Tim Wright, Editor, Contract Pharma07.23.20
MedPharm, a UK-based developer of topical and transdermal products, recently unveiled a substantial expansion at its Center of Excellence in Durham, NC. Supporting clients from discovery lead optimization to GMP clinical batch supply, MedPharm has facilities in Guildford, UK, in addition to the Durham site. The company’s expertise covers products to be applied to and/or through the skin, nail, eye, airway or mucosal membranes. Contract Pharma spoke with Jeremy Drummond, senior vice president of business development, about the expansion and MedPharm’s plans for future growth on both sides of the Atlantic.
Contract Pharma (CP): Could you please tell me about the features of the Durham facility?
Jeremy Drummond (JD): MedPharm’s facility in Durham, NC has recently been expanded to 25,000 square feet, tripling the area of the existing footprint. The $4 million investment will predominantly provide additional laboratory space and equipment.
In addition to the performance testing using our proprietary in vitro models based on human tissue, MedPharm now can offer pre-formulation/formulation development, histology and microbiology services out of North Carolina. Importantly the facility will also encompass a dedicated innovation laboratory to help solve unique problems presented by clients and ensure that MedPharm stays at the forefront of technology.
This new facility will be able to accommodate 100 new highly skilled scientific personnel.
CP: Why was the expansion necessary—were you looking to add capabilities in certain areas, capacity or both?
JD: The expansion has become necessary because of the increased demand for MedPharm’s services across all sectors of the pharmaceutical industry. There is increased demand, from biotech start-ups to Big Pharma, to develop topical and transdermal products based on new chemical entities. These companies recognize the inherent risks in topical formulation development and increasingly appreciate how MedPharm’s specialist skills coupled with its in-depth experience can de-risk their development plans and help them to attract investors when they seek funding.
The increased demand is fueled by the growing interest in developing new and repurposed drugs currently registered for oral or IV delivery for indications which require delivery through the skin, direct to the eye or into an airway. Another contributing factor has been MedPharm’s pioneering expertise in the use of in vitro models based on human tissue to meet the recently published FDA and EMEA guidances on demonstrating generic equivalence for topical medicines.
MedPharm is now also attracting projects from OTC companies who are keen to use its in vitro models to help educate their key opinion leaders about their products and broaden the marketing claims of their products with regulatory authorities.
This investment is just a first step in MedPharm’s vision to expand its services in the future, particularly around contract manufacturing.
CP: Could you tell me a little more about the dedicated innovation laboratory—its features and capabilities?
JD: MedPharm’s Innovation Laboratory has a wide-ranging remit to help customers resolve key questions to de-risk or simplify their product development.
By example, recently the team has developed a new model for assessing penetration through human nasal epithelia based on air liquid interface tissue culture of primary human cells in the laboratory. This allows clients to assess the performance of their products before they commit to clinical trial decisions.
In a further step, MedPharm has expanded these models based to support pharmaceutical development programs targeting Coronavirus treatments. These models allow clients to assess therapeutic effectiveness in nasal, airway (bronchial), and deep lung (alveolar) epithelia against members of the Coronaviridae family. The work will help to de-risk development programs and screen drugs for therapeutic effectiveness to accelerate development prior to clinical trials.
Studies have shown that human tissue can vary significantly from that of animals used in in vivo models and so this approach provides the most realistic read out of how a topical drug product is going to behave in the clinical environment.
In a similar way the innovation laboratory has refined MedPharm’s whole eye model for monitoring penetration to encompass the activity of formulations on key biochemical pathways and is extending the viability of fresh skin kept in the laboratory from weeks to months to open the opportunity for novel assays for monitoring wound healing and acne amongst others.
Contract Pharma (CP): Could you please tell me about the features of the Durham facility?
Jeremy Drummond (JD): MedPharm’s facility in Durham, NC has recently been expanded to 25,000 square feet, tripling the area of the existing footprint. The $4 million investment will predominantly provide additional laboratory space and equipment.
Medpharm's Jeremy Drummond
This new facility will be able to accommodate 100 new highly skilled scientific personnel.
CP: Why was the expansion necessary—were you looking to add capabilities in certain areas, capacity or both?
JD: The expansion has become necessary because of the increased demand for MedPharm’s services across all sectors of the pharmaceutical industry. There is increased demand, from biotech start-ups to Big Pharma, to develop topical and transdermal products based on new chemical entities. These companies recognize the inherent risks in topical formulation development and increasingly appreciate how MedPharm’s specialist skills coupled with its in-depth experience can de-risk their development plans and help them to attract investors when they seek funding.
The increased demand is fueled by the growing interest in developing new and repurposed drugs currently registered for oral or IV delivery for indications which require delivery through the skin, direct to the eye or into an airway. Another contributing factor has been MedPharm’s pioneering expertise in the use of in vitro models based on human tissue to meet the recently published FDA and EMEA guidances on demonstrating generic equivalence for topical medicines.
MedPharm is now also attracting projects from OTC companies who are keen to use its in vitro models to help educate their key opinion leaders about their products and broaden the marketing claims of their products with regulatory authorities.
This investment is just a first step in MedPharm’s vision to expand its services in the future, particularly around contract manufacturing.
CP: Could you tell me a little more about the dedicated innovation laboratory—its features and capabilities?
JD: MedPharm’s Innovation Laboratory has a wide-ranging remit to help customers resolve key questions to de-risk or simplify their product development.
By example, recently the team has developed a new model for assessing penetration through human nasal epithelia based on air liquid interface tissue culture of primary human cells in the laboratory. This allows clients to assess the performance of their products before they commit to clinical trial decisions.
In a further step, MedPharm has expanded these models based to support pharmaceutical development programs targeting Coronavirus treatments. These models allow clients to assess therapeutic effectiveness in nasal, airway (bronchial), and deep lung (alveolar) epithelia against members of the Coronaviridae family. The work will help to de-risk development programs and screen drugs for therapeutic effectiveness to accelerate development prior to clinical trials.
Studies have shown that human tissue can vary significantly from that of animals used in in vivo models and so this approach provides the most realistic read out of how a topical drug product is going to behave in the clinical environment.
In a similar way the innovation laboratory has refined MedPharm’s whole eye model for monitoring penetration to encompass the activity of formulations on key biochemical pathways and is extending the viability of fresh skin kept in the laboratory from weeks to months to open the opportunity for novel assays for monitoring wound healing and acne amongst others.
