Estefi Alvarez, Phd Email & Phone Number

San Francisco, Ca, Us

New York, Ny, Us

Bonn, De

New Haven, Ct, Us

Yale Ventures Entrepreneurs-in-Residence (EIRs) have deep operational experience and have gone through the process of turning new technologies to new businesses. Serve as an early “sounding board” for Yale innovators contemplating a new startup. In a logical, stepwise fashion, EIRs help frame both the risks and the benefits of starting a new company, asking relevant questions about everything from the science, to the business, to the market and helping faculty chart a successful path forward and explore additional fundraising opportunities. Directly contribute to PIs and Yale Ventures' team by bringing in hands-on expertise developing, launching and commercializing medtech & digital health platforms, as well as established network within industry and the investment community.

Framingham, Massachusetts, Us

As a Principal, Estefi successfully sourced, closed and executed a wide range of engagements with global companies (startups to strategically) delivering actionable recommendations and value by leading a variety of engagements e.g., go to market strategy, commercial due diligence, market landscape, opportunity assessment, market access strategy, commercial strategy & pricing.

Framingham, Massachusetts, Us

Framingham, Massachusetts, Us

As a seasoned strategic leader, drives client engagement for global Medtech and Pharma clients providing project leadership, domain and industry experience, and develops new business to support the growth and industry leadership of Alira's Global Market Access Practice (GMA). GMA is a multidisciplinary, global team focused on helping clients navigate the rapidly changing payer environment, and recommending actionable strategies to address complex evidence requirements and breakdown payer barriers to achieve optimal price and access. Areas of expertise include: healthcare economic and outcomes research (HEOR), value based pricing, reimbursement, market access strategies, value proposition development, value messaging, payer landscape & positioning, clinical strategy, regulatory strategy, KOL engagement and board development, licensing and potential partnership/strategics recommendations, commercial due diligence.Hands-on knowledge of global healthcare systems, regulations and reimbursement processes for devices and pharmaceuticals (USA, Europe) to inform and de-risk clients’ organic and inorganic strategies and deliver a roadmap for short and long term actionable recommendations and evidence generation milestones. Collaborates with internal and external stakeholders in order to plan, validate and execute value demonstration studies and data collection projects to generate required clinical and economic evidence that would drive adoption and meet payers’ expectations for reimbursement.Validates and refines product and service value propositions by leveraging insights uncovered through primary (Qualitative and Quantitative), secondary research activities, market/competitive research. Develops product specific value evidence strategies and communications by identifying health and economic outcomes research (endpoints) needed to be met in order to fulfill payers’ expectations and enable providers’ and patients’ adoption.

Marlborough, Ma, Us

For $3 billion, publicly traded women’s health medical devices company, played key role in multi-disciplinary science team translating clinical and global market insights into actionable corporate/business development and pipeline decisions.Led company’s entry, from concept to product development, into the adjacent market via an acquisition. Innovated in minimally invasive, image-guided bladder and uterine pathology solutions including prototype development. Completed due diligence and provided actionable recommendations that led to one direct distribution and three product development licensing deals. Advanced projects for two commercial tissue removal solutions, fibroids, biopsies, endometrial ablation, and both core and adjacent-space products in pelvic, uterine and urology sectors. As a key player in corporate decision-making, integrated business strategy, technical, clinical, regulatory, competitive market/revenue potential, and risk mitigation issues. Weighed organic versus external development options. Partnered with academic and clinical partners. Spearheaded and executed pre-clinical animal models, supported clinical trial executions and strategies for FDA pre-market approval submissions.Won recognition for corporate leadership potential as one of fewer than 1% of Hologic staff – most at vice president level – selected for prestigious leadership development program conducted by outside management consulting firm.

Marlborough, Ma, Us

As the only member of a 20-scientist multidisciplinary team focused on interventional breast health technologies, laid the foundation for the company’s profitable development of a full continuum of breast care solutions (diagnostic, treatment, surgical, post-operative), encompassing internal product development, company acquisitions and licensing deals.Drove research and business due diligence leading directly to later $125 and $80 million acquisitions of breast surgery marker (Focal Therapeutics) and digital specimen radiology (Faxitron Bioptics) companies. Identified, led due diligence and partnered on clinical trial for image-based biopsy implant technology from Germany’s Somatex, leading to development/distribution deal and commercial launch generating $5 million in annual revenue.Benchmarked Hologic’s portfolio against competitors’ to win corporate leadership support for targeted technology solutions for biopsies, implants, biomarker cancer diagnosis & monitoring and MRI-based platform in urology market. Presented pre-clinical model to FDA for Brevara automated X-ray guided breast biopsy system leading to 510(k) approval; and provided expert Brevera and Sertera (ultrasound-guided biopsy) launch/commercialization support.

Clemson, Sc, Us

At state-of-the-art Biomedical Innovation Campus, led Institutional Review Board (IRB)-sanctioned post-market surveillance program for total joint replacements. Built partnerships with two biotech companies on joint replacement projects.

Clemson, Sc, Us

Led team that developed/validated predictive test model to assess damage/failure of joint replacement components, improving industry and FDA guidelines. Also led DJO Surgical company-sponsored testing/report on knee replacement product that won FDA 510(k) approval. Built alliances with orthopedic surgeons and four hospital systems for academic research/clinical partnerships and new statewide Implant Retrieval System, as well as with Hospital of Special Surgery (NY) and UC Berkeley.

Marlborough, Ma, Us

For $9 billion, publicly traded manufacturer of devices for interventional medical specialties, led failure investigation and recommended design changes for new Endovations disposable endoscope product.

Phd, Bioengineering

Ms, Materials Science And Engineering

Bs, Engineering Science, Mechanical (Minor In Economics)