On September 8, 2022 Medable Inc., the leading software provider for patient-centered clinical trials, reported that it has entered a four-year enterprise contract with GSK to enable decentralized clinical trials (DCTs) across their portfolio using the company’s industry-leading DCT platform (Press release, Medable, SEP 8, 2022, View Source [SID1234619232]). Medable was selected by GSK to accelerate the delivery of new medicines and enable their clinical trials to be more inclusive and representative of all patient populations.

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Medable’s technology was chosen after a rigorous evaluation of the leading clinical trial platforms, as it best aligns with GSK’s goals of increasing access to research, improving diversity, and creating more patient-centric trial designs. Medable’s end-to-end DCT platform provides many critical digital capabilities, including eConsent, TeleVisit, and eCOA, as well as the flexibility to deploy modern, patient-centered clinical trials.

"It is an honor to be selected by GSK as its preferred partner for decentralized clinical trials," said Dr. Michelle Longmire, Co-founder and CEO of Medable. "GSK has been a leader in innovative science for decades and is taking yet another transformational step forward by leveraging a modern, patient-centric model to conduct clinical trials with Medable. It’s incredibly exciting, and we are looking forward to helping millions of patients together."

Medable has deployed its software-as-a-service platform via more than 300 decentralized and hybrid clinical trials in 60 countries, serving more than one million patients and research participants globally. Medable’s customers have achieved impressive results with decentralized and hybrid trials – including 200 percent faster enrollment and 50 percent cost reductions. A recent 2022 financial modeling of DCTs using industry benchmark and Medable data conducted by the Tufts Center for the Study of Drug Development shows that, on average, decentralized trials can achieve net financial benefits ranging from five to 13 times for Phase II and Phase III trials, due to reduced trial timelines and other factors.

Learn more about Medable’s partnership with GSK and other life science leaders at the 12th annual DPharm Disruptive Innovations U.S. conference (Sept 13-14, 2022) in Boston – booth #48.

On September 8, 2022 Cardinal Health (NYSE: CAH) reported Debbie Weitzman, current President of Pharmaceutical Distribution, will become CEO of the Company’s Pharmaceutical Segment (Press release, Cardinal Health, SEP 8, 2022, View Source [SID1234619231]). Weitzman will replace Victor Crawford, who will be stepping down as Pharmaceutical Segment CEO effective September 19, but will remain with the company until November 13 to help with the transition. The role of President of Pharmaceutical Distribution will be eliminated.

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The company has further streamlined the Pharmaceutical Segment by restructuring and eliminating additional roles. As a result of these changes, the Pharmaceutical and Specialty Distribution businesses will both report directly to Debbie Weitzman.

"Debbie has been a tremendous leader at Cardinal Health, and we believe her knowledge and experience make her the right person to lead our redesigned Pharmaceutical Segment," said Jason Hollar, Chief Executive Officer of Cardinal Health. "I believe this new design will allow us to have added focus on specialty distribution, which is a key growth area for the company, as well as simplify how our customers and manufacturers work with us."

Hollar added, "On behalf of the Board and entire company, I want to thank Victor for his leadership and many contributions to our business and culture during his time with Cardinal Health. Victor’s steadfast leadership helped our Pharmaceutical Segment navigate the challenging environment during the pandemic, and we’re grateful he will remain with us through November 13 to ensure a smooth transition."

The moves in the Pharmaceutical Segment come as part of the company’s broader simplification efforts to streamline its organizational structure and are specifically aimed to strengthen the company’s Pharmaceutical and Specialty Distribution, as well as bring together similar services under one team.

About Debbie Weitzman
Debbie Weitzman has been President of Pharmaceutical Distribution at Cardinal Health since 2017, leading the company’s distribution efforts to thousands of pharmacies across the care continuum, from retail and hospital pharmacies to long-term care and community health center pharmacies. Debbie also led the launch of and oversees Outcomes, a unified ecosystem that brings together patient engagement, clinical intervention and pharmacy workflow solutions to enhance patient outcomes.

Throughout her 16-year career at Cardinal Health, Debbie has served in varying leadership roles across sales and distribution operations. Debbie has extensive international experience having previously served as the senior vice president and general manager of Cardinal Health Puerto Rico, responsible for sales and distribution operations for pharmaceutical products, medical-surgical products, hospital pharmacy management and logistics services in Puerto Rico and Latin America.

Prior to joining Cardinal Health, Debbie held positions of increasing responsibility at Johnson & Johnson Medical Caribbean. She began her career in banking at J.P. Morgan, followed by various marketing roles in consumer brand management both in the United States and Puerto Rico.

Debbie serves on the Board of Directors for the National Association of Chain Drug Stores, and is a delegate with the National Association of Wholesalers. She earned her bachelor’s degree in history from Dartmouth College and a master’s degree from Kellogg Graduate School of Management at Northwestern University.

On September 8, 2022 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company) a leader in the development of targeted radiotherapies for patients with unmet needs, reported that it will be participating in the H.C. Wainwright 24th Annual Global Investment Conference, being held September 12-14, 2022 (Press release, Actinium Pharmaceuticals, SEP 8, 2022, https://ir.actiniumpharma.com/news/detail/422/actinium-pharmaceuticals-to-participate-in-the-h-c-wainwright-24th-annual-global-investment-conference [SID1234619230]). The conference will be hybrid and occur virtually and in person at the Lotte New York Palace Hotel in New York City.

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Members of Actinium’s management team will conduct one-on-one meetings. Please contact your representative at H.C. Wainwright to schedule a one-on-one meeting with the Actinium management team. For information about the H.C. Wainwright Global Investment Conference, please refer to the event’s website. Actinium’s investor presentation will be available on the conference website as well the investor relations page of the Company’s website at www.actiniumpharma.com/presentations-webinars.

On September 8, 2022 Philogen S.p.A., a clinical-stage biotechnology company focused on antibody and small
molecule-based targeted therapeutics, reported the conferences its management team will be participating in the coming months (Press release, Philogen, SEP 8, 2022, View Source [SID1234619229]).

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European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, 9-13 September

European Association of Neuro-Oncology (EANO) Congress 2022, 15-18 September

Emerging Technologies and Methodologies in Small Molecule Drug Discovery & Synthesis Symposium, 27-29
September
• From Encoded Combinatorial Libraries To Targeted Therapeutics, Prof. Dr. Dario Neri, Co-founder, Chief Executive and Chief Scientific Officer (28 September)

Festival of Biologics Basel 2022, 2-4 November
• Tripokin: tumor-targeted delivery of IL2 potentiated by TNF, Roberto De Luca, PhD, Head of Antibody
Therapeutics (2 November)
• Small Molecule Therapeutics targeting Fibroblast Activation Protein in the tumor microenvironment of solid tumors, Samuele Cazzamalli, Head of Small Molecule Therapeutics (2 November)

10th International Symposium on DNA-Encoded Chemical Libraries, 3-4 November
• Quantification of DEL selections and implications for good selection protocols, Prof. Dr. Dario Neri, Co-founder,
Chief Executive and Chief Scientific Officer (November 3)
The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting 2022, 8-12 November
• Combinatorial chemoimmunotherapy based on the antibody-cytokine fusion protein L19TNF unleashes potent
anti-tumor immunity against treatment-refractory glioblastoma, Teresa Hemmerle, PhD, Senior Project Manager
• A novel IL12-based immunocytokine targeting Fibroblast Activation Protein (FAP) for the treatment of cancer,
Roberto De Luca, PhD, Head of Antibody Therapeutics
• Decreasing toxicity of immunocytokines by transient and selective inhibition of their intracellular signaling
activation, Sheila Dakhel, PhD, Senior Scientist
• A novel fully human CD28 antibody that cross-reacts with CTLA-4 and mouse CD28 for potential applications in
cancer immunotherapy, Abdullah Eisayed, PhD student at Philogen

14th Annual PEGS Europe Protein & Antibody Engineering Summit 2022, 14-16 November
• Antibody-cytokine fusions: emerging clinical data in glioblastoma, sarcoma and dermato-oncology indications,
Prof. Dr. Dario Neri, Co-founder, Chief Executive and Chief Scientific Officer

TIDES Europe 2022, 16-18 November
• Non-internalizing Small Molecule-Drug Conjugates and Radioligand Therapeutics targeting Fibroblast Activation
Protein in solid lesions, Samuele Cazzamalli, Head of Small Molecule Therapeutics

On September 8, 2022 PharmaMar (MSE:PHM) reported that new data on Zepzelca (lurbinectedin) and Yondelis (trabectedin) will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress, which is being held in Paris from 9th to 13th September (Press release, PharmaMar, SEP 8, 2022, View Source [SID1234619228]).

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Two new posters of different studies with lurbinectedin will be presented during the congress. In the first poster, entitled "Synthetic control arm (SCA) analysis of lurbinectedin compared to the standard of care (SoC) among patients with Small Cell Lung Cancer (SCLC) previously treated with platinum-based chemotherapy," the authors conclude that lurbinectedin has potential benefit compared to SoC in the post-platinum setting of SCLC.

In the second poster, entitled "Real-world (RW) outcomes of second-line (2L) Small Cell Lung Cancer (SCLC) patients treated with lurbinectedin," the authors report that outcomes of patients treated with second-line lurbinectedin monotherapy in the RW setting are consistent with those found in the phase II clinical trial. Furthermore, they conclude that lurbinectedin provides an additional treatment option for relapsed SCLC patients, including those with platinum-sensitive disease.

Regarding trabectedin, three posters will be presented, among which those entitled "Trabectedin induces apoptosis regardless of acquired resistance to PARP inhibitors in BRCA2 mutant high grade ovarian cancer cell lines" and "Randomized phase II study of trabectedin/olaparib compared to physician’s choice in subjects with previously treated advanced or recurrent solid tumors harboring DNA repair deficiencies" stands out, in which new data on trabectedin, showing its activity on advanced/metastasic cancer with defective Homologous Recombination (HR) DNA repair are presented.

The former shows preclinical data, suggesting that some high grade ovarian cancer cell lines with BRCA2 mutation and resistant to PARPi could potentially be overcome with trabectedin. The latter shows interim analyses from a phase II clinical trial suggesting that trabectedin could enhance the effect of PARP inhibitors in HR-deficient cancers, i.e., in those patients in whom their body is unable to repair double-strand breaks in DNA. The study has successfully passed the interim analysis. The trial is expected to be completed in 2022.

Highlighted studies at ESMO (Free ESMO Whitepaper) 2022

Lurbinectedin:

TITLE LEAD AUTHOR PRESENTATION
Synthetic control arm (SCA) analysis of lurbinectedin compared to the standard of care (SoC) among patients with small cell lung cancer (SCLC) previously treated with platinum-based chemotherapy Devon J. Boyne (Calgary, Canada) PRESENTATION NUMBER: 1536P FECHA: Saturday, September 10, 2022
Real-world (RW) outcomes of second-line (2L) small cell lung cancer (SCLC) patients treated with lurbinectedin Adina Estrin (New York, United States of America) PRESENTATION NUMBER: 1539P FECHA: Saturday, September 10, 2022
Trabectedin:

Trabectedin for patients with advanced soft tissue sarcoma: a non-interventional, prospective, multicenter study Viktor Grünwald (Essen, Germany) PRESENTATION NUMBER: 1496P FECHA: Sunday, September 11, 2022
Trabectedin induces apoptosis regardless of acquired resistance to PARP inhibitors in BRCA2 mutant high grade ovarian cancer cell lines Jose Alejandro Perez Fidalgo (Valencia, Spain) PRESENTATION NUMBER: 585P FECHA: Sunday, September 11, 2022
Randomized phase II study of trabectedin/olaparib compared to physician’s choice in subjects with previously treated advanced or recurrent solid tumors harboring DNA repair deficiencies Christoph E. Heilig (Heidelberg, Germany) PRESENTATION NUMBER: 487P FECHA: Monday, September 12, 2022