Biotechnology Awards 2022

16 GHP / Biotechnology Awards 2022 Feb22407 ExquisiteBiomedical Consulting (EBC) is a boutique-stylemedical affairs consultingfirm based inVancouver, BC, Canadawith roots inSanAntonio, TX, USA. The company is led byphysician ShabnamVaezzadeh, whohas extensive experience in thisfield in corporate and consulting capacities. She is joined by expert clinicians, biostatisticians, and reimbursement professionals tobest serve the needs of clients as required. Best Clinical & Economical Evidence Generation Consulting Firm 2022 A tremendous amount of innovation occurs in academia and the medical industry, where businesses develop medical products to improve the lives of populations and produce favourable clinical and economic outcomes. Exquisite Biomedical Consulting delivers consulting to these entities, with typical clients including funded medical device, regenerative medicine , and pharmaceutical companies who either have not convened their own medical affairs teams yet, or need experts to augment their manpower. EBC CEO, Shabnam Vaezzadeh, MD, MPA, BCMAS, through leading large medical and clinical affairs teams in established corporations, believes in the power of medical affairs, when well executed, in establishing support and advocacy for medical products and overall company brands. As the liaison between the company and the medical community, Medical affairs is in a unique position to communicate the merits of the products and build peer to peer collaborative initiatives with healthcare professionals, within compliance guardrails, and without ties to generating revenue. EBC helps innovators and manufacturers with critical considerations as they are approved by regulatory bodies, covered by private and government insurers, and further included in the formulary of healthcare institutions--with the hope they will be utilized safely and effectively and received well by patients and caregivers. Gaining acceptance with stakeholders and addressing their inquiries requires thoughtful generation and communication of clinical and economic evidence. Educational and marketing communications should be founded on evidence-based scientific platforms. In the absence of such a foundation, many innovative products have failed in the marketplace, depriving patients of the benefits and the companies from the successes they would have experienced. The strategy for evidence generation involves understanding the requirements and timelines of stakeholders and geographies, identifying gaps in existing evidence, selecting an appropriate level of evidence, designing studies, partnering with field experts, securing budgets, selecting journals for publication, and specifying appropriate forums for presenting the data. Types of clinical studies include phase I-IV studies, randomised clinical trials (RCT) to case series, and prospective and retrospective studies collecting clinical and economic data. Also, secondary analysis of existing data sets, evaluating real world evidence, systematic reviews, and metaanalysis of published literature can help establish safety, efficacy, and economic outcomes of medical products. Generating and utilizing evidence at the appropriate phase of product lifecycle, communication and preparation of an evidence-based scientific platform to support the products are within the expertise of Exquisite Biomedical Consulting. In one client case, EBC worked with a medical company that had acquired a new product quite effective in clinical use. However, adequate evidence was not available to solidify reimbursement with private payers or push for market adoption. EBC reviewed the company’s existing data and customer experience, including case studies, pilot studies, presented posters and abstracts. It also reviewed the timelines and requirement of payers, alongside questions and concerns expressed by potential customers. An RCT was needed by private payers for reimbursement. A study was designed that would capture clinical data, as well as economically related data points such as impact on length of stay, rate of complications, and rate of and time to achieve treatment goals. This study, once completed, demonstrated not only the clinical efficacy but also the value provided by the product, versus its cost across total cost of care for patients. As the longer timeline of an RCT would not accommodate the shorter-term needs for customer introductions, a post-market study was also designed to collect real world evidence on use of the product by institutions who had long-standing experience with the product. EBC has been recognized with the Biotechnology Awards 2022 based on its extensive expertise, dedication to improving patients’ lives and meeting the needs of the medical community through generation and communication of evidence. Now looking towards a bright future, the company remains focused on building long-term relationships with clients. Having spent five years doing so in the US and establishing a footprint in Canada as of 2021, the company is looking forward to extending its service to clients globally. Company: Exquisite Biomedical Consulting Contact: Shabnam Vaezzadeh, MD, MPA, BCMAS Email: [email protected] Website: Exquisite Biomedical Consulting