Working With Clients

We are driven to deliver the highest level of quality in our output. The success of our clients directly translates into success for us.

We are a purely services-based organization, with no competing internal programs of our own. We work on a fee for service model, where the output for our efforts is owned by the clients.

We provide solutions to our clients by providing them the ability to focus on their key priorities, while leaving the heavy lifting to us, especially when it comes to global collaborations in the realm of:

  •  Sourcing meaningful global collaborations
  •  Setting up the legal agreements and collaborative structure
  •  Project oversight and management by means of regular face-to-face meetings with the collaborator(s)
  •  Navigating inter-cultural communication
  •  Ensuring project milestones and successful completion

The typical sequence of interactions with clients is described in the flow chart below.

Case Study 01: Voice of Customer (VoC) and R&D for Medical Device Innovation

 Some specific details for Case Studies might be available under a Confidentiality Agreement

 

Project Objectives

Worked for one of the largest US-based Medical Device companies to collect Voice of Customer (VoC) data, in order to understand unmet surgeon needs for a medical device to treat tumors with a specific procedure.

Execution of Project

In executing on the project objectives, Enable Life Sciences:

  • Created a competitive landscape summary of available medical devices for the specific tumor-treatment procedure of interest
  • Created Surgeon questionnaire to understand and prioritize unmet customer needs for the specific surgical procedure [early 2013]
  • Executed the Voice of Customer (VoC) data collection with well-recognized Europe, Asia and US-based surgeons, i.e. Key Opinion Leaders (KOLs) [mid – late 2013; countries covered included the US, Germany, UK, France, Greece, India, Singapore and Vietnam]
  • Quantified and interpreted the Voice of Customer (VoC) Data [late 2013]
  • Organized a Medical Advisory Board (MAB) on the sidelines of a major European medical devices conference, in order to validate the interpretation of the collected VoC data [fall of 2013]
  • Brainstormed with Key Opinion leaders (KOLs) to create the product concept [fall of 2013]
  • Translated the crystallized product concept into a technology development plan for the client [2013-2014], including
    • Intellectual Property (IP) creation
    • Generation of proof-of-principle preclinical data
    • Optimization of the manufacturing process, and
    • Method development for analytical characterization

Concrete Project Outcomes

Enable Life Sciences made contributions to successfully build a business case around the product concept, in collaboration with the Upstream Marketing function at the client. In collaboration with the R&D function at the client, a collective set of 15+ patent applications were filed on the technology, and successful proof-of-principle preclinical testing was carried out. Eventually, these efforts facilitated the securement of internal funding for the formal product development activities (Design Control) for the envisioned medical device.

 

Case Study 02: Vascular Graft Performance Testing for Regulatory Submission

 

Project Objectives: Enable Life Sciences was engaged by a European division of one of the largest global medical device companies to plan and oversee the performance testing of the new coating on two of their CE-marked vascular grafts [anti-microbial and anti-thrombotic performance], in preparation for the regulatory submission of this performance data.

Execution of Project

In executing on the project objectives, Enable Life Sciences:

  • Led detailed internal discussions at the medical devices company to review historical performance data, and translate the project objectives into a project-execution plan
  • Created Request for Proposals (RFPs) for the medical device biomaterial performance testing
  • Vetted and selected 3 contract labs for the experimental execution [two labs based in the US, and one lab based in Canada]
  • Created the legal framework for the performance testing to be pursued at the selected contract labs
  • Led the project management efforts for the performance testing at the 3 contract labs, in coordination with the client’s R&D and Regulatory leadership
  • Oversaw the documentation (comprehensive reports) of the analytical results, and created a data-driven framework for the regulatory submission

Concrete Project Outcomes

In a period of less than 10 weeks, the data sets for the anti-microbial and anti-thrombotic performance of the medical device biomaterial were produced under GMP or ISO-13485, and in time for the regulatory submission deadline.

 

 

Case Study 03: Creating Global Collaborations for Generic Pharmaceuticals and Novel Formulations Development

 Some specific details for Case Studies might be available under a Confidentiality Agreement

 

Project Objectives

Carry out a global search for a US-based Fortune 500 Pharmaceutical company to identify global resources for collaboration, in order to pursue generic pharmaceuticals and novel formulations development.

Execution of Project

In executing on the project objectives, Enable Life Sciences:

  • Focused on non-traditional geographies for the client, i.e. outside of North America and Western Europe, per client requirements
  • Evaluated and analyzed the pharmaceutical industries of 14 countries located in 4 continents, namely:
    • Asia (China, India, Taiwan, Vietnam and Malaysia)
    • Eastern Europe (Poland, Hungary, Turkey, Romania, Czech Republic)
    • Latin America (Brazil, Chile)
    • Africa / Mid-East (Israel, South Africa)
  • Put together a customized project team of regional pharmaceutical experts located in these 4 continents [on a sub-contracting basis] for the project
  • Listed more than 150 organizations in the above 14 countries for the client
  • Rank-ordered the short-listed organizations in each region on the basis of objective, quantifiable criteria developed in close collaboration with the client and the sub-contracting regional experts
  • Conducted site-visits at the short-listed organizations in Taiwan and India
  • Orchestrated and led conference-call discussions with short-listed entities (less than 5 for the final choice), and mapped the unique strengths and weaknesses of each short-listed entity
  • Created a final project plan for the client, with project components distributed between organizations and entities [on the basis of the unique strengths of the various organizations and countries]

Concrete Project Outcomes

In a period of less than 6 months, Enable Life Sciences was able to navigate a wide global geography to successfully identify the most relevant validated contract resources for the client. In addition, Enable Life Sciences created a concrete project-plan to distribute project components between organizations and countries based on their unique strengths. Additionally, a project-management plan for project-oversight and project-integration [through Enable Life Sciences resources located in various geographies] was created.

 

Case Study 04: Extractables and Leachables Testing for PMA Medical Device

 

Project Objectives

Enable Life Sciences was engaged by a US-based Medical Devices company to lead Extractables and Leachables testing for the company’s PMA (Pre Market Approval) implantable medical device, and answer a formal question (posed to the medical devices company) by the US FDA (Food and Drug Administration)

Execution of Project

In executing on the project objectives, Enable Life Sciences:

·      Led detailed internal discussions at the medical devices company to comprehensively interpret the FDA question and facilitated translation of the question into an action plan for analytical testing

·      Created a Request for Proposal (RFP) for the Analytical testing effort required for the Extractables and Leachables testing

·      Evaluated a short list of US-based service Contract service providers for the Extractables and Leachables testing, and recommended one to the client based on site visits

·      Created the legal agreement framework for the testing to be initiated (in coordination with the client’s legal resources)

·      Led the project management efforts for the Extractables and Leachables testing carried out by the chosen contract lab, in coordination with the client’s R&D and Regulatory leadership, including analysis based on:

  • high performance liquid chromatography (HPLC)
  • gas chromatography (GC)
  • nuclear magnetic resonance (NMR)
  • inductively coupled plasma mass spectrometry (ICP-MS), and
  • gel permeation chromatography (GPC)

·      Led the documentation (comprehensive reports) of the analytical results and created a data-driven framework to answer the question posed by the FDA

Concrete Project Outcomes

In a period of a few months, Enable Life Sciences was able to deliver concrete results for the medical devices client. These included (a) planning and creating an analytical frame of reference to answer the FDA question (b) executing and overseeing the testing with the appropriate analytical methodology, and (c) documentation of the results in the context most relevant to answering the question posed by the FDA

 

Case Study 05: Medical Device Prototyping and IP Creation

 

Project Objectives

Creation of Intellectual Property (IP) for energy-based interventional medical devices, and the evolution of prototypes on the basis of filed patent applications

Execution of Project

In executing on the project objectives, Enable Life Sciences:

·      Led synergistic brainstorming and ideation sessions involving 3 client sites (1 based in China and 2 based in the US). These included on-site brainstorming sessions in China and the US

·      Led the creation of a family of 4 filed patent applications with the United States Patent and Trademark Office (USPTO). Participants from both the China and US sites of the client ended up as co-inventors, based on their contributions.

·      Oversaw the project efforts at a 3rd contract entity (chosen and recommended to the client by Enable Life Sciences), which resulted in the creation of 3-D working prototypes of the energy based interventional medical devices conceptualized in the patent applications

Concrete Project Outcomes

The efforts by Enable Life Sciences on behalf of its medical devices client resulted in (a) synergy and collaboration between the client’s R&D sites (b) creation of valuable IP assets, and (c) evolution of 3-D prototypes of the innovative medical device concepts, thus forming a basis for downstream VoC (Voice of Customer) efforts with the surgeon communities in both developed and emerging markets

Case Study 06: Leveraging Collaborations in Asia for Preclinical Evaluation of Drug-Device Combination Product Development

 

Project Objectives

Identification of high-quality, but cost-effective contract resources for the preclinical evaluation of the client’s drug-device combination product prototype

Execution of Project

In executing on the project objectives, Enable Life Sciences:

·      Led the search in Asia for high-quality but cost-effective contract resources for the preclinical testing – primarily in Taiwan and India

·      Created Requests for Proposals (RFPs) for the preclinical evaluation, and based on the response to RFPs and site visits, made a final recommendation to the client (which was accepted)

·      Facilitated the formal site visit to the chosen contract lab in India by the client’s preclinical organization head

·      Created the legal agreement framework for the testing to be initiated (in coordination with the client’s legal resources)

·      Led the project management efforts for the preclinical testing carried out by the chosen contract lab, in coordination with the client’s R&D leadership. This project-management effort included site visits in India every 8-12 weeks during the course of the project execution

·      Led the documentation (comprehensive reports) of the preclinical results for the client

Concrete Project Outcomes

The efforts by Enable Life Sciences resulted in (a) the successful identification of a global resource for its medical devices client, resulting in ~70% cost savings as well as the yield of high-quality and well-documented preclinical results (b) the communication of the obtained preclinical results at international scientific conferences by the client, and (c) the internal approval and funding (at the client end) for the R&D efforts advancing the combination product development