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Case Study: Delivering RUO & GMP LeukoPAC™ collections to Singapore

OrganaBio Case Study

INTRODUCTION The monoclonal antibodies (mAbs) daratumumab, and elotuzumab have been approved by the US Food and Drug Administration for treating multiple myeloma (MM) in 2015. Although clinical responses have been promising, most patients’ disease eventually progresses [1]. One of the potential anti-tumor mechanisms of mAbs in MM patients is antibody-dependent cellular cytotoxicity (ADCC) which is […]

The OrganaBio method for cultivation of a highly recallable leukapheresis donor pool

OrganaBio and its wholly-owned leukapheresis collection subsidiary, HemaCenter, have designed processes and procedures to curate and maintain a highly recallable donor pool. Access to robust, reliable cellular starting materials is critical to the success of a cell therapy program, and donor recallability is one of the largest challenges facing cell therapy developers who rely on […]

You Need Access to a Robust and Reliable Donor Pool

De-Risking the Path to Cell & Gene Therapy Commercialization Part 1: You Need Access to a Robust and Reliable Donor Pool   When cell and gene therapy researchers step into the lab each morning, we envision transforming what may be an early stage experiment into a clinical success. Therapeutics developers spend years working tirelessly to generate pre-clinical […]

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Andrew Larson

Project Manager

Andrew joins OrganaBio as a project manager with varied experience in project management, client relations, and process improvement.

Prior to OrganaBio, Andrew was a client relations manager for the cGMP nucleic acids business unit at Aldevron, coordinating and managing contracts at each stage of the contract lifecycle in support of cell and gene therapy program development. Andrew supported small- and large-scale biotechnology and pharmaceutical clients anywhere from pre-IND work through commercial supply chain establishment. Before Aldevron, Andrew was a project manager for the commercialization and business development department for Sanford Health, a worldwide hospital institution. At Sanford Health, Andrew helped manage medical device patent and prototype development efforts for employee innovations primarily in the cardiovascular, neurovascular, and software spaces. Andrew was also an engineer for Atirix Medical Systems and supported the buildout of automated analysis worksheets to streamline radiology department quality control procedures.

Andrew received his Bachelor of Science in Physics from Minnesota State University Moorhead and his Master of Science in Biomedical Engineering from the University of Minnesota. At the University of Minnesota, Andrew was part of the Center for Magnetic Resonance Research, assisting efforts to automate MRI dataset registration and workflow improvement.

Michael Dee

Associate Director, QC and Analytical Development

Michael Dee has spent the last 17 years researching the immune system. Initially studying the recombinant cytokine IL-2 and its role in T cell subset differentiation and function at the University of Miami. He also helped elucidate the lower level of TCR diversity of T regs required to prevent autoimmunity in mice. Michael also supported construction, cloning, production, purification, and testing both in vitro and in vivo a novel IL-2/IL2Rα complex currently under clinical development with BMS. Michael also was a member of the department of immunology’s program project delineating the effect of a novel Eg7GP96 heat shock protein vaccine on tumor immunity.

While at Immunity Bio (formerly Altor Biosciences), he helped to characterize over 20 novel drugs for immune modulation and treatment of cancer.  After Immunity Bio, Michael was a founding team member of HCW Biologics, where he continued his role in design and initial production and characterization of several novel biologics. He has experience with proof of principle experiments with the generation CAR-NK and CAR T cells. His research at HCW was highlighted by his discovery of a process using novel biologics to activate and expand CIML NK cells. The process and rights were sold to Wugen and is currently in Phase I clinical trials. He also is listed as an Inventor on patent number: US20210268022A1 on method of activating regulatory T cells.

Elice Campbell

Senior Cell Processing Specialist

Elice Campbell received her master’s degree in Bioengineering with a focus in tissue engineering and neurology from Florida Atlantic University and her bachelor’s in Neuroscience and Behavior also from Florida Atlantic University.

Before starting at OrganaBio, Elice worked as a donor eligibility specialist for Vivex biomedical where she developed insight into the world of biotechnology.

Meram Alamoudi

Senior Cell Processing Specialist

Meram received her master’s degree in biomedical sciences from Barry University and bachelor’s in Biology from Palm Beach Atlantic University.

Before her position at OrganaBio, Meram conducted research at Larkin University where she worked on assessing the impact of Hurricane Maria on respiratory diseases in Puerto Rico, which provided her with insight into research investigation and analysis along with generation of grant documentation.

Shilpa Ramesh

Director, Marketing

With a B.Sc in Psychology from Florida International University coupled with a background of more than 15 years in healthcare marketing, Shilpa joined OrganaBio as a Marketing Director.  Her translatable experiences within pharmaceuticals (OTC and Rx), biotech (clinical decision support tools) and genomics to logistics providers and manufacturing, places Shilpa in a position to successfully conceptualize, develop, and implement patient-centric strategies while addressing a spectrum of challenges faced in the healthcare industry. 

With a proven track record of building high-performing teams and successfully managing outside agencies to grow brands and build the sales pipeline, Shilpa can balance strategic thinking with execution, and designs marketing programs and campaigns to drive sales, engagement, retention, leads while ensuring positive customer sentiment.

Valeria Beckhoff-Ferrero

Principal Scientist

Valeria Beckhoff Ferrero has over 5 years of experience in the fields of stem cell research and tissue engineering. Valeria received her Bachelor of Science in Biomedical Engineering, specializing in Biomaterials and Tissue Engineering, from Drexel University in Philadelphia. Valeria has expertise in problem solving and finding manufacturing solutions for isolating various types stem cells and other cell derived products from different tissues.

Before joining OrganaBio, Valeria was a lead manufacturing engineer at the Amnion Foundation. She aided in instituting a GMP infrastructure, including documentation, to manufacture clinical grade placental derived stem cells. In her role, she worked in perfecting isolation, culture, selection and cell maintenance processes for perinatal derived stem cells.

Valeria’s experience includes working as an Automation Engineer at the New York Stem Cell Foundation, where she aided in the creation and coding procedures for liquid handlers to manufacture induced pluripotent stem cells. At NYSF, Valeria researched new methods of sorting, reprogramming and differentiating iPSCs.

During her studies, Valeria worked at Thomas Jefferson University Hospital’s Radiation Oncology department, where she engineered various devices to aid in hyperthermia treatments. Additionally, Valeria co-authored multiple publications on magnetic resonance guided focused ultrasound and radiation antennas for hyperthermia treatments.

Arlen Graham

Associate director, Process Development

Arlen Graham is an experienced Manufacturing Science & Technology Bioprocess Engineer that has driven the success of multiple cell therapy products in both commercial and clinical settings. He joined OrganaBio from Takeda Boston where he was part of a small team, charged with the objective of establishing Takeda’s first cGMP Cell Therapy Manufacturing Facility. While there, he executed the tech transfer, development, and manufacturing of immunotherapies. His primary focus was serving as a Manufacturing SME and lead trainer for the promising, pre-clinical CAR-NK product, TAK-007. He wrote and implemented the cGMP documentation and business practices used to produce the material required for tech transfer, assay development and the clinical trials planned for TAK-007. Prior, Arlen was a cell processing specialist at Novartis’ groundbreaking CAR-T cell therapy site.

His quality mindset enabled him to perform hundreds of successful commercial manufacturing runs without any deviations for the cGMP product Kymriah. His experience in the selection and activation of cells is varied, including manual techniques to the widely used semi- and fully automated technologies on the market and several proprietary systems. His background also includes training and execution of large- and small-scale aseptic fill/finish processes. Arlen has earned a Bachelor’s of Science in Biomathematics from Florida State University.

Marisa Reinoso

Director, Regional Scientific Sales

Marisa has experience leading marketing and sales life sciences programs for over a decade. Originally a lab researcher, she made the jump to marketing & sales in life sciences and never looked back.

At OrganaBio, she connects cell therapy developers on the West coast and in Asia with the healthy donor starting materials they need to develop their therapies. Prior to OrganaBio, she was the cell therapy marketing lead at Invetech, heading the launch of the company’s first cell therapy product. Marisa has led marketing programs at clinical supply companies Sherpa Clinical Packaging and PCI Pharma Services. In her spare time, Marisa enjoys traveling, eating, and pretending she’s a tennis player. She has a Bachelor of Arts in Biology from Reed College and an MBA from Portland State University.

Thelma Cela

Senior Director, Tissue Procurement

Thelma Cela is a top performing professional with over 25 years’ experience in management, leadership, business development and marketing fields with business acumen and skills in driving revenue and profit growth in multiple corporate cultures. Prior to joining OrganaBio, Thelma served as Senior Director for Health and Human Services for the Seminole Tribe of Florida. Her role had oversight for health clinics, health plan administration, the behavioral health department, and elder services. In this governmental administrative capacity, Thelma had primarily responsibility for the HHS’ divisions’ budget, capital projects, utilization management, efficiency, and efficacy.

Thelma’s prior work experiences include Vice President of Clinical Operations for OrthoNOW. In this role, she provided guidance on all clinical matters, set direction on clinical policies and procedures and monitoring healthcare policy changes. As the national Vice President of Clinical Operations, Thelma also designed, developed, and implemented guidelines and protocols and ensured compliance regarding overall patient experience.

Before joining OrthoNOW, Thelma had been recruited by Leon Medical Centers, a private healthcare company operating comprehensive medical centers to launch a new business line addressing the health and wellness of an aging population. As Director, Thelma researched, created, and launched the company’s Health Living Centers which provided first of its kind facilities in the South Florida market to offer services to the community of health aging.

Thelma has a proven track record in multiple corporate healthcare cultures having worked for Mercy Hospital where she was Senior Program Director of their Diabetes Treatment Center and Director of their Surgical Weight Loss Program. She enhanced these service lines awareness in the community, improved both lines’ clinical outcomes, and built volume growth while maintaining ongoing physician support. She served in a similar capacity for American Healthways.

Thelma earned her MBA from Miami Regional University where she graduated Cum Laude and her undergraduate degree in Psychology is from the University of Miami.

She serves on the advisory panel for Florida International University’s Women in Business Leadership Program helping future women become future business leaders through thought leadership, barrier destruction, and the power of influence.

Dominic Mancini

Vice President, Operations

Dominic Mancini brings 12 years of experience working the interfaces between Analytical Development, Process Development, Quality, and Manufacturing Science to OrganaBio. A lifelong learner, Dominic enjoys solving the many scientific and operational challenges presented in the field of cell and gene therapy.

Prior to OrganaBio, Dominic spent 8 years at Bluebird Bio as the company grew from 45 to 1200+ employees and from 1 clinical asset to a robust commercial pipeline. At Bluebird, Dominic initially supported the development and technology transfer of lentiviral vector manufacturing processes. As demand grew for lentiviral process and product characterization, Dominic led the development, qualification, transfer, and validation two commercial release methods. Dominic transitioned back to the Process Development organization to lead the vector manufacturing core team, increasing operational efficiency through a 5S implementation, process schedule intensification, and reverse technology transfer initiative. More recently, Dominic supported the build-out of bluebird’s Manufacturing Science & Technology team followed by the Data Systems & Analytics team, handling late-stage commercial asset support.

Dominic received his Bachelor of Chemical Engineering with Distinction from the University of Delaware. Dominic’s undergraduate research culminated in his thesis on heterologous expression of G-protein coupled receptors in Saccharomyces cerevisiae. After graduation, Dominic was the premier hire of the Zhou Laboratory at Brigham and Women’s hospital in Boston, MA. In three years, Dominic established an animal model of COPD and co-authored several papers with his collaborators in the Pulmonary division.

Laura Malagon

Vice President, Learning & Development

Laura Malagon brings more than 30 years of combined expertise in the field of Quality Assurance, Compliance and Regulatory Affairs in the Pharmaceutical, Biotechnology and Drug Delivery industries with 17 of those years in an executive leadership capacity.

Prior to joining OrganaBio, LLC, Laura was the Vice President of Compliance & Regulatory at CutisPharma in Wilmington, MA, where she was a member of the Executive Leadership team and responsible for growing and developing the Quality Department. At CutisPharma she developed their new inspection process, led the company through their first successful PAI and as a result received the company’s first FDA product approval.

Prior to that, Laura held several senior leadership positions across different disciplines in the Biotech, HCTp, and Pharmaceutical Industry. These roles include: Noven Pharmaceuticals (Hisamitsu), where she led the Quality Department for a multi-site facility, Aveva Drug Delivery Systems (Apotex) where she was responsible for all facets of the Quality, Compliance, FDA remediation and product release functions.

Laura also worked with Vivex Biomedical, Inc. as the Senior Directory of Quality. She worked successfully with the AATB to obtain multiple recovery and processing site certifications as well as being a member of the AATB accreditation committee.

In each of her roles she provided strategic direction, FDA readiness support and leadership in all aspects of developing the quality team. Laura is passionate about quality, a patient advocate, and has a dynamic, diverse background which allows her to assist both large and small life science technology companies. Laura graduated from Barry University with a BS in Professional Administration and lives in Miami, FL.

Christopher B. Goodman

Vice President, Quality & Regulatory Affairs

Christopher B. Goodman is a biopharmaceutical consultant and executive making a global impact in the cellular therapy technology arena. The scope of Christopher’s expertise encompasses Cellular Therapeutic Operations, Quality and Regulatory Affairs, Global Corporate Operations, Scientific Strategic Planning, Scientific R&D Collaborations, and Marketing & Commercialization.

Christopher recently joined OrganaBio as their Vice President of Regulatory Affairs. In this role, Christopher will be helping the company, its clients and partners navigate the complexities of the domestic and international regulatory requirements governing advanced cellular therapy products and manufacturing.

Previously, Christopher held positions with the Association for the Advancement of Blood and Biotherapies (AABB), Virgin Health Bank, Ventana Medical Systems, and Celgene.

While with AABB, he held the positions of Senior Director of New Products and Lead Quality Assessor, auditing both domestic and international organizations to known standards in an effort to promote and ensure patient quality care and manufactured product consistency and standardization within Cellular Therapy, Blood Banking, Transfusion Services, Perioperative and Donor Center industries and operations. He contributed greatly to the work of AABB’s accreditation program providing his deep breadth of knowledge and technical acumen on many committees during his tenure. His pioneering work in the realm of virtual assessments during the COVID pandemic allowed AABB to flex into the planning and execution of this novel approach to the maintenance of accreditation activities during a global travel crisis. His agile thinking and approach to planning provided as minimal disruption as possible to AABB’s customer facilities.

While working with Virgin Health Bank in the State of Qatar and the United Kingdom, Christopher advanced through a series of executive roles. He joined Virgin Health Bank as the Director of Operations, during which time he managed the successful design, and build out of a new state-of-the-art cGMP facility, the first in the Middle East. As Director and Chief Executive Officer, he directed the launch of the first Arab-centric stem cell bank, and strategically guided the organization to enhanced shareholder value and expansion across the Middle East and UK. In these roles, he also oversaw global corporate operations, research collaborations, product portfolio expansion, and regulatory framework.

Christopher managed the Detection and Chemistry Assay Development Group for Ventana Medical Systems, a global leader and innovator of tissue-based diagnostic solutions. In this role, he directed overall program goals, optimized resources, and guided technical and product direction in global regulated environments.

Prior to Ventana Medical Systems, he held the position of Director of Operations for the high-growth Cellular Therapeutics Division of Celgene. As a senior-level scientist and member of the executive team, he directed divisional operations, medical affairs and executed business and scientific strategic planning.

Elina Linetsky, Ph.D.

Vice President, Manufacturing Lead, Process Development

Elina is a motivated leader with over 25 years of experience in product development, scale-up and cGMP manufacture; construction, validation and operation of cGMP manufacturing facilities; quality assurance, regulatory compliance and product regulatory strategy development; and core facilities management. She is a recognized expert in the field of cellular therapies and regenerative medicine, product translation from bench-to-bedside, and clinical research programs. She joins OrganaBio from the University of Miami (UM), where she directed the cGMP Advanced Cell and Biologic Products Manufacturing Facility, charged with the development and manufacture of advanced investigational cellular therapies for a number of clinical trials in patients with brittle Type 1 Diabetes (T1D), COVID-19, Alzheimer’s spectrum disorders, Graft-vs-Host Disease (GVHD), cardiovascular disease, cancer and central nervous system (CNS) injuries. During her tenure at UM cGMP, Elina has supported advanced cellular therapy and combination product development, characterization, scale-up, validation and manufacturing activities in support of a number of UM-initiated, extramural academic and industry initiated clinical trials. She has vast experience in working with allogeneic and autologous pancreatic islet cells, Mesenchymal Stromal Cells (MSCs) from various sources that include bone marrow (BM), adipose, cord blood (CB) and birth tissue, cellular-based vaccine products, NK, natural T-regulatory cells (nT-regs) and endothelial cells.

Elina’s scientific training began as an undergraduate student at the University of Alberta, where she earned a Bachelor of Science degree, majoring in Genetics. She earned her MSc and PhD degrees in Public Health from Walden University. She focused her PhD thesis on the evaluation of educational programs for patients living with T1D. Working closely with Dr. Camillo Ricordi, Elina applied the knowledge gained as part of her thesis work to the manufacture of allogeneic islet cells to treat patients with severe cases of T1D, and was an integral part of Phase 2/3 multi-center clinical trials of allogeneic islets that paved the way to initiation of a licensure process for this therapeutic. Recently, she was a Co-PI of one of the first controlled, randomized Phase 1/2a clinical trials of MSC therapy in patients with COVID-19, which resulted in highly regarded publication and initiation of a Phase 2b/3 clinical trials in a similar patient population.

Elina is the author and co-author of dozens of peer-reviewed manuscripts and book chapters in the area of cellular therapies, applicable regulatory framework, and cGMP manufacture. She has contributed her time to the development of Standards for Cellular Therapy Products on behalf of FACT and AABB, has served as an inspector for both organizations, and is a member of FACT’s Regenerative Medicine Task Force.

Danielle Smyla

Senior Director, Quality Assurance

Danielle Smyla, M.S., brings 14 years of Quality Assurance and GMP experience in the Biotechnology and Medical Device industries. Ms. Smyla is an established Quality Leader with expertise in the implementation, management and continuous improvement of Quality Management Systems for GMP operations.

Prior to joining OrganaBio, Danielle was a key member of the Quality Management team at Canon BioMedical, where she led the cross-functional development and implementation of their Quality Management System. She also managed a team of Quality Specialists and Sr. Specialists, coaching them in the implementation, management and identification of improvements to quality processes.

Ms. Smyla’s Quality-focused career is complimented by valuable hands-on experience in GMP product manufacturing, as well as R&D laboratory experimentation and formulation work in support of product development.

Danielle has earned a Master’s in Biotechnology from the Johns Hopkins University and a Bachelor of Science in Chemistry from the George Washington University.

Oscar Robles

Director, Quality Systems

Oscar Robles has over thirty years of experience in pharmaceutical and medical device industries. His main areas of expertise are in Quality Systems, Quality Assurance, Manufacturing Systems Validation, Computerized Systems Validation, implementation of GxP Computerized Systems and ERP Systems such as TrackWise, Electronic Document Management, JDEwards, SAP, and Oracle. Prior to joining OrganaBio, Oscar was a member of the Quality Management team at Apotex – Aveva Drug Delivery Systems for ten years. Oscar has earned a Master’s in Business Administration from Nova Southeastern University and a Bachelor of Science in Electrical Engineering from Florida International University.

Carlos Carballosa, Ph.D

Director, Birth Tissue Product Sales

Carlos Carballosa is a biomedical engineer with over 8 years of stem cell research experience with broad expertise in the culture, differentiation, and cryopreservation of adult stem cell populations. Carlos earned his bachelors, masters and doctorate degrees in Biomedical Engineering from the University of Miami, where his research focused on the effects of nicotine and electronic cigarette vapor exposure on the regeneration potential of adult stem cells. In addition to his dissertations, Dr. Carballosa has authored numerous publications related to stem cell biology.

Sarah Alter, Ph.D.

Senior Director, Scientific Affairs

Sarah Alter, Ph.D., has 15 years of immunology research experience which includes autoimmunity, cancer, and infectious disease.

Before her position at OrganaBio, Sarah was responsible for leading a team of scientists at Altor Bioscience where she facilitated the advancement of Altor’s technologies. As a Research and Development Manager, Dr. Alter coordinated immunotherapy-focused preclinical and clinical studies and contributed to the progress of Altor’s drug discovery and therapeutic applications.

Sarah received her Doctor of Philosophy from the University of Miami, Miller School of Medicine. She is also a registered Patent Agent, licensed to practice before the United States Patent and Trademark Office. Her work was published in many peer-reviewed journals and presented at national and international business and scientific meetings.

Priya Baraniak, Ph.D.

Chief Business Officer

Dr. Baraniak is a proven strategic thinker, problem solver and leader who brings 20 years of expertise in stem cells and tissue engineering, coupled with a keen business acumen, to OrganaBio. Dr. Baraniak has published multiple peer-reviewed papers and book chapters on the use of stem cells and biomaterials in cardiac repair and regeneration and is routinely invited to speak at conferences.

Before joining OrganaBio, Priya was a founding member of RoosterBio and was a vital member of the company’s Leadership Team. At RoosterBio, Priya leveraged her technical expertise to build and rapidly scale the company’s sales and marketing engines in a fast-paced start-up environment, delivering impressive growth in revenue year-over-year. Additionally, in her role as Business Development lead at RoosterBio, Priya structured, negotiated and executed multiple strategic partnerships for aggressive growth of the organization.

Priya’s industry experience includes a role as Senior Director of R&D for Garnet BioTherapeutics, a clinical-stage stem cell-based regenerative medicine company, where Priya led multiple projects on tissue repair and regeneration using mesenchymal stem cell (MSC)-based therapeutics and devices. While at Garnet Bio, Priya also worked on the company’s FDA filings, contributed to drafting and prosecuting the company’s patent portfolio, managed CRO, CMO and industry partner relationships and actively participated in establishing Garnet’s strategic R&D plan, thereby gaining critical insights into business operations across a small organization.

Priya’s scientific training began as an undergraduate student at Duke University, where she earned a Bachelor of Science in Engineering (BSE) from Duke University in 2001 after double majoring in Electrical Engineering and Biomedical Engineering. While at Duke, Priya conducted research in the lab of Dr. Doris A. Taylor on the use of skeletal myoblasts and stem cells for cardiac repair and regeneration. Priya went on to receive her Ph.D. in Bioengineering from the University of Pittsburgh in 2008. She completed her dissertation research in the laboratory of Dr. William R. Wagner working on developing a controlled release biodegradable elastomer for applications in cardiovascular regenerative medicine. In 2008, Priya joined Dr. Todd McDevitt’s lab in the Department of Biomedical Engineering at Georgia Tech and Emory University as a post-doctoral fellow. Her post-doctoral research as an American Heart Association Fellow focused on harnessing the secretome and isolating the extracellular matrix from MSCs and other cell types, including pluripotent stem cells, for cardiac tissue repair and regeneration. Priya co-authored many grants while a post-doc and went on to contribute critical sections to a NIST grant that resulted in the first ever National Cell Manufacturing Consortium in the United States.

Justin Irizarry, CFA

Chief Executive Officer

Justin Irizarry brings more than 17 years of entrepreneurial experience and executive-level leadership of business operations, finance, corporate development, and M&A.

Previously, Justin co-founded OrthoNOW, the nation’s only network of immediate orthopedic care facilities. He led OrthoNOW through its various stages of growth and development, and his success has been featured in numerous publications, such as Entrepreneur Magazine, CFO Magazine, the South Florida Business Journal, the Miami Herald, the Orlando Sentinel, MedCity News, and Becker’s Hospital Review and the Pivotal Leader podcast.

Prior to the healthcare industry, Justin was a Wall Street investment banker at Scott-Macon, Ltd., where he helped build the Education and Information Group. As an investment banker, he was responsible for sourcing and executing transactions between $50 million and $350 million, running the group’s day-to-day activities, and developing its long-term growth and technology strategies.

Justin earned a Bachelor of Arts degree in economics from Cornell University – where he was a four-year varsity baseball scholar-athlete – and a Master of Business Administration from The Wharton School at the University of Pennsylvania – where he was a Joseph Wharton Fellow. He has also earned the Chartered Financial Analyst® (CFA) designation, the most respected and recognized investment designation in the world.

Justin is the recipient of numerous honors and awards, including South Florida Business Journal’s 40 Under 40, South Florida Business Journal’s CFO of the Year, South Florida Business & Wealth’s Up and Comer Award, Hispanic Unity of Florida Foundation’s American Dreamer Award, and Diversity MBA Magazine’s Top 100 Under 50 Executive Leaders.

He has been an invited speaker at Columbia University’s Business School, University of Miami’s Business School, The Society for Healthcare Strategy & Market Development, South Florida Business Journal’s Roundtable Series, the South Florida Executive Roundtable, the American Academy of Orthopedic Executives, and the Coral Gables Chamber of Commerce.