It doesn’t show signs of stopping… Let is sale! Let it sale! Let it sale!

‘Tis the season! As our holiday gift to you, here’s 30% off the standard rates when you register for Pharma and Healthcare events from now through Wednesday, December 31! Use the code “Holiday30” at checkout.

This event was specially selected for your interests:

19th Annual Drug Delivery Partnerships
January 29-30, 2015 in Boca Raton, FL

The largest strategic drug delivery and device partnering community to strike your next big deal, catch up on the future of innovative technologies, and stay FDA compliant.

Find out more about the event.
Register to join us.

For a full list of all events you and your colleagues can save on this holiday season, visit the Future of Biopharma blog.

Have any questions? Email Jennifer Pereira.

Happy Holidays!

Tiny Sensors May Soon Monitor Seniors’ Medicines From Inside

Story via Kaiser Health News

Ever been lost on a new trail on a hike? Or confused between north and south in a new city? Or after a certain age, unsure if you really took that anti-cholesterol pill last night, or was it the blood pressure pill?  They kind-of look the same.

Only about 50 percent of patients take their medications as prescribed. And, according to the Centers for Disease Control and Prevention, in 2010 almost 40 percent of adults older than 65 were taking five or more prescriptions a day.

With families sometimes far away and many older people unable to afford personal caregivers, companies have searched for a technological solution to monitoring medicine.

Forget armband monitors like Fitbit, the newest body monitors are as tiny as BBs. These so-called nanomeds, miniscule sensors embedded in a placebo pill that you swallow, set up shop in your gut. As they slowly work their way through your system, these “ingestibles” – which are actually not digested – are switched on by contact with saliva and/or gastric juices. The signal is picked up by another sensor which looks like a Band-Aid and is worn on your chest.

This system records medicine intake as well as other measures, such as heart rate. The information shows up on your smartphone or tablet, via Bluetooth and can automatically go to your doctors, family members or caregivers, with your permission.

The Food and Drug Administration approved these devices in 2012, but they’re not on the open market yet. They’re still being tested in pilot projects, including with England’s National Health Service.

Proper use of powerful, sophisticated meds aimed at keeping the elderly active and out of institutional care, Bill Satariano of the UC Berkeley’s School of Public Health believes, will depend increasingly on these “indigestible chips.”


New for 2015 at Drug Delivery Partnerships, digital medicine will be addressed with the goal of improving patient adherence and outcomes. How will the industry leverage digital medicine for the future of drug delivery?

Join us at DDP 2015 to learn more about the future of digital medicine. Register now and save $100 - just use the code XP2078BLOG | Register now! 

Whitepaper: The Recently Launched Non-Invasive Macromolecule Delivery Consortium (NMDC) Initiative

The Catalent Applied Drug Delivery Institute, a 2015 Drug Delivery Partnerships (DDP) conference partner, combined the efforts of Terry Robinson, Executive Director, Catalent Applied Drug Delivery Institute and Dr. Randy Mrsny, Professor, University of Bath, UK to talk about the recently launched Non-Invasive Macromolecule Delivery Consortium (NMDC) initiative as reflected in the insightful Q&A that can be found here. At DDP 2015, Dr. Mrsny, Chair of the NMDC, will moderate the panel “To Begin A New Adventure: Engaging Academic and Industrial Expertise in Non-Invasive Delivery of Macromolecules”. Be sure to join him this January in Boca Raton, FL to learn more.

Download the whitepaper here.

Teaser:

How has the evolution of modern medicines evolved to bring in a wide diversity of therapeutic modalities?

Molecular biology techniques and high-speed sequencing methods have been the primary drivers. These methods have allowed us to better understand the molecular basis of health and disease. That we now can more fully appreciate these events provides us the opportunity to design medicines that can address selected targets more specifically.

The types of medicines we can now imagine have also evolved from the traditional small molecules that have driven the development of a robust pharmaceutical industry. Protein and peptide therapeutics have now become over 50% of the product pipelines for the major pharmaceutical companies. It is anticipated that nucleic acid-based medicines will be the focus of the next evolutionary step.

What are these modalities? What challenges do they present to the science and technology?

While proteins and peptides are currently leading the way in changing the face of modern medicine, the future seems to be headed toward utilizing novel and unexpected findings that have defined a complex and elaborate role of RNA in controlling cell function. Sequencing of the human genome has demonstrated that only a small fraction of cells’ DNA is transcribed into RNA that is then translated into proteins and peptides via the classical pathway. It is now clear that most of the genome elaborates RNA that has a variety of non-classical actions in health and disease.

Proteins, peptides, and RNA-based molecules all present similar challenges of delivery. Such molecules, due to their physicochemical properties, are labile and excluded from moving efficiently across biological barriers of the body. While some of these molecules can be delivered successfully by injection to overcome these challenges, optimal benefit of these highly potent therapeutic agents often requires overcoming systemic and cellular barriers that limit their patient-friendly delivery for chronic therapy. Thus, the main challenge of all of these is their delivery into the body and into specific cells to optimize their actions while limiting potential side effects.

Download the complete whitepaper here. 

Today is the last day to save $300 to attend DDP 2015 - Use the code XP2078BLOG to save. Register here.

Look Who's Attending DDP 2015

DDP 2015 is quickly approaching next month, taking place January 28-30 in Boca Raton, DL. From Amgen to Zogenix, the overwhelming attendee list is growing day after day. This year is on track to be the largest and best attended than Drug Delivery Partnerships since 2009. Don't forget to register by this Friday, December 19th and save $200 before time runs out!

Join the BioPharma leaders such as AstraZeneca, Amgen, Eli Lilly, GSK, J&J, Novartis and more as well as the top names in drug delivery like 3M, Bend Research, Catalent Pharma Solutions and West. With partneringONE® , the leading conference networking solution for the life sciences, you will find potential new partners from the increasing DDP delegate pool  to connect and help your business move to the next level. All meetings will be pre-arranged for you, based on your availability, to maximize every second of your time at DDP 2015.

            Register Now                                  Download Brochure
Save $100, use code: XP2078BLOG            To view the full agenda


Partial List of Attendees as of 12/17/14

Vice President - 3M Drug Delivery Systems
Director of Business Development - 3M Drug Delivery Systems
Director Technology Licensing & Collabo - AbbVie Inc
Director Combination Product Devl - AbbVie Inc
Pharmaceutical Devl & Technology Mgr - Ache Labs Farmaceuticos SA
Vice President - Allergan
Principal Business Analyst - Amgen Inc
Principal Engineer Device Strategy - Amgen Inc
Sr Dir Licensing & Pharma Tech - Aptalis Pharma US Inc
Account Manager - Aptar Pharma
Vice President Business Development - ARx LLC
Worldwide Director Medical Affairs - BD Medical Pharmaceutical Systems
Platform Leader Self Injection Sys - BD Medical Pharmaceutical Systems
Manager Bio-Analytical & Pharmaceutical - Becton Dickinson & Company
Innovation Director - Bespak Europe Ltd
Commercial Manager - Bespak Europe Ltd
Head of Business Development - Biocorp
Associate Director - Biogen Idec
President - BioPharm Solutions
Vice President - Boehringer Ingelheim Pharmaceuticals Inc
Associate Director - Bristol Myers Squibb
Partner - Cambridge Design Partnership
Head of Drug Delivery - Cambridge Design Partnership
VP of Corp Development & Strategy & Inve - Catalent Pharma Solutions LLC
Drug Delivery Technologies Director - Chiesi Farmaceutici SpA
VP Research & Development - Corium International Inc
President - Cureport Inc.
Business Development Manager - Delsitech Ltd
President & Publisher - Drug Development & Delivery
Strategic Technology Development Manager - Eastman Chemical Co.
Director COO Global External R&D Operat - Eli Lilly & Company
Director Technology Management - Flextronics Medical
Manager of Product Development - Gebauer Company
Director Device Development - Genentech Incorporated
Director Platform Technology & Science - GlaxoSmithKline Pharmaceuticals
President - H2A Associates
President Business Develement - Haselmeier
Chief Medical Officer - HealthPrize Technologies
Director - Hospira Inc
Editor - Inhalation
Vice President Business Development - Insulet Corporation
Senior Director, Corporate Development - Johns Hopkins University
Chief Scientific Officer - Kashiv Pharma LLC
Business Development Director - Key Technologies Inc
Chief Executive Officer - Keystone Nano Inc
Director Business Dev & Strategy - Kimberly Clark
President - Leading Edge Medical
Technical Project Leader - LEO Pharma A/S
Drug Delivery & Device Development Vice - MedImmune
Principal Chemist - Medtronic
Executive Director - Merck
Associate Director Respiratory Product - Merck
Key Account Manager - Mikron
Director of Business Development - MonoSol Rx
Vice President - Mott Corporation
Head Global Device Development - Mylan Inc
Director Business Development - Nanomi BV
Project Manager  Office of Biotechnology - NCI Frederick
Business Development Manager - Neopac
Managing Director - New Directions Technology Consulting
President - Nissen Consulting Group, LLC
Executive Vice President - Noble International Inc
Director New Products - Novaliq GmbH
Director, Strategy and Sourcing - Novo Nordisk AS
Director - Novozymes
Sr Director Pharmaceutical Development - NPS Pharmaceuticals Inc
Product Business Development - NYE Lubricants Inc
VP, Business Dev & Alliance Mgmt - Ophthotech
Life Science Executive - Oval Medical Technologies
General Manager Business Development - Owen Mumford Ltd
President - P/L Biomedical
Executive VP & Chief Scientific Officer - Pfizer
CTO - Phillips-Medisize Corporation
VP Bus Dev & Strategy - Phillips-Medisize Corporation
Chief Business Officer - PolyPid Ltd
CEO & Owner - PTM Consulting
CEO & Co-Founder - Qrono Inc
Head - Reckitt Benckiser
Head of Drug Delivery - Sagentia
Associate VP Medical Device Development - Sanofi
Senior Program Manager - Scandinavian Health Ltd Taiwan Branch
Vice President Business Development - Sensile Medical AG
Director of Biopharmaceutical Packaging - Sharp Packaging Solutions
Marketing Director - SHL Group
VP Business Development - SkyePharma AG
Business Development Manager - SPI PHARMA
Editor - Tablets & Capsules
VP, Pharmaceutical Business Dev - Tapemark
Founder - Team Consulting Ltd
Vice President - Technology Catalysts International
Director - Teikoku Seiyaku Co Ltd
Strategic Accounts Manager - Terumo Medical Corporation
Director Specialty Life Cycle Initiativ - Teva Pharmaceuticals
Professor - TU Graz
SVP Chief Commercial Officer - Unilife
Professor Auxiliar com Agregacao Faculd - Universidade De Coimbra
Professor, Director Center for Pharmacom - University of Florida
Professor, School of Pharmacy - University of Maryland
Partner - Valeo Partners
Chief Scientific Officer & Founder - Viscogel AB
Chief Executive Officer - Viscogel AB
Technical Leader - W L  Gore & Associates
Director of Innovation - West Pharmaceuticals
VP Strategic Device Technology - West Pharmaceuticals
Director Prefilled Syringe Technologies - West Pharmaceuticals
Vice President - Ximedica LLC
Vice President & General Manager - Zogenix
   

Download the brochure to view the full list of speakers and sessions

Register Now

Is Silent Innovation Driving Patient-Centric Medicine Forward?

By Sven Stegemann, Professor for Patient Centric Product Design and Manufacturing, Graz University of Technology, Austria

Scientists tend not to look backwards but sometimes it is an interesting exercise to do so if only to  confirm how much science has advanced in a relatively short time.

When I left university with the degree in pharmaceutical science and pharmacy in 1989, the first proton pump inhibitor was about to be launched, the Cytochrome P450 System had just been discovered and Kary Mullis was four years away from receiving the Nobel Prize for the development of the polymerase chain reaction (PCR) method. At this point, only a few people were envisioning high-throughput screening and combinatorial chemistry as a major tool for drug discovery or that the human genome would be sequenced by the beginning of the new century. During the past decade we have progressed in not only DNA sequencing but in understanding the DNA, the "omics," Single nucleotide polymorphism (SNPs) and disease networks. While personalized medicine is still considered as being somewhere in the future by many scientists and healthcare professionals, it is already the reality for life-threatening diseases like cancer while making silent inroads into the treatment of many other diseases.

Scientists who finished their thesis in the mid-90s will recall the huge and heavy volumes of scientific journals in the library and the cumbersome process of making hard copies to reference. Today, literature research can be made at any time, easily, from a laptop with immediate access to download the full publication. The Internet has revolutionized access to scientific data. Thanks to the tangible value and ease of use, this information technology progress and its applications were quickly adopted by our society. But what about digital health applications? Young people like their wireless activity trackers to share their heart rates when exercising within their social network. But implementing digital monitoring of various clinical parameters and adherence into daily treatment practice still encounters concerns regarding data protection and potential misuse of digital clinical data as well as genomics data. However, once the benefit of digital health becomes evident for high risk patients or older people with mobility issues who cannot easily visit a healthcare professional, this innovation will be implemented. Moreover, wouldn´t it be interesting and motivating for a patient to track the positive clinical effects when taking the prescribed drugs using their smartphone? Some healthcare professionals might reply that every patient is different and not everyone can cope with technology or wants to know about the clinical parameters. This is a fair remark and we have to recognize that different patient populations have different needs. We are starting to recognize that patients play a critical role in achieving positive therapeutic outcomes and that the “one-size-fits-all” product concept no longer fits. What if we develop products that precisely meet patients’ needs and can be used intuitively, as intended? Wouldn´t the patient perceive this as a similar “innovation” to the smartphone?

Looking forward, pharmacogenomics and patient centricity are becoming integral to the design of innovative drug delivery technologies and resulting drug products. Innovation will come from integrated and flexible drug delivery systems tailored to patients with regard to their personalized therapy and specific needs.

Patient-centricity will be a new topic featured at the 2015 Drug Delivery Partnerships meeting, with a full day of presentations slated on Friday, January 30. Stop by during our panel discussion at 2:15 p.m. on “The Era of Personalized Medicine and Patient-Centric Therapeutics: Has the Future Already Become the Present?”

To hear more from Sven, register for DDP now. Save $300 when you register by Friday 12/19 - use the code XP2078BLOG | Register here.

partneringONE for Drug Delivery Partnerships 2015 is Now Open!

With nearly 400 meetings arranged in 2014, its inaugural year, be sure to sign-up early for maximum partnering and exposure in 2015!

This state-of-the-art partneringONE® tool allows you to scour hundreds of attendees from across the entire drug delivery ecosystem to find new potential partners and meet companies that fit your criteria for your next multi-million dollar deal. Efficiently plan your DDP agenda, from the pre-event invitations to the final handshakes on-site, to be more productive than ever.

IIR is excited to announce the 19th Annual Drug Delivery Partnerships has opened partneringONE® today.

This means you will be able to:
• Set your availability for participating in partnering meetings during the event in your online agenda
• Browse and search profiles from companies attending Drug Delivery Partnerships 2015.
• Bookmark companies of interest and make contact via partneringONE® messaging system by sending and receiving "meeting requests"

All profiles will be made visible by default, unless you have specifically requested to stay invisible. Ensure both your company and your personal profiles are up to date.

Profiles provide an important first impression. Please ensure that you have entered all relevant information to accurately describe your partnering goals at Drug Delivery Partnerships 2015.

Once you have logged into your partnering account

• Go to Edit Profile -> Company , and fill in the relevant fields.
• Press 'Save' periodically.
• Make yourself visible by clicking on the "Set Profile Visible" button.
• All registrants from your company can edit your company's profile so please coordinate with your colleagues.

To learn more about partneringONE, please watch our video tutorials here.

It is not too late to register for DDP - save $300 when registering by this Friday 12/19, just use the code XP2078BLOG. Register now!

Quality-by-Design in Pharmaceutical Product Development

Last year at Drug Delivery Partnerships, Chetan Pujara, Ph.D. Senior Director, Small Molecule Product Development, Pharmaceutical Development, Global Pharmaceutical Sciences, Allergan presented on "Quality-by-Design and Quality Risk Management in Pharmaceutical Product Planning". Below is a brief teaser of the presentation - in order to view the complete presentation, click here. 

Pharmaceutical Development
To design a quality product and its manufacturing process to deliver the intended performance of the product.

Quality by Design
QbD is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding based on sound science and quality risk management

Overall Principle of this approach:
Quality cannot be tested into products; i.e.,
Quality should be built in by design.

Key Principles of QbD
• Systematic approach to
   – Product design
   – Process design & control
   – Process performance & continuous improvement
• Quality: Quality cannot be tested in the product; it should be built in by design
• Product Knowledge: Scientific understanding in the establishment of design, specifications and manufacturing
• Regulatory Flexibility
   – Design space proposed by applicant is subject to regulatory assessment and working within the space is not a change
   – Movement out of design space is considered to be a change and requires post-approval change process

Is QbD really a new concept?
• QbD is not a new concept from the technology perspective
• QbD is new relative to regulatory review and submission
• QbD is optional and should not become a regulatory requirement as agreed to in ICH Q8
• QbD will not necessarily be included in all submissions
• Generation of QbD information during IND phases should be at industry discretion

7 Step QbD Process for Pharmaceutical Product Development
1. Quality target product profile
2. Identify approach to drug product formulation/manufacturing process.
3. Identify potential Critical Quality Attributes of RM/DS/DP
4. Identify potential Critical Process Parameters
5. Using risk assessment & experimental approaches, determine the functional relationships that link raw material CQAs and unit operation CPPs to drug product CQAs
6. Refine formulation and manufacturing process, if necessary and repeat steps 3 -5 to meet QTPP defined in Step 1.
7. Establish Design Space and Control Strategy


Be sure to join us at Drug Delivery Partnerships 2015 to hear from Sesha Neervannan PhD, Vice President, Pharmaceutical Development, Allergan who is on the 2015 DDP Advisory Board.

Register before Friday 12/19 and save $300 - Use the code XP2078BLOG to save!

Register here.

Leveraging Digital Medicine in the Future of Drug Delivery

Picture via Zipnosis website

Zipnosis, a digital medicine startup has developed a 24/7 online diagnosis and treatment option for common medical conditions.

Zipnosis partners with health systems across the country to power virtual care services that are white labeled. In hopes to make mainstream medicine both affordable and readily available, they connect the patients with local clinicians. Patients can receive care for common medical conditions such as sinus infections, female bladder infections, pink eye, or cold, cough and flu via a mobile phone, computer or tablet - a simple online diagnosis and treatment in minutes. 

At Drug Delivery Partnerships 2015, we are going to address a critical gap in patient adherence and treatment outcomes with evolving digital technologies that will shape the future of drug delivery in the healthcare ecosystem.

Digital health technologies are addressing a critical gap in patient adherence and treatment outcomes that have the potential to transform the way we think about and create innovative health care products and services. Ingestible, wearable and implantable physiological sensors, “smart” packaging and digital health feedback systems are a few of the rapidly evolving technologies that are shaping the healthcare ecosystem. This discussion provides a perspective on some of these innovative technologies and concepts and the future direction of drug delivery and product development.

In a session titled "Leveraging Digital Medicine in the Future of Drug Delivery", Ronald L. Smith, Distinguished Scientist, Pharmaceutical Sciences, Merck Research Laboratories will dive into these ideas and discuss what the future direction of drug delivery looks like.

Register for DDP & save $300! Use the code XP2078BLOG | Register here.

Nasal Vaccine Formulation and Delivery: Potential and Challenges

Nasal Vaccine Formulation and Delivery: Potential and Challenges

A presentation by MedImmune at last years Drug Delivery Partnerships. Below you can find a brief overview of the presentation, but download the complete presentation here.

Presentation Overview:

• Why vaccines?
• Vaccines contain an agent resembling a disease-causing agent
• Vaccines are cost-effective for the prevention of ID
• Vaccines elicit immune responses
• Vaccination is one of the most cost-effective investments in global health
• Disease eradication

• Nasal delivery of vaccines
• Promising environment for the delivery of vaccines
• Non-mucosal versus mucosal administration route
• Addresses hurdles faced by other routes of delivery
• Most pathogens enter the body through the mucosal route

• Challenges in the nasal cavity
• Dose volume restrictions
• Mucosal clearance
• Potential enzymatic degradation
• Small anterior anatomy

• Pharmaceutical factors affecting nasal vaccine delivery

• Case study: Validating API

• Future directions
• Vaccine formulation compositions that increase residence time in the NALT
• Intranasal delivery of the vaccine might need to be synchronize with inhalation
• Using anatomically correct nasal models

To view this entire presentation, click here.

Did you like this presentation? Be sure to join us at this years Drug Delivery Partnerships taking place in Boca Raton, FL from January 28-30. Your roadmap to success starts at DDP — the only event that delivers the perfect mix of technology, insights and innovation.

Download the event brochure here.

Register before Friday December 19th and save $300 - Just use the code XP2078BLOG | Register here. 

Unilife Signs Agreement for Use of Depot-ject™ Delivery System

Unilife, a developer and supplier of drug delivery systems recently announced signing a worldwide, 10-year commercial supply agreement with a global pharmaceutical company for the use of Depot-ject with an ocular injection therapy.

However, the company's name is still being withheld as well as the target therapy in order to protect their commercial interests. Unilife has made it known that the target therapy is approved in both the US and Europe for a common retina disease. This arrangement is going to support the lifecycle management of this approved therapy, which is administered via intravitreal injection into the eye. Unilife anticipates the commercial availability of Depot-ject with this therapy after a 12 to 24 month process of customization and regulatory approval for the drug-device combination.

This Depot-ject technology was designed to help administer the drug depot precisely into the eye - all while a clinician is in complete control over the implantation site (the implant is contained within the needle).

Mr. Alan Shortall, Chairman and Chief Executive Officer of Unilife said: "Unilife has created a broad portfolio of ocular delivery systems to enhance the intravitreal injection of ophthalmic therapies. The safety, simplicity and convenience of our Depot-ject delivery system has significant potential to improve patient care in the delivery of sustained release drug depots, and allow customers to further differentiate their brands of therapy from current or future competition. We are pleased to have signed our first commercial supply agreement within this fast-growing market segment, and look forward to supporting the customer in the rapid conversion of its approved therapy into our Depot-ject delivery system."

View the complete Press Release here. 


Want to hear from Unilife directly? Join them at Drug Delivery Partnerships this January 28-30 in Boca Raton, FL. At the conference, Michael C. Ratigan, SVP & Chief Commercial Officer at Unilife will be presenting a Case Study titled "New Business Models for Partnering on Injectable Drug Delivery System".

 
Through multiple successful Partnerships, Unilife has created a new paradigm for injectable drug delivery that is pharmaceutical customer-centric, patient-centric, health care provider specific and outcomes focused; rather than the traditional industry model, which is rapidly becoming obsolete. Their dynamic business structure allows them to operate and serve partners with speed, agility, and reliability.

So be sure to join them at DDP 2015 in order to learn more. Register for Drug Delivery Partnerships now and use the code XP2078BLOG to save $300!

New at DDP 2015 | More Non-Invasive Delivery Than Ever Before!

NEW - the largest showcase of non-invasive delivery!

DDP showcases the most comprehensive selection of delivery systems for a truly all-inclusive technology evaluation.

Recent advances in non-invasive delivery strategies and technologies are instrumental to improve patient adherence and compliance. DDP has dedicated an entire track on January 29th to discuss Non-Invasive Delivery Systems. Join us on January 28-30 in Boca Raton, FL to hear from the industry and academic experts about the current landscape in delivering innovative biologics to increase health outcomes.

Sessions include:

nPortTM Nanotechnology for Liposome Manufacturing: From 20 to 200nm and From Milligram to Kilogram
De-Min Zhu, PhD, President & CEO, Cureport, Inc.

Dendrimer-based Targeting of Neuroinflammation - Therapeutics for Neurodegenerative Disorders
Kannan Rangaramanujam, Co-director, Center for Nanomedicine, Professor,Department of Ophthalmology/Wilmer Eye Institute, Johns Hopkins School of Medicine

Improve Cancer Therapies Through Nano-Reformulation
Scott E. McNeil, PhD, Director, Nanotechnology Characterization Laboratory (NCL) Leidos Biomedical Research, Inc. Frederick National Laboratory for Cancer Research

Why Mostly of Oral Insulin Formulations Do Not Reach Clinical Trials
António J. Ribeiro, PhD, Professor Auxiliar com Agregação, Faculdade de Farmácia da Universidade de Coimbra, Portugal

Enhancing Oral Bioavailability Using Amorphous and Crystalline Nanoparticles
Michael Morgen, PhD, Director of New Technology Development Bend Research Inc., Capsugel Dosage Form Solutions

To Begin a New Adventure: Engaging Academic and Industrial Expertise in Non-invasive Delivery of Macromolecules

Moderator:

• Randy Mrsny, PhD, Professor, University of Bath, UK; Chair, NMDC 

Panelists:

• Justin Hanes, PhD, Professor, John Hopkins University; Ocular Working Group, Academic      Co-Chair (NMDC)
• Ralph Niven, PhD, Novartis R&D; Pulmonary/Nasal Working Group, Industry Co-Chair (NMDC)
• Siddhesh Patil, PhD, Takeda; Oral Working Group, Industry Co-Chair (NMDC)
• Mark Tomai, PhD, Head of TLR and MTS Business Development, 3M Delivery Systems Division

Download the brochure to view complete agenda and check the DDP website regularly for program updates.

Register now to save $300! Click here.
Use the code: XP2078BLOG

See you in Boca this January!

Drug Delivery Trends of 2014

Current Partnering is the leading publisher of deal term reports within the life sciences. Current Partnering report titles cover all aspects of partnering best practice and deal terms, providing users with the information and insight required to optimise their partnering activities. Further details for each report can be viewed online at: www.currentpartnering.com/

Current Partnering is a media partner for the upcoming Drug Delivery Partnerships conference taking place in Boca Raton, FL this Jan 28-30. For more information about the event, click here.


 
Raveena Bhambra
December 2014


Drug Delivery in the pharmaceutical and biotechnology remains to be an important and attractive area. With so many different delivery methods available to administer drugs, the opportunities for new technologies are plentiful and drug delivery companies globally are making deals to utilize or develop these technologies further.

Many of the areas within the body are difficult to reach and therefore treat e.g. Inside the inner ear, so there remains a lot of scope for new drug delivery inventions and as different aged patients prefer to administer medications in different ways eg. old and young, this also provides a lot of room for innovation.

Drug delivery innovations can also be modified so that they are applicable to different types of medications so this results in higher numbers of deals being made in the drug delivery arena from companies who have taken on a taken technology and used or modified it using their expertise.

In general drug delivery partnering has been very healthy, although there was a dip in deals during 2011 the figure before and after then has been very high. Last year 414 deals were recorded which was a high value compared with the previous two years.

Figure 1: Recent deals (Jan 2009 to present) - By date

 Source: CurrentAgreements, 2014

Drug delivery is complex and many different administration methods have been devised to target and apply different medications, all of which we capture in our deals database and dealmaking reports. Delivery methods are often dependent on the nature and stability of the medication being administered so the right method must to be combined with the right treatment.

Drug delivery technology is broken down into these more specific areas in our research -

• Drug delivery
     o Bioavailability
     o Implantable
     o Oral delivery
          • Rapid release
          • Delayed release
     o Parenteral
          • Infusion
          • Injectable
     o Pro-drug
     o Targeted
     o Topical
     o Transdermal
     o Transmucosal
          • Buccal
          • Inhaled
          • Nasal
          • Ocular
          • Rectal
          • Sublingual
          • Urogenital

This thorough break down and thus categorization helps to easily identify the companies involved in a specific drug delivery technology and to spot the most popular area of partnering.

The figure below looks specifically at all these different types of drug delivery and illustrates which is the most popular when it comes to partnering. It seems topical partnering is the most active area, followed closely by injectable. Topical is perhaps the most straight forward and easiest method of application, however some therapies need to be inserted direct into the bloodstream of the system to have an effect, so this is explains why the next popular types are transdermal and oral delivery, two methods which ensure that the treatment reaches inside the system and past the outer layers of the skin.

Figure 2: Recent deals (Jan 2009 to present) - By technology type

Source: CurrentAgreements, 2014

In many other areas of partnering our analysts have noticed that many of the deals have been conducted at the early stages of development, however when it comes to drug delivery most of the deals are signed at the marketed stage. Almost 600 deals were signed at this stage highlighting the fact that companies are possibly using drug delivery technologies that are already available to incorporate into their new innovative medications.

Figure 3: Recent deals (Jan 2009 to present) - By stage of development

Source: CurrentAgreements, 2014

As drug delivery technology is so broad it is also interesting to look at the most popular types of therapy areas it is targeted towards. From the graph below it can be seen that drug delivery applications in oncology treatments are the most common. Central Nervous System diseases are the next to employ many drug delivery technologies in recent deals. The third most popular therapy area for deal making was interestingly dermatology and this is quite probably because many topically applied medications are indicated for skin disorders, so it’s only natural for these two combinations to go hand in hand.

Figure 4: Recent deals (Jan 2009 to present) - By therapy area

Source: CurrentAgreements, 2014

In addition to therapy and development stage of the deals, Drug delivery deal financials also make an interesting read. As expected, drug delivery deal headline values tend to increase with stage of development at deal signing, as is the case with upfront payments at deal signing. The effect on royalty rate agreed based on stage of development at deal signing also makes interesting reading.
Of course, if any of these data points are to make sense there is a need to view each deal on its merits and any contract document in the public domain. The report outlined below provides this data, enabling the reader to determine in detail how drug delivery deals are structured.

A recent example drug delivery partnering deal

Collaboration and licensing agreement for lipid nanoparticle delivery technology for use in hyperoxaluria type 1 development program

Nov 18th 2014

Tekmira Pharmaceuticals announced a licensing and collaboration agreement with Dicerna Pharmaceuticals. Tekmira will license its proprietary lipid nanoparticle (LNP) delivery technology for exclusive use in the primary hyperoxaluria type 1 (PH1) development program undertaken by Dicerna.

The deal will see Dicerna pay Tekmira $2.5million upfront and aggregate development milestone payments of $22million plus a mid-single-digit royalty on future PH1 sales.

Conferring to the new style of partnering, where a few deals are merged into one this deal will also include a supply agreement where Tekmira will provide clinical drug supply and regulatory support in the rapid advancement of the product candidate.

Tekmira’s third generation technology will be used by Dicerna to deliver its Dicer substrate RNA (DsiRNA) molecule DCR-PH1 for the treatment of PH1 which is an inherited liver disorder that often leads to kidney failure and for which there are currently no therapies available.

The agreement came about after positive results were demonstrated in animal models where the technology and DCR-PH1 was tested.

A full deal record can be viewed here

The above is abstracted from a recent report from Current Partnering (www.currentpartnering.com) called Drug Delivery Partnering Terms and Agreements that provides a comprehensive overview of deal making in the drug delivery technology sector.

The report provides a detailed understanding and analysis of how and why companies enter drug delivery partnering deals. The majority of deals are discovery or development stage whereby the licensee obtains a right or an option right to license the licensors drug delivery technology. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes.

This report contains over 2,000 links to online copies of actual drug delivery deals and contract documents as submitted to the Securities Exchange Commission by companies and their partners. Contract documents provide the answers to numerous questions about a prospective partner’s flexibility on a wide range of important issues, many of which will have a significant impact on each party’s ability to derive value from the deal.

Sources

The above information has been abstracted from the following resources:
• Drug Delivery Partnering Terms and Agreements report 
• Drug Delivery Deals and Alliances of 2013 
• Current Agreements life sciences partnering, M&A and financing deals database

Related
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Insight into the World of Drug Delivery Devices: New Developments in Advance Drug Delivery

Steven Kaufman, Vice President of Marketing at SHL Group presented at DDP 2014 and the overview of his presentation titled "Insight into the World of Drug Delivery Devices: New Developments in Advanced Drug Delivery" can be found below. To download the complete 2014 presentation, click here. 

Topics:
• What is driving increased demand for devices?
• Which specifications should be known when starting?
• How many partners will be involved?
• What considerations should you take when selecting a partner?

Summary:
• Biopharmaceutical & device companies must work together to be successful.
• Look at case studies of devices on the market today & develop your teams knowledge internally.
• Understand what it takes to get a device project started & finished
• Always be looking at new technologies but be aware that the market is quite conservative
• Choose the right partners & move forward with them - start today...

Steven will be joining us at DDP again in 2015 where he will be presenting on "Insight into the Changing World of Auto Injectors: Trends, Partnerships and Innovations". This presentation provides an overview of key self-injection devices, such as auto injectors, and how they support the growing trend of injectable biologics coming to market. The session starts with an introduction of different types of auto injectors and pen injectors, including some products that have helped to revolutionize the industry. Trends such as the increased importance of human factors, regulatory changes and speed to market demands related to an influx of generic injectable and biosimilars are highlighted. Based on the practical experience of working with leading biopharmaceutical companies to develop such devices, Steven will provide advice on what to look for when identifying suitable partners to support these combination product programs.

• Overview of auto injector related launches, highlighting the drivers of the market, such as increased number of injectable products needing devices – ranging from innovator, generic and biosimilars injectables.

• Trends in the area of combination products related to human factors, regulatory changes, FTO/IP & speed to market concerns.

• Partnerships will highlight which parties need to be involved in your device program, such as primary container supplier, filler, device manufacturer and various consultants.

• Innovation will be an interesting section where the speaker will show some new technologies that are being introduced to the device programs of the future – such as connectivity, smart tech and more.


Be sure to join Steven at Drug Delivery Partnerships this January in Boca Raton, FL - Plus, save an extra $100 off the current rate with the code XP2078BLOG | Register here.