OBIO hosted 'Going Virtual for Product Development, Manufacturing & Clinical Trials' workshop on Tuesday, March 5th, which featured three industry professionals who discussed virtual operations and shared advice on how to be successful as a virtual company. In an ecosystem where the virtual operations model for health science start-ups has become the norm, this workshop was timely and relevant for industry.
‘Going virtual’ allows companies to be very efficient in an environment where funding is limited. This model requires that you work closely with consultants and contract services organizations to develop, manufacture and test and your product.
Mary Speagle (Senior Director Regulatory & Scientific Affairs, TPIReg Innomar Strategies) talked about developing a regulatory strategy and the importance of:
Preparing a Target Product Profile (TPP) – Including indication, target population, duration of use, delivery, outcomes, risks, and modality of your product.
Determining your product’s designation – This will affect not only your regulatory pathway but what quality system you need, pharmacovigilance requirements and reimbursement strategy. This can be different in the different countries.
Conducting your regulatory intelligence – Identify relevant regulatory standards and guidances (including draft guidances), review regulatory filings of competitors to understand what they did and sign up for notifications of updates and events from the relevant regulators (FDA etc.)
Develop your plan and identify tools required (SOPs, tools for project management/communication/risk assessment, regulatory guidance and intelligence)
Identify personnel and resources needed to execute plan and timelines to execute.
Mary outlined these steps as a framework to help identify the gaps in your competencies and limits in resources, to further determine which elements of your business should be outsourced.
Kevin McCarthy (President, Bio-Atomic Scientific Marketing) talked about how to select and work with CDMOs (Contract Development and Manufacturing Organizations).
Some key takeaways were:
Consider smaller/speciality CDMOs, which tend to be more attuned to the needs and capabilities of earlier stage clients.
Quality and compliance is everything! Check for results of any regulatory inspections (FDA 483’s are especially informative), and then discuss with the CDMO what have they done to address these. Pay special attention to observations of systematic or repeated problems.
Before you sign an agreement, visit the CDMO and conduct a quality audit (typical audits are 2 days with 2 people). If you don’t have expertise in this, consider having a consultant participate.
Once you have a confidentiality/non-disclosure agreement (CDA) in place, share as much as you can about the project and any factors that might affect it (i.e. your financing status). Establishing open communication and trust will go a long way to ensuring a successful long-term relationship.
Shari-Anne Burgess (CEO, Clinsytes) wrapped up the day talking about working with clinical CROs. She outlined different services that clinical CROs can provide, including: protocol development, medical writing (such as investigator brochures, informed consent documents), site selection, site management, laboratory testing management, medical monitoring, data analysis, and regulatory support.
Some of her important points included:
Once you understand what gaps you need the CRO to fill, as Mary Speagle outlined, decide what the key drivers are (cost, time, quality) and prepare your RFP.
Review the proposals and short-list a few CROs based on their experience, their country coverage, capacity and cost. Make sure to weight these based on your key drivers – for example, faster completion might require more sites or sites in multiple countries. As Kevin McCarthy also advised, be open to smaller CROs who are often more attentive to the needs of smaller companies.
In assessing CRO quality, look at how experienced the Clinical Research Associates (CRAs) are and the level of staff turnover.
Invite the short listed CROs to visit and defend their proposal. Develop a series of questions to ask each CRO, including but not limited to: how they will manage your trial, mitigation strategies they have included, change orders, and performance monitoring.
Make sure delivery of data is independent of payment, so the CRO cannot hold or slow progress should disputes arise.
Shari strongly recommended that you, as the sponsor, be involved in site selection and relationship building. This could result in referrals to potential clinical champions and provides a direct line of communication should the sites have concerns about the CRO.
———
A recording of all three of the presentations and the associated slides will be available on the OBIO Members’ portal.
Be sure not to miss the useful template documents for an RFP and a clinical trial budget estimation tool that were provided. These will also be posted on the OBIO Members’ portal.
