Worldwide Clinical Trials LLC

In the survey, 80% of respondents no longer favoured the ‘one-stop shop’ model of large CROs. Image credit: Shutterstock / Sai Thaw Kyar. Pharma and biotechs have shared concerns about working with large CROs, saying that the ‘one-stop shop’ model is no longer a cost-effective business model. CRO Worldwide Clinical Trials conducted a survey that asked pharma and biotech companies for their thoughts on both large and midsize CROs. The industry has been rocky for some time, with Covid-19 having a big impact on outsourcing relationships. In the survey, nearly 80% of respondents felt the ‘one-stop-shop’ claim of large CROs is not a cost-effective business model and 50% of respondents said that the instability of large CROs had impacted their willingness to partner due to project team disruptions, lack of access to top talent, poor service delivery, and more. Other concerns raised by respondents included lack of personalised attention (75%), apprehension about high development costs (71%) and team disruptions within the CRO impacting turnaround times (70%). Meanwhile, the survey found that midsize CROs are seen more favourably, citing agility (83%), personalised attention (79%), and access to senior-level scientific and medical expertise (80%) as reasons why they prefer to work with them. See Also: LCAR-G08 by Legend Biotech for Pancreatic Cancer: Likelihood of Approval Worldwide Clinical Trials CEO Peter Benton said that sponsors are looking for transparent communication, responsiveness, flexibility, and proactive personalised attention. “Customers don’t want to be treated like just a number. Some of them have only one asset and they need to be treated like they are our only customer. They want true partnerships, including regular access to and assurance from our senior leaders and scientific experts,” said Benton. “Clinical research is moving fast into new areas – and emerging to midsize biotechs need our collective experience. They also need a CRO partner that is flexible – one that is willing and able to adapt when needed – and one that they can have confidence in.” The data also revealed that there is due to be a shift of 41% to 46% (net gain of 5%) from large to midsize CROs over the next three years. Samir Shah, principal of Shah Pharma Consulting Services, said that the findings by Worldwide Clinical Trials are supported by a McKinsey & Company report that includes data from the biotech segment and provides insights on how CROs can improve their partnership models.

NEW YORK, April 6, 2021 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient focused biopharmaceutical company, announced that it has engaged Worldwide Clinical Trials ("Worldwide"), a full-service Contract Research Organization ("CRO") for its upcoming Phase 2a dose ranging clinical trial of HT-001 for treatment of cutaneous toxicities associated with EGFR inhibitor therapy for cancer patients. Worldwide is a midsized, full-service, global CRO founded by physicians committed to advancing medical science. From early phase and bioanalytical sciences through late phase, post-approval, and real-world evidence, the company offers expertise in oncology, neuroscience, cardiovascular, metabolic disease, and rare diseases. Worldwide manages clinical trials in more than 60 countries throughout North America, Latin America, Europe, Russia, and Asia Pacific. "We are excited to bring on a high-caliber partner in Worldwide, which has extensive expertise in managing clinical studies to the highest of standards, as the CRO for Hoth's upcoming Phase 2a HT-001 clinical trial for cancer patients," commented Robb Knie, CEO of Hoth Therapeutics, Inc. "Engaging Worldwide is one of the key pieces of our preparation towards IND submission to FDA. We believe that with Worldwide's deep clinical experience, and through our achievements in drug development, we are optimally positioned for our upcoming Phase 2a clinical trial." Worldwide Clinical Trials' President and COO, Peter Benton, said, "From the beginning, the relationship between Hoth Therapeutics and Worldwide has exemplified state-of-the-art strategic program development. I speak on behalf of the scientific, medical and operational experts at Worldwide who express our personal and professional commitment to the success of Hoth's innovative clinical development program seeking to address the significant unmet clinical need represented by cutaneous disorders associated with EGFR inhibitors." Hoth's Phase 2a dose ranging clinical trial will investigate the efficacy and safety of varying dose strengths of HT-001 in comparison to placebo for treatment of cutaneous disorders (skin, nails, and scalp) associated with EGFR inhibitor therapy. The study will be conducted in cancer patients receiving EGFR inhibitors, inclusive of both small molecule and biologic drug classes. About Hoth Therapeutics, Inc. Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs. Hoth's pipeline development is focused to improve the quality of life for patients suffering from indications including atopic dermatitis, skin toxicities associated with cancer therapy, chronic wounds, psoriasis, asthma, acne, mast-cell derived cancers & anaphylaxis and pneumonia. Hoth has also entered into two different agreements to further the development of two therapeutic prospects to prevent or treat COVID-19. To learn more, please visit . Forward-Looking Statement This press release includes forward-looking statements based upon Hoth's current expectations which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current Coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole; our intellectual property; our reliance on third party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section entitled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. Investor Relations Contact: LR Advisors LLC Email: investorrelations@hoththerapeutics.com Phone: (678) 570-6791 Media Relations Contact: Makovsky Miriam Brito, Assistant Vice President Email: hoth@makovsky.com Phone: (914)-406-0435 Company Codes: NASDAQ-NMS:HOTH