Advanced Clinical Forms Scientific and Medical Affairs Division

June 10, 2011

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


Partnerships in Clinical Trials – Conference Highlights

April 6, 2011

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:

1. New revenue
2. R&D productivity
3. 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:

1. 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”)
2. 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

March 17, 2011

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

March 3, 2011

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