Caught in the Grip of COVID Stress? Nine Quick and Easy Ways to Stop Stress in the Moment Even when stress levels skyrocket, you can reclaim a sense of calm and control. Mark Goulston, MD, and Diana Hendel, PharmD, share simple ways frontline healthcare employees can lower their stress anytime, anyplace.
Nashville, TN (January 2021)—After a year of fighting COVID-19, no one doubts the toughness, drive, or dedication of healthcare workers. But the pandemic has still taken a crushing toll on our frontline heroes. Though many put on a brave face, their stress levels are at an all-time high, say Diana Hendel, PharmD, and Mark Goulston, MD. And if you’re caught in the grip of COVID-related stress, it’s better to take decisive action in the moment than to ignore it until it escalates into something more serious.
“No matter how much you pride yourself on staying calm under pressure, it’s important to mitigate stress, especially when you are in the middle of your shift and can’t leave,” says Diana Hendel, PharmD, coauthor along with Mark Goulston, MD, of Why Cope When You Can Heal?: How Healthcare Heroes of COVID-19 Can Recover from PTSD(Harper Horizon, December 2020, ISBN: 978-0-7852-4462-2, $17.99).
“No one thrives while they are in perpetual survival mode,” adds Dr. Goulston. “Constantly feeling afraid, exhausted, and overwhelmed is dangerous and puts you at risk for burnout—something neither you nor our community can afford right now.”
The authors say every healthcare worker should have a tool kit of “stress stoppers” at their fingertips. For example:
Do frequent self “check-ins” to recognize when your stress levels are rising. When you’re busy and under pressure to perform, it’s easy to go on “autopilot.” Therefore, periodically pause and do a quick self-assessment throughout the day. Consider your emotional state (Do I feel friendly and engaged, or edgy and aggressive?) as well as your physical state (Is my body calm and at ease, or is it holding onto tension?).
“Take 20 or 30 seconds to scan your body and identify areas that may be holding onto tension or stress,” says Dr. Hendel. “For example, you might be carrying tension in your jaw or shoulders. When you notice an area that is tense, gently release the tension. Over time it should become easier to recognize when stress begins to take hold—and to do something about it.”
Ground yourself when you start feeling overwhelmed. Grounding is a great way to reduce anxiety and arrive in the here and now. Use it anytime you feel carried away by anxious thoughts or feelings, or triggered by upsetting memories and flashbacks.
Find a comfortable place to sit (or stand). If sitting, rest your hands on your legs. Feel the fabric of your clothing. Notice its color and texture.
Next, bring your awareness to your body. Stretch your neck from side to side. Relax your shoulders. Tense and relax your calves. Stomp your feet.
Look around and notice the sights, sounds, and scents around you for a few moments.
Name 15-20 things you can see. For example, the floor, a light, a desk, a sink.
As you keep looking around, remind yourself that “The flashback or emotion I felt is in the past. Right now, in this moment, I’m safe.”
Pause and take a few deep breaths. We tend to hold our breath whenever we are stressed, but this only exacerbates feelings of anxiety and panic. Instead, use “box breathing” to calm yourself and heighten your concentration. Box breathing is the technique of taking slow, deep, full breaths. Here’s a tutorial for when you’re feeling triggered.
Slowly exhale your breath through your mouth. Consciously focus on clearing all the oxygen from your lungs. Inhale slowly and deeply through your nose for four slow counts. Hold your breath for four more slow counts. On the next four counts, exhale again through your mouth until your lungs are empty. Hold your breath again for a final slow count of four beats.
Reach for something that anchors you in the present moment. Carry a small reminder of what you love about your life and focus on it if you feel triggered and need to center yourself. It might be a photo of your kids or pet, a small rock you picked up on a scenic nature hike, or a special necklace. Think of the gratitude you feel for your life whenever you look at this token.
Keep something that makes you laugh nearby. Humor is a great way to alleviate stress. Tape a clip of a funny cartoon to your work area or carry a small notebook with jokes that make you laugh every time you read them.
Use calming affirmations to give you strength and peace. Written positive statements can give you a lift when you feel yourself sinking. If self-talk is not for you, imagine a supportive other saying these to you in your mind’s eye. A few examples:
I am great at my job, and my training and skills are empowering.
I feel energized and ready for anything the day has in store for me.
I accept myself as I am. I am enough.
I am safe in this moment.
Let your feelings out (when possible). At times you may find you need to step away from your duties for a few minutes and give those intense emotions some “breathing room.” Try to move to a different room so you can cry or discreetly express your feelings. Sometimes you need to release the stress that’s built up in your body, and finding a private place to let the tears fall or vent for a few minutes can lighten your stress and enable you to get back to work.
Play a mind game. “If there is no way to speak to someone else and you need comfort in the moment, imagine talking to someone who loves you,” says Dr. Goulston. “Imagine that they are listening and lovingly holding and encouraging you. As you hear them talking and walking you through it, you will feel their love and belief in you. This kind of mental pep talk can be a bridge until you are able to speak your feelings to somebody in person.”
Head outdoors for a few minutes. If at all possible, try to get outside for a few minutes of fresh air. Take deep breaths, stretch your arms and legs, and take in the gifts of nature around you. And if possible, find someone else who is on a break and invite them for a 10-minute walk so the two of you can blow off steam.
Don’t just turn to these strategies when you feel stress or anxiety rising in your mind or body. Intentionally practice them daily—even if you are feeling calm and in control. Stress management is a skill you must work at until it becomes a natural part of your life.
“Managing stress is a key to resilience and a valuable life skill,” concludes Dr. Hendel. “If you can learn to control your stress levels during a pandemic, you will be more than prepared to meet and conquer other challenges further down the road.”
# # #
About the Authors: Mark Goulston, MD, FAPA Dr. Mark Goulston is the coauthor of Why Cope When You Can Heal?: How Healthcare Heroes of COVID-19 Can Recover from PTSD (Harper Horizon, December 2020) and Trauma to Triumph: A Roadmap for Leading Through Disruption and Thriving on the Other Side (HarperCollins Leadership, Spring 2021). He is a board-certified psychiatrist, fellow of the American Psychiatric Association, former assistant clinical professor of psychiatry at UCLA NPI, and a former FBI and police hostage negotiation trainer. He is the creator of Theory Y Executive Coaching—which he provides to CEOs, presidents, founders, and entrepreneurs—and is a TEDx and international keynote speaker.
He is the creator and developer of Surgical Empathy, a process to help people recover and heal from PTSD, prevent suicide in teenagers and young adults, and help organizations overcome implicit bias.
Dr. Goulston is the author or principal author of seven prior books, including PTSD for Dummies, Get Out of Your Own Way: Overcoming Self-Defeating Behavior, Just Listen: Discover the Secret to Getting Through to Absolutely Anyone, Real Influence: Persuade Without Pushing and Gain Without Giving In, and Talking to Crazy: How to Deal with the Irrational and Impossible People in Your Life. He hosts the My Wakeup Call podcast, where he speaks with influencers about their purpose in life and the wakeup calls that led them there. He also is the co-creator and moderator of the multi-honored documentary Stay Alive: An Intimate Conversation About Suicide Prevention.
He appears frequently as a human psychology and behavior subject-area expert across all media, including news outlets ABC, NBC, CBS, and BBC News, as well as CNN, Today, Oprah, the New York Times, the Wall Street Journal, Forbes, Fortune,Harvard Business Review, Business Insider, Fast Company, Huffington Post, and Westwood One. He was also featured in the PBS special “Just Listen.”
Diana Hendel, PharmD Dr. Diana Hendel is the coauthor of Why Cope When You Can Heal?: How Healthcare Heroes of COVID-19 Can Recover from PTSD (Harper Horizon, December 2020) and Trauma to Triumph: A Roadmap for Leading Through Disruption and Thriving on the Other Side (HarperCollins Leadership, Spring 2021). She is an executive coach and leadership consultant, former hospital CEO, and author of Responsible: A Memoir, a riveting and deeply personal account of leading during and through the aftermath of a deadly workplace trauma.
As the CEO of Long Beach Memorial Medical Center and Miller Children’s and Women’s Hospital, Hendel led one of the largest acute care, trauma, and teaching hospital complexes on the West Coast. She has served in leadership roles in numerous community organizations and professional associations, including chair of the California Children’s Hospital Association, executive committee member of the Hospital Association of Southern California, vice chair of the Southern California Leadership Council, chair of the Greater Long Beach Chamber of Commerce, board member of the California Society of Health-System Pharmacists, and leader-in-residence of the Ukleja Center for Ethical Leadership at California State University Long Beach.
She earned a BS in biological sciences from UC Irvine and a Doctor of Pharmacy degree from UC San Francisco. She has spoken about healthcare and leadership at regional and national conferences and at TEDx SoCal on the topic of “Childhood Obesity: Small Steps, Big Change.”
About the Book: Why Cope When You Can Heal?: How Healthcare Heroes of COVID-19 Can Recover from PTSD (Harper Horizon, December 2020, ISBN: 978-0-7852-4462-2, $17.99) is available in bookstores nationwide and from major online booksellers.
Incyte and MorphoSys Announce Acceptance by Health Canada of the New Drug Submission for Tafasitamab
MONTREAL and PLANEGG/MUNICH, Germany, Jan. 12, 2021 /CNW/ - Incyte (NASDAQ: INCY) and MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) today announced that Health Canada has accepted the New Drug Submission (NDS) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT).
"With the acceptance of the NDS by Health Canada, review of the data can begin, an important step on the path to making tafasitamab available in Canada for use in combination with lenalidomide in eligible patients with relapsed or refractory DLBCL," said Josée Brisebois, Ph.D., Head of Medical Affairs, Incyte Biosciences Canada. "We intend to work closely with Health Canada as we seek to bring this innovative targeted therapeutic option to the clinical community and to appropriate patients for whom few treatment options exist."
"This important milestone moves tafasitamab in combination with lenalidomide into the regulatory review process in Canada, with the potential to significantly advance patient care in the treatment of relapsed or refractory DLBCL," said Nuwan Kurukulasuriya, Ph.D., Senior Vice President Global Medical Affairs, MorphoSys.
The NDS, submitted by Incyte, is based on data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL not eligible for autologous stem cell transplant, and is supported by the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL.
Incyte has exclusive commercialization rights for tafasitamab outside of the United States and, if approved, Incyte will hold the marketing authorization for tafasitamab in Canada. This NDS marks the second marketing application that Incyte Biosciences Canada has made to Health Canada since establishing operations in Canada in April 2020.
About Diffuse Large B-cell Lymphoma (DLBCL) DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide1, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter2, leading to a high medical need for new, effective therapies3, especially for patients who are not eligible for an autologous stem cell transplant in this setting.
About L-MIND The L-MIND trial is a single arm, open-label, multicentre Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy or refuse subsequent autologous stem cell transplant The study's primary endpoint is Overall Response Rate (ORR). Secondary outcome measures include Duration of Response (DoR), Progression-Free Survival (PFS) and Overall Survival (OS). In May 2019, the study reached its primary completion.
About RE-MIND RE-MIND, an observational retrospective study (NCT04150328), was designed to isolate the contribution of tafasitamab in combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys' L-MIND trial. RE-MIND collected the efficacy data from 490 relapsed or refractory DLBCL patients in the U.S. and EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible RE-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective Response Rates (ORR) were validated based on this subset of 76 patients in RE-MIND and L-MIND, respectively. The primary endpoint of RE-MIND was met and shows a statistically significant superior best ORR of the tafasitamab-lenalidomide combination compared to lenalidomide monotherapy.
About Tafasitamab Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).
In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Following approval by the U.S. Food and Drug Administration in July 2020, tafasitamab is being co-commercialized by MorphoSys and Incyte in the United States. Incyte has exclusive commercialization rights outside the United States.
Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.
XmAb® is a registered trademark of Xencor, Inc.
The safety and efficacy of tafasitamab is under review and the market authorization in Canada has not yet been obtained.
About Incyte Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.
About MorphoSys MorphoSys (FSE & NASDAQ: MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya®, developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of MorphoSys' proprietary product Monjuvi® (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma.
Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has more than 600 employees. More information at www.morphosys.com or www.morphosys-us.com.
Monjuvi® is a registered trademark of MorphoSys AG.
Tremfya® is a registered trademark of Janssen Biotech, Inc.
Incyte Forward-looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether or when tafasitamab might be approved in Canada for the treatment of, and whether or when tafasitamab might provide a successful treatment option for, in combination with lenalidomide, certain patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), and the L-MIND and RE-MIND clinical trial programs. These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by Canadian regulatory authorities or other regulatory authorities, including the U.S. FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ending September 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.
MorphoSys Forward-looking Statements This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.
1 Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:209–16. doi.org/10.1016/j.beha.2018.07.014.
2 Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253–265. doi.org/10.3747/co.26.5421.
3 Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253–265. doi.org/10.3747/co.26.5421.
SOURCE Incyte Biosciences Canada
For further information:
Incyte: Media Contacts: Catalina Loveman, Executive Director, Public Affairs, Tel: +1 302 498 6171, cloveman@incyte.com; Jenifer Antonacci, Senior Director, Public Affairs, Tel: +1 302 498 7036, jantonacci@incyte.com; Investor Contacts: Dr. Michael Booth, Division VP, IR & Global Responsibility, Tel: +1 302 498 5914, mbooth@incyte.com; Christine Chiou, Senior Director, Investor Relations, Tel: +1 302 274 4773, cchiou@incyte.com; MorphoSys: Media Contacts: Thomas Biegi, Vice President, Tel.: +49 (0)89 / 89927 26079, thomas.biegi@morphosys.com; Jeanette Bressi, Director, US Communications, Tel: +1 617 404 7816, jeanette.bressi@morphosys.com; Investor Contact: Dr. Julia Neugebauer, Senior Director, Investor Relations, Tel: +49 (0)89 / 899 27 179, julia.neugebauer@morphosys.com; Myles Clouston, Senior Director, Investor Relations, Tel: +1 857 302 7575, miles.clouston@morphosys.com
Multi-Cultural Channel for Youth on YouTube collaborates with world’s leading ebook app to offer youth both an audience and the opportunity to learn modern literacy skills for a changing world.
NEW YORK (PRWEB) JANUARY 12, 2021
Questions around shrinking attention spans have been a popular area of research, but is it about quantity or is it about quality?
Over 100 million ebooks have been created using Book Creator’s worldwide app, making it one of the essential apps for schools everywhere using iPads. Now Book Creator (No. 1 on the iTunes App Store in 90+ countries) is launching its first Write a Story in One Page which the Planet Classroom Network will feature on its YouTube Channel to build more awareness for original stories authored by youth.
“We have the privilege of presenting Book Creator as a curator on our platform,” says co-founder and author C.M. Rubin (Cathy). In an age when the average human attention span is rapidly decreasing, we loved the concept of a youth story-telling challenge in just one page. Learning the skills to make story-telling more innovative, entertaining, engaging and relevant to a changing world will help youth build confidence and sharpen their communication and critical-thinking skills.”
“We are very excited to be associated with Planet Classroom in this brilliant initiative. Literacy is such an important skill, but we know that a lot of kids today are not motivated to write. We believe that's because they don't have an audience for their writing,” noted Dan Kemp, Marketing and Community Manager Book Creator.
The Planet Classroom Network, organized by CMRubinWorld, brings together musicians, dancers, video game creators, filmmakers, learning innovators and emerging technologists from all over the world to entertain, educate and engage youth, and to provide a rich cultural experience at a time when art and learning institutions everywhere are not accessible. Curators and content contributors include Global Nomads, Global Oneness, the Martha Graham Dance Company, Commffest, KIDS FIRST!, Dream a Dream Foundation, OddWorld Inhabitants, Psyon Games, Challenge 59, LXL Ideas, Alliance for Young Artists & Writers/Scholastic Art & Writing Awards, Creative Visions Foundation, Battery Dance, SIMA Classroom, Young Voices for the Planet, Bard Conservatory, Taking It Global, Materials for the Arts, Book Creator, XTalks, NFFTY, Young People’s Chorus of New York City, The International Forum for the Literature and Culture of Peace, Ryan Wong Classroom, The Global Search for Education, Voice America, Rocketium and Brandartica. Young people from around the world played a significant role in conceptualizing, creating, and producing the network’s vision and programming.
The Fertility Partners Welcomes Another IVF Centre to its Growing Network, The Toronto Institute For Reproductive Medicine, and Acquires Sperm Bank ReproMed
The rapidly growing partnership of leading fertility clinics expands its Ontario presence
TORONTO, Jan. 13, 2021 /CNW/ - The Fertility Partners ("TFP"), Canada's leading platform of fertility practices, announced today the acquisition of The Toronto Institute For Reproductive Medicine (TTIRM) and ReproMed. With the west-end Greater Toronto Area (GTA) fertility treatment providers joining its network of partner clinics, TFP has expanded its presence in the GTA to 5 locations and expands its high-quality Canadian donor sperm services.
The Fertility Partners launched in 2019 and continues to solidify its commitment to being the business partner of choice with Clinicians and Researchers, making it the fastest-growing network offering comprehensive fertility treatment and associated services in the country. The network delivers all aspects of reproductive medicine, a wide range of laboratory diagnostics, and is supported by world-renowned Physicians, Research Scientists, Embryologists and Andrologists. Since July 2020, the combined group of companies has grown to 9 clinics with full IVF laboratories, across 21 locations in 5 provinces.
As a world-class business partner of choice for leading fertility centres across North America, The Fertility Partners aims to support its partner clinics by collaborating on medical, strategic and operational best practices, investing in new technologies, promoting research and development, and offering synergistic back-office support. The TFP partner model empowers physicians and their teams to focus on what they do best – provide the highest quality medicine and patient-focused fertility care.
"Dr. Alfonso Del Valle and his team are highly dedicated to providing optimal clinical outcomes and compassionate patient care," says Dr. Andrew Meikle, TFP Founder, CEO & Executive Chairman. "With values well-aligned with TFP, TTIRM and ReproMed will undoubtedly have a positive impact on our collective goals to foster global best clinical outcomes, achieve an international reputation for excellence, and deliver exceptional patient and employee experiences."
Since 1990, the TTIRM team has been committed to continuous innovation and research into the most effective new procedures and technologies available in infertility treatment, which has helped thousands of couples fulfill their dream of having a family.
"The Toronto Institute for Reproductive Medicine and ReproMed teams are excited for the opportunity to build on our decades-long success in delivering excellent patient care, and to partner with other leading fertility care providers and centers" says Dr. Alfonso P. Del Valle, MD FRCS(C), TTIRM and ReproMed founder and Medical Director. "By joining the TFP network, we look forward to furthering our ability to provide patients both local and international with world-class services and experiences."
"With the strong leadership of Dr. Del Valle, the TTIRM and ReproMed teams have built an admired practice known for its high pregnancy success rates and internationally-recognized research achievements.," says Dr. Al Yuzpe, Chief Medical Officer at TFP. "We're proud to welcome them to the TFP network where they will be a valued contributor to our collective goal of expanding services and elevating the experience of fertility care for patients."
About The Fertility Partners
The Fertility Partners ("TFP") is a new venture creating a network of fertility clinics across North America. The combined group of companies includes 9 clinics and 21 locations across 5 Canadian provinces, with further growth to include additional IVF clinic acquisitions, de novo clinics and the development of adjacent services. The company aims to be a world-class business partner of choice for leading IVF and prenatal practitioners with the goal of achieving best clinical outcomes, operational excellence and exceptional patient experiences. TFP provides partner clinics with back-office support and a collaborative, synergistic medical-scientific, professional and business environment. www.thefertilitypartners.com
About The Toronto Institute For Reproductive Medicine and ReproMed
The collective mission of The Toronto Institute For Reproductive Medicine (TTIRM) and ReproMed is to provide the highest quality of compassionate and comprehensive health care services for the treatment of male and female infertility. Since 1990, the physicians and professional staff at TTIRM and ReproMed have been committed to providing cutting-edge reproductive technology and surgical techniques, and have helped thousands of couples fulfill their dreams of becoming parents. TTIRM and ReproMed are at the forefront of reproductive sciences, with high pregnancy success rates and internationally-renowned research achievements. The TTIRM and ReproMed facility is located in the west-end of the Greater Toronto Area (GTA). www.repromed.ca
SOURCE The Fertility Partners
Health Canada Approves IMBRUVICA®* (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)
Patients aged 70 or younger with previously untreated CLL lived longer without disease progression compared to patients treated with FCR, a chemoimmunotherapy regimen
TORONTO, Jan. 13, 2021 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).i Today's milestone marks the tenth Health Canada approval for IMBRUVICA® across five disease areas and is the fifth approval for IMBRUVICA® in CLL.ii
This latest approval is based on the Phase 3 ECOG1912 study (also referred to as E1912) that demonstrated newly diagnosed patients age 70 or younger (median age of 58) treated with IMBRUVICA® plus rituximab had significantly improved progression-free survival (PFS) compared to patients treated with fludarabine, cyclophosphamide and rituximab (FCR). iii The risk of disease progression or death was reduced by 66 per cent in the IMBRUVICA® arm compared with FCR, with a median follow-up time of 37 months.iv
"For younger patients, chemoimmunotherapy is a common first-line treatment," says Dr. Matthew Kang*, Hematologist, Joseph Brant Hospital Oncology Clinic, Assistant Clinical Professor, McMaster University. "With this new indication for IMBRUVICA®, we have entered a new treatment era, one that is targeted, chemotherapy-free, and shown to help patients live longer without disease progression."
This approval was granted under a modified version of the newly established Project Orbis, an initiative of the FDA Oncology Center of Excellence, which provides a framework for submission and review of oncology medicine applications among international regulatory agencies.v This initiative gives international regulators the ability to provide patients with cancer earlier access to important medicines.vi
"We commend the ECOG-ACRIN Cancer Research Group and the National Cancer Institute for conducting a robust study that has generated insightful and landmark results in the treatment of CLL," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "We are committed to the continued study of IMBRUVICA-based regimens and building upon the efficacy and safety of the most comprehensively studied Bruton's tyrosine kinase (BTK) inhibitor in our efforts to improve the lives of patients facing a blood cancer diagnosis."
About the ECOG1912 Study The randomized, multi-centre, open-label, controlled Phase 3 E1912 study was designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute, part of the National Institutes of Health in the United States.vii
The study evaluated 529 previously untreated CLL patients ages 70 years or younger (median age of 58) who were randomly assigned to receive IMBRUVICA® plus rituximab (n=354) or the chemoimmunotherapy FCR (n=175) and the primary endpoint was PFS as assessed by an independent review committee, according to the International Workshop on CLL.viiiWith a median follow-up time on study of 37 months, a PFS benefit was observed for the IMBRUVICA® plus rituximab arm as compared to the FCR treatment arm (hazard ratio [HR], 0.34; 95 per cent confidence interval [CI], 0.22-0.52; p<0.0001).ix With a median follow-up time of 49 months, median overall survival was not reached with a total of 23 deaths: 11 (3 per cent) in the IMBRUVICA® plus rituximab arm and 12 (7 per cent) in the FCR treatment arm.x
The most commonly occurring adverse reactions in studies of CLL patients treated with IMBRUVICA® (≥20%) were neutropenia, diarrhea, fatigue, musculoskeletal pain, rash, thrombocytopenia, anemia, bruising, nausea, hemorrhage, cough, pyrexia, arthralgia, headache, upper respiratory tract infection and hypertension.xi
About Chronic Lymphocytic Leukemia (CLL) CLL is a cancer that begins in blood stem cells, starting in abnormal lymphoid stem cells. It usually develops slowly over the course of months or years.xii In 95 per cent of cases, the abnormal lymphoid stem cells develop into cancerous, or malignant, B lymphocytes. CLL is one of the most common types of leukemia in adults.xiii Over 2,200 people in Canada are diagnosed with CLL each year.xiv
About IMBRUVICA® IMBRUVICA® contains the medicinal ingredient ibrutinib which is a targeted inhibitor of Bruton's tyrosine kinase (BTK), and it is the only once-daily BTK inhibitor in Canada. Ibrutinib blocks BTK activity, inhibiting cancer cell survival and spread.xv
IMBRUVICA® was first approved in Canada in 2014. It is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL),xvi including those with 17p deletion; or adult patients with CLL who have received at least one prior therapy, including those with 17p deletion.xvii It is indicated in combination with bendamustine and rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and in combination with obinutuzumab for treatment-naïve adult patients with CLL.xviii It is now also indicated in combination with rituximab for the treatment of adult patients with previously untreated CLL.xix
For adult patients with Waldenström's macroglobulinemia (WM), IMBRUVICA® is indicated as a single agent or in combination with rituximab.xx Other indications are for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL); patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy; and for patients with steroid dependent or refractory chronic graft-versus-host disease (cGVHD).xxi
IMBRUVICA® is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics LLC, an AbbVie company. Janssen Inc. commercializes IMBRUVICA® in Canada.
About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com/canada. Follow us at @JanssenCanada. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson.
*All trademark rights used under license.
**Dr. Kang was not compensated for any media work. He has been compensated as a consultant.
Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding IMBRUVICA® (ibrutinib). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Inc., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
_______________________________
i IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. December 15, 2020
ii IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. December 15, 2020
iii IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. December 15, 2020
iv IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. December 15, 2020
xv IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. December 15, 2020
xvi IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. December 15, 2020
xvii IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. December 15, 2020
xviii IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. December 15, 2020
xix IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. December 15, 2020
xx IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. December 15, 2020
xxi IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. December 15, 2020
SOURCE Janssen Inc.
CARDIO SPORTAnnounces Livestream Event Series Kicking off on Friday, January 29thFeaturing Ryan Key of Yellowcard & Derek Sanders of Mayday Parade Register Now
January 13, 2021 – The Workout of Sports™ brought to you by Cardio Sport®, is the most fun, dynamic and innovative fitness training program that both novices and gurus will ever experience. The brand is excited to announce their next few virtual workout events in their virtual Workout Event Series. Kicking off later this month, the series will feature co-band-led workouts events designed to get participants motivated and moving – from the comfort of their own homes. The first event will take place on Friday, January 29th at 8pm ET, featuring special guests Ryan Key of Yellowcard and Derek Sanders of Mayday Parade, whom will co DJ the event and hang out for a post workout fan chat. Ryan shares: “When I heard about Cardio Sport’s method of using rock music to inspire workouts, I knew I wanted to be involved. I’m always looking for new ways to change up my own exercise routine, and I think this program will be super fun for fans of rock and pop punk music. It’s a nice change from the same old gym experience.” Registration is now open for $11 per ticket here. $1 per ticket will be donated to MusiCares. Cardio Sport will continue rolling out their live events over the next few months. Details to be announced soon. Cardio Sport utilizes innovative compound, sports related, total body movements combined with a one of kind music driven exercise environment to effectively achieve ANY fitness goal. The company is headquartered in Massachusetts, but has programs all over the nation in college recreation centers, health clubs and YMCAs through their licensing program. As of January 1, 2021, they launched their brand new On Demand Workout platform that features all of the best of pop punk and alt rock. For just $14.99 per month, subscribers are given access to Cardio Sport’s workout database. There they can follow along with on demand workouts categorized by sport (soccer, basketball, football, hockey, or multisport), set to songs from pop punk artists including State Champs, Yellowcard, Sense Fail, Sum 41, Mayday Parade, Silverstein, We the Kings, Falling in Reverse, ADTR, ATL and more. Many of the bands will also begin to be featured in the system over the coming months, building an exciting and unique platform for users. For more information or to sign up, please visit: https://cardiosportondemand.vhx.tv/Follow Cardio Sport:https://www.instagram.com/cardiosport/https://twitter.com/cardiosportllchttps://www.facebook.com/cardiosportcs/WHO: Cardio Sport featuring Ryan Key & Derek Sanders WHEN: Friday, January 29th @ 8pm ETINFO: $11 per ticket, $1 per ticket donated to MusiCares LINK: https://cardiosport.veeps.com/stream/events/849e665d295d
Rheumatoid arthritis patients at heightened risk for life-threatening blood clot
VANCOUVER, BC, Jan. 13, 2021 /CNW/ - A new Arthritis Research Canada study reveals rheumatoid arthritis patients have an increased risk of cardiovascular disease after diagnosis compared to the general population.
Researchers specifically looked at the risk of venous thromboembolism (VTE) – a blood clot that starts in a vein and can travel to the lungs (pulmonary embolism or PE) and deep vein thrombosis (DVT) – a blood clot in the leg veins.
"These are serious cardiovascular events associated with increased mortality," said Dr. Antonio Aviña-Zubieta, a rheumatologist and senior scientist of rheumatology at Arthritis Research Canada.
Venous thromboembolism (which includes pulmonary embolism and deep vein thrombosis), represents a relatively common cardiovascular event that is associated with increased mortality and affects more than one in 1000 persons each year in the Western population.
The study found that VTE risk was the highest during the first year after RA diagnosis, then progressively declined but remained statistically significant even five years after diagnosis.
"These findings have important implications for clinical care, both immediately after a rheumatoid arthritis diagnosis and in long-term treatment as treating inflammation decreases the risk," Aviña-Zubieta said. "Clinicians should be aware that RA causes patients to have a higher risk not only of heart attacks and strokes, but also VTE, particularly in the period soon after diagnosis."
Rheumatoid arthritis is the most common form of autoimmune arthritis. It is a serious disease that occurs when the immune system mistakenly attacks healthy cells in the body. Inflammation caused by RA can damage joints and many other parts of the body. Approximately 374,000 Canadians over the age of 16 live with rheumatoid arthritis.
To read the full research paper, please click here.
ABOUT ARTHRITIS RESEARCH CANADA:
Arthritis Research Canada is the largest clinical arthritis research institution in North America. Our mission is to transform the lives of people living with arthritis through research and engagement. Arthritis Research Canada's scientific director, Dr. Diane Lacaille is leading a team of over 100 researchers, trainees and staff whose world recognized research is creating a future where people living with arthritis are empowered to triumph over pain and disability. Arthritis Research Canada is conducting research across Canada in British Columbia, Alberta and Quebec and is affiliated with five major universities: University of British Columbia, Simon Fraser University, University of Calgary, Université Laval, and McGill University. Arthritis Research Canada is leading research aimed at arthritis prevention, early diagnosis, new and better treatment, and improved quality of life.
Salvation: It Should Not Be Complicated or Confusing
Dallas, TX, January 11, 2021— “What do I have to do to be saved?” is the Christian faith’s most important question and one that Lucas Kitchen started asking as a young boy. It should have been an easy question to answer, though no one in the piney woods seemed to agree what that simple answer should be. Despite growing up in the buckle of the Bible belt, confusion about the Christian faith plagued every step of Lucas’ journey.
In Naked Grace: A Quest For Clarity In A World Of Confusion, Lucas Kitchen uses wit, humor and visual storytelling to invite you to join his life-long quest for answers. This multi-decade pursuit took Lucas to some laugh-out-loud places. When the stakes were as high as they could be, the simple answer finally came.
The true-life story in Naked Grace explores the confusion that many Christians quietly experience on a weekly basis. As this book demonstrates: just because they are quiet doesn’t mean they get it. This self-deprecating tale will resonate with anyone who has wrestled with unanswered questions and is dying to know the truth.
One Verse Podcast host Jeremy Myers wrote, “If you have questions about eternal life, the message of the gospel, what it means to follow Jesus as a disciple, or how grace helps us defeat sin in our lives, read his book. I guarantee his story will resemble parts of your own and will help you ask questions and find answers about the Gospel.”
Lucas Kitchen is an Amazon bestselling author with over 20 books written. His writing has been seen and heard by millions, through viral videos, radio and books. Lucas' books have covered genres such as sci-fi, urban fantasy, memoir, biography, children's literature, Christian theology and more. In addition to his writing career, Lucas is a filmmaker, pastor and international speaker. He can also be heard weekdays on the syndicated radio show Grace in Focus. He holds a bachelor's degree in interdisciplinary studies in Bible, psychology and history/political science from Letourneau University. He has a Master of Theology from Liberty University. He lives in East Texas with his family.
Naked Grace: A Quest For Clarity In A World Of Confusion Publisher: Free Grace International ISBN-10: 1661761119 ISBN-13: 978-1661761110 Available from Amazon.com
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Make ‘Go on a Diet’ Resolutions Obsolete with the Whole Person Integrative Eating Program
San Francisco, CA, January 11, 2021 — What if you never again need to make a New Year’s resolution to lose weight or “go on a diet” because your most-of-the-time way of eating empowers you to eat and weigh less? Original, pioneering research by holistic nutrition researcher Deborah Kesten, M.P.H., and behavioral scientist Larry Scherwitz, Ph.D.—authors of the award-winning Whole Person Integrative Eating: A Breakthrough Dietary Lifestyle to Treat the Root Causes of Overeating, Overweight, and Obesity—reveals that replacing the complex reasons you overeat— called“overeating styles”—with the scientifically sound Whole Person Integrative Eating (WPIE) dietary lifestyle (meaning, WPIE is a way of life; it’s not a traditional diet) may make weight-loss resolutions obsolete.
“Now is the time to ‘reset’ and rethink what and how we eat; to replace traditional dieting with a scientifically sound way of eating that lessens overeating and that leads naturally to weight loss, health and healing,” says Kesten.
Kesten and Scherwitz share a simple yet powerful premise: Identify the reasons you overeat (your overeating styles) and gain weight—with the illuminating self-assessment quiz—then overcome overeating and lose weight by replacing your overeating styles with the antidotes: the elements of the Whole Person Integrative Eating program.
By shedding light on the root causes of overeating, Kesten and Scherwitz present a program that empowers readers with a personalized plan, and in turn new hope and new choices to help them reduce overeating, lose weight and keep it off.
WPIE is not a diet that a person goes on … then off. It is a scientifically sound, dietary lifestyle designed to be practiced for a lifetime.
"If people follow the revolutionary program outlined in this game-changing, insightful book, it may be the most helpful step they can take toward losing weight and keeping it off," says bestselling author Kenneth Pelletier, M.D., Ph.D., clinical professor of medicine at University of California School of Medicine, San Francisco.
The authors’ paradigm-shifting message is that food influences not only the physical dimensions of health, but also our emotional, spiritual and social well-being. Their dietary lifestyle can build bridges between the millions who struggle with overeating and weight issues and the medical community. And it can inspire us all to re-envision our relationships with food, eating and weight, so that each time we eat, we are nourished … for life.
Deborah Kesten, M.P.H.,is an international nutrition researcher, award-winning author and health journalist, with a specialty in preventing and reversing obesity and heart disease. She is also an experienced, expert speaker and presenter—from TV and podcast interviews to large conferences and small-group workshops.
Kesten served as Nutritionist on Dean Ornish, M.D.’s first clinical trial for reversing heart disease through lifestyle changes, the results of which were published in the Journal of the American Medical Association. She was Director of Nutrition at cardiovascular clinics in Europe and on the Board of Directors of the American Heart Association, San Francisco.
Kesten has published more than 400 nutrition and health articles. Her first book, Feeding the Body, Nourishing the Soul, received the first-place gold award in the Spirituality category from the Independent Publisher Book Awards. Whole Person Integrative Eating has been honored with the No.1 gold, best-book award in the Health category by Book Excellence Awards and is a No. 1 Amazon best seller. Kesten is a VIP Contributor at Arianna Huffington’s Thrive Global, and is married to behavioral scientist and co-author of Whole Person Integrative Eating, Larry Scherwitz, Ph.D.
Powerful True Story Inspires Others to Seek Adventure, Turn Each Day into a Gift
Fort Wayne, IN, January 11, 2021 — Brittany Moser’s short life was not defined by how she died, but rather, by how she lived each day to the fullest and the profound impact she had on those around her. Brittany died from a rare condition, Addison’s disease, in 2017 at the age of 32. She had been a happy-go-lucky flight attendant, soaring high above reality, when her diagnosis suddenly brought her down to earth.
Rather than buckle under the weight of fear, she chose to be fearless and embarked upon the adventure of a lifetime with her best friend — her father. Free and Fearless: The Amazing Impact of One Precious Lifeis Brittany’s unforgettable story as told by her father, Philip Moser.
“This book is not about the grief of losing a child, but about making the most out of what we are given and living our lives positively and not out of fear,” Moser writes. “Brittany inspired me, an ordinary farm boy, to explore life, to climb mountains and to write a book.”
Free and Fearless is an honest, poignant account of Brittany’s legacy and the ripple effect that her outlook on life had on everyone who knew her. Philip hopes that by hearing her story, readers will be inspired by Brittany’s contagious spirit and unwavering desire for new adventures and experiences — even in the shadow of an incurable illness.
Among Brittany’s valuable life lessons that Philip shares with readers are:
1. How precious life is and how we can affect the people around us; 2. How an open mind and a positive attitude can inspire us to do things we never thought possible; 3. How to move out of our comfort zones and into a challenging existence that can turn each day into an exciting gift to be explored; 4. How to not let fear control us, and to use our abilities to seek unique, positive and inspiring adventures; 5. To embrace change as a natural part of life; 6. And finally, that we won’t be remembered by our things or our savings accounts, but by how we made other people feel.
“I want to share the same inspiration that I received for 32 years,” Philip added. “In the end, love truly does conquer all, and Brittany wanted us to know that.”
Author Philip Moser grew up on a farm in Angola, Indiana. After high school, he began working in different aspects of the grocery business, a career that continues to this day. He and his wife, Marilyn Wells, raised two incredible daughters, Camille and Brittany.
