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

June 2, 2011

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).

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Recap of San Francisco Healthcare Conferences

January 26, 2011

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

December 14, 2010

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

October 29, 2010

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

October 27, 2010

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


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

September 30, 2010

 

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

September 27, 2010

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.”

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