Gil Roth, Contract Pharma09.05.13
When we think of pharma/academia tie-ups, we tend to think of drug discovery partnerships and enormous (potential) milestones and royalties. But as the new school year begins, we thought we’d take a look at some intriguing collaborations overin the pharmaceutical technology department and see how some CMOs are benefiting from university connections.
A number of CMOs and CDMOs we spoke with told us that they’ve worked on projects with academia, but that these are generally fee-for-service transactions, not true partnerships. A number of them also have relationships with local universities to provide internships and training for pharmaceutical students. However, Aesica and Catalent have each forged deeper bonds with academia through new initiatives.
In 2012, UK-based Aesica (twitter: @aesica) established the Aesica Innovation Board (AIB), a lineup consisting of in-house and external experts, with the goal of “stimulat[ing] pharmaceutical innovation in a climate where developing original technologies and formulations is an ongoing challenge.”
The AIB has formed partnerships with several universities in the UK in the past year, including the Centre for Pharmaceutical Engineering Science at the University of Bradford (centering on clinical trial materials and hot melt extrusion expertise), the University of Durham and the University of Leeds (new manufacturing processes for APIs at Aesica’s Cramlington plant), and University of Nottingham (for commercial development of alternative methods in amide bond synthesis). Some of the universities had been working with Aesica previously, but the AIB provides a way to leverage those relationships, putting a framework in place to find the opportunities that make a strategic fit for both sides.
Alan Raymond, Ph.D., Aesica’s Sales and Marketing director, cited the innovation gap as the reason Aesica established AIB. He remarked, “Rather than investing substantial money into an R&D facility, we decided to explore another way of gaining access to proprietary technologies and know-how that would increase our competitiveness. We realized that if you look at the competitive landscape in terms of what customers are looking for from their partners, there was an opportunity to do more than offer cost-effective, quality, effective solutions.”
Those initial partnerships are with UK universities, but Mr. Raymond noted that the AIB is looking to establish a global network of partners in both academia and industry. “We’re pursuing opportunities in chemistry — novel chemical processes, ways to shorten a synthetic route, greener models — and pharmaceutical technologies: formulation development and processing, and trying to improve operational effectiveness in the finished dosage form manufacturing environment,” he said.
And how do university professors and students feel about collaborating with industry? Mr. Raymond answered, “There’s a bit of a culture clash, certainly. In a sense, we have conflicting objectives. Academia is traditionally focused on publishing papers, but that runs up against a commercial company’s IP strategy. Also, academia can be very interested in something that they can patent, regardless of its commercial feasibility. But there’s a key factor that helps translational science, and that’s the people. If you get key people from both sides, you can exploit the synergies between academia and the marketplace. That’s the model we’re trying to create with Aesica’s Innovation Board. We have an understanding of market needs and competitive value propositions. We can understand the science, but the academics are the experts and thought leaders. We want to map out a translation plan to take fantastic ideas and put together a proof-of-concept study.”
With the EU’s penchant for post-crash austerity, academia in the region seems to have more interest in partnering with industry. They’re facing significant cost pressure as government funding is under severe constraints, so they need alternate funding sources for the research they want to undertake. Said Mr. Raymond, “They realize that there’s nothing ‘substandard’ about doing research work that has industrial and practical applications.
“The AIB is not going to be about having fantastic patents and wonderful ideas; they have to be commercially viable,” he added. “Their benefits have to be worth something to a patient, to a doctor, to a pharmacist, to the marketer. That’s the question we’re focused on: how does this technology make the medicine better?”
Improving medicines and outcomes is also the goal for the Catalent Applied Drug Deliery Institute (CADDI, twitter: @drugdeliveryins), established by Catalent Pharma Solutions in 2012. CADDI’s stated aim is focusing on increasing adoption of drug delivery technology across the industry by strengthening the bridge between academia and industry, facilitating collaboration, disseminating knowledge of applied drug delivery and encouraging innovation in new drug delivery methods.
CADDI includes partnerships with both academia and industry. Also, in contrast to the AIB, Catalent’s initiative encompasses a broader educational mission, featuring seminars and publications, as well as an annual academic competition.
Terry T. Robinson, executive director of CADDI, told us, “CADDI was founded because several of Catalent’s executives felt that there are unmet needs in the drug delivery space. Dr. Kurt Nielsen [Catalent’s chief technology officer and senior vice president of R&D] and several colleagues felt that drug delivery technology was really not fully utilized and could help get more molecules to market and improve their clinical profiles.
“There was a feeling that the industry needed to come together to help overcome the issues of thin and complex pipelines, with pharma and technology companies needing to bring in academia and other experts to really collaborate on solutions,” she added. “There was also a strong feeling that there needed to be more focus on real-world outcomes and designing products for success from the beginning (for example: ability to manufacture, built-in patient adherence features, simplicity of dosing regimens and optimized dose forms, etc.).”
Elliot Berger, founding executive board member of CADDI and global vice president, Marketing & Strategy at Catalent, stressed that the institute isn’t intended to be self-promotion for Catalent: “The goal of the institute is to get the industry to look at applied drug delivery technologies earlier in the process as a key enabler to get more products to market with better outcomes. This is not a commercial effort; we need this to be a forum where multiple industry players can be involved. It’s important that we’re not proprietary about this. If a formulation is best served as a transdermal, you should go to 3M. If it should be in silica, Formac Pharmaceuticals has technologies you should use. BASF is a key resource for functional excipients.”
A CADDI seminar in NJ last June brought together large and small pharma company scientists to discuss new technologies with presenters from New Jersey Institute of Technology (NJIT), Bend Research, BASF, Catalent and Formac. The Institute will follow that up with a European event, “Overcoming Bioavailability Challenges,” at The Royal Society of Chemistry’s (RSC) headquarters in London on October 3. The UK event will include a talk about pulmonary delivery by Dr. Rob Price, a professor at University of Bath, and an R&D leader from 3M who will focus on transdermal drug delivery technologies.
“We feel there is a growing need to tie universities and industry together earlier in the drug development process and ensure that there is increased awareness of innovative delivery platforms,” said Ms. Robinson. “The Catalent Institute wants to support the incubation of innovative technologies to help them advance to commercialization where possible.”
To that end, CADDI is also working with other institutions beyond industry and academia. This year, the American Asso-ciation of Pharmaceutical Scientists (AAPS) is coordinating jointly on CADDI’s academic competition; AAPS helped provide annual memberships to the students who submitted for the competition. Last year, more than 30 students submitted review articles for the competition, and all of them received a year’s membership for AAPS. The top four winners received complimentary registration for the AAPS Annual Meeting, which is a significant value to these students, and several advising professors also received complimentary registration for this year’s meeting in San Antonio based on their efforts supporting the academic competition. Those of us who were on the ramen diet in college and grad school remember how limited our funds were; having AAPS dues covered can mean a lot for students who need to begin networking for their first pharma jobs.
The Catalent Institute has also published the Oral Drug Delivery Reference Guide, an overview of drug delivery techniques, and has other publications planned. “The institute will gain credibility on its own through educational training, drug delivery collaborations and publications, and technology incubation that results in optimal outcomes for patients,” said Ms. Robinson. She added that CADDI has public awareness goals beyond its work with universities and students, noting, “We hope to become involved with teaching hospitals, patient advocacy groups, disease state groups, and more. We’re working on a whitepaper with the Geriatric Medicines Society focused on improving drug delivery for that patient population.”
Mr. Raymond at Aesica noted that the Innovation Board is also about moving beyond pharma’s standard models. He commented, “It’s not about selling the Aesica Innovation Board. The AIB is an enabler to let us reach out to a new target audience. Our target traditionally has been the pharma industry, but now we’re interested in raising our awareness among scientists and technologists who have great ideas that could make a difference in the pharma industry.”
The key for both of these initiatives is that the CMOs are willing to learn from outside experts. Which, in a sense, is what education is all about.
Gil Y. Roth has been the editor of Contract Pharma since its debut in 1999. He can be reached at groth@rodmanmedia.com.
A number of CMOs and CDMOs we spoke with told us that they’ve worked on projects with academia, but that these are generally fee-for-service transactions, not true partnerships. A number of them also have relationships with local universities to provide internships and training for pharmaceutical students. However, Aesica and Catalent have each forged deeper bonds with academia through new initiatives.
In 2012, UK-based Aesica (twitter: @aesica) established the Aesica Innovation Board (AIB), a lineup consisting of in-house and external experts, with the goal of “stimulat[ing] pharmaceutical innovation in a climate where developing original technologies and formulations is an ongoing challenge.”
The AIB has formed partnerships with several universities in the UK in the past year, including the Centre for Pharmaceutical Engineering Science at the University of Bradford (centering on clinical trial materials and hot melt extrusion expertise), the University of Durham and the University of Leeds (new manufacturing processes for APIs at Aesica’s Cramlington plant), and University of Nottingham (for commercial development of alternative methods in amide bond synthesis). Some of the universities had been working with Aesica previously, but the AIB provides a way to leverage those relationships, putting a framework in place to find the opportunities that make a strategic fit for both sides.
Alan Raymond, Ph.D., Aesica’s Sales and Marketing director, cited the innovation gap as the reason Aesica established AIB. He remarked, “Rather than investing substantial money into an R&D facility, we decided to explore another way of gaining access to proprietary technologies and know-how that would increase our competitiveness. We realized that if you look at the competitive landscape in terms of what customers are looking for from their partners, there was an opportunity to do more than offer cost-effective, quality, effective solutions.”
Those initial partnerships are with UK universities, but Mr. Raymond noted that the AIB is looking to establish a global network of partners in both academia and industry. “We’re pursuing opportunities in chemistry — novel chemical processes, ways to shorten a synthetic route, greener models — and pharmaceutical technologies: formulation development and processing, and trying to improve operational effectiveness in the finished dosage form manufacturing environment,” he said.
And how do university professors and students feel about collaborating with industry? Mr. Raymond answered, “There’s a bit of a culture clash, certainly. In a sense, we have conflicting objectives. Academia is traditionally focused on publishing papers, but that runs up against a commercial company’s IP strategy. Also, academia can be very interested in something that they can patent, regardless of its commercial feasibility. But there’s a key factor that helps translational science, and that’s the people. If you get key people from both sides, you can exploit the synergies between academia and the marketplace. That’s the model we’re trying to create with Aesica’s Innovation Board. We have an understanding of market needs and competitive value propositions. We can understand the science, but the academics are the experts and thought leaders. We want to map out a translation plan to take fantastic ideas and put together a proof-of-concept study.”
With the EU’s penchant for post-crash austerity, academia in the region seems to have more interest in partnering with industry. They’re facing significant cost pressure as government funding is under severe constraints, so they need alternate funding sources for the research they want to undertake. Said Mr. Raymond, “They realize that there’s nothing ‘substandard’ about doing research work that has industrial and practical applications.
“The AIB is not going to be about having fantastic patents and wonderful ideas; they have to be commercially viable,” he added. “Their benefits have to be worth something to a patient, to a doctor, to a pharmacist, to the marketer. That’s the question we’re focused on: how does this technology make the medicine better?”
Improving medicines and outcomes is also the goal for the Catalent Applied Drug Deliery Institute (CADDI, twitter: @drugdeliveryins), established by Catalent Pharma Solutions in 2012. CADDI’s stated aim is focusing on increasing adoption of drug delivery technology across the industry by strengthening the bridge between academia and industry, facilitating collaboration, disseminating knowledge of applied drug delivery and encouraging innovation in new drug delivery methods.
CADDI includes partnerships with both academia and industry. Also, in contrast to the AIB, Catalent’s initiative encompasses a broader educational mission, featuring seminars and publications, as well as an annual academic competition.
Terry T. Robinson, executive director of CADDI, told us, “CADDI was founded because several of Catalent’s executives felt that there are unmet needs in the drug delivery space. Dr. Kurt Nielsen [Catalent’s chief technology officer and senior vice president of R&D] and several colleagues felt that drug delivery technology was really not fully utilized and could help get more molecules to market and improve their clinical profiles.
“There was a feeling that the industry needed to come together to help overcome the issues of thin and complex pipelines, with pharma and technology companies needing to bring in academia and other experts to really collaborate on solutions,” she added. “There was also a strong feeling that there needed to be more focus on real-world outcomes and designing products for success from the beginning (for example: ability to manufacture, built-in patient adherence features, simplicity of dosing regimens and optimized dose forms, etc.).”
Elliot Berger, founding executive board member of CADDI and global vice president, Marketing & Strategy at Catalent, stressed that the institute isn’t intended to be self-promotion for Catalent: “The goal of the institute is to get the industry to look at applied drug delivery technologies earlier in the process as a key enabler to get more products to market with better outcomes. This is not a commercial effort; we need this to be a forum where multiple industry players can be involved. It’s important that we’re not proprietary about this. If a formulation is best served as a transdermal, you should go to 3M. If it should be in silica, Formac Pharmaceuticals has technologies you should use. BASF is a key resource for functional excipients.”
A CADDI seminar in NJ last June brought together large and small pharma company scientists to discuss new technologies with presenters from New Jersey Institute of Technology (NJIT), Bend Research, BASF, Catalent and Formac. The Institute will follow that up with a European event, “Overcoming Bioavailability Challenges,” at The Royal Society of Chemistry’s (RSC) headquarters in London on October 3. The UK event will include a talk about pulmonary delivery by Dr. Rob Price, a professor at University of Bath, and an R&D leader from 3M who will focus on transdermal drug delivery technologies.
“We feel there is a growing need to tie universities and industry together earlier in the drug development process and ensure that there is increased awareness of innovative delivery platforms,” said Ms. Robinson. “The Catalent Institute wants to support the incubation of innovative technologies to help them advance to commercialization where possible.”
To that end, CADDI is also working with other institutions beyond industry and academia. This year, the American Asso-ciation of Pharmaceutical Scientists (AAPS) is coordinating jointly on CADDI’s academic competition; AAPS helped provide annual memberships to the students who submitted for the competition. Last year, more than 30 students submitted review articles for the competition, and all of them received a year’s membership for AAPS. The top four winners received complimentary registration for the AAPS Annual Meeting, which is a significant value to these students, and several advising professors also received complimentary registration for this year’s meeting in San Antonio based on their efforts supporting the academic competition. Those of us who were on the ramen diet in college and grad school remember how limited our funds were; having AAPS dues covered can mean a lot for students who need to begin networking for their first pharma jobs.
The Catalent Institute has also published the Oral Drug Delivery Reference Guide, an overview of drug delivery techniques, and has other publications planned. “The institute will gain credibility on its own through educational training, drug delivery collaborations and publications, and technology incubation that results in optimal outcomes for patients,” said Ms. Robinson. She added that CADDI has public awareness goals beyond its work with universities and students, noting, “We hope to become involved with teaching hospitals, patient advocacy groups, disease state groups, and more. We’re working on a whitepaper with the Geriatric Medicines Society focused on improving drug delivery for that patient population.”
Mr. Raymond at Aesica noted that the Innovation Board is also about moving beyond pharma’s standard models. He commented, “It’s not about selling the Aesica Innovation Board. The AIB is an enabler to let us reach out to a new target audience. Our target traditionally has been the pharma industry, but now we’re interested in raising our awareness among scientists and technologists who have great ideas that could make a difference in the pharma industry.”
The key for both of these initiatives is that the CMOs are willing to learn from outside experts. Which, in a sense, is what education is all about.
Gil Y. Roth has been the editor of Contract Pharma since its debut in 1999. He can be reached at groth@rodmanmedia.com.