News

VALIDANT ACQUIRES GREENLEAF HEALTH

Validant, a leading global quality, compliance and regulatory consulting group (the Group), has acquired Greenleaf Health, Inc. (Greenleaf), a leading U.S. Food and Drug Administration (FDA) regulatory consulting firm. Concurrent with the acquisition, Validant announced the appointment of Patrick Ronan, founder and former Chief Executive Officer (CEO) of Greenleaf, as the new CEO of Validant.

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s team of experts draw on a combined total of more than 300 years of FDA experience to deliver reliable, objective advice to FDA-regulated companies. Founded in 2007, Greenleaf is headquartered in Washington, D.C.

Validant’s acquisition of Greenleaf is another important step in its international growth strategy, focused on combining best-in-class regulatory and quality providers, and accelerating their growth with further investment. The accelerated growth strategy is supported by GHO Capital, the European specialist investor in healthcare, having partnered with Validant since December 2018. Today’s announcement follows Validant’s December 2020 acquisition of Oriel STAT A MATRIX, a New Jersey-based global consultancy and training firm; November 2020 acquisition of IDEC, a leading regulatory consultancy in Japan; and the acquisition of DataRevive in 2019, a regulatory strategy and consultancy for global clients, based in Washington D.C.

Commenting on the announcement, The Partners at GHO Capital, said: “We are delighted to welcome the entire Greenleaf team to Validant. They bring a wealth of complementary experience and expertise to the Group and the combination is set to benefit the customers of both companies. We would like to take this opportunity to thank Brian Burns for his support and leadership in overseeing the rapid growth of Validant. We are excited to continue this trajectory under Patrick’s leadership and believe that his experience and passion will help consolidate our position as the leading global life science regulatory consultancy.”

Patrick Ronan brings more than 25 years of leadership experience to his role as CEO of Validant. Prior to founding Greenleaf in 2007, Patrick served as Vice President of Regulatory Policy & External Affairs at Novartis Pharmaceuticals Corporation, where he supervised U.S. regulatory policy issues and advised all therapeutic areas on FDA-related regulatory matters.  Patrick’s extensive experience includes leadership roles at the FDA where he served as Chief of Staff and Assistant Commissioner of Legislation; on Capitol Hill, where he served as a member of the Professional Staff to the Committee on Energy and Commerce; and the Washington, D.C.-based Biotechnology Innovation Organization (BIO).

Patrick Ronan, newly appointed CEO of Validant, commented: “Greenleaf Health enhances the expertise and capabilities of Validant as we work to support clients and their evolving global regulatory needs. I am excited to serve in the role of CEO and bring our teams together as we create a platform for continued growth and success.”

Fairmount Partners provided investment banking and advisory services, and Goodwin Procter provided legal advice to Greenleaf Health, Inc.

OMM provided legal advice, RSM Global provided financial and accounting advice, and Deloitte provided tax advice to Validant.

About Validant

Validant is a leading international Quality, Compliance, and Regulatory consulting firm, blending industry expertise with innovation to create custom solutions for companies on the frontier of health. With deep experience working within and alongside the FDA and other regulatory agencies, we understand how to navigate the complexities facing today’s healthcare industry. For further information, please visit www.validant.com

About Greenleaf

Greenleaf Health is a leading FDA regulatory consulting firm that provides expert services to FDA-regulated entities. Greenleaf includes former leaders and regulatory professionals from the FDA, Capitol Hill, top global pharmaceutical and medical device companies, leading law firms, and the top U.S. biotechnology trade organization. Greenleaf’s team of respected professionals work cross-functionally to provide unmatched expertise to companies navigating today’s evolving regulatory environment. For more information on Greenleaf Health, visit www.greenleafhealth.com.

GREENLEAF LANDSCAPE SERIES PROVIDES EXPERT INSIGHT ON EMERGING REGULATORY TOPICS

Greenleaf Health, Inc. (Greenleaf) is expanding the firm’s advisory services portfolio to include a Regulatory Landscape Series that addresses emerging topics related to FDA regulation. Authored by the firm’s expert advisors, these brief analyses provide valuable, timely insight into the current state and future direction of regulatory developments and activity at the FDA.

Greenleaf’s robust blend of technical skill and FDA institutional knowledge enables the firm to provide reliable, objective guidance on developing regulatory matters. A sample of the series topics includes: 

Medical Device EUAs:  Greenleaf experts provide an overview and analysis of the recent activity within the Center for Devices and Radiological Health (CDRH) to address the volume and diversity of Emergency Use Authorization (EUA) requests that have emerged in the in vitro diagnostic (IVD) space as a result of the COVID-19 pandemic. 

COVID-19 Inspections:  Greenleaf compliance experts address FDA inspectional activities during the COVID-19 pandemic and alternative approaches to ensure the continued supply of quality medicines.

COVID-19 Pandemic Accelerates Digitalization of Clinical Trials:  Greenleaf discusses the FDA’s recent support of digital health tools (DHTs) and the impact of digital health technologies in medical product development.

New installments in the Regulatory Landscape Series are published on a regular basis and distributed via Greenleaf e-communication. The complete series is available on the Greenleaf website

The Regulatory Landscape Series is presented by Greenleaf’s Advisory Services Team, which serves as a trusted partner to investors evaluating life sciences transactions. Greenleaf experts provide investors with extensive research and due diligence on potential deals that require regulatory risk analyses before and after decisions and transactions. By working cross-functionally across all areas of expertise, the Greenleaf team is able to offer insight on the FDA’s current thinking in multiple areas and set appropriate expectations for investors. To learn more about Greenleaf’s advisory services, visit the Greenleaf website.

Greenleaf Health is a leading FDA regulatory consulting firm that provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges.

To be included in future communications, please register by completing the below form:

Regulatory Landscape Series

GREENLEAF PORTFOLIO NOW INCLUDES REMOTE COMPLIANCE SERVICES

Greenleaf Health expands its compliance and manufacturing portfolio to include remote quality and compliance support for clients.

Entities regulated by the FDA encounter challenges on a regular basis. But no recent challenge has placed as great of a strain on the life sciences industry as COVID-19. The impact of this global pandemic is experienced by companies of every size, and increased effort and adaptability are required from all parties to preserve the integrity of the supply chain and ensure a consistent supply of safe, high-quality products.

“Greenleaf Health recognizes that quality and compliance activities cannot be stalled. Despite global disruptions in surveillance inspections and other regulatory operations, Greenleaf’s work on behalf of our clients continues. The firm’s team of experts has identified opportunities to assist clients remotely while continuing to support all public health measures in effect throughout the course of the pandemic,” said John Taylor, President, Greenleaf Health, and Principal, Compliance and Regulatory Affairs.

Greenleaf’s remote compliance services concentrate on the FDA’s evolving alternative approaches to on-site inspections that may exist for many months to come. Although not a full substitution for on-site work, the remote opportunities provided by Greenleaf enable companies to continue essential quality and compliance activities while preparing for the time when on-site activities fully or partially resume.

STRATEGIC & TECHNICAL GUIDANCE
Greenleaf’s Product Quality, Manufacturing, and Compliance Team identifies and promotes practices and procedures that will align a client’s approach with the FDA’s quality, safety, and compliance expectations. Greenleaf also engages a network of independent contractors to provide technical expertise, both on site and remotely.

While companies face the complexities of navigating today’s challenging public health landscape, Greenleaf and our network of independent compliance experts are prepared to assist clients with the following remote quality and compliance services:

  • Procedural and Record Review. Comprehensive review of new or revised Standard Operating Procedures (SOPs) for acceptability and compliance with requirements and objective evaluation of selected records (e.g., deviations, nonconformance reports, OOS, complaints) for accuracy, completeness, and compliance with requirements.
  • Data and Trending Review. Examination of documents and objective feedback on key quality data and metrics, and trending reports prepared for quality or management reviews.
  • Corrective Action Assessment. Evaluation of responses, corrective action records, and change control records related to issues identified by the client, or identified during previous inspections by the FDA and other health authorities, and determination of whether the actions are appropriate, complete, and effective.
  • Regulatory Response Support. Objective review and expert guidance on providing effective responses to FDA 483s, warning letters, requests for additional information, and other critical regulatory correspondence.
  • Issue-Specific Information. Review of information relating to a specific issue of interest identified by the client to provide an objective assessment and feedback to help with resolution, documentation, and communication.
  • Training. Live video training on specific topics such as inspection preparedness, design controls, CAPA, etc.

ABOUT GREENLEAF
Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges.

The firm includes former leaders and regulatory professionals from the FDA, Capitol Hill, top global pharmaceutical and medical device companies, leading law firms, and the top U.S. biotechnology trade organization. Greenleaf’s blend of former FDA officials and industry experts provides a unique set of capabilities when advising entities regulated by the FDA.

For more information on remote compliance services and Greenleaf Health, visit greenleafhealth.com.

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GREENLEAF HEALTH and TRIO HEALTH PARTNER TO APPLY FDA-LEVEL RIGOR TO GROUNDBREAKING DATA PLATFORM

WASHINGTON, D.C, October 1, 2019— Greenleaf Health, a leading Food and Drug Administration (FDA) regulatory consulting firm, today announced it has entered into an exclusive agreement with Trio Health, a leading provider of real-time data on real-world patients, to unite in utilizing and validating the data analyses from the groundbreaking Multi-Disease Platform (MDX) technology platform.

By partnering with Greenleaf, Trio’s advanced analytics MDX platform delivers unrivaled insights to the industry; in particular, the ability to transform real world data into actionable intelligence to innovate and make better decisions across the product lifecycle with confidence.

Trio, founded in 2013, tracks a patient through the entire treatment journey by combining disparate information from the physician, pharmacy, and payer ‘trio,’ to produce comprehensive and high-quality databases that are on caliber with FDA-level rigor.

Greenleaf CEO Patrick Ronan, Trio CEO, Brent Clough, and Greenleaf Principals of Drug and Biological Products, John Jenkins, M.D. and Robert Meyer, M.D., will present the MDX platform at the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) Conference in Copenhagen, November 4.

Under the terms of the partnership, Greenleaf Health will pair its robust blend of technical expertise and vast institutional knowledge of the FDA process to deliver valuable insight and guidance for the MDX Platform.  Greenleaf’s team of experts will be led by three FDA leadership veterans: John Jenkins, M.D., former Director of the Office of New Drugs within the FDA’s Center for Drug Evaluation and Research; Robert Meyer, M.D., previously Director of FDA’s Office of Drug Evaluation II; and Karen Midthun, M.D., an infectious disease physician by training who most recently served as the Director of the FDA’s Center for Biologics Evaluation and Research (CBER).

Greenleaf’s Ronan said, “Trio’s MDX platform is a game-changer for the biopharmaceutical industry. The pairing of Greenleaf’s best in class regulatory expertise with Trio’s MDX Platform, creates an unmatched tool for improving patient outcomes and the safety of medicines.”

“The MDX platform is transformational for patients,” said Trio CEO, Brent Clough. “It can provide physicians unmatched insights into credible data sets validated by former FDA experts so that they can optimize patient care. In turn, the platform offers our life science customers best-in-class speed, data certainty, and unparalleled visibility across the clinical and commercial lifecycle. Such knowledge can be leveraged to support pre-and post-marketing activities to drive significant cost-savings and support greater patient outcomes.”

About Trio Health

Trio Health’s mission is to improve the quality of care in patient outcomes through coordinating the efforts of all patient care stakeholders. Their first-of-its-kind Multi-Disease Platform (MDX) tracks patients throughout the course of their treatment, giving pharmaceutical/biotechnology companies, specialty pharmacies and physicians access to information and opportunities that simply doesn’t exist anywhere else. Learn more at www.triohealth.com.

About Greenleaf

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges.

With decades of experience in senior positions at the FDA and throughout industry, Greenleaf’s team of respected professionals brings unmatched expertise that companies need when navigating today’s evolving regulatory environment.  For more information on Greenleaf Health, visit www.greenleafhealth.com.

GREENLEAF HEALTH EXPANDS SERVICES TO SUPPORT CELL and GENE THERAPY

Karen Midthun, M.D. & John Taylor to Lead Team of Experts

WASHINGTON, D.C. – Greenleaf Health, Inc., a leading Food and Drug Administration (FDA) regulatory consulting firm, today announces that the firm has expanded its portfolio of services to guide companies developing cell and gene therapy products. Greenleaf’s team of regulatory experts will be led by Karen Midthun, M.D., former Director of the FDA’s Center for Biologics Evaluation and Research (CBER), and John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner.

REGULATORY LANDSCAPE: Cell & Gene Therapy

The rapidly evolving fields of cell and gene therapy offer the possibility of novel treatments, and perhaps ultimately cures, for devastating and intractable illnesses. In response to what the FDA has called a “turning point in the development of these technologies and their application to human health,” new policies have been introduced to address the development of safe and effective cell and gene therapies.

With innovation often comes uncertainty. In the case of cell and gene therapy products, the FDA has raised concerns about developers operating outside of the existing regulatory paradigm. To prevent this, the FDA has clarified the regulatory framework for regenerative medicine products and announced near-term enforcement actions aimed at ensuring compliance by companies developing and manufacturing cell and gene therapies.

Greenleaf’s expanded services support companies striving to introduce cell and gene therapy products to patients. The firm’s team of experts has a robust blend of technical skill and FDA institutional knowledge that spans all therapeutic areas and quality, manufacturing, and compliance systems. By working cross-functionally, Greenleaf ensures that clients have the comprehensive, specialized support needed to understand and navigate the complex regulatory landscape for cell and gene therapies.

FULL-SERVICE SUPPORT

Members of Greenleaf’s Drug and Biological Products Team work together with the firm’s Product Quality, Manufacturing, and Compliance Team to deliver guidance on cell and gene therapy products.

Product Development & Review

With the expert direction of Karen Midthun, M.D., Greenleaf’s team of advisors assists sponsors of cell and gene therapies by optimizing FDA interactions and submissions to support development and regulatory review. Greenleaf also helps sponsors understand and respond to the FDA requirements applicable to various cellular products, and provides guidance to sponsors of cell and gene therapies to treat rare and ultra-rare diseases on ways to maximize trial design using appropriate clinical endpoints and natural history study data to aid efficient product development.

Quality, Manufacturing & Compliance

Greenleaf’s Product Quality, Manufacturing, and Compliance Team, led by John Taylor and supported by the firm’s network of independent compliance experts, offers credible, informed guidance to help manufacturers of cell and gene therapies comply with the FDA’s multiple current GXP regulations. Greenleaf experts provide strategic and technical support for establishing manufacturing and quality controls; pre- and postapproval inspection readiness; compliance assessments; evaluating and responding to FDA regulatory correspondence; and engaging with CBER’s Advanced Technologies Team.

UNMATCHED EXPERTISE

Greenleaf is comprised of experts with a combined total of more than 250 years of FDA experience. The firm’s team of advisors demonstrates unmatched levels of skill in its specialties of drug and biological products and product quality, manufacturing, and compliance. Greenleaf’s Cell and Gene Therapy Team, led by Dr. Karen Midthun and John Taylor, is guided by decades of regulatory experience in senior FDA positions, global public health organizations, academia, and industry.

Karen Midthun, M.D., Principal, Drug & Biological Products

Dr. Midthun contributes specialized insight — informed by her regulatory, research, and clinical experience — to FDA-regulated entities developing cell and gene therapies. Dr. Midthun joined Greenleaf following a distinguished 28-year career in public health, of which 22 years were dedicated to the FDA.

An infectious disease physician by training, Dr. Midthun most recently served as the Director of the FDA’s Center for Biologics Evaluation and Research (CBER). During her FDA tenure, Dr. Midthun played a critical role in facilitating policy and technology development in the areas of cell, tissue, and gene therapies, blood products, and vaccines.

John Taylor, J.D., President, Greenleaf Health, and Principal, Compliance & Regulatory Affairs

Taylor has held many high-profile positions at the FDA, as well as senior leadership roles within industry. Taylor’s wealth of regulatory experience, robust technical skills, and unique strategic perspective are unmatched. Clients working with Greenleaf’s Product Quality, Manufacturing, and Compliance Team benefit from Taylor’s vast FDA institutional knowledge.

Taylor joined Greenleaf following a distinguished 20-year career at the FDA, where he served in multiple leadership positions, including as the FDA’s Acting Deputy Principal Commissioner, FDA Counselor to the Commissioner, Acting Deputy Commissioner for Global Regulatory Operations and Policy, and Associate Commissioner for Regulatory Affairs.

ABOUT GREENLEAF

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges.

The firm includes former leaders and regulatory professionals from the FDA, Capitol Hill, top global pharmaceutical and medical device companies, leading law firms, and the top U.S. biotechnology trade organization. Greenleaf’s blend of former FDA officials and industry experts provides a unique set of capabilities when advising entities regulated by the FDA.

For more information on Greenleaf’s cell and gene therapy services and Greenleaf Health, visit greenleafhealth.com.

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