On April 19, 2022 Akoya Biosciences, Inc., (Nasdaq: AKYA), The Spatial Biology Company, reported the appointment of Dr. Ehab A. El-Gabry as the company’s Chief Medical Officer (CMO) (Press release, Akoya Biosciences, APR 19, 2022, View Source [SID1234612461]). In this newly created position, Dr. El-Gabry will lead Akoya’s strategy in advancing the use of its spatial phenotyping solutions in the clinical setting.

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Dr. El-Gabry brings a wealth of experiences that are critical to the company’s vision of advancing spatial phenotyping in precision medicine and cancer care. He is a board-certified pathologist who served as the Senior Medical Director for Roche Tissue Diagnostics Personalized Health Care Solutions (PHCS). As the head of the Roche Companion Diagnostics Pathology group, Dr. El-Gabry led the development of multiple digital and manual scoring algorithms and guided the clinical development of numerous commercially available predictive assays, including PD-L1 IHC. He served as Roche Pharma Services Medical Director and provided medical oversight for Roche Digital Solutions, Roche’s portfolio of digital pathology platforms.

At Akoya, Dr. El-Gabry will be a key member of the executive leadership team, responsible for the direction and execution of the company’s translational research and clinical strategy. He will be focused on the evaluation and commercial development of the company’s platforms for future clinical use, including regulatory submissions, cross-sector collaborations with academia and industry, and will ensure that the company’s portfolio of cutting-edge products and services meets the needs of patients, providers, payors, and regulatory agencies.

"We are extremely pleased to welcome an innovative physician-executive of Ehab’s caliber to lead Akoya’s translational and clinical strategy, just as spatial phenotyping is accelerating translational cancer research and as emerging evidence supports its potential to improve patient care," said Brian McKelligon, Chief Executive Officer of Akoya. "Ehab’s expertise and leadership will be invaluable to facilitating the platform advancements and partnerships that are central to our success in the translational and clinical markets."

"I am delighted to assume this leadership role at Akoya and build on the company’s pioneering role in transforming tissue analysis for cancer and life-threatening diseases," said Dr. Ehab El-Gabry. "Throughout my career, I have had a strong interest in discovering and developing new diagnostic tests that enhance our understanding and treatment of diseases like cancer. Spatial phenotyping is evolving from a discovery research technology towards a powerful platform for new, more informative diagnostics. Akoya is pioneering and leading this charge. I am excited to support Akoya and our partners in making this aspiration a reality."

Dr. El-Gabry completed his preliminary general surgery and pathology residencies at the Cleveland Clinic, Ohio. Subsequently, he finished his fellowship training in breast pathology and cytopathology at the University of Florida, Jacksonville. He then joined University of Pittsburgh Medical Center (UPMC) as an independent pathologist and research associate, where he focused on digital pathology.

Dr. El-Gabry has authored over 100 publications and speaks frequently at domestic and international scientific workshops. He received his medical degree from Cairo University Hospitals in Egypt.

On April 19, 2022 Voisin Consulting Life Sciences (VCLS), a leading global regulatory, access to market and clinical consultancy, reported a strategic partnership with EC Innovations in China, a global localization service provider with extensive experience in translating highly regulated life sciences & medical content (Press release, VCLS, APR 19, 2022, View Source [SID1234612452]). The alliance between VCLS and EC Innovations is set to build a long-term and robust relationship to further grow and enhance both companies’ capabilities to provide mutual clients with a higher level of services.

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As life sciences and medical industries gather pace and expand globally, regulatory and clinical requirements have become increasingly demanding, stringent and specific, with standards varying between countries. To ensure compliance across this complex regulatory landscape is thus a challenge for any company preparing to expand its footprint and strengthen its presence in foreign markets.

As a matter of course, the complex and ever-changing regulatory requirements call for a comprehensive solution to meet all needs with regard to regulatory consulting, clinical research and medical translation. Hence, this highly anticipated partnership shall bring together industry-leading regulatory consulting services from VCLS and high-quality translation & localization services from EC Innovations to unlock the potential of a full range of consulting & translation solutions. The combined resources, technologies and expertise of the two companies shall enable us to make multilingual compliance issues as painless as possible, helping complete transnational submissions, clear regulatory hurdles and shorten time to market.

As part of this partnership, VCLS and EC Innovations will jointly host multiple virtual and in-person events each year, sharing the knowledge and experience of the leading subject matter experts and our partners to guide clients in complying with the strict regulatory requirements in the life sciences and medical industry.

Dr. Linsen DU, General Manager of VCLS China said:"We at VCLS are excited to combine forces with EC Innovation. We believe that this is a perfect fit to facilitate our local and international clients who need to bring their innovative healthtech products faster to the highly regulated market, to the patients. We are looking forward to developing this partnership further towards achieving common goals."

"Our Life Science Business Unit works for hundreds of pharmaceutical/medical device companies in all kinds of application dossier translation. We are so thrilled to partner with VCLS, who has a deep knowledge and expertise of the global regulatory affairs and clinical consultancy," said Jane Du, Managing Director of EC Innovations (Chengdu), Inc. "This partnership enables us to further assist our clients in navigating the regulatory challenges and ensuring compliance with region-specific language requirements."

On April 19, 2022 Curium reported that it will be increasing production capacity of Detectnet to accommodate the significant demand in the market (Press release, Curium, APR 19, 2022, https://www.curiumpharma.com/2022/04/19/curium-announces-significant-increase-in-detectnet-copper-cu-64-dotatate-injection-production-capacity/ [SID1234612446]). Curium will now be offering 50% more doses for patient use Monday-Friday beginning the week of May 1, 2022.

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"We are incredibly pleased with the overwhelming response to Detectnet that has warranted an increase in production. Further, we are proud of the dedication of all the Curium employees who worked so diligently to support this effort. We now feel confident in our ability to service the entire adult neuroendocrine market, who may require a somatostatin receptor PET scan." said Curium CEO of North America, Michael Patterson. "At Curium, we are focused on redefining the experience of cancer through our trusted legacy in nuclear medicine. Today’s announcement further demonstrates our commitment to the physicians and patients in the neuroendocrine cancer community."

"Neuroendocrine cancer continues to be a priority focus for Curium," said Michael Wessler, Senior Director of Marketing. "We are very pleased with this increase in commercial capacity and are excited Detectnet will be even more accessible. Having the high accuracy of Detectnet readily available to patients and their physicians can help determine the best treatment plan."

About Detectnet
INDICATIONS AND USAGE
Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.

IMPORTANT RISK INFORMATION

WARNINGS AND PRECAUTIONS

Radiation Risk
Diagnostic radiopharmaceuticals, including Detectnet, contribute to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.
Hypersensitivity Reactions
Hypersensitivity reactions following administration of somatostatin receptor imaging agents predominantly consisted of cutaneous reactions such as rash and pruritis. Reactions reversed either spontaneously or with routine symptomatic management. Less frequently hypersensitivity reactions included angioedema or cases with features of anaphylaxis.
Risk for Image Misinterpretation
The uptake of copper Cu 64 dotatate reflects the level of somatostatin receptor density in NETs, however, uptake can also be seen in a variety of other tumors that also express somatostatin receptors. Increased uptake might also be seen in other non-cancerous pathologic conditions that express somatostatin receptors including thyroid disease or in subacute inflammation, or might occur as a normal physiologic variant (e.g. uncinate process of the pancreas).

A negative scan after the administration of Detectnet in patients who do not have a history of NET disease does not rule out disease.

ADVERSE REACTIONS

In clinical trials, adverse reactions occurred at a rate of < 2% and included nausea, vomiting and flushing. In published trials nausea immediately after injection was observed.

DRUG INTERACTIONS

Somatostatin Analogs
Non-radioactive somatostatin analogs and copper Cu 64 dotatate competitively bind to somatostatin receptors (SSTR2). Image patients just prior to dosing with somatostatin analogs. For patients on long-acting somatostatin analogs, a wash-out period of 28 days is recommended prior to imaging. For patients on short-acting somatostatin analogs, a washout period of 2 days is recommended prior to imaging.

USE IN SPECIFIC POPULATIONS

Pregnancy
All radiopharmaceuticals, including Detectnet, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. Advise a pregnant woman of the potential risks of fetal exposure to radiation from administration of Detectnet.
Lactation
Advise a lactating woman to interrupt breastfeeding for 12 hours after Detectnet administration in order to minimize radiation exposure to a breastfed infant.
Pediatric use
The safety and effectiveness of Detectnet have not been established in pediatric patients.
Geriatric use
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

OVERDOSAGE
In the event of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by reinforced hydration and frequent bladder voiding. A diuretic might also be considered.

On April 18, 2022 Aadi Bioscience, Inc. ("Aadi") (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that Founder, Chief Executive Officer and President, Neil Desai, Ph.D., and senior members of Aadi’s executive team will participate at the Jefferies "Biotech on the Bay" Summit, to be held in-person in Miami, FL April 26-27, 2022 (Press release, Aadi Bioscience, APR 18, 2022, View Source [SID1234614202]).

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The Aadi executive team will be available for one-on-one meetings throughout the conference. Please contact your sales representative at Jefferies to register for a meeting with the company.

On April 18, 2022 Sutro Biopharma, Inc. (the "Company") reported that entered into amendment No. 1 (the "Amendment") to its licensing agreement (the "Tasly License Agreement") with Tasly Biopharmaceuticals Co., Ltd. ("Tasly") regarding Tasly’s exclusive license to develop and commercialize STRO-002 in Greater China, consisting of China, Hong Kong, Macau and Taiwan (Filing, 8-K, Sutro Biopharma, APR 18, 2022, View Source [SID1234612587]). Pursuant to the Amendment, the initial payment due by Tasly was amended to $25 million, and a $15 million payment will be placed in escrow by Tasly in the second quarter of 2022 and become payable to the Company upon satisfaction of certain regulatory milestones. The Amendment also added an additional regulatory milestone payment to the Tasly License Agreement, providing potential payments totaling up to $350 million related to development, regulatory and commercialization milestones, beyond the payments described above, and made certain other ministerial edits.

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