Arm Your Business With the Market Intelligence it Needs

2019 Biologics Market Report & CDMO Pricing Study

Data collection from 100 biopharmaceutical CDMOs
Primary data from one-on-one interviews with KOLs
CDMO pricing on all common line items that is typically impossible to find
Validate what you think you know about the market
Give your sales team the intelligence they need

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Global Compliance

How does your company manage to provide local services/support while still efficiently managing global compliance?

Regulatory Harmonization

What do you identify as the greatest advances that have been achieved in recent years with respect to harmonization of pharmaceutical regulations?

Ethical Practice

Given the ongoing evolution of the pharma industry today, how does your organization incorporate ethical concerns into your business practices?

Artificial Intelligence

What do you believe the role of artificial intelligence and other advanced technologies will be in driving the development of the pharmaceutical industry over the next decade?

Innovative Technologies

What innovative technologies had the greatest impact on your company this year? What were the impacts?

Roundtable Topics

Global Compliance

Regulatory Harmonization

Ethical Practice

Artificial Intelligence

Innovative Technologies

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Alcami aims to be “Connected at Every Level,” and our compliance and quality team members work every day to help us deliver that vision. Like all cGMP companies in the CDMO industry, we host many external and internal audits every year. Our risk-based approach promotes the internal review of activities across all systems, processes and facilities, while concurrently managing a high volume of external audits, which can range from paper assessments to full-scale mock pre-approval inspections. Alcami’s corporate regulatory and compliance team works in concert with site-based quality, compliance and leadership teams to support these audits and maintain a constant state of inspection readiness. Operational resource talent pools are leveraged across the Alcami network to tackle opportunities and potential concerns with a holistic approach.

Joseph Payne
Vice President, Regulatory Affairs & Compliance, Alcami

RxGen is a preclinical contract research organization with global reach that offers specialized nonhuman primate models in ophthalmic, CNS and other prevalent disease conditions, with broad experience in small molecule, biologics and gene therapy candidate evaluation. RxGen partners to achieve the development objectives of sponsors in North America, Europe and Asia and complies with international animal research, regulatory and shipping guidelines, and all of those that apply within respective regions. RxGen’s commitment to efficiently conducting resource-intensive research with the objective of improving the lives of patients is inherently a heavily social activity, built on positive relationships maintained at a local level within immediate communication and execution time frames. This includes the physical communities in which RxGen directly works and our emulating the qualities of local-level connectivity in our engagement with clients at distant sites, allowing RxGen to act as an extension of their labs. Our mission is to drive substantial gains in R&D productivity in serving the diverse needs of the biomedical research community globally. Critical to that capability is bringing immediate, first-hand know-how to demands that are specific to a given project and location –– an expertise we have achieved through working long and effectively within local and global compliance standard and managing the logistical dependencies associated with multi-site science.

Matthew Lawrence
Chief Executive Officer and Chief Scientific Officer of RxGen

Isofol is currently advancing lead developmental candidate arfolitixorin in a global phase III clinical study in patients with metastatic colorectal cancer treated in the first line. With trial sites in the United States, Canada and Europe, we have to be keenly aware of maintaining global compliance throughout the process of designing and executing the trial. We have worked closely with regulatory agencies, as well as top oncology experts from each of these regions, to ensure that we have accounted for as many potential concerns as possible, including regulatory differences and variances in existing standard of care to make sure that this process is as smooth as possible. We also have regular dialogue with individual trial sites in local regions to ensure that all their trial planning, enrollment and execution needs are met.

Anders Rabbe
Chief Executive Officer of Isofol Medical

Catalent provides customized regulatory services for customers utilizing our contract development and manufacturing services. Compliance is interwoven into the regulatory support we provide. Whether Catalent authors applicable sections of a customer’s dossier or supports its generation, the customer provides us the applicable sections of the dossier for review and comment prior to submission, ensuring that the regulatory documentation accurately reflects the development history, Catalent’s manufacturing process and applicable Health Authority requirements. Regulatory affairs specialists also review proposed changes to assess which products are affected and the type of regulatory reporting that will be required for the change, prior to it being implemented. We have regulatory affairs experts in various regions to help evaluate the impact of any regulatory changes for the jurisdiction in which a product is registered. Our CDMO regulatory affairs organization stays current with regulatory requirements through the experience of supporting numerous customers. Additionally, we have a dedicated regulatory intelligence team, which shares information throughout Catalent, so we can transform the information into actionable plans to mitigate risk. It is to our advantage to be well informed so we can identify opportunities and optimize product development to deliver successful outcomes for customers and the patients we all serve.

Veda K. Walcott
Vice President, Global Regulatory Affairs & Compliance, Catalent

As the world of pharmaceuticals rapidly advances, it is more important than ever to manage both local services and global compliance. We are developing a corrective eye drop for presbyopia, also known as age-related farsightedness, which affects more than 1.8 billion people globally. Our goal is to bring a convenient and on-demand solution to these people in our local community and other regions of the world. We have designed a strategic path forward to navigate the local and global regulatory and compliance landscape. More than 115 million people in the United States are affected by presbyopia and that number will increase to over 130 million in the next 10 years. We want to bring a pharmaceutical solution to these people and that’s why it’s incredibly important for us to understand the U.S. market and regulatory path. After successfully completing phase IIa studies locally in Israel, we started testing our product candidate in a phase IIb clinical study across several states in the United States.

Elad Kedar
Chief Executive Officer of Orasis Pharmaceuticals

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As a Belgian biotech company running global clinical trials advancing treatments intended to reach multiple major world markets, synchronizing regulatory bodies, including the U.S. Food and Drug Administration (FDA), the EMA and Belgium’s Federal Agency for Medicines and Health Products (FAMHP), is of the utmost importance to our business. A major advancement in recent years is increased harmonization between these agencies, especially on rapid regulatory approval of production and process updates with therapies tested globally. A good example of such harmonization is the simultaneous approval by both the FDA and FAMHP to use our new proprietary OptimAb manufacturing process for our NKG2D-based CAR-T cell therapies CYAD-01 and CYAD-02. This dual approval allows smooth transition of this innovation from the laboratory to the clinic to ensure that we offer the most advanced solution to patients involved in our clinical trials worldwide. Synchronizing global regulators ultimately benefits the patient by allowing innovative companies to provide clinical trial sites around the world with the most up-to-date products.

Filippo Petti
Chief Executive Officer, Celyad

Speed and ease of communication has resulted in real global participation. Formal and informal groups are easily developed across the industry to facilitate open communication and knowledge sharing. Communication tools are readily available to enable this participation, and the result is real harmonization of pharmaceutical regulations. Scientific consensus on innovative advancements can be reached quicker due to the ability to easily communicate on a global scale and the willingness of regulatory and industry experts to openly share information. And harmonized guidelines are more readily adopted when the community has the opportunity to participate during the development of technical documents.

Daniel G. Lachapelle
PE, Regional Leader, CRB

MilliporeSigma welcomes the harmonization of regulations, which makes it easier to operate as a global life science business. On the other hand, we still see different local interpretations of global regulations, which can make things more complicated for our worldwide supply chain.

Robert Nass
Head of Quality & Regulatory Management at MilliporeSigma

Our ability to leverage data and work done in one jurisdiction to support regulatory approval in another to bring lifesaving biotherapeutics to market faster is certainly a big step forward. Regulatory agencies worldwide seem to use technology to enhance speed in moving drugs from application to approval. They also seem to be more receptive than ever to industry input, especially where they have a lack of internal expertise, such as new regulations around use of artificial intelligence as either a manufacturing or clinical enhancement. Hopefully, regulators will continue this momentum of cross-agency collaboration.

Christian Krautkramer, Senior Counsel & Head of Ethics and Compliance for Life Sciences, GE Healthcare

International agencies, such as the World Health Organization (WHO) or the International Organization for Standardization (ISO), have developed important initiatives over the years to advance global harmonized medical device regulations. The ISO has published a set of voluntary international standards, extensively adopted both at regional and national levels, in relation to product development, manufacturing, quality assurance and control to provide the different governments with a technical base for health, safety and environmental requirements. The WHO has similarly published international guides to help member states develop internationally compatible regulations. At Check-Cap, we are constantly monitoring and adopting to these initiatives and guidelines to ensure that our product is being held to the highest standards in terms of patient safety, product quality and global compliance and to ensure that patients from multiple countries can access and benefit from our C-Scan technology.

Alex Ovadia
Chief Executive Officer of Check-Cap

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The biopharma sector has been growing incredibly fast over the past few years. Biologics are now the fastest growing class of therapeutics in the world, with the market growing at 7–8% in the United States and Europe and around 18% in India and China. However, there are still some major challenges around affordability and access that need to be tackled before biologics become a realistic treatment option globally. Most of the manufacturing capacity is still located in the traditional Western markets, and we need to develop fast, flexible and cost-efficient manufacturing solutions that spread biologics production more evenly, as a local presence has a central role in driving the increased availability of these treatments.

Olivier Loeillot
Senior VP, BioProcess, GE Healthcare

Transparency is the best policy. I learned from a consultant that, if you want to set yourself apart from your competition, you need to identify what people hate about your industry, and then find ways to correct that problem within your organization. We know people hate negative surprises like delays and out-of-control costs, and just not knowing the status of their projects. That happens a lot with other CMOs.

Ed Price
CEO, SEQENS North America CDMO (previously PCI Synthesis)

The pharmaceutical industry is continually evolving — from laboratory and research advances in life sciences to the rapidly expanding use of new technologies such as artificial intelligence, advanced analytics and robotics. The one thing that has remained constant is our mission — to enable our customers to make the world healthier, cleaner and safer. This is the foundation for all that we do. We offer integrated solutions that help our customers bring medicines to the market.

Franco Negron
President, Commercial Operations, Thermo Fisher Scientific, Pharma Services

Catalent formally introduced a corporate responsibility commitment in 2017 that cements our belief that ethical business practices are essential to fulfilling Catalent’s mission of helping people live better, healthier lives. Our corporate values, including integrity and ethics, are at the foundation of our culture.

Shannon Trilli
Director of Corporate Responsibility, Catalent

As a company, SGS takes ethics very seriously and conducts itself to the highest standard of professional behavior. The SGS Code of Integrity defines the main principles of professional integrity for the organization, and all staff — from the senior management to entry-level employees — must complete the corporate integrity training program each year.

Jessica Martin
Global Head of Marketing, SGS

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We are at a pivotal time in the pharmaceutical industry — advancing technologies, including the use of advanced analytics and artificial intelligence are transforming the development and manufacturing of new medicines. Analytics, using the enormous data sets generated by drug development, are being used to develop systems that have the potential to predict the properties of new drug candidates.

Franco Negron
President, Commercial Operations, Thermo Fisher Scientific, Pharma Services

AI is poised to play an increasingly important role, as the pharmaceutical industry understands itself more and more as a data- and knowledge-intensive enterprise — and as it engages in the full “healthcare package” of prevention, diagnosis, personalized treatment and maintenance.

Andreas Persidis, Ph.D.
Co-founder and CEO, Biovista Inc. & President, Hellenic BioCluster

We believe that artificial intelligence (AI) and machine learning will play an increasingly important role in the diagnosis and prediction of disease — and will eventually become part of routine practice.

Ben Newton
Chief Digital Officer, GE Healthcare Life Sciences

AI and robotics will help with analytics. The science we help clients with is getting increasingly complex, which means that the demand for increasingly sophisticated equipment, technology and training will continue to be important. We’re constantly evaluating new equipment and approaches to see if they can handle the complexity, speed up processes and reduce overall costs.

Ed Price
CEO, SEQENS North America CDMO (previously PCI Synthesis)

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Colorcon continues to provide solutions for pharmaceutical technology and manufacturing trends to meet the industry needs for coating flexibility and productivity while addressing patient adherence by making tablets easier to swallow.

Ali Rajabi-Siabhoomi, Ph.D.
Vice President/Chief Scientific Officer, Colorcon

The low cost and availability of IoT (internet-of-things) technology continues to have a significant impact on our company this year. Snapdragon develops chemical manufacturing processes that rely on the integration of a wide range of mechanical and electronic components. We use IoT technology to coordinate the working of complex flow systems. We are also able to continuously harvest rich data sets from these systems with IoT-enabled sensors and process analytical technologies (PAT). This combination of automated equipment and sensors in our laboratory systems enables automated experimentation. We can rapidly perform large numbers of experiments and gather incredibly rich data sets from every experiment. This capability delivers much greater process knowledge and leads to more rapid process development and ultimately more efficient and controlled processes for drug substance and fine chemical manufacturing.

Matthew M. Bio, Ph.D.
President and CEO, Snapdragon Chemistry, Inc.

Green chemistry is at the forefront of minds within the chemical industry, and utilizing our enzyme technology is becoming the norm rather than the exception. Within Arran Chemical Company (acquired by Almac in 2015), our AdaPT (Arran Deploys Advanced Product Technologies) strategy and through a multi-million Euro investment and application of our selectAZyme™ technology, we have remained at the forefront of innovation to ensure our customers receive best-in-class solutions. Our team has researched more than 30 projects in the last year involving multi-disciplinary research on enzyme optimization and chemical process design. Another key milestone was winning the Irish Industrial Chemistry Award for the achievement of complete commercialization of an enzyme immobilization process involved in a medical device destined for the U.S. market.

Michael Cannarsa, Ph.D.
Director of North American Business Development, Almac

As a busy CDMO, we are always looking for new opportunities to expand our toolbox, and this year was no different. There are several reasons for this. The first is to make development of cGMP materials faster, cheaper and more efficient for our sponsors. To that end, we carefully evaluate new technology exhibited at the industry meetings we attend. For example, this year we have augmented our capabilities in cryogenics, micronization, large-scale chromatography and lyophilization, to name just a few.

Ed Price
President and CEO, PCI Synthesis

Although continuous flow has been utilized in similar industries for over a century, the pharmaceutical industry has been slow to adopt this technology for a variety of historical and regulatory reasons.

Shawn Conway, Ph.D.
Director of Engineering, R&D, Cambrex

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