Advanced Clinical

Advanced Clinical Forms Scientific and Medical Affairs Division

2011-06-10T13:56:00.000-07:00

We have just added a Scientific and Medical Affairs Division to our core client offerings. New divisional service offerings include Pharmacovigilance, Regulatory Affairs, Clinical Pharmacology/Translational Medicine, Medical Monitoring, and Quality Assurance. The Division will also encompass Advanced Clinical’s already established and proven Medical Writing, Biometric, Clinical Monitoring, and Project Management services.

Heading the Scientific and Medical Affairs Division is Dr. Christina Fleming, Advanced Clinical’s newly appointed Executive Vice President, Scientific and Medical Affairs. A highly respected leader in medical affairs and clinical services, Dr. Fleming will build, manage, and lead the Division’s full range of offerings.

“We are committed to providing our clients with a full range of specialized services and to ensuring that such services are delivered in conjunction with strong clinical insight and expertise,“ said Dr. Fleming. “Advanced Clinical’s new Scientific and Medical Affairs Division will optimize clinical trials and advance discoveries in clinical research, bringing seamless workflow integration to our clients.”

To learn more, visit http://www.advancedclinical.com.

Advanced Clinical to Exhibit at the Drug Information Association's 47th Annual Conference

2011-06-09T11:50:00.000-07:00

We will be attending and exhibiting at the upcoming Drug Information Association’s (DIA) Annual Conference from June 19 through June 23 at the McCormick Place Convention Center in Chicago, IL. We intend to leverage our presence at DIA in an effort to share our approach for “advancing discoveries through insight.”

DIA’s annual conference is touted as “new vision, new mission, new annual meeting,” according to the event’s website, as it brings together industry professionals, clinicians, patient representatives, and regulatory agencies from all continents. The conference will facilitate knowledge exchange through 250 educational opportunities. It will also build upon DIA’s traditional breadth and depth of topics, and provide a forum for professionals involved in the discovery, development, and life cycle management of pharmaceuticals, medical devices, and related products.

“Advanced Clinical is proud to exhibit at this year’s DIA conference,” said Leo Sheridan, Chief Executive Officer, Advanced Clinical. “With more than 8,000 attendees from 80 countries, this show is an important step in continuing to build awareness around the value Advanced Clinical can bring as a trusted partner for optimized CRO services and talent management. We look forward to demonstrating how our full range of capabilities can create measurable impact and value in clinical research results.”

“Advanced Clinical is headquartered in the Chicagoland area, so we are especially pleased to welcome the clinical world to our home town,” said Julie Heneghan, Vice President. “We look forward to the opportunity to connect with so much knowledge and so many leaders in our industry. We have several special events planned, including a private party at one of Chicago’s most exciting venues”.

The Drug Information Association: To access additional information about the annual DIA conference, visit: http://www.diahome.org/diahome/FlagshipMeetings/home.aspx?meetingid=2375...

New Executive Vice President of Scientific and Medical Affairs Joins Advanced Clinical

2011-06-02T14:53:00.000-07:00

We welcome an addition to our leadership team: Dr. Christina Fleming, Ph.D. has been hired as Executive Vice President, Scientific and Medical Affairs, to lead Advanced Clinical in its expansion of service offerings.

Dr. Fleming is a highly respected leader in medical affairs and clinical services. As Executive Vice President of Scientific and Medical Affairs, Dr. Fleming is responsible for building, managing and leading a portion of Advanced Clinical’s service offerings, including medical writing, clinical monitoring, medical monitoring, safety operations, regulatory affairs, quality assurance, and biometrics, which are all in line with her previous industry experience.

Over her tenure in the industry, Dr. Fleming has successfully directed departments within Delta Pharma as Vice President of Outsourcing; Baxter Healthcare as Senior Director, Safety Writing and Acting Vice President, Medical Vigilance; TAP Pharmaceuticals as Associate Director of Medical Writing; and NeoPharm, Inc. as Director of Clinical and Medical Communications. In addition, Dr. Fleming has worked as a Clinical Scientist at both Pharmacia and SCIREX Corporation as well as a Lead Clinical Project Manager at Searle.

“We are honored and excited to welcome Christina’s caliber and experience to our leadership team,” said Leo Sheridan, CEO of Advanced Clinical. “Her unparalleled commitment to life sciences innovation, along with her insightful expertise and passion for scientific merit, is a critical asset to the industry and a perfect marriage for the goals of our company. Dr. Fleming’s new role promises an invigorating advancement to scientific and medical affairs in the pharmaceutical space.”

Christina earned her Ph.D. in Pharmacy from the University of Illinois at Chicago and her Bachelor’s Degree in Biology from Saint Mary’s College in Notre Dame, Indiana. In addition, Dr. Fleming has contributed to more than 40 life sciences publications and presentations, including the American Society of Clinical Oncology, Outsourcing in Clinical Trials – East Coast, International Conference on Brain Tumor Research and Therapy, Annual Partnerships with CROs, and World Federation Society for Neuro-Oncology. Dr. Fleming is a 2010 recipient of PharmaVoice’s Top 100 Most Inspiring People in the Life Sciences Industry award and is a current member of the Drug Information Association (DIA), the American Medical Writer’s Association (AMWA), and the Regulatory Affairs Professionals Society (RAPS).

Partnerships in Clinical Trials - Conference Highlights

2011-04-06T11:28:00.000-07:00

Advanced Clinical attended the Partnerships Conference in Phoenix, Arizona last week. The conference had a lot of energy with a great agenda, excellent speakers and a fantastic showing of exhibitors.

One of the standout sessions was “Operational Long Term Strategies for Profitability and Growth in Global Clinical Trials.” Monitored by Steve Whittaker, a seasoned industry executive, this panel put forth a myriad of the current issues surrounding emerging markets in pharma. With session speakers from Eli Lilly, Purdue Pharma, PPD, ICON Clinical Research, Takeda and Allergan, this session particularly honed in on the growth we are witnessing in China. And rightfully so – the China market exemplifies opportunities and challenges around the three key imperatives as they relate to profitability and growth:

New revenue
R&D productivity
Workforce optimization

If these imperatives sound surprising, think about these numbers:

China has experienced a 47 percent increase in clinical trials
China has a 20-25 percent growth rate in demand
China will become the third largest consumer of medical products by year’s end

In fact, 30-40 percent of people resources have already shifted to Asia from the likes of Eli Lilly and GSK. The growth is happening now, though many life sciences companies are still figuring out how to manage the dynamics that this geography represents.

While there are strong reasons to expand business in China from a cost and revenue perspective, globalization remains tough. From an ethical standpoint, life sciences companies, for example, must commit to rigorous research and testing of medical products prior to selling in emerging markets, as translation is not always seamless in a global marketplace.

Another complication related to conducting clinical trials was pointed out by Allergan’s SVP of Global Development Operations, Ira Sharfin. Ira mentioned that the U.S. is a transactional society. China is more relationship-based, and this means that local CROs must be engaged to conduct clinical trials locally. This distinction cannot be overlooked as expansion continues in emerging markets. This means that leading practices from outside China need to be incorporated into China business practices. However, the panel highlighted that the use of regional/local CROs introduces additional complications from a quality and communication perspective and, as a result, can introduce process fragmentation. The panel agreed that integrated processes and frameworks across the globe are critical.

The discussion raised further questions regarding discovery. As Paul Colvin of PPD posed, “Where will discovery go?” Ira Spector also duly noted, “We need great therapies [in discovery]. This is the most critical problem of the industry.”

Notably, the speakers were hopeful about the industry, as each distinctly discussed how to ensure the success of global clinical trials through various recruiting methods, preventative vs. reactive controls, integrated processes, FDA approvals, discovery, and others.

What does this mean for CROs? Some leading practices are to use a regional hub that is diverse and has regional experience. For this reason, localized CROs fare best. In addition, using local CRO alliances becomes increasingly critical as the industry continues to expand to global markets, and economically, it doesn’t make sense for large CROs to invest in local capabilities.

This has far-reaching implications for the pharmaceutical industry:

When leveraging smaller firms and, at the same time, implementing leading practices, there is an opportunity for a hub-and-spoke model or an apprenticeship model, where all people involved are trained on processes and procedures, rather than simply allowing smaller local CROs to take all ownership (i.e., “do it with them” vs. “do it for them”)
It will also be critical to have a model to allow for ongoing training and learning

The growth happening in Asia, China in particular, is undeniable. Not only does the industry need to prepare for widely dispersed growth, but there is also a dire need to systemize the industry with a complete, integrated suite of processes and frameworks. Before further dissemination, now is the time to hone in on leading practices to maximize successes.

One example was noted of bringing together three CROs and performing an end-to-end process flow integration and sharing of best practices across each. This is new for the CRO industry, but is something that’s been done with consulting services for years.

I’m convinced the more global we get, the more we should all be speaking, shaping and sharing the same industry language, leading practices, and adapt to common frameworks and processes to allow for optional discovery and development.

On another topic, we would be remiss if we didn’t note the fabulous showing of Pat Benatar and her husband, Neil Giraldo. They both put on a spectacular show, hosted by RPS.

Awareness is Much Deserved for BioFlorida Event

2011-03-17T05:43:00.000-07:00

I had the opportunity to speak at the 2011 BioFlorida Southeast Chapter Event in Miami. I was very impressed! From my humble perspective, the structure, speakers, networking and leadership endorsement were unparalleled.

There were nearly 100 great people who attended! The room had a mixture of life sciences professionals, Florida International University faculty and students as well as service providers.

A nice social hour opened the event where they served. Then, the evening was kicked off by some brilliant and very successful people in the industry: Michael Keller, Partner, McDermott, Will & Emery and BioFlorida Event Planning Committee Chair, and FIU Director of Research, Andrés G. Gil, PhD. Both were spectacular in their support of this meeting. Andrés Gil also mentioned the significant initiatives and investments being put into Research at FIU and goal to grow capabilities.

Next, a series of 15-20 minute speeches occurred on the topic of optimizing pre-clinical. The first speaker provided a case study on analyzing oncology research in pre-clinical and in-vitro. There also were two other amazing speakers from Aptuit as well as Reid Patterson Consulting. Reid Patterson did a brilliant job of outlining the risks and considerations one must address, as it related to the medical and scientific concerns in selecting the right product. Next, Aptuit provided a fantastic presentation as it related to targeting the right chemical space and, from a medical/scientific standpoint, what is important at this stage.

Advanced Clinical had the fortunate opportunity to present "How to Pick the Right Products/Solutions to Drive Profitable Growth," which focused on the Discovery phase - soup to nuts. I outlined the methodology and several client case studies.

Something BIG is happening in Florida....we all should make sure we are proactively involved.

New 2011 Webinar Series to Educate, Enhance and Empower Life Sciences Professionals

2011-03-03T10:34:00.000-08:00

We have just launched our 2011 webinar series to educate, enhance and empower life sciences professionals. Webinar topics range from how to position for optimal capital raising, successfully commercializing products, picking the right growth targets, optimizing clinical trials, heightening R&D productivity, advancing in a shifting job market, creating a workforce strategy, and more.

Each of the webinars addresses how to respond to different critical issues in life sciences to become more efficient and effective. Attendees will range from clinical research professionals to broad leadership executives.

The first of the 13 webinars in the series, titled “Dynamics in the Life Science Industry: The Tsunami in Full Swing,” begins on March 10. This webinar will examine the state of the industry, the implications for changes as well as methodologies and leading practices to improvement.

“Many in life sciences understand the challenges that continue to plague our industry, as well as those that lie ahead,” said Advanced Clinical Executive Vice President Rosemarie Truman, a 19-year strategy veteran and chief presenter of the series. “From the economic crisis, globalization, new business models, the transition to personalized medicine and Health Care Reform, life sciences professionals have experienced massive disturbances, further strained by numerous quick fixes. This series will offer information and solutions to show life sciences professionals how to effectively respond to these challenges to achieve sustainability.”

Online registration is now open. Webinars are offered to participants at no cost, with the exception of one for which contact hours may be earned. Interested attendees can register online at advancedclinical.com/webinars.

Recap of San Francisco Healthcare Conferences

2011-01-25T15:18:00.000-08:00

With five or more conferences occurring just over a week ago in San Francisco, it seems nearly every Life Sciences company was represented by at least one senior executive. Also very impressive was the sheer volume of investors. Some of the notable conferences included: the Biotech Showcase, the JP Morgan Conference, and OneMedForum.

The event was the proverbial place 'to see and be seen.' The titans of Biotech and

Pharma were out in full force. We were fortunate to attend the conference during the day and watch pitches from many exciting Life Sciences companies. The key takeaways from the event include:

While emerging markets are a focus, the largest focus is organic and inorganic growth in China
Leadership cultivation and networks is a new initiative in the biotechnology industry
Investors and “Big Pharma” alike are searching for investments; Big Pharma in particular has a keen interest in purchasing later stage companies to fill their pipeline with proven drugs, biologics, diagnostics and/or devices
The valley of death is more like a canyon for many early stage companies; we heard many stories of companies literally hanging on by a shoestring
Finally, everyone is looking for ways to transform R&D productivity – lower cycle times, lower costs, and fewer resources with high quality results. Biomarkers were one of the levers discussed extensively being that, in Research, they help with lead identification and lead optimization. In Development, they aid in accelerating trials and enabling Life Sciences companies to gather higher-quality data

A few companies to highlight due to their novel technology included:

Cytori: Christopher J. Calhoun, Cytori's Chief Executive Officer, did a wonderful job providing an overview of the company's cell regenerative technology. He provided an example of how Cytori's technology has been used for reconstructive surgery for breast cancer. Cells are harvested from the fat in one's own body; therefore, this company circumvents key issues typically found that cover story of cell regeneration. In late 2010, Wired Magazine featured Cytori in their article "All Natural: Why Breasts Are the Key to the Future of Regenerative Medicine"
Echo: We also heard a great pitch from Patrick T. Mooney, MD, Chairman & Chief Executive Officer. This gentleman had a company that has an exciting platform for glucose monitoring or dermal injection of drugs (without the dead cells). It’s nothing short of amazing. He dropped his device a few times, and it didn’t break! Very amusing, but, more important, the diagnostic is somewhat bulletproof! The ADDRESSABLE market size is ~$1B, so, possibly perceived as not so much given no one else is in the market, they have 100% share at present. They have already done two due diligences with very large companies

In the evening, we attended several social gatherings hosted by the industry Goliaths. Some notable social gatherings include:

Burrill: Well, I must admit, because I personally like the Burrill analysis so much, I’m a bit partial to the networking event held at Burrill’s office in downtown San Francisco. It was simply awesome! There were probably more than 500 people there at the time my colleague and I were there, which speaks to the value that was being provided by this event
Lazard: This gathering was simply amazing. I met so many of the best of the best that it’s difficult to begin naming names…but there are many
Rodman & Renshaw: Another “WOW”; this was one of the first events at the beginning of the week. Much to say about this event, but this is a blog after all…

Other events of the week that we attended included:

The Global Leader's Forum where we had an opportunity to see Myrtle Potter and Dana Hee, Olympic Gold Medalist
A panel on the future trends in healthcare; significant insights as it relates to the implication of “life diagnostics” on health

Highlights from the 2010 Mid-Atlantic Biotech Conference

2010-12-03T00:26:00.000-08:00

The Mid-Atlantic Biotech Conference was a smashing success! I had the opportunity to listen to the following biotech leaders: Dr. Martine Rothblatt, founder and CEO of United Therapeutics; Thomas Watkins, CEO of Human Genome Sciences; John Crowley, CEO of Amicus; James Greenwood, CEO of BIO; Dr. Joshua Sharfstein, Principal Deputy Commissioner; and many more! Even more exciting was, with the exception of Dr. Sharfstein, subsequently meeting all those listed!

The speakers were indeed insightful. A few key highlights of the conference:

a) Many of us already know that the company founders are the ones that infuse the breath of life into their companies, but, in biotech, it literally means life and death! So, therefore, first and foremost of my key highlights — many successful biotech companies are successful due to the passion and relentless drive of their founders. The story of Amicus CEO John Crowley has been turned into a film, given the sacrifices he made to save his children from their deadly disease. His is truly an inspirational story. The film about Mr. Crowley, “Extraordinary Measures,” tells the story of a father's commitment to save two of his three children from an Orphan (very rare) disease called Pompe disease. Mr. Crowley quit his job and raised money to establish his own biotech company called Amicus. He literally breathed new life into his children and his company. At the conference, Mr. Crowley stated: “It costs way too much and takes way too long to get much needed drugs to market”

b) Technology transfer / commercialization was a common theme throughout nearly every presentation / panel. The technology transfer topic focused on the new challenges that have arisen as a result of comparative effectiveness and scarce capital. It’s really not just about “technology” anymore – biotechs need to provide solutions at the lowest possible cycle time at the lowest possible cost and illustrate strong due diligence that what they are focused on WILL work

c) The next highlight may seem like an obvious one, but I found it interesting, having spent 17 years outside of the Life Sciences industry. According to several speakers, traditionally, the FDA has only looked at risk to evaluate drugs. Now, the FDA is establishing a risk-benefit framework for evaluating BLAs, NDAs and PMAs

d) We all know that the FDA was established to protect public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. I find this reoccurring message in a conference setting very interesting. Given a direct and indirect cost of ~$3B to get an NME to market, and the extreme revenue and margin compression that has been occurring in the Life Sciences industry, the unparalleled retraction of capital to the tune of 80-1000% (depending on the benchmark you’re looking at), not to mention the fact that there are many patients who need those riskier drugs to survive, I’m wondering how people perceived these repetitive remarks

e) Finally, the last insight I would share is from BIO’s James Greenwood’s speech, which I thought was truly brilliant! This gentleman understands that the Life Sciences industry is truly shattered and has just come through “the perfect storm.” Mr. Greenwood charismatically asked the audience questions about health care reform. One question was: “Do you think health care reform is going to make a positive impact on the biotech industry?” From the series of questions he posed to 300 people in the audience, there was a consensus that the reform is bad for biotech business. He then talked about an important initiative he’s working on called “the Next Big Thing”; this was a thrilling topic for me personally, as I would love to contribute to Mr. Greenwood’s efforts here.

Several implications come as a result of these insights. The key needs:

a) Breakthrough innovation in clinical development performance / operations – can you shorten the cycle time and lower the cost of getting a solution to market? Can this be done with the highest probability of success?

b) An industry framework for success – could there be an industry framework for operational, medical and market success to aid with “sure thing” technology transfer?

c) Breakthrough innovation in new solution development – do you have the right solution?

d) Breakthrough innovation – full stop – in Life Sciences industry dynamics – how can the Life Sciences landscape change to rebuild the value that has eroded?

Rosemarie Truman
Executive Vice President, Solutions

Achieving Breakthrough Innovation in Biotechnology through R&D Productivity

2010-10-29T08:47:00.001-07:00

With Advanced Clinical's Executive Vice President, Rosemarie Truman, attending the 2010 Mid-Atlantic Biotech Conference, we would like to provide you with our ideas on achieving breakthrough in biotechnology through R&D Productivity. The following abstract will be presented at the Conference today, and we are giving you an sneak peek online in case you can't make it to the conference!

With recent announcements of significant budget cuts in the R&D workforce and spending, it is clear the R&D model has changed for biotech companies and an innovative turnaround in R&D is needed. Advanced Clinical's poster presentation will demonstrate a codified framework for biotechnology companies to achieve true R&D productivity.

Through a strong framework and approach, biotech companies can ensure their product has market adoption and is differentiated; they can ensure operational efficiency in the clinical trial and they can make sure the medical/scientific focus is correct.

The comprehensive framework will assess the "what," the "how" and the "why" of R&D productivity.

1. What is needed for effective R&D productivity? First, the right medical / scientific focus is required. This includes, but is not limited to:
Protocol
Target label claims
Doses and routes
Enrollment and drop-out rates
Heterogeneity of the population
Precision endpoints

2. How can R&D productivity be achieved? Clinical trial operational execution factors to assess include, but are not limited to:
Clinical operations, enrollment, investigators and sites
Regulatory management
Data management
Biostatistics
Drug supply
Labs
Medical writing
Medical safety and monitoring

3. Why should the drug reach the market? Will it have adoption? Market viability and comparative effectiveness are critical to a drug's success.

By providing a framework for biotech companies to ensure their product is successful, they gain a higher probability of success in getting much needed products to market.

Advanced Clinical to Present an R&D Productivity Poster at the 2010 Mid-Atlantic Biotech Conference

2010-10-27T14:21:00.000-07:00

Join our Facebook page and watch for an update and pictures following the conference! www.facebook.com/advclinical

Advanced Clinical, a leading provider of clinical research services, announced today that Executive Vice President Rosemarie Truman will present a poster on R&D productivity at the 2010 Mid-Atlantic Biotech Conference on Friday, October 29, 2010. Ms. Truman will provide an overview of Advanced Clinical’s R&D framework and approach, which biotech companies can use to ensure their product has market adoption, is differentiated, has operational efficiency in a clinical trial, and has the correct medical/scientific focus.

“We look forward to presenting our R&D productivity framework for the biotechnology sector,” said Rosemarie Truman. “The framework we will discuss is proven to create step-change R&D improvement by improving probability of success as well as reducing cycle time and costs.”

About Advanced Clinical: Advanced Clinical provides consulting services, strategic sourcing (CRO), talent management, and technology solutions to the Life Sciences industry. With 15+ years of experience, Advanced Clinical is an established presence in the clinical research field, providing services specifically for Pharmaceutical, Biopharmaceutical, Biotechnology and Medical Device organizations. Advanced utilizes a value-based, “One Team” approach. To learn more, visit http://www.advancedclinical.com.

Contact:
Rosemarie Truman
rtruman(at)advancedclinical(dot)com
1200 Lakeside Drive
Bannockburn, IL 60015
Ph: 202-438-2208

Working Her Dream Job: Insight from a Clinical Development Expert

2010-10-15T01:34:00.000-07:00

Patricia Walicke MD, PhD, a core member of Advanced Clinical’s strategic advisory ecosystem, describes her experience in achieving her dream career: “I’ve followed a desire to try to make the world a better place and serve humanity through improving health and health care.”

As a strategic advisor, Dr. Walicke brings years of leadership strategy experience across several areas of clinical research, including protocol design and clinical plan development across multiple phases. Additionally, she has experience in regulatory submissions and interactions as well as medical monitoring and safety. Her expertise combined with her current work as an independent consultant for clinical development programs contributes to Advanced Clinical’s Industry Leading R&D Performance (ILRDP) framework that seeks to make the “business of R&D” more effective and efficient for Life Sciences companies.

“The team at Advanced is very bright, dedicated and determined, and, by working together, we have the opportunity to share how to operate more efficiently and effectively in the industry,” said Patricia Walicke, Advanced Clinical Strategic Advisor.

Formerly a practicing neurologist, Dr. Walicke changed careers to drug development approximately 15 years ago. She has experience with biologics and small molecules, and has worked on indications in neurology, autoimmune rheumatologic disorders, dermatology, ophthalmology and oncology. She explains that creativity, balanced by practicality, is the key to drug development: “When evaluating a potential therapeutic, first it is important to think broadly of all the possible ways that it might be used in medicine. Then the range of indications needs to be narrowed down to what is feasible. Matching the mechanism of action of the compound to the pathophysiology of the disease is also an important determinant.”

Notably, Dr. Walicke led the Phase 3 team for approval of efalizumab (Raptiva) for psoriasis; helped design extension of rituximab to non-oncology indications, particularly multiple sclerosis; obtained the first clinical proof of concept for anti-NGF in analgesia; and has been awarded several drug patents. “Drug development was a way for me to help more people more efficiently. You can potentially help hundreds of thousands of people,” said Dr. Walicke.

In addition, Dr. Walicke took a leadership role in establishing clinical groups in two start-up companies and restructuring the clinical department for biopharmaceutical company Oxigene with relocation from the East Coast to the West Coast.

Of compiling clinical teams, Dr. Walicke says, “While it is important for the team to be knowledgeable, it is perhaps most important that the team members communicate effectively and stay focused on the overall goal.”

Dr. Walicke offers advice to others in the clinical field, based on attributes to which she credits her own success: “Represent the needs and interests of patients and clinicians within industry, follow the science, keep timelines and deliverables, and pay attention along the way.”

Find your dream job at www.advancedclinical.com

Advanced Clinical Announces Bernice Welles as a Core Member of its Strategic Advisory Ecosystem

2010-09-30T12:20:00.000-07:00

Advanced Clinical, a leading provider of clinical research services, announces Bernice Welles as a core member of its strategic advisory ecosystem.

Bannockburn, Ill. (Vocus) September 30, 2010

Advanced Clinical, a leading provider of clinical research services, announces Bernice Welles as a core member of its strategic advisory ecosystem.

As a strategic advisor, Bernice Welles has contributed to Advanced Clinical’s Industry Leading R&D Performance (ILRDP) framework that seeks to make the “business of R&D” more effective and efficient for Life Sciences companies. Bernice has been a key driver in the development and regulatory approval of drugs, biologics, devices as well as combination therapies across multiple therapeutic areas. “Moving a drug and/or biologic from development to approval is, possibly, the hardest earned process in the Life Sciences industry,” says Bernice Welles, Advanced Clinical Strategic Advisor.

Welles’ accomplishments span several leadership roles in companies at different stages of growth. At Genentech, Welles was appointed to several management positions to drive the drug and biologics development portfolio across multiple therapeutic areas. Two of Welles positions included: Senior Director of the Specialty Therapeutics Unit and Vice President of Product Development. One important program that Welles progressed was the Lucentis injection for wet age-related macular degeneration (AMD). AMD is a disease of the eye that is the leading cause of blindness in older Americans and causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities. By moving forward this program, several thousand patients were able to be treated.

Welles held a Venture Partner position at MPM Capital LLP, where she participated in discussions on medical devices and helped assess device instruments. At MPM, Welles also took the lead on several investments and helped portfolio companies such as CoTherix maneuver the regulatory process leading to an early approval for Ventavis®, a new therapy for pulmonary hypertension.

Welles currently holds executive positions as CEO of Alquest Therapeutics Inc. and Vice President, Clinical and Regulatory, of Enject Inc., both innovative biotechnology startup companies.

With years of experience heading teams across functional areas, Welles credits integration as being one of the keys to her success. Using her capability to integrate the knowledge she has gained during her career, Welles is able to pull together all of the elements of clinical and regulatory as well as leverage the science behind development programs to create a significant, positive impact on the Life Sciences industry.

“I am proud to be working with Advanced Clinical,” said Bernice Welles. “Being part of this expert strategic advisory team allows me to continue to work with a topflight team to create new levels of R&D Productivity for companies in Life Sciences and bring much needed treatments to the market for those who need them.”

About Advanced Clinical: Advanced Clinical provides consulting services, strategic sourcing (CRO), talent management, and technology solutions to the Life Sciences industry. With 15+ years of experience, Advanced Clinical is an established presence in the clinical research field, providing services specifically for Pharmaceutical, Biopharmaceutical, Biotechnology and Medical Device organizations. Advanced utilizes a value-based, “One Team” approach. To learn more, visit http://www.advancedclinical.com/.

Contact:
Rosemarie Truman
rtruman@advancedclinical.com
1200 Lakeside Drive
Bannockburn, IL 60015
Ph: 202-438-2208

Advanced Clinical Announces a New Approach to Project Management to Improve R&D Productivity

2010-09-27T08:49:00.000-07:00

Advanced Clinical (AC), a leading provider of clinical research services, announces a new approach to project management to improve R&D productivity.

Bannockburn, IL (Vocus) September 17, 2010

Advanced Clinical (AC), a leading provider of clinical research services, announces a new approach to project management to improve R&D productivity.

Project management issues often plague clinical trials, and the planning process for trials is daunting. Numerous complexities need to be considered to construct a good clinical trial roadmap. Both medical/scientific and operational considerations demand careful management. Operational considerations include: country specific regulations; site monitoring intervals; drug shipments and handling; delivery methods, such as adaptive; and EDC technology. In addition, further planning and due diligence are critical to ensure comparative effectiveness. As a result, a new approach to project management is needed to improve R&D productivity.

AC starts with a strong foundation of processes, tools and templates for project management, including: risk management, knowledge management, continuous learning, resource management, benefits realization, financial management, service management, and many other elements, to delivery on key metrics.

AC has created a project management framework that identifies the right talent to make the project successful. The framework includes a comprehensive structure of components, such as therapeutic area; specific clinical trial method (e.g., Adaptive); clinical functions and country-specific requirements. Once the framework is applied, AC then identifies critical knowledge requirements and formulates a team of strategic advisor experts. This expert team provides critical insights to the project manager as well as the core team during the course of the trial.

The project management approach is based on AC’s Industry Leading R&D Performance (ILRDP) framework model, which contains, among other things, known risks for every part of a clinical trial and associated mitigation techniques as well as leading practices within and outside of the life sciences industry.

“Advanced Clinical drives rigor into project management to deliver strong results for clients,” said Leo Sheridan, CEO of Advanced Clinical. “It is a critical element of our ILRDP framework.”

Contact:
Rosemarie Truman
rtruman(at)advancedclinical(dot)com
1200 Lakeside Drive
Bannockburn, IL 60015
Ph: 202-438-2208

Advanced Clinical is Changing the Paradigm for Clinical Research Organizations Through Strategic Sourcing

2010-09-09T09:29:00.000-07:00

Many Life Sciences companies need some or all functions of their studies outsourced in some manner. After eight months of studying sponsors’ needs, we are introducing a new outsourcing paradigm called “Strategic Sourcing.” This model will provide sponsors a solution specifically designed for their unique needs.

We have experience in all aspects of clinical research, including adaptive seamless trials across Phases I-IV. In addition, the Advanced Clinical team brings an expert ecosystem and industry affiliations (CDISC, DIA, ASA, SCDM, RAPS, IDSA, AMA, ACRP, ASM, CDER, CBER), therapeutic expertise in 17+ areas, and extensive methodology expertise.

Our move to strategic sourcing provides the following:

Accelerated Trials: Advanced Clinical’s codified methodology, “Industry Leading R&D Performance” (ILRDP), allows us to accelerate clinical trials and create success at the lowest Total Cost of Ownership. ILRDP is patent pending and is the foundation for our services and solutions.
“One Team” Client Partnering Model: We align with each client’s vision and works to ensure transparency, two-way open dialogue, and one point of accountability. The “One Team” approach creates a program management structure that combines Advanced Clinical and client leadership for successful implementation and management.
Value: We use a value-based approach to deliver solutions at the lowest Total Cost of Ownership. Codified delivery tools ensure consistency and allow us to incorporate best practices from each trials experience. This learning approach creates measurable net profit impact for clients.
Lowest Total Cost of Ownership: We employ a hybrid approach to staffing teams. Clinical trials require continuity over time, and we provide a dedicated and thoroughly trained team. We supplement the team with contingent talent to increase flexibility.
eClinical Platform: Our technology platform supports all elements of managing a clinical trial: a Clinical Data Management System, Interactive Voice Response System (IVRS), Interactive Web Response System (IWRS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), and Business Intelligence/Reporting.

“Our clients expect their CRO to have proven experience, they expect lowest Total Cost of Ownership, and they expect the company to provide value,” said Leo Sheridan, CEO of Advanced Clinical.

Rosemarie Truman, Executive Vice President of Solutions, adds, “Advanced Clinical’s differentiators are what clients should expect from any CRO, and we provide these in all of our solutions.”

To learn more, visit http://www.advancedclinical.com

Writing the Future of Clinical Research

2010-09-02T10:24:00.000-07:00

The past several years have seen the rapid growth of the Medical Writing field, with the market more than doubling from an estimated $345 million in 2003 to $694 million in 2008, according to a Centerwatch Monthly report. Membership in the American Medical Writers Association, which sets the profession’s standards, increased 14% in the same time to nearly 5,700 members globally. Additionally, two dozen colleges and universities have recently established either certificate or degree programs in medical or scientific communication. Across the industry, Medical Writers are being highly prized for their ability to communicate scientific data effectively and efficiently, as well as taking on additional roles, such as transnational trial coordination and quality assurance, in the drug development process.

What do Medical Writers do?
Medical Writers both have a thorough background in scientific areas and are adept at communicating this information to various audiences. They perform numerous important functions, including the following:
• Communicate scientific and clinical data to a range of audiences in a wide variety of formats
• Combine scientific knowledge and their research skills to present information for targeted audiences
• Write clinical trial protocols, clinical study reports, and other documents for submission to the FDA
• Prepare journal articles, conference posters/presentations, internet content, and training/marketing materials

Is Medical Writing for me?
Before you consider entering the Medical Writing field, know that there are several key attributes that make the field a fit for individuals:
• Interest in scientific fields and writing
• Excellent written and oral communication skills
• High-level detail orientation
• Good interpersonal skills and “team player” attitude
• Ability to multi-task, learn “on-the-job”, and meet project deadlines

Additionally, Medical Writers are expected to have a level of technical knowledge and skills such as:
• Current scientific writing and editing techniques
• Software and systems, such as document management software, Microsoft Office suite, as well as reference, literature, and publishing software
• Company policies, procedures, and tools
• Industry guidelines
• Scientific area background with statistical knowledge preferred

Who do Medical Writers work for?
• Pharmaceutical companies
• Medical communication agencies
• Contract Research Organizations (CRO)
• Freelance Publishers
• Academic Medical Centers, Medical Associations, Publishers, Magazines, Websites

What are the benefits?
• High involvement with the latest scientific research and information
• Rewarding work that makes a difference
• Can have flexible work hours
• Current high market demand for Medical Writers
• A number of opportunities for career development
• High entry level compensation (~$50-60,000) and employee benefits
• Flexibility to switch jobs

What jobs are available?
Advanced Clinical has a number of exciting Medical Writing opportunities available across a wide range of experience, including:

Senior Medical Writing Program Manager (Oncology) – Northern Suburbs of Chicago, Illinois
One of our clients is seeking a Senior Medical Writing Program Manager (Oncology) also known as Global Medical Writing Lead, generally for early- to mid-stage development global project teams and may act as a back-up/supporting GMWRL for several projects.

The individual will provide:
• Project leadership with respect to program documents and writing activities commensurate with experience
• Review of work and manage/coordinate writing activities across an entire program, and may review and amend the work plans developed by a Document Working Group Facilitator (DWGF; lead medical writer in a working group) for a particular document
• Intellectual leadership and contributes document knowledge and expertise to the project team

Associate Director, Medical Writing – Princeton, New Jersey
A client in the Princeton NJ area is looking to add a permanent Associate Director of Medical Writing to their team.

The individual’s responsibilities include:
• Deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects
• Prepare clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format
• Coordinate and prepare Meeting Content Packages, and responses to regulatory authorities as well as the management and preparation of a variety of clinical documents including clinical study reports, narratives, investigator brochures for Phase I to IV clinical trials, and drug safety related documents such as Periodic Safety Update Reports

Senior Medical Writers/Writing Team Leaders – Worldwide
A client is seeking experienced medical writers to serve as Team Leaders at their office locations around the world.

Team Leaders are strategic consultants, project leaders, and hands-on writers who:
• Serve as subject-matter experts for clients, guiding and advising them on strategies and best practices for achieving approval from health authorities
• Serve as subject-matter experts for team writers, providing leadership, advice, and continual mentoring
• Actively participate in development and writing of documents
• Ensure quality, adherence to budgets and timelines, and compliance with SOPs, policies, and other guidance as required by the company, regulatory bodies, and individual clients

Key Levers for R&D Effectiveness and Efficiency

2010-09-01T12:48:00.000-07:00

Optimization needs to occur in two ways: “what is done” (effectiveness) and “how it is done” (efficiency). Key R&D areas that should be re-aligned to increase effectiveness include:

From Opportunistic to Focused Innovation: Drive rigor into the selection of new products/solutions. Capitalize more effectively on new ideas that present great opportunities for the company

From Full Integration to Partnership: Partner with other companies to manage risk and return on R&D capabilities; outsource capabilities that aren’t central to company strategy

From Therapeutic Problem to Differentiated Customer Solutions: Shift from therapeutic R&D that addresses diseases to meeting patients’ needs through curing ailments and fully managing patient conditions. Payors and consumers are demanding solutions, as well as differentiation

From a Functional to an Integrated Business Model: Map out an integrated R&D model focused on a specialized therapeutic, customer or scientific area to provide tighter coordination and more rapid decision-making; use comparative effectiveness to bring to market the right drug, biological entity and/or medical device

While “what companies do” creates 70-80% of problems for R&D, companies must not forget to also focus on the other 20%: addressing efficiency gaps to streamline its processes, people and technology. Efficiency gaps are broken out as follows: Technology and Resource Management, Project and Resource Management, Product Development Processes, R&D Investment Guidelines, and Asset, Knowledge and IP Management.

Technology and Resource Management: There are few standard technologies to support R&D processes. Where technologies are used, they are used inconsistently, with overlapping duplicate efforts. There is no comprehensive application and information architecture that would allow Life Sciences companies to understand performance across ALL product development and clinical trial efforts. An integrated eClinical platform would provide fully integrated business and technology solutions to minimize duplication and harmonize data

Project and Resource Management: Proper project management and associated resource allocation is critical to ensure the right resources are on the right projects at the right time. Project management needs to include a comprehensive, cross-functional approach including: risk management, decision management, issue management, change management, quality management, knowledge management as well as service/metrics management

Product Development Processes: R&D also suffers from inconsistent development processes, poor collaboration, and weak customer insight. Developing, implementing and adhering to a standard set of product development processes (e.g. BLAs for vaccines), which include regular collaboration and market insight injection, will enable R&D to develop the drugs that consumers actually want and bring them to market quickly

R&D Investment Guidelines: With tightening budgets, talent turnover, and increased competition, an R&D investment strategy is needed for sustained growth; companies need guidelines to mitigate risks and accelerate clinical trial time while reducing spending

Asset, Knowledge and IP Management: Proactive collection of knowledge is critical to ensure continuous learning and constant improvement of current practices. In addition, codification of knowledge into repeatable processes and methods is also important to create intellectual property assets

http://www.advancedclinical.com/

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The Current Dynamics at Play in the Life Sciences

2010-08-25T12:21:00.000-07:00

Results are getting worse for Life Sciences R&D. Failure rates of experimental drugs are on the rise, with the number of products abandoned in late-stage Phase 3 trials having doubled to almost 40 in 2007-2009, compared with 2004-2006. Now it takes 12-13 drugs to enter the pre-clinical phase to gain one commercial success vs. 8 in the year 2000. Direct and indirect costs to achieve one commercial success have nearly tripled, going from $800 million in the year 2000 to $2.5 billion in the year 2010. Meanwhile, R&D cost growth has outpaced sales growth rates significantly. Only one in five marketed drugs manages to recoup R&D costs and new products developed over the last five years account for merely 7% of current revenue. Worse, the growth rate of R&D outlays has outpaced the growth rates of Gross Margins since 1996.

In addition to the financial dynamics outlined above, R&D operational performance is poor. Greater than 90% of all clinical trials are delayed due to over-ambitious timelines and difficulty with patient enrollment. Approximately one-third (35%) of trials are substantially delayed due to ‘Rescue Mode’ patient recruitment activities. Also, eighty percent of studies run over by 30-42%, an average of 6 months.

What are Life Sciences companies doing to address these issues? They are cutting people and costs. In the first three months of 2010, the pharmaceutical industry cut 25,857 jobs. Life Sciences companies have also cut back on R&D activities in 2010 to preserve funds, with aggregate spending to develop new drugs falling by 0.3 percent. Overall, cumulative investment as a proportion of sales has decreased to 15 percent across the pharmaceutical industry.

Unfortunately, these effectiveness and efficiency challenges have all led to the same result: staggering failure rates. An incredible 65% of product launches fail and 46% of product development resources are spent on products that either fail or never make it to market.

These results combined with the aforementioned financial and operational challenges clearly show one thing: an R&D transformation is needed.

See www.advancedclinical.com

Upcoming Brand Launch: Breaking the Mold

2010-08-14T10:46:00.000-07:00

New Framework
Next week marks a vital time for Advanced Clinical (AC), as we will officially announce our new market and brand launch. On Tuesday, August 17th, we will be introducing our game-changing Industry-Leading R&D Performance (ILRDP) framework, unveiling our new website, as well as highlighting the new additions to our executive staff, social media platform, and our innovative service offerings.

Through our ILRDP model, AC is shifting the paradigm in the clinical research outsourcing (CRO) space, ensuring a positive, sustainable net profit impact for our clients. We have augmented our offerings and capabilities to better serve the needs of our life sciences clients in strategic effectiveness, clinical planning and clinical operations. While ILRDP will benefit all four of our core competencies: Consulting, Strategic Sourcing, Talent Management and Technology, our Consulting services will be impacted significantly. Through our Consulting services, we provide breakthrough performance with Portfolio Strategy, ILRDP Transformation, and Workforce Strategy. Below are examples of how our ILRDP framework will drive results:

Our Portfolio Strategy offering provides complete analysis of company-wide business investments, through which we aim to restructure the overall investment portfolio to drive the best value for the client. Note that value is defined differently by each client (e.g., value could be either net profit, or top line growth, as well as other alternatives)
Impact: This strategy ensures that clients are focused on the right initiatives and/or products solutions with the appropriate resource investment stance

Our ILRDP Transformation identifies how R&D can become more effective and efficient; aligns clients’ R&D with the business strategy and identifies operational/maturity improvements, utilizing our ILRDP framework
Impact: This transformation enables clients to embrace R&D to drive company-wide growth and create positive net profit impact, as well as contribute to business strategy and innovation

Our Workforce Strategy approach determines core/context disposition for R&D functions. Assesses/benchmarks the current state workforce at the R&D level, clinical development level and/or the clinical trial level. Develops resource blueprint, plan and business case
Impact: This offering provides a significant net-profit impact for clients by optimizing the mix of workforce for each element of the business. The outcome is a workforce blueprint, a roadmap as well as a P&L impact model

New Social Media Platform
In addition to our offerings and our ILRDP framework, we are excited to unveil our comprehensive social media platform, through which we can share up-to-date information more quickly and conveniently with our clients and consultants. Our new website provides opportunities for interaction and exploration regarding AC solutions, capabilities, experience and team members. You can find out the latest news and updates on our blog, Facebook fan page, LinkedIn group, YouTube page, and Twitter account.

New Leadership Team Members
We welcome two new members to our leadership team: Rosemarie Truman, executive vice president, and Julie Heneghan, vice president. Both leadership team members bring a wealth of knowledge and experience that will continue to evolve the future of Advanced Clinical.

Share in the excitement of our brand launch next week, as we continue to innovate and break the mold in the life sciences industry. Don’t forget to add us on Facebook, join us on LinkedIn or follow us on Twitter to view our latest news.

See www.advancedclinical.com

Database Development and Biostatistics: A Collaborative Process

2010-08-12T16:05:00.000-07:00

If you could put a price on your clinical data in a given trial, how much would yours be worth? Millions, perhaps. With the ability to unlock discoveries, trends and relationships, you likely view this data as invaluable. It has all the potential of being either a perfectly packaged group of key findings – or a mass of erroneous variables.

The same group of variables that can reveal remarkable findings can also produce ceaseless headaches when handled incorrectly. When can you determine which path your data are headed down?

The Oracle Clinical database development and biostatistics teams at Advanced Clinical are standardizing the data upfront in a collaborative effort to streamline projects. By making the data CDISC compatible at the beginning of a trial, there is far less room for error and miscommunication throughout each project, from start to finish.

Typically, the database development and biostatistics teams are separate entities. Although they serve the same client, they often operate completely independently of one another. In the traditional paradigm, data inconsistencies are often discovered far along into the project. As a result, teams have to go backwards to see where the problem originated. The new process involves collaboration between the database development and biostatistics teams and implementation of CDISC standards early in the development life cycle.

What does this mean for a client? The teams now understand each other’s language, resulting in seamless workflow communication, increased data quality, easier transfer of data between teams and consistency across studies as well as time and cost savings. And, most important, there is more time to enhance your discoveries.

See www.advancedclinical.com

Game Changing Framework in Advancing Discoveries: ILRDP & Contest!

2010-07-29T13:43:00.000-07:00

Advance Discoveries Contest! Shorten clinical trials. Reduce risk. Reduce cost. We need YOUR ideas!

Eighty billion drugs are predicted to come off patent in the next three years. EIGHTY BILLION DOLLARS WORTH OF DRUGS FALLING OFF PATENTS! There are indications that the release of patents may save money for the healthcare system as a whole because generics are expected to increasingly take the place of those coming off patent. However, while many patients require several drugs coming off patent, there are no replacements for many of them. As a result, pharmaceutical, biopharma, medical device and biotech companies have two key imperatives:

"Advance discoveries," aka, reduce clinical trial cycle time
Reduce the escalating costs (Total Cost of Ownership) and risks associated with drug development… while maintaining quality

In response, Advanced Clinical has just launched the game-changing framework to deliver the best clinical trial results within the “Business of R&D.”

AC has analyzed clinical trials across all phases and has identified a series of ways to accelerate delivery timelines. As a result, we have either met or exceeded timelines by 10-40 percent. In addition, we have identified key risks, risk mitigation techniques as well as leading practices to accelerate trial delivery. Finally, we have identified Key Performance Indicators, which are a measurable means to ensure the best performance against timelines.

How have we done this? Using ILRDP as the foundational framework, Advanced Clinical augmented its offerings and capabilities to be able to help Life Sciences companies identify the capabilities that are important to “what they do”, aka, be more effective, as well as ensure “how they do it”, aka, be more efficient in clinical clinical planning as well as clinical operations:

Our unique strategic sourcing approach to CRO (Program Management, Functional Sourcing, Managed Services Provider) – We work collaboratively with clients to reach strategically sourced solutions as a Clinical Research Outsourcer (CRO) to create breakthrough value
Consulting services help clients gain breakthrough performance through Portfolio Strategy, ILRDP Transformation, and Workforce Strategy
Talent management (Contract Staffing, Asset Transfer, Executive Search) – Provide a platform for talented individuals to establish and grow their career, working for us as consultants. Our clients are matched with the perfect consultants
Technology solutions that cover end-to-end data management and reporting / analytics needs (Software as a Service Technology platform, including EDC, IVRS, CTMS and CDM as well as Analytics and Reporting)

By advancing discoveries through ILRDP we are now able to execute clinical trials at lowest total cost of ownership (TCO) and highest probability of success with robust quality, safety and efficacy. We go beyond for our clients and consultants and have created the highest standards in the industry, as we have gone to all industry segments to pull best in class practices, tools and techniques and have codified these into everything we do. The result: the best, most effective solution …We advance discoveries through insight.

How do you advance discoveries? NOW--Win an iPad!

Advanced Clinical wants to ask pharmaceutical, biotechnology and medical device companies, “How do you advance discoveries?” What are the best practices you use to shorten clinical trials? How do you reduce risk and cost in drug development? Do you have a strong risk management approach, employee training, or metrics management? Advanced Clinical would like your ideas to create Industry Leading Trial Performance in clinical research.

Let us know how you advance discoveries here. If you win, your ideas will be part of our press release August 17th and you will win an iPad! The winning list of ideas will be posted end of August, 2010.

See www.advancedclinical.com

Advancing Discoveries: Regulatory and Risk Decisions in Adaptive Designs

2010-07-09T09:53:00.000-07:00

Although adaptive designs produce numerous benefits for clinical trials, there are also a number of risks associated with it. Below, Advanced Clinical outlines some of the key risks when conducting adaptive designs as well as ways people mitigate them. Also are some FDA-accepted designs, including the more well known Bayesian approach.

What are the big, key risks?
One major concern is the effect of adaptive designs on statistical measures. Though addressed broadly, the issue of preservation of type I error rate remains a key issue in adaptive design. Also, changes in sample size, hypotheses, and other statistical measures affect the validity of the outcome data in clinical trials. Logistic concerns include methods on how to collect data. With interim decision making, data must be collected rapidly, and with short follow-up times in order for that data to remain relevant to the current state of the study. The main procedural issue to be followed closely relates to data review, careful decision making, and implementation of decisions during adaptive trials while maintaining trial integrity.

Click picture for full view!

How do you mitigate those risks?
To mitigate risks that come with adaptive design, careful planning pre-clinical trial must take place. The right statistical measures must be in place and through simulation, the right statistical changes must be determined in case interim data suggests changes on statistical procedures. During clinical trials, it is recommended to have a Data Monitoring Committee (DMC) to review interim results and determine whether relative changes can be made. Also during trials, the use of clinical technologies such as EDC, IVRS and IWRS as well as light EDC are highly recommended in order to deal with the logistic concern of quick, responsive data analysis.

Some commonly accepted designs approved by the FDA (click picture for full view!)

Bayesian Adaptive Dose Allocation Approach (click picture for full view!)

See www.advancedclinical.com

Advancing Discoveries: Adaptive Designs in Clinical Trials

2010-07-07T14:03:00.000-07:00

What is Adaptive?

In the past several decades there has been a recognized trend of increased spending within pharmaceutical, biopharmaceutical, medical device as well as biotechnology research without a proportional increase in success rate of clinical trials - there used to be 8 IDAs for 1 commercial success; now 16 INDs for 1 commercial success. Some of these could be due to diminishing improvement margins for new drugs, unchanging failure rates, escalating costs, and other clinical limitations. By advancing discoveries, Advanced Clinical seeks to determine the most efficient and effective way to conduct clinical trials without decreasing the safety or efficacy of the trial. Adaptive designs have recently become the frontrunner in advancing clinical trials. Adaptive designs are clinical study designs that utilize accumulating clinical data to modify the study as it progresses, without undermining the validity and integrity of the trial. Not all clinical trials are suited for adaptive design. Stay tuned for our next blog post on Adaptive Risk Management, and FDA accepted adaptive designs/regulatory perspectives!

Why do it?

Adaptive clinical designs save resources and increases efficiency of the clinical trial. Greater flexibility within the adaptive design framework can translate into better treatment of patients within trials (stopping ineffective/dangerous doses early), more efficient drug development, and better use of available resources (need for less patients). Adaptive designs are not only advantageous to drug development, but they are ethically beneficial to the patients. Trials can be cut earlier if they are ineffective, thus efficiently and effectively ensuring patients are well served with the appropriate dosages. This is most important not only because the clinical trial can save resources by cutting off ineffective arms, but the trial can also stop harmful treatments early on in order to prevent patient harm and preserve the overall safety of the clinical trial. Adaptive designs for clinical trials provide efficient tools to demonstrate the safety and effectiveness of new medical products in faster timeframes with more certainty, at lower costs, and with better information.

Types of Adaptive Design Options (click picture to view!)

With adaptive study design, there are many design options that affect different aspects of a trial. above are some of the more widely known adaptive options.

What are the Pros and Cons of Adaptive Design? (click picture to view!)

Adaptive designs, though having a lot of advantages, can have some disadvantages as well. Stay tuned for our next blog posting about the risks and regulatory perspectives surrounding adaptive designs.

Also, don't forget to add our facebook page! www.facebook.com/advclinical

See www.advancedclinical.com

DIA Conference Recap: Come join our discussion!

2010-06-20T13:12:00.000-07:00

Advanced Clinical attended the DIA conference June 13-17^th, 2010 in downtown DC at the Washington Convention Center. It was an awesome week. We were able to meet so many people, while networking, brainstorming, and discussing numerous topics surrounding the clinical and pharmaceutical industry.

Our team was able to sit in on and discuss many interesting presentations. The one presentation that really hit it for us was the session “Fiscally Responsible Protocol Development: Minimizing Potholes and Avoiding Sinkholes” hosted by Anna Hindle, Anne Cropp and Ken Getz. The session outlined:

a) The financial impact of protocol amendments including the hidden costs

b) Protocol amendments correlation with therapeutic areas and functional areas, e.g., data management, clinical operations, etc.

c) Triggers/causes of protocol amendments

d) Characteristics of protocols that generate lots of amendments, e.g., the more Investigator sites, the more amendments

e) Amendments that are avoidable and amendments that are not avoidable

f) Lessons learned and tips / techniques for circumventing / preventing the avoidable amendments

Some interesting facts about amendments we learned: 40% of amendments occur before the first patient is in, 631 hours/amendment approval, 484 hours/amendment to implement, and a minimum of $60K per amendment - $400K per amendment. We also learned that the key triggers of amendments were due to: standard of care changes, safety issues, and the need to deal with sub-populations.

Advanced Clinical had some additional thoughts on the amendment front upon reflecting on this presentation:

a) Would be good to determine the characteristics of a good amendment and a “bad amendment”

b) It’s important to perform the analysis of doing the amendment vs. not doing the amendment

c) Perhaps consider the following items to deal with amendments more efficiently:

Think about doing amendments in “release” schedules like people do in software development
Use tools that allow standard language document components – there are some good document management tools that have this functionality
Create guidelines for the organization to evaluate whether or not an amendment should be performed
Understand the causes of amendments in your organization. Gather data around amendments for therapeutic area; cause; sub-population; hours to design/gain approval for amendment; hours to implement amendment
Create an ecosystem of experts to review the protocol before finalizing it to avoid amendments. Put more time into the protocol up front to ensure completeness and consideration of key areas where changes could occur
Make the language more flexible in the protocol to avoid the amendment, e.g., put in “5-9 sites” instead of “7 sites”

On top of the presentations, the exhibitions were excellent. Our favorite was Oracle’s demonstration of their new Oracle Clinical product. We were able to talk with Oracle and their product roadmap as it relates to their EDC product, “RDC”. Also we were able to discuss Oracle Clinical’s “big picture architecture including IVRS, IWRS, EDC, Business intelligence as well as the anchor Oracle Clinical Product.

Were there any presentations or exhibitions you particularly enjoyed or thought was informational? What are some of your thoughts on the presentations given? Hanging questions? Comments? Please let us know! Come join our discussion and comment or write on our wall in our Blog or on our Facebook page. We’d love to hear your ideas and takeaways from the DIA Conference.

AC also had the opportunity to host OYA for a networking happy hour. It was a huge success! We were able to gather so many great people from the DIA Conference. There was a lot of relaxing, socializing and brainstorming for advancing discoveries. If you weren’t able to make it, please join our discussion for Advancing Discoveries on our Facebook page at www.facebook.com/AdvClinical

See www.advancedclinical.com

Men's Health and Cancer Awareness Week

2010-06-16T14:03:00.001-07:00

With Father's Day coming up this Sunday, June 20, it also marks the week for men's health and cancer awareness. See our blog post on women's cancer awareness week.

Due to a lack of awareness, poor health education and culturally induced behavioral patterns in their work and personal lives, men’s health and well being are deteriorating rapidly. Statistics show that men live sicker and die younger than American women. Men’s Health Week is to bring awareness to the fact that men can do things to prevent suffering and even dying from many avoidable and treatable diseases. It is important for men to pay attention to their bodies and visit a doctor whenever suspicious symptoms arise. Annual physicals are recommended to ensure proper screenings are done. Early detection and treatment of disease is extremely important to maximize your health. To download a Blueprint For Men’s Heath – a publication that discusses the main health issues that men face today – click on this link here.

Best wishes to all Fathers this coming Sunday. To quote Congressman Bill Richardson (Congressional Record, H3905-H39906, May 24, 1994):

“Recognizing and preventing men’s health problems is not just a man’s issue. Because of its impact on wives, mothers, daughters, and sisters, men’s health is truly a family issue.”

Medicine is making new strides everyday to advance discoveries to ease symptoms, cure disease, and better the human situation. Enter our “how do you advance discoveries” contest and your company could win an iPad and get a mention in our press release.

See www.advancedclinical.com

Advanced Clinical: The CRO with Experience

2010-06-10T07:11:00.000-07:00

Advanced Clinical has advanced many discoveries and has experience in over 192 trials in many therapeutic areas across Phases 1 though 4. Over the years, we've worked together with pharmaceutical companies to enhance medicine in disciplines which include but are not limited to:

1. Analgesia
2. Anti-Infective
3. Antiviral
4. Cardiology
5. Endocrinology
6. Gastrointestinal*
7. Geriatrics
8. Gynecology*
9. Hematology
10. Infectious Disease
11. Infertility
12. Musculoskeletal
13. Neurology
14. Oncology
15. Urology
16. Ophthalmology
17. Renal
18. Respiratory
19. Rheumatology*
20. Women's Health

*Advanced Clinical has over 25 trials' experience in these indicated disciplines.

Of our 192 trials, a whopping 191 of them used Advanced Clinical's Data Management service. Our Data Management service is reliable, resilient, and depended on by the best pharmaceutical, biotech and medical device companies in the industry. Our technology platform utilizes state-of-the-art tools: Oracle Clinical, Electronic Data Capture (EDC), and IVRS and IWRS (Interactive Voice or Web Response Systems).

Advanced Clinical also adheres to CDISC and SDTM standards with integrity checks and trial monitoring reports. Advanced Clinical is compliant with ICH, the FDA (21 CFR part 11) and GCP.

Our Biostatistics team is among the best in the nation and we continue to add strength and capabilities to the team in strategic therapeutic areas.

Advanced Clinical is prepared to handle any size trial. Within our body of work, 15 percent had over 500 subjects; one of those trials had over 5,000. We've done trials within the US at one site, and globally over hundreds of sites. Whatever your trial needs are, we will develop a plan and do our part to partner in your development.

Advanced Clinical's leading practices help drive the speed, improve the quality, and ensure the highest probability of success at the lowest total cost of ownership. Some of the delivery assets we use are:

• Our approach to collaborate, innovate, and optimize. Advanced Clinical believes in working together in collaboration, innovation through the Industry Leading R&D Process, and maintaining a continuous learning approach to optimize trials.

• Resource Management Model. Advanced Clinical not only retains, but nurtures our consultants to keep the best ones loyal and available for our exciting projects.

• Team Integration. Advanced Clinical wants to make the client team and the Advanced Clinical team integrated into one.

• Risk Management. Advanced Clinical identifies, assesses, prioritizes, mitigates, and tracks risks to proactively avoid issues that might arise

• Continuous Learning. Continually improving the trial as it goes on will optimize its overall success.

• Ramping. Advanced Clinical onboards, trains, and adapts the team to the client's environment, culture, project and needs.

• Project Management with Supply / Demand Management. Advanced Clinical will ensure clients get the right team, at the right time, and with optimal productivity with collaborative project management.

Use a clinical research organization with experience and an approach to support your growth: Advanced Clinical.

Does this sound like a great way to advance discoveries? We think it is. Enter our “how do you advance discoveries” contest and your company could win an iPad and get a mention in our press release.

See www.advancedclinical.com

How do you advance discoveries? EXTENDED THROUGH JULY!

2010-06-03T18:13:00.000-07:00

Now, you have through July to enter to win an iPad and a mention in our winners press release!

Shorten clinical trials. Reduce risk. Reduce cost! We need YOUR ideas!

Eighty billion drugs are predicted to come off patent in the next three years. While some say this release of patents may save money for the healthcare system as a whole because generics will take the place of those coming off patent, there is no replacement for many drugs and there are patients that need these drugs. As a result, Pharmaceuticals and Biotech companies have two key imperatives:

"Advance discoveries", aka, reduce clinical trial timelines

Reduce the escalating costs and risks associated with drug development

A recent article in the Wall Street Journal "Clinical Trial Death Watch" (March 16th 2010) echoes these imperatives. The message from the Wall Street Journal article is: there is a resounding need for efficiency and effectiveness to accelerate clinical trials. Even the government is trying to help with the acceleration of clinical trials. One recent study focused on collaboration. There are, however, still many complex issues that create barriers to realizing these imperatives. See, Forbes (March 26th, 2010 "Research and Markets: Investigating Clinical Trial Costs").

Advanced Clinical wants to ask pharmaceutical, biotechnology, and medical device companies, “How do you advance discoveries?” What are the best practices you use to shorten clinical trials? How do you reduce risk and cost in drug development? Do you have a strong risk management approach, employee training, or metrics management? Advanced Clinical would like your ideas to create Industry Leading Trial Performance in clinical research.

Let us know how you advance discoveries here. If you win, your ideas will be part of our press release in July, and you will win an iPad!

For winning list announcement, you can follow Advanced Clinical on facebook or on one of our social networks:

Advanced Clinical Facebook Page
http://twitter.com/AdvClinical
http://youtube.com/AdvancedClinical
http://AdvancedClinical.blogspot.com
http://AdvancedClinical.wordpress.com

See www.advancedclinical.com

Advanced Clinical: Asset Delivery

2010-05-24T14:36:00.000-07:00

Upon signing your discovery to Advanced Clinical, you will find there are a lot of assets with your decision. Advanced Clinical is home of the Industry Leading Trial Performance Method, a method which carefully combines strategy, management, structures and execution strategies to advance discoveries.

Parts of our ILTP method include risk management, team integration, continuous learning, ramping/onboarding, project management with supply and demand management, recruiting and sourcing, and marketing.

Advanced Clinical takes a three-part overall approach to trials:

Collaborate: One team approach, we work together
Innovate: Work together to find the best technology and team members to find new ways of testing and advancing your discovery, apply the Industry Leading Trial Performance Method
Optimize: Enhance the trial after it has begun with continuous learning and training, make step-change improvements to better the trial

Does this sound like a great way to advance discoveries? We think it is. Enter our “how do you advance discoveries” contest and your company could win an iPad and get a mention in our press release.

See www.advancedclinical.com

Big Pharma aims for reinvention

2010-05-21T14:15:00.000-07:00

With some of his most profitable medicines going off patent, and the uncertainty of replacement drugs continuing to rise, US healthcare reform has been the least of Andrew Witty’s recent worries.

When the chief executive of GlaxoSmithKline presented his company’s most recent financial results last month, he gave a sense of how the UK’s biggest drugmaker – and the industry more generally – is responding to structural pressures: diversify to survive.

For his company, he says, this means a shift away from “white pills in western markets”, with the proportion of traditionally core patent-protected, chemically based drugs, which are sold mainly in North America and western Europe, falling to just more than a quarter of total sales.

For many years, large companies such as GSK have relied on a handful of typically high-priced, mass-market “blockbusters” that generate billions of dollars a year in sales. But as patents expire on drugs such as Lipitor, Pfizer’s anti-cholesterol medicine that is the biggest selling medication in history, big pharma is having to rethink its business model.

Most large pharmaceutical companies have adopted four principal strategies to diversify. First, expand the range of products in the research and development pipeline and the use of external as well as in-house scientists to discover them. Second, expand geographically, especially into emerging markets. Third, increase sales of products other than patented prescription medicines. Fourth, experiment with greater flexibility in pricing in different countries and with ways to ensure drugs provide value for money.

Read the rest of the article -- FinancialTimes.com

Visit us at www.advancedclinical.com

Risk Management from Advanced Clinical

2010-05-15T09:41:00.000-07:00

Risk is a huge problem in clinical trials, and Advanced Clinical is swift and professional about identifying, assessing, prioritizing, mitigating and tracking risks to proactively avoid those risks – before they become issues that cause the trial to delay the trial. Some risks, unmitigated, can cause 2 years of delay! At a direct and indirect slippage cost of $6MM - $15MM/day, that adds up!

Advanced Clinical:

o Assesses risks
o Prioritizes risks
o Reduces uncertainty
o Mitigates risks
o Manages/monitors risks
o Optimizes procedures to reverse risks

Advanced Clinical recognizes the four types of risk: operational, strategic, financial, and market, so no area is overlooked. Advanced Clinical also assesses the scale of the impact, and the likelihood of occurrence of the risk over the trial period.

We want success and advancement for your discovery's trial as much as you do, and managing and mitigating risks is one of our keys to success.

Does this sound like a great way to advance discoveries? We think it is. Enter our “how do you advance discoveries” contest and your company could win an iPad and get a mention in our press release.

See www.advancedclinical.com

Women’s Cancer Awareness Week

2010-05-04T00:19:00.000-07:00

With Mother's Day around the corner on May 9, it also marks the week for women's health and cancer awareness.

In spite of social leaps and bounds women have made in recent decades, there are still distinct differences between the bodies of men and women. There are many cancers that affect only women, or mostly women: breast cancer, fallopian tube cancer, ovarian cancer, uterine cancer, vaginal cancer, and vulvar cancer. Birth control pills can put women at risk of breast tenderness, gall bladder disease, bloating, nausea, acne, and headaches. Women are more susceptible to mood disorders like depression and anxiety.

Women go through menopause. Here is a great article from Google about how to ease symptoms of menopause and what to expect.

It's not all that bad being a lady, though. Women typically have a larger deep limbic system than men, which allows them to be more in touch with feelings and better able to express those feelings, which promotes bonding and friendship with others. Women are also blessed with the gifts of childbirth and breastfeeding, which form immediate and permanent bonds with her child.

Medicine is making new strides everyday to advance discoveries to ease symptoms, cure disease, and better the human situation. Enter our “how do you advance discoveries” contest and your company could win an iPad and get a mention in our press release.

See www.advancedclinical.com

DIA-bound? Join us for networking and brainstorming at Oya

2010-04-30T12:39:00.000-07:00

Pharmaceutical, biotechnology, and medical device executives: are you going to the Drug Information Association (DIA) meeting in Washington, DC, June 13-17?

How do you advance discoveries? Join Advanced Clinical for cocktails, networking happy hour, brainstorming and make clinical trials better. We are meeting at Oya on Monday, June 14 at 5 p.m.

Oya is a beautiful contemporary Asia-French fusion restaurant and lounge in Penn Quarter, blocks from the DIA conference headquarters.

We hope you can join us! Please email jheneghan@advancedclinical.com for more details and to RSVP.

Don't forget! Enter our “how do you advance discoveries” contest and your company could win an iPad and get a mention in our press release.

See www.advancedclinical.com

Propel clinical trials with Continuous Learning

2010-04-26T21:37:00.000-07:00

Advanced Clinical, the trusted CRO among the world's top pharmaceutical, biotechnology, and medical device companies, is enhancing Continuous Learning as a part of their Industry Leading Trial Performance method.

Advanced Clinical is experienced enough with trials to know that trials sometimes deviate from the original plan to improve scheduling, avoid risk, and improve efficiency and optimize the entire project. Continuous learning keeps everyone working on a trial up-to-date with those improvements. Change is not always good for a trial, but continuous learning and improvements means the right changes are being made.*

Continuous learning leads to success,** which is what AC wants for its clients.

Does this sound like a good way to advance discoveries? We think it is. Enter our “how do you advance discoveries” contest and your company could win an iPad and get a mention in our press release.

See www.advancedclinical.com

Sources:

*Is Change Always Good In Business?, Brian Chernett, CEO of the Academy for Chief Executives .

**Success Made Simple, Erik Wesner.

How do you advance discoveries? NOW--Win an iPad!

2010-04-22T08:36:00.000-07:00

Now, winners receive an iPad and mention in our winners press release!

"Advance discoveries", aka, reduce clinical trial timelines

Reduce the escalating costs and risks associated with drug development

A recent article in the Wall Street Journal "Clinical Trial Death Watch" (March 16th 2010) echoes these imperatives. The message from the Wall Street Journal article is: there is a resounding need for efficiency and effectiveness to accelerate clinical trials. Even the government is trying to help with the acceleration of clinical trials. One recent study focused on collaboration. There are, however, still many complex issues that create barriers to realizing these imperatives. See, Forbes (March 26th, 2010 "Research and Markets: Investigating Clinical Trial Costs").

Advanced Clinical wants to ask pharmaceutical, biotechnology, and medical device companies, “How do you advance discoveries?” What are the best practices you use to shorten clinical trials? How do you reduce risk and cost in drug development? Do you have a strong risk management approach, employee training, or metrics management? Advanced Clinical would like your ideas to create Industry Leading Trial Performance in clinical research.

Let us know how you advance discoveries here. If you win, your ideas will be part of our press release in June, and you will win an iPad! The winning list of ideas will be posted on June 20, 2010.

For winning list announcement, you can follow Advanced Clinical on facebook or on one of our social networks:

Advanced Clinical Facebook Page
http://twitter.com/AdvClinical
http://youtube.com/AdvancedClinical
http://AdvancedClinical.blogspot.com
http://AdvancedClinical.wordpress.com

See www.advancedclinical.com

Team Integration from Advanced Clinical

2010-04-15T11:12:00.000-07:00

Many times there is limited or no effort taken to create a joint view of the goals that should be achieved during a clinical trial. As a result, the clinical team is not productive as a unit as they become "disengaged". Disengaged employees are 33% less productive on average according to several reports*.

This loss of productivity is unacceptable at Advanced Clinical. We want to give you your dream team.

This costs companies a lot of money, risk, and time. Several studies* have been performed on the linkage among team building, team cohesion, and team performance. An integrated team will achieve improvements in performance by developing the right "Team Culture" and adopting the behaviors needed to support and reinforce that culture. A strong Team Culture leads to reduction of waste, duplication, unnecessary processes and procedures. Most importantly, team culture leads to the willingness to succeed.

To keep clinicians and consultants in the loop with your project, Advanced Clinical has built a "Team Integration Method." Our method succeeds in creating a completely harmonized team, whether working on-site or off-site to ensure maximum employee engagement, productivity and overall performance.

Advanced Clinical believes our consultants should be "close" with not only their colleagues on a project, but the project managers and your colleagues as well. Bonding exercises and introductions take place before our clinical trials. Mutual respect and complete communication is ongoing to keep workplace karma good, and, ultimately, to ensure successful trials completion. Goal setting keeps their eyes on the prize, and personality awareness makes better working relationships.

Does this sound like a good way to advance discoveries? We think it is. Enter our “How do you advance discoveries” contest and your company could be mentioned in our press release.

Enter today.

See www.advancedclinical.com

*Sources:

Bloom, G. A., Stevens, D. E., and Wickwire, T. L. (2003). Expert coaches’ perceptions of team building. Journal of Applied Sport Psychology. 15: 129-143.
Crron, A.V., Brawley, L.R., and Widmeyer, W. N. (1985). The Group Environment Questionnaire.
Carron, A.V., Bray, S.R., and Eys, M.A. (2002).Team cohesion and team success in sport. Journal of Sports Sciences, 20, 119-126.
Dirks, K.T. (2000). Trust in leadership and team performance: evidence from NCAA basketball. Journal of Applied Psychology, 85(6) 1004-1012.
Ebbeck, V. and Gibbons, S. L. (1998). The effect of a team building program on the self-conceptions of grade 6 and 7 physical education students. Journal of Sport and Exercise Psychology, 20; 300-310.
Everett, J. J., Smith, R. E., and Williams, K.D. (1992). Effects of team cohesion and identifiably on social loafing in relay swimming performance. International Journal of Sport Psychology. 23: 311-324.
Kozub, S.A. & Button, C.J. (2000). The influence of a competitive outcome on perceptions of cohesion in rugby and swimming teams. International Journal of Sport Psychology. 31: 82-95.
Landers, D. M. and Luschen, G. (1974). Team performance outcomes and the cohesiveness of competitive coacting groups. International Review of Sports Sociology. 5: 57-69.
Martin, R. and Davids, K. (1995). The effects of group development techniques on a professional athletic team. The Journal of Social Psychology, 135 (4) 533-535.
Meyer, B.B., Wenger, M.S. (1998). Athletes and adventure education: An Empirical Investigation. International Journal of Sport Psychology, 29, 243-266.
Murphy, J. M. (2001). The effect of a one-time team building exercise on team cohesion.
Sencecal, J., Loughead, T.M., and Bloom (2008). A season-long team-building intervention: examining the effect of team goal setting on cohesion. Journal of Sport & Exercise Psychology, 30, 186-199.

Advanced Clinical launches “How Do You Advance Discoveries?” contest

2010-04-05T18:38:00.000-07:00

Shorten clinical trials. Reduce risk. Reduce cost! We need YOUR ideas!

Eighty billion drugs are predicted to come off patent in the next three years. While some say this release of patents may save money for the healthcare system as a whole because generics will take the place of those coming off patent, there is no replacement for many drugs and there are patients that need these drugs. As a result, Pharmaceuticals and Biotech companies have two key imperatives:

“Advance discoveries”, aka, reduce clinical trial timelines
Reduce the escalating costs and risks associated with drug development

A recent article in the Wall Street Journal “Clinical Trial Death Watch” (March 16th 2010) echoes these imperatives. The message from the Wall Street Journal article is: there is a resounding need for efficiency and effectiveness to accelerate clinical trials. Even the government is trying to help with the acceleration of clinical trials. One recent study focused on collaboration. There are, however, still many complex issues that create barriers to realizing these imperatives. See, Forbes (March 26th, 2010 “Research and Markets: Investigating Clinical Trial Costs“).

Advanced Clinical wants to offer pharmaceutical, biotechnology and medical device companies a chance to be in our press release by answering the question: "How do you accelerate a clinical trial"?

Is it by ensuring strong team chemistry/integration; using robust communication methods, etc? Is it something else? Advanced Clinical would like your ideas to create Industry Leading Trial Performance in clinical research.

Let us know how you advance discoveries here. If you win, your ideas will be part of our press release in the beginning of August! The winning list of ideas will be posted on August 1st, 2010.

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How do you advance discoveries?

For winning list announcement, you can follow Advanced Clinical on facebook or on one of our social networks:

http://www.facebook.com/pages/Advanced-Clinical/310724322038?ref=search&sid=1468411198.3440133258..1
http://twitter.com/AdvClinical
http://youtube.com/AdvancedClinical
http://AdvancedClinical.blogspot.com
http://AdvancedClinical.wordpress.com

See www.advancedclinical.com