Our Consortia Management Team forms and supports life sciences industry collaborations that help companies throughout the world address topics of mutual interest. Our work with these collaborations for the past 25 years have yielded new scientific knowledge, sound, data-driven policies and technological advances that are improving the drug development process.
Composed of attorneys, life sciences professionals and project managers, we provide a comprehensive range of services to more than a dozen consortia. We support these organizations with project management, strategic planning and business development advice, in addition to legal advice. Frequently, we facilitate collaborative scientific research and development of new technology in conjunction with subject matter experts from the pharmaceutical industry along with vendors, academics and other professionals.
Our team has extensive experience engaging industry’s external stakeholders, including regulatory authorities and policymakers, health care professionals and patient advocates. We have represented companies and associations in rulemaking proceedings before the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), as well as other regulators and standards bodies. Periodically, we help manage relationships between consortia and patient and health care professional groups, whose perspectives are integral to the research and development process.
When relevant, we collaborate with other practices across the firm to provide advice on legal topics such as antitrust compliance, intellectual property and organizational structures.
Our capacity to serve life sciences collaborations has been shaped by a longstanding dedication to the pharmaceutical, biotechnology and medical device industries, the diverse experiences our team members and our desire to work in close partnership with our clients to achieve optimal outcomes. Given the uncertainty and expense of drug and medical device development, as well as the highly regulated nature of these markets, the collaborations we support – which address a host of science, technology and policy challenges – are of significant value to the industry.
Representative endeavors include:
Allotrope Foundation is an association of companies collaborating to create a “Laboratory Framework” to address the data management problems facing the entire analytical community. The Allotrope Framework provides a standardized data format, standardized metadata vocabulary and reusable software components to enable developers to embed the Framework into their software easily and consistently. Implementation of the Allotrope Framework will result in data that is easily read, searched, and shared and will address data integrity and compliance issues faced by the pharmaceutical industry. www.allotrope.org
International Pharmaceutical Aerosol Consortium on Regulation and Science
International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), which is celebrating its 15th anniversary in 2016, seeks to advance the science, and especially the regulatory science, of orally inhaled and nasal drug products (OINDP) by collecting and analyzing data and conducting joint research and development projects. Members include innovator and generic companies that develop, manufacture or market orally inhaled and nasal drug products for local and systemic treatment of a variety of debilitating diseases. www.ipacrs.org
International Consortium for Innovation and Quality in Pharmaceutical Development
International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) is a collaboration between more than three dozen companies with a mission of advancing science and technology to augment the capability of member companies to develop transformational solutions that benefit patients, regulators and the broader R&D community. IQ engages more than 1,000 scientists in its more than 40 Working Groups, and has produced more than 100 publications, presentations and regulatory comments since being formed in 2010. www.iqconsortium.org
International Pharmaceutical Privacy Consortium
International Pharmaceutical Privacy Consortium (IPPC) is an association of more than a dozen multinational pharmaceutical companies, which provides a forum for industry dialogue and consensus-building on privacy and data security issues related to the research, marketing, adverse event reporting and other activities of member companies. www.pharmaprivacy.org
Model Partner AwardRx - 360
MORE THAN 25 YEARS OF EXPERIENCE SUPPORTING LIFE SCIENCES COLLABORATIONS