CRO industry continues to expand

Outsourcing is an integral part of the biopharmaceutical industry’s value chain, primarily during the clinical phases of research and development. Frost and Sullivan highlights that the increasing cost of research, the loss of revenue from leading blockbusters going off patent and the lack of extensive in-house R&D infrastructure has driven many biotechnology companies to outsource clinical trials to contract research organizations. The industry has been growing consistently over the past decade as more and more pharmaceutical companies are opting to outsource clinical research activities. BioSpectrum Asia takes a look at clinical research companies that made headlines in the last one year through their expansion, acquisition and growth strategy to harness the opportunity.

Charles River partners with Microbiologics

Charles River Microbial Solutions has partnered with Microbiologics, a ready-to-use QC microorganisms provider, for quality control testing in the clinical, pharmaceutical, food, water and educational industries. Through this distribution agreement, Charles River customers can use Microbiologics capabilities to facilitate the preservation, manufacturing and secure storage of their isolates into a customized quality control reagent kit. Customers can then demonstrate that bacterial or fungal species found in their production environment that represent risk are detectable when used in growth promotion of media, sterility testing, preservative effectiveness and validation studies. Nimbus Therapeutics and Charles River Laboratories have launched a multi-year strategic partnership to advance new programs spanning the disease areas of immunology, metabolic disorders and oncology from the discovery phase through to Investigational New Drug (IND) submission.

PAREXEL acquires The Medical Affairs Company

PAREXEL has acquired The Medical Affairs Company (TMAC), a leading provider of outsourced medical affairs services to the pharmaceutical, biotechnology, and medical device industries. TMAC is a full-service contract medical organization that provides strategic and tactical medical science liaison (MSLs) and clinical nurse educator support services in addition to medical affairs consulting, medical communications support, and direct placement services. Outsourcing medical affairs services presents a compelling option for biopharmaceutical companies as a way to reduce fixed costs. The increasingly complex nature of new products, and the need to demonstrate the therapeutic and reimbursement value of a product, is creating demand for credentialed healthcare professionals, such as MSLs, to lead clinically robust dialogues with key medical stakeholders on a peer-to-peer level, the company states.

WuXi AppTec acquires HD Biosciences

WuXi AppTec, a leading global pharmaceutical, biotechnology and medical device open-access capability and technology platform, has acquired HD Biosciences (HDB), a leading biology focused preclinical drug discovery CRO. After acquisition, HD Biosciences is a wholly-owned subsidiary of WuXi, and will continue to focus on growing its core competences and providing greater services. WuXi NextCODE and the National Heart Centre Singapore (NHCS) have partnered to advance population-based genomic research and precision medicine applications in Singapore. This marks an important first step in a national precision medicine initiative that brings together NHCS as a leading research hospital in cardiovascular disease, SingHealth Duke-NUS PRISM, as the institutional flagship program on Precision Medicine. Under the partnership, WuXi NextCODE will create an instantly queriable cloudbased enterprise data warehouse integrating largescale whole genome sequence, medical and wearables data from both cardiovascular patients and healthy control subjects recruited by NHCS. WuXi AppTec has acquired Crelux, a leading structure based drug discovery provider based in Munich, Germany. The addition of Crelux provides augmented scientific depth and complements existing capabilities within the WuXi structure-based drug discovery platform. Crelux was founded in 2005 and has its laboratories at the Innovation Center for Biotechnology (IZB) in Martinsried. As a global leader in structure-ased drug discovery, Crelux has been providing the drug discovery industry with highly individualized and efficient solutions to inform and accelerate their programmes for more than a decade.

INC Research to merge with inVentiv Health

Clinical research organizations INC Research and inVentiv Health have agreed for a merger pursuant to which their businesses would combine in an all-stock transaction, creating a leading global biopharmaceutical solutions organization.Upon completion of the transaction the combined company will leverage commercial insights to inform the clinical trial process, designing studies to be more efficient and effective to address evolving patient and payer needs. INC Research has expanded its Osaka, Japan office in support of the company’s long-term growth strategy both in Japan and across the Asia/Pacific region. Since 2015 INC Research’s Japanese operations have more than tripled their employee headcount and expect continued strong growth.

PPD enhances real-time analysis services

Pharmaceutical Product Development (PPD), has developed a dedicated unit combining its medical affairs research operations (MARO) team and Evidera, the provider of evidence-based solutions to demonstrate the real-world effectiveness, safety and value of biopharmaceutical and biotechnology products. PPD acquired Evidera to create transformative opportunities for biopharmaceutical clients. The new dedicated unit, retaining the Evidera name, will provide customers with global comprehensive and integrated solutions, including modeling and simulation, interventional studies (including expanded access/compassionate use and extended access), observational studies (including registries), health economics, outcomes research, market access, epidemiology, real-world evidence, safety and risk management.