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.

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

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

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).

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.

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