Privacy Policy

This Privacy Policy describes how the domain organabio.com (the “Site” or “we”) collects, uses, and shares your Personal Information when you visit or make a purchase from the Site. By visiting any part of organabio.com, you are accepting the practices described in this Privacy Policy.

OrganaBio, LLC and its subsidiaries and affiliates (collectively and individually, “OrganaBio”) are concerned about its users and protection of their Personal Information (as defined below).  Accordingly, OrganaBio has created this Privacy Policy (the “Policy”) that applies to the products and services offered by OrganaBio, including this Site (the “Services”).

Collecting and Sharing Personal Information

When you visit the Site, we collect certain information about your device, your interaction with the Site, and other information necessary to process your purchases. We may also collect additional information if you contact us directly, including for customer support. In this Policy, we refer to any information that can uniquely identify an individual (including the information below) as “Personal Information” or “PI”. See the list below for more information about what Personal Information we may collect and why. You can find a full list of the other lawful bases we may rely on under the General Data Protection Regulation (“GDPR”) in GDPR Art. 6.

We share your Personal Information with service providers to help us provide our Services and fulfill our contracts with you, as described above. We may also share your Personal Information as set forth below:

  • We use Shopify to power our online store. You can read more about how Shopify uses your Personal Information here: https://www.shopify.com/legal/privacy.
  • We may share your Personal Information: to comply with applicable laws and regulations; to respond to a subpoena, search warrant or other lawful request for information we receive; in the event of any reorganization, merger, sale, joint venture, assignment, transfer or other disposition of any or all portion of our business, assets or equity interests, whether as a going concern or as part of bankruptcy, liquidation or similar proceeding; to our payment processing partner to process certain credit card payments; to enforce or apply our Terms of Use and other agreements that we may have with you; or to otherwise protect our rights.
  • On our Site there may be links to webpages, tools or services owned or offered by third parties. Third party providers may provide some services such as credit card, registration, payment or settlement services and, if used, such services may be subject to such third party provider’s privacy policies. This Policy does not apply to such webpages, tools or services owned or offered by third parties and OrganaBio disclaims any responsibility for them or for PI provided by a user through them. Third parties we work with may include the following: Google, Facebook, Microsoft, LinkedIn, Science Exchange, Twitter.

Customer Support and Device Information, including mobile websites and applications

  • Examples of Personal Information collected, which may evolve to include categories of PI we collect.  In that case, we will update this Policy:
    • Identifiers include real name, alias, postal address, unique personal identifier collected through Shopify, email address, account name, social security number, driver’s license number, version of web browser, IP address, time zone, cookie information, what sites or products you view, search terms, how you interact with the Site, or other similar identifiers.
    • Other elements include name, signature, characteristics, or description defining persona of user, telephone number, educational level, current and historical employment, bank account number.
  • Purpose of collection:
    • Fulfill your requests for products and services, contact and conduct research, and to provide Services to users such as loading the Site accurately for you, to perform analytics on Site usage to optimize our Site or deliver enhanced Services while demonstrating functionality of the Services.
    • Send information on products and promotions, provided proper opt-in to OrganaBio’s newsletters, blogs or this Site.
    • Process applications of candidates for open positions at OrganaBio.
    • Identify and contact you as needed with product or service updates, including sending messages regarding the Services we provide while managing our relationship with you to carry out any related administration.
    • Promote our Services as well as our events, conferences by email, telephone and via social media platforms.
    • Compare and verify information with third parties such as vendors, agencies and other service providers.
    • Detect and prevent activity that may be potentially illegal, unlawful and harmful and to enforce our Policy and/or our terms
    • Carry out various types of research such as market and statistical research, website traffic, sales and other commercial information to support improvements with the Services provided to you and tailor the Site accordingly.
    • Performance related cookies, cookies used for advertising purposes and lead generation, or when a user opts in via the consent box of the Site.  In the event a user does not want their PI used in this manner, the user may unsubscribe to all digital communications such as email campaigns and ensure only necessary cookies are collected.  Please see below for a further discussion on cookies.
  • Source of collection: Collected automatically when you access our Site or one of our subsidiaries or trading partners, using cookies, log files, web beacons, tags, or pixels or blog comments.
  • Disclosure for a business purpose: shared with our processor Shopify, HubSpot, and other third-party providers’ and relevant trading partners’ websites to enhance our Site and promote and sell our products and services.
  • Attendance at one of our events or an event OrganaBio plans or will attend.
  • Phone and email communications from OrganaBio
  • Social media interactions through our Site as well as other third-party websites such as Facebook, YouTube, Twitter, and Instagram.
  • Viewing or engaging with our digital promotions such as advertisements or emails through our authorized service providers.

Order information

  • Examples of Personal Information collected: name, billing address, shipping address, payment information (including credit card numbers, purchase orders, invoices, direct billing to company), email address, and phone number.
  • Purpose of collection: to provide products or services to you to fulfill our contract, to process your payment information, arrange for shipping, and provide you with invoices and/or order confirmations, communicate with you, screen our orders for potential risk or fraud, enforce our terms of use, and when in line with the preferences you have shared with us, provide you with information or advertising relating to our products or services.
  • Source of collection: collected from you.
  • Disclosure for a business purpose: shared with our processor Shopify, HubSpot, and other relevant trading partners’ websites to promote and sell our products and services.

Minors

Without a parent or legal guardian’s consent, no Personal Information should be submitted to our Site by children (as defined by local law). OrganaBio does not intentionally and will not knowingly collect Personal Information of children.  In the event that we learn that we have collected Personal Information from a child, we will delete such Personal Information as soon as possible.  If you believe we might have any Personal Information from or about a child, then please contact us using the contact information listed below.

Behavioral Advertising

As described above, we use your Personal Information to provide you with targeted advertisements or marketing communications we believe may be of interest to you. For example:

  • We use Google Analytics, a web analytics service provided by Google, Inc. (“Google”) to help us understand how our customers use the Site. You can read more about how Google uses your Personal Information here: https://policies.google.com/privacy?hl=en. You can also opt-out of Google Analytics here: https://tools.google.com/dlpage/gaoptout. Google Analytics uses “cookies”, which are text files placed on your computer, to help websites analyze how users use such sites. The information generated by the cookie about your use of the Site (including your IP address) will be transmitted to and stored by Google on servers in the United States. Google will use this information for the purpose of evaluating your use of the Site, compiling reports on Site activity for Site operators and providing other services relating to Site activity and internet usage. Google may also transfer this information to third parties where required to do so by law, or where such third parties process the information on Google’s behalf. OrganaBio also uses various Google services including Google Maps to give directions to our offices and YouTube to show videos. Google may aggregate data from our Site with other data that they hold about you. You may refuse the use of cookies by selecting the appropriate settings on your browser, however please note that if you do this you may not be able to use the full functionality of this Site. By using this Site, you consent to the processing of data about you by Google in the manner and for the purposes set out above. For more information, please visit Google’s privacy page.
  • We may share information about your use of the Site, your purchases, and your interaction with our ads on other websites with our advertising partners. We may also collect and share some of this information directly with our advertising partners, and in some cases through the use of cookies or other similar technologies (which you may consent to, depending on your location).
  • OrganaBio may share information with third-parties that contains non-personal information unless you have opted to not share data with third-party websites such as social media. Their servers may not be secure resulting in potential, unlawful interception or access to private transmission of data. 

Remarketing

OrganaBio also uses third party vendor re-marketing tracking cookies, including the Google Adwords tracking cookie. This means we will continue to show ads to you across the internet, specifically on the Google Content Network (GCN). As always we respect your privacy and are not collecting any identifiable information through the use of Google’s or any other third party remarketing system.

The third-party vendors, including Google, whose services we use will place cookies on web browsers in order to serve ads based on past visits to our site. Third party vendors, including Google, use cookies to serve ads based on a user’s prior visits to a website. This allows us to make special offers and continue to market our services to those who have shown interest in our service.

Additionally, you can opt out of some of these services by visiting the Digital Advertising Alliance’s opt-out portal at: http://optout.aboutads.info/.

For more information about how targeted advertising works, you can visit the Network Advertising Initiative’s (“NAI”) educational page at http://www.networkadvertising.org/understanding-online-advertising/how-does-it-work.

Using Personal Information

We use your Personal Information to provide our Services to you, which includes: offering products for sale; processing payments; shipping and fulfillment of your order; keeping you up to date on new products, services, and offers; enforcing our terms of use ; protecting our rights, privacy, safety or property, and/or that of our affiliates, subsidiaries, you or others; preventing, investigating and responding to fraud, unauthorized access to or use of our Site, breaches of our policies or other wrongful behavior; fixing problems you may have with our Site, including, without limitation, answering support questions and resolving disputes; complying with legal process; responding to requests from governmental authorities; and for any other purpose with your consent.

Lawful basis

Pursuant to the GDPR, if you are a resident of the European Economic Area (“EEA”), we process your Personal Information under the following lawful bases:

  • Your consent;
  • The performance of the contract between you and us;
  • Compliance with our legal obligations;
  • To protect your vital interests;
  • To perform a task carried out in the public interest;
  • For our legitimate interests, which do not override your fundamental rights and freedoms.

Retention

When you place an order through the Site, we will retain your Personal Information for the period necessary to fulfill the purposes outlined in this Policy, unless a longer retention period is required or allowed by law or to otherwise fulfill a legal obligation. For more information on your right of erasure of your Personal Information, please see the ‘Your rights’ section below.

Automatic decision-making

If you are a resident of the EEA, you have the right to object to processing based solely on automated decision-making (which includes profiling), when that decision-making has a legal effect on you or otherwise significantly affects you.

We do not engage in fully automated decision-making that has a legal or otherwise significant effect using customer data.

Our processor Shopify uses limited automated decision-making to prevent fraud that does not have a legal or otherwise significant effect on you.

Services that include elements of automated decision-making include:

  • Temporary denylist of IP addresses associated with repeated failed transactions. This denylist persists for a limited number of hours.
  • Temporary denylist of credit cards associated with denylisted IP addresses. This denylist persists for a limited number of days.

Selling Personal Information

Upon receipt of a verifiable consumer request that is confirmed and required by the California Consumer Privacy Act (“CCPA”), OrganaBio will be able to provide a response to the following requests.  If you would like to exercise these rights, please contact us through the contact information below.

  • Categories and sources of PI collected and its business purpose.
  • Business or commercial purpose for collecting the PI.
  • Categories of third parties and specific pieces of PI collected about you .

Your rights

GDPR

If you are a resident of the EEA, you have the right to access the Personal Information we hold about you, to port it to a new service, and to ask that your Personal Information be corrected, updated, or erased. If you would like to exercise these rights, please contact us through the contact information below.

Your Personal Information will be initially processed in Ireland and then will be transferred outside of Europe for storage and further processing, including to Canada and the United States. For more information on how data transfers comply with the GDPR, see Shopify’s GDPR Whitepaper: https://help.shopify.com/en/manual/your-account/privacy/GDPR.

CCPA

If you are a resident of California, you have the right to access the Personal Information we hold about you (also known as the ‘Right to Know’), to port it to a new service, and to ask that your Personal Information be corrected, updated, or erased. If you would like to exercise these rights, please contact us through the contact information below.

If you would like to designate an authorized agent to submit these requests on your behalf, please contact us at the address below.

Cookies

A cookie is a small amount of information that’s downloaded to your computer or device when you visit our Site. We use a number of different cookies, including functional, performance, advertising, and social media or content cookies. Cookies make your browsing experience better by allowing the Site to remember your actions and preferences (such as login and region selection). This means you don’t have to re-enter this information each time you return to the Site or browse from one page to another. Cookies also provide information on how people use the Site, for instance whether it’s their first time visiting or if they are a frequent visitor.

We use the following cookies (in addition to the cookies discussed elsewhere in this Policy), to optimize your experience on our Site and to provide our Services.

Cookies Necessary for the Functioning of the Store

NameFunction
_abUsed in connection with access to admin.
_secure_session_idUsed in connection with navigation through a storefront.
cartUsed in connection with shopping cart.
cart_sigUsed in connection with checkout.
cart_tsUsed in connection with checkout.
checkout_tokenUsed in connection with checkout.
secretUsed in connection with checkout.
secure_customer_sigUsed in connection with customer login.
storefront_digestUsed in connection with customer login.
_shopify_uUsed to facilitate updating customer account information.

Reporting and Analytics

NameFunction
_tracking_consentTracking preferences.
_landing_pageTrack landing pages
_orig_referrerTrack landing pages
_sShopify analytics.
_shopify_sShopify analytics.
_shopify_sa_pShopify analytics relating to marketing & referrals.
_shopify_sa_tShopify analytics relating to marketing & referrals.
_shopify_yShopify analytics.
_yShopify analytics.

The length of time that a cookie remains on your computer or mobile device depends on whether it is a “persistent” or “session” cookie. Session cookies last until you stop browsing and persistent cookies last until they expire or are deleted. Most of the cookies we use are persistent and will expire between thirty (30) minutes and two (2) years from the date they are downloaded to your device.

You can control and manage cookies in various ways. Please keep in mind that removing or blocking cookies can negatively impact your user experience and parts of our Site may no longer be fully accessible.

Most browsers automatically accept cookies, but you can choose whether or not to accept cookies through your browser controls, often found in your browser’s “Tools” or “Preferences” menu. For more information on how to modify your browser settings or how to block, manage or filter cookies can be found in your browser’s help file or through such sites as www.allaboutcookies.org.

Additionally, please note that blocking cookies may not completely prevent how we share information with third parties such as our advertising partners. To exercise your rights or opt-out of certain uses of your information by these parties, please follow the instructions in the “Behavioral Advertising” section above.

Do Not Track

Please note that because there is no consistent industry understanding of how to respond to “Do Not Track” signals, we do not alter our data collection and usage practices when we detect such a signal from your browser.

Changes

We may update this Policy from time to time to reflect, for example, changes to our practices or for other operational, legal, or regulatory reasons.  Your continued use of our Site after we make changes is deemed to be acceptance of those changes, so please check this Policy periodically for updates.

Limitation of Liability

Unfortunately, new vulnerabilities arise in the realm of technology every day and circumstances beyond our control may compromise the security of your information. As with any website or mobile application, please be conscious of the data you share.  If you are not comfortable providing any information, it is your right to withhold it.  IN NO EVENT SHALL WE BE LIABLE FOR ANY DAMAGES (WHETHER CONSEQUENTIAL, DIRECT, INCIDENTAL, INDIRECT, PUNITIVE, SPECIAL OR OTHERWISE) ARISING OUT OF, OR IN ANY WAY CONNECTED WITH, A THIRD PARTY’S UNAUTHORIZED ACCESS TO YOUR INFORMATION, REGARDLESS OF WHETHER SUCH DAMAGES ARE BASED ON CONTRACT, STRICT LIABILITY, TORT OR OTHER THEORIES OF LIABILITY, AND ALSO REGARDLESS OF WHETHER WE ARE GIVEN ACTUAL OR CONSTRUCTIVE NOTICE THAT DAMAGES WERE POSSIBLE, EXCEPT AS PROVIDED UNDER APPLICABLE LAWS.

Indemnity

As a condition to accessing or using our Site and Services, you agree to indemnify and hold harmless OrganaBio (including its subsidiaries and affiliates) and its and their respective directors, managers, shareholders, members, officers, employees and agents from and against any and all liabilities, expenses (including, without limitation, attorneys’ fees and court costs) and damages arising out of or otherwise in connection with third party claims resulting from or otherwise in connection with your access to or use of our Site or Services, including, without limitation, any claims alleging facts that, if true, would constitute a breach of the terms and conditions stated in this Policy.

Contact

For more information about our privacy practices, if you have questions, or if you would like to make a complaint or request, please contact us by e-mail at [email protected] or by mail using the details provided below:

7800 SW 57th Ave. Suite 225, South Miami FL 33143, United States

Last updated: December 6, 2022

If you are not satisfied with our response to your complaint, you have the right to lodge your complaint with the relevant data protection authority. You can contact your local data protection authority, or our supervisory authority.

305.676.2586
[email protected]

7800 SW 57th Ave., Suite 225, South Miami, FL 33143

© 2022, ALL RIGHTS RESERVED

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

Senior Bioprocess 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.

Matthew Adler

Director, Pharmaceutical Product Sales

Matt is an experienced and dedicated business development professional in the Cell & Gene Therapy Industry.

Prior to joining OrganaBio, Matt was a Senior Business Development Executive for HemaCare Corporation (Charles River Laboratories) At HemaCare, he was responsible for supporting Pharmaceutical and Biotechnology companies’ cell therapy pipelines through sourcing custom RUO and GMP compliant leukapheresis derived starting material.

Matt was also a key member of the business development group for AUM BioTech focusing on Next Generation Oligonucleotide Therapies.

Before transitioning to the commercial side of life science, Matt started his career as a Research Scientist for the Functional Genomics Core at Cold Spring Harbor Laboratory. His key responsibilities included cloning, lentiviral production, and shRNA in-vivo studies.

Matt received his Bachelor of Science from the University of Pittsburgh, Dietrich School of Arts & Sciences.

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.

Vice President, Corporate Development Lead, Product Development

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.