The CRO Advantage: Outsource Clinical Trials to Launch Biotech Development Success - - BioPharm International


The CRO Advantage: Outsource Clinical Trials to Launch Biotech Development Success

BioPharm International

WHAT TO LOOK FOR IN A CRO PARTNER Aside from the usual criteria for selecting a CRO, finding an outsourcing partner for biologic product development requires some unique and distinct features. Included here are some criteria to establish when choosing a CRO to implement an effective biotech clinical development program.

The CRO should understand the issue of limited resources and utilize its assets to address this concern.

For emerging biotech firms, issues of financing can hinder the success of a drug. Choosing the right CRO who understands sound decision-making is critical to saving time and money. Clinical proof-of-concept to be achieved rapidly is a key goal. Look for a CRO who can design proof-of-concept studies that demonstrate efficacy early on. The CRO should also have a record of reproducibility for developing clinical proof-of-concept in record time. This allows a small biotech to use this information (if it is positive) to help a drug candidate attract either venture-capital revenue or a development partner. Alternatively, if the results are not positive, they can help a biotech company refocus its efforts in an alternative direction, saving considerable time and money.

When a biotech company partners or outsources with a CRO, one of its main goals should be to gain knowledge from the alliance that can be applied to drug development. CROs who have experience running clinical trials with biologics usually have skills that the biotech company lacks, and vice versa. The CRO can offer an understanding of how to create a medicine, while the biotech company can offer other skills such as a different philosophy of chemical design, a different approach to choosing targets, or an alternative method of assessing the targets that are more likely to succeed. When combined with the CRO's skills, these qualities are likely to make each party more successful, leading to a successful clinical trial program.

The CRO should have experience working with novel, complex therapies — especially products in new, untested drug classes.

The new frontiers of medicine reside in research that biotech companies are conducting with large molecules and macro-molecules. Many pharmaceutical companies are reevaluating the potential of biotech drugs and are focusing internal initiatives in this direction. For example, Eli Lilly has redirected its focus in drug development from traditional small molecule pharmaceuticals to biologics.

Unlike traditional new molecular entities (NMEs), biological products often require novel trial designs. This is because experience with biologics is very young versus small molecules for which decades of clinical and regulatory experience exists. Regulatory guidance and experience with biotech product development helps. However, biotech drug development will always be challenging because development is rarely repeated. It is important to find a CRO with an established record of working with regulatory agencies on behalf of novel trial designs, and is flexible and innovative in its development approach.

The process of discovering when to terminate research seems to be different for biologics than for chemical entities. Biologics are less likely than chemical compounds to be eliminated in Phase I and II testing, but they are more likely to be discontinued at Phase III.5 A CRO with experience navigating these clinical waters is key to developing a successful product submission.

The CRO should have experience in implementing demanding fast-track and accelerated approval programs.

FDA is predisposed to accelerating the approval for drugs that fulfill unmet medical needs such as cancer and viral diseases. Biotech companies developing products that fall into these two therapeutic categories, including oncology, infectious diseases, autoimmune, HIV/AIDS, and central nervous system (neurodegenerative diseases), should consider partnering with CROs who can maneuver the complex trial implementation and conduct that accelerated approval processes present. With more biotech products entering late-stage trials, Ernst and Young analysts have said, "Biotech companies no longer are the minor-league managers of drug development, passing off potential star products to big pharma for a license fee and single-digit royalties, then returning to the laboratory to make more discoveries."6 They are now collaborating in co-development deals with big pharma companies where they often take the lead in development while the pharma company provides the sales and marketing efforts to ensure an equitable share of the profits. With biotech companies taking the lead in terms of development, a key issue they face is outsourcing to the appropriate CRO if they do not have the resources to carry out the clinical trial programs internally.

The CRO should facilitate a smooth integration of specialty vendors and service providers into the development team.

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