Market Newsdesk

EDMONTON, Alberta, Nov. 19, 2020 (GLOBE NEWSWIRE) — The Alberta Machine Intelligence Institute (Amii) has launched applications for Supply Chain AI West, an eight-month accelerator focused on empowering startups and early-stage founders to incorporate artificial intelligence (AI) technologies toward creating AI-powered supply chains. The program, made possible through a $500,000 investment from SCALE AI, will support companies to upskill their teams as well as progress an AI project that has the potential to make meaningful improvements to operational efficiency, health and safety protocols, economic performance or a core product. Applications close on December 15, 2020; for more information, visit, amii.ca.

Supply Chain AI West is Amii’s first accelerator stream and is focused on creating the disciplined environment required for founders to establish an AI strategic direction and begin execution while bringing together a community of experts to provide advice and access to their extended networks.

Programming is designed to expose startups and early-stage founders to the opportunities available to create AI-powered supply chains, and includes:

• Training: Access to facilitated and self-directed workshops and courses including ML Foundations 1 and 2, AI Planning and Initiating sessions, and a dedicated study group for online learning produced by Amii on the Coursera platform.
• Coaching: Through dedicated time with an applied AI scientist, participants will gain insight into their specific challenges and opportunities related to AI adoption while working toward executing their first proof of concept ML model.
• Demo Day: At the conclusion of the program, participants will showcase their work to members of the AI ecosystem including researchers, business leaders, funders and investors. In preparation for this opportunity, startups will receive investor relations mentorship with an AI lens.

Upon graduation from the program, companies will have the skills required to develop a first proof of concept machine learning (ML) model that addresses a specific business problem – and a strategic plan for further AI adoption. This proof of concept ML model is an important first step for startups to drive a culture of AI adoption and rapid ML prototyping. This AI mind-set and product roadmap has the potential to serve as a competitive differentiator in a globally competitive market.

“Startups play an important role in the adoption of novel technologies like AI in traditional industries. As a former tech founder, I know that startup teams have the drive, flexibility and motivation to solve big problems. With Supply Chain AI West, Amii is able to work with nimble startup teams to provide hands-on training and act as their coach as they build AI-powered supply chain products and solutions,” says Cam Linke, CEO of Amii.

“As Canada’s AI Supercluster, we believe that now is the time to take AI out of the lab and into the real world. The team at Amii has a track record of success in translating scientific excellence into industry adoption, and we’re thrilled to accelerate their work. The Supply Chain AI West program is an opportunity for early-stage tech companies to receive insight and support from a multidisciplinary team of scientists, educators and project managers dedicated to their success. I look forward to Demo Day and seeing these 10 startups’ technology in action,” says Julien Billot, CEO of SCALE AI

“If Alberta wants to grow its economy for the future, it’s important that we create ecosystems where technology and innovation startups in our province can thrive. The creation of this eight-month accelerator by Amii and SCALE AI means Alberta’s innovators will have hands-on access to critical training and coaching that will help them grow their startups into successful companies that create great jobs for Albertans,” says the Honourable Doug Schweitzer, Minister of Jobs, Economy and Innovation.

Supply Chain AI West is available to 10 ventures that share SCALE AI and Amii’s vision of positioning Canada as a global leader in AI and supply chain management.

To make up the cohort of 10 ventures, Amii is seeking seven startups. Additionally, up to three places will be considered for early-stage founders looking for a de-risked and supportive environment to begin their business through participation in a cohort-based program.

Companies will represent a variety of industry sectors and with different areas of focus across the end-to-end supply chain. Eligible companies must meet the following criteria:

• A willingness to invest resources in their own internal AI capabilities
• A focus on solving challenges in supply chain management through AI
• Product or services launched within the past 36 months
• Proof of customers and/or demonstrate a clear understanding of their product/market fit
• Pre-seed, Seed or Series A funding
• Generate annual revenue under $3M
• Provide references that demonstrate their ability to be mentored and coached

Key Program Dates

About SCALE AI

As Canada’s AI supercluster, SCALE AI acts as an investment and innovation hub that accelerates the rapid adoption and integration of artificial intelligence (AI) and contributes to the development of a world-class Canadian AI ecosystem.

Based in Montréal, funded by the federal government and the Quebec government, SCALE AI has nearly 120 industry partners, research institutes and other players in the AI field. It develops programs aimed at supporting investment projects of companies that implement real-world applications in AI, the emergence of future Canadian flagships in the sector, as well as the development of a skilled workforce. For more information, visit scaleai.ca.

About Amii

One of Canada’s three centres of AI excellence as part of the Pan-Canadian AI Strategy, Amii (the Alberta Machine Intelligence Institute) is an Alberta-based non-profit institute that supports world-leading research in artificial intelligence and machine learning and translates scientific advancement into industry adoption. Amii grows AI capacity through advancing leading-edge research, delivering exceptional educational offerings and providing business advice – all with the goal of building in-house AI capabilities. For more information, visit amii.ca.

Spencer Murray
Marketing and Communications
587.415.6100 ext. 109
[email protected]

RALEIGH, N.C. , Nov. 19, 2020 (GLOBE NEWSWIRE) — PRA Health Sciences, Inc. (NASDAQ: PRAH) announced today the appointment of Isaac Rodriguez-Chavez, PhD, MHS, MS, as Senior Vice President, Scientific and Clinical Affairs. He will lead the company’s Global Center of Excellence for Decentralized Clinical Trial (DCT) Strategy. Dr. Rodriguez-Chavez’s responsibilities will involve the continued growth and development of PRA’s industry-leading decentralized clinical trial strategy, regulatory framework creation, and clinical trial modernization.

Dr. Rodriguez-Chavez has more than 32 years of experience in virology, microbiology, immunology, vaccinology and viral oncology, including basic, pre-clinical and clinical research (phase I-IV). Most recently as a Senior Officer for Clinical Research Methodologies, Regulatory Compliance, and Medical Policy Development with the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), he led the development of guidance around decentralized clinical trials using digital health technologies. With the FDA, he evaluated and modernized clinical research protocols that impact multiple disease areas.

“We are honored to have one of the pioneers in decentralized clinical trials and an established expert in clinical trial modernization join PRA Health Sciences,” said Colin Shannon, President and Chief Executive Officer at PRA. “The clinical drug development paradigm continues to evolve into a more decentralized model to better align with how healthcare is delivered to individuals. By pairing Dr. Rodriguez-Chavez, one of the leading experts in decentralized clinical trials, with PRA’s state-of-the-art DCT platform, we will modernize the clinical trial process.”

“I am honored to join PRA Health Sciences to lead the Global Center of Excellence for Decentralized Clinical Trial Strategy and enable their implementation with novel digital health technologies,” said Dr. Rodriguez-Chavez. “PRA Health Sciences has the vanguard infrastructure, human capital, and experience to provide excellence in a global suite of clinical research and healthcare services. We are currently experiencing an exponential adoption of modern clinical trial designs in the field, including decentralized clinical trials, and I am truly honored to help lead the change. Importantly, PRA Health Sciences also has the pulse and voice of trial participants and the right approach to assist individuals with their health using the latest innovations in health care systems.”

Prior to his work with the FDA, Dr. Rodriguez-Chavez was founder and CEO of 4Biosolutions Consulting and was the Vice President for Research at the Texas Biomedical Research Institute. Before that, he was the Director of the AIDS & Immunosuppression Program at the National Institute of Dental and Craniofacial Research, National Institutes of Health (NIH). Dr. Rodriguez-Chavez also held the position of Senior Clinical Scientist at Schering Plough Corporation and the Director of a portfolio for HIV Vaccines at the National Institutes of Allergy and Infectious Diseases, NIH.

Dr. Rodriguez-Chavez also serves the clinical research community in many capacities, including:

• Board Member of the Scientific Leadership of the Digital Medical Society (DiME)
• Regulatory Advisor of the Institute of Electrical and Electronics Engineers (IEEE), focusing on initiatives on decentralized trials using digital health technologies
• Leadership Council member of the Decentralized Trials & Research Alliance (DTRA)
• Board Member of the Hypertrophic Cardiomyopathy Association (HCMA)
• Published 50 scientific and technical articles in his areas of expertise
• Speaker at 68 global conferences

Dr. Rodriguez-Chavez has a B.S. in Biology (Venezuela), M.S. in Microbiology (Venezuela), M.H.S. in Clinical Research (Duke School of Medicine), and a Ph.D. in Virology and Immunology (University of Delaware).

PRA’s
Global Center of Excellence
for
Decentralized Clinical Trial
Strategy

The appointment of Dr. Rodriguez-Chavez is the culmination of more than five years of investment in people, processes, and technology to build the Global Center of Excellence for Decentralized Clinical Trial Strategy, the industry’s most robust and integrated clinical research consultancy.

“Our focus for many years has been creating an innovative mobile healthcare ecosystem to be able to deliver decentralized clinical trials on behalf of our clients and sponsors,” said Kent Thoelke, Executive Vice President and Chief Scientific Officer at PRA. “We are thrilled to have Dr. Rodriguez-Chavez join PRA to lead that effort within our Global Center of Excellence and use his regulatory expertise to help PRA ensure clinical research is a care option for all patients.”

In just the past year, PRA has put those investments into action, guiding sponsors and partners in the development of decentralized and hybrid clinical trial strategy, protocol development, and securing regulatory approval. PRA has set the standard for the planning and execution of technology integration into clinical research and decentralized trial-focused milestones including:

• In addition to activating more than 50 hybrid clinical trials involving novel digital health technologies over the last three years, PRA launched the first-ever completely decentralized, mobile, indication-seeking clinical trial for heart failure in November 2019. Participants in the ongoing trial are able to engage using their phones and computers right from their own homes. The study uses PRA’s Mobile Health Platform and smart, wearable technology to assess its participants’ quality of life and track their physical activity.
• PRA expanded its Mobile Health Platform in March 2020, allowing sponsors to do everything that is possible at a clinical site, remotely. The platform includes a mobile app available to both sponsors and participants for use when engaging in clinical trials. The mobile app has the ability to gather electronic informed consent and e-signatures, and complete patient reported outcomes — right from the participant’s personal phone or tablet. Using connected devices, the app also can collect home healthcare data and serve it into the source for the clinical trial.
• PRA acquired Care Innovations in January 2020, a leader in consumer-focused telehealth and remote trial participant monitoring. Together, PRA and Care Innovations utilized the Health Harmony app to launch the COVID-19 Monitoring Program in March. The app-driven program allows employers, payers, providers and healthcare systems to track the health and wellbeing of individuals who may be asymptomatic, exposed to SARS-CoV-2 infection or diagnosed with COVID-19.

The Global Center of Excellence for Decentralized Clinical Trial Strategy brings together the expertise of PRA teams who have the practical experience to quickly implement effective solutions that sponsors need when implementing decentralized or hybrid trial designs. For more information about PRA’s decentralized trials capabilities and solutions, please visit https://prahs.com/decentralized-clinical-trials.

About PRA Health Sciences

PRA Health Sciences is one of the world’s leading global contract research organizations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 75 offices across North America, Europe, Asia, Latin America, Africa, Australia and the Middle East and more than 17,500 employees worldwide. Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 95 drugs. To learn more about PRA, please visit www.prahs.com.

INVESTOR INQUIRIES: [email protected]

MEDIA INQUIRIES: Laurie Hurst, Sr. Director, Communications and Public Relations
[email protected] | +1 (919) 786-8435

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8b9eff95-a2d6-4284-bf0d-8bd680b5098c

Southfield, Michigan, Nov. 19, 2020 (GLOBE NEWSWIRE) — Credit Acceptance Corporation (Nasdaq: CACC) (referred to as the “Company”, “Credit Acceptance”, “we”, “our”, or “us”) has been named one of the Best and Brightest Companies to Work For^® in the nation. This is the ninth year in a row that Credit Acceptance has won this honor. We were selected as one of the top 151 companies out of 1,100 nominations in the Fall 2020 competition.

We were evaluated by the National Association for Business Resources (NABR), an independent research firm, which reviewed several key measures such as communication, work-life balance, diversity, recognition, retention and more.

This is the ninth workplace award that we’ve received this year as we also received:

• FORTUNE 100 Best Companies to Work For (last seven years in a row)
• Best Workplaces in Financial Services & Insurance (last six years in a row)
• 2019 National Best and Brightest Companies to Work For
• 2020 Nevada Top Workplaces
• Computerworld Best Places to Work in IT (six-time winner)
• Crain’s Fast 50 (last seven years in a row)
• Michigan’s Best and Brightest in Wellness
• 2020 Detroit Free Press Top Workplaces (last nine years in a row)

To see the complete 2020 List of the Best and Brightest Companies to Work For^®, visit thebestandbrightest.com.

About Credit Acceptance

Since 1972, Credit Acceptance has offered financing programs that enable automobile dealers to sell vehicles to consumers, regardless of their credit history.  Our financing programs are offered through a nationwide network of automobile dealers who benefit from sales of vehicles to consumers who otherwise could not obtain financing; from repeat and referral sales generated by these same customers; and from sales to customers responding to advertisements for our financing programs, but who actually end up qualifying for traditional financing.

Without our financing programs, consumers are often unable to purchase vehicles or they purchase unreliable ones.  Further, as we report to the three national credit reporting agencies, an important ancillary benefit of our programs is that we provide consumers with an opportunity to improve their lives by improving their credit score and move on to more traditional sources of financing.  Credit Acceptance is publicly traded on the Nasdaq Stock Market under the symbol CACC.  For more information, visit creditacceptance.com.

About the Best and Brightest Programs

The Best and Brightest Companies to Work For^® competition identifies and honors organizations that display a commitment to excellence in operations and employee enrichment that lead to increased productivity and financial performance. This competition scores potential winners based on regional data of company performance and a set standard across the nation. This national program celebrates those companies that are making better business, creating richer lives and building a stronger community as a whole.

• The phase 1b study showed a complete response (CR) rate of 46% (objective response rate [ORR] of 88%) at the recommended dose level in patients with relapsed/refractory (R/R) Hodgkin lymphoma, whereas in a separate study MSD’s KEYTRUDA demonstrated an ORR of 69% and a CR of 22.4% as a monotherapy
• Investigators
  concluded that AFM13 in combination with KEYTRUDA for R/R Hodgkin lymphoma patients was well-tolerated with adverse events that were generally manageable
• Novel immunotherapy combination worthy of further investigation

Heidelberg, Germany, November 19, 2020
– Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the Phase 1b study of AFM13, a CD30/CD16A innate cell engager (ICE^®), in combination with KEYTRUDA was published in Blood, the renowned Journal of the American Society of Hematology. The results demonstrate promising signs of efficacy including an objective response rate (ORR) of 88% at the highest treatment dose, as well as a complete CR of 46%. As a monotherapy, KEYTRUDA demonstrated an ORR of 69% and a CR of 22.4% in the KEYNOTE-087 trial.

“We showed for the first time that the combination of an ICE^® with a PD-1 checkpoint inhibitor can be safely administered with manageable side effects,” said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. “The high objective response rate and complete response rate seen in this proof-of-concept study of AFM13 combined with KEYTRUDA are very encouraging and indicate that the activation of innate immunity could improve upon current therapies.” 

The study assessed the safety and efficacy of AFM13 in combination with KEYTRUDA in 30 heavily pre-treated patients with R/R Hodgkin lymphoma. The safety profile for the combination was described as well-tolerated and similar to the known profiles for each agent alone. Most adverse events were low grade and remained manageable with standard-of-care therapies.

AFM13 presents a novel approach of activating innate immunity through CD16A-directed tumor-cell killing by NK cells and macrophages. The phase 1b study supports the notion that in combination with an established therapy such as an immune checkpoint inhibitor, that releases the brakes on adaptive immune responses, the ICE^® AFM13 complements the PD-1 checkpoint inhibitor, thereby triggering both arms of the immune system against tumors.

Dr. Nancy Bartlett, a medical oncologist and Koman Chair in Medical Oncology at Washington University School of Medicine in St. Louis and lead author on the publication, said, “There is an unmet need for patients with Hodgkin lymphoma who have relapsed or are refractory to current therapies. For these patients, there are no therapies that show durable efficacy. The combination of AFM13 with KEYTRUDA was well tolerated and showed an 88% response rate with a very encouraging 46% complete metabolic response rate in a heavily pretreated patient population.  This exciting data shows that there are potential treatments on the horizon for patients with limited options.”

“Engagement of the innate immune system to kill tumors is novel. The studies of AFM13 and KEYTRUDA in Hodgkin lymphoma, as well as AFM13 in patients with T-cell lymphoma, present exciting approaches to controlling blood cancers that could significantly benefit patients,” said Lee Greenberger, Ph.D., Chief Scientific Officer of The Leukemia & Lymphoma Society (LLS), which supported Affimed’s clinical study of AFM13 through its Therapy Acceleration Program® (TAP), LLS’s strategic venture philanthropy funding initiative. 

More details about the Phase 1b of AFM13 in combination with KEYTRUDA study can be found at www.clinicaltrials.gov using the identifier NCT02665650.  The article published in Blood, Volume 136, Number 21 can be found here https://bit.ly/2KiL293 .

About AFM13

AFM13 is a first-in-class innate cell engager that induces specific and selective killing of CD30-positive tumor cells by engaging and activating natural killer (NK) cells and macrophages, thereby leveraging the power of the innate immune system. AFM13 is Affimed’s most advanced ICE^® clinical program, and it is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). The study is actively recruiting and can be found at www.clinicaltrials.gov using the identifier NCT04101331.

Affimed is currently studying AFM13 in combination with cord blood-derived allogeneic natural killer cells in cooperation with the MD Anderson Cancer Center in Houston. The investigator-sponsored Phase 1 study is preparing to administer a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells, the study can be found at www.clinicaltrials.gov using the identifier NCT04074746.

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer. Affimed’s fit-for-purpose ROCK^® platform allows innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and into a Phase 1/2a dose escalation/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. For more information, please visit www.affimed.com.

About The Leukemia & Lymphoma Society and


Therapy Acceleration Program® (TAP)

The Leukemia & Lymphoma Society^® (LLS) is a global leader in the fight against cancer. The LLS mission: cure leukemia, lymphoma, multiple myeloma, and improve the quality of life of patients and their families. LLS TAP is a strategic initiative that builds business alliances and collaborations with biotechnology companies and academic researchers to identify potential breakthrough therapies with the potential to change the standard of care. LLS TAP funds late stage pre-clinical studies, and proof of concept or registrational clinical trials to help advance these more quickly along the drug development and approval pathway. To learn more, visit www.LLS.org.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM24, the value of our ROCK® platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation and the risks, uncertainties and other factors described under the heading “Risk Factors” in Affimed’s filings with the Securities and Exchange Commission. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.

Affimed Investor and Media Contacts

Alex Fudukidis
Head of Investor Relations
[email protected]

Mary Beth Sandin
Head of Marketing and Communications
[email protected]