Advanced Clinical Forms Scientific and Medical Affairs Division

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.

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

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

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

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

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

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:

1. While emerging markets are a focus, the largest focus is organic and inorganic growth in China
2. Leadership cultivation and networks is a new initiative in the biotechnology industry
3. 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
4. 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
5. 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

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

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

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

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 http://www.advancedclinical.com