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BOSTON—Emerging biotech companies face an increasingly critical task of identifying and developing new medicines in a more cost-efficient, timely and simple manner than ever before. PAREXEL Biotech, a new, dedicated division of PAREXEL International Corp., attempts to support emerging biotech companies in reaching their drug development and commercialization goals quickly and cost-effectively. It combines the biopharmaceutical service company’s expertise and global infrastructure with a model tailored to this specific segment, providing enhanced strategic consulting and asset development capabilities through a new biotech-focused team and organizational structure.
The new division, which is being led by James Anthony, global head of biotech, and Graciela Racaro, global head of biotech operations, is designed to assist emerging companies in minimizing complexity, reducing costs and accelerating timelines. PAREXEL Biotech takes a consultative approach to develop tailored strategies that help companies achieve their objectives throughout the journey from discovery to proof of concept, development, registration and ultimately, commercialization.
PAREXEL Biotech includes the following services: global regulatory consulting, with over 50 former regulators from around the world and more than 1,000 regulatory experts on staff; strategy consulting led by Health Advances, a boutique consultancy with over 26 years of experience in the biotech sector; China Advisory Services to enable companies to participate in the growing, yet complex market opportunity within China; Quantitative Clinical Development and Genomic Medicine Services to optimize clinical success and maximize product value; and patient recruitment services said to provide 22 percent faster enrollment from first subject randomized to last subject randomized. Additionally, there are trial execution services, with completion rates historically 4 percent faster than industry averages from final protocol available to Clinical Study Report approved, and Real World Evidence programs informed by and connected to biotech stakeholder perspectives and requirements.
To solve challenges for emerging biotech companies, PAREXEL Biotech provides strategic guidance for challenging decisions, such as partnering options, indication selection, M&A, raising capital and competitive assessments, according to its website. The company focuses on developing strategies based upon an emerging company’s unique goals backed by PAREXEL’s track record.
Believing that starting with the end in mind is the best way to maximize a company’s chances of success, PAREXEL Biotech offers expert consultants to supply strategic, regulatory, development and market access guidance. That includes many former regulators, payers and business experts who can help emerging companies to optimize the value of their assets and chart the fastest, most efficient course to achieve business goals.
The new division takes a flexible approach to drug development. It can provide as much advice as is needed, customizing and scaling the approach specifically to meet a biotech company’s unique needs. It gives companies the opportunity to work with a single development partner across clinical development, providing regulatory and strategic consulting and commercialization expertise to keep a company’s study from stagnating in incomplete planning or missing pieces.
According to Anthony, “Today’s emerging biotech companies have an increasingly critical role in identifying and developing new medicines that truly serve as the innovative arm of the industry. However, these companies face significant pressures and challenges in terms of timelines, resources and funding to succeed. Our reputation for supporting clients gives us the opportunity to work on a wide variety of projects. So, no matter your drug’s method of action or therapeutic area, we’ve run trials with similar therapies and can guide you to appropriate sites and protocol definition.”
Racaro added, “We look forward to combining PAREXEL’s expertise and global infrastructure with an agile and efficient delivery model that is aligned to this specific segment, enabling emerging biotech companies to focus on their core capabilities and reach their strategic goals.”
“PAREXEL has been working to support biotech companies across the globe with clinical research services and regulatory consulting for many years, successfully accomplishing more than 650 projects in this space and developing a deep understanding of the needs of these companies,” summarized Peyton Howell, chief commercial and strategy officer for PAREXEL. “To build on our commitment to biotech success, we have grown our capabilities to include management and strategy consulting, pipeline development, value substantiation and evidence vetting. This enables us to provide experience, expertise and partnership throughout the biotech journey, and bring even greater value to this sector.”