Shift in Cancer Therapy with Antibody-Drug Conjugates

Posted on August 3, 2015February 22, 2016 by Valentina Rosa

As a professional writing services company for the Life Sciences and Pharmaceutical industry, TRA360 attempts to stay current with recent scientific developments and shares them in our blog.

More than a century ago, Dr. Paul Erlich discovered certain chemicals are selectively absorbed by tissues and they could be a delivery vehicle for drugs to the disease site. [ref]Wang, Jeffrey, Shen, Wei-Chiang and Zaro, (Eds.),- Antibody-Drug Conjugates; The 21st Century Magic Bullets for Cancer, Springer 2015[/ref] In cancer therapy, monoclonal antibodies (mAbs) have shown fewer side effects compared to chemotherapy. And a combination of mAbs and chemicals often brings even more efficacy and fewer side effects. Antibody Drug Conjugates (ADCs) are created by attaching mAbs to biologically active drugs with chemical linkers.

cancer research.org — www.cancerresearch.org

Each ADC has three important parts: a) antibody b) chemical molecule c) linker. Despite this simple concept, discovering each specific part and, most importantly, conjugating them, is a complex but promising field in life sciences. Early ADCs were too toxic or not enough effective or linkers were not stable in the blood.

The industry’s belief in ADCs is high and there are more than 100 ADCs in the development pipelines of pharmaceutical companies. Currently, only two drugs; ADCETRIS® for treatment of Hodgkin’s lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL) and KADCYLA® for treatment of HER2-positive metastatic breast cancer (MBC) are available on the market. Seattle Genetics and ImmunoGen are on the edge of development of these drugs and many ADCs researchers are using this scientific methodology. In 2014, Roche had 10 molecules in clinical development.[ref]http://www.reportlinker.com/p02280919/Antibody-Drug-Conjugates-Market-Edition.html[/ref]

There are also current co-development agreements in the market. A consortium of Chinese companies including Shanghai Fosun Pharmaceutical Group, HOPU Investment Management, China Everbright Limited’s healthcare fund (“CEL Healthcare Fund”), and WuXi PharmaTech have started negotiations to acquire Ambrx. ADCs are the main reason for this targeted acquisition. Ambryx is anticipating clinical trial evaluation of ARX-788, an ADC that targets HER2 over-expressing tumors including breast, gastric, colon, pancreatic and ovarian cancers in 2015.[ref]http://ambrx.com/chinese-consortium-enters-into-agreement-to-acquire-ambrx[/ref]

Another example is Mersana Therapeutics, a Cambridge MA-based biotech company that specializes in immunoconjugate therapies with 6 ADCs in its pipeline. The company has development agreements with Takeda and EMD Serono for two of them.

The development of commercially viable ADCs is still in its early stages and the FDA is expecting to approve two more by 2020. As new products continue to move through the phases of clinical trials and if the results are successful in treating people with life-threatening and terminal diseases, the future looks promising for patients and investors.

Are you a health professional with an interest in ADCs? Do you have any comments on this article? Let us know here or tweet at us @TRA360!

Introducing Organogenesis and the Apligraf

Posted on October 23, 2013June 10, 2013 by Valentina Rosa

As promised, we’re back with more about Regenerative Medicine. Our first profile is on Organogenesis, a company based in Canton, Massachusetts, who is at the forefront of the field. Their website states that “in the future, regenerative medicine technologies may deliver neural regeneration, islet cells for diabetes, and more substantial heart repair.” For Organogenesis, this process starts with healing chronic wounds.

Organogenesis has a product on the market called the Apligraf. The Apligraf mimics human skin to kick-start the healing process. Imagine living for years with an open wound—if you last this long without having to lose your limb that is. Organogenesis’ Apligraf can save the lives of people doing just that, it can save limbs and lives with the simple regeneration of skin cells. The new skin-like graft is created from donated foreskin from circumcision. That may sound weird, but since the Apligraf was developed it has taken twelve donated foreskins and made enough cell lines to create half a million Apligrafs. They take the foreskin cells, break them down, and then fibroblasts and keratinocytes, a bottom and top layer respectively, are used to create a remarkably skin-like bilayer graft.

This forty-four square centimeter cell culture can be applied to diabetic foot ulcers as well as venous leg ulcers, which makes it unique from any other similar product. It is designed to be applied to the patient’s wound and using the young and healthy cells in the Apligraf stimulate the body to make cells and heal itself. This revolutionizes the healing process for people with chronic wounds and can give them their lives back!

Want to know more about what else Organogenesis is doing? Stay tuned until our next post when we talk about the rest of their technology! Let us know what you think so far at @TRA360!

10 Tips for Successful Grant Writing

Posted on May 31, 2013June 14, 2013 by Valentina Rosa

In the world of ever-shrinking federal, state, and private dollars in the USA for research and education, it’s more critical than ever to identify and win foundation support. The National Institutes of Health (NIH), for example, has cut funding 8.2% because of the United States federal budget sequester. And cuts like these are not alone.

Follow these 10 tips for success in grant writing.

Be prepared. Many researchers don’t start working on a grant application until they hear about a deadline. If you do, it will too late; there is too much to do and not enough time. Write up your proposed ideas—even if they’re only in draft form—so you’re ready and can act on vs. react to the deadline.
Research foundation sources. Most scientific disciplines have funding sources that “everyone knows about.” As a result, there is a lot of competition for these research dollars. Try to identify smaller foundations that provide grants in your discipline. While the amount of the awards might be smaller, there is often less competition, therefore increasing your chance for success.
Use professional and personal contacts. Once you know the foundation sources, share the names of the trustees and foundation staff by your board. They often run in the same circles, and one phone call can help put your grant proposal on the top of the pile.
Contact the foundation and ask clarifying questions. Foundations almost always post their applications on their websites. Typically the procedures for submitting a proposal are clear, but sometimes they are not. When in doubt, contact the foundation and ask any questions you have to clarify their submission procedure. You don’t want to not understand or miss an important step when you’re about to press Submit.
Obtain and review the grant application. Once you have the grant application in hand, review the guidelines. in detail If you have any questions about any of the content that is required, contact the foundation again. Because of your pre-existing relationship (see step #3), it’s likelier you’ll get a faster response which will enable you to keep the grant writing process alive.
Identify and assign sections of the grant application to subject matter experts (SMEs). “Many hands make light work,” the adage says. The same is true for success in grant writing. The most successful grants are written by SMEs who contribute their expertise to one or more sections. Depending on the size of your organization and your budget, SMEs may be internal or external. Recruit the right people who have the time to contribute.
Complete the draft grant application. SMEs are experts in their fields. Individual sections will most likely require independent reviews. However, it is important that every section of the grant proposal is completed before a single, complete draft can be reviewed.
Develop metrics and assessments. You need to determine metrics and/or key performance indicators that can be measured. And, once these data are collected, you need to describe what they mean and how they will be assessed. Don’t load up your grant proposal with “big data”; fill it with big results you expect to achieve if the grant proposal is accepted.
Review the grant application. Successful grant proposals need an über alles grant writer or project manager. This person can be an in-house resource or an independent third party. This person must recognize the inconsistencies in style, tone, depth and breadth of the presentation written by the SMEs and smooth them out. A successful grant proposal has a single voice not many disparate voices.
Revise and submit the final grant proposal on schedule. This is one of the most critical steps that determines whether your grant proposal will be awarded. Give yourself enough time to do a quality revision and don’t rush. If you, your haste will be obvious to any reviewer and your proposal will be summarily denied. And never, ever miss the deadline.

CIRION Contract Research Laboratory

Posted on April 18, 2013June 10, 2013 by Valentina Rosa

The Medical Writing practice at TRA360 looks for companies that can add value to our clients. CIRION Central Laboratory is a mid-sized Canadian-based contract research laboratory that helps biotech and pharmaceutical companies through the clinical testing process. Their goal upon establishment was to design an organization that can offer companies resources for their clinical trials and expertise in the sciences.

But what do they do? According to the CIRION website they “offer the complete range of services of a larger organization with the added personalized attention and dedication you expect for your projects, regardless of their size.” They also provide services in the development of assays and have the capability to validate per GLP standards. In addition to GLP , they are are also compliant with and adherent to GCP regulations. In addition, CIRION is accredited by the College of American Pathologists (CAP), as well as the Center for Disease Control (CDC). Do they send out their work, or do it on site? CIRION has the ability to run all of their tests and assays in-house which ensures the consistent quality across their testing. This also allows for cost saving and rigorous control of the tests being done.

What do they have for experience? The scientist that work with CIRION all have a science background and a knowledge of clinical logistics for the benefit of the customer. CIRION’s talent pool includes scientists that have experience in biologistics, biosimilars, biomarkers, biochemistry, cell biology, immunology, microbiology, and molecular assays. Each project is assigned a project manager with the appropriate qualifications for that project. This ensures that the quality of their projects are up to the best of their ability.

Are you in the market for a company to help you with your clinical testing? CIRION Central Laboratory could help you. Let us know what you think @TRA360!