating its POD technology in its second combination product candidate, INP105, an intranasal olanzapine product (a widely used atypical, second-generation antipsychotic) as an acute treatment for agitation in persons with autism spectrum disorder.

Research team:
John Hoekman, PhD, co-founder and Chief Technology and Development Officer at Seattle-based Impel Pharmaceuticals;
Chris Fuller, Impel Pharmaceuticals, Senior Director of Technical Operations, Devices;
Craig Kohring, Impel Pharmaceuticals, Engineering Manager;
Scott Youmans, Impel Pharmaceuticals, Product Development and Operations Leader;
Michael Hite, former Impel employee, Currently CEO at Parachute Medical;
Alan Brunelle, PhD, former Impel employee, Currently Independent Pharmaceutical Consultant at Brunelle Biotech Consulting;
Joel Relethford, former Impel employee, Currently Retired Engineer at Aqueduct Critical Care.

Product: Tablo® Hemodialysis System

Company: Outset Medical, Inc.

Therapeutic Area & Indication: Total enterprise solution to kidney dialysis at patient point-of-care using advance machine engineering, automated ease of use and connected wireless data technologies.

About the Product:
Delivering kidney care innovation that’s been needed for decades, the Tablo® Hemodialysis System directly addresses the complexity of traditional dialysis. Tablo was specifically designed to simplify treatment for patients and providers. It’s an all-in-one machine that combines consumer product simplicity, wireless connectivity, and real-time integrated water purification in one compact 35-inch unit. The machine is easy to learn and use, offering flexible, intelligent dialysis that lowers costs, streamlines workflow, and improves the patient experience. Tablo can serve as a single enterprise solution for the continuum of care from hospital to home, allowing dialysis to be delivered anytime and anywhere.

Research team:
Gopi Lingam
Dean Hu
Manish Khemani
James Ritson
Doug Gallinat
Michael Hogard
Steve O. Miller
Bhavesh Patel
Johnny Bui
Travis Morgan
Lenny George
Steve M Miller
Hector Vidal
Agastya Anishetty
Shapour Golzar
Paul Bridges
Neal Vanderlaan
Tanuj Chirimar
Grego Ardley
Claire Mellin
Marc Garcia
Norman Ferrer
Charles Goodman
Sirisha Gutta
Rashmi Gaba

Product: Titan SGS®

Company: Standard Bariatrics, Inc.

Therapeutic Area & Indication:

About the Product:
The Titan SGS™ gastric stapler is an instrument used for resecting and stapling the stomach during laparoscopic, robotic-assisted laparoscopic, and open surgical procedures. The Titan SGS offers a 23cm staple line, the longest in the industry, designed specifically for gastric tissue and offers a novel alternative for performing sleeve gastrectomy. It is designed to simplify visualization, reduce complexity, save time, and enable consistently optimal surgical sleeve anatomy, helping surgeons set their patients up for the best possible clinical outcomes.